G H M/S GENENTECH INC. & ORS. versus DRUGS CONTROLLER GENERAL OF INDIA & ORS. on 17 December 2019

SUPREME COURT REPORTS

[2019] 15 S.C.R.

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M/S GENENTECH INC. & ORS.

v.

DRUGS CONTROLLER GENERAL OF INDIA & ORS.

(Civil Appeal No. 9491 of 2019)

BDECEMBER 17, 2019

[R. BANUMATHI, A. S. BOPANNAAND HRISHIKESH ROY, JJ.]

Drugs and Cosmetics Act, 1940 – A suit was filed by theappellants before the High Court to restrain respondent No. 3 fromClaunching, marketing or selling ‘TrustuRel’ the biosimilar versionof the appellants drug ‘Trastuzumab’ – Prior to this suit, appellants’had filed a similar suit against ‘B&M’ and High Court had allowed‘B&M’ to market their drugs – However, respondent no. 3 in itssuit was restrained from launching and selling ‘TrustuRel’ andDinjunction was ordered by the Single Judge of High Court on25.04.2016 – According to the Single Judge of the High Court,the approvals granted to ‘TrustuRel’ product were not on the basisof the adherence of the guidelines 2012 and rules framed underthe Drug Act – However, respondent no. 3 was permitted to launchand market ‘TrustuRel’ on the basis of the approval from the DCGIEand without projecting their product as a biosimilar to theappellants’ product – The Division Bench of the High Courtgranted interim stay of the Single Judge Order dated 25.04.2016and allowed respondent no. 3 parity of operation with ‘B&M’ –Earlier Supreme Court had in another Special Leave Petition hadFdirected the Division Bench of the High Court to simultaneouslytake up the appeals and interim applications filed by both sides –Held: As permitted by the interim order dated 25.04.2016, therespondent no.3 had launched its biosimilar product and they werein market with their drug for the last three and a half years – TheDivision Bench of the High Court had only considered the appealGand application filed by the respondent no.3 on merit withoutentertaining appellants’ application – The Division Bench of theHigh Court committed an error – Without analogous considerationof the appellants’ applications, the Court should not have unsettledthe prevailing situation for last three and half years, without finalconclusion of the respondents’ suit – Therefore, the impugned orderH

passed by the Division Bench of the High Court set aside – Theinterim direction given by the Single Judge on 25.04.2016 madeoperational – Further, the High Court directed to dispose of thepending suit expeditiously.

Allowing the appeal, the Court

HELD: 1. As permitted by the interim order dated25.4.2016, the respondent no.3 launched their biosimilar product‘TrastuRel’ and they have been in the market with their drugfor the last about three and a half years. They have alsoparticipated in Government tenders and when certain doubtswere raised on whether the drug ‘TrastuRel’ is biosimilar with‘Trastuzumab’, the High Court had intervened in favour ofrespondent no.3, in separate proceeding. However, while theinterim order passed by the Single Judge of the High Court didnot stop the marketing of the drug ‘TrastuRel’, the DivisionBench of the High Court even while adverting to the concernraised by the Single Judge on the issues, which are to bedetermined when the suit is finally decided, allowed respondentno.3 the parity of operation with ‘B&M’. The Division Benchof the High Court felt that respondent no.3 is on similar footingas ‘B&M’ and therefore parity in marketing of their respectivebiosimilar product can be allowed. [Para 17] [329-D-F]

2. In their challenge to the impugned order, the appellantshave contended that in passing the impugned order, the DivisionBench of the High Court had failed to simultaneously considerand dispose of the pending appeals and the interim applicationsfiled by the plaintiffs. This Court had earlier referred to the orderpassed by this Court on 8.3.2019 in SLP (C) No.6203/2019 whichrequired the High Court to simultaneously take up the appealsand the interim applications filed by both sides. Although someof the contentions raised by the appellants counsel were takeninto consideration, those submissions were examined by theDivision Bench of the High Court only in the context of theapplication filed by respondent no.3. On this aspect, therespondent no.3 submitted that non mentioning of the FAO andthe IA of the appellants was an inadvertent omission. Howeversuch submission, in the face of the specific observation madeby the Division Bench of the High Court in the impugned order,cannot be accepted. [Para 18] [329-G-H; 330-A-B]

