[REPORTABLE]

IN THE SUPREME COURT OF INDIA CIVIL APPELLATE JURISDICTION

CIVIL APPEAL NO. 9491 OF 2019 (Arising out of SLP(C) No.24727 of 2019)

M/s Genentech Inc. & Ors.       Appellant(s)

Versus

Drug Controller General of India & Ors.       Respondent(s)

J U D G M E N T

Hrishikesh Roy, J.

Leave granted.

2. This appeal  has been preferred against  the interim order  dated

18.09.2019 passed by the Division Bench of High Court of Delhi in C.M.

Application  No.  22510/2016  in  FAO  (O.S)  No.181/2016.  Under  the

impugned  order,  the  Division  Bench  allowed  the  application  filed  by

respondent No.3-M/s Reliance Life Sciences Pvt. Ltd.1.  The CS(OS) No.

1 Defendant no.3 in O.S No.181/2016

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3284/20152 before the High Court of Delhi was filed by appellant no.1-

M/s Genentech Inc. together with appellant nos. 2 and 3 namely Roche

Products (India) Pvt. Ltd. and F. Hoffmann-La Roche, AG3 respectively.  

3. Plaintiff  no.1- M/s Genentech Inc. claimed themselves to be the

innovators  of  the  monoclonal  antibody  drug  ‘Trastuzumab’  which  is

manufactured by the plaintiff no.3- F. Hoffmann-La Roche and is being

marketed  in  India  by  plaintiff  no.2-  Roche  Products  (India)  Pvt.  Ltd.

under the brand name HERCEPTIN,  HERCLON and BICELTIS.   The

drug ‘Trastuzumab’ is approved globally for treatment of cancer.  The

suit before the Delhi High Court came to be filed seeking to  inter alia

restrain  respondent  No.3-M/s  Reliance  Life  Sciences  Pvt.  Ltd.  from

launching, marketing or selling ‘TrastuRel’, the biosimilar version of the

appellants drug ‘Trastuzumab’.    In  the suit,  the approval  granted by

respondent no.1-Drugs Controller General of India4 to M/s. Reliance Life

Sciences Pvt. Ltd. for the manufacture and marketing ‘TrastuRel’, was

also challenged.  The suit was filed at a stage when respondent no.3

was yet  to  introduce  their  drug  in  the  market.    The  appellants  had

obtained patent for the drug ‘Trastuzumab’ but the same had lapsed on

2 Reliance Suit

3 Plaintiffs in O.S. No. 181/2016

4 DCGI

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3.5.2013 but they sought to restraint respondent no.3 from representing

their product ‘TrastuRel’, as biosimilar to ‘Trastuzumab’   

4. According to the appellants, the biosimilar product in India to be

launched by respondent no.3, has not been tested as a biosimilar drug

in accordance with the law under the Drugs and Cosmetics Act, 19405

and other applicable norms and guidelines with the projection that the

respondent no.3 has not undertaken requisite chemical trials and has not

also generated adequate data  to establish, inter alia, the safety, efficacy

and  immunogenicity  of  the  drug-‘TrastuRel’,  manufactured  by

respondent no.3.  

5. Respondent no.3, however, contended that the appellants have no

enforceable  right  in  the  drug  ‘Trastuzumab’  as  the  patent  right  with

respect to the drug, available with the appellants had lapsed in 2013.

Therefore,  any  other  intending  manufacturer  could  rely  upon  the

appellant’s data relating to Phase I and Phase II trials, as available in

public domain.

6. Prior  to  the  Reliance  suit  filed  against  respondent  no.3,  the

appellants  had filed  the suit  being CS (OS)  No.  355/2014 against  F.

Hoffmann-La  Roche,  AG,  their  associate  Mylan  Inc,  seeking  similar

5 The Act  

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restraint  against  purported  biosimilar  version  of  the  appellants  drug,

“Trastuzumab”.   Biocon and Mylan were however already in the market

by  selling  their  products  “Trastuzumab’  -  ‘CANMab’  and

‘Trastuzumab’-‘HERTRAZ’ in the market.

