w w w . L a w y e r S e r v i c e s . i n



Indoco Remedies Ltd. v/s Bristol Myers Squibb Holdings Ireland Unlimited Company & Others


Company & Directors' Information:- BRISTOL-MYERS SQUIBB INDIA PRIVATE LIMITED [Active] CIN = U24230MH2004FTC147232

Company & Directors' Information:- A V S R HOLDINGS PRIVATE LIMITED [Active] CIN = U67120TG2005PTC045117

Company & Directors' Information:- INDOCO REMEDIES LIMITED [Active] CIN = L85190MH1947PLC005913

Company & Directors' Information:- S R HOLDINGS LIMITED [Active] CIN = U65993TN1988PLC083659

Company & Directors' Information:- S R HOLDINGS PRIVATE LIMITED [Active] CIN = U65993TN1988PTC083659

Company & Directors' Information:- A B HOLDINGS PRIVATE LIMITED [Active] CIN = U70102KA2006PTC040894

Company & Directors' Information:- S K A HOLDINGS LIMITED [Active] CIN = U65993DL1981PLC012592

Company & Directors' Information:- S K A HOLDINGS LIMITED [Active] CIN = L65993DL1981PLC012592

Company & Directors' Information:- G J HOLDINGS PRIVATE LIMITED [Active] CIN = U51100DL2004PTC126687

Company & Directors' Information:- G J HOLDINGS PRIVATE LIMITED [Active] CIN = U65993DL2004PTC126687

Company & Directors' Information:- P P HOLDINGS LTD [Active] CIN = U65993PN1981PLC025916

Company & Directors' Information:- G S D HOLDINGS PVT LTD [Strike Off] CIN = U70109WB1990PTC048518

Company & Directors' Information:- S T HOLDINGS PRIVATE LIMITED [Active] CIN = U67120MH1979PTC021588

Company & Directors' Information:- M C HOLDINGS PRIVATE LIMITED [Active] CIN = U67190DL2009PTC190957

Company & Directors' Information:- J S K HOLDINGS PVT LTD [Active] CIN = U67120WB1994PTC065660

Company & Directors' Information:- P R HOLDINGS LIMITED [Active] CIN = L27310AS1983PLC007154

Company & Directors' Information:- P R HOLDINGS LIMITED [Active] CIN = L27310DL1983PLC314402

Company & Directors' Information:- G R A HOLDINGS PVT LTD [Active] CIN = U70101WB1992PTC055865

Company & Directors' Information:- B S S HOLDINGS PVT LTD [Active] CIN = U67120WB1992PTC056874

Company & Directors' Information:- H M HOLDINGS PRIVATE LIMITED [Active] CIN = U65993ML2005PTC007956

Company & Directors' Information:- S M H HOLDINGS PRIVATE LIMITED [Active] CIN = U65993TG2006PTC049309

Company & Directors' Information:- M M HOLDINGS PVT LTD [Active] CIN = U70109WB1993PTC058147

Company & Directors' Information:- D J HOLDINGS PRIVATE LIMITED [Active] CIN = U67120MH1992PTC067448

Company & Directors' Information:- R S M P HOLDINGS PRIVATE LIMITED [Active] CIN = U67190MH1995PTC088443

Company & Directors' Information:- S P C REMEDIES PRIVATE LIMITED [Active] CIN = U24239DL2004PTC125962

Company & Directors' Information:- V A G HOLDINGS PRIVATE LIMITED [Active] CIN = U74899DL1994PTC057817

Company & Directors' Information:- K E HOLDINGS PRIVATE LIMITED [Active] CIN = U70101TN2013PTC089953

Company & Directors' Information:- K C HOLDINGS PRIVATE LIMITED [Active] CIN = U65990MH1981PTC024688

Company & Directors' Information:- A TO Z HOLDINGS PRIVATE LIMITED [Active] CIN = U74899DL1987PTC028294

Company & Directors' Information:- V R HOLDINGS PRIVATE LIMITED [Active] CIN = U70102KA2009PTC051724

Company & Directors' Information:- J B HOLDINGS LIMITED [Strike Off] CIN = U91110ML1995PLC004396

Company & Directors' Information:- P G T HOLDINGS LIMITED [Strike Off] CIN = U74899DL1994PLC057886

Company & Directors' Information:- S M HOLDINGS PRIVATE LIMITED [Active] CIN = U65990MH2011PTC225004

Company & Directors' Information:- M S R HOLDINGS LIMITED [Active] CIN = U85110KA1995PLC018599

Company & Directors' Information:- V N C A HOLDINGS PRIVATE LIMITED [Active] CIN = U74999TN2011PTC081684

Company & Directors' Information:- S C HOLDINGS PRIVATE LIMITED [Strike Off] CIN = U74899DL1986PTC025017

Company & Directors' Information:- S G HOLDINGS PVT LTD [Active] CIN = U70109WB1986PTC040839

Company & Directors' Information:- J. B. REMEDIES PRIVATE LIMITED [Active] CIN = U24239UR2007PTC032413

Company & Directors' Information:- K C A HOLDINGS PRIVATE LIMITED [Active] CIN = U74899DL1995PTC066204

Company & Directors' Information:- S N J HOLDINGS PRIVATE LIMITED [Active] CIN = U67120DL1997PTC084488

Company & Directors' Information:- H P HOLDINGS LIMITED [Strike Off] CIN = U67120HP1997PLC019474