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A3. When the impugned order of the Division Bench of theHigh Court is read in the context of the express direction ofthis Court, it is clearly discernible that the Division Bench ofthe High Court had only considered the appeal and applicationfiled by respondent no.3 on merit; without entertaining theappellants’ application. [Para 19] [330-B-C]B

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4. The appellants’ suit before the Delhi High Court is nota trade mark action nor it is an attempt to enforce the appellants’patent, which admittedly expired in 2013. The suit is an actionfor extended passing off and to prevent the respondent fromusing the appellants’ data and improper reference to its drugC‘Trastuzumab’. Therefore, the expiry of the appellants’ patentright on the drug ‘Trastuzumab’ may not have any direct bearingon the contention raised in the Reliance suit. [Para 24] [331-C- D]

5. Reverting back to the impugned order, the DivisionDBench of the High Court had not only considered the contentionraised by the appellants but then rejected those, in the sameorder. In such circumstances, directing the Division Bench tonow consider the appellant’s appeal and application would benothing but an empty formality, more particularly in the presentappeal when this Court taking note of the order passed by theESingle Judge imposing conditions and the same being inoperation from 25.4.2016 has approved the same to be anappropriate interlocutory order considering the nature of the suitwhere all other issues are to be considered. [Para 26] [331-F- G]

6. Because of the foregoing, and more particularly becauseFthe Division Bench did not keep in view the order of this Courtdated 8.3.2019 to ensure analogous consideration of the interimapplications of both sides in terms of this Court’s earlierdirection and having regard to the fact that the positionprevailing since last three and a half years (pursuant to the SingleGJudge’s order dated 25.4.2016) have been upset withoutconsidering the issue of balance of convenience, this Court ispersuaded to hold that the Division Bench was in error. Withoutanalogous consideration of the appellant’s applications, the Courtshould not have unsettled the prevailing situation for the lastthree and half years, without final conclusion of the respondentHno.3’s suit. [Para 27] [331-H; 332-A-B]

CIVIL APPELLATE JURISDICTION : Civil Appeal No. 9491of 2019.

From the Judgment and Order dated 18.09.2019 of the HighCourt of Delhi at New Delhi in C.M. Appl. No. 22510 of 2016 inF.A.O. (OS) No. 181 of 2016.

Shyam Divan, Sajan Poovayya, Sr. Advs., Abhishek Tewari,Ms. Niti Dixit, N. Mahabir, Aubert Sebastian, M/s. Muizz Drabu,Ms. Sugandha Yadav, Aditya Garg, Pradeep Misra, Ms. Bitika Sharma,Ms. Namrita Kochar, Luv Virmani, Pratibhanu, Kharola, Gaurav Sharma,Gopal Jha, Mohd. Akhil, G.S. Makker, Advs. for the appearing parties.

The Judgment of the Court was delivered by HRISHIKESH ROY, J.

1. Leave granted.

2. This appeal has been preferred against the interim order dated18.09.2019 passed by the Division Bench of High Court of Delhi inC.M. Application No. 22510/2016 in FAO (O.S) No.181/2016. Underthe impugned order, the Division Bench allowed the application filedby respondent No.3-M/s Reliance Life Sciences Pvt. Ltd.[1]. TheCS(OS) No. 3284/2015[2] before the High Court of Delhi was filed byappellant no.1-M/s Genentech Inc. together with appellant nos. 2 and3 namely Roche Products (India) Pvt. Ltd. and F. Hoffmann-La Roche,AG[3] respectively.