7. The  High  Court  of  Delhi  passed  respective  orders  on

5.12.2014,14.2.2014 and 28.02.2014 in the Biocon’s suit and permitted

Biocon and Mylan to market their drugs subject to the conditions that

they  would  not  claim  bio  similarity  with  the  appellants’  product

HERCEPTIN, HERCLON and BICELTIS.  However, in the Reliance suit,

the learned Single Judge was of the prima facie view that the approval

by the DCGI for the biosimilar drug of respondent no.3, was far more

egregious than in the case of the drug marketed by Biocon.  Accordingly,

an interim order was passed on 2.11.2015 in the Reliance suit whereby

respondent no.3 was restrained from launching and selling their product

‘TrastuRel’ in India, until the next date of hearing.   In the Biocon and the

Reliance suits, the appellants had claimed that the biosimilar version of

the appellants ‘Trastuzumab’, were being launched without the required

test and studies under the applicable laws requiring conducting of tests

and  obtaining  of  appropriate  approval  from  the  regulatory  authority

including the DCGI.  The appellants’ injunction application was ordered

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by the learned Single  Judge on 25.04.2016.  The Court  recorded the

prima facie  finding that  ‘TrastuRel  was approved by the DCGI under

applicable law.  The learned Single Judge observed that the approvals

granted to ‘TrastuRel’ product are not on the basis of the adherence of

the Guidelines 2012 and rules framed under the Drug Act.   However, it

was observed that the final finding in this respect is yet to be arrived

after  the suit  is  heard and completion of  the trial.   Accordingly,  while

permitting respondent no.3 to launch and market ‘TrastuRel’ on the basis

of the approval from the DCGI, certain conditions were imposed by the

learned Judge to safeguard public health and safety as also to protect

the  innovator  of  the  biosimilar  drug  ‘Trastuzumab’.  The  relevant

stipulations of the learned Single Judge are noted as follows:

“262.  I  am of  the view that  the approvals granted to TrastuRel product are not on the basis of the adherence of the Guidelines of 2012 and rules framed under the Drug Act.  The final finding in this respect is yet to be arrived after the present suit is heard upon completion of the trial.  Pending the final outcome of the suit, there is  need  to  arrive  at  interim  measure  by  working  out certain  terms  between  the  parties  by  passing  the following directions:-

(a) The defendant No.3 may launch to manufacture, market and advertise their product under the name TrastuRel  on  the  basis  of  the  approvals  already granted  to  defendant  No.3  without  calling  their product  as  “bio  similar”  and/  or  “bio  similar  to HERCEPTIN, HERCLON, BICELTIS” or in any way

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ascribing any bio-similarity with that of the plaintiffs products HERCEPTIN, HERCLON, BICELTIS in any press releases, public announcements, promotional or  other  in  printed form and from relying upon or referring the plaintiffs' names.  

(b) The defendant No.3 may also manufacture and market  the  drug  by  qualifying  the  INN  name Trastuzumab but  not  to  use the said  name stand alone on the carton or package insert  as a brand name. The defendant No.3 can use the INN name as  Reliance  Trastuzumab  or  TrastuRel  wherever applicable to describe the composition of molecule on the product as well as in its insert and not in a prominent  manner.  The  said  expression  shall  be used at the bottom part of the carton and should be in small size letters than the brand name TrastuRel.  

(c) In view of prima facie findings that the use of the data  by  the  defendant  No.3  in  the  product  insert without undergoing the entire process of the trials is misleading,  the  defendant  No.3  is  also  restrained from  using  the  data  relating  to  manufacturing process, safety, efficacy and tests conducted for the safety of the drugs as complained of by the plaintiffs till the time the final decision on the issue of the bio similarity is made in the present suit.  

(d) In the event, the defendant No.3 intends to claim bio similar as a description of its product or part of its promotional campaign or otherwise in any other form, the defendant No.3, if so advised, can re-apply the  said  license  before  the  relevant  authorities including  defendant  No.1  and  in  which  case,  the defendant  No.1,  the  authorities  and  committees framed  therein  shall  decide  the  said  approval application  in  accordance  with  the  Rules  and Guidelines of 2012 and also the observations made by  this  court  in  the  present  order.  The  defendant No.3 shall  also be entitled to use the data of  the

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plaintiffs  for  the  comparison  purposes  before  the Regulatory  Authority.  In  the  alternative,  the defendant  No.3  may  await  the  outcome  of  the present  suit  and  can  continue  with  the  present arrangement as an interim measure.  

(e) This interim measure is made only in view of the peculiar facts in the present case only wherein the defendant  No.3  is  already  in  possession  of approvals granted rightly or wrongly validity of which is  questioned in  this  suit.  In  future  application  for approval(s)  of  biosimilar  shall  be  decided  by  the defendant  No.1  and  authorities  and  committees while  considering the guidelines of  2012 and also the findings arrived at in the present order by this Court as well as strictly as per the provisions of the Act and Rules.”

