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REPORTABLE

IN THE SUPREME COURT OF INDIA

CIVIL APPELLATE JURISDICTION

CIVIL APPEAL Nos. 2706-2716 OF 2013 (ARISING OUT OF SLP(C) Nos. 20539-20549 OF 2009)

NOVARTIS AG        ….APPELLANT

VERSUS

UNION OF INDIA & OTHERS ….RESPONDENTS  

WITH    

CIVIL APPEAL No. 2728 OF 2013 (ARISING OUT OF SLP(C) No. 32706 OF 2009)

NATCO PHARMA LTD.                       ….APPELLANT

VERSUS  

UNION OF INDIA & OTHERS             ….RESPONDENTS  

AND

CIVIL APPEAL Nos. 2717-2727 OF 2013

(ARISING OUT OF SLP(C) Nos.  12984-12994 OF 2013) SLP(C)………../2011 CC Nos.6667-6677

M/S CANCER PATIENTS  AID ASSOCIATION   ….APPELLANT

Versus

UNION OF INDIA & OTHERS  ….RESPONDENTS

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J U D G M E N T

Aftab Alam, J.

1. Delay condoned.

2. Leave granted in all the special leave petitions.

3. What  is the true import  of  section 3(d) of  the Patents  Act,  1970?  How does it  

interplay with clauses (j) and (ja) of section 2(1)? Does the product for which the appellant   

claims patent qualify as a “new product” which comes by through an invention that has a  

feature that involves  technical advance over the existing knowledge and that makes the   

invention “not obvious” to a person skilled in the art?  In case the appellant’s product  

satisfies the tests and thus qualifies as “invention” within the meaning of clauses (j) and  

(ja) of section 2(1), can its patentability still be questioned and denied on the ground that  

section 3(d) puts it out of the category of “invention”? On the answer to these questions  

depends whether the appellant is entitled to get the patent for the beta crystalline form of a   

chemical  compound called  Imatinib  Mesylate  which  is  a  therapeutic  drug  for  chronic  

myeloid leukemia and certain kinds of tumours and is marketed under the names “Glivec”  

or “Gleevec”.

4. These questions were debated at the bar intensely and at great length. The debate  

took  place  within  a  very  broad  framework.  The  Court  was  urged  to  strike  a  balance  

between the need to promote research and development in science and technology and to  

keep private  monopoly (called an ‘aberration’  under  our  Constitutional  scheme) at  the  

minimum. Arguments were made about India’s obligation to faithfully comply with its  

commitments  under  international  treaties  and  counter  arguments  were  made to  protect  

India’s status as “the pharmacy of the world”. The Court  was reminded of  its  duty to

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uphold the rights granted by the statute, and the Court was also reminded that an error of  

judgment  by  it  will  put  life-saving  drugs  beyond the  reach of  the  multitude  of  ailing  

humanity not only in this country but in many developing and under-developed countries,  

dependent on generic drugs from India. We will advert to these and a number of other  

arguments at their proper place but we must first take note of the facts that give rise to the  

above questions and provide the context for the debate.

5. Jürg  Zimmermann invented  a  number  of  derivatives  of  N-phenyl-2-  pyrimidine-

amine,  one  of  which  is  CGP  571481 in  free  base  form (later  given  the  International  

Nonproprietary Name ‘Imatinib’ by the World Health Organisation). These derivatives,  

including Imatinib2,  are capable of  inhibiting certain protein kinases,  especially  protein  

kinase C and PDGF (platelet-derived growth factor)-receptor tyrosine kinase and thus have  

valuable  anti-tumour  properties  and  can  be  used  in  the  preparation  of  pharmaceutical  

compositions  for  the treatment  of  warm-blooded animals,  for  example,  as  anti-tumoral  

drugs and as drugs against atherosclerosis. The N-phenyl-2-pyrimidine-amine derivatives,  

including Imatinib, were submitted for patent in the US. The application was made on  

April 28, 1994 and patent was granted on May 28, 1996 under US Patent No. 5,521,184  

(hereinafter referred to as ‘the Zimmermann Patent’). The Zimmermann compounds (i.e.,  

derivatives of N-phenyl-2-pyrimidine-amine) were also granted a European patent under  

Patent No. EP-A-0 564 409.

6. The appellant  claims that  beginning with Imatinib3 in free base form (as the ‘e-

duct’), in a two-stage invention they first produced its methanesulfonic acid addition salt,  

Imatinib Mesylate, and then proceeded to develop the beta crystalline form of the salt of  

1  4-(4-methylpiperazin-1–ylmethyl)-N-[4-methyl-3-(4-pyridin-3-yl)pyrimidin-2-ylamino)phenyl] benzamide. 2  Ibid 3  Ibid

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Imatinib. According to the appellant, starting from Imatinib free base they could reach to  

the beta crystal form of Imatinib Mesylate in two ways: one “by digesting another crystal  

form,  especially  the  alpha  crystal  form,  or  an  amorphous  starting  material  of  the  

methanesulfonic  acid  addition  salt  of  compound  of  formula  I  …”;  and  second  “by  

dissolving another crystal form, especially the alpha crystal form, or an amorphous starting  

material  of  the  methanesulfonic  acid  addition  salt  of  compound  of  formula  I…”.  

Describing the different processes, step by step, for producing Imatinib Mesylate starting  

from Imatinib,  it  is  stated  that  in  the  first  process  they  would  first  arrive  at  Imatinib  

Mesylate in amorphous form, as the intermediate stage, and thereafter, following further  

processes, reach the beta crystal form of Imatinib Mesylate. Following the second process,  

they  would  reach  the  beta  crystal  form  of  Imatinib  Mesylate  directly,  skipping  the  

intermediate stage in which Imatinib Mesylate first appears in amorphous form. In the third  

process, they would start with the alpha crystal form of Imatinib Mesylate and arrive at its  

beta crystal form.  

7. It was stated in course of submissions, however, that for practical purposes, the best  

way to produce the beta form is by proceeding directly from the free base form to the beta  

form, as in examples 2 and 3 given below, by introducing a specified amount of the beta  

crystals at the step specified.  The three processes are described by the appellant under the  

following three examples:                  

EXAMPLE – 1  1   

Step 1- 98.6 gms of Imatinib free base is added to 1.4 liters of ethanol.

Step 2 - To the above, 19.2 gms of methanesulfonic acid is added drop wise for over  

1  Examples 1 to 3 stated below are reproduced from the written notes titled “Novartis  Document – XIV: Examples in  1602/MAS/1998  (Subject  Patent  Specification),  submitted  by  Mr.  Subramanium,  Senior  Advocate  appearing  for  the  appellant in course of hearing on September 20, 2012.

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20 minutes.  

Step 3 - Solution obtained in Step 2 is heated under reflux (i.e. boiling).  It is heated in  a  manner  to  preserve  the  solution  from escaping  as  a  gas,  so  the  gas  is  captured, condensed and obtained as a liquid. This solution is heated for 20  minutes.  

Step 4 -   Filtering  the  solution  –  the  filtrate  (which  is  obtained  after  filtering  the  resulting liquid) is evaporated down to 50%. In other words, half of the filtrate  is allowed to vaporize.  

Step 5 - Residue is again filtered at 25 degrees Celsius.

Step 6 - Mother liquor (the liquid filtrate of step 5) is evaporated to dryness.  

Step 7 - Residue obtained after Step 6, and residue obtained after Step 5 are suspended  in 2.2 l ethanol.  

Step 8 - The suspension obtained after Step 7 is dissolved under reflux and it becomes  clear upon heating. Thereafter, 30 ml water is added to it.  

Step 9 - Substance is cooled overnight to 25 degrees Celsius, filtered and dried at 65  degrees  Celsius,  until  weight  is  constant.  This  results  in  alpha  crystalline  form.

Step 10 - Alpha form is stirred in methanol for two days at about 25 degrees Celsius.  Then  the  crystals  are  isolated  by  filtration  and  dried  overnight  at  room  temperature. This results in beta crystalline form.  

EXAMPLE – 2

Step 1 - 50 gms of Imatinib free base is added to 480 liters (sic milliliters!) of methanol.  

Step 2 - To the above, 9.71 gms of methanesulfonic acid and 20 ml methanol is added.  This mixture (sic is heated) at 50 degrees Celsius.  

Step 3 - To the solution obtained from Step 2, 5 gms of activated carbon is added and  the mixture is boiled for 30 minutes under reflux, filtered and evaporated.

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Step 4 - The residue obtained from Step 2 (sic 3) is dissolved in 150 ml methanol and  inoculated (introduced) with a few mgms (sic mg) of beta form of imatinib  mesylate leading to crystallization of the product.  

Step 5 - The product is  dried at  50 megabars (unit  to measure pressure)  and at  60  degrees  Celsius.  This  leads  to  crystallization  of  beta  form  of  imatinib  mesylate.  

Step 6 - The  retention  values  (distance  traveled  by  each  chemical  component  in  relation to the distance the solution front moves) obtained are as follows;

Methylene  chloride:  ethyl  acetate:  Methanol:  concentrated  aqueous  ammonium hydroxide solution = 6:10:30:2 (sic 60:10:30:2)

Step 7 - To the above,  High Pressure Chromatography (technique for  separation of  mixtures) is applied for 10.2 minutes

EXAMPLE – 3  

Step 1 - 670 gms of alpha form of imatinib mesylate is heated in 1680 ml of methanol.  

Step 2 - The solution obtained from Step 1 is then inoculated at 60 degrees Celsius  with 55 (sic mg of) beta form of imatinib mesylate. Upon this, the product  starts to crystallize.  

Step 3 - Thereafter, the crystals are dried at 50 megabars and at 100 degrees Celsius.  This leads to crystallization of beta form of imatinib mesylate.  

Step 4 - The  retention  values  (distance  traveled  by  each  chemical  component  in  relation to the distance the solution front moves) obtained are as follows;

Methylene  chloride:  ethyl  acetate:  Methanol:  concentrated  aqueous  ammonium hydroxide solution = 6:10:30:2 (sic 60:10:30:2)

Step 5 - To the above, High Pressure Chromatography is applied for 10.2 minutes.  

[Examples  are  also  given  for  preparation  of  100  mg tablets  and  100  mg  capsules  of  

Imatinib Mesylate but there is no need to go into that at this stage.]

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8. The appellant filed the application (Application No.1602/MAS/1998)1 for grant of  

patent for Imatinib Mesylate in beta crystalline form at the Chennai Patent Office on July  

17, 1998. In the application it claimed that the invented product, the beta crystal form of  

Imatinib  Mesylate,  has  (i)  more  beneficial  flow  properties:  (ii)  better  thermodynamic  

stability; and (iii) lower hygroscopicity than the alpha crystal form of Imatinib Mesylate. It  

further  claimed  that  the  aforesaid  properties  makes  the  invented  product  “new”  (and  

superior!) as it “stores better and is easier to process”; has “better processability of the  

methanesulfonic  acid  addition  salt  of  a  compound  of  formula  I”,  and  has  a  “further  

advantage for processing and storing”.

9. It is significant to note that the comparison of the aforesaid properties of the beta  

crystal  form of Imatinib Mesylate  was made with its  alpha crystal  form. In the patent  

application, there is no claim of superiority of the beta crystal form of Imatinib Mesylate in  

regard to the aforesaid three properties, or any other property, over the starting material  

Imatinib, or even over Imatinib Mesylate in amorphous form or any form other than the  

alpha crystal form. On the contrary, insofar as Imatinib in free base form is concerned, it  

was unambiguously stated in the patent application as under:       

“It  goes  without  saying  that all  the  indicated  inhibitory  and  pharmacological  effects  are  also  found  with  the  free  base,  4-(4- methylpiperazin-1-ylmethyl)-N-[4-methyl-3-(4-pyridin-3-yl)  pyrimidin-2- ylamino)phenyl] benzamide,  or other cells thereof.   The present invention  relates especially to the  β−crystal form of the methanesulfonic acid addition  salt of a compound of formula I in the treatment of one of the said diseases or  in the preparation of a pharmacological agent for the treatment thereto.”

(emphasis added)

10. In fairness to the appellant, however, it should be stated that the application was  

1  The initial application that was filed was for “Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes   for its manufacture and its use”. This application included both the alpha and beta crystalline forms. Later on during the  course of prosecution of the patent application, the claims of the original application were restricted only to the beta form of  Imatinib Mesylate and a separate divisional application no. 799/CHE/04 was filed for the alpha form in 2004.

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made at the time when there was a different patent regime. After the application was made  

and before it was taken up for consideration, a number of amendments were introduced in  

the Indian Patents Act, 1970, which brought about fundamental changes in the patent law  

of the country. The appellant was, however, fully aware of these changes in the law and, in  

order to reinforce its claim for patent for the subject product and to bring its claim within  

the four corners of the changed law, it filed four (4) affidavits of certain experts, two of  

which  stated  that  the  beta  crystal  form  of  Imatinib  Mesylate  has  much  higher  

bioavailability as compared to Imatinib in free base form. In due course, we shall examine  

how far the properties attributed to the subject product in the patent application and the  

affidavits make it “new” and entitled to grant of patent, but for the moment we may note  

how the case has come to the present stage.

11. As noted above the patent application was made on July 17, 1998, giving July 18,  

1997,  the  date  on  which the  appellant  had applied  for  grant  of  patent  for  the  subject  

product in Switzerland, as the “priority date”. On July 18, 1997, Switzerland was not one  

of the “Convention Countries” as defined under section 2 (1)(d) read with section 133 of  

the Act  and it  was notified as a  convention country as  per  section 133 of  the Act  on  

November 30, 1998.

12. In 1997, when the appellant filed its application for patent, the law in India with  

regard to product patent  was in a transitional  stage and the appellant’s application lay  

dormant under an arrangement called “the mailbox procedure”. Before the application for  

patent was taken up for consideration, the appellant made an application (Application No.  

EMR/01/2002)  on March 27, 2002, for grant of exclusive marketing rights (EMR) for the  

subject product under section 24A of the Act, which was at that time on the statute book

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and which now stands deleted. The Patent Office granted EMR to the appellant by order  

dated November 10, 2003.  

13. The  appellant’s  application  for  patent  was  taken  out  of  the  “mailbox”  for  

consideration  only  after  amendments  were  made  in  the  Patents  Act,  with  effect  from  

January 1, 2005. But before it was taken up for consideration, the patent application had  

attracted five (5) pre-grant oppositions1 in terms of section 25(1) of the Act.  And it was in  

response to the pre-grant oppositions that the appellant had filed the affidavits on the issue  

of bioavailability of Imatinib Mesylate in beta crystalline form.  

14. The Assistant Controller of Patents and Designs heard all the parties on December  

15, 2005, as provided under rule 55 of the Patent Rules, 2003, and rejected the appellant’s  

application for grant of patent to the subject product by 5 (five) separate, though similar,  

orders  passed on January  25,  2006 on the  5 (five)  opposition  petitions.  The Assistant  

Controller  held  that  the  invention  claimed  by  the  appellant  was  anticipated  by  prior  

publication, i.e., the Zimmermann patent; that the invention claimed by the appellant was  

obvious  to  a  person  skilled  in  the  art  in  view  of  the  disclosure  provided  in  the  

Zimmermann  patent  specifications;  and  further  that  the  patentability  of  the  alleged  

invention was disallowed by section 3(d) of the Act; and also that July 18, 1997, the Swiss  

priority date, was wrongly claimed as the priority date for the application in India and  

hence,  the  alleged  invention  was  also  anticipated  by  the  specification  made  in  the  

application submitted in Switzerland.   

15. At that time, the appellate authority under the Act had yet to become functional. The  

appellant,  therefore,  challenged  the  orders  passed  by  the  Assistant  Controller  in  writ  

1  The  oppositions  were  made  by  M/s.  Cancer  Patients  Aid  Association  (Respondent  No.  4),  NATCO  Pharma  Ltd.   (Respondent No. 5), CIPLA Ltd. (Respondent No. 6), Ranbaxy Laboratories Ltd. (Respondent No. 7), Hetro Drugs Ltd.  (Respondent No. 8).

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petitions filed directly before the Madras High Court. Apart from challenging the orders of  

the Assistant Controller, the appellant also filed two writ petitions (one by the appellant  

and the other by its Indian power of attorney holder) seeking a declaration that section 3(d)  

of the Act is unconstitutional because it not only violates Article 14 of the Constitution of  

India but is also not in compliance with “TRIPS”. After the formation of the Intellectual  

Property  Appellate  Board,  the  five  writ  petitions  challenging  the  five  orders  of  the  

Assistant Controller were transferred from the High Court to IPAB by order dated April 4,  

2007,  where  these  cases  were  registered  as  appeals  and  were  numbered  as  TA/1  to  

5/2007/PT/CH. The other two writ petitions assailing section 3(d) of the Act were finally  

heard by a Division Bench of the High Court and dismissed by the judgment and order  

dated August 6, 2007. The appellant did not take that matter any further.  

16. The appellant’s appeals against the orders passed by the Assistant Controller were  

finally heard and dismissed by the IPAB by a long and detailed judgment dated June 26,  

2009.

17. The  IPAB  reversed  the  findings  of  the  Assistant  Controller  on  the  issues  of  

anticipation and obviousness. It held that the appellant’s invention satisfied the tests of  

novelty and non-obviousness,  and further that in view of the amended section 133, the  

appellant was fully entitled to get July 18, 1997, the date on which the patent application  

was  made in  Switzerland,  as  the priority  date  for  his  application  in  India.  The IPAB,  

however, held that the patentability of the subject product was hit by section 3(d) of the  

Act. Referring to section 3(d) the IPAB observed:

“Since India is having a requirement of higher standard of inventive step by  introducing the amended section 3(d) of the Act, what is patentable in other  countries will not be patentable in India.  As we see, the object of amended  section 3(d) of the Act is  nothing but a requirement of  higher standard of

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inventive step in the law particularly for the drug/pharmaceutical substances.”

18. The IPAB also referred to the judgment of the Madras High Court, dismissing the  

appellant’s writ petitions challenging the constitutional validity of section 3(d) where the  

High Court had observed:

“We  have  borne  in  mind  the  object  which  the  amending  Act  wanted  to  achieve  namely,  to  prevent  evergreening;  to  provide  easy  access  to  the  citizens of the country to life saving drugs and to discharge their constitutional  obligation of providing good health care to its citizens.”  

19. In light of the High Court’s observation, the IPAB also referred to the pricing of the  

drug Gleevec by the appellant while it enjoyed EMR over it, and held that the patentability  

of the subject product would also be barred by section 3(b) of the Act and in this regard  

observed as follows:

“We are fully conscious of the Appellant’s benevolent GIPAP program for  free  distribution  of  GLEEVEC  to  certain  cancer  patients.  But  as  per  information furnished in its written counter–argument by R 3 that when the  Appellant  was  holding the right  as  EMR on GLEEVEC it  used to  charge  Rs.1,20,000/- per month for a required dose of the drug from a cancer patient,  not disputed by the Appellant,  which in our view is too unaffordable to the  poor cancer patients in India.  Thus, we also observe that a grant of product  patent on this application can create a havoc to the lives of poor people and  their families affected with the cancer for which this drug is effective.  This  will  have  disastrous  effect  on  the  society  as  well.  Considering  all  the  circumstances  of  the  appeals  before  us,  we  observe  that  the  Appellant’s  alleged invention won’t be worthy of a reward of any product patent on  the  basis  of  its  impugned  application  for  not  only  for  not  satisfying  the  requirement of section 3(d) of the Act,  but also for its possible disastrous  consequences on such grant as stated above, which also is being attracted by  the provisions of section 3(b) of the Act which prohibits grant of patent on  inventions,  exploitation of which could create public disorder among other  things (Sic .) We, therefore, uphold the decision of R 8 on section 3(d) of the  Act  to  the  extent  that  product  patent  cannot   be  made  available  to  the  Appellant…”

20. Though agreeing with the Assistant Controller that no product patent for the subject  

patent could be allowed in favour of the appellant, the IPAB held that the appellant could

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not be denied the process patent for preparation of Imatinib Mesylate in beta crystal form.  

The IPAB ordered accordingly.

21. Against the order of the IPAB the appellant came directly to this Court in a petition  

under  Article  136 of  the Constitution.  When the matter  was  first  taken up before this  

Bench, we first thought of dismissing the SLPs at the threshold as the appellant had an  

alternative remedy to challenge the judgment and order of the IPAB before the Madras  

High Court.  However,  Mr.  Gopal  Subramanium, the senior  advocate  appearing for  the  

appellant, submitted that the SLPs were filed on August 11, 2009, and the Court issued  

notice to the respondents on September 11, 2009. Further, before coming to this Bench, the  

matter was listed before another Bench, where it was heard on merits on different dates  

from August  9,  2011  to  September  6,  2011.  Mr.  Subramanium further  submitted  that  

relegating the appellant to the High Court might render the matter infructuous in as much  

as the period for the patent applied for would come to end after 20 years from the date of  

the application, i.e. in July 2018. He submitted that the High Court would take at least 2 –  

3 years before a final decision would be rendered and then, whatever be the High Court’s  

decision, the matter was bound to come to this Court. In this to and fro whatever remains  

of the patent period would also lapse. Mr. Subramanium further submitted that the case  

involved a number of seminal issues and it was in the larger interest that an authoritative  

pronouncement on those issues be made by this Court.

22. Initially  some  of  the  respondents  strongly  opposed  the  maintainability  of  the  

petitions made directly to this Court by-passing the High Court, but in the end all agreed  

that given the importance of the matter, this Court may itself decide the appeals instead of  

directing the appellant to move the High Court. It is in such circumstances that we agreed

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to hear the parties and decide the appeals on merits. However, we, wish to make it clear  

that any attempt to challenge the IPAB order directly before this Court, side-stepping the  

High Court, needs to be strongly discouraged and this case is certainly not to be treated as  

a precedent in that regard.

23. As this Court now proceeds to decide the case on merits, it needs to be noted that  

after notice was issued in the SLPs filed by Novartis AG, all the five parties who had filed  

pre-grant oppositions before the Controller (hereinafter referred to as the Objectors) filed  

their respective counter-affidavits. Two of the Objectors, namely NATCO Pharma Ltd. and  

M/s Cancer Patients Aid Association, additionally filed Special Leave Petition, challenging  

the findings recorded by the IPAB in favour of Novartis AG. Leave to appeal has also been  

granted in all those SLPs, and hence, all the issues are open before this Court and this  

Court is deciding the case unbound by any findings of the authority or the tribunal below.

24. In connection with the case of the appellant, the first and foremost thing that needs  

to be kept in mind is that it  falls in the transitional period between two fundamentally  

different  patent  regimes.  In  1998,  when  the  application  was  made  on  behalf  of  the  

appellant, the Patents Act, 1970, had a provision in section 5 with the marginal heading,  

“Inventions where only methods or processes of manufacture patentable” that barred grant  

of patent to substances intended for use, or capable of being used, as food or medicine or  

drug, or prepared or produced by chemical processes. The application was then put in the  

“mailbox” and was taken out for consideration when many changes had been made in the  

Patents Act, 1970, with effect from January 1, 2005, to make the patent law in the country  

compliant with the terms of an international agreement entered into by the Government of  

India. Following the international agreement, the Patents Act, 1970, was subjected to large

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scale changes in three stages; and finally, by the Patents (Amendment) Act, 2005, section 5  

was altogether deleted from the Parent Act (Patents Act, 1970). Between January 1, 1995  

and January 1, 2005, the Patents Act, 1970, underwent wide ranging changes, but if we are  

asked to identify the single most important change brought about in the law of patent in  

India as a result of the country’s obligations under the international agreement, we would  

unhesitatingly say the deletion of section 5 from the Patents Act, which opened the doors  

to product patents in the country. It is,  however, important to note that the removal of  

section 5 from the statute book was accompanied by amendments in clauses (j) and (ja) of  

section  2(1),  apart  from  some  other  ancillary  clauses  of  section  2(1),  as  well  as  

amendments in section 3, which redefined the concepts of invention and patentability.

25. Some  important  provisions  of  the  Patents  Act,  1970,  as  they  stand  after  the  

amendment of the Act in 2005, and with which we are especially concerned in this case,  

indeed present a problem of interpretation. Why was section 5, which, in one sense, was  

the distinctive feature of the patent law in India, taken off the statute book? What does the  

legislature wish to say through clauses (j) and (ja) of section 2(1), section 3 and several  

other sections? How is it that some of the provisions of the Act apparently seem to be of no  

use  or  purpose,  e.g.,  sections  2(1)(l)  and  2(1)(ta)?  Why is  it  that  some of  the  crucial  

provisions in the Act appear to be wanting in precision and clarity?  

26. It is easy to know why section 5 was deleted but to understand the import of the  

amendments in clauses (j) and (ja) of section 2(1) and the amendments in section 3 it is  

necessary to find out the concerns of Parliament, based on the history of the patent law in  

the country, when it made such basic changes in the Patents Act. What were the issues the  

legislature was trying to address? What was the mischief Parliament wanted to check and

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what were the objects it intended to achieve through these amendments?  