3. Plaintiff no.1- M/s Genentech Inc. claimed themselves to bethe innovators of the monoclonal antibody drug ‘Trastuzumab’ whichis manufactured by the plaintiff no.3- F. Hoffmann-La Roche and isbeing 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 interalia restrain respondent No.3-M/s Reliance Life Sciences Pvt. Ltd.from launching, marketing or selling ‘TrastuRel’, the biosimilar versionof the appellants drug ‘Trastuzumab’. In the suit, the approval granted 1 Defendant no.3 in O.S No.181/2016

2 Reliance Suit

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

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Aby respondent no.1-Drugs Controller General of India[4] to M/s. RelianceLife Sciences Pvt. Ltd. for the manufacture and marketing ‘TrastuRel’,was also challenged. The suit was filed at a stage when respondentno.3 was yet to introduce their drug in the market. The appellants hadobtained patent for the drug ‘Trastuzumab’ but the same had lapsed Bon 3.5.2013 but they sought to restraint respondent no.3 fromrepresenting their product ‘TrastuRel’, as biosimilar to ‘Trastuzumab’

4. According to the appellants, the biosimilar product in India tobe launched by respondent no.3, has not been tested as a biosimilardrug in accordance with the law under the Drugs and Cosmetics Act,C1940[5] and other applicable norms and guidelines with the projection thatthe respondent no.3 has not undertaken requisite chemical trials andhas not also generated adequate data to establish, inter alia, the safety,efficacy and immunogenicity of the drug-‘TrastuRel’, manufactured byrespondent no.3.

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D5. Respondent no.3, however, contended that the appellants haveno enforceable right in the drug ‘Trastuzumab’ as the patent right withrespect to the drug, available with the appellants had lapsed in 2013.Therefore, any other intending manufacturer could rely upon theappellant’s data relating to Phase I and Phase II trials, as available inpublic domain.E

6. Prior to the Reliance suit filed against respondent no.3, theappellants had filed the suit being CS (OS) No. 355/2014 against F.Hoffmann-La Roche, AG, their associate Mylan Inc, seeking similarrestraint against purported biosimilar version of the appellants drug,F“Trastuzumab”. Biocon and Mylan were however already in themarket by selling their products “Trastuzumab’ - ‘CANMab’ and‘Trastuzumab’-‘HERTRAZ’ in the market.

7. The High Court of Delhi passed respective orders on5.12.2014,14.2.2014 and 28.02.2014 in the Biocon’s suit and permittedGBiocon and Mylan to market their drugs subject to the conditions thatthey would not claim bio similarity with the appellants’ productHERCEPTIN, HERCLON and BICELTIS. However, in the Reliancesuit, the learned Single Judge was of the prima facie view that the 4 DCGI

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approval by the DCGI for the biosimilar drug of respondent no.3, wasfar more egregious than in the case of the drug marketed by Biocon.Accordingly, an interim order was passed on 2.11.2015 in the Reliancesuit whereby respondent no.3 was restrained from launching and sellingtheir product ‘TrastuRel’ in India, until the next date of hearing. In theBiocon and the Reliance suits, the appellants had claimed that thebiosimilar version of the appellants ‘Trastuzumab’, were being launchedwithout the required test and studies under the applicable laws requiringconducting of tests and obtaining of appropriate approval from theregulatory authority including the DCGI. The appellants’ injunctionapplication was ordered by the learned Single Judge on 25.04.2016. TheCourt recorded the prima facie finding that ‘TrastuRel was approvedby the DCGI under applicable law. The learned Single Judge observedthat the approvals granted to ‘TrastuRel’ product are not on the basisof the adherence of the Guidelines 2012 and rules framed under theDrug Act. However, it was observed that the final finding in this respectis 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, certainconditions were imposed by the learned Judge to safeguard public healthand safety as also to protect the innovator of the biosimilar drug‘Trastuzumab’. The relevant stipulations of the learned Single Judgeare noted as follows:

“262. I am of the view that the approvals granted to TrastuRelproduct are not on the basis of the adherence of the Guidelinesof 2012 and rules framed under the Drug Act. The final findingin this respect is yet to be arrived after the present suit is heardupon completion of the trial. Pending the final outcome of thesuit, there is need to arrive at interim measure by working outcertain terms between the parties by passing the followingdirections:- (a) The defendant No.3 may launch to manufacture, marketand advertise their product under the name TrastuRel onthe basis of the approvals already granted to defendantNo.3 without calling their product as “bio similar” and/ or“bio similar to HERCEPTIN, HERCLON, BICELTIS” orin any way ascribing any bio-similarity with that of theplaintiffs products HERCEPTIN, HERCLON, BICELTIS

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in any press releases, public announcements, promotionalor other in printed form and from relying upon or referringthe plaintiffs’ names.