Company & Directors' Information:- K L N HOLDINGS PRIVATE LIMITED [Active] CIN = U65990TG1986PTC006344

Company & Directors' Information:- M R HOLDINGS LIMITED [Active] CIN = U67120MH1978PLC020559

Company & Directors' Information:- J T HOLDINGS PRIVATE LIMITED [Active] CIN = U67120MH1979PTC021585

Company & Directors' Information:- B M D HOLDINGS PRIVATE LIMITED [Strike Off] CIN = U51909TN1995PTC031179

Company & Directors' Information:- H K R HOLDINGS PRIVATE LIMITED [Active] CIN = U74899DL1982PTC013032

Company & Directors' Information:- R J HOLDINGS PRIVATE LIMITED [Active] CIN = U74899DL1982PTC013033

Company & Directors' Information:- K D R HOLDINGS PRIVATE LIMITED [Active] CIN = U74899DL1982PTC013034

Company & Directors' Information:- P D R HOLDINGS PVT LTD [Amalgamated] CIN = U67120WB1996PTC077248

Company & Directors' Information:- W A HOLDINGS PRIVATE LIMITED [Active] CIN = U65993DL1997PTC084687

Company & Directors' Information:- W D HOLDINGS PRIVATE LIMITED [Active] CIN = U65993DL1997PTC084667

Company & Directors' Information:- A K HOLDINGS PRIVATE LIMITED [Active] CIN = U74899UP1986PTC037306

Company & Directors' Information:- J R D HOLDINGS PRIVATE LIMITED [Active] CIN = U74899DL1994PTC059769

Company & Directors' Information:- C S HOLDINGS PRIVATE LIMITED [Strike Off] CIN = U85110KA1995PTC018441

Company & Directors' Information:- R A HOLDINGS LIMITED [Strike Off] CIN = U17119GJ1986PLC037333

Company & Directors' Information:- W. M. F. HOLDINGS PRIVATE LIMITED [Active] CIN = U70101CT2011PTC022482

Company & Directors' Information:- A V HOLDINGS PVT LTD [Active] CIN = U51109WB1992PTC054035

Company & Directors' Information:- K B R HOLDINGS PRIVATE LIMITED [Active] CIN = U67120TG1998PTC030518

Company & Directors' Information:- U B P HOLDINGS LTD [Strike Off] CIN = U67120WB1988PLC045279

Company & Directors' Information:- E K HOLDINGS PRIVATE LIMITED [Active] CIN = U74899DL1990PTC040323

Company & Directors' Information:- N R HOLDINGS PVT LTD [Strike Off] CIN = U67120WB1993PTC060077

Company & Directors' Information:- B P A HOLDINGS PVT LTD [Strike Off] CIN = U74990DL1982PTC013326

Company & Directors' Information:- V V HOLDINGS PRIVATE LIMITED [Active] CIN = U74899DL1994PTC060480

Company & Directors' Information:- D D B HOLDINGS PVT LTD [Strike Off] CIN = U67120WB1992PTC055592

Company & Directors' Information:- M D HOLDINGS PRIVATE LIMITED [Active] CIN = U67120DL2001PTC111221

Company & Directors' Information:- V H A HOLDINGS PRIVATE LIMITED [Converted to LLP and Dissolved] CIN = U65993DL2003PTC120147

Company & Directors' Information:- K E F HOLDINGS LTD [Amalgamated] CIN = U67120WB1988PLC045280

Company & Directors' Information:- A P HOLDINGS PVT LTD [Active] CIN = U65993PN1981PTC025915

Company & Directors' Information:- N. R. HOLDINGS PRIVATE LIMITED [Active] CIN = U67120MH1993PTC140612

Company & Directors' Information:- M B HOLDINGS LTD. [Not available for efiling] CIN = U70109WB1986PLC041226

Company & Directors' Information:- J S R HOLDINGS PRIVATE LIMITED [Active] CIN = U45200KA2006PTC040195

Company & Directors' Information:- K M HOLDINGS PRIVATE LIMITED [Active] CIN = U74899DL1995PTC064343

Company & Directors' Information:- A S H HOLDINGS PRIVATE LIMITED [Active] CIN = U74899DL2004PTC125403

Company & Directors' Information:- C M HOLDINGS PVT LTD [Strike Off] CIN = U45203WB1986PTC041627

Company & Directors' Information:- M H HOLDINGS PRIVATE LIMITED [Active] CIN = U74899DL1995PTC067392

Company & Directors' Information:- I K HOLDINGS LTD [Strike Off] CIN = U70101WB1951PLC019703

Company & Directors' Information:- C & R HOLDINGS PVT. LTD. [Active] CIN = U65929WB1991PTC051376

Company & Directors' Information:- J J HOLDINGS LTD [Amalgamated] CIN = U65993WB1980PLC032736

Company & Directors' Information:- K G HOLDINGS PVT LTD [Active] CIN = U65929WB1987PTC042868

Company & Directors' Information:- B & T HOLDINGS PRIVATE LIMITED [Active] CIN = U74920DL2007PTC171796

Company & Directors' Information:- M K REMEDIES PRIVATE LIMITED [Strike Off] CIN = U24231UP1997PTC022812

Company & Directors' Information:- H D HOLDINGS PVT LTD [Amalgamated] CIN = U51109WB1991PTC051415

Company & Directors' Information:- N AND N HOLDINGS PRIVATE LIMITED [Active] CIN = U74899DL1990PTC040846