27. The best way to understand a law is to know the reason for it. In Utkal Contractors   

and Joinery Pvt. Ltd. and others v. State of Orissa and others1, Justice Chinnappa Reddy,  

speaking for the Court, said:

“9.  …  A statute is  best  understood if  we know the reason for it.  The  reason for a statute is the safest guide to its interpretation. The words of a  statute take their colour from the reason for it. How do we discover the reason  for  a  statute?  There  are  external  and  internal  aids.  The  external  aids  are  statement of Objects and Reasons when the Bill is presented to Parliament,  the  reports  of  committees  which  preceded  the  Bill  and  the  reports  of  Parliamentary  Committees.  Occasional  excursions  into  the  debates  of  Parliament are permitted. Internal aids are the preamble, the scheme and the  provisions of the Act.  Having discovered the reason for the statute and so  having set the sail to the wind, the interpreter may proceed ahead…”

(emphasis added)

28. Again in  Reserve Bank of India v. Peerless General Finance and Investment Co.   

Ltd. and others2 Justice Reddy said:  

“33.  Interpretation must  depend on the text  and the context.  They are  the  bases of interpretation. One may well say if the text is the texture, context is  what  gives  the  colour.  Neither  can  be  ignored.  Both  are  important.  That  interpretation  is  best  which  makes  the  textual  interpretation  match  the  contextual.  A  statute  is  best  interpreted  when  we  know  why  it  was  enacted. With this knowledge, the statute must be read, first as a whole and  then section by section, clause by clause, phrase by phrase and word by word.  If a statute is looked at, in the context of its enactment, with the glasses of  the  statute-maker,  provided  by  such  context,  its  scheme,  the  sections,  clauses, phrases and words may take colour and appear different than  when the statute is looked at without the glasses provided by the context .  With these glasses we must look at the Act as a whole and discover what each  section, each clause, each phrase and each word is meant and designed to say  as to fit into the scheme of the entire Act. No part of a statute and no word of  a statute can be construed in isolation. Statutes have to be construed so that  every word has a place and everything is in its place.  It is by looking at the  definition as a whole in the setting of the entire Act and by reference to what  preceded the enactment and the reasons for it that the Court construed the  expression 'Prize Chit' in Srinivasa and we find no reason to depart from the  

1  (1987) 3 SCC 279 2  (1987) 1 SCC 424

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Court's construction.” (emphasis added)

29. In order to understand what the law really is, it is essential to know the “why” and  

“how” of the law. Why the law is what it is and how it came to its present form? The adage  

is more true in case of the law of patents in India than perhaps any other law.

30. Therefore, in order to correctly understand the present law it would be necessary to  

briefly delve into the legislative history of the law of patents in the country.       

31. At the time of Independence, India’s patent regime was governed by the Patents and  

Designs Act, 1911, which had provisions both for product and process patents1. It was,  

however, generally felt that the patent law had done little good to the people of the country.  

The way the Act was designed benefited foreigners far more than Indians. It did not help at  

all in the promotion of scientific research and industrialization in the country, and it curbed  

the innovativeness and inventiveness of Indians.

32. Shortly after Independence, therefore, in 1949, a committee was constituted under  

the chairmanship of Justice (Dr.) Bakshi Tek Chand, a retired judge of the Lahore High  

Court, to undertake a comprehensive review of the working of the 1911 Act.  

33. The Committee submitted its interim report on August 4, 1949 and the final report in  

1950 making recommendations for prevention of misuse or abuse of patent rights in India.  

It  also  observed  that  the  Patent  Act  should  contain  a  clear  indication  that  food  and  

medicine and surgical and curative devices were to be made available to the public at the  

cheapest price commensurate with giving reasonable compensation to the patentee. Based  

1 Section 2(8) “Invention” means any manner of new manufacture and includes an improvement and an alleged invention Section 2(10) “Manufacture” includes any art, process or manner of producing, preparing or making an article, and  

also any article prepared or produced by manufacture. Section 14- Term of Patent. (1)The term limited in every patent for the duration thereof shall, save as otherwise   

expressly provided by this Act, be sixteen years from its date.

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on the committee’s recommendations, the 1911 Act was amended in 1950 (by Act XXXII  

of  1950)  in  relation  to  working  of  inventions,  including  compulsory  licensing  and  

revocation of patents. In 1952, a further amendment was made (by Act LXX of 1952) to  

provide for compulsory license in respect of food and medicines, insecticide, germicide or  

fungicide, and a process for producing substance or any invention relating to surgical or  

curative devices. The committee’s recommendation prompted the Government to introduce  

a bill (Bill no. 59 of 1953) in Parliament, but the bill was not pressed and it was allowed to  

lapse.

34. In 1957, another committee came to be appointed under the chairmanship of Justice  

N. Rajagopala Ayyangar to take a fresh look at the law of patent and to completely revamp  

and recast it to best sub-serve the (contemporary) needs of the country1.

35. Justice Ayyangar painstakingly collected valuable data (taking the figures for the  

years 1930 to 1939 from the Bakshi Tek Chand report) and, compiling them into a number  

of tables,2 showed the share of Indians in the field of patents. He analyzed the figures in the  

tables and pointed out that during the period 1930-37, the grant of patents to Indians and  

foreigners was roughly in the ratio of 1:9. Even after Independence, though a number of  

institutions for post-graduate training were set up and several national laboratories were  

established to encourage a rapid growth of scientific education, the proportion of Indian  

and the foreign patents remained substantially the same, at roughly 1:9. Justice Ayyangar  

further pointed out that this ratio does not take into account the economic or industrial or  

scientific  importance of  the inventions.  If  these factors  are taken into account,  Indians  

would appear to be lagging even further behind. Further, taking into reckoning the number  

1  The Bakshi Tek Chand Committee’s (also called Patents Enquiry Committee I) report  and the Ayyangar Committee’s   report are important milestones in the development of the patent law in the country.

2  The different tables compiled in the Justice Ayyangar’s report are put together at one place at the end of this judgment in  Appendix I.

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of inventions for which renewal fees were paid beyond the 6th year, which would give a  

rough idea of the value attached to the invention by the patentee, the patents taken by  

Indians  would  appear  to  be  of  little  worth  as  compared  with  patents  held  by  foreign  

nationals.

36. Justice  Ayyangar  examined  the  nature  of  the  patent  right  and  considered  the  

arguments advanced as justifications/rationalizations for grant of patents. He described the  

patent  law,  in  his  report,  as  an  instrument  for  managing the  political  economy of  the  

country. He observed:

“It  would  not  be  an  exaggeration  to  say  that  the  industrial  progress  of  a  country is considerably stimulated or retarded by its patent system according  as to whether the system is suited to it or not.” (p. 9, para 16)

He also quoted from Michel1 with approval as under:

“* * * Patent systems are not created in the interest of the inventor but in the  interest of national economy. The rules and regulations of the patent systems  are not governed by civil or common law but by political economy.”  

37. Observing  that  industrial  countries  and  under-developed  countries  had  different  

demands and requirements, Justice Ayyangar pointed out that the same patent law would  

operate differently in two countries at two different levels of technological and economic  

development, and hence the need to regulate the patent law in accordance with the need of  

the country. Commenting upon the Patents and Designs Act, 1911, (even after its post–

Independence amendments) Justice Ayyangar said:

“It  is  further  obvious  however  that  the  system would  not  yield  the  same  results when applied to under-developed countries. I entirely agree with the  views of the Patents Enquiry Committee that “the Indian Patent system has  failed in its main purpose, namely, to stimulate invention among Indians and  to  encourage  the  development  and  exploitation  of  new  inventions  for  industrial purposes in the country so as to secure the benefits thereof to the  

1  Michel on Principal National Patent Systems, Vol. I, P.15

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largest section of the public.” (Interim Report, p. 165).

38. Justice Ayyangar observed that the provisions of the Patent law have to be designed,  

with special reference to the economic conditions of the country, the state of its scientific  

and technological advancement, its future needs and other relevant factors, and  so as to   

minimize, if not to eliminate, the abuses to which a system of patent monopoly is capable   

of being put. Bearing in view the matters set above, he recommended retaining the patent  

system, but with a number of improvements.  

39. One of the improvements suggested was to define, with precision, those inventions  

which should be patentable  and equally clearly identify certain inventions, the grant of   

patents to which would retard research, or industrial progress, or be detrimental to the   

national health or well-being, and to make those inventions non-patentable.

40. Justice Ayyangar’s report specially discussed (a) patents for chemical inventions;  

and (b) patents for inventions relating to food and medicine.

41. In regard to patents for chemical substances, he examined the history of the law in  

other countries and pointed out that Germany was the first to adopt the system of confining  

the  patentability  of  inventions  relating  to  chemical  products  or  substances  to  process  

claims. The law was then followed  in many other countries in the world, for instance  

Austria, Brazil, Czechoslovakia, Holland, Hungary, Japan, Mexico, Norway, Poland and  

the U.S.S.R. Products produced by chemical process were not patentable though processes  

for making such products were patentable, if, of course, they satisfied the other tests of  

patentability,  e.g.  novelty,  subject  matter,  etc.  In  light  of  the  experience  of  the  other  

countries, Justice Ayyangar recommended:

“I  have  considered  the  matter  with  the  utmost  care  and have  reached the  conclusion  that  the  chemical  and  pharmaceutical  industry  of  this  country

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would be advanced and the tempo of research in that field would be promoted  if the German system of permitting only process claims were adopted.”

42. Coming next to the patents for  inventions relating to food and medicine,  Justice  

Ayyangar  pointed  out  that  barring  the  US,  there  was  hardly any country that  allowed  

unrestricted grant  of  patents  in  respect  of  articles  of  food and medicines,  or  as  to  the  

licensing and working of patents in this class. In none of the countries of Europe were  

patents granted for product claims for articles of food or medicine, and in a few (Denmark  

for articles of food; and Italy, under the law of 1957, for medicinal products) even claims  

for processes for producing them were non-patentable. He explained that the reason for this  

state of law is stated to be that the denial of product claims is necessary in order that  

important articles of daily use such as medicine or food, which are vital to the health of the  

community,  should  be  made  available  to  everyone  at  reasonable  prices  and  that  no  

monopoly should be granted in respect of such articles. It is considered that the refusal of  

product patents would enlarge the area of competition and thus result in the production of  

these articles in sufficient quantity and at the lowest possible cost to the public.  

43. Justice  Ayyangar  submitted  a  comprehensive  Report  on  Patent  Law Revision  in  

September 1959 and the new law of patent, namely, the Patents Act, 1970, came to be  

enacted mainly based on the recommendations of the report, and came into force on April  

20, 1972, replacing the Patents and Designs Act, 1911.

44. Section 1 of the new Act gave it its name and territorial extent and provided that it   

would  come  into  effect  on  such  date  as  the  Central  Government  may  appoint,  by  

notification in the official  gazette.  Section 2 contained the definition and interpretation  

clauses; it defined the terms “invention” and “medicine” in clauses (j) and (l) respectively

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as under1:

“Section 2(1)(j) “invention” means any new and useful – (i)  art, process, method or manner of manufacture; (ii) machine, apparatus or other article;

(iii)  substance produced by manufacture, and includes any new and useful improvement of any of them, and an alleged  invention. Section 2(1)(l) “medicine or drug” includes – (i) all medicines for internal or external use of human beings or animals, (ii) all  substances  intended to be used for  or  in  the  diagnosis,  treatment,  

mitigation or prevention of diseases in human beings or animals, (iii) all substances intended to be used for or in the maintenance of public  

health, or the prevention or control of any epidemic disease among human  beings or animals,

(iv) insecticides,  germicides,  fungicides,  weedicides  and  all  other  substances intended to be used for the protection or preservation of plants;

(v) all chemical substances which are ordinarily used as intermediates in the  preparation or manufacture of any of the medicines or substances above  referred to.”  

45. Sections  1  and  2  comprised  Chapter  I,  following  which  Chapter  II  was  headed  

“Inventions not patentable”. Chapter II had three sections which, as originally framed, are  

as under:

“Section 3. What  are  not  inventions.– The  following are  not  inventions  within the meaning of this Act,– (a) an  invention  which  is  frivolous  or  which  claims  anything  obviously  

contrary to well established natural laws; (b) an invention the primary or intended use of which would be contrary to  

law or morality or injurious to public health; (c) the  mere  discovery  of  a  scientific  principle  or  the  formulation  of  an  

abstract theory; (d) the mere discovery of any new property or new use for a known substance  

or of the mere use of a known process, machine or apparatus unless such  known process  results  in  a  new product  or  employs  at  least  one  new  reactant;

1  The  provisions  quoted  here  are  as  those  were  enacted  in  the  1970  Act  and  before  those  provisions  underwent  the  amendments with effect from January 1, 2005.

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(e) a  substance  obtained  by  a  mere  admixture  resulting  only  in  the  aggregation of the properties of the components thereof or a process for  producing such substance;  

(f) the mere arrangement or re-arrangement or duplication of known devices  each functioning independently of one another in a known way;

(g) a  method  or  process  of  testing  applicable  during  the  process  of  manufacture  for  rendering  the  machine,  apparatus  or  other  equipment  more  efficient  or  for  the  improvement  or  restoration  of  the  existing  machine, apparatus or other equipment or for the improvement or control  of manufacture;

(h)  a method of agriculture or horticulture; (i) any process  for  the  medicinal,  surgical,  curative,  prophylactic  or  other  

treatment  of  human  beings  or  any  process  for  a  similar  treatment  of  animals  or  plants  to  render  them  free  of  disease  or  to  increase  their  economic value or that of their products.

Section 4. Inventions relating to atomic energy not patentable.– No patent  shall be granted in respect of an invention relating to atomic energy falling  within sub-section (1) of section 20 of the Atomic Energy Act, 1962 (33 of  1962). Section 5. Inventions where only methods or processes of manufacture  patentable.– In the case of inventions– (a) claiming substances  intended for  the use,  or  capable  of  being used,  as  

food or as medicine or drug, or (b) relating  to  substances  prepared  or  produced  by  chemical  processes  

(including  alloys,  optical  glass,  semi-conductors  and  inter-metallic  compounds),  no  patent  shall  be  granted  in  respect  of  claims  for  the  substances  themselves,  but  claims  for  the  methods  of  processes  of  manufacture shall be patentable.”

46. It is significant to note that section 5 in chapter II of the Act expressly excluded  

product patents for substances intended for use and capable of being used as food or as  

medicine or drug, and substances prepared or produced by chemical process, and made  

these substances non-patentable. Section 4 similarly prohibited grant of patent in respect of  

an invention relating to atomic energy. The Act thus clearly recognized and maintained the  

distinction between invention and patentability.

47. We have briefly examined some aspects of the legislative history of the patent law in

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India. We may now take a look at how the Patent and Designs Act, 1911, and the Patents  

Act,  1970,  impacted  the  pharmaceutical  industry  and  the  availability  of  drugs  in  the  

country.

48. Sudip Chaudhuri in his book titled, The WTO and India’s Pharmaceuticals Industry1  

describes the market shares of multi-national companies and Indian companies in India by  

means of a table as under:

Market Shares of MNCs & Indian Companies in the Pharmaceutical Industry in India

Year MNCs (%) Indian Companies 1952 38 62 1970 68 32 1978 60 40 1980 50 50 1991 40 60 1998 32 68 2004 23 77

Sources: For 1952, Pharmaceutical Enquiry Committee 1954, pp. 20 – 1, 61 – 6;

For 1970, Ministry of Petroleum & Chemicals 1971, p. 1;

For 1978, Chaudhuri 1984, p. 176 (based on ORG 1978);

For 1980, 1991, and 1998, Kalsekar 2003;

49. The fall and rise of the Indian pharmaceutical industry is explained as the result of  

certain factors, not the least important of which was the change in the patent law in the  

country,  which  made  medicines  and  drugs  and  chemical  substances  non-patentable.  

Chaudhuri  explains  that  before  the  introduction  of  sulfa  drugs  (1930s)  and  penicillin  

(1940) that brought about the therapeutic revolution, drugs of natural origin were more  

important than synthetic ones.  Also,  medicinal  plants (that  is,  raw materials) for about  

three-fourths of the drugs mentioned in British and other pharmacopoeias actually grew in  

India.  

50. By the time the Second World War started (1939), several indigenous firms were  

1  Chaudhuri, Sudip, The WTO and India’s Pharmaceuticals Industry (Patent Protection, TRIPS, and Developing Countries)  (Oxford University Press, 2005).

Page 24

engaged  in  manufacturing  drugs,  and  indigenous  producers  met  13  per  cent  of  the  

medicinal  requirements of  the country.  They still  had a long way to go to attain self-

sufficiency but in terms of the range of operations they were already manufacturing all  

types of drugs. By the early 1950s, because of the spread of manufacturing activities, the  

indigenous sector dominated the pharmaceutical industry in India. It accounted for about  

62 per cent  of the market in 1952 (the table above).  However,  the rise and growth of  

multinational corporations (MNCs) worldwide in the post-Second World War period, as  

well as the therapeutic revolution changed these dynamics. The MNCs started research for  

developing new drugs in the 1930s-40s. As a result, in the late 1940s and during the 1950s  

and even after  that  at  a slower  rate,  new drugs discovered by the MNCs began to be  

available  for  medical  use.  The  indigenous  sector  was  not  equipped  for  research  for  

developing new drugs, that is, for developing a new chemical entity. With the introduction  

of new drug at a rapid rate by the MNCs, the role of patents became important. Because of  

the  patent  regime  under  the  1911  Act  and  the  unsupportive  industrial  policy,  the  

indigenous sector lost its status in the 1950s and the 1960s. In contrast to 62 per cent of the  

market in the early 1950s, the market share of the indigenous sector declined to 32 per cent  

by 1970. In contrast, the market share of the MNCs increased from 38 per cent in 1952 to  

68 per cent in 1970 (the table above).

51. However,  according  to  Chaudhuri,  the  situation  changed  in  the  1970s.  Several  

official  initiatives  were taken in  the  1970s,  of  which the most  important  one  was the  

enactment  of  the  Patents  Act,  1970,  which changed the  environment  in  favour  of  the  

indigenous sector.  

52. In  regard  to  the  Patents  Act,  1970,  Chaudhuri  maintains  that  Patent  “reforms”

Page 25

contributed directly to the transformation of the pharmaceutical industry. He points out that  

under the Patents Act, 1970, articles of food, medicines and drugs and chemical substances  

could be patented only for a new method or process of manufacture, not for the products as  

such (section 5 of the 1970 Act). Further, unlike in the previous patent regime, for each  

particular drug only one method or process – the best known to the applicant - could be  

patented (sections 5 and 10 of the 1970 Act). Also, even in case of a process patent for an  

article of food, medicine or drug, the term of the patent was brought down from fourteen  

(14) years to five (5) years from the date of sealing of the patent, or seven (7) years from  

the date of patent whichever was earlier.    

53. He then examines the growth of the Indian pharmaceutical industry driven by the  

new patent regime in three phases:

• Till the early 1970s; • The late 1970s and the 1980s; and • Since the 1990s  

54. Till the early 1970s the industry was dominated by MNCs who commanded 68% of  

the market  share.  India was dependent on imports for  many essential  bulk drugs.  This  

import dependence constricted consumption in a country deficient in foreign exchange, and  

inhibited the growth of the industry. Drug prices in India were very high.   

55. In the late 1970s and 1980s, Indian companies started large-scale production of bulk  

drugs.  The  development  of  the  bulk  drugs  sector  is  actually  the  most  important  

achievement of the pharmaceutical industry in India. This led to the transformation of the  

industry.

56. The most rapid growth of the Indian pharmaceutical industry took place from the  

1990s onwards. Both production and exports grew remarkably fast. The production of both

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bulk drugs and formulations started increasing sharply and steadily. From Rs.6,400 million  

in 1989-90, bulk drugs production increased to Rs.77,790 million in 2003-04; and from  

Rs.34,200 million in 1989-90, formulation productions increased to Rs.276,920 million in  

2003-04. The growth was most remarkable from 2000 to 2005, when production increased  

much more than it had in the last two decades.  Indian companies further consolidated their  

domination in the domestic market. Their market share increased from 60 per cent in 1991  

to 68 per cent in 1998 and 77 per cent in 2003.

57. The growth was also very fast in the export markets. India became a net exporter by  

1988-89, and since then there has only been an increase in the Indian exports. As a result,  

net exports as a percentage of exports have increased from 4.4 per cent in 1988-9 to about  

50 per cent in the early 1990s and more than 75 per cent in the early 2000s. More than  

three-fourths of bulk drug production and almost one-fourth of the formulations production  

are exported. The USA, which has the toughest regulatory requirements, has emerged as  

India’s largest export partner in pharmaceuticals.

58. Dealing with the growth of the Indian pharmaceutical industry after the change in  

the patent law, Chaudhuri writes:

“Because of the rapid growth and structural transformation in the last three  decades or so, India now occupies an important position in the international  pharmaceutical industry… India has received worldwide recognition as a low  cost  producer  of  high quality bulk drugs and formulations.  India  produces  about  350  bulk  drugs  ranging  from  simple  pain  killers  to  sophisticated  antibiotics and complex cardiac products. Most of the bulk drugs are produced  from basic stages, involving complex multi-stage synthesis, fermentation and  extractions. For more than 25 bulk drugs, India accounts for more than 50 per  cent of the international trade. India is a major force to reckon with in the  western markets for such drugs as ibuprofen, sulphamethoxasole…”

59. Even as the country’s pharmaceutical industry, helped by the basic changes made in  

the patent system by the Patent Act, 1970, was going from strength to strength, certain

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developments were taking place at the international level that would deeply impact the  

Patent system in the country. Following the Uruguay round of multilateral negotiations  

under the General Agreement on Tariffs and Trade (GATT), the Agreement on Trade-

Related Aspects of Intellectual Property Rights (The TRIPS) was arrived at and it came  

into  force  on  January  I,  1995.  The  TRIPS  Agreement  is  the  most  comprehensive  

multilateral  agreement  to  set  detailed  minimum  standards  for  the  protection  and  

enforcement of intellectual property rights, and aims at harmonizing national intellectual  

property systems. All members of the World Trade Organisation (WTO) are bound by the  

obligations under the TRIPS Agreement.  India is  one of  the founding members of  the  

GATT and thus a member of the WTO from its inception from January 1, 1995, and is  

bound by the obligations under TRIPS Agreement like all other members of the WTO.  

Some of  the  Articles  of  the  Agreement,  which have  a  bearing  on  our  discussion,  are  

reproduced below.

“Article 1 Nature and Scope of Obligations

1. Members shall  give effect  to the provisions  of  this  Agreement.  Members  may,  but  shall  not  be  obliged  to,  implement  in  their  law  more  extensive  protection than is required by this Agreement,  provided that such protection  does not contravene the provisions of this Agreement. Members shall be free to  determine  the  appropriate  method  of  implementing  the  provisions  of  this  Agreement within their own legal system and practice. 2. For the purposes of this Agreement, the term “intellectual property” refers to  all categories of intellectual property that are the subject of Sections 1 through  7 of Part II. 3. xxx

Article 3 National Treatment

1. Each Member shall accord to the nationals of other Members treatment

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no less favourable than that it accords to its own nationals with regard to the  protection1 of intellectual property, subject to the exceptions already provided  in, respectively, the Paris Convention (1967), the Berne Convention (1971), the  Rome  Convention  or  the  Treaty  on  Intellectual  Property  in  Respect  of  Integrated  Circuits.  In  respect  of  performers,  producers  of  phonograms and  broadcasting organizations, this obligation only applies in respect of the rights  provided under this Agreement. Any Member availing itself of the possibilities  provided in  Article 6  of  the  Berne  Convention  (1971)  or  paragraph 1(b)  of  Article 16 of  the Rome Convention shall  make a notification as foreseen in  those provisions to the Council for TRIPS. 2. Members  may  avail  themselves  of  the  exceptions  permitted  under  paragraph 1 in relation to judicial and administrative procedures, including the  designation of an address for service or the appointment of an agent within the  jurisdiction of a Member, only where such exceptions are necessary to secure  compliance  with  laws  and  regulations  which  are  not  inconsistent  with  the  provisions of  this Agreement and where such practices are not  applied in a  manner which would constitute a disguised restriction on trade.

Article 7 Objectives

   The  protection  and  enforcement  of  intellectual  property  rights  should  contribute to the promotion of technological innovation and to the transfer and  dissemination of technology, to the mutual advantage of producers and users of  technological knowledge and in a manner conducive to social and economic  welfare, and to a balance of rights and obligations.

Article 8 Principles

1. Members may, in formulating or amending their laws and regulations,  adopt measures necessary to protect public health and nutrition, and to promote  the public interest in sectors of vital importance to their socio-economic and  technological development, provided that such measures are consistent with the  provisions of this Agreement.  2. Appropriate  measures,  provided  that  they  are  consistent  with  the  provisions  of  this  Agreement,  may  be  needed  to  prevent  the  abuse  of  intellectual  property  rights  by  right  holders  or  the  resort  to  practices  which  unreasonably  restrain  trade  or  adversely  affect  the  international  transfer  of  technology.  

PART II

1  For the purposes  of  Articles  3  and 4,  “protection”  shall  include matters  affecting  the availability,  acquisition, scope,  maintenance  and  enforcement  of  intellectual  property  rights  as  well  as  those  matters  affecting  the  use  of  intellectual   property rights specifically addressed in this Agreement.

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Section 5: Patents

Article 27 Patentable Subject Matter

1. Subject  to  the  provisions  of  paragraphs 2  and  3,  patents  shall  be  available  for  any inventions,  whether  products  or  processes,  in  all  fields of  technology,  provided  that  they  are  new,  involve  an  inventive  step  and  are  capable  of  industrial  application.1 Subject  to  paragraph 4  of  Article 65,  paragraph 8  of  Article 70  and  paragraph 3  of  this  Article,  patents  shall  be  available and patent rights enjoyable without discrimination as to the place of  invention, the field of technology and whether products are imported or locally  produced. 2. Members  may  exclude  from  patentability  inventions,  the  prevention  within their territory of the commercial exploitation of which is necessary to  protect  ordre public or morality, including to protect human, animal or plant  life or health or to avoid serious prejudice to the environment, provided that  such exclusion is not made merely because the exploitation is prohibited by  their law. 3. Members may also exclude from patentability:     (a)    diagnostic,  therapeutic  and  surgical  methods  for  the  treatment  of  humans or animals;      (b)    plants  and  animals  other  than  micro-organisms,  and  essentially  biological processes for the production of plants or animals other  than non- biological and microbiological processes. However, Members shall provide for  the protection of plant varieties either by patents or by an effective sui generis  system or  by any combination thereof.  The provisions  of  this  subparagraph  shall  be reviewed four  years  after  the date  of  entry into force of  the WTO  Agreement.  

