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

    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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