(b) The defendant No.3 may also manufacture and market thedrug by qualifying the INN name Trastuzumab but not touse the said name stand alone on the carton or packageinsert as a brand name. The defendant No.3 can use theINN name as Reliance Trastuzumab or TrastuRelwherever applicable to describe the composition ofmolecule on the product as well as in its insert and not ina prominent manner. The said expression shall be used atthe bottom part of the carton and should be in small sizeletters than the brand name TrastuRel.

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(c) In view of prima facie findings that the use of the data bythe defendant No.3 in the product insert without undergoingthe entire process of the trials is misleading, the defendantNo.3 is also restrained from using the data relating tomanufacturing process, safety, efficacy and tests conductedfor the safety of the drugs as complained of by theplaintiffs till the time the final decision on the issue of thebio similarity is made in the present suit.

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(d) In the event, the defendant No.3 intends to claim bio similaras a description of its product or part of its promotionalcampaign or otherwise in any other form, the defendantNo.3, if so advised, can re-apply the said license beforethe relevant authorities including defendant No.1 and inFwhich case, the defendant No.1, the authorities andcommittees framed therein shall decide the said approvalapplication in accordance with the Rules and Guidelinesof 2012 and also the observations made by this court inthe present order. The defendant No.3 shall also be entitledto use the data of the plaintiffs for the comparisonGpurposes before the Regulatory Authority. In the alternative,the defendant No.3 may await the outcome of the presentsuit and can continue with the present arrangement as aninterim measure.

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(e) This interim measure is made only in view of the peculiarHfacts in the present case only wherein the defendant No.3

is already in possession of approvals granted rightly orwrongly validity of which is questioned in this suit. In futureapplication for approval(s) of biosimilar shall be decidedby the defendant No.1 and authorities and committeeswhile considering the guidelines of 2012 and also thefindings arrived at in the present order by this Court aswell 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 onrespondent no.3.

9. Aggrieved by such restriction, Biocon and Mylan approachedthe Division Bench of the High Court. Likewise, the appellants filedappeal 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 marketfor almost two years and accordingly permitted them to continue tomarket ‘CANMab’ and ‘HERTRAZ’ without complying with theadditional directions set forth in the order dated 28.06.2016.

10. In the appeals filed by respondent no.3 and in their challengeto the Single Judge order of 25.04.2016, the Division Bench had notgranted any interim relief to respondent no.3 until the recent impugnedorder (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 thisCourt on 8.3.2019 with a request to the High Court of Delhi tosimultaneously take up the appeals preferred by the contesting partiesat an early date and dispose of the same as expeditiously as possiblepreferably within four months. In case, the appeals are not heard anddisposed of within the stipulated time frame, the High Court wasrequested to take up the interlocutory application(s) filed by bothappellant and Respondent No. 3. The order passed by this Court on8.3.2019 related to the FAO (OS) No.181/2016 and FAO (OS) No.227/2016.

12. The Division Bench of the High Court thereafter consideredthe FAO (OS) No.181/2016 and the C.M. Appln. No.22510/2016 filedby respondent no.3 against the interim order passed by the learned SingleJudge on 25.04.2016 whereunder, respondent no.3 was permitted to AB

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Alaunch and market their product ‘TrastuRel’ without projecting the sameas biosimilar to the appellants’ drugs HERCEPTIN, HERCLON andBICELTIS. Under the impugned order dated 18.9.2019, the DivisionBench allowed the application of respondent no. 3 and granted interimstay of the learned Single Judge order dated 25.04.2016 in terms ofthe orders dated 28.4.2016 and as clarified vide order dated 3.3.2017,Bin the FAO (OS) Nos.132/2016 and 133/2016, filed by Biocon andMylan. The Court justified the interim order by observing that theregulatory authorities have granted their approval to the biosimilar drugof respondent no.3 and prima facie the said approval cannot beconsidered to be illegal. But it was not possible to determine at thatCstage, whether respondent no.3 has conducted the requisite trials asare prescribed for a bio similar drug. The Division Bench held that inthe face of the expiry of the patent in favour of the plaintiff, their locusstandi to file the suit was considered to be relevant issue to bedetermined and the possibility of the suit being filed with the objectiveof stifling competition was taken into account and accordingly relief wasDgranted to respondent no.3 in marketing their product ‘TrastuRel’ onthe same terms, as was granted to Biocon and Mylan.