Article 28 Rights Conferred

1.    A patent shall confer on its owner the following exclusive rights:     (a) where the subject matter of a patent is a product, to prevent third parties  not having the owner's consent from the acts of: making, using, offering for  sale, selling, or importing2 for these purposes that product;      (b) where the subject matter of a patent is a process, to prevent third parties  not having the owner's consent from the act of using the process, and from the  acts of: using, offering for sale, selling, or importing for these purposes at least  the product obtained directly by that process.  

1   For the purposes of this Article, the terms “inventive step” and “capable of industrial application” may be deemed by a  Member to be synonymous with the terms “non-obvious” and “useful” respectively.

2  This right, like all other rights conferred under this Agreement in respect of the use, sale, importation or other distribution   of goods, is subject to the provisions of Article 6.

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2. Patent  owners  shall  also  have  the  right  to  assign,  or  transfer  by  succession, the patent and to conclude licensing contracts.

PART V Dispute Prevention and Settlement

Article 63 Transparency

1. Laws and regulations, and final judicial decisions and administrative rulings  of general application, made effective by a Member pertaining to the subject  matter of this Agreement (the availability, scope, acquisition, enforcement and  prevention of the abuse of intellectual property rights) shall be published, or  where such publication is not practicable made publicly available, in a national  language,  in  such  a  manner  as  to  enable  governments  and right  holders  to  become acquainted with them. Agreements concerning the subject  matter of  this Agreement which are in force between the government or a governmental  agency of a Member and the government or a governmental agency of another  Member shall also be published. 2. Members shall notify the laws and regulations referred to in paragraph 1 to  the  Council  for  TRIPS in  order  to  assist  that  Council  in  its  review of  the  operation of this Agreement. The Council shall attempt to minimize the burden  on  Members  in  carrying  out  this  obligation  and  may  decide  to  waive  the  obligation  to  notify  such  laws  and  regulations  directly  to  the  Council  if  consultations with WIPO on the establishment of a common register containing  these laws and regulations are successful. The Council shall also consider in  this  connection  any  action  required  regarding  notifications  pursuant  to  the  obligations under this Agreement stemming from the provisions of Article 6ter  of the Paris Convention (1967). 3. Each Member shall be prepared to supply, in response to a written request  from another Member, information of the sort referred to in paragraph 1. A  Member,  having  reason  to  believe  that  a  specific  judicial  decision  or  administrative ruling or bilateral agreement in the area of intellectual property  rights affects its rights under this Agreement, may also request in writing to be  given access  to  or  be  informed in  sufficient  detail  of  such specific  judicial  decisions or administrative rulings or bilateral agreements. 4.  Nothing  in  paragraphs  1,  2  and  3  shall  require  Members  to  disclose  confidential information which would impede law enforcement or otherwise be  contrary to the public interest  or would prejudice the legitimate commercial  interests of particular enterprises, public or private.

Article 64 Dispute Settlement

1. The provisions of Articles XXII and XXIII of GATT 1994 as elaborated and

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applied by the Dispute Settlement Understanding shall apply to consultations  and  the  settlement  of  disputes  under  this  Agreement  except  as  otherwise  specifically provided herein. 2. Subparagraphs 1(b) and 1(c) of Article XXIII of GATT 1994 shall not apply  to the settlement of disputes under this Agreement for a period of five years  from the date of entry into force of the WTO Agreement. 3. During the time period referred to in paragraph 2, the Council for TRIPS  shall examine the scope and modalities for complaints of the type provided for  under  subparagraphs  1(b)  and  1(c)  of  Article  XXIII  of  GATT  1994  made  pursuant to this Agreement, and submit its recommendations to the Ministerial  Conference  for  approval.  Any  decision  of  the  Ministerial  Conference  to  approve such recommendations or to extend the period in paragraph 2 shall be  made only by consensus, and approved recommendations shall be effective for  all Members without further formal acceptance process.

Article 65 Transitional Arrangements

1.    Subject to the provisions of paragraphs 2, 3 and 4, no Member shall be  obliged to apply the provisions of this Agreement before the expiry of a general  period  of  one  year  following  the  date  of  entry  into  force  of  the  WTO  Agreement. 2.    A developing country Member is entitled to delay for a further period of  four years the date of application, as defined in paragraph 1, of the provisions  of this Agreement other than Articles 3, 4 and 5. 3.    Any  other  Member  which  is  in  the  process  of  transformation  from  a  centrally-planned  into  a  market,  free-enterprise  economy  and  which  is  undertaking  structural  reform of  its  intellectual  property  system  and  facing  special problems in the preparation and implementation of intellectual property  laws and regulations, may also benefit from a period of delay as foreseen in  paragraph 2.  4.    To  the  extent  that  a  developing  country  Member  is  obliged  by  this  Agreement to extend product patent protection to areas of technology not so  protectable in its territory on the general date of application of this Agreement  for that Member, as defined in paragraph 2, it may delay the application of the  provisions on product patents of Section 5 of Part II to such areas of technology  for an additional period of five years. 5.    A Member availing itself of a transitional period under paragraphs 1, 2, 3  or 4 shall ensure that any changes in its laws, regulations and practice made  during  that  period  do  not  result  in  a  lesser  degree  of  consistency  with  the  provisions of this Agreement.

Article 70 Protection of Existing Subject Matter

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1 to 6 xxx 7.   In the case of intellectual property rights for which protection is conditional  upon registration, applications for protection which are pending on the date of  application of this Agreement for the Member in question shall be permitted to  be amended to claim any enhanced protection provided under the provisions of  this Agreement. Such amendments shall not include new matter. 8.    Where a Member does not make available as of the date of entry into force  of the WTO Agreement patent protection for pharmaceutical and agricultural  chemical  products  commensurate  with  its  obligations  under  Article 27,  that  Member shall:     (a)    notwithstanding the provisions of Part VI, provide as from the date of  entry into force of the WTO Agreement a means by which applications for  patents for such inventions can be filed;     (b)    apply  to  these  applications,  as  of  the  date  of  application  of  this  Agreement, the criteria for patentability as laid down in this Agreement as if  those criteria were being applied on the date of filing in that Member or, where  priority is available and claimed, the priority date of the application; and     (c)    provide patent protection in accordance with this Agreement as from  the grant of the patent and for the remainder of the patent term, counted from  the filing date in accordance with Article 33 of this Agreement, for those of  these  applications  that  meet  the  criteria  for  protection  referred  to  in  subparagraph (b). 9.    Where a  product  is  the subject  of  a  patent  application in  a  Member  in  accordance with paragraph 8(a),  exclusive marketing rights shall  be granted,  notwithstanding  the  provisions  of  Part VI,  for  a  period  of  five  years  after  obtaining  marketing  approval  in  that  Member  or  until  a  product  patent  is  granted or rejected in that Member, whichever period is shorter, provided that,  subsequent to the entry into force of the WTO Agreement, a patent application  has been filed and a patent granted for that product in another Member and  marketing approval obtained in such other Member.”

60. The Agreement (vide. Part V: Article 64) provides for a mechanism for resolution of  

disputes between the members of  the WTO. In case of  a dispute,  a  panel  of  specially  

appointed trade experts interprets the provisions of the Agreement and issues a report. The  

panel’s decision may be subjected to appeal before the WTO Appellate Body. If a party to  

the decision fails to abide by a decision, the other party can impose trade sanctions on the  

member  in  breach,  upon  authorization  by  the  Dispute  Settlement  Body.  The  dispute

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resolution mechanism in the TRIPS is strong and effective as was proved in the case of  

India herself.

61. Article  65  (sub-articles  1and  2)  allowed  India  to  delay  the  application  of  the  

provisions of the Agreement for a period of 5 years, that is,  till  January 1, 2000; sub-

Article 4 allowed India to delay for a further period of five years, that is, till January 1,  

2005, the application of the provision relating to product patent, in respect of all articles  

excluded  by  the  Patent  Act,  19701,  which  included  pharmaceuticals  and  agricultural  

chemical products. But, Article 70 (sub-articles 8 and 9) enjoined that in the meanwhile it   

should provide for a means by which applications for patents for inventions in respect of  

pharmaceutical and agricultural chemical products could be filed and also for the grant of  

“exclusive marketing rights” for such products. In discharge of its obligations under the  

Agreement, the Government of India promulgated the Patents (Amendment) Ordinance,  

1994 (Ordinance No. 13 of 1994), on December 31, 1994, amending the Patents Act, 1970.  

The Ordinance provided for making “a claim for patent of an invention for  a substance  

itself intended for use, or capable of being used, as medicine or drug” (as required by  

sub-paragraph (a) of Article 70.8 of the TRIPS Agreement) and for the grant of exclusive  

marketing rights with respect to the product that is the subject matter of such a patent claim  

(as required by Article 70.9 of the Agreement). The Ordinance, however, lapsed on March  

26, 1995, on expiration of six weeks from the commencement of the next session of the  

Parliament, without being replaced by any corresponding Act2. The Patents (Amendment)  

Bill, 1995, which was intended to give permanent legislative effect to the provisions of the  1  Section 5 of the Act as before it was amended:

Section 5. Inventions where only methods or processes of manufacture patentable.– In the case of inventions – (a) claiming substances intended for the use, or capable of being used, as food or as medicine or drug, or (b) relating  to  substances  prepared  or  produced  by  chemical  processes  (including  alloys,  optical  glass,  semi-

conductors  and  inter-metallic  compounds),  no patent  shall  be granted  in  respect  of  claims for  the  substances  themselves, but claims for the methods of processes of manufacture shall be patentable.

2  During this brief period, 125 applications for product patents were received and filed.

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Ordinance, was introduced in the Lok Sabha in March 1995. The Bill was passed by the  

Lok Sabha and it was then introduced in the Rajya Sabha where it was referred to a Select  

Committee of the House for examination and report. The Select Committee was unable to  

give its  report before the dissolution of the Lok Sabha on May 10,  1996. The Patents  

(Amendment) Bill, 1995, lapsed with the dissolution of the 10th Lok Sabha.  

62. In this state of the patent law in the country, India was twice taken to the WTO  

panel, first on a complaint by the USA (WT/DS50/AB/R, dated December 19, 1997) and  

the second time on a complaint filed by the European Communities (WT/DS79/R, dated  

August 24, 1998). The complaint by the USA was in regard to the absence, in India, of  

either  patent  protection  for  pharmaceutical  and  agricultural  chemical  products  under  

Article 27 of the TRIPS Agreement, or of a means for the filing of patent applications for  

pharmaceutical and agricultural chemical products pursuant to Article 70.8 of the TRIPS  

Agreement and of the legal authority for the grant of exclusive marketing rights for such  

products pursuant to Article 70.9 of the TRIPS Agreement. The WTO panel returned the  

finding that India had not complied with its obligations under Article 70.8 (a) and, in the  

alternative, paragraphs 1 and 2 of Article 63 and also 70.9 of the TRIPS Agreement. India   

took the matter in appeal. By a decision dated December 19, 1997, the Appellate Body  

affirmed the panel’s findings that India had not complied with its obligations under Article  

70.8(a) and Article 70.9 of the TRIPS Agreement, but set aside the panel’s finding relating  

to the alternative claim by the United States under Article 63 of TRIPS Agreement. In  

conclusion, the Appellate Body recommended “that the Dispute Settlement Body request  

India to  bring its  legal  regime for  patent  protection of  pharmaceutical  and agricultural  

chemical products into conformity with India’s obligations under Article 70.8 and 70.9 of

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the TRIPS Agreement”.

63. In  the  proceedings  arising  from  the  complaint  filed  by  the  United  States,  the  

European Communities were added as the Third Party before the panel and as the Third  

Participant before the Appellate Body. Nonetheless, the European Communities and their  

members filed a similar but separate complaint against India (WT/DS79/R, dated August  

24, 1998). The WTO panel, accepting the complainant’s request, extended the findings in  

the earlier dispute (WT/DS50), as modified by the Appellate Body, to the complaint filed  

by the European Communities and their member States as well. This matter did not go to  

the WTO Appellate Body.

64. The TRIPS Agreement also provides for a built-in mechanism for review through  

the biennial Ministerial Conference (vide Article 71). The Ministerial Conference is the  

highest decision-making body of the WTO and it can make decisions on all matters under  

any  of  the  WTO  agreements,  including  the  TRIPS  Agreement.  The  fourth  WTO  

Ministerial Conference in Doha on November 14, 2001, adopted the Doha Declaration on  

the TRIPS and Public Health. The Doha Declaration is as follows:   

“1. We recognize the gravity of the public health problems afflicting many  developing  and  least-developed  countries,  especially  those  resulting  from  HIV/AIDS, tuberculosis, malaria and other epidemics.  2. We stress the need for the WTO Agreement on Trade-Related Aspects  of  Intellectual  Property  Rights  (TRIPS Agreement)  to  be  part  of  the  wider  national and international action to address these problems. 3. We recognize that intellectual property protection is important for the  development  of  new  medicines.  We  also  recognize  the  concerns  about  its  effects on prices. 4. We agree that the TRIPS Agreement does not and should not prevent  members from taking measures to  protect  public health.  Accordingly,  while  reiterating  our  commitment  to  the  TRIPS  Agreement,  we  affirm  that  the  Agreement  can  and  should  be  interpreted  and  implemented  in  a  manner  supportive of WTO members' right to protect public health and, in particular, to  promote access to medicines for all.

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In this connection, we reaffirm the right of WTO members to use, to the full,  the  provisions  in  the  TRIPS  Agreement,  which  provide  flexibility  for  this  purpose. 5. Accordingly and in the light of paragraph 4 above, while maintaining  our commitments in the TRIPS Agreement, we recognize that these flexibilities  include: a. In applying the customary rules of interpretation of public international law,  

each provision of the TRIPS Agreement shall be read in the light of the  object  and  purpose  of  the  Agreement  as  expressed,  in  particular,  in  its  objectives and principles.

b. Each member has the right to grant compulsory licences and the freedom to  determine the grounds upon which such licences are granted.

c. Each  member  has  the  right  to  determine  what  constitutes  a  national  emergency or other circumstances of extreme urgency, it being understood  that  public  health  crises,  including  those  relating  to  HIV/AIDS,  tuberculosis,  malaria  and  other  epidemics,  can  represent  a  national  emergency or other circumstances of extreme urgency.

d. The effect of the provisions in the TRIPS Agreement that are relevant to the  exhaustion of intellectual property rights is to leave each member free to  establish its own regime for such exhaustion without challenge, subject to  the MFN and national treatment provisions of Articles 3 and 4.

6. We recognize that WTO members with insufficient or no manufacturing  capacities  in  the  pharmaceutical  sector  could  face  difficulties  in  making  effective use of compulsory licensing under the TRIPS Agreement. We instruct  the Council for TRIPS to find an expeditious solution to this problem and to  report to the General Council before the end of 2002. 7. We reaffirm the commitment of developed-country members to provide  incentives  to  their  enterprises  and  institutions  to  promote  and  encourage  technology transfer  to  least-developed  country  members  pursuant  to  Article  66.2.  We  also  agree  that  the  least-developed  country  members  will  not  be  obliged,  with  respect  to  pharmaceutical  products,  to  implement  or  apply  Sections  5  and  7  of  Part  II  of  the  TRIPS  Agreement  or  to  enforce  rights  provided for under these Sections until 1 January 2016, without prejudice to the  right  of  least-developed  country  members  to  seek  other  extensions  of  the  transition periods as provided for in Article 66.1 of the TRIPS Agreement. We  instruct the Council for TRIPS to take the necessary action to give effect to this  pursuant to Article 66.1 of the TRIPS Agreement.”

65.  In  the  course  of  the  hearing,  we  were  told  that  the  Doha  Declaration  effectively  

reflected  and  addressed  the  deep  disquiet  of  the  developing  and  the  least-developed  

countries  regarding  their  obligation  under  TRIPS  to  grant  patent  protection  for

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pharmaceutical and agricultural chemical products and the likelihood of its highly adverse  

consequence on public-health. Dr. Dhawan, appearing for Cipla (one of the Objectors),  

was particularly severe in his criticism of the TRIPS Agreement and called it a “predatory  

and coercive” agreement. The other counsel, though, appearing for the different Objectors,  

were  more  muted in  their  criticism of  the  TRIPS Agreement.  Mr.  Kuhad,  the learned  

Additional  Solicitor  General  appearing for the Union of  India,  and Mr. Grover, Senior  

Advocate, appearing on behalf of the M/s. Cancer Patients Aid Association (one of the  

Objectors), especially adapted their submissions, taking the TRIPS Agreement as a fact  

that cannot be simply wished away. However, all the counsel representing the Union of  

India and the different Objectors unanimously took the stand that the TRIPS Agreement  

has sufficient flexibility (vide Articles 7, 8 and 27), which was further reaffirmed by the  

Doha Declaration (in paragraphs 4 to 6), to enable the member States to control the patent   

rights in a manner as to avoid any adverse impact on public-health. It was contended on  

behalf of the Union of India and the Objectors that the TRIPS Agreement coupled with the  

Doha Declaration leaves it  open to the member States to adjust  their  respective patent  

systems  by  regulating  the  grant  of  patents  and  to  set  up  higher  standards  for  patent  

protection for pharmaceutical and agricultural chemical products. The Union of India and  

all the Objectors maintained that the patent law in India, as it stands to-day after major  

changes were brought about in the Patents Act, 1970 in 2005, is fully TRIPS compliant.  

But they insisted that the Indian law must be judged and interpreted on its own terms, and  

not on the basis of standards of patentability prescribed in some countries of the western  

world.   

66. We have referred to the TRIPS Agreement and certain developments arising from it

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not  to  comment  upon the  fairness  or  otherwise  of  the  Agreement  nor  to  examine  the  

correctness and wisdom of the decision of the Government of India to subscribe to the  

Agreement. That is farthest from our mind. We have referred to the Agreement as being  

the main reason behind the basic changes brought about in the patent law of the country by  

legislative action. We have also referred to the Agreement as being the cause of a good  

deal of concern not only in this country but also (as we shall see presently) in other parts of  

the  world;  the  concern  being  that  patent  protection  to  pharmaceutical  and  agricultural  

chemical products might have the effect of putting life-saving medicines beyond the reach  

of  a  very large  section  of  people.  In  the following lines  we shall  see  how the  Indian  

legislature addressed this concern and, while harmonizing the patent law in the country  

with the provisions of the TRIPS Agreement, strove to balance its obligations under the  

international  treaty  and  its  commitment  to  protect  and  promote  public  health  

considerations, not only of its own people but in many other parts of the world (particularly  

in the Developing Countries and the Least Developed Countries).

67. We have seen above that, simultaneously with the TRIPS coming into force, the  

Government of India had brought an Ordinance to comply with the provisions of Article 70  

(8) and (9), but the Ordinance lapsed without being replaced by any enactment. Complaints  

were then filed on which pronouncements were made against India. On the complaint filed  

by the USA, the decision of the Appellate Body was rendered on December 19, 1997; and  

on the complaint filed by the European Communities,  the report of the Panel came on  

August  24,  1998. Thus faced with the threat  of  trade sanctions,  Parliament passed the  

Patents (Amendment) Act 1999 (Act No. 17 of 1999) on March 26, 1999, which amended  

the provisions of the Patents Act 1970 retrospectively, with effect from January 1, 1995,

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the date when the TRIPS Agreement came into force. By the Amendment Act of 1999,  

section 5 of the Parent Act was amended to provide for making “a claim for patent of an  

invention for a substance itself intended for use or capable of being used, as medicine  

or  drug”1.  The  Amendment  Act  further  incorporated  in  the  Parent  Act,  Chapter  IVA,  

which  contained  provisions  for  grant  of  exclusive  marketing  rights  in  respect  of  

pharmaceutical substances for which a claim for patent was made under section 5 of the  

Act. The Amendment Act of 1999 thus complied with Article 70(8) and (9) of the TRIPS  

Agreement.  

68. Three years later the Patents (Amendment) Act, 2002 (Act No. 38 of 2002) came to  

be enacted on June 25, 2002. It brought large scale amendments in the Patents Act, 1970.  

The Statement of Objects and Reasons for the Amendment Act of 2002 is stated as under:

“Amendment Act 38 of 2002 – Statement of Objects and Reasons.– The law  relating to patents is contained in the Patents Act, 1970 which came into force  on the 20th April, 1972. The Act was last amended in March, 1999 to meet  India’s  obligations  under  the  Agreement  on  Trade  Related  Aspects  of  Intellectual  Property Rights  (TRIPS)  which forms part  of  the  Agreement  establishing  the  World  Trade  Organisation  (WTO).  ……..  Development  of  technological  capability  in  India,  coupled  with  the  need  for  integrating  the  intellectual  property  system  with  international  practices  and  intellectual  property regimes, requires that the Act be modified into a modern, harmonised  and  user-friendly  legislation  to  adequately  protect  national  and  public  interests  while  simultaneously  meeting  India’s  international  obligations  under the TRIPS Agreement which are to be fulfilled by 31st December,  1999. 2. xxx 3. While considering amendment to the Act, efforts have been made to make  the  law  not  only  TRIPS  complaint  (sic)  but  also  to  provide  therein  necessary  and  adequate  safeguards  for  protection  of  public  interest,  national security, bio-diversity, traditional knowledge, etc. Opportunity is  also  proposed  to  be  availed  of  for  harmonising  the  procedure  for  grant  of  patents in accordance with international practices and to make the system more  user friendly.  

1  Excepting all chemical substances which are ordinarily used as intermediates in the preparation or manufacture of any of   the medicines or substances referred to in sub-clauses (i) to (iv) of section 2 (1) (l) of the Parent Act.

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4. Some of the salient features of the Bill are as under:–  (a) to define the term “invention” in consonance with international practices  and consistent with TRIPS Agreement; (b) to modify section 3 of the present Act to include exclusions permitted by  TRIPS Agreement  and also subject-matters like discovery of any living or  non-living substances occurring in nature in  the list of exclusions which in  general do not constitute patentable invention;  (c) to align rights of patentee as per article 28 of the TRIPS Agreement; (d) to (k) xxx;   (l)  to amend several  provisions of  the Act with a view to simplifying and  rationalising the procedures aimed at benefiting users.

(emphasis added)    

69. The Amendment Act of 2002 greatly expanded the definition clause in section 2 of  

the Parent Act by including a number of new expressions and terms and redefining some  

earlier terms.

70. “Invention” was defined in the Parent Act as under:

“Section 2(1)(j) “Invention” means any new and useful- (i) art, process, method or manner of manufacture; (ii) machine, apparatus or other article; (iii) substance produced by manufacture, and includes any new and useful improvement of any of them, and an alleged  invention.”

71. “Invention” was re-defined by the Amendment Act of 2002 as under:

“Section 2(1)(j)  “invention” means  a  new product  or  process  involving an  inventive step and capable of industrial application.”

72. The  expressions  “capable  of  industrial  application”  and  “inventive  step”  were  

separately defined in clauses (ac) and (ja) respectively which are as under:

“Section  2(1)(ac) “capable  of  industrial  application”,  in  relation  to  an  invention,  means that  the invention is  capable of  being made or  used in an  industry. Section 2(1)(ja) “inventive step” means a feature that makes the invention not

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obvious to a person skilled in the art.”

73. Section 3 of the Parent Act, which provided for exclusions from patentability, was  

recast.  In section 5 of the Parent  Act,  an Explanation was added after sub-section (2).  

Chapter XVI was substituted with the Chapter Heading “Working of Patents, Compulsory  

Licenses and Revocation”.  Section 83 in this Chapter  laid down the general  principles  

applicable to working of patented inventions; section 84 provided for compulsory licenses;  

and section 85 for revocation of patents for non-working. Here, it may not be out of place  

to take note of section 83 which provided as under:

“Section  83:  General  principles  applicable  to  working  of  patented  inventions.– Without prejudice to the other provisions contained in this Act, in  exercising the powers conferred by this  Chapter,  regard shall  be had to the  following general considerations, namely: -  (a) that  patents  are  granted  to  encourage  inventions  and  to  secure  that  the  

inventions are worked in India on a commercial  scale and to the fullest  extent that is reasonably practicable without undue delay;

(b) that they are not granted merely to enable patentees to enjoy a monopoly for  the importation of the patented article;

(c) that  the  protection  and  enforcement  of  patent  rights  contribute  to  the  promotion of technological innovation and to the transfer and dissemination  of  technology,  to  the  mutual  advantage  of  producers  and  users  of  technological knowledge and in a manner conducive to social and economic  welfare, and to a balance of rights and obligations;

(d) that patents granted do not impede protection of public health and nutrition  and should act as instrument to promote public interest specially in sectors  of vital importance for socio- economic and technological development of  India;

(e) that  patents  granted  do not  in  any way prohibit  Central  Government  in  taking measures to protect public health;

(f) that the patent right is not abused by the patentee or person deriving title or  interest on patent from the patentee, and the patentee or a person deriving  title  or  interest  on patent  from the patentee  does  not  resort  to  practices  which  unreasonably  restrain  trade  or  adversely  affect  the  international  transfer of technology; and

(g) that  patents  are  granted  to  make  the  benefit  of  the  patented  invention  available at reasonably affordable prices to the public.”