8. In a separate order, also dated 25.04.2016 in the Biocon suit, the

learned Single Judge imposed similar conditions as those on respondent

no.3.

9. Aggrieved by such restriction, Biocon and Mylan approached the

Division Bench of the High Court.  Likewise, the appellants filed appeal

FAO (OS) No. 227 of 2016. Respondent no.3 filed appeal (FAO(OS) No.

181/2016) against the interim order dated 25.4.2016. The Division Bench

noted that  Biocon and Mylan has been in the market  for  almost  two

years and accordingly permitted them to continue to market ‘CANMab’

and ‘HERTRAZ’ without complying with the additional directions set forth

in the order dated 28.06.2016.   

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10. In the appeals filed by respondent no.3 and in their challenge to

the  Single  Judge  order  of  25.04.2016,  the  Division  Bench  had  not

granted any interim relief to respondent no.3 until the recent impugned

order  (18.9.2019);  The  respondent  no.3  accordingly  filed  SLP(C)

No.6203/2019 in this Court.  

11. The earlier SLP(C) No.6203/2019 was disposed of by this Court on

8.3.2019 with a request to the High Court of Delhi to simultaneously take

up the appeals preferred by the contesting parties at an early date and

dispose of the same as expeditiously as possible preferably within four

months.  In case, the appeals are not heard and disposed of within the

stipulated  time  frame,  the  High  Court  was  requested  to  take  up  the

interlocutory application(s)  filed  by  both appellant  and Respondent No.

3.  The order passed by this Court on 8.3.2019 related to the FAO (OS)

No.181/2016 and FAO (OS) No.227/2016.

12. The Division Bench of  the High Court  thereafter  considered the

FAO (OS)  No.181/2016 and the  C.M.  Appln.  No.22510/2016 filed  by

respondent no.3 against the interim order passed by the learned Single

Judge on  25.04.2016 whereunder,  respondent  no.3  was permitted  to

launch and market their product ‘TrastuRel’ without projecting the same

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as  biosimilar  to  the  appellants’  drugs  HERCEPTIN,  HERCLON  and

BICELTIS.   Under  the impugned order  dated  18.9.2019,  the  Division

Bench allowed the application of respondent no. 3 and granted interim

stay of the learned Single Judge order dated 25.04.2016 in terms of the

orders dated 28.4.2016 and as clarified vide order dated 3.3.2017, in the

FAO (OS) Nos.132/2016 and 133/2016, filed by Biocon and Mylan.  The

Court  justified  the  interim  order  by  observing  that  the  regulatory

authorities  have  granted  their  approval  to  the  biosimilar  drug  of

respondent no.3 and prima facie the said approval cannot be considered

to be illegal.  But it was not possible to determine at that stage, whether

respondent no.3 has conducted the requisite trials as are prescribed for

a bio similar drug.   The Division Bench held that in the face of the expiry

of the patent in favour of the plaintiff, their locus standi to file the suit was

considered to be relevant issue to be determined and the possibility of

the suit being filed with the objective of stifling competition was taken

into account and accordingly relief was granted to respondent no.3 in

marketing their product ‘TrastuRel’ on the same terms, as was granted to

Biocon and Mylan.   

13.1 Assailing the impugned order of the Division Bench of the High

Court, Mr. Shyam Divan, learned Senior Counsel appearing on behalf of

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the appellants contends that the Division Bench failed to comply with the

express directions contained in this Court’s order dated 8.3.2019 in the

SLP(C) No. 6203 of 2019 whereby this Court had expressly directed that

the respective appeals and/or interim applications filed by the appellants

and  respondent  No.  3  be  heard  analogously  and  disposed  of.

According  to  the  appellants’  counsel,  the  Division  Bench  however

considered only the application of respondent No. 3 on merit,  without

simultaneously entertaining the appellants’ application.

13.2. On the claim for parity for the drug ‘TrastuRel’, with the biosimilar

drug produced and marketed by Biocon and Mylan, Mr. Divan submits

that  the  DCGI  itself  did  not  consider  the drug of respondent no. 3 to

be entitled to be treated at par with the product of Biocon and Mylan.

But this vital fact was ignored by the Division Bench in allowing parity of

operation to Reliance, with Biocon and Mylan.