13.1 Assailing the impugned order of the Division Bench of theHigh Court, Mr. Shyam Divan, learned Senior Counsel appearing onbehalf of the appellants contends that the Division Bench failed toEcomply with the express directions contained in this Court’s order dated8.3.2019 in the SLP(C) No. 6203 of 2019 whereby this Court hadexpressly directed that the respective appeals and/or interim applicationsfiled by the appellants and respondent No. 3 be heard analogously anddisposed of. According to the appellants’ counsel, the Division BenchFhowever 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 thebiosimilar drug produced and marketed by Biocon and Mylan, Mr. Divansubmits that the DCGI itself did not consider the drug of respondentGno. 3 to be entitled to be treated at par with the product of Biocon andMylan. But this vital fact was ignored by the Division Bench in allowingparity of operation to Reliance, with Biocon and Mylan.

13.3 The appellants then project that the Reliance has beensuccessful in participating in government tenders with their drugH‘TrastuRel’ and therefore, the conditions imposed by the learned Single Judge on 25.4.2016, should not have been interdicted without the finaldecision in the Reliance suit, pending before the Court instead the appealfiled by appellant ought to have been considered, allowed and absoluteinjunction 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 betweenthe parties. He contends that Reliance is not entitled to use the INN,since their drug has been approved without undergoing the requiredtesting, prescribed under the Act, the Rules and the 2012 Guidelines.

13.5 Referring to the consideration made by the learned SingleJudge in the Reliance Suit in disallowing parity to the drug ‘TrastuRel’manufactured by the respondent No. 3, the appellants’ counsel submitsthat the DCGI too had admitted that the Reliance did not conductPhase-I and II of the mandatory three phase sequential clinical trialsand that Reliance has misappropriated and reproduced the appellants’data in their test dossiers and marketing material and therefore thepossibility of jeopardising public safety was considered by the learnedSingle Judge in stipulating certain conditions to allow marketing of thedrug ‘TrastuRel’, manufactured by Reliance. The learned SeniorCounsel emphasizes that the direction issued to Reliance to add qualifierto the word ‘Trastuzumab’ was to avoid jeopardising the health andsafety of the patients and also to distinguish the Reliance’s drug fromthat of the innovator.

14.1 On the other hand, Mr. Sajan Poovayya, learned SeniorCounsel submits that the Division Bench while passing the impugnedorder had considered elaborate arguments advanced by the counselrepresenting the appellants and all their contentions were duly consideredand therefore, there was adequate compliance with this Court’s orderdated 8.3.2019 in SLP(C) No. 6203 of 2019. According to therespondent no. 3, the Division Bench was conscious of this Court’s orderand therefore, dealt with the submissions of the appellants as can beseen from paragraphs 41 to 50 in the impugned order. The learnedSenior Counsel would therefore argue that the impugned order of theDivision Bench cannot be said to be in violation of the direction issuedfor analogous consideration of the appeals and interim applications, ofthe rival parties.

14.2 The learned Senior Counsel submits that the appellants’patent right on the product ‘Trastuzumab’ has lapsed in 2013 and A

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Atherefore, in the Reliance’s suit, the conditions imposed by the learnedSingle Judge on 25.4.2016 should not be allowed to continue to theprejudice of respondent No. 3.

14.3 Mr. Poovayya submits that respondent No. 3 has facedconsiderable difficulties in participating in tenders where the requiredBproduct is described in its generic name ‘Trastuzumab’ and therefore,despite being identically placed with other Indian manufacturers likeBiocon, Mylan, Zydus, the respondent No. 3 is unfairly restricted tomarket their bio similar drug.