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74. The many amendments to and enlargement of the Parent Act by the Amendment Act  

of 2002 laid most of the ground-work, but India was yet to take the one final step to make  

its patent law compliant with the mandate of TRIPS. And that was to amend the Act to  

allow for grant of product patents for pharmaceutical and agricultural chemical substances.  

Steps  were  taken to  finally  amend  the  Patents  Act,  1970,  but  the  draft  Bill  lapsed  in  

February  2004.  Further  efforts  were  made  but  the  legislature  was  unable  to  bring  an  

enactment  to  make  that  final  amendment  in  the  Act  by  December  2004;  thus,  the  

Government of India had no option but to amend the law through an Ordinance. Therefore,  

in order not to default on its obligations under the TRIPS Agreement, the Government  

brought the Patents (Amendment) Ordinance, 2004 (Ordinance No. 7 of 2004) with effect  

from January 1, 2005. By this Ordinance, section 5 of the Patents Act, 1970, which barred  

the grant of patent for substances intended for use or capable of being used as food or as  

medicine or drugs or substances prepared or produced by chemical processes was done  

away  with,  opening the  doors  for  grant  of  patents  to,  amongst  others,  pharmaceutical  

products.  

75. But the troubles were far from over, because the Ordinance was to lapse on March  

31,  2005. Hence,  it  was imperative for  Parliament to pass an enactment,  replacing the  

Ordinance  before  it  lapsed  on  March  31,  2005.   The  pressure  of  time  under  which  

Parliament was obliged to deal with the matter and pass the Act, replacing Ordinance No. 7  

of 2004 and amending the Patents Act, 1970, is best stated in the Statement of Objects and  

Reasons for the Patents (Amendment) Act, 2005 (Act 15 of 2005). In paragraph 5 of the  

Statement of Objects and reasons it is stated as under:          

“Amendment Act 15 of 2005 – Statement of Objects and Reasons.– 5. The time-frame for this set of amendments was most crucial as any slippage

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in  meeting  the  January  01,  2005  deadline  had  the  potential  of  inviting  retaliatory action under the WTO disputes mechanism. Having availed of the  entire ten-year transition period provided under the TRIPS Agreement, India  had no legal  basis to defend its default  on the deadline.  The past  record of  delayed  implementation  would  also  not  have  helped  the  Indian  case.  This  default would also have created a legal vacuum for the “mailbox” applications,  as there would not be any mechanism to deal with them from January 01, 2005.  This  would  have  amounted  to  a  specific  default  on  the  international  commitment  to  examine  and  dispose  of  these  cases,  and  might  have  again  provided an opportunity to WTO member countries to raise a dispute against  India in the WTO. There would also have been a legal vacuum in respect of  fresh applications after January 01, 2005, as the law was salient on whether the  “mailbox” provision would subsist or whether it would have ceased. Finally,  there would have been an erosion of India’s credibility in the international field.  In  the  circumstances  it  was  considered  necessary  to  bring  in  the  required  amendments  in  time  and  as  Parliament  was  not  in  session,  the  President  promulgated the Patents (Amendment) Ordinance, 2005 (Ord. 7 of 2004) on the  26th December, 2004.”

76. Parliament had an absolutely unenviable task on its hands. It was required to forge,  

within a very limited time, an Act that would be TRIPS compliant without, in any way,  

compromising on public health considerations. It is seen above that the TRIPS Agreement  

had  aroused  grave  concerns  about  its  impact  on  public  health.  India  had  learnt  from  

experience  the  inverse  relationship  between  product  patents  and  the  indigenous  

pharmaceutical industry, and its effects on the availability of essential drugs at affordable  

prices. It is also seen above that after the patent system in India barred the grant of patents  

for pharmaceutical and chemical substances, the pharmaceutical industry in the country  

scaled great heights and became the major supplier of drugs at cheap prices to a number of  

developing and under developed countries. Hence, the reintroduction of product patents in  

the Indian patent system through the TRIPS Agreement became a cause of alarm not only  

in this country but also for some international agencies. Our attention was invited to a letter  

of  the HIV/AIDS Director  of  the WHO, dated December 17,  2004, to the Minister  of  

Health and Family Welfare, Government of India. The letter deserves to be noted in full.

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“17 December 2004 Dr. A Ramadoss Minister of Health and Family Welfare Government of India Nirman Bhawan, Maulana Azad Road New Delhi-110 001 India Dear Dr. Ramadoss, We would like to bring to your attention that several of our Member States  have  expressed  their  concern  that  in  the  future,  generic  antiretroviral  drugs from India may no longer be available to them. Among other places,  these  concerns  were  expressed  by  the  delegations  of  Ghana,  Lesotho,  Malawi, and Namibia at our recent Procurement & Supply Management  (PSM)  Workshop  in  Nairobi,  Kenya  (2-9  December,  2004),  and  by  Bangladesh, Cambodia, China, Indonesia, Korea, Laos, Thailand, Papua  New  Guinea,  and  Vietnam  at  the  Asian  Regional  Workshop  on  the  WTO/TRIPS Agreement and Access to Medicines held in Kuala Lumpur,  Malaysia (28-30 November 2004). As you are aware, WHO has been actively monitoring the implications of trade  agreements on public health.  One key issue is the impact  of  the end of the  transition period at 1 January 2005 allowed under the TRIPS Agreement, which  delayed the application of product patents, on the local production and supply  of generic antiretroviral agents. The WTO Ministerial Declaration on the TRIPS Agreement and Public Health  adopted in Doha, 2001 affirmed that "the TRIPS Agreement can and should be  interpreted and implemented in a manner supportive of WTO Members' right to  protect public health and, in particular, to promote access to medicines for all."  In line with this, recent resolutions of the World health Assembly have also  urged that national legislation should be adapted in order to use to the full the  flexibilities contained in the TRIPS Agreement (WHA 56.27, May 2003 and  57.14, May 2004). In accordance with its mandate, WHO will therefore seek to  provide  technical  assistance  and  support  to  Member  States  to  promote  implementation  of  the  TRIPS  Agreement  consistent  with  the  public  health  objective of ensuring access to medicines. As India  is  the  leader  in  the  global  supply  of  affordable  antiretroviral  drugs and other essential medicines, we hope that the Indian government  will take the necessary steps to continue to account for the needs of the  poorest  nations  that  urgently  need  access  to  antiretrovirals,  without  adopting unnecessary restrictions that are not required under the TRIPS  Agreement and that would impede access to medicines. We thank you for your attention to this issue and send our best regards. Sincerely, Dr. Jim Yong Kim

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Director Department of HIV/AIDS”

(emphasis added)

77. We were also shown another letter dated February 23, 2005, from the Director of  

Advocacy, Communication and Leadership for UNAIDS, to the Minister of Commerce  

and Industry, Government of India. This letter is also useful as reflecting the concern of the  

international community over the impending change in the patent system in India. This  

letter is as under:  

“Honourable Minister Mr Kamal Nath Ministry of Commerce and Industry Udyog Bahavan New Delhi 110001 India 23 February 2005 Reference: ACL/AD/lp Excellency, I have the honour to refer  to India’s  leadership in promoting access  to and  supplying affordable essential generic HIV medicines to those most in need in  developing countries, which has long been recognized and applauded by the  international  community.  India  can rightly take pride  in  the  fact  that  it  has  significantly supported the response  to  the global  AIDS emergency through  helping to ensure AIDS medicines are more affordable and accessible. Affordable HIV medications from India have so far saved thousands of lives  yet more than 8,000 people around the world continue to die every day because  they have no access to treatment. Despite concerted efforts across the world,  only about one in ten people in urgent need of HIV antiretroviral treatment in  low- and middle-income countries has access to existing medicines. Current  legislative  proposals  intended  to  take  the  1970  Indian  Patents  Act  beyond the commitments agreed in the World Trade Organization’s Agreement  on Trade-Related Aspects of Intellectual Property Rights (TRIPS) threaten to  undermine India’s leadership in providing affordable medicines. For example,  the requirement that countries wishing to import from India under the WTO 30  August 2003 Decision must issue a compulsory license in every case goes far  beyond the WTO Decision. This requirement in the Indian Ordinance places a  cumbersome  and  often  unnecessary  administrative  burden  on  the  importing  country. Often, there will be no patent in the importing country and compulsory

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licenses are only required where a valid patent has been issued. Under the WTO  Declaration on TRIPS and Public Health (the Doha Declaration) of November  2001, Least Developed Countries are not even required to issue patents in the  pharmaceutical  sector  until  2016.  In  addition,  the  limitations  under  the  Ordinance  of  the  pre-grant  opposition  rule  contained  in  the  previous  law  removes  an  important  opportunity  for  People  Living  with  HIV  and  other  members of civil society to participate in an open and transparent process. The implications of the current Ordinance are potentially devastating: the vast  majority of countries hardest hit by AIDS do not have sufficient manufacturing  capacity in the pharmaceutical sector and must rely upon imports from major  producing countries such as India if they are to succeed in scaling up access to  HIV treatment to the millions of their people in need. UNAIDS strongly supports the rights of governments to avail themselves of the  flexibilities  in  TRIPS in promoting the widest  possible  access  to  affordable  medicines and technologies. Therefore,  we would respectfully  urge you to consider  all  appropriate  legal  means to protect  and scale  up access to essential  affordable medicines.  The  Doha Declaration, in which India played an important role, makes clear that the  interests of public health and equitable access to medicines for all should be  primary concerns in the application of the TRIPS Agreement and related trade  and intellectual property rules. UNAIDS has learnt that a Global Day of Action is planned for 26 February  2005 against the Indian Patent Ordinance. Civil society, organizations of people  living with HIV and AIDS and the media will be watching closely. This day  presents an opportunity for India to send out a strong message in support of  both research innovation and access to affordable HIV-related pharmaceuticals  and  other  essential  medicines,  while  fully  complying  with  the  applicable  multilateral trade and intellectual property agreements.

Please accept, Excellency, the assurance of my highest consideration. Achmat Dangor Director Advocacy, Communication and Leadership cc: Dr Prasada Rao, UNAIDS Regional Director, Regional  Support Team, Bangkok Permanent  Mission  of  India  to  the  United  Nations  and  other  International  Organizations in Geneva”

78. It was thus under the twin pressure of time and anxiety to safeguard the public health  

objectives that Parliament was called upon to deliberate over the amendments required to  

be made in the patent law to make it fully compliant with the TRIPS Agreement.

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79. On December 18, 2004, the Bill to further amend the Patents Act, 1970, which was  

materially the same as  Ordinance No. 7 of 2004,  was introduced in Parliament. The Bill  

evoked a highly insightful and informed debate on the subject. To anyone going through  

the debate on the Bill, Parliament would appear keenly alive to national interests, human-

rights considerations and the role of India as the producer and supplier of drugs to different  

parts of the world where impoverished humanity is critically in need of those drugs at  

cheap and affordable prices. Cutting across party lines, member after member from the  

Opposition benches highlighted the grave risk in creating private monopolies in an area  

like pharmaceuticals, the abuses to which product patents in pharmaceutical products were  

vulnerable, and the ploys used by big companies to artificially extend the period of patent  

to keep competitors out and keep the prices of the patented product high. It was strongly  

argued that, while fulfilling its commitment under the TRIPS agreement, the Government  

must  not  bring  in  a  patent  regime  where  all  the  gains  achieved  by  the  Indian  

pharmaceutical industry are dissipated and large sections of Indians and people in other  

parts of the world are left at the mercy of giant multinational pharmaceutical companies.

80. One of the members from the Opposition benches said:

“Sir, even if this were a Bill, which affects only India, still it would be an  extremely important one. But it is a Bill, which affects most parts of the world.   We are supplying 50 per cent of the cheapest drugs in the world to places like  Papua  New  Guinea,  Laos,  Kenya,  Africa,  etc.  All  these  countries  have  complained to the WHO about this Bill.  The two biggest international health organizations in the world, namely WHO,  and Medicines Sans Frontiers have written to the Government saying that this is  a very very serious matter. This has been the subject of editorials all over the  world  right  from  America  onwards  to  every  country  from  Bangladesh,  Cambodia, China, Indonesia, Nairobi, Korea, Laos, Thailand, Vietnam, etc.  All  of them have complained about our Bill. It is a Bill that affects so many parts of  the  world.  Do  you  not  think  that  we  should  have  a  slightly  more  serious  discussion on it, rather than attempting to pass it through?”

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The same member speaking at a later stage in the debate said:  

“India has benefited from the low cost generic industry to dominate 30 per cent  of the low cost drugs in the world…. Secondly,  it  (the  bill)  is  vague  about  the  evergreening  effect  in  which  companies extend their patent rights by switching from capsules to tablets, for  instance. This extends monopolies.  Parliament must make sure that it protects  the  rights  of  India  to  make  these  generic  drugs. We  should  remove  the  provision that allows this evergreening. … What should and what should not be  patentable has also been left open to interpretation. Earlier, the new use for a  substance could not be patented. Now this has been qualified to allow it  by  putting “mere new use” instead of “new use”. xxx Sir, I am going to limit my speech to six points only. This is what we need:  1. We need to limit the scope of patentability to only new chemical entities.  2. No patents for new usage and dosage of known drugs.  3. Retain pre-grant opposition in its original form.  4. Simple procedures with a time limit for grant of compulsory licences.  5. Immunity for generic drugs which are already available in the market.  6. Introduction of ceiling on royalty to pharmaceutical companies”

81. Another member, also from one of the parties in the Opposition, had this to say:

“Sir,  a  lot  of  things  have  been  said  for  and  against  the  Bill.  Certain  basic  positions have to be re-stated even now. That is, in India, we had legislation in  1891 on the Patents and Designs. That was product regime, under which it had  been told that in India, in relation to medicines, at that time, 85 per cent of our  medicinal requirements was met by import of medicines from abroad. In those  days, probably, the transnational corporations were not as big as they are today.  But even then, with the product regime that was there upto 1911, the situation  in this country was such that we had to depend upon imports for the 85 per cent  of our medicinal requirements. After  1970,  when  India  adopted  a  new  Patents  legislation,  where  we  had  adopted a process regime, the situation was reversed. This 85 per cent of our  country’s  medicinal  requirement  was met by our  own products.  That  was  a  remarkable achievement. Not only that, we started exporting to countries which  does not have the facility of infrastructure to produce their own medicines. We  supplied medicine to meet their requirements. But will the Minister now assure  that  we  will  be  able  to  meet  our  own requirements  at  a  cheaper  rate  after  adopting this product regime? Can it be assured that we would be able to meet  the  requirements  of  medicine  of  our  people?  Because,  that  was  not  our  experience in the past. …”

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82. It is interesting to note that in the Parliamentary debate, the names of the appellant  

company (Novartis)  and the drug (Gleevec) being the subject  matter of this case were  

repeatedly mentioned, and the excessively high price fixed for the drug after the grant of  

“exclusive marketing rights” to the appellant was expressly cited as the likely result of  

bringing in the product patent regime in pharmaceuticals. One of the members said:   

“Sir, a company which obtains a patent by changing their chemicals, before the  expiry  of  the  patent,  they  will  again  apply  for  a  patent  and  again  get  a  patent. So,  in  this  way,  they  will  continue  to  get  a  patent  for  the  same  medicine.  For example, the drug called ‘Glevic’ (sic Gleevec/Glivec), is used  for the treatment of Leukaemia. It is patented by Novartis. This was originally  patented in 1993. The cost of the drug for the treatment of this disease comes to  about Rs.1,20,000 per month1 in India. At the same time, the generic versions  are available in the country which cost only Rs.8,000 to Rs.10,000.”

83. As  the  deliberations  were  going  on  in  Parliament,  negotiations  were  also  held  

between the ruling party and some of the opposition parties, in course of which certain  

amendments were suggested in the Bill. And in order to allay the apprehensions and fears  

voiced by the Opposition, one of the members from the Government said:

“Madam, I am concluding. I would only like to refer to the amendment  which is being incorporated in Clause 3 which talks of the known inventions,  the products which are not considered to be inventions and therefore cannot be  covered  by  the  patent  and  patents  cannot  be  sought  for  them.  A  good  amendment is being introduced to that effect in Clause 3 of the Bill which says:  “The mere discovery of a new form of a known substance which does not result  in the enhancement of the known efficacy of that substance of (sic or) the mere  discovery of any new property or new use for a known substance or of the mere  use  of  a  known process,  machine  or  apparatus  unless  such  known process  results in a new product or employs at least one new reactant.”  

The explanation to that should completely allay the fears of our friends on  the other side. I hope they would accept that.”

1  Here it will be unfair not to state that in course of hearing of the case when the Court expressed its bewilderment over the   price of the drug, it was strenuously stated on behalf of the appellant that they also ran a huge charitable programme under  which the drug was supplied free to the needy persons. However, to the question by the Court why the appellant could not  abolish the charitable programme and at the same time bring down the price of the drug so as the total revenue from the sale  of the drug remains the same as it is with the abnormally high price and the charitable programme, no satisfactory answer  was provided on behalf of the appellant.   

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84. Speaking at the conclusion of the debate, the minister who had sponsored the Bill  

also referred to the amendment proposed in section 3(d). He said:

“There are so many provisions here. In regard to evergreening, I just want to  read out section 3(d) which says that a mere discovery of a new property or a  new use for a known substance or the mere use of known process in a new  product  –  these  are  exceptions,  these  will  not  be  granted  any  patent  –  and  substances  obtained  by  a  mere  ad-mixture  resulting  only  in  aggregation  of  properties  of  the  components  thereof  or,  processes  of  producing  such  substances will not be given patents…”

85. Finally, after three days of debate (March 18, 21 and 22) the Bill, along with the  

amendments proposed by the minister, was passed by the Lok Sabha on March 22, 2005.  

Some of  the  very  important  amendments  that  were  incorporated  in  the  Bill  related  to  

section 2(1)(ja) and section 3(d), and the insertion of the provision for pre-grant opposition  

to grant of patent. After being passed by the Lok Sabha, the Bill was presented in the Rajya  

Sabha where it was passed on March 23, 2005. It received the assent of the President on  

April 4, 2005, and was published in the official gazette of April 5, 2005.

86. Thus, after deliberations that took place for just four days, the Patents Act, 1970,  

came in a completely new avatar. The haste with which the Government was constrained  

to rush the Bill through Parliament to make the law compatible with the TRIPS Agreement  

perhaps explains the somewhat unclear drafting of some very important provisions, which  

called  for  much  greater  clarity;  the  presence  of  some  terms  and  expressions  in  the  

definition section1 that are nowhere used in the Act; and a few loose ends that could have  

been properly tied up if more time and attention was given to the drafting.

87. We have seen in  some detail  the “why” and the “how” of the law. Let  us now  

examine what  the law is  in  light  of  its  “why” and “how”.  In order  to  understand the  

1  Section 2(1)(l): “New Invention”, section 2(1)(ta) “Pharmaceutical substance”.

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meaning of “invention” under the Patents Act, 1970, as it stands today after its amendment  

by the amending Act of 2005, we must refer to clauses (ac), (j) and (ja) of section 2(1) of  

the Act1:

“Section  2.  Definitions  and interpretation. — (1)  In  this  Act,  unless  the  context otherwise requires,— (ac) "capable of industrial application", in relation to an invention, means  that the invention is capable of being made or used in an industry; (j) "invention" means a new product or process involving an inventive step  and capable of industrial application; (ja) "inventive step" means a feature of an invention that involves technical  advance  as  compared  to  the  existing  knowledge  or  having  economic  significance  or  both  and  that  makes  the  invention  not  obvious  to  a  person  skilled in the art;”

88. Section  2(1)(j)  requires  a  product  to  satisfy  three  conditions  to  qualify  as  an  

invention.  

(i) It must be “new”, that is to say it must not have been anticipated;

(ii) Its coming into being must involve an “inventive step”; and  

(iii) It must be “capable of industrial application”, that is to say it must be capable of  

being made or used in an industry [section 2(1)(ac)].

89. “Inventive  step”  is  separately  defined  in  section  2(ja)  to  mean  a  feature  of  an  

invention  that  involves  technical  advance  as  compared  to  the  existing  knowledge,  or  

having economic significance or both and that makes the invention not obvious to a person  

skilled in the art.  To paraphrase, the invention that creates the product must have a feature  

that  involves  technical2 advance  as  compared  to  the  existing  knowledge  or  having  

economic significance or both and this feature should be such as to make the invention not  

1 Clauses (l) and (ta) of section 2(1) are also on the issue of “invention” but as noted above those provisions, though defined in   section 2 are not used anywhere else in the Act and, therefore, we do not take those provisions in consideration for construing  the meaning of “invention”.    2  “Adjective: 1. of or relating to a particular subject, art, or craft or its techniques. 2. of, involving, or concerned with applied  

or industrial sciences” : The New Oxford Dictionary of English, Edition 1998.

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obvious to a person skilled in the art.  

90. On a combined reading of causes (j), (ac) and (ja) of section 2(1), in order to qualify  

as “invention”, a product must, therefore, satisfy the following tests:

(i)  It must be “new”;

(ii) It must be “capable of being made or used in an industry”

(iii) It must come into being as a result of an invention which has a feature that:

(a) entails technical advance over existing knowledge;

Or

(b)has an economic significance

And

(c) makes the invention not obvious to a person skilled in the art.

91. We have seen the meaning of “invention”; we have also seen earlier that the Patents  

Act, 1970, dealt with “invention” and “patentability” as two distinctly separate concepts.  

The duality of the two concepts is best illustrated by section 4 of the Act, which prohibits  

the grant of patent (either process or product) “in respect of inventions relating to atomic  

energy falling within sub-section (1) of section 20 of the Atomic Energy Act, 1962”, and  

which has not undergone any change since inception. It is, therefore, fundamental that for  

grant of patent the subject must satisfy the twin tests of “invention” and “patentability”.  

Something may be an “invention” as the term is generally understood and yet it may not  

qualify as an “invention” for the purposes of the Act. Further, something may even qualify  

as an “invention” as defined under the Act and yet may be denied patent for other larger  

considerations as may be stipulated in the Act. Having, therefore, seen the meaning of  

“invention”, we may now advert to section 3 as it stands after the amendment of the Act in

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2005.

92. Section 3 is in Chapter II of the Act, which initially contained sections 3, 4 and 5,  

but after the deletion of section 5 with effect from January 1, 2005, Chapter II has only two  

sections: sections 3 and 4. The Chapter has the Heading “Inventions Not Patentable” and  

section 3 has the marginal heading “What are not inventions.” As suggested by the Chapter  

heading and the marginal  heading of  section  3,  and as  may be  seen simply  by going  

through section 3, it puts at one place provisions of two different kinds: one that declares  

that certain things shall not be deemed to be “inventions” [for instance clauses (d) & (e)];  

and the other that provides that, though resulting from invention, something may yet not be  

granted patent for other considerations [for instance clause (b)].

93. For the purpose of these appeals, however, we need only to focus on clause (d) of  

section 3.  

94. We have seen earlier that, in course of the debate in Parliament, an amendment (by  

way of addition) in clause (d) of section 3 was proposed by the Government in order to  

allay the fears of the members from the Opposition concerning the introduction of product  

patents for pharmaceuticals and agricultural chemicals, and it was on the Government’s  

assurance that the proposed amendment in section 3(d) (besides some other changes in the  

Act) would take care of the apprehensions about the abuse of product patent in medicines  

and agricultural  chemical  substances  that  the Bill  was passed by Parliament.  We once  

again examine here what was the amendment introduced in section 3(d) by the amending  

Act of 2005. Immediately before its amendment in 2005, section 3(d) was, in the Patents  

(Amendment) Ordinance, 2004 (Ordinance No. 7 of 2004), as under:—

“Section 3. What are not inventions.– The following are not inventions within  the meaning of this Act,—

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(d)  the mere discovery of  any new property or  mere  new use  for  a  known  substance or of the mere use of a known process, machine or apparatus unless  such known process  results  in  a  new product  or  employs  at  least  one  new  reactant.”

95. After the amendment with effect from Jan 1, 2005, section 3(d) stands as under: -

“Section 3. What are not inventions.– The following are not inventions within  the meaning of this Act,— (d) the mere discovery of a new form of a known substance which does not  result in the enhancement of the known efficacy of that substance or  the  mere discovery of any new property or new use for a known substance or of the  mere use of a known process, machine or apparatus unless such known process  results in a new product or employs at least one new reactant.  Explanation.—For  the  purposes  of  this  clause,  salts,  esters,  ethers,  polymorphs,  metabolites,  pure  form,  particle  size,  isomers,  mixtures  of  isomers,  complexes,  combinations  and  other  derivatives  of  known  substance shall be considered to be the same substance, unless they differ  significantly in properties with regard to efficacy.”

96. As may be seen, the amendment (i) adds the words “the mere discovery of a new  

form of  a  known  substance  which  does  not  result  in  the  enhancement  of  the  known  

efficacy of  that  substance  or”  at  the  beginning of  the  provision;  (ii)  deletes  the  word  

“mere” before “new use”; and (iii) adds an explanation at the end of the clause.  

97. A perusal of the Parliamentary debate would further reveal that the whole debate  

centered on medicines and drugs. It would not be an exaggeration to say that eighty per  

cent of the debate was focused on medicines and drugs and the remaining twenty per cent  

on agricultural chemicals. In the entire debate, no substance of any other kind came under  

discussion.  

98. The  aforementioned  amendment  in  section  3(d)  is  one  of  the  most  crucial  

amendments  that  saw  the  Bill  through  Parliament  and,  as  noted,  the  amendment  is  

primarily in respect  of  medicines and drugs and,  to some extent,  agricultural  chemical

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substances.