Company & Directors' Information:- I V A REMEDIES PRIVATE LIMITED [Active] CIN = U24118UP1990PTC011740

Company & Directors' Information:- M P HOLDINGS PRIVATE LIMITED [Under Process of Striking Off] CIN = U67120DL1997PTC088350

Company & Directors' Information:- O R N REMEDIES PRIVATE LIMITED [Active] CIN = U00304DL2005PTC140854

Company & Directors' Information:- B P HOLDINGS PRIVATE LIMITED [Active] CIN = U74899DL1989PTC038274

Company & Directors' Information:- K P R HOLDINGS PRIVATE LIMITED [Active] CIN = U74900TZ2011PTC017467

Company & Directors' Information:- U AND V HOLDINGS PRIVATE LIMITED [Strike Off] CIN = U65999TN2005PTC057659

Company & Directors' Information:- B AND B HOLDINGS PRIVATE LIMITED [Active] CIN = U70101AS1999PTC005674

Company & Directors' Information:- M. G. HOLDINGS PRIVATE LIMITED [Strike Off] CIN = U67120DL2010PTC198226

Company & Directors' Information:- D G HOLDINGS PRIVATE LIMITED [Active] CIN = U65110DL1998PTC094466

Company & Directors' Information:- I R HOLDINGS PRIVATE LIMITED [Strike Off] CIN = U74120DL2008PTC185743

Company & Directors' Information:- S I HOLDINGS PRIVATE LIMITED [Strike Off] CIN = U74120DL2008PTC186043

Company & Directors' Information:- C J G HOLDINGS INDIA PRIVATE LIMITED [Active] CIN = U70101KL2010PTC038559

Company & Directors' Information:- U P L HOLDINGS PVT LTD [Strike Off] CIN = U67120OR1990PTC002414

Company & Directors' Information:- N N HOLDINGS PVT LTD [Strike Off] CIN = U65999WB1990PTC048493

Company & Directors' Information:- O M K HOLDINGS PVT LTD [Strike Off] CIN = U67120WB1995PTC072914

Company & Directors' Information:- M K HOLDINGS (INDIA) PRIVATE LIMITED [Strike Off] CIN = U65993TN1996PTC036985

Company & Directors' Information:- K I HOLDINGS PVT LTD [Strike Off] CIN = U67120MH1981PTC024069

Company & Directors' Information:- D R HOLDINGS PRIVATE LIMITED [Active] CIN = U65993DL1982PTC013031

Company & Directors' Information:- R R HOLDINGS PRIVATE LIMITED [Active] CIN = U74899DL1983PTC017127

Company & Directors' Information:- G J HOLDINGS PVT LTD [Not available for efiling] CIN = U65993PB1985PTC006327

Company & Directors' Information:- M S D REMEDIES LIMITED [Strike Off] CIN = U24232RJ2001PLC017342

Company & Directors' Information:- M G L HOLDINGS PRIVATE LIMITED [Active] CIN = U65993TN1994PTC029354

Company & Directors' Information:- K V R HOLDINGS PRIVATE LIMITED [Active] CIN = U65191KA2012PTC063353

Company & Directors' Information:- S R REMEDIES PRIVATE LIMITED [Active] CIN = U24232DL2004PTC128921

Company & Directors' Information:- A B S REMEDIES PRIVATE LIMITED [Active] CIN = U24232DL1998PTC096360

Company & Directors' Information:- R N M HOLDINGS P LTD. [Active] CIN = U65921WB1990PTC050174

Company & Directors' Information:- M D HOLDINGS PVT LTD [Strike Off] CIN = U67120CH1983PTC005399

Company & Directors' Information:- R V HOLDINGS PRIVATE LIMITED [Strike Off] CIN = U74899DL1989PTC036577

Company & Directors' Information:- B J HOLDINGS PRIVATE LIMITED [Active] CIN = U67120MH1982PTC028820

Company & Directors' Information:- R S HOLDINGS PVT LTD [Active] CIN = U70109WB1986PTC040255

Company & Directors' Information:- A D HOLDINGS PVT LTD [Strike Off] CIN = U65993WB1976PTC030525

Company & Directors' Information:- S P HOLDINGS PVT LTD [Strike Off] CIN = U65993WB1988PTC044540

Company & Directors' Information:- R A HOLDINGS PVT LTD [Strike Off] CIN = U70200WB1986PTC040138

Company & Directors' Information:- A HOLDINGS PVT LTD [Strike Off] CIN = U70101WB1962PTC025617

Company & Directors' Information:- K T R HOLDINGS PVT LTD [Strike Off] CIN = U67120WB1993PTC059078

Company & Directors' Information:- B I HOLDINGS PVT LTD [Strike Off] CIN = U65922WB1988PTC043690

Company & Directors' Information:- E TO E HOLDINGS INDIA PRIVATE LIMITED [Active] CIN = U65999KA2008PTC047780

Company & Directors' Information:- H & S REMEDIES PRIVATE LIMITED [Active] CIN = U24232UP2002PTC026801

Company & Directors' Information:- M A HOLDINGS PRIVATE LIMITED [Active] CIN = U26106UP2003PTC027990

Company & Directors' Information:- G L HOLDINGS PRIVATE LIMITED [Dormant under section 455] CIN = U74996KA2008PTC044867

Company & Directors' Information:- A AND M HOLDINGS PRIVATE LIMITED [Strike Off] CIN = U67190TG1995PTC021464