14.4 Respondent No. 3 next contends that the condition imposedCby the learned Single Judge on the packaging/labelling on the drugmanufactured by the Reliance is contrary to Rule 96 of the Drugs andCosmetic Rules, 1945 and accordingly, he argues that the DivisionBench order which allows respondent No. 3 to manufacture and markettheir bio similar product with the labelling direction given in theReliance’s suit, would not enable respondent No. 3 to conform to theDstatutory rules.

14.5 Questioning the timing of the Reliance suit, Mr. Poovayyasubmits that the suit was filed by the appellants just when Reliance wasready to launch their product after obtaining all requisite approvalsincluding manufacturing and marketing authorisation granted by theESubject Expert Committee (Oncology and Hematology) as also theapproval granted by the DCGI for manufacturing ‘Trastuzumab’, underForm No. 46 and 46A of the Act. It was submitted that the packageinsert, the carton package were duly approved by the Subject ExpertCommittee, but on account of the interim order passed by the learnedFSingle Judge on 25.4.2016, the respondent No. 3 had to revise theirpackaging 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 nospecific submissions in the appeal but only submitted that DCGI hasGgranted the approval to respondent No. 3.

16. Before we consider the rival contentions, at the outset it isnoted that the Reliance suit is now pending for final disposal in the HighCourt. In the detailed interim order recorded on 25.04.2016, thesubmissions of the learned ASG to the effect that the clinical trials ofHPhase I and Phase II for the drug manufactured by respondent no.3, are not registered with the DCGI but approvals were accorded on thebasis of the justification given by respondent no.3 was noted by thecourt. Whether the injunction suit filed by the appellants is an abuse ofthe process of law and whether the approval was granted to the similardrug manufactured by respondent no.3, without following 2012Guidelines was also borne in mind. The possibility of the attempt bythe defendants to pass off their drug as biosimilar product‘Trastuzumab’, marketed by the appellants was thought out. Aftercareful consideration of all those aspects including the projection fromthe DCGI, the learned Single Judge felt that the process of obtainingapproval was flawed due to non-adherence to the statutory provisionsof the Act and the Rules as also of the 2012 Guidelines. Then reflectionwas made on the protective conditions which can be imposed forallowing 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, therespondent no.3 launched their bio similar product ‘TrastuRel’ and theyhave been in the market with their drug for the last about three and ahalf years. They have also participated in Government tenders and whencertain doubts were raised on whether the drug ‘TrastuRel’ is biosimilarwith ‘Trastuzumab’, the High Court had intervened in favour ofrespondent no.3, in separate proceeding. However, while the interimorder passed by the learned Single Judge did not stop the marketing ofthe drug ‘TrastuRel’, the Division Bench even while adverting to theconcern raised by the learned Single Judge on the issues, which are tobe determined when the suit is finally decided, allowed respondent no.3the parity of operation with Biocon and Mylan. The Division Benchfelt that respondent no.3 is on similar footing as Biocon and Mylan andtherefore parity in marketing of their respective biosimilar product canbe allowed.

18. In their challenge to the impugned order, the appellants havecontended that in passing the impugned order, the Division Bench hadfailed to simultaneously consider and dispose of the pending appealsand the interim applications filed by the plaintiffs. We had earlier referredto the order passed by this Court on 8.3.2019 in SLP (C) No.6203/2019which required the High Court to simultaneously take up the appealsand the interim applications filed by both sides. Although some of thecontentions raised by the appellants counsel were taken intoconsideration, those submissions were examined by the Division Bench AB

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Aonly in the context of the application filed by respondent no.3. On thisaspect, the learned senior counsel for respondent no.3 submitted thatnon mentioning of the FAO and the IA of the appellants was aninadvertent omission. However such submission, in the face of thespecific observation made by the Division Bench in paragraph 51 ofthe impugned order, cannot be accepted by us.