99. In regard to section 3(d) both Mr.  Andhyarujina and Mr.  Subramanium, learned  

counsel appearing for the appellant, strenuously argued that section 3(d) is not meant to be  

an exception to clauses (j) and (ja) of section 2(1) of the Act. Both the learned counsel  

insisted that section 3(d) has no application to the case of the subject product. The subject  

product, having satisfied the tests of invention as provided in clauses (j) and (ja) of section  

2(1), cannot be denied patent for allegedly failing to satisfy the tests under section 3(d).  

Mr. Andhyarujina submitted that section 3(d) is a provision put in  ex abundanti cautela  

non nocet1 to remove all doubts.

100. Mr. Subramanium submitted that section 3(d) is  ex majore cautela2.  The learned  

counsel  submitted  that  the  primary  purpose  of  section  3(d),  as  is  evidenced  from the  

legislative  history,  is  to  prevent  “evergreening”  and  yet  to  encourage  incremental  

inventions. “Evergreening” is a term used to label practices that have developed in certain  

jurisdictions wherein a trifling change is made to an existing product, and claimed as a new  

invention. The coverage/protection afforded by the alleged new invention is then used to  

extend  the  patentee’s  exclusive  rights  over  the  product,  preventing  competition.  Mr.  

Subramanium submitted that, by definition, a trifling change, or in the words of the section  

“a mere discovery of a new form of a known substance”, can never ordinarily meet the  

threshold  of  novelty  and inventive  step  under  clauses  (j)  and (ja)  of  section  2(1).  An  

invention cannot be characterized by the word “mere”. The word “invention” is distinct  

from the word “discovery”. He, therefore, submitted that section 3(d) operates only as ex  

majore cautela, ensuring that mere discoveries can never, by an effort at interpretation of  

1  Abundant caution does no harm. 2  Out of abundant caution.

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clauses (j) and (ja) of section 2(1), be considered inventions.  

101. In regard to the concerns about public health issues and the flexibility of the TRIPS  

Agreement coupled with the Doha Declaration, allowing the scope to address the issues of  

public health, Mr. Subramanium submitted that those concerns are addressed in the Act, in  

provisions relating to compulsory licensing1, revocation of patents2, and the multiple stages  

for opposition to the grant of patent3.

102. The submission may appear plausible if the scrutiny of the law is confined only to  

the Act as it stands today after undergoing the amendments in 2005. But examined in the  

larger perspective of the development of the law of patent over the past 100 years and  

especially keeping in mind the debates in the Parliament preceding the 2005 amendment, it  

would appear completely unacceptable. We find no force in this submission that section  

3(d) is a provision ex majore cautela. To our mind, the submission completely misses the  

vital distinction between the concepts of invention and patentability – a distinction that was  

at the heart of the Patents Act as it was framed in 1970, and which is reinforced by the  

2005 amendment in section 3(d).

103. We are clearly of the view that the importance of the amendment made in section  

3(d),  that  is,  the  addition  of  the  opening  words  in  the  substantive  provision  and  the  

insertion of explanation to the substantive provision, cannot be under-estimated. It is seen  

above that, in course of the Parliamentary debates, the amendment in section 3(d) was the  

only provision cited by the Government to  allay the fears  of  the Opposition members  

concerning the abuses to which a product patent in medicines may be vulnerable. We have,  

therefore, no doubt that the amendment/addition made in section 3(d) is meant especially  

1   See Chapter XVI: “Working of Patents, Compulsory Licences and Revocation” in the Patents Act, 1970. 2  See sections 63, 64, and 65 of the Patents Act, 1970. 3  See section 25 of the Patents Act, 1970.

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to  deal  with  chemical  substances,  and  more  particularly  pharmaceutical  products.  The  

amended portion of section 3(d) clearly sets up a second tier of qualifying standards for  

chemical substances/pharmaceutical products in order to leave the door open for true and  

genuine inventions but, at the same time, to check any attempt at repetitive patenting or  

extension of the patent term on spurious grounds.

104. We have so far seen section 3(d) as representing “patentability”, a concept distinct  

and separate from “invention”. But if clause (d) is isolated from the rest of section 3, and  

the legislative history behind the incorporation of Chapter II in the Patents act, 1970, is  

disregarded,  then it  is  possible to see section 3(d) as an extension of  the definition of  

“invention” and to link section 3(d) with clauses (j) and (ja) of section 2(1). In that case, on  

reading clauses (j) and (ja) of section 2(1) with section 3(d) it would appear that the Act  

sets different standards for qualifying as “inventions” things belonging to different classes,  

and for medicines and drugs and other chemical substances,  the Act sets the invention  

threshold further higher, by virtue of the amendments made in section 3(d) in the year  

2005.   

105. Admittedly, the genesis of this patent application lies in one of the derivatives of N-

phenyl-2-  pyrimidine-amine  in  free  base  called  Imatinib1,  vide  example  21  of  the  

Zimmermann  patent.  According  to  the  appellant,  beginning  with  Imatinib,  the  subject  

product, i.e., Imatinib Mesylate in beta crystalline form, was brought to being by not one  

but two inventions.  

106. The first invention lies in selecting example 21 out of the 37 examples given in the  

Zimmermann  patent  and  then  choosing  methanesulfonic  acid  to  produce  the  

1  4-(4-methylpiperazin-1–ylmethyl)-N-[4-methyl-3-(4-pyridin-3-yl)pyrimidin-2-ylamino)phenyl] benzamide.

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methanesulfonic acid addition salt of the free base Imatinib, called Imatinib Mesylate. It  

was  emphasized  by  both  Mr.  Gopal  Subramanium  and  Mr.  Andhyarujina,  Senior  

Advocates  appearing  for  the  appellant,  that  the  Zimmermann  patent  did  not  teach  or  

suggest to a person skilled in the art to select example 21 in preference to other compounds  

of which examples were given in the Zimmermann patent. Further, even if example 21 was  

selected, the Zimmermann patent did not teach a person to select one particular salt. The  

Zimmermann patent did not teach a person how to prepare Mesylate salt of example 21.  

Hence, the coming into being of Imatinib Mesylate from Imatinib in free base was the  

result  of  an  invention  that  involved  technical  advance  as  compared  to  the  existing  

knowledge and brought into existence a new substance.  

107. In  the  second  invention,  the  appellant  arrived  at  the  beta  crystal  form  of  

methanesulfonic acid addition salt of Imatinib. It was contended on behalf of the appellant  

that once the salt form of Imatinib was arrived at, the inventors had to further research to  

be able to ensure that that particular salt form of Imatinib is suitable for administration in a   

solid oral dosage form. This research further required defining the process parameters that  

brought into being the beta crystalline form of Imatinib Mesylate. It was argued on behalf  

of the appellant that there is certainly no mention of polymorphism or crystalline structure  

in the Zimmermann patent. The relevant crystalline form of the salt that was synthesized  

needed to be invented. There was no way of predicting that the beta crystalline form of  

Imatinib  Mesylate  would  possess  the  characteristics  that  would  make  it  orally  

administrable to humans without going through the inventive steps. It was further argued  

that the Zimmermann patent only described, at most, how to prepare Imatinib free base,  

and that this free base would have anti-tumour properties with respect to the BCR ABL

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kinase.  Thus,  arriving  at  the  beta-crystalline  form  of  Imatinib  Mesylate  for  a  viable  

treatment of  Chronic Myeloid Leukemia required further  invention – not  one but  two,  

starting from Imatinib in free base form, as stated above.    

108. The subject product admittedly emerges from the Zimmermann patent.  Hence, in  

order to test the correctness of the claim made on behalf of the appellant, that the subject  

product is brought into being through inventive research, we need to examine in some  

detail the Zimmermann patent and certain developments that took place on that basis  

109. An  application  for  grant  of  patent  for  the  Zimmermann  invention  (Pyrimidine  

Derivatives and Processes for the Preparation thereof) was filed in the United States of  

America on April 2, 1993, by Ciba Geigy1 (US Patent Application No. 08/042,322). This  

application was abandoned and another continuation-in-part application was then filed on  

April  28,  1994  (US  Patent  Application  No.  5,521,184).  The  Zimmermann  invention2  

1  In 1996, CIBA Geigy merged with Sandoz to form Novartis, the present appellant. 2 The invention relates to N-phenyl-2-pyrimidine-amine derivatives, to processes for the preparation thereof, to medicaments  comprising those compounds, and to the use thereof in the preparation of pharmaceutical compositions for the therapeutic   treatment of warm-blooded animals.  

The invention relates to N-phenyl-2-pyrimidine-amine derivatives of formula I  

wherein  R1 is 4-pyrazinyl, 1-methyl-1H-pyrrolyl, amino- or amino-lower alkyl-substituted phenyl wherein the amino group in  

each  case  is  free,  alkylated  or  acylated,  1H-indolyl  or  1H-imidazolyl  bonded  at  a  five-membered  ring  carbon  atom,  or  unsubstituted or lower alkyl-substituted pyridyl bonded at a ring carbon atom and unsubstituted or substituted at the nitrogen   atom by oxygen,  

R2 and R3 are each independently of the other hydrogen or lower alkyl,  one or two of the radicals R4, R5, R6, R7 and R8 are each nitro, fluoro-substituted lower alkoxy or a radical of formula  

II  –N(R9)–C(=X)–(Y)n–R10

wherein  R9 is hydrogen or lower alkyl,  X is oxo, thio, imino, N-lower alkyl-imino, hydroximino or O-lower alkyl-hydroximino,  Y is oxygen or the group NH,

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related  to  N-phenyl-2-pyrimidine-amine  derivatives  (called,  “formula  I”  in  the  patent  

application),  and the compounds thereof,  the process for  their  preparation, and to their  

therapeutic uses. In the patent application, it was expressly stated that the compounds of  

formula I included their respective salts:

“Salt-forming groups in a compound of formula I are groups or radicals having  basic or acidic properties.  Compounds having at least one basic group or at  least one basic radical, for example a free amino group, a pyrazinyl radical or a  pyridyl radical, may form acid addition salts, for example with inorganic  acids, such as hydrochloric acid, sulfuric acid or a phosphoric acid, or with  suitable organic carboxylic or sulfonic acids…”

Further: “Owing to the close relationship between the novel compounds in free form and  in the form of their salts, including those salts that can be used as intermediates,  for example in the purification of the novel compounds or for the identification  thereof,  hereinbefore and hereinafter  any reference to the free compounds  should  be  understood  as  including  the  corresponding  salts,  where  appropriate and expedient.”

(emphasis added)

110. As regards the pharmacological properties of the compounds of formula I it  was  

stated in the application:

“The compounds of formula I have valuable pharmacological properties and  can be used, for example, as anti-tumoral drugs and as drags (sic drugs) against  atherosclerosis.”

111. The  application  also  described  the  tests  undertaken  for  determining  the  protein  

kinase  C-inhibiting  activities  of  compounds  of  formula  I  and  their  pharmaceutically  

acceptable salts as follows:

“To determine protein kinase C-inhibiting activity, protein kinase C from pig  n is 0 or 1 and  R10 is  an  aliphatic  radical  having  at  least  5  carbon  atoms,  or  an  aromatic,  aromatic-aliphatic,  cycloaliphatic,  

cycloaliphatic-aliphatic, heterocyclic or heterocyclic-aliphatic radical,  and the remaining radicals R4, R5, R6, R7 and R8 are each independently of the others hydrogen, lower alkyl that is  

unsubstituted or substituted by free  or alkylated amino,  piperazinyl,  piperidinyl,  pyrrolidinyl or by morpholinyl,  or  lower   alkanoyl, trifluoromethyl, free, etherified or esterifed hydroxy, free, alkylated or acylated amino or free or esterified carboxy,  

and to salts of such compounds having at least one salt-forming group.

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brain purified in accordance with the procedure described by T. Uchida and C.  R. Filburn in J. Biol. Chem. 259, 12311-4 (1984) is used. The protein kinase C- inhibiting activity of the compounds of formula I is determined by the method  of D. Fabbro et at., Arch. Biochem. Biophys. 239, 102-111 (1985). In that test  the compounds of formula I inhibit protein kinase C at a concentration IC50 of  as low as approximately from 0.1 to 10 µmol/liter, especially approximately  from 0.05 to  5 µmol/liter.  On the other  hand,  the compounds of  formula  I  inhibit  other  enzymes,  for  example  protein  kinase  A,  phosphorylase  protein  kinase and certain types of tyrosine protein kinase, for example the tyrosine  protein kinase of EGF (epidermal growth factor) receptors, only at a far higher  concentration,  for  example  100  times  higher.  That  is  an  indication  of  the  selectivity of the compounds of formula I. With a view to reducing undesired  side effects, it is important for the protein kinase C-inhibitors to be as selective  as possible, i.e. inter alia to have as little effect as possible on other enzymes,  especially  when  the  effect  of  the  activity  of  those  other  enzymes  has  no  equivalent or synergistic effect on the disease to be treated.  xxx

As might already be expected on the basis of the inhibiting action on protein  kinase C described above, the compounds of formula I wherein R4  and R8 are  hydrogen, and their pharmaceutically acceptable salts,  have anti-proliferative  properties which can be demonstrated directly in the following, different test. In  that  test  the  inhibiting action  of  compounds of  formula  I  on the growth of  human T24 bladder carcinoma cells is determined…”

It was also stated:

“The  tumour-inhibiting  activity  of  the  compounds  of  formula  I  can  also  be  demonstrated in vivo. The  tumour-inhibiting  activity  is  determined  using  female  Balb/c  nude  mice  in  which human T24 bladder carcinoma has been transplanted…”

The application further claimed:

“Owing to the properties described, compounds of formula I can be used not  only  as  tumour-inhibiting  active  ingredients  but  also  as  drugs  against  non- malignant  proliferative  diseases,  e.g.  atherosclerosis,  thrombosis,  psoriasis,  sclerodermitis and fibrosis. They are also suitable for the further applications  mentioned above for protein kinase C-modulators and can be used especially in  the  treatment  of  diseases  that  respond  to  the  inhibition  of  PDGF-receptor  kinase. Some  of  the  compounds  of  formula  I,  e.g.  N-[3-(1,1,2,2-  tetrafluoroethoxy)phenyl]-4-(3-indolyl)-2-pyrimidine-amine,  furthermore  inhibit  the tyrosine kinase activity  of  the receptor  for  the epidermal growth  factor (EGF). This receptor-specific enzyme activity is a key factor in the signal  transmission in a host of mammalian cells, including human cells, especially

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epithelial  cells,  cells  of  the  immune  system  and  cells  of  the  central  and  peripheral nervous system.”

It was also said in the application:

“These compounds of formula I, which inhibit the tyrosine kinase activity of  the receptor for the epidermal growth factor (EGF) are therefore useful, inter  alia, for the treatment of benign or malignant tumours. They are able to effect  tumour  regression  and  to  prevent  metastasic  spread  and  the  growth  of  micrometastases.  In  particular,  they  can  be  used  for  treating  epidermal  hyperproliferation (psoriasis), for treating neoplasms of epithelial character, e.g.  mastocarcinomas, and leucemias. In addition, the compounds of formula I are  useful for treating diseases of the immune system and inflammations, subject to  the involvement of protein kinases. These compounds of formula I can also be  used for treating diseases of the central or peripheral nervous system, subject to  the involvement of signal transmission by protein kinases.”

It was further stated in the application:

“Acid addition salts can be convened into the free compounds in customary  manner, for example by treatment with a suitable basic agent. xxx

The processes described above, including the processes for removing protecting  groups and the additional process steps, are, unless otherwise indicated, carried  out  in a manner known per se,  for example in the presence or absence of  preferably  inert  solvents  and  diluents,  if  necessary  in  the  presence  of  condensation agents or catalysts…”

It was also affirmed in the application:

“The  invention  relates  also  to  a  method  of  treating  warm-blooded  animals  suffering from a tumoral disease,  which comprises administering to warm- blooded animals requiring such treatment an effective, tumour-inhibiting  amount of a compound of formula I or of a pharmaceutically acceptable  salt thereof… Effective doses, for example daily doses of approximately from  1 to  1000 mg,  especially  from 50 to 500 mg,  are  administered  to  a  warm- blooded animal of approximately 70 kg body weight according to species, age,  individual condition, mode of administration and the individual syndrome. The  invention  relates  also  to  pharmaceutical  compositions  comprising  an  effective amount, especially an amount effective in the prevention or therapy of  one of the above-mentioned diseases,  of the active ingredient together with  pharmaceutically acceptable carriers that are suitable for topical, enteral,  for  example  oral  or  rectal,  or  parenteral  administration,  and  may  be  inorganic  or  organic,  solid  or  liquid.  For oral  administration there  are  used especially tablets or gelatin capsules comprising the active ingredient

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together  with diluents,  for  example lactose,  dextrose,  sucrose,  mannitol,  sorbitol, cellulose and/or glycerol… Tablets may also comprise binders, for  example magnesium aluminium silicate, starches, such as corn, wheat or rice  starch,  gelatin,  methylcellulose,  sodium  carboxymethylcellulose  and/or  polyvinylpyrrolidone, and, if desired, disintegrators, for example starches, agar,  alginic  acid  or  a  salt  thereof,  such  as  sodium alginate,  and/or  effervescent  mixtures, or adsorbents, dyes, flavourings and sweeteners.”

112. The application gave examples to illustrate the invention, making it clear at the same  

time that those illustrations did not limit the invention in any way.   Example 21, which  

admittedly relates to Imatinib, the “e-duct” for the subject product, is as under:

“EXAMPLE 21 Analogously  to  Example  20,  N-{5-[4-(4-methyl-piperazinomethyl)- benzoylamido]-2-methylphenyl}-4-(3-pyridyl)-2-pyrimidine-amine is  prepared  from 10.68 g (32.8 mmol) of 4-(4-methyl-piperazinomethyl)-benzoyl chloride;  m.p. 211º-213º, Rf =0.33 (methylene chloride:methanol: 25% aqueous ammonia  solution=95:5:1).”

Examples 35 to 37 were in respect of tablets in different doses.  

113. In the claim at the end of the application under serial no. 23, it was stated as follows:

“The compound according to claim 1 of the formula I, said compound being N- {5-[4-(4-Methyl-piperazino-methyl)-benzoylamido]-2-methyl-phenyl}-4-(3- pyridyl)-2-pyrimidine-amine or a pharmaceutically acceptable salt thereof.”

(emphasis added)

114. The US Patent No. 5,521,184 (the Zimmermann patent) was granted on May 28,  

1996.

115. Later,  the  appellant  made the  application  for  patent  for  beta  crystalline  form of  

Imatinib Mesylate (the subject of the present appeals) in the US on January 18, 2000. The  

US patent for beta crystalline form of Imatinib Mesylate was granted to the appellant about  

five and a half years later on May 17, 2005 following the order of the US Appellate Court  

dated November 23, 2003. It is, however, interesting to note that Gleevec, the drug was  

launched much earlier in the market, on the basis of the Zimmermann patent itself.

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116. On April 9, 1998, the appellant filed the Investigational New Drug Application (IND  

# 55,666) for Gleevec and on February 27, 2001, the original New Drug Application (NDA  

# 21-335) before the Food and Drug Administration (FDA), USA, for Imatinib Mesylate,  

formerly  STI571,  CGP57148B  (capsules)  for  the  treatment  of  patients  with  Chronic  

Myeloid Leukemia. The application contained results of extensive preclinical,  technical  

and clinical research, and it stated as under:

“The  clinical  studies  discussed  in  this  NDA  include  one  multiple  dose  tolerability/dose-finding  study  (phase  I)  and  three  large  open,  uncontrolled  efficacy and safety studies (phase II), as an accelerated development to allow  early registration in CML patients. A total of 1234 patients with CML and other  Ph+ leukemias have been enrolled in  these trials.  The results  of  the Glivec  studies are discussed in the perspective of the current state of knowledge in the  treatment of CML as described with a comprehensive review of the literature  for  each  target  population  (Appendix  4-6  of  the  Integrated  Summary  of  Efficacy).”

117. In the patent information furnished in connection with the NDA as required under  

(US Code) 21 C.F.R. § 314.53, the active ingredient of the drug was stated as Imatinib  

Mesylate.  The  Drug  Substance1 (active  ingredient),  Drug  Product2  

(composition/formulation) and method of use were declared to be covered by US Patent  

No. 5,521,184 (i.e. the Zimmermann patent). It was further declared that the United States  

Patent  No.  5,521,184  covered  the  composition,  formulation,  and/or  method  of  use  of  

Imatinib Mesylate (STI571).  

118. In the chemistry review(s) of the NDA # 21-335 (drug approval for capsules) made  

on March 27, 2001, there was again a reference to US Patent # 5,521,184 (expiration date –  

5/28/2013).

1  21  Code  of  Federal  Regulations  s  314.3:  Drug  substance means  an  active  ingredient  that  is  intended  to  furnish  pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to   affect the structure or any function of the human body, but does not include intermediates use in the synthesis of such  ingredient.  

2  21 Code of Federal Regulations s 314.3:  Drug product means a finished dosage form, for example, tablet, capsule, or  solution, that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients.

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119. The FDA approval for the drug Gleevec (Imatinib Mesylate) 50 mg and 100 mg  

capsules  was  granted  vide  Letter  dated  May  10,  2001.3 Following  this,  the  drug  was  

commercially launched in the market long before the grant of patent for beta crystalline  

form of Imatinib Mesylate.  

120. In the package insert of Gleevec™ (Imatinib Mesylate capsules) the description of  

the drug was stated as follows:

“GLEEVEC™ capsules  contain  imatinib  mesylate  equivalent  to  100  mg of  imatinib free base. Imatinib mesylate is designed chemically as 4-[(4-Methyl-1- piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]- phenyl]benzamide methanesulfonate…”

121. After the grant of drug approval for Gleevec, on July 3, 2001, the appellant made a  

Patent Term Extension Application for the Zimmermann patent (US Patent No. 5,521,184)  

under 35 USC § 156(g)(1)(B), for extending the term of the patent for the time taken in the  

regulatory review for Gleevec. This application leaves no room for doubt that Imatinib  

Mesylate, marketed under the name Gleevec, was submitted for drug approval as covered  

by the Zimmermann patent. In column 4 of the application, it was stated that the sole active  

ingredient in Gleevec is Imatinib Mesylate. Further, it was stated that Imatinib, or any salt   

thereof, including Imatinib Mesylate, had not previously been approved for commercial  

marketing under the Federal Food, Drug and Cosmetic Act prior to the approval of NDA #  

21-235. In column 9 of the application, it was stated as under:

“(9)  Statement Showing How the Claims of the Patent for Which Extension is  Sought Cover the     Approved Product:   The operative claims in question are Claims 1-5, 10-13, and 21-23. Each of claims  1-5, 10-13 and 23 claim a compound or compounds which include the approved  product, imatinib mesylate. Claim 21 claims a composition containing a compound  or compounds which include the approved product,  imatinib mesylate.  Claim 22  

3  Later on the appellant also got the drug approval vide letter dated April 18, 2003 in NDA # 21-588 granting approval to   commercially market Gleevec (Imatinib Mesylate) Tablets, 100 mg and 400 mg. Needless to say that in regard to the tablet   as well the reference is to the Zimmermann patent.  

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claims a method of treating tumors in warm-blooded animals with a compound or  compounds which include the approved product, imatinib mesylate.”

122. The application was accepted and the term of the patent, which was due to expire on  

May 28, 2013, was extended for the period of 586 days.  

123. It is noted above that the appellant had made an application no. 09/463,097 in the  

USA for grant of patent for beta crystalline form of Imatinib Mesylate. The application  

was rejected by the examiner and, against the examiner’s decision, the appellant preferred  

an  appeal  (that  is,  appeal  no.  2003-0919)  before  the  Board  of  Patent  Appeals  and  

Interferences. The Board of Patent Appeals, by its judgment and order dated November 23,  

2003, allowed the appellant’s appeal and reversed the examiner’s decision, rejecting claims  

1 through 8, 10, and 13 through 16. Dealing with the examiner’s rejection of appellant’s  

claim 14 under 35 USC § 112, the Board of Patent Appeals referred to claims 21 and 22 of   

the Zimmermann patent. With reference to those claims in the Zimmermann patent, the  

Board of Patent Appeals observed and held as under:

“Under the provisions 35 U.S.C. § 282, a patent shall be presumed valid; and  each claim of a patent shall be presumed valid independently of the validity of  other claims. Accordingly,  claims  21  and  22  of  the  U.S.  Patent  No.5,521,184  (the  Zimmermann patent), shall be presumed valid.  We may presume, therefore,  that claims 21 and 22 are based on an enabling disclosure; and that the  specification of the Zimmermann patent teaches any person skilled in the  art how to use a compound of formula I, or a pharmaceutically acceptable  salt thereof, in a pharmaceutical composition for treating tumours or in a  method  of  treating  warm-blooded  animals  suffering  from  a  tumoral  disease. In claim 23, Zimmermann recites imatinib, a specific compound  within  the  scope  of  formula  I,  or  a  pharmaceutically  acceptable  salt  thereof. In light of 35 U.S.C. § 282, therefore, we may presume that the  specification of the Zimmermann patent teaches any person skilled in the  art how to use imatinib, or a pharmaceutically acceptable salt thereof, in a  pharmaceutical  composition  for  treating  tumours  or  in  a  method  of  treating warm-blooded animals suffering from a tumoral disease. On these  facts, we disagree that the examiner has set forth adequate reasons or evidence

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to doubt the objective truth of statements in applicants’ specification that an  effective  amount  of  the    β−  crystal  form  of  imatinib  mesylate   may  be  administered  to  a  patient  as  the  manipulative  step  in  a  method for  treating  tumour disease in a patient. The rejection under 35 U.S.C. § 112, first paragraph, is reversed.”