Company & Directors' Information:- K V S HOLDINGS PVT LTD [Strike Off] CIN = U65993WB1993PTC060850

Company & Directors' Information:- S S REMEDIES PRIVATE LIMITED [Strike Off] CIN = U24231HP1991PTC011595

Company & Directors' Information:- V K HOLDINGS PRIVATE LTD [Strike Off] CIN = U27924DL1987PTC027924

Company & Directors' Information:- R R REMEDIES PRIVATE LIMITED [Strike Off] CIN = U24231KA1990PTC011480

Company & Directors' Information:- Q AND A HOLDINGS PRIVATE LIMITED [Strike Off] CIN = U67120MH2000PTC127319

Company & Directors' Information:- S K HOLDINGS PVT. LTD [Strike Off] CIN = U99999UP1988PTC010231

Company & Directors' Information:- V S REMEDIES PRIVATE LIMITED [Active] CIN = U51397UP1998PTC023583

Company & Directors' Information:- V A HOLDINGS PVT LTD [Strike Off] CIN = U67120KL1986PTC004442

Company & Directors' Information:- S R HOLDINGS PRIVATE LIMITED [Strike Off] CIN = U65993TN1980PTC008388

Company & Directors' Information:- M T R HOLDINGS PRIVATE LIMITED [Active] CIN = U67110KA2007PTC042600

Company & Directors' Information:- C S A HOLDINGS PRIVATE LIMITED [Strike Off] CIN = U65990MH1995PTC092555

Company & Directors' Information:- K N Z HOLDINGS PRIVATE LIMITED [Strike Off] CIN = U67120MH1998PTC117331

Company & Directors' Information:- S H HOLDINGS PRIVATE LIMITED [Active] CIN = U67120MH2001PTC131041

Company & Directors' Information:- K S R REMEDIES PRIVATE LIMITED [Strike Off] CIN = U74999MH2010PTC210243

Company & Directors' Information:- D L HOLDINGS PRIVATE LIMITED [Strike Off] CIN = U67100TN2012PTC083929

Company & Directors' Information:- P C T HOLDINGS PRIVATE LIMITED [Active] CIN = U70101TZ2004PTC010971

Company & Directors' Information:- M J P HOLDINGS PRIVATE LIMITED [Active] CIN = U74900TG2015PTC098835

Company & Directors' Information:- J. D. REMEDIES PRIVATE LIMITED [Under Process of Striking Off] CIN = U74999UP2014PTC063593

Company & Directors' Information:- P H HOLDINGS PVT LTD [Active] CIN = U67120WB1985PTC039369

Company & Directors' Information:- D S REMEDIES PRIVATE LIMITED [Active] CIN = U24230CH2005PTC028348

Company & Directors' Information:- G S REMEDIES PRIVATE LIMITED [Active] CIN = U24230CH2005PTC028349

Company & Directors' Information:- J D S HOLDINGS PRIVATE LIMITED [Active] CIN = U65993DL1993PTC053637

Company & Directors' Information:- M R S HOLDINGS PRIVATE LIMITED [Strike Off] CIN = U67120DL2001PTC113197

Company & Directors' Information:- J S M S HOLDINGS PRIVATE LIMITED [Strike Off] CIN = U45201DL2002PTC117110

Company & Directors' Information:- R M G HOLDINGS PVT LTD [Active] CIN = U67120MP1987PTC004209

Company & Directors' Information:- G R REMEDIES INDIA PRIVATE LIMITED [Strike Off] CIN = U24100KA2013PTC072184

Company & Directors' Information:- B R HOLDINGS PRIVATE LIMITED [Amalgamated] CIN = U74899HR1994PTC064054

Company & Directors' Information:- J N REMEDIES PRIVATE LIMITED [Active] CIN = U24100GJ2015PTC083303

Company & Directors' Information:- P R S HOLDINGS PRIVATE LIMITED [Strike Off] CIN = U67120KA2010PTC052295

Company & Directors' Information:- S AND L REMEDIES PRIVATE LIMITED [Active] CIN = U33309DL2021PTC377313

Company & Directors' Information:- M AND D HOLDINGS PRIVATE LIMITED [Strike Off] CIN = U67120MH1981PTC025882

Company & Directors' Information:- A T HOLDINGS PRIVATE LIMITED [Under Process of Striking Off] CIN = U74899DL1994PTC057216

Company & Directors' Information:- J AND S HOLDINGS PVT LTD [Strike Off] CIN = U67120RJ1996PTC012114

Company & Directors' Information:- S K V HOLDINGS PRIVATE LIMITED [Strike Off] CIN = U65993DL1981PTC012910

Company & Directors' Information:- S M K S HOLDINGS PVT LTD [Strike Off] CIN = U45400WB1990PTC048498

Company & Directors' Information:- S J P HOLDINGS PRIVATE LIMITED [Strike Off] CIN = U99999GJ1981PTC004682

    CM APPL. Nos. 16257, 602 of 2020 in FAO(OS) (COMM). No. 3 of 2020

    Decided On, 18 September 2020

    At, High Court of Delhi

    By, THE HONOURABLE CHIEF JUSTICE MR. D.N. PATEL & THE HONOURABLE MR. JUSTICE C. HARI SHANKAR

    For the Petitioner: Chetan Sharma, Sr. Advocate, Manisha Singh, Abhai Pandey, Varun Sharma, Gautam Kumar, Advocates. For the Respondents: Amit Sibal, Sr. Advocate, Pravin Anand, Prachi Agarwal, Tusha Malhotra, Ridhie Bajaj, Rashi Punia, Ambar Bhushan, Saksham Dhingra, Advocates.