13.3 The appellants then project that the Reliance has been successful

in  participating in  government  tenders  with  their  drug ‘TrastuRel’ and

therefore,  the  conditions  imposed  by  the  learned  Single  Judge  on

25.4.2016, should not have been interdicted without the final decision in

the Reliance suit, pending before the Court instead the appeal filed by

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appellant  ought  to  have  been  considered,  allowed  and  absolute

injunction should have been granted.

13.4 According to Mr. Divan the issue of International Non-Proprietary

Name (“INN”) goes to the very root of the dispute between the parties.

He contends that Reliance is not entitled to use the INN, since their drug

has been approved without undergoing the required testing, prescribed

under the Act, the Rules and the 2012 Guidelines.    

13.5 Referring to the consideration made by the learned Single Judge in

the  Reliance  Suit  in  disallowing  parity  to  the  drug  ‘TrastuRel’

manufactured by the respondent No. 3, the appellants’ counsel submits

that   the  DCGI  too  had  admitted  that  the  Reliance  did  not  conduct

Phase-I and II of the mandatory three phase sequential clinical trials and

that Reliance has misappropriated and reproduced the appellants’ data

in their test dossiers and marketing material and therefore the possibility

of jeopardising public safety was considered by the learned Single Judge

in  stipulating  certain  conditions  to  allow  marketing  of  the  drug

‘TrastuRel’,  manufactured  by  Reliance.  The  learned  Senior  Counsel

emphasizes that the direction issued to Reliance to add qualifier to the

word ‘Trastuzumab’ was to avoid jeopardising the health and safety of

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the patients and also to distinguish the Reliance’s drug from that of the

innovator.

14.1 On the other hand, Mr. Sajan Poovayya, learned Senior Counsel

submits that the Division Bench while passing the impugned order had

considered elaborate arguments advanced by the counsel representing

the  appellants  and  all  their  contentions  were  duly  considered  and

therefore, there was adequate compliance with this Court’s order dated

8.3.2019 in SLP(C) No. 6203 of 2019.  According to the respondent no.

3, the Division Bench was conscious of this Court’s order and therefore,

dealt  with  the  submissions  of  the  appellants  as  can  be  seen  from

paragraphs 41 to 50 in the impugned order.  The learned Senior Counsel

would therefore argue that  the impugned order of the Division Bench

cannot be said to be in violation of the direction issued for analogous

consideration of the appeals and interim applications, of the rival parties.

14.2  The learned Senior Counsel submits that the appellants’ patent

right on the product ‘Trastuzumab’ has lapsed in 2013 and therefore, in

the Reliance’s suit, the conditions imposed by the learned Single Judge

on  25.4.2016  should  not  be  allowed  to  continue  to  the  prejudice  of

respondent No. 3.

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14.3 Mr.  Poovayya  submits  that  respondent  No.  3  has  faced

considerable  difficulties  in  participating in  tenders  where the required

product is described in its generic name ‘Trastuzumab’ and therefore,

despite  being  identically  placed  with  other  Indian  manufacturers  like

Biocon,  Mylan,  Zydus,  the  respondent  No.  3  is  unfairly  restricted  to

market their bio similar drug.

14.4 Respondent No. 3 next contends that the condition imposed by the

learned  Single  Judge  on  the  packaging/labelling  on  the  drug

manufactured by the Reliance is contrary to Rule 96 of the Drugs and

Cosmetic  Rules,  1945  and  accordingly,  he  argues  that  the  Division

Bench order which allows respondent No. 3 to manufacture and market

their  bio  similar  product  with  the  labelling  direction  given  in  the

Reliance’s suit,  would not enable respondent No. 3 to conform to the

statutory rules.

14.5 Questioning the timing of the Reliance suit, Mr. Poovayya submits

that the suit was filed by the appellants just when Reliance was ready to

launch  their  product  after  obtaining  all  requisite  approvals  including

manufacturing  and  marketing  authorisation  granted  by  the  Subject

Expert  Committee  (Oncology  and  Hematology)  as  also  the  approval

granted by the DCGI for manufacturing ‘Trastuzumab’, under Form No.

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46 and 46A of the Act.  It was submitted that the package insert, the

carton package were duly approved by the Subject Expert Committee,

but on account of the interim order passed by the learned Single Judge

on 25.4.2016, the respondent No. 3 had to revise their packaging and

package insert to the extent that the INN name ‘Trastuzumab’ was to be

qualified with the company’s name.