(emphasis added)

124. From the above passage from the judgment, it is evident that, according to the Board  

of Patent Appeals, the Zimmermann patent teaches any person skilled in the art how to use  

Imatinib, a compound of formula I,  or a pharmaceutically acceptable salt  thereof,  in a  

pharmaceutical composition for treating tumours or in a method of treating warm-blooded  

animals suffering from a tumoral disease. However, the Board of Patent Appeals held that  

the teaching in the Zimmermann patent did not go beyond Imatinib Mesylate and did not  

extend to beta crystalline form of Imatinib Mesylate, which represented a  manipulative  

step1 in a method of treating tumor disease in a patient.  

125. Further, NATCO Pharma Ltd., one of the Objectors to the grant of patent to the  

appellant in this country, had marketed a drug called VEENAT 100 (capsules) in the UK.  

A legal notice on behalf of the appellant was given to NATCO Pharma Ltd. on February  

13, 2004. The notice stated that the appellant was the proprietor of European patent EP-A-  

0 564 409 (the Zimmermann patent) and that this patent claimed, among other things, the  

compound Imatinib and acid addition salts of that compound such as the Mesylate salt. In  

the notice it was pointed out that NATCO Pharma Ltd. was selling, in the UK market,  

VEENAT  100  capsules,  the  active  pharmaceutical  ingredient  of  which  was  Imatinib  

Mesylate as claimed in the Zimmermann patent. The importation, sale and offer to sell  

VEENAT 100 capsules in the UK market infringed the Zimmermann patent and NATCO  

1  Not an “inventive step”! A “manipulative step” may or may not be an “inventive step”, which is the requirement under  Indian law.

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Pharma  Ltd.  was  therefore  warned  to  immediately  cease  the  importation,  sale  and  

promotion of VEENAT 100 capsules and other pharmaceutically substances containing  

“Imatinib”. The matter was finally settled out of court, we are told, at considerable expense  

to NATCO Pharma Ltd. which of course had to stop marketing its drug VEENAT 100  

capsules in the UK.  

126. From the above discussion it would be clear that the drug Gleevec directly emanates  

from the Zimmermann patent and comes to the market for commercial sale. Since the grant  

of the Zimmermann patent, the appellant has maintained that Gleevec (that is, Imatinib  

Mesylate) is part of the Zimmermann patent. It obtained drug approval for Gleevec on that  

basis.  It  claimed  extension  of  the  term  of  the  Zimmermann  patent  for  the  period  of  

regulatory review for  Gleevec,  and it  successfully  stopped NATCO Pharma Ltd.  from  

marketing  its  drug  in  the  UK on  the  basis  of  the  Zimmermann  patent.  Not  only  the  

appellant but the US Board of Patent Appeals,  in its judgment granting patent for beta  

crystalline form of Imatinib Mesylate, proceeded on the basis that though the beta crystal  

form might not have been covered by the Zimmermann patent, the Zimmermann patent  

had the teaching for the making of Imatinib Mesylate from Imatinib, and for its use in a  

pharmacological  compositions  for  treating  tumours  or  in  a  method  of  treating  warm-

blooded animals suffering from a tumoral disease. This finding was recorded by the US  

Board of Patent Appeals, in the case of the appellant itself, on the very same issue that is  

now under consideration. The appellant is, therefore, fully bound by the finding and cannot  

be heard to take any contrary plea.      

127. We have looked, so far, at the Zimmermann patent and the developments that have  

taken place on its basis. We now propose to take a look at certain publications. A journal

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called  Cancer Research, in its issue of January 1996, published an article under the title  

“Inhibition  of  the  Abl  Protein-Tyrosine  Kinase  in  Vitro  and  in  Vivo  by  a  2-

Phenylaminopyrimidine  Derivative”.  This  article  was  authored  by  several  people,  

including Jürg Zimmermann. In this article there is a detailed discussion about the anti-

tumoral properties of Imatinib and its methanesulfonate salt, i.e., Imatinib Mesylate. In the  

abstract at the beginning of the article, it is stated as under:

“ABSTRACT Oncogenic activation of Abl proteins due to structural modifications can occur  as  a  result  of  viral  transduction or  chromosomal  translocation.  The tyrosine  protein kinase activity of oncogenic Abl proteins is known to be essential for  their transforming activity. Therefore, we have attempted to identify selective  inhibitors of the Abl tyrosine protein kinase. Herein we describe an inhibitor  (CGP  571481)  of  the  Abl  and  platelet-derived  growth  factor  (PDGF)  receptor protein-tyrosine kinases from the 2-phenylaminopyrimidine class,  which is highly active in vitro and in vivo. Submicromolar concentrations of  the compound inhibited both v-Abl and PDGF receptor autophosphorylation  and  PDGF-induced  c-fos mRNA  expression  selectively  in  intact  cells.  …  Furthermore,  anchorage-independent  growth  of  v-abl-  and  v-sis-transformed  BALB/c 3T3 cells was inhibited potently by CGP 57148. When tested in vivo,  CGP 57148 showed antitumor activity at tolerated doses against tumorigenic v- abl- and v-sis- transformed BALB/c 3T3 cells. In contrast, CGP 57148 had no  antitumor activity when tested using src-transformed BALB/c 3T3 cells. These  findings  suggest  that  CGP  57148  may  have  therapeutic  potential  for  the  treatment of diseases that involve abnormal cellular proliferation induced by  Abl protein-tyrosine kinase deregulation or PDGF receptor activation.”

(emphasis added)  

128. Under the heading “MATERIALS AND METHODS”, it is stated as under:

“Materials. CGP 57148 and its methane sulfonate salt (CGP 57148B2) were  synthesized by CIBA Pharmaceuticals Division, as will be described elsewhere.  For  in vitro and cellular assays, a stock concentration of 10 mM CGP 57148  was  prepared in  Me2SO and  stored  at  –  20ºC.  No significant  difference  in  results could be seen between the two forms of CGP 57148. The form used in  in vitro experiments is indicated in the text and legends. All in vivo experiments  were performed using CGP 57148B. …”

1  Imatinib. 2  Imatinib Mesylate.

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129. The article goes on to discuss the in vivo experiments and the in vitro selectivity of  

CGP 57148 for inhibition of protein kinases: Identification of CGP 57148 as an inhibitor  

of v-Abl kinase.  The article also discussed the in vivo anti-tumour activity of CGP 57148B  

and it states as follows:

“In Vivo Antitumor Activity. The maximally tolerated dose for a single p.o. or i.p. administration of CGP  57148B in BALB/c mice was >500 mg/kg. BALB/c AMuLV and BALB/c 3T3  v–sis cells, which were sensitive in the colony-forming assay, were used to test  CGP 57148B for antitumor activity in female BALB/c nude mice. Once daily  i.p.  applications  of  50,  12.5,  or  3.13  mg/kg  CGP  57148B  given  for  30  consecutive  days  resulted  in  a  strong  antitumor  effect  against  AMuLV- transformed BALB/c 3T3 tumors (Fig. 5A). Similarly, anti-tumor experiments  using v–sis- transformed BALB/c 3T3 cells revealed dose-dependent antitumor  activity (Fig. 5B). Maximal T/C (X100%) values of 4% (AMuLV tumors) and  11% (v–sis tumors)  were obtained when CGP 57148B was  administered at  50mg/kg body weight. In contrast, CGP 57148B showed no antitumor activity  against  tumors  derived  from  NIH-527src cells  when  50  mg/kg  were  administered p.o. once daily for 30 days (T/C, 102%). Using the same route of  application,  T/C  values  of  7  and  22%  against  AMuLV  and  v–sis tumors,  respectively, were obtained when 50 mg/kg CGP 57148B were given.”

It is further stated in the article:

“CGP 57148 selectively inhibited the  in  vitro activity of  the v-Abl protein- tyrosine  kinase  and  showed  preferential  inhibition  of  v-Abl  autophosphorylation in cells. We have examined the specificity of CGP 57148  by  analyzing  its  effects  on  signal  transduction  via  different  tyrosine  kinase  receptor-mediated  pathways.  Although  the  ligand-induced  activation  of  the  EGF, bFGF, insulin, and IGF-1 receptor tyrosine kinases were not affected by  CGP 57148, the PDGF pathway was sensitive to inhibition by the compound.  The  antiproliferative  activity  of  CGP  57148  against  both  v-abl- and  v-sis-  transformed BALB/c 3T3 support the selectivity profile of CGP 57148 further.”

The article concludes by observing as follows:

“The reported findings with CGP 57148 suggest that it may be a development  candidate  for  use  in  the  treatment  of  Philadelphia  chromosome-positive  leukemias.  Additional  potential  applications  for  CGP  57148  may  include  proliferative diseases that involve abnormal PDGF receptor activation.”

130. Another article was published in Nature Medicine magazine of the year 1996 under

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the title “Effects of a selective inhibitor of the Abl tyrosine kinase on the growth of Bcr-

Abl  positive  cells”.  This  article,  too,  was  authored  by  several  people,  including  Jürg  

Zimmermann.  In this  article  also,  there  is  a  discussion  about  Imatinib as  a  compound  

designed to inhibit Abl protein tyrosine kinase.  

131. In the face of the materials referred to above, we are completely unable to see how  

Imatinib Mesylate can be said to be a new product, having come into being through an  

“invention” that has a feature that involves technical advance over the existing knowledge  

and that would make the invention not obvious to a person skilled in the art.  Imatinib  

Mesylate  is  all  there  in  the  Zimmermann  patent.  It  is  a  known  substance  from  the  

Zimmermann patent.  

132. That Imatinib Mesylate is fully part of the Zimmermann patent is also borne out  

from  another  circumstance.  It  may  be  noted  that  after  the  Zimmermann  patent,  the  

appellant applied for, and in several cases obtained, patent in the US not only for the beta  

and alpha crystalline forms of Imatinib Mesylate, but also for Imatinib in a number of  

different forms. The appellant, however, never asked for any patent for Imatinib Mesylate  

in non-crystalline  form, for the simple reason that it had always maintained that Imatinib  

Mesylate  is fully a  part  of  the Zimmermann patent  and does not  call  for  any separate  

patent.

133. We thus find no force in the submission that the development of Imatinib Mesylate  

from  Imatinib  is  outside  the  Zimmermann  patent  and  constitutes  an  invention  as  

understood in the law of patent in India.  

134. Mr.  Andhyarujina  and  Mr.  Gopal  Subramanium,  learned  Senior  Advocates  

appearing for the appellant, strenuously argued that the patent information furnished by the

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appellant before the US FDA, or its Patent Term Extension Application, or the legal notice  

given at its behest to NATCO Pharma Ltd. should not be construed to mean that Imatinib  

Mesylate was anticipated in the Zimmermann patent. Mr. Andhyarujina submitted that the  

Zimmermann patent did not disclose Imatinib Mesylate. The Zimmermann patent did not  

describe any working method for converting Imatinib to Imatinib Mesylate. It only stated  

that a salt may be formed by acid without disclosing any method, but simply calling the  

method to be “per se”. The Zimmermann patent mentioned multiple choices of compounds  

including  Imatinib  free  base  but  not  any  salt  of  any  compound,  much  less  Imatinib  

Mesylate. Mr. Andhyarujina further submitted that it is well settled that the disclosure of  

an invention must be in a manner clear enough and complete enough for the invention to  

be performed by a person skilled in the art (Terrell on Law of Patents 16th edition, page no.  

51, para 3.2/7). The learned counsel further submitted that there was a difference between  

that which is  covered and that which is  disclosed.  Imatinib Mesylate is  covered by the  

Zimmermann patent but not  disclosed  therein. He further submitted that, in any case, in  

patent law subsequent conduct of the patentee is irrelevant in construing the patent (Terrell  

on Law of Patent 16th edition, page no. 192 citing Glaverbel vs. British (1993) RPC 80).  

Referring to the two articles in Cancer Research and Nature Medicine, Mr. Andhyarujina  

submitted that though in the first article there was a reference to Imatinib Mesylate, there  

was no teaching as to how it is to be prepared. In the Nature Medicine article there was no  

reference to Imatinib Mesylate but only to Imatinib.

135. Mr.  Gopal  Subramanium submitted  that  the  Zimmermann patent  is  a  patent  for  

“Pyrimidine Derivatives and Processes for the Preparation thereof”. The patent is related to  

a genus of compounds, and each of the compounds within the genus shares a common

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chemical  structure  (Markush  structure)  and  common  properties  with  respect  to  the  

inhibition of certain tyrosine kinases (there being a total of 518 kinases in existence). Mr.  

Subramanium further submitted that the appellant in its application before the US Food  

and Drug Administration Authority had made a reasonable assertion that the Zimmermann  

patent  covers the  product  that  was  made  out  of  the  beta  crystalline  form of  Imatinib  

Mesylate,  i.e.,  Gleevec1.  Further,  on  the basis  of  the  US FDA approval,  the  appellant  

obtained  an  extension  of  the  period  of  protection  under  the  Zimmermann patent  with  

respect to Gleevec.

136. Mr. Subramanium further submitted that the scope of coverage is distinct from the  

scope of disclosure in a patent. Imatinib Mesylate could be said to be not new and known  

from the Zimmermann patent only in case there was a complete disclosure of the method  

of its preparation in the Zimmermann patent. The learned counsel strongly contended that  

coverage under a patent of the Markush kind cannot lead to any presumption of disclosure,  

much less any  enabling disclosure of all the compounds within the genus. The learned  

counsel further contended that coverage that is granted in respect of a patent is not always  

coextensive with what is  disclosed in that patent. In certain circumstances, where it is a  

pioneering invention (as in the case of the Zimmermann invention), the patent may be  

entitled to larger  coverage than what is specifically  disclosed in it. The learned counsel  

argued  that  coverage cannot  be  used  to  presume  an  enabling  disclosure of  the  beta  

crystalline  form  of  Imatinib  Mesylate  in  the  Zimmermann  patent.  Disclosure in  a  

specification can never be presumed, and that is a question of the clear teaching contained  

in  the  specification.  The  teaching  of  a  patent  lies  in  the  disclosure/specification that  

1  There is a factual error in the submission in as much as in the Drug Approval application before the US FDA the drug  Gleevec is represented as Imatinib Mesylate. Before the US FDA there is no reference to the beta crystalline form of   Imatinib Mesylate.   

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supports  the  claim.  The  disclosure describes  the  invention.  The claim defines  through  

language the various ways the invention could be used, i.e., possible but not actualized  

products. This is the scope of protection granted under the patent. For the purpose of prior  

art,  it  is  the  disclosure in  the  specification supporting  the  claim  and  not  the  written  

description or the claims themselves, that must be assessed. The claim can never be the  

teaching. He further contended that it would be wrong to say that the appellant’s claims for  

beta crystalline form of Imatinib Mesylate is a case of double or repeat patenting, that is,  

the same invention is being sought to be patented twice. The claim for patent for beta  

crystalline form of Imatinib Mesylate relates to a second and different invention. Though  

the invention in the first part (Imatinib) may be necessary to arrive at the invention in the  

second  part,  the  final  product  does  not  come  into  existence  without  inventions.  The  

principle is that if a product is  covered, it means that it infringes a patent. Whether the  

patent  infringed disclosed every aspect  of  the product in its  specification is  a separate  

inquiry.  

137. Mr.  Subramanium maintained that  the  boundary of  the  Zimmermann patent  was  

extended up to Imatinib Mesylate but the enablement or disclosure made therein ended at  

Imatinib.  He submitted that it was possible for Zimmermann himself, or for anyone else,  

to invent Imatinib Mesylate starting from Imatinib. The inventor of Imatinib Mesylate, be  

it Zimmermann or anyone else, would also be entitled to get patent for Imatinib Mesylate,  

but  in  case  the  inventor  was  anyone  other  than  Zimmermann,  he  would  require  

Zimmermann’s  permission  for  marketing  Imatinib  Mesylate,  since  Imatinib  had  the  

protection of the Zimmermann patent1.

138. The submissions of Mr. Andhyarujina and Mr. Subramanium are based on making a  

1  Blocking Patents!

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distinction between the coverage or claim in a patent and the disclosure made therein. The  

submissions on behalf of the appellant can be summed up by saying that the boundary laid  

out  by  the  claim  for  coverage is  permissible  to  be  much  wider  than  the  

disclosure/enablement/teaching in a patent.   

139. The dichotomy that is sought to be drawn between  coverage or claim on the one  

hand and  disclosure or  enablement or  teaching in a patent on the other hand, seems to  

strike at the very root of the rationale of the law of patent. Under the scheme of patent, a  

monopoly is granted to a private individual in exchange of the invention being made public  

so that, at the end of the patent term, the invention may belong to the people at large who  

may be benefited by it. To say that the  coverage in a patent might go much beyond the  

disclosure thus seem to negate the fundamental rule underlying the grant of patents.  

140. In India, section 10(4) of the Patents Act, 1970 mandates:

“Section 10. Contents of specifications.–  (4)  Every Complete specification  shall –

(a) fully and particularly describe the invention and its operation or use and  the method by which it is to be performed;

(b) disclose the best method of performing the invention which is known to  the applicant and for which he is entitled to claim protection; and

(c) end with a claim or claims defining the scope of the invention for which  protection is claimed;

(d) be accompanied by an abstract to provide technical information on the  invention:

Provided that – (i) the Controller may amend the abstract for providing better information to  third parties; …”

And, section 10(5) provides as under:

“(5) The claim or claims of a complete specification shall  relate to a single  invention, or to a group of inventions linked so as to form a single inventive  concept,  shall  be clear  and succinct  and shall  be fairly based on the matter  disclosed in the specification.”

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141. The UK Patents Act, 1977, in sub-sections (2), (3), and (5) of section 14, provides as  

under:

“Making of an application 14. – (2) Every application for a patent shall contain –

(a) a request for the grant of a patent; (b) a  specification  containing  a  description  of  the  invention,  a  claim  or  

claims and any drawing referred to in the description or any claim; and (c) an abstract;

but the foregoing provision shall not prevent an application being initiated by  documents complying with section 15(1) below. (3) The specification of an application shall disclose the invention in a manner  which is clear enough and complete enough for the invention to be performed  by a person skilled in the art. (5) The claim or claims shall –  

(a) define the matter for which the applicant seeks protection; (b) be clear and concise; (c) be supported by the description; and (d) relate to one invention or to a group of inventions which are so linked as  

to form a single inventive concept.”

142. Further, section 112(a) of the Title 35 of US Code provides as under:

“35 U.S.C. § 1121

(a) IN GENERAL.– The specification shall contain a written description of the  invention, and of the manner and process of making and using it, in such full,  clear,  concise,  and exact  terms as to enable any person skilled in the art  to  which it pertains, or with which it is most nearly connected, to make and use  the same, and shall set forth the best mode contemplated by the inventor or  joint inventor of carrying out the invention.”

143. Terrell  on  the  Law  of  Patents (Seventeenth  Edition,  2011)  in  Chapter  9:  

“Construction  of  the  Specification  and Claims”,  under  the  heading  “Principles  equally  

applicable to infringement and validity” states:

1  Recall that it is on the basis of this provision that the U.S. Board of Patent Appeals had held in the case regarding the  appellant’s claim for patent for beta crystalline form of Imatinib Mesylate that “in light of 35 U.S.C. § 282, therefore, we  may presume that the specification of the Zimmermann patent teaches any person skilled in the art how to use Imatinib, or a   pharmaceutically acceptable salt thereof,…”.

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“9.05 – Section 125(1) defines an “invention” as (unless the context otherwise  requires) that specified in a claim of the specification, and both validity (see  sections 1 to 4 and 72 of the Act) and infringement (see section 60) are to be  tested by reference to the “invention”. It is, of course, a fundamental principle  that the construction of a claim is the same whether validity or infringement is  to be considered; no patentee is entitled to the luxury of an “elastic” claim  which has a narrow meaning in the former case but a wide meaning in the  latter. Under  English  procedure,  infringement  and  validity  are  normally  litigated at the same time and therefore the court is astute to avoid such a result.  …”

(emphasis added)

144. Chisum  on  Patents:  A  Treatise  on  the  Law  of  Patentability,  Validity,  and   

Infringement (Vol. 3, June 2007) in Chapter: “Adequate Disclosure” notes:

“§ 7.03 – The Enablement Requirement Since 1790, the patent  laws have required that  the inventor set  forth in a patent  specification sufficient information to enable a person skilled in the relevant art to  make and use the invention. The “invention”  that  must  be  enabled  is  that  defined by the  particular  claim or  claims  of  the  patent  or  patent  application.  This  is  consistent  with  the  general  principle of patent law that the claim defines the invention for purposes of both  patentability and infringement.”

145. Nevertheless, both Mr. Andhyarujina and Mr. Subramanium strenuously argued that  

the coverage or the claim, and the disclosure or the teaching, have different parameters in a  

patent, and that the former may have an extended boundary within which  disclosure or  

teaching  may  be  confined  to  a  narrower  extent.  In  support  of  the  submission,  Mr.  

Andhyarujina relied upon a decision of the Court of Appeal in A.C. Edwards Ltd. v. Acme  

Signs & Displays Ltd.1 and another of the High Court of Justice Chancery Divisions Patent  

Court in Astellas Pharma Inc v. Comptroller-General of Patents2.

146. Mr. Gopal Subramanium strongly relied upon the decision of United States Court of  

1  [1992] R.P.C. 131 2  [2009] EWHC 1916 (Pat)

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Customs and Patent Appeals in In re Hogan1 in support of his contention.

147. In  Hogan, the Court of Customs and Patent Appeals held that a patent application  

that disclosed and enabled a method of making the crystalline form of polymer was entitled  

to a claim for the method of making a solid polymer, because the only known method for  

making a solid polymer at the time was the applicants’ method of making the crystalline  

form.  

148. The Hogan decision was rendered in a jurisdiction that has the historical background  

of Blocking Patents. Further, Hogan that relates to the saga of acrimonious litigation over  

the  claim of  priority  of  invention  for  crystalline  polypropylene  among five  competing  

companies was a rather unusual decision even in the US.

149. In Hogan,2 the Court of Custom and Patent Appeals had before it an appeal from the  

decision of the Board of Appeals, affirming the rejections by the Patent and Trademark  

Office (PTO) of the applicant’s claims 13-15 for “Solid Polymers of Olefins” under 35  

USC § 102, 103, 112 (first paragraph) and 132.   

150. The application, though filed in 1971, was in continuation of the first application  

filed on January 27, 1953. One of the main issues involved in the case was whether a “later  

state of the art” could be taken as evidence to support a rejection of the patent claim.  

151. Among the reasons given by the Board for rejecting the claim of the applicant was  

that the disclosure in the original 1953 Hogan and Banks’ application was not enabling,  

because the disclosure was limited to making crystalline polymers. But the claims which  

the Board rejected included an amorphous polymer as well, which was manifestly outside  

the scope of the enabling teaching present in the case. The Court of Customs and Patent  

1  559 F.2d 595 2  The following discussion on the Hogan decision is partially based on the article “Allocating Patent Rights Between Earlier  

and Later Inventions” by Charles W Adams, Professor of Law at the University of Tulsa College of Law, published in the   Saint Louis University Law Journal (Vol. 54-55, 2009, pp 56-112).

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Appeals reversed the decision of the Board of Patent Appeals, observing and holding as  

under:  

“The PTO has not challenged appellants’ assertion that their 1953 application  enabled those skilled in the art in 1953 to make and use “a solid polymer” as  described in claim 13. Appellants disclosed, as the only then existing way to  make such a polymer, a method of making the crystalline form. To now say that  appellants should have disclosed in 1953 the amorphous form which on this  record did not exist until 1962, would be to impose an impossible burden on  inventors and thus on the patent system. There cannot, in an effective patent  system,  be  such  a  burden  placed  on  the  right  to  broad  claims,  To  restrict  appellants to the crystalline form disclosed, under such circumstances, would  be a poor way to stimulate invention, and particularly to encourage its early  disclosure. To demand such restriction is merely to state a policy against broad  protection for pioneer inventions, a policy both shortsighted and unsound from  the  standpoint  of  promoting  progress  in  the  useful  arts,  the  constitutional  purpose of the patent laws.”

152. The Court seems to have taken the view that the amorphous form did not exist at the  

time of the patent application and therefore, that the patentee could not have been expected  

to claim the amorphous form at that time. The Court further took the view that the broad  

claim for a solid polymer would satisfy the enablement requirement under the state of the  

art,  as that was known at  the time of the filling of  the patent  application,  because the  

amorphous form was not known at that time. The Court observed:

“Consideration of a later existing state of the art in testing for compliance with  § 112, first paragraph, would not only preclude the grant of broad claims, but  would wreak havoc in other ways as well. The use of a subsequently-existing  improvement to show lack of enablement in an earlier-filed application on the  basic invention would preclude issuance of a patent to the inventor of the thing  improved, and in the case of issued patents, would invalidate all claims (even  some  “picture  claims”)  therein.  Patents  are  and  should  be  granted  to  later  inventors  upon  unobvious  improvements.  Indeed,  encouragement  of  improvements on prior inventions is a major contribution of the patent system  and the vast majority of patents are issued on improvements. It is quite another  thing,  however,  to  utilize  the  patenting  or  publication  of  later  existing  improvements  to  “reach  back”  and  preclude  or  invalidate  a  patent  on  the  underlying invention.”

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153. The polypropylene case in the US gave rise to an extraordinary legal precedent for  

the enablement requirement, according to which a patentee is free to claim a genus that  

includes  unknown  species  that  may  be  discovered  in  the  future,  if  the  specification  

describes  and  enables  all  the  species  that  are  known at  the  time  of  filing  the  patent  

application. The rationale on which the decision is based is described by Professors Merges  

and Duffy as the “temporal paradox”1.  The professors  explain that,  approached in this  

way, the description and enablement requirements for the genus are determined as of the  

date of filling the patent, and the patentee gets the benefit of any addition to the genus  

discovered later.  