Judgment Text

(Video-Conferencing):

C. Hari Shankar, J.

CM APPL. 16257/2020 in FAO(OS) (COMM) 3/2020

1. This application, preferred by the appellant in FAO (OS) (COMM) 03/2020 – M/s Indoco Remedies Ltd. (hereinafter referred to as “the applicant”) – contains two prayers. Prayer (a) is for permitting the applicant to manufacture and sell its product “APIXABID”, a generic product of the formulation “Apixaban”, during the COVID-2019 pandemic. Prayer (b) is for permission, to the applicant, to sell, and authorise the sale of, approximately 58,000 strips of APIXABID, stated to have been manufactured by the applicant, prior to the passing of the judgment, dated 24th December, 2019, by the learned Single Judge – which constitutes the subject matter of challenge in the appeal – stated to be lying with the applicant, or with its stockists, distributors and retailers.

2. Mr. Chetan Sharma, learned Senior Counsel appearing for the petitioner, submits, at the outset, that he was restricting his relief to the prayer (b) in the application, i.e. for permission to sell the 58,000 strips of APIXABID, manufactured by his client prior to 24th December, 2019.

A brief factual background.

3. FAO (OS) (COMM) 03/2020 arises from CS (COMM) 731/2019, preferred by the respondent M/s Bristol Myers Squibb Holdings Ireland Unlimited Company (hereinafter referred to as “Bristol Myers”), alleging infringement, by the applicant, of Indian patent “IN 247381” (hereinafter referred to as “IN 381”), granted to Bristol Myers, in respect of “Lactam-Containing Compounds and Derivatives thereof, as Factor Xa Inhibitors”.

4. The learned Single Judge, vide judgment, dated 24th December, 2019, impugned in the appeal, directed, by way of ad interim relief, maintenance of status quo as on 5th July, 2019, in respect of manufacture and sale of the products which, allegedly, infringed the suit patent.

5. It was opined, by the learned Single Judge, inter alia, that the suit patent IN 381 specifically disclosed Apixaban, and was valid till 17th September, 2022, so that the manufacture and sale of any pharmaceutical preparations of Apixaban by any other party, during the life of the said suit patent, without any license from Bristol Myers, would infringe the suit patent, resulting in irreparable loss to Bristol Myers.

6. The present applicant is one of the entities against which ad interim injunction has been granted by the learned Single Judge.

7. It may be noted, here, that substantially similar ad interim orders were passed by the learned Single Judge, in a batch of suits, preferred by Bristol Myers against various companies, allegedly infringing the IN 381 suit patent.

8. The alleged infringers were M/s Torrent Pharmaceuticals Ltd., M/s Cipla Limited, M/s Emcure Pharmaceutical Limited and the present applicant.

9. Appeals have been preferred against all such orders, which have been consolidated and are presently being heard by this Court. One such appeal is FAO (OS) (COMM) 03/2020, preferred by the present applicant.

10. As on date, therefore, it is clear that, as the ad interim order, dated 24th December, 2019, of the learned Single Judge, continues to operate, the applicant is not entitled to manufacture or sell its APIXABID product.

11. It is in such circumstances, when the appeals are pending before this Court and substantial arguments have been advanced therein, by the various appellants – including the present applicant – that, by way of the present application, the applicant seeks permission to sell the aforesaid 58,000 strips of APIXABID, purportedly manufactured by the applicant prior to the passing of the judgment dated 24th December, 2019, by the learned Single Judge.

12. Before proceeding to the ground on which this somewhat extraordinary relief is being sought by the applicant, it merits mention that, in para 21 of the impugned judgment dated 24th December, 2019, the contention of the present applicant that, prior to the passing of the said order, the applicant had already manufactured 40,000 to 50,000 strips, of which 30,000 strips had been sent to the market, and 20,000 strips were in its possession and yet to be dispatched, was specifically noted. The learned Single Judge, however, held that the applicant was clearly anticipating the litigation and was aware of the passing of the ad interim injunctions, in the suits filed by Bristol Myers against Emcure Pharmaceuticals Ltd, Torrent Pharmaceuticals Ltd and Alkem Laboratories Ltd, on 12th December, 2019, 13th December, 2019 and 19th December, 2019 – against which FAO (OS) (COMM) 371/2019, FAO (OS) (COMM) 372/2019 and FAO (OS) (COMM) 377/2019, have been preferred and are being heard along with FAO (OS) (COMM) 03/2020.

13. The observations/findings of the learned Single Judge in this regard, to the extent they are relevant, may be reproduced thus:

“21. Case of the defendant is that since it has already launched its product, it should be continued to sell the medicine which fact cannot be accepted in view of the admission that it has been launched only on 20th December, 2019 and 40,000 to 50,000 strips of drug have been manufactured out of which 30,000 strips of drug have been sent to the market and 20,000 strips are yet to be dispatched. The plaintiffs have also filed a document from the website of the defendant at page 711 of the paper-book which indicates that on the website of the defendant as on 21st December, 2019 the product APIXABAN was under compilation.......

22. Date of filing the caveat by the defendant is 17th December, 2019. Learned counsel for the defendant states that the defendant launched the product under the bona fide belief that patent of the plaintiffs was expired. The caveat was filed by the defendant on 17th December, 2019 clearly anticipating the litigation and would have had the knowledge that interim injunctions were passed in similar cases on 12th December, 2019, 13th December, 2019 and 19th December, 2019.