15. The  learned  counsel  appearing  for  Union  of  India  makes  no

specific  submissions in the appeal  but  only submitted that  DCGI has

granted the approval to respondent No. 3.

16. Before we consider the rival contentions, at the outset it is noted

that the Reliance suit is now pending for final disposal in the High Court.

In the detailed interim order recorded on 25.04.2016, the submissions of

the learned ASG to the effect that the clinical trials of Phase I and Phase

II for the drug manufactured by respondent no.3, are not registered with

the DCGI but approvals were accorded on the basis of the justification

given by respondent no.3 was noted by the court. Whether the injunction

suit filed by the appellants is an abuse of the process of law and whether

the  approval  was  granted  to  the  similar  drug  manufactured  by

respondent no.3, without following 2012 Guidelines was also borne in

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mind. The possibility of the attempt by the defendants to pass off their

drug as biosimilar  product  ‘Trastuzumab’,  marketed by the appellants

was  thought  out.   After  careful  consideration  of  all  those  aspects

including the projection from the DCGI, the learned Single Judge felt that

the process of obtaining approval was flawed due to non-adherence to

the statutory provisions of the Act and the Rules as also of the 2012

Guidelines. Then reflection was made on the protective conditions which

can be imposed for allowing respondent no.3 to launch their  product.

Upon due assessment,  the interim order  dated 25.04.2016 was then

passed.

17. As permitted by the interim order dated 25.4.2016, the respondent

no.3 launched their bio similar product ‘TrastuRel’ and they have been in

the market with their drug for the last about three and a half years.  They

have also participated in Government tenders and when certain doubts

were  raised  on  whether  the  drug  ‘TrastuRel’  is  biosimilar  with

‘Trastuzumab’, the High Court had intervened in favour of respondent

no.3, in separate proceeding.  However, while the interim order passed

by  the  learned  Single  Judge did  not  stop  the  marketing  of  the  drug

‘TrastuRel’,   the  Division  Bench even while  adverting to  the  concern

raised  by  the  learned  Single  Judge  on  the  issues,  which  are  to  be

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determined when the suit is finally decided, allowed respondent no.3 the

parity of operation with Biocon and Mylan. The Division Bench felt that

respondent no.3 is on similar footing as Biocon and Mylan and therefore

parity in marketing of their respective biosimilar product can be allowed.   

18. In  their  challenge  to  the  impugned  order,  the  appellants  have

contended that in passing the impugned order, the Division Bench had

failed to simultaneously consider and dispose of the pending appeals

and the interim applications filed by the plaintiffs. We had earlier referred

to the order passed by this Court on 8.3.2019 in SLP (C) No.6203/2019

which required the High Court to simultaneously take up the appeals and

the  interim  applications  filed  by  both  sides.  Although  some  of  the

contentions  raised  by  the  appellants  counsel  were  taken  into

consideration, those submissions were examined by the Division Bench

only in the context of the application filed by respondent no.3. On this

aspect, the learned senior counsel for respondent no.3 submitted that

non  mentioning  of  the  FAO  and  the  IA  of  the  appellants  was  an

inadvertent  omission.  However  such  submission,  in  the  face  of  the

specific observation made by the Division Bench in paragraph 51 of the

impugned order, cannot be accepted by us.  

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19. When the impugned order  of  the Division Bench is  read in  the

context of the express direction of this Court, it is clearly discernible that

the Division Bench had only considered the appeal and application filed

by Reliance on merit that is FAO(OS) No. 227/2016 and C.M. Appl. No.

22510/2016; without entertaining the appellants’ application.   In fact the

Bench itself clarified the position in paragraph 51 of the impugned order

by stating the following:-

“……. ………….……

51.  We have heard learned counsels and considered their respective submissions.   The submissions made on  behalf  of  the  parties  are  being  examined  in  the context  of  the appellant’s  application for  stay  of  the impugned order.

…………. …… ……..…… ……. …… ……………….”

20. The fact  that  the Division Bench was singularly  concerned with

taking up the Reliance’s interim application is further established from

the separate order passed on 16.7.2019 in FAO (OS) No. 132, 133, 226,

227 and 268 of 2016 which directs the applications (including the appeal

and the application of the plaintiffs) to be listed on 11.2.2020.   By way of

a separate order, of the same date i.e. 16.7.2019, the Division Bench

reserved orders on Reliance’s application.   Therefore, it is difficult for us

to accept as has been suggested by the learned Senior Counsel for the

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respondent no.3 that the segregation of the application of one party by

the Division Bench, could be an inadvertent error.