154. It needs to be noted here that even in the US, Hogan represents a decision given in  

the  context  of  the  special  set  of  facts  and  circumstances  of  the  litigation  over  

polypropylene. In later decisions, the Federal Circuit appears to have drastically narrowed  

Hogan’s scope as a precedent. In Plant Genetics System, N.V. v. DeKalb Genetics Corp,2  

the effect of Hogan was considerably constricted and its effect is virtually eliminated in  

Chiron Corp.  v.  Genentech,  Inc3. Since  Chiron,  the Federal  Circuit  has not referred to  

Hogan  in  any of  its  cases  that  involve  claims to  a  genus  where  a  single  species  was  

enabled.

155. Mr. Subramanium refers to the  Hogan decision in order to support his contention  

that the Zimmermann patent is a patent covering a genus with certain known species, and  

many other species that were unknown at that time, but which are equally covered by the  

patent, even though there is no enabling disclosure in the patent in respect thereof. But it is   

1  Apart from the Hogan Decision, Mr. Subramanium also relied upon the relevant passage under the heading “Enablement   and the Temporal Paradox” from the book “Patent Law and Policy: Cases and Materials” (Fifth Edition) by Robert Patrick   Merges and John Fitzgerald Duffy…at pg. 298- 300   

2   315 F. 3d 1335, 1341 (Fed. Cir. 2003) 3   363 F. 3d 1247, 1257 (Fed. Cir. 2004)

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already  found and  held  earlier  that  Imatinib  Mesylate  is  a  known substance  from the  

Zimmermann patent. The finding that Imatinib Mesylate is a known substance from the  

Zimmermann patent is not based on the conduct of the appellant alone, as objected to by  

Mr. Andhyarujina, but the finding has been arrived at on an objective consideration of all  

the material facts and circumstances. In view of that finding, we fail to see any application  

of the Hogan decision to the facts of the case. We have also considered the two decisions  

relied upon by Mr. Andhyarujina. Those two decisions also have no application to the facts  

of the present case, for the same reason as in case of Hogan.

156. However, before leaving Hogan and proceeding further, we would like to say that in  

this country the law of patent,  after the introduction of product patent  for all  kinds of  

substances in the patent regime, is in its infancy. We certainly do not wish the law of  

patent  in this country to develop on lines where there may be a vast  gap between the  

coverage and the disclosure under the patent; where the scope of the patent is determined  

not on the intrinsic worth of the invention but by the artful drafting of its claims by skillful  

lawyers, and where patents are traded as a commodity not for production and marketing of  

the patented products but to search for someone who may be sued for infringement of the  

patent.

157. In light of the discussions made above, we firmly reject the appellant’s case that  

Imatinib  Mesylate  is  a  new  product  and  the  outcome  of  an  invention  beyond  the  

Zimmermann patent. We hold and find that Imatinib Mesylate is a known substance from  

the Zimmermann patent itself. Not only is Imatinib Mesylate known as a substance in the  

Zimmermann  patent,  but  its  pharmacological  properties  are  also  known  in  the  

Zimmermann patent and in the article published in the Cancer Research journal referred to

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above. The consequential finding, therefore, is that Imatinib Mesylate does not qualify the  

test of “invention” as laid down in section 2(1)(j) and section 2(1)(ja) of the Patents Act,  

1970.

158. This leaves us with the beta crystal form of Imatinib Mesylate, which, for the sake of  

argument,  may  be  accepted  to  be  new,  in  the  sense  that  it  is  not  known  from  the  

Zimmermann patent. (Whether or not it involves an “inventive step” is another matter, and  

there is no need to go into that aspect of the matter now). Now, the beta crystalline form of  

Imatinib  Mesylate  being  a  pharmaceutical  substance  and  moreover  a  polymorph  of  

Imatinib  Mesylate,  it  directly  runs  into  section  3(d)  of  the  Act  with  the  explanation  

appended to the provision. Mr. Subramanium, however, contended that section 3(d) has no  

application in this case. The main ground on which he denied the applicability of section  

3(d) to decide the question of grant of patent to the beta crystalline form of the Imatinib  

Mesylate  is  earlier  held  to  be  untenable.  He,  however,  questioned the  applicability  of  

section 3(d) on another ground. Mr. Subramanium submitted that in order to attract section  

3(d), the subject product must be a new form of a known substance having known efficacy.  

The learned counsel laid some stress on the expression “known” that equally qualifies the  

substance  of  which the subject  product  may be another form, and the efficacy of  that  

substance. The learned counsel submitted that a “conceivable” substance is not a “known  

substance” within the meaning of the provision. He contended that the word “known” here  

connotes  proven  and  well-established;  “known  efficacy”  implies  efficacy  established  

empirically  and  proven  beyond  doubt.  He  further  contended  that  neither  Imatinib  nor  

Imatinib Mesylate had any known efficacy and that, therefore, there was no question of  

showing that the beta crystalline form of Imatinib Mesylate had any enhanced efficacy

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over Imatinib or Imatinib Mesylate.  

159. There  is  no  sanction  to  construe  the  expression  “known”  in  section  3(d)  in  the  

manner suggested by Mr. Subramanium, and the submission is unacceptable both in law  

and on facts.  It may be noted here that clauses (e) and (f) of section 64(1) of the Act,  

which  contain  two  of  the  grounds  for  revocation  of  patents,  also  use  the  expression  

“publicly known”.  The expression “publicly known” may normally be construed more  

widely  than  “known”,  and  in  that  sense  it  is  closer  to  the  submission  made  by  Mr.  

Subramanium.  But  even  the  expression  “publicly  known”  received  quite  the  opposite  

interpretation by this Court in Monsanto Company v. Coramandal Indag Products (P) Ltd.1  

In paragraph 6 of the judgment, Justice Chinnappa Reddy, speaking for the Court, held and  

observed as under:

“…To satisfy the requirement of being publicly known as used in clauses (e)  and (f) of Section 64(1), it is not necessary that it should be widely used to the  knowledge of the consumer public. It is sufficient if it is known to the persons  who are engaged in the pursuit of knowledge of the patented product or process  either as men of science or men of commerce or consumers. The section of the  public,  who,  as  men  of  science  or  men  of  commerce,  were  interested  in  knowing about Herbicides which would destroy weeds but not rice, must have  been aware of the discovery of Butachlor. There was no secret about the active  agent  Butachlor  as  claimed  by  the  plaintiffs  since  there  was  no  patent  for  Butachlor, as admitted by the plaintiffs. Emulsification was the well-known and  common process by which any herbicide could be used. Neither Butachlor nor  the process of emulsification was capable of being claimed by the plaintiff as  their exclusive property. The solvent and the emulsifier were not secrets and  they were admittedly not secrets and they were ordinary market products. From  the beginning to the end, there was no secret and there was no invention by the  plaintiffs. The ingredients, the active ingredients the solvent and the emulsifier,  were known; the process was known, the product was known and the use was  known. The plaintiffs were merely camouflaging a substance whose discovery  was known through out the world and trying to enfold it in their specification  relating to Patent Number 125381. The patent is, therefore, liable to be revoked.  …”

1  (1986) 1 SCC 642

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160. On facts also we are unable to accept that Imatinib Mesylate or even Imatinib was  

not a known substance with known efficacy. It is seen above that Imatinib Mesylate was a  

known substance from the Zimmermann patent. In the NDA submitted by the appellant  

before the US FDA, it was clearly stated that the drug had undergone extensive preclinical,  

technical  and  clinical  research.  The  clinical  studies  included  one  multiple  dose  

tolerability/dose-finding study (Phase I) and three large open, uncontrolled efficacy and  

safety studies (Phase II); and a total of 1,234 patients with CML and other Ph+ leukemias  

were enrolled in the studies. The efficacy of Imatinib was equally known, as is evident  

from the Zimmermann patent itself, besides the two articles referred to above.  

161. The  subject  product,  that  is,  beta  crystalline  form of  Imatinib  Mesylate,  is  thus  

clearly a new form of a known substance, i.e., Imatinib Mesylate, of which the efficacy  

was well known.  It, therefore, fully attracts section 3(d) and must be shown to satisfy the  

substantive provision and the explanation appended to it.  

162. We now proceed to examine how far the beta crystalline form of Imatinib Mesylate  

stands up to the test of section 3(d) of the Act. It is noted, in the earlier part of judgment,  

that the patent application submitted by the appellant contains a clear and unambiguous  

averment that all the therapeutic qualities of beta crystalline form of Imatinib Mesylate are  

also possessed by Imatinib in free base. The relevant extract from the patent application is  

once again reproduced here:

“It  goes  without  saying  that all  the  indicated  inhibitory  and  pharmacological  effects  are  also  found  with  the  free  base,  4-(4- methylpiperazin-1-ylmethyl)-N-[4-methyl-3-(4-pyridin-3-yl)  pyrimidin-2- ylamino)phenyl] benzamide,  or other cells thereof.   The present invention  relates especially to the  β−crystal form of the methanesulfonic acid addition  salt of a compound of formula I in the treatment of one of the said diseases or  in the preparation of a pharmacological agent for the treatment thereto.”

(emphasis added)

Page 85

163. Now, when all the pharmacological properties of beta crystalline form of Imatinib  

Mesylate  are  equally possessed by Imatinib in  free base form or  its  salt,  where is  the  

question of the subject product having any enhanced efficacy over the known substance of  

which it is a new form?     

164. It  may also be stated here that while going through the Zimmermann patent one  

cannot but feel that it relates to some very serious, important and valuable researches. The  

subject patent application, on the other hand, appears to be a loosely assembled, cut-and-

paste job, drawing heavily upon the Zimmermann patent. As a matter of fact, Mr. Kuhad,  

learned Additional Solicitor General, submitted before us a tabular chart showing over a  

dozen statements and averments made in the subject application that are either lifted from  

the  Zimmermann  patent  or  are  very  similar  to  corresponding  statements  in  the  

Zimmermann  patent.  The  aforesaid  chart  is  appended  at  the  end  of  the  judgment  as  

Appendix II.

165. It further needs to be noted that, on the issue of section 3(d), there appears to be a  

major weakness in the case of the appellant. There is no clarity at all as to what is the  

substance immediately preceding the subject product, the beta crystalline form of Imatinib  

Mesylate. In course of the hearing, the counsel appearing for the appellant greatly stressed  

that, in terms of invention, the beta crystalline form of Imatinib Mesylate is two stages  

removed  from  Imatinib  in  free  base  form.  The  same  is  said  in  the  written  notes  of  

submissions filed on behalf of the appellant. But this position is not reflected in the subject  

application, in which all the references are only to Imatinib in free base form (or to the  

alpha crystalline form of Imatinib Mesylate in respect of flow properties, thermodynamic  

stability  and  lower  hygroscopicity).  On  going  through  the  subject  application,  the

Page 86

impression  one  gets  is  that  the  beta  crystalline  form of  Imatinib  Mesylate  is  derived  

directly from Imatinib free base. This may, perhaps, be because once the beta crystalline  

form of the methanesulfonic acid salt of Imatinib came into being, the Imatinib free base  

got  seeded with the nuclei  of  Imatinib Mesylate  beta crystalline form and, as  a result,  

starting from Imatinib one would inevitably arrive directly at the beta crystalline form of  

Imatinib Mesylate. But all this is nowhere said in the subject application.

166. Apart  from the  subject  application,  the  appellant  filed  four  affidavits  before  the  

Controller.  Two  of  the  affidavits  are  meant  to  explain  and  refute  the  results  of  the  

experiments  conducted  by  the  IICT  at  the  instance  of  one  of  the  objectors,  NATCO  

Pharma Ltd. But the other two, one by Paul William Manley, dated July 22, 2005, and the  

other  by  Giorgio  Pietro  Massimini,  dated  __September  2005,  were  filed  to  meet  the  

requirements  of  section  3(d),  which  was  amended  while  the  application  lay  in  the  

“mailbox”.  

167. Massimini, in paragraph 8 of the affidavit, explained that it was being filed to meet  

the conditions under section 3(d) of the Act. He stated that the proviso to section 3(d) was  

unique to India and there was no analogous provision in any other country of the world.  

The appellant was, therefore, never called upon to satisfy the tests laid down in section  

3(d) of the Act to establish the patentability of the patent subject. He further stated that  

since no occasion to do so had arisen earlier, no study relating to the efficacy of the free  

base was carried out in the past. Upon coming to know the requirement of section 3(d), the  

deponent,  asked by the appellant,  immediately commenced such a study, ensuring that  

accuracy and universally accepted scientific and ethical guidelines were not sacrificed.  

168. Manley, in paragraph 8 of his affidavit, stated:

Page 87

“The physical properties of the Free Base and imatinib mesylate differ in that  the Free Base is only very slightly soluble in water (0.001 g/100 ml) while  imatinib mesylate is very soluble in water (beta crystalline form: 130 g/100 ml).  Other physical characteristics of the subject compound are described at pages 2  – 3 of the specification. The attendant advantages because of these properties  are also simultaneously described therein. These characteristics and hence the  attendant properties/advantages are not shared by the Free Base. Furthermore,  the Beta form significantly differs from the alpha form: Physical attributes: (a) The beta crystal form has substantially more beneficial flow properties and  

thus results in better processability than the alpha crystal form. (b) The  beta-crystal  form  of  the  methanesulfonic  acid  addition  salt  is  the  

thermodynamically more stable form at room temperature. Greater stability  is thus to be expected.

(c) The beta-crystal form is less hygroscopic than the alpha-crystal form of the  methanesulfonic acid addition salt of a compound of formula I.

(d) The lower hygroscopicity is a further advantage for processing and storing  the acid addition salt in the beta-crystal form.”

(emphasis added)

169. Massimini, in paragraph 9 of his affidavit stated:

“A study conducted in rats provided statistical evidence for a difference in the  relative  bioavailability  of  the  Free  Base  and  Imatinib  mesylate  in  the  beta  crystalline  form.  In  such  study,  a  mean  AUC  (0-48h)  value  of  264.000  h*ng/mL was found for the Free Base compared with a mean AUC (0-48h)  value of 344000 h*ng/mL for Imatinib mesylate having the beta crystal form.  In other words, an about 30% improvement in bioavailability was observed for  the beta crystalline for of Imatinib mesylate compared to the Free Base. The  test results are attached herewith as Annexure “A”.”

170. It is to be noted that the higher solubility of the beta crystalline form of Imatinib  

Mesylate is being compared not to Imatinib Mesylate but, once again, to Imatinib in free  

base form. The whole case of the appellant, as made out in the subject application and the  

affidavits, is that the subject product, the beta crystalline form of Imatinib Mesylate, is  

derived from Imatinib, and that the substance immediately preceding the beta crystalline  

form is not Imatinib Mesylate but Imatinib in free base form. This position is sought to be

Page 88

canvassed in the subject application and the affidavits on the premise that the Zimmermann  

patent ended at Imatinib in free base and did not go beyond to Imatinib Mesylate. Not only  

is  this  premise  unfounded  as  shown earlier,  but  the  appellant  itself  appears  to  take  a  

somewhat different stand, as before this Court it was contended that the subject product, in  

terms of invention, is two stages removed from Imatinib in free base, and the substance  

immediately preceding the subject product is Imatinib Mesylate (non-crystalline).

171. That being the position, the appellant was obliged to show the enhanced efficacy of  

the beta crystalline form of Imatinib Mesylate over Imatinib Mesylate (non-crystalline).  

There is, however, no material in the subject application or in the supporting affidavits to  

make any comparison of efficacy, or even solubility, between the beta crystalline form of  

Imatinib Mesylate and Imatinib Mesylate (non-crystalline).

172. As regards the averments made in the two affidavits, for all one knows the higher  

solubility that is attributed to the beta crystalline form of Imatinib Mesylate may actually  

be a property of Imatinib Mesylate itself. One does not have to be an expert in chemistry to  

know that salts normally have much better solubility than compounds in free base form. If  

that be so, the additional properties that may be attributed to the beta crystalline form of  

Imatinib Mesylate would be limited to the following:

i. More beneficial flow properties,

ii. Better thermodynamic stability, and

iii. Lower hygroscopicity

173. The aforesaid properties, (“physical attributes” according to Manley), would give the  

subject product improved processability and better and longer storability but, as we shall  

see presently, on the basis of those properties alone, the beta crystalline form of Imatinib

Page 89

Mesylate certainly cannot be said to possess enhanced efficacy over Imatinib Mesylate, the  

known substance immediately preceding it, within the meaning of section 3(d) of the Act.  

174. We have so far considered the issue of enhanced efficacy of the subject product in  

light  of  the  finding  recorded  earlier  in  this  Judgment  that  Imatinib  Mesylate  (non-

crystalline) is a known substance from the Zimmermann patent and is also the substance  

immediately preceding the patent product,  that is,  Imatinib Mesylate in beta crystalline  

form.  

175. Let us now consider the case of the appellant as made out in the subject application  

and the  supporting  affidavits,  and examine  the  issue  of  enhanced  efficacy  of  the  beta  

crystalline form of Imatinib Mesylate vis-à-vis Imatinib in free base form.  It is seen above  

that  all  the  pharmacological  effects  of  Imatinib  Mesylate  in  beta  crystalline  form are  

equally possessed by Imatinib in free base form. The position is not only admitted but  

repeatedly reiterated in the patent application. Mr. Subramanium, with his usual fairness  

and candour, explained the position by stating that Imatinib free base is actually the active  

therapeutic ingredient, but in free base form Imatinib has very little or no solubility. It is,   

therefore, not capable of being administered as a drug to human beings. In the words of  

Mr.  Subramanium,  if  given in  solid  dosage  form,  Imatinib  free  base  would  sit  in  the  

stomach like a  brick and would pass  out  with no therapeutic  effect.  The invention  of  

methanesulfonic  acid  addition  salt  of  Imatinib  makes  the  therapeutic  ingredient  (that  

continues to be the same) highly soluble, and therefore very suitable for being administered  

as  a  drug  to  humans.  The  further  invention  of  the  beta  crystalline  form  of  Imatinib  

Mesylate adds to its properties and makes it an even better drug than Imatinib Mesylate.  

The  subject  product,  that  is,  the  beta  crystalline  form  of  Imatinib  Mesylate,  thus

Page 90

demonstrates a definite and tangible enhancement of efficacy over Imatinib in free base  

form.  

176. The way in which the case is presented by Mr. Subramanium is an entirely new case  

made before this Court  for  the first  time. Nevertheless,  let  us consider the case of the  

appellant as presented by Mr. Subramanium.  

177. The portion added in section 3(d) by the 2005 amendment reads as under:

The mere discovery of a new form of a known substance which does not result  in the enhancement of the known efficacy of that substance… [is not inventions  within the meaning of the Act].

178. The  Explanation to section 3(d) also added by the 2005 amendment provides as  

under:

“Explanation.—For  the  purposes  of  this  clause,  salts,  esters,  ethers,  polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers,  complexes,  combinations and other derivatives of  known substance  shall  be  considered  to  be  the  same  substance,  unless  they  differ  significantly  in  properties with regard to efficacy.”

179. It  may  be  seen  that  the  word  “efficacy”  is  used  both  in  the  text  added  to  the  

substantive provision as also in the explanation added to the provision.   

180. What is “efficacy”? Efficacy means1 “the ability to produce a desired or intended  

result”.  Hence,  the  test  of  efficacy  in  the  context  of  section  3(d)  would  be  different,  

depending  upon  the  result  the  product  under  consideration  is  desired  or  intended  to  

produce. In other words, the test of efficacy would depend upon the function, utility or the  

purpose  of  the  product  under  consideration.  Therefore,  in  the  case  of  a  medicine  that  

claims  to  cure  a  disease,  the  test  of  efficacy  can  only  be  “therapeutic  efficacy”.  The  

question then arises, what would be the parameter of therapeutic efficacy and what are the  

1  The New Oxford Dictionary of English, Edition 1998.

Page 91

advantages and benefits that may be taken into account for determining the enhancement  

of therapeutic efficacy? With regard to the genesis of section 3(d), and more particularly  

the circumstances in  which section 3(d) was amended to make it even more constrictive  

than before, we have no doubt that the “therapeutic efficacy” of a medicine must be judged  

strictly and narrowly. Our inference that the test of enhanced efficacy in case of chemical  

substances, especially medicine, should receive a narrow and strict interpretation is based  

not only on external factors but there are sufficient internal evidence that leads to the same  

view.  It may be noted that the text added to section 3(d) by the 2005 amendment lays  

down the  condition  of  “enhancement  of  the  known efficacy”.  Further,  the  explanation  

requires the derivative to “differ significantly in properties with regard to efficacy”. What  

is evident, therefore, is that not all advantageous or beneficial properties are relevant, but  

only such properties that directly relate to efficacy, which in case of medicine, as seen  

above, is its therapeutic efficacy.

181. While dealing with the explanation it must also be kept in mind that each of the  

different forms mentioned in the explanation have some properties inherent to that form, e.  

g., solubility to a salt and hygroscopicity to a polymorph. These forms, unless they differ  

significantly in property with regard to efficacy, are expressly excluded from the definition  

of  “invention”.  Hence,  the mere  change of  form with properties  inherent  to  that  form  

would not qualify as “enhancement of efficacy” of a known substance. In other words, the  

explanation is meant to indicate what is not to be considered as therapeutic efficacy.

182. We have just noted that the test of enhanced therapeutic efficacy must be applied  

strictly, but the question needs to be considered with greater precision. In this connection,  

we take note of two slightly diverging points of view urged before this Court.

Page 92

183. Mr.  Anand  Grover,  learned  counsel  appearing  for  one  of  the  Objectors,  Cancer  

Patients Aid Association, took a somewhat rigid position. The learned counsel submitted  

that in the pharmaceutical field, drug action is explained by “pharmacokinetics” (effect of  

the  body on the  drug)  and “pharmacodynamics”  (effect  of  the  drug on the  body).  He  

further submitted that efficacy is a pharmacodynamic property, and contended that, in the  

field of pharmaceuticals, efficacy has a well-known meaning. Efficacy is the capacity of a  

drug to produce an effect.  The IUPAC describes efficacy as “the property that enables  

drugs to produce responses”. It is that property of a drug which produces stimulus. When  

comparing the efficacy of two substances, efficacy describes “the relative intensity with  

which agonists vary in the response they produce even when they occupy the same number  

of receptors”. [IUPAC Glossary of Terms used in Medicinal Chemistry, 1998 in CPAA  

volume 9, at page 7]. In the words of Goodman and Gilman, “the generation of response  

from the drug receptor complex is governed by a property described as efficacy”. They  

further clarify that “efficacy is that property intrinsic to a particular drug that determines  

how good an agonist the drug is” [Goodman and Gilman in CPAA compilation, volume 9,  

at page 22, LHC]. Another source describes efficacy as “the ability of the drug to produce  

the desired therapeutic effect” [Dorland’s Medical dictionary in Novartis’ volume P, at  

page 19].

184. Mr. Grover further submitted that in pharmacology, efficacy is distinct from affinity,  

potency and bioavailability. Affinity, a pharmacodynamics property, “is the tendency of a  

molecule  to associate  with another”.  The affinity of  a drug is its  ability to bind to its  

biological target (receptor, enzyme, transport system, etc.). Potency is “the dose of drug  

required  to  produce  a  specific  effect  of  given  intensity  as  compared  to  a  standard

Page 93

reference”. Bioavailability, on the other hand, is a pharmacokinetic property. It “is the term  

used to indicate the fraction extent to which a dose of drug reaches its site of action or a  

biological fluid from which the drug has access to its site of action” [Goodman and Gilman  

in CPAA compilation, volume…, internal page 4]; or “the degree to which a drug or other  

substance becomes available to the target tissue after administration” [Dorland’s Medical  

Dictionary  in  Novartis’  volume  B,  at  page  65].  A  demonstration  of  increase  in  

bioavailability is not a demonstration of enhanced efficacy.   

185. Prof. Basheer,  who appeared before this Court purely in academic interest  as an  

intervenor-cum-amicus, agreed that not all advantageous properties of a new form (such as  

improved processability  or  flow characteristics,  storage potential,  etc.)  ought to qualify  

under section 3(d), but only those properties that have some bearing on efficacy. However,  

taking  a  less  rigid  position  than  Mr.  Grover,  Prof.  Basheer  argued  that  safety  or  

significantly reduced toxicity should also be taken into consideration to judge enhanced  

therapeutic efficacy of a pharmaceutical product in terms of section 3(d).1

186. We have taken note of the submissions made by Mr. Grover and Prof. Basheer in  

deference to the importance of the issue and the commitment of the counsel to the cause.  

However, we do not propose to make any pronouncement on the issues raised by them, as  

this case can be finally and effectively decided without adverting to the different points of  

1  Prof. Basheer traced the origins of the amended part of section 3(d) in Article 10(2)(b) of European Drug Regulatory  Directive, 2004 which defines a “generic medicinal product” as:

“a medicinal product which has the same qualitative and quantitative composition in active substances and the  same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference  medicinal  product  has been  demonstrated by appropriate  bioavailability studies.  The different  salts,  esters,   isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the  same active substance, unless they differ significantly in properties with regard to safety and/or efficacy. In   such cases, additional information providing proof of the safety and/or efficacy of the various salts, esters or   derivatives of a authorized active substance must be supplied by the applicant.”  

He pointed out that the expressions used in a different context in the European Drug Regulatory Directive were incorporated  in the Patents Act for an altogether different purpose and raised some important and interesting points for interpretation of  section 3(d) but in this case we see no reason to go into those aspects of the matter.

Page 94

view noted above.