23. Consequently, an ad-interim injunction is granted in favour of the plaintiffs and against the defendant in terms of prayer (a) in the application and the defendant is directed to maintain status quo as on 24th December, 2019 qua further launching/delivery/dispatch of its product APIXABID till disposal of the application.”

14. Mr. Amit Sibal, learned Senior Counsel appearing for the respondent Bristol Myers, submitted, inter alia, that the fact of manufacture, by the applicant, of 50,000 strips, prior to the 24th December, 2020, had been brought to the notice of learned Single Judge, and, for cogent and convincing reasons, the learned Single Judge did not treat this as a ground to insulate the applicant from the interlocutory injunctions granted in similar cases. Mr. Sibal submits, therefore, that the present application essentially seeks allowing of the appeal of the applicant, qua the said 58,000 strips, at the interlocutory stage, without advancing any submission on merits, and ought to be dismissed even on that ground.

15. The response, of Mr. Chetan Sharma, learned Senior Counsel appearing for the applicant, is that the present application is related to the situation in which the nation finds itself, consequent to the COVID-2019 pandemic and that, therefore, the observations/findings of the learned Single Judge, as extracted hereinabove, cannot impact the adjudication of the present application.

16. Mr. Chetan Sharma advances the following submissions, to support the prayer in the application:

(i) Thromboembolic inhibitors are necessary and inevitable adjuncts to the treatment of persons afflicted by the COVID-2019 virus, as coagulation is one of the natural sequalae of the ailment. Apixaban is a forerunner in the list of drugs administered for thromboembolic therapy. Mr. Sharma has drawn our attention to literature, placed by him on record, to the effect that even after recovery from the COVID-2019 infection, patients require forty-five days’ post-discharge anticoagulant therapy. Apixaban being one of the major anticoagulants, Mr. Sharma submits that public interest would justify grant of permission to the applicant to sell the 50,000 strips of APIXABID manufactured prior to 24th December, 2019.

(ii) APIXABID, manufactured by the applicant, was much cheaper than the generic Apixaban product of Bristol Myers. Persons, afflicted by COVID-2019 were not, all, in a position to afford expensive Apixaban products, so that availability of the cheaper APIXABID product of the applicant was essential, given the fact that the number of persons, infected by the COVID-2019 virus, was increasing exponentially day by day. In this context, Mr. Sharma has drawn our attention to the sales figures of Bristol Myers, which indicated that, consequent on the COVID-2019 pandemic, the sales figures of Bristol Myers had increased substantially. The importance of Apixaban, as essential therapy, for COVID-2019, thereby, submits Mr. Sharma, stands established.

(iii) Mr. Sharma further undertakes, drawing an analogy, for the purpose, from Section 41 of the Specific Relief Act, 1963, that his client was willing to maintain accounts of every strip of APIXABID sold in the market and also to to restitute Bristol Myers, were it to fail in its appeal before the Division Bench.

(iv) NATCO Limited, which was similarly situated, had been allowed, by this Court, vide order dated 16th July, 2019 passed in FAO (OS) (COMM) 160/2019 (NATCO Pharma Limited vs. Bristol Myers Squibb Holdings Ireland Unlimited Company), to sell its Apixaban product in the market. There was no justification for discriminating against the applicant in this regard.

17. For the aforesaid reasons, chiefly the element of public interest in the wake of the present COVID-2019 pandemic, Mr. Chetan Sharma would submit that a clear case for allowing the applicant to clear and sell the aforesaid 58,000 “APIXABID” strips, manufactured by it prior to 24th December, 2019, exists.The arrangement, he submits, would be ad hoc, interim and without prejudice to the merits of the case of either party, either before the learned Single Judge, or before the Division Bench.

18. Mr. Amit Sibal, learned Senior Counsel appearing for the respondent, has emphatically contested the claim of Mr. Sharma.

19. The submissions advanced by Mr. Sibal, in this regard, may be enumerated thus:

(i) No stay had been sought by the applicant, in FAO (OS) 03/2020. It could not, therefore, now seek permission to manufacture or sell its APIXABID product.

(ii) De hors its merits, the application was, in any case, not maintainable, as the Patents Act, 1970 (hereinafter referred to as “the Patents Act”) was self-regulatory and contains, in Section 84, an adequate mechanism to deal with a situation in which the patented invention is not available to the public at a reasonably affordable price. In such circumstances, the remedy with the applicant would be for applying for grant of compulsory licence, and not to frustrate the appeal by requesting this Court to pass an order in violation of the judgment, dated 24th December, 2019 (supra) of the learned Single Judge. For ready reference, Section 84(1) of the Patents Act may be reproduced thus:

“84. Compulsory licences.

(1) At any time after the expiration of three years from the date of the grant of apatent, any person interested may make an application to the Controller for grant of compulsory licence on patent on any of the following grounds, namely:—

(a) that the reasonable requirements of the public with respect to the patented invention have not been satisfied, or

(b) that the patented invention is not available to the public at a reasonably affordable price, or

(c) that the patented invention is not worked in the territory of India.”

(iii) In fact, the applicant has not referred to any material, on the basis of which this Court could conclude, even prima facie, that the Apixaban product of Bristol Myers was not “reasonably affordable”. Neither had it provided evidence of any shortfall, in the availability of Apixaban, for patients who were in need of the drug, either on account of the price of the product, or for any other reason.