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19. When the impugned order of the Division Bench is read inthe context of the express direction of this Court, it is clearly discerniblethat the Division Bench had only considered the appeal and applicationfiled by Reliance on merit that is FAO(OS) No. 227/2016 and C.M.Appl. No. 22510/2016; without entertaining the appellants’ application.CIn fact the Bench itself clarified the position in paragraph 51 of theimpugned order by stating the following:- “……. …………. ……

51. We have heard learned counsels and considered theirDrespective submissions. The submissions made on behalf of theparties are being examined in the context of the appellant’sapplication for stay of the impugned order.

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20. The fact that the Division Bench was singularly concernedEwith taking up the Reliance’s interim application is further establishedfrom the separate order passed on 16.7.2019 in FAO (OS) No. 132,133, 226, 227 and 268 of 2016 which directs the applications (includingthe 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 DivisionFBench reserved orders on Reliance’s application. Therefore, it is difficultfor us to accept as has been suggested by the learned Senior Counselfor the respondent no.3 that the segregation of the application of oneparty by the Division Bench, could be an inadvertent error.

21. In the above context, the Division Bench even withoutGconsidering the appellants’ interim application through their observationsin 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 on25.4.2016, the conditions imposed on Reliance’s product by the DCGIHwere taken into account. The said interim order was operating without causing much hindrance and respondent No. 3 was successful inparticipation in government tenders and supplies, with their drug.Therefore, the contrary submission made by the learned Senior Counselfor respondent no.3 is found to be incorrect.

23. As regards the contention made by Mr. Poorvayya that thecondition imposed by the learned Single Judge on the packaging/labellingis contrary to the statutory prescriptions, it must be borne in mind thatthe arrangement ordered by the learned Single Judge has been inoperation since 25.04.2016. Therefore without a final decision on thesuit on the basis of relevant evidence, the continuing arrangement inour opinion should not have been disturbed, on this count.

24. The appellants’ suit before the Delhi High Court is not a trademark action nor it is an attempt to enforce the appellants’ patent, whichadmittedly expired in 2013. The suit is an action for extended passingoff and to prevent the respondent from using the appellants’ data andimproper reference to its drug ‘Trastuzumab’. Therefore, the expiry ofthe appellants’ patent right on the drug ‘Trastuzumab’ may not haveany direct bearing on the contention raised in the Reliance suit.

25. As regards the submission on the timing of the suit and theother contentions raised on the approval secured from the SubjectExpert Committee, these are matters which should appropriately bedealt with when the suit is finally decided. Those need not be factoredin at this stage, in support of the impugned interim order.

26. Reverting back to the impugned order, the Division Benchhad not only considered the contention raised by the appellants inparagraphs 41 to 50 but then rejected those, in paragraphs 52 to 60 ofthe same order. In such circumstances, directing the Division Benchto 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 present appeal when this Court taking note ofthe order passed by the learned Single Judge imposing conditions andthe same being in operation from 25.4.2016 has approved the same tobe an appropriate interlocutory order considering the nature of the suitwhere all other issues are to be considered.

27. Because of the foregoing, and more particularly because theDivision Bench did not keep in view the order of this Court dated8.3.2019 to ensure analogous consideration of the interim applications A

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Aof both sides in terms of this Court’s earlier direction and having regardto 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) havebeen upset without considering the issue of balance of convenience,we are persuaded to hold that the Division Bench was in error. Withoutanalogous consideration of the appellant’s applications, the Court shouldBnot have unsettled the prevailing situation for the last three and halfyears, without final conclusion of the Reliance suit.

28. In view of the aforesaid, the impugned order is set aside andappeal is allowed. The interim direction given by the learned Single Judgeon 25.4.2016 is accordingly made operational. At the same time, asCthe Reliance’s suit is pending since 2016, the High Court is requestedto dispose of the CS (OS) No. 3284/2015 expeditiously and preferablywithin 12 months of receipt of this order. In the meantime, to avoidprejudice to respondent No. 3, whenever government procurement isproposed for the drug by its generic name ‘Trastuzumab’, the RelianceDshould be allowed to participate with their biosimilar product, withoutany impediment. It is made clear that the views expressed here is onlyfor the purpose of this appeal and should have no bearing in theproceeding pending in the High Court.

29. With the above order, the appeal stands allowed without anyEorder on cost.

Ankit Gyan

Appeal allowed.

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