21. In the above context, the Division Bench even without considering

the  appellants’  interim  application  through  their  observations  in

paragraph  57,  had  clearly  shut  out  any  scope  for  the  appellants’

application to be heard and in effect, ordered on the application.

22. In  the  interim  order  passed  by  the  learned  Single  Judge  on

25.4.2016, the conditions imposed on Reliance’s product by the DCGI

were taken into account.  The said interim order was operating without

causing  much  hindrance  and  respondent  No.  3  was  successful  in

participation  in  government  tenders  and  supplies,  with  their  drug.

Therefore, the contrary submission made by the learned Senior Counsel

for respondent no.3 is found to be incorrect.    

23. As  regards  the  contention  made  by  Mr.  Poorvayya  that  the

condition  imposed  by  the  learned  Single  Judge  on  the

packaging/labelling is contrary to the statutory prescriptions, it must be

borne in mind that the arrangement ordered by the learned Single Judge

has  been  in  operation  since  25.04.2016.   Therefore  without  a  final

decision on the suit  on the basis of relevant evidence, the continuing

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arrangement  in  our  opinion  should  not  have  been  disturbed,  on  this

count.   

24. The appellants’ suit before the Delhi High Court is not a trade mark

action  nor  it  is  an  attempt  to  enforce  the  appellants’  patent,  which

admittedly expired in 2013.  The suit is an action for extended passing

off and to prevent the respondent from using the appellants’ data and

improper reference to its drug ‘Trastuzumab’. Therefore, the expiry of the

appellants’ patent  right  on the drug ‘Trastuzumab’ may not  have any

direct bearing on the contention raised in the Reliance suit.  

25. As regards the submission on the timing of the suit and the other

contentions  raised  on  the  approval  secured  from the  Subject  Expert

Committee, these are matters which should appropriately be dealt with

when the suit is finally decided. Those need not be factored in at this

stage, in support of the impugned interim order.   

26. Reverting back to the impugned order, the Division Bench had not

only considered the contention raised by the appellants in paragraphs 41

to 50 but then rejected those, in paragraphs 52 to 60 of the same order.

In such circumstances, directing the Division Bench to now consider the

appellant’s appeal FAO No. 227/2016 and CM No. 26902 of 2016 would

in our view be nothing but an empty formality, more particularly in the Page 19 of 21

present appeal when this Court taking note of the order passed by the

learned  Single  Judge  imposing  conditions  and  the  same  being  in

operation from 25.4.2016 has approved the same to be an appropriate

interlocutory  order  considering  the  nature  of  the  suit  where  all  other

issues are to be considered.

27. Because  of  the  foregoing,  and  more  particularly  because  the

Division  Bench  did  not  keep  in  view  the  order  of  this  Court  dated

8.3.2019 to ensure analogous consideration of the interim applications of

both sides in terms of this Court’s earlier direction and having regard to

the fact  that  the position prevailing since last  three and a  half  years

(pursuant  to  the learned Single Judge’s  order  dated 25.4.2016)  have

been upset without considering the issue of balance of convenience, we

are persuaded to hold that  the Division Bench was in error.   Without

analogous consideration of the appellant’s applications, the Court should

not  have unsettled the prevailing situation for  the last  three and half

years, without final conclusion of the Reliance suit.  

28. In  view of  the  aforesaid,  the  impugned  order  is  set  aside  and

appeal  is  allowed.  The  interim  direction  given  by  the  learned  Single

Judge on 25.4.2016 is accordingly made operational.  At the same time,

as the Reliance’s suit is pending since 2016, the High Court is requested

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to dispose of the CS (OS) No. 3284/2015 expeditiously and preferably

within 12 months of  receipt  of  this order.   In the meantime,  to avoid

prejudice to respondent  No.  3,  whenever  government  procurement  is

proposed for the drug by its generic name ‘Trastuzumab’,  the Reliance

should be allowed to participate with their biosimilar product, without any

impediment.  It is made clear that the views expressed here is only for

the purpose of this appeal and should have no bearing in the proceeding

pending in the High Court.  

29. With the above order, the appeal stands allowed without any order  

on cost.

…………………………J.    [R.BANUMATHI]

  …………………………J.    [A.S.BOPANNA]

…………………………J.    [HRISHIKESH ROY]

NEW DELHI DECEMBER 17, 2019

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