(iv) The applicant had proceeded to manufacture the aforesaid 50,000 strips of APIXABID in full awareness of the injunctive orders, dated 12th December, 2019, 13th December, 2019 and 19th December, 2019 of the learned Single Judge. It was after the passing of the said orders that on 20th December, 2019 – according to the applicant – it had manufactured the aforesaid 50,000 strips of APIXABID. If, in full awareness of the aforesaid injunction orders, the applicant did so, it did so at its own peril. It is settled, in patent jurisprudence that such manufacture of an infringing product is impermissible, without, in the first instance, clearing the way. The prayer of the applicant, if granted, would turn this jurisprudence on its head. Besides, the prayer of the applicant was also directly contrary to para 87 of the judgment, dated 20th March, 2015, of this Court in FAO (OS) 190/2013 (MERCK Sharp and Dohme Corporation v. Glenmark Pharmaceuticals), which reads thus:

“87. A related concern that this Court heeds – the fourth principle operative in this case – is that of the chronology of events and Glenmark’s decision to release Zita without first challenging Januvia or Janumet. Undoubtedly, the Act creates a right to oppose patents even after grant. There is no obligation to only utilize the pre or post grant opposition mechanisms. Neither does a patent benefit from a presumption of validity if it is challenged in the course of an infringement suit. However, if a defendant is aware that there may be a possible challenge to its product, but still chooses to release the drug without first invoking revocation proceedings or attempting to negotiate, that is surely a relevant factor. The defendant’s legal right to challenge the patent at any point in time is intact, but that does not mean that this factor cannot determine the interim arrangement. This is more so where Glenmark today argues that MSD ought to have disclosed international patent applications for SPM and Sitagliptin plus Metformin since they were the “same or substantially the same” as the suit patent under Section 8. That is Glenmark’s stated position. Such being the state of things, it is surely reasonable for Glenmark to detect the possibility to challenge, when a US patent application for SPM filed by it was opposed by MSD. Despite this, Glenmark released the drug without initiating revocation proceedings under the Act, which is also a right vested in Glenmark that would have obviated the need for the interim arrangement we are today considering. This does not mean that Glenmark’s right to question the validity of the patent in an infringement is affected, but the manner of challenge is a relevant factor against it at the interim stage. As Justice Jacob noted in both Smithkline Beecham cases (supra):

“I remain of the same opinion that I was in the Generics case. Where litigation is bound to ensue if the defendant introduces his product he can avoid all the problems of an interlocutory injunction if he clears the way first. That is what the procedures for revocation and declaration of non-infringement are for.”

Similarly, in the Australian decision of Pharmacia Italia S.p.A v. Interpharma Pty Ltd, [2005] FCA 1675, the Court noted the fact that Inter-pharma had acted in full knowledge of Pharmacia’s patent and the possible consequences flowing from that.This consideration that the patentee is already in the market and has been operating the patent has found favour in Indian Courts as well. In K. Ramu v. Adayar Ananda Bhavan and Muthulakshmi Bhavan, 2007 (34) PTC 689 (Mad), Bajaj Auto Ltd. v. TVS Motor Company Ltd., 2008 (36) PTC417 (Mad) and National Research Development Corporation of India v. The Delhi Cloth and General Mills Co. Ltd. and Others, AIR 1980 Del 132, the fact that the patentee was already dealing in the market on the basis of the patent weighed in as a factor in granting the interim injunction.”

(Emphasis supplied)

(v) The prayer of the applicant, essentially, therefore, sought reversal, by this Bench, of the findings and decision of the learned Single Judge, in paras 22 and 23 of the judgment, dated 24th December, 2019 (supra) (extracted hereinabove), even while the appeal thereagainst is pending before this Bench, without an adjudication on merits. This was clearly unsustainable in law.

(vi) The APIXABID batch, in respect of which the present application has been filed by the applicant, was due to expire only in October, 2021. As such, the plea of urgency was merely artificial, and was an attempt to secure the relief in the appeal, without adjudication on merits.

For, inter alia, the above reasons, Mr. Sibal prayed that the application of the applicant be dismissed.

20. Certain other submissions were advanced by Mr. Sibal, on the merits of the case of Bristol Myers; however, we are in agreement with Mr. Sharma that the adjudication of the present application does not necessitate examination of the comparative merits of the stands of the parties in appeal. As such, we refrain from making any reference thereto.

21. Arguing in rejoinder, in response to the submissions of Mr. Sibal, Mr. Sharma, apart from reiterating some of the submissions advanced by him in the first instance, additionally sought to submit, with respect to Section 84 of the Patents Act, that the exercise of applying for grant of compulsory license was cumbersome and time consuming, and was intended to cater to ordinary times, and not to a pandemic situation. Were the respondent to apply for compulsory license, by the time the license was obtained, the pandemic would, in all probability, be over. Mr Sharma submits that the resistance, by Bristol Myers, to the grant of the said prayer is unreasonable and opposed to public interest, on which the application of his client was premised.

22. Having heard learned Senior Counsel, we are clear in our mind that it is impossible, for this Court, to accede to the prayer of the applicant.