187. In whatever way therapeutic efficacy may be interpreted, this much is absolutely  

clear: that the physico-chemical properties of beta crystalline form of Imatinib Mesylate,  

namely (i) more beneficial flow properties,  (ii) better thermodynamic stability, and (iii)  

lower hygroscopicity,  may be otherwise beneficial  but  these properties cannot  even be  

taken  into  account  for  the  purpose  of  the  test  of  section  3(d)  of  the  Act,  since  these  

properties have nothing to do with therapeutic efficacy.

188. This leaves us to consider the issue of increased bioavailability. It is the case of the  

appellant  that  the beta crystalline form of Imatinib Mesylate  has 30 per cent increased  

bioavailability as compared to Imatinib in free base form. If the submission of Mr. Grover  

is to be accepted, then bioavailability also falls outside the area of efficacy in case of a  

medicine. Leaving aside the submission of Mr. Grover on the issue, however, the question  

is,  can  a  bald  assertion  in  regard  to  increased  bioavailability  lead  to  an  inference  of  

enhanced therapeutic efficacy? Prof. Basheer quoted from a commentator1 on the issue of  

bioavailability as under:

“It is not the intent of a bio-availability study to demonstrate effectiveness, but  to determine the rate and extent of absorption. If a drug product is not bio- available, it cannot be regarded as effective. However a determination that a  drug  product  is  bio-available  is  not  in  itself  a  determination  of  effectiveness.”

(emphasis added)

189. Thus,  even  if  Mr.  Grover’s  submission  is  not  taken  into  consideration  on  the  

question of bioavailability, the position that emerges is that just increased bioavailability  

alone may not necessarily lead to an enhancement of therapeutic efficacy. Whether or not  

1  42 FR 1640 (1977). Cf. Moffitt, Jane, Appropriateness of Bioavailability and Bioequivalency as Pre-Market Clearance  Considerations, 34 Food Drug Cosm. L.J. 640 (1979)

Page 95

an increase in bioavailability leads to an enhancement of therapeutic efficacy in any given  

case must be specifically claimed and established by research data. In this case, there is  

absolutely nothing on this score apart  from the adroit  submissions of  the counsel.  No  

material has been offered to indicate that the beta crystalline form of Imatinib Mesylate  

will produce an enhanced or superior efficacy (therapeutic) on molecular basis than what  

could be achieved with Imatinib free base in vivo animal model.

190. Thus,  in  whichever  way section  3(d)  may be  viewed,  whether  as  setting  up the  

standards of “patentability” or as an extension of the definition of “invention”, it must be  

held that on the basis of the materials brought before this Court, the subject product, that is,  

the beta crystalline form of Imatinib Mesylate, fails the test of section 3(d), too, of the Act.  

191. We  have  held  that  the  subject  product,  the  beta  crystalline  form  of  Imatinib  

Mesylate, does not qualify the test of Section 3(d) of the Act but that is not to say that   

Section  3(d)  bars  patent  protection  for  all  incremental  inventions  of  chemical  and  

pharmaceutical substances. It will be a grave mistake to read this judgment to mean that  

section 3(d) was amended with the intent to undo the fundamental change brought in the  

patent  regime  by  deletion  of  section  5  from the  Parent  Act.  That  is  not  said  in  this  

judgment.

192. Section 2(1)(j)  defines “invention” to mean, “a new product or …”, but the new  

product in chemicals and especially pharmaceuticals may not necessarily mean something  

altogether new or completely unfamiliar or strange or not existing before.  It may mean  

something “different from a recent previous” or “one regarded as better than what went  

before”  or  “in  addition  to  another  or  others  of  the  same kind”1.  However,  in  case  of  

chemicals  and especially  pharmaceuticals  if  the product  for  which patent  protection is  

1  The New Oxford Dictionary of English Edition 1998

Page 96

claimed is a new form of a known substance with known efficacy, then the subject product  

must pass, in addition to clauses (j) and (ja) of section 2(1), the test of enhanced efficacy as  

provided in section 3(d) read with its explanation.

193. Coming back to the case of the appellant, there is yet another angle to the matter. It  

is seen above that in the US the drug Gleevec came to the market in 2001. It is beyond  

doubt that what was marketed then was Imatinib Mesylate and not the subject product,  

Imatinib Mesylate in beta crystal form. It is also seen above that even while the appellant’s  

application for grant of patent lay in the “mailbox” awaiting amendments in the law of  

patent in India, the appellant was granted Exclusive Marketing Rights on November 10,  

2003, following which Gleevec was marketed in India as well. On its package1, the drug  

was described as “Imatinib Mesylate Tablets 100 mg” and it was further stated that “each  

film coated tablet contains: 100 mg Imatinib (as Mesylate)”. On the package there is no  

reference at all to Imatinib Mesylate in beta crystalline form. What appears, therefore, is  

that what was sold as Gleevec was Imatinib Mesylate and not the subject product, the beta  

crystalline form of Imatinib Mesylate.

194. If that be so, then the case of the appellant appears in rather poor light and the claim  

for patent for beta crystalline form of Imatinib Mesylate would only appear as an attempt  

to obtain patent for Imatinib Mesylate, which would otherwise not be permissible in this  

country.  

195. In view of the findings that the patent product, the beta crystalline form of Imatinib  

Mesylate, fails in both the tests of invention and patentability as provided under clauses (j),  

(ja) of section 2(1) and section 3(d) respectively, the appeals filed by Novartis AG fail and  

are dismissed with cost. The other two appeals are allowed.

1  A copy of the package is enclosed at the end of the judgment as appendix III.

Page 97

196. Before putting down the records of this case, we would like to express our deep  

appreciation for the way the hearing of the case took place before the Court. Every counsel  

presented the issues under consideration from a different angle and every counsel  who  

addressed the Court had something important and valuable to contribute to the debate. It  

was also acknowledged that the illuminating addresses of the counsel were the result of the  

hard work and painstaking research by the respective teams of young advocates working  

for each senior advocate. The presence of those bright young ladies and gentlemen in the  

court room added vibrancy to the proceedings and was a source of constant delight to us.  

..…..………………………..J. (Aftab Alam)

..…..………………………..J. (Ranjana Prakash Desai)

New Delhi; April 01, 2013

Page 98

APPENDIX I

Table (1)

Comparative Table of Applications for Patents in India during the periods (a) 1930-38: (b)   

1949-58

1930-1938 1949-58

Year Total number  of applications  

filed

By  Indians

By other  than  

Indian

Year Total number  of applications  

filed

By  Indians

By other  than  

Indians

1930 1, 099 114 985 1949 1,725 345 1,380 1931 940 109 831 1950 1,851 352 1,499

1932 928 162 766 1951 2,108 422 1,686

1933 954 199 755 1952 2,272 473 1,799

1934 1,007 203 804 1953 2,235 406 1,829

1935 980 156 824 1954 2,497 403 2,094

1936 1,068 199 869 1955 2,736 403 2,333 1937 1,246 202 1,044 1956 3,067 482 2,585

1938 1,243 220 1,023 1957 3,456 527 2,929

1939 1,060 238 822 1958 3,572 529 3,043

10,525 1,802  (17%)

8,723 25,519 4,342  (17%)

21,177

Page 99

Table (2) Patents Granted From 1950-57- analysed according to the subject of the inventions

Food  Year Indian Foreign Total

No. Percentage No. Percentage 1950 22 16.5 111 83.5 133 1951 35 28.6 87 71.4 122 1952 18 18.9 77 81.1 95 1953 30 18.8 129 81.2 159 1954 31 8.3 341 91.7 372 1955 48 10.0 430 90.0 478 1956 30 7.0 402 93.0 432 1957 8 13.5 51 86.5 59 Total 222 1628 1850

Chemical 1950 13 4.5 271 95.4 284 1951 33 8.7 378 91.3 411 1952 36 8.0 414 92.0 450 1953 27 7.1 351 92.9 378 1954 44 9.7 409 90.3 453 1955 56 12.5 448 87.5 504 1956 34 6.6 479 93.4 513 1957 68 9.3 656 90.7 727

Total 311 3406 3717

Table (3)

Applications for Patents relating to Drugs and Pharmaceuticals

Pharmaceuticals Year Indian Foreign

No. Percentage No. Percentage 1947 12 7.7 (sic  

17.7) 143 72.3 155

1948 7 5.5 121 94.5 128 1949 5 3.5 139 96.5 144 1950 8 5.0 151 95.0 159 1951 17 7.7 203 92.3 220 1952 18 6.2 224 93.8 242 1953 18 6.3 267 93.7 285 1954 13 4.1 300 95.9 312 1955 7 2.1 325 97.9 332 1956 13 2.6 476 97.4 489 1957 25 5.3 543 94.7 568 Total 143 2892 3035

Page 100

  Table (5)  

Number of Patents in force on the 1st January, 1958

Total Number 13,774 Owned by Indians 1,157 Owned by Indians and Foreigners jointly 21 Owned by Foreigners 12,596

Page 101

APPENDIX II

Comparative Chart of Zimmermann Patent & Application for Beta-Crystalline form  

of Imatinib Mesylate in India

Zimmermann Patent (Vol. C-4) Beta-crystal  Application  in  India  

(Vol. C-4) 1. Column 4:

The  compounds  of  formula  I  have  

valuable pharmacological properties  

and  can  be  used,  for  example,  as  

anti-tumoral drugs and as drags (sic  

drugs) against atherosclerosis.  

Page No. 60:

The  methanesulfonic  acid  addition  

salt  of  a  compound  of  formula  I,  

which  is  preferably  used  in  the  β-

crystal  form…possesses  valuable  

pharmacological properties and may,  

for  example,  be  used  as  an  anti-

tumour  agent,  as  an  agent  to  treat  

atherosclerosis. 2. Column 5:

“…and  anti-bacterial  active  

ingredients..”

Page No. 60:

“…preventing the invasion of warm-

blooded  animal  cells  by  certain  

bacteria,  such  as  Porphyromonas  

gingivalis.” 3. Column 4:

The phosphorylation of proteins has  

long  been  known  as  an  important  

step  in  the  differentiation  and  

proliferation  of  cells.  The  

Page No. 60:

The phosphorylation of proteins has  

long been known as an essential step  

in the differentiation and division of  

cells.  Phosphorylation  is  catalysed

Page 102

phosphorylation  is  catalysed  by  

protein  kinases  which  are  divided  

into  serine/threonine  kinases  and  

tyrosine  kinases.  The  

serine/threonine  kinases  include  

protein  kinase  C  and  the  tyrosine  

kinases  the  PDGF (platelet-derived  

growth  factor)-receptor  tyrosine  

kinase.  

by  protein  kinases  subdivided  into  

serine/threonine  and  tyrosine  

kinases. The tyrosine kinases include  

PDGF  (Platelet-derived  Growth  

Factor) receptor tyrosine kinase.

4. Column 7:

PDGF  (platelet-derived  growth  

factor) is a very frequently occurring  

growth  factor  which  plays  an  

important  role  both  in  normal  

growth  and  in  pathological  cell  

proliferation,  such  as  in  

carcinogenesis  and disorders of  the  

smooth  muscle  cells  of  blood  

vessels,  for  example  in  

atherosclerosis and thrombosis.  

Page No. 60:

PDGF  (Platelet-derived  Growth  

Factor)  is  a  very  commonly  

occurring growth factor, which plays  

an  important  role  both  in  normal  

growth and also in pathological cell  

proliferation,  such  as  is  seen  in  

carcinogenesis and in diseases of the  

smooth-muscle  cells  of  blood  

vessels,  for  example  in  

atherosclerosis and thrombosis. 5. Column 7:

The  inhibition  of  PDGF-stimulated  

receptor  tyrosine  kinase  activity  in  

vitro is measured in PDGF receptor  

Page No. 60:

The  inhibition  of  PDGF-stimulated  

receptor  tyrosine  kinase  activity  in  

vitro is measured in PDGF receptor

Page 103

immunocomplexes of  BALB/c 3T3  

cells,  analogously  to  the  method  

described  by  E.  Andrejauskas-

Buchdunger  and  U.  Regenass  in  

Cancer  Research  52,  5353-5358  

(1992). The compounds of formula I  

described  in  detail  above  inhibit  

PDGF-dependent  cell-free  receptor  

phosphorylation at concentrations of  

from  0.005  to  5  µmol/liter,  

especially  from  0.01  to  1.0,  more  

especially  from  0.01  to  

0.1µmol/liter.  The  inhibition  of  

PDGF-receptor  tyrosine  kinase  in  

the intact cell is detected by means  

of  Western  Blot  Analysis,  likewise  

analogously to the method described  

by E. Andrejauskas-Buchdunger and  

U. Regenass in Cancer Research 52,  

5353-5358  (1992).  In  that  test  the  

inhibition  of  ligand-stimulated  

PDGF-receptor autophosphorylation  

in BALB/c mouse cells is measured  

immune complexes of BALB/c 3T3  

cells,  as  described  by  E.  

Andrejauskas-Buchdunger  and  U.  

Regenass  in  Cancer  Research  52,  

5353-5358 (1992).  A compound of  

formula  I  described  in  more  detail  

hereinbefore,  such  as  especially  its  

β-crystal  form,  inhibits  PDGF-

dependent  acellular  receptor  

phosphorylation.

Page 104

with the aid of anti-phosphotyrosine  

antibodies.  The  compounds  of  

formula I described in detail  above  

inhibit the tyrosine kinase activity of  

the PDGF receptor at concentrations  

of  from  0.005  to  5  µmol/liter,  

especially from 0.01 to 1.0 and more  

especially  from  0.01  to  0.1  

µmol/liter. At concentrations below  

1.0  µmol/liter,  those  compounds  

also  inhibit  the  cell  growth  of  a  

PDGF-dependent  cell  line,  namely  

BALB/c 3T3 mouse fibroblasts.  6. Column 8:

The  compounds  of  this  invention  

inhibit  enzyme  activity  by  50%  

(IC50) typically in a concentration of  

0.1 to 10 µm.  

Page No. 61:

“…the  corresponding  

methanesulfonate  salt  inhibit  the  

tyrosine kinase activity of the PDGF  

receptor at an IC50  (concentration at  

which activity  is  inhibited  by  50%  

compared with the control) of about  

120  nM  and  about  100  nM,  

respectively.” 7 Column 7:

Owing  to  the  properties  described,  

Page No. 61:

On  the  basis  of  the  described

Page 105

compounds of formula I can be used  

not only as tumour-inhibiting active  

ingredients but also as drugs against  

non-malignant  proliferative  

diseases,  e.g.  atherosclerosis,  

thrombosis, psoriasis, sclerodermitis  

and fibrosis.

They are also suitable for the further  

applications  mentioned  above  for  

protein  kinase  C-  modulators  and  

can  be  used  especially  in  the  

treatment of diseases that respond to  

the  inhibition  of  PDGF-receptor  

kinase.  

properties, the methanesulfonic acid  

addition  salt  of  a  compound  of  

formula I, such as especially the β-

crystal  form  thereof,  may  be  used  

not  only  as  a  tumour-inhibiting  

substance, for example in small cell  

lung cancer, but also as an agent to  

treat  non-malignant  proliferative  

disorders,  such  as  atherosclerosis,  

thrombosis,  psoriasis,  scleroderma,  

and fibrosis…

It  may  especially  be  used  for  the  

treatment of diseases which respond  

to  an  inhibition  of  the  PDGF  

receptor kinase.  8. Column 9:

In  addition,  the  compounds  of  

formula  I  prevent  the  development  

of resistance (multi-drug resistance)  

in  cancer  treatment  with  other  

chemotherapeutic  drugs  or  remove  

existing  resistance  to  other  

chemotherapeutic drugs.  

Page No. 62:

In addition, the methanesulfonic acid  

addition  salt  of  a  compound  of  

formula I,  such as especially  its  β-

crystal  form  C,  prevents  the  

development of multidrug resistance  

in  cancer  therapy  with  other  

chemotherapeutic  agents  or

Page 106

abolishes a pre-existing resistance to  

other chemotherapeutic agents. 9. Column 6:

Some of the compounds of formula I  

wherein  R4 and  R8 are  hydrogen  

inhibit not only protein kinase C but,  

at  a  concentration  IC50 as  low  as  

approximately  from  0.01  to  5  

µmol/liter, especially approximately  

from  0.05  to  1  µmol/liter,  also  

certain  tyrosine  kinases,  such  as  

especially PDGF-receptor kinase or  

abl-kinase,  for  example  v-abl-

kinase.

Page No. 62:

Also  abl  kinase,  especially  v-abl  

kinase,  is  inhibited  by  4-(4-

methylpiperazin-1-ylmethyl)  –N-(4-

methyl-3-(4-pyridin-3-yl)pyrimidin-

2-ylamino)  phenyl]  benzamide  and  

its methanesulfonate salt.

10. Column 7:

The  above-mentioned  inhibition  of  

v-abl-tyrosine  kinase  is  determined  

in accordance  with  the methods of  

N. Lydon et at., Oncogene Research  

5,  161  –  173  (1990)  and  J.F.  

Geissler et al., Cancer Research 52,  

4492-4498 (1992). In those methods  

[Val5]-angiotensin  II  and  [γ-32P]-

ATP are used as substrates.  

Page No. 62:

The  inhibition  of  v-abl  tyrosine  

kinase is determined by the methods  

of  N.  Lydon  et  at.  Oncogene  

Research  5,  161 –  173 (1990)  and  

J.F. Geissler et al., Cancer Research  

52, 4492-8 (1992). In those methods  

[Val5]-angiotensinII and [y-32P]-ATP  

are used as substrates.

11. Column 20: Page No.68:

Page 107

The  invention  relates  also  to  a  

method  of  treating  warm-blooded  

animals  suffering  from  a  tumoral  

disease,  which  comprises  

administering  to  warm-blooded  

animals requiring such treatment an  

effective,  tumour-inhibiting  amount  

of a compound of formula I or of a  

pharmaceutically  acceptable  salt  

thereof.  

The  invention  relates  also  to  a  

process  for  the treatment  of  warm-

blooded animals suffering from said  

diseases,  especially  a  tumour  

disease, .…is administered to warm-

blooded  animals  in  need  of  such  

treatment.  

12. Column 20:

The invention relates further to the  

use of a compound of formula I or  

of a pharmaceutically acceptable salt  

thereof  for  inhibiting  PDGF-

receptor  kinase  or  to  the  use  of  a  

compound of formula I wherein R4,  

and R8 are  each hydrogen,  or  of  a  

pharmaceutically  acceptable  salt  

thereof, for inhibiting protein kinase  

C in  warm-blooded  animals  or  for  

preparing  pharmaceutical  

compositions  for  use  in  the  

therapeutic  treatment  of  the human  

Page No.68 :

The  invention  relates  moreover  to  

the use of the β-crystal form of the  

methanesulfonic acid addition salt of  

a  compound  of  formula  I  for  the  

inhibition  of  the  above-mentioned  

tyrosine  kinases,  especially  PDGF  

receptor kinase, v-abl kinase, and/or  

c-kit  receptor  kinase,  or  for  the  

preparation  of  pharmaceutical  

compositions for use in treating the  

human or animal body.

Page 108

or animal body.  13. Column 20:

Effective  doses,  for  example  daily  

doses  of  approximately  from  1  to  

1000 mg, especially from 50 to 500  

mg,  are  administered  to  a  warm-

blooded animal of approximately 70  

kg  body  weight  according  to  

species,  age,  individual  condition,  

mode  of  administration  and  the  

individual syndrome.  

Page No. 68:

Depending  on  species,  age,  

individual  condition,  mode  of  

administration,  and  the  clinical  

picture in question,  effective doses,  

for example daily doses of about 1-

2500  mg,  preferably  1-1000  mg,  

especially  5-500  mg,  are  

administered  to  warm-blooded  

animals of about 70 kg bodyweight. 14. Column 20:

The  invention  relates  also  to  

pharmaceutical  compositions  

comprising  an  effective  amount,  

especially an amount effective in the  

prevention or therapy of one of the  

above-mentioned  diseases,  of  the  

active  ingredient  together  with  

pharmaceutically acceptable carriers  

that are suitable for topical, enteral,  

for  example  oral  or  rectal,  or  

parenteral  administration,  and  may  

be  inorganic  or  organic,  solid  or  

Page No. 68:

The  invention  relates  also  to  

pharmaceutical  preparations  which  

contain  an  effective  amount,  

especially  an  effective  amount  for  

prevention or treatment of one of the  

said diseases, of the methanesulfonic  

acid addition salt of a compound of  

formula  I  in  the  –crystal  (sic  β-

crystal) form,  together  with  

pharmaceutically acceptable carriers  

which  are  suitable  for  topical,  

enteral for example oral or rectal, or

Page 109

liquid. For oral administration there  

are used especially tablets or gelatin  

capsules  comprising  the  active  

ingredient together with diluents, for  

example  lactose,  dextrose,  sucrose,  

mannitol,  sorbitol,  cellulose  and/or  

glycerol,  and/or  lubricants,  for  

example  silicic  acid,  talc,  stearic  

acid  or  salts  thereof,  such  as  

magnesium  or  calcium  stearate,  

and/or  polyethylene  glycol.  Tablets  

may  also  comprise  binders,  for  

example  magnesium  aluminium  

silicate,  starches,  such  as  corn,  

wheat  or  rice  starch,  gelatin,  

methylcellulose,  sodium  

carboxymethylcellulose  and/or  

polyvinylpyrrolidone,  and,  if  

desired,  disintegrators,  for  example  

starches, agar, alginic acid or a salt  

thereof,  such  as  sodium  alginate,  

and/or  effervescent  mixtures,  or  

adsorbents,  dyes,  flavourings  and  

parenteral  administration  and  may  

be inorganic or organic and solid or  

liquid.  Especially  tablets  or  gelatin  

capsules  containing  the  active  

substance together with diluents, for  

example  lactose,  dextrose,  sucrose,  

mannitol,  sorbitol,  cellulose  and/or  

glycerin,  and/or  lubricants,  for  

example silicic, talc, stearic acid, or  

salts thereof, typically magnesium or  

calcium  stearate,  and/or  

polyethylene  glycol,  are  used  for  

oral  administration.  Tablets  may  

likewise  contain  binders,  for  

example  magnesium  aluminium  

silicate,  starches,  typically  corn,  

wheat  or  rice  starch,  gelatin,  

methylcellulose,  sodium  

carboxymethylcellulose  and/or  

polyvinylpyrrolidone,  and,  if  so  

desired,  disintegrants,  for  example  

starches, agar, alginic acid or a salt  

thereof,  typically  sodium  alginate,

Page 110

sweeteners.  The  pharmacologically  

active  compounds  of  the  present  

invention  can  also  be  used  in  the  

form  of  parenterally  administrable  

compositions  or  in  the  form  of  

infusion  solutions.  Such  solutions  

are  preferably  isotonic  aqueous  

solutions or suspensions, which, for  

example  in  the  case  of  lyophilised  

compositions  that  comprise  the  

active  ingredient  alone  or  together  

with a carder, for example mannitol,  

can  be  prepared  before  use.  The  

pharmaceutical  compositions  may  

be  sterilised  and/or  may  comprise  

excipients,  for  example  

preservatives,  stabilisers,  wetting  

agents  and/or  emulsifiers,  

solubilisers,  salts  for  regulating the  

osmotic pressure and/or buffers. The  

present  pharmaceutical  

compositions which, if desired, may  

comprise  further  pharmacologically  

and/or  effervescent  mixtures,  or  

adsorbents,  colouring  agents,  

flavours, and sweetening agents. The  

pharmacologically  active  

compounds of the present invention  

may further be used in the form of  

preparations  for  parenteral  

administration or infusion solutions.  

Such  solutions  are  preferably  

isotonic  aqueous  solutions  or  

suspensions,  these  possibly  being  

prepared before use, for example in  

the case of  lyophilised preparations  

containing  the  active  substance  

either  alone  or  together  with  a  

carrier,  for  example  mannitol.  The  

pharmaceutical  substances  may  be  

sterilised  and/or  may  comprise  

excipients,  for  example  

preservatives,  stabilisers,  wetting  

agents  and/or  emulsifiers,  

solubilisers,  salts  for  regulation  of  

the osmotic pressure, and/or buffers.

Page 111

active  substances,  such  as  

antibiotics, are prepared in a manner  

known per se, for example by means  

of conventional mixing, granulating,  

confectioning,  dissolving  or  

lyophilising processes, and comprise  

approximately  from  1%  to  100%,  

especially  from  approximately  1%  

to  approximately  20%,  active  

ingredient(s).  

The  present  pharmaceutical  

preparations  which,  if  so  desired,  

may  contain  further  

pharmacologically active substances,  

such as antibiotics, are prepared in a  

manner  known per  se,  for  example  

by  means  of  conventional  mixing,  

granulating,  coating,  dissolving  or  

lyophilising  processes,  and  contain  

from about 1% to 100%, especially  

from about 1% to about 20%, of the  

active substance or substances. 15. Column 21:

The  following  Examples  illustrate  

the  invention  but  do  not  limit  the  

invention in any way. The Rf values  

are  determined  on  silica  gel  thin-

layer  plates  (Merck,  Darmstadt,  

Germany). The ratio to one another  

of the eluants in the eluant mixtures  

used  is  given  in  proportions  by  

volume (v/v),  and temperatures  are  

given in degrees Celsius.  

Page No. 69:

The  following  Examples  illustrate  

the  invention  without  limiting  the  

scope  thereof.  R1 –  values  are  

determined  on  TLC  plates  coated  

with  silica  gel  (Merck,  Darmstadt,  

Germany). The ratio of the solvents  

to one another in the solvent systems  

used  is  indicated  by  volume  (v/v),  

and  temperatures  are  given  in  

degrees Celsius (ºC).

Page 112

APPENDIX III