23. As on date, the order dated 24th December, 2019, of the learned Single Judge, continues to hold the field. Short of merits, this Court is unaware of any law, which would permit interference, with the said order, or frustrate the operation thereof, by way of any interlocutory directions. It is obvious, on its face, that the application, essentially seeks allowing of its appeal, qua the aforesaid 50,000 strips, and reversal of the findings of the decision of the learned Single Judge in this regard, to the said extent, as contained in paras 22 and 23 of the order dated 24th December, 2019, without pressing the merits of the appeal and without adjudication thereof. It is equally obvious that no such course of action, by this Court, is permissible in law.

24. Even if it were to be assumed, arguendo, that there is a shortage of Apixaban, and that the drug is needed for COVID-2019 treatment, that cannot empower us to allow clearing of products which infringe the patent of Bristol Myers and, thereby, allow violation of the injunction granted by the learned Single Judge vide her order dated 24th December, 2019, without returning a finding, in the first instance, that the order is prima facie, unsustainable on merits. Grant of interlocutory relief, it is well settled, requires cumulative satisfaction of three indicia of existence of a prima facie case, balance of convenience and irreparable loss to the person seeking interim injunction, were injunction not to be granted. (State of Mizoram v. Pooja Fortune Pvt Ltd, 2019 SCC OnLine 1741)

25. To these criteria, the Supreme Court, in its decisions in Ramniklal N. Bhutta v. State of Maharashtra ((1997) 1 SCC 134) and Raunaq International Ltd. v. I.V. R. Construction Ltd ((1999) 1 SCC 492). added, as another important criterion, the element of public interest. That, however, does not mean that, merely on supposed public interest, a court can grant interlocutory injunction, unmindful of the existence of a prima facie case, or the considerations of balance of convenience and irreparable loss. Far less could any such direction be granted where, as on date, the judgment dated 24th December, 2019, of the learned Single Judge, is still in place, merely on the ground of perceived public interest.

26. We have also perused, minutely, the material placed on record, by the applicant, as demonstrating that public interest lay in allowing the sale of the aforesaid 58,000 strips of APIXABID. We are not satisfied that, even cumulatively, the material discloses any such overwhelming public interest, as would justify the grant of the reliefs prayed in the application. Not an iota of material, indicating shortage of “APIXABAN”, qua the requirements of patients in need of the drug, or of the product of the Bristol Myers being prohibitively priced, or, for that matter, not being reasonably affordable, has been placed on record. Mr. Sibal, has, in this context, undertaken, on behalf of his client, that sufficient stock of Apixaban, manufactured by Bristol Myers, is available, to cater to patients who may be in need thereof. Mr. Sibal has contended, emphatically, that the plea of shortage, forming one of the main planks of the reasoning of the applicant, is entirely artificial and unsupported by evidence, and we are persuaded to agree with the submission. It is also noteworthy in this regard that the applicant has not placed, on record, any notification, or other official release, by the Government, to indicate that there was a shortage of Apixaban in the market.

27. Mr. Sibal has also drawn our attention to the material, placed on record by the applicant, which indicates that, apart from Apixaban, there are other direct acting oral anticoagulants, chiefly Rivaroxaban, Edoxaban and Dabigatran. Though Mr. Sibal has also pointed out that the material, placed on record by the applicant further reveals that, as per recent studies of the aforesaid anticoagulants, the most beneficial was not Apixaban but Rivaroxaban, we do not intend to traverse that path, as it involves technical knowledge, which we do not possess. Suffice it to state that the perception, on the part of the applicant, that there is a shortage of affordable Apixaban in the market and that, therefore, permission to sell the 58,000

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strips of APIXABID, manufactured by it, ought to be granted, is merely a perception, and nothing more. The material on record is hopelessly inadequate to sustain the submission. 28. The reliance, by the applicant, on the aforesaid order, dated 16th July, 2019, of the Division Bench of this Court in NATCO Pharma Ltd. (supra), also, in our view, does not advance the prayers in the application. In that case, the order, of the learned Single Judge, was set aside by the Division Bench on the ground that the learned Single Judge had not returned any clear findings of the existence of a prima facie case, balance of convenience and irreparable loss, which constitute the sine qua non for grant of interim injunction. The matter was, therefore, remanded to the learned Single Judge for a reconsideration. 29. That situation is completely distinct from the present case, in which, during the currency of the injunction, granted by the learned Single Judge, vide the order dated 24th December, 2019 supra, and without advancing any submissions on merits, to demonstrate the unsustainability of the said order, the applicant is, merely on the ground of the COVID-2019 pandemic and its own perceived notion of shortage of Apixaban in the market, seeking an interim order, effectively allowing its appeal and reversing the findings of the learned Single Judge in paras 22 and 23 of the order dated 24th December, 2019 supra, insofar as they apply to the aforesaid 50,000 strips of APIXABID, stated to have been manufactured by the applicant on 20th December, 2019. 30. For all the aforesaid reasons, we are clear that the prayers in the application cannot be granted. 31. Prayer (a) has, rightly, not been canvassed by Mr. Chetan Sharma. Prayer (b) is also devoid of substance, as, without any decision on the merits of the matter, we cannot, by adjudicating the present application, reverse the findings contained in paras 22 and 23 of the judgment dated 24th December, 2019 supra of the learned Single Judge, and effectively allow the appeal of the applicant, qua the 50,000 strips of APIXABID, stated to have been manufactured by it on 20th December, 2019. 32. Though, therefore, even on the issue of maintainability, we are satisfied that the prayers in the application cannot be granted, we have, additionally, examined the plea of urgency and public interest, assiduously canvassed by Mr. Chetan Sharma, but find no merit, whatsoever, therein. 33. We, therefore, dismiss the application.
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