Del HC | Interim stay on Natco Pharma’s generic drug APIGAT quashed; importance of the ‘3 elements’ while granting interim injunction in pharmaceutical patent cases stressed upon 

Delhi High Court: The Division Bench of Dr S. Muralidhar and Talwant Singh, JJ. allowed the appeal filed by Natco Pharma Ltd. and quashed the order of the Single Judge restraining Natco Pharma from infringing the suit patent held by Bristol Myers. 

The plaintiff, Bristol Myers is a company incorporated in Ireland. Bristol Myers averred that they were registered owners of the suit patent which covers a molecule having an International Non-proprietary Name (INN) “Apixaban” used in the prevention and treatment of thromboembolic diseases. Natco Pharma had filed a petition before the Intellectual Property Appellate Board seeking revocation of the suit patent, which petition is still pending. Bristol Myers brought the present suit because as per its information, Natco Pharma was planning to launch a generic version of Apixaban under the probable brand name “Apigat”. Bristol Myers made prayers for a permanent injunction, restraining the Natco Pharma from using, making, selling, storing, distributing, advertising, marketing, exporting, offering for sale, importing or in any other manner directly or indirectly dealing in any product, including but not limited to Apigat that was alleged to infringe the subject matter of the suit patent. Along with the suit, Bristol Myers also filed an application seeking an interim injunction under Order 39 Rules 1 and 2 CPC. 

Before the Single Judge, Natco Pharma appeared on caveat. The Single Judge, however, passed the order of interim injunction as mentioned above on the lines of an earlier order in Sterlite Technologies Ltd. v. ZTT (India) (P) Ltd., CS (Comm) No. 314 of 2019, dt. 31-5-2019. Aggrieved, Natco Pharma filed the present appeal. 

Sai Deepak, Advocate representing Natco Pharma, contended that the impugned interim order was contrary to the settled law explained in several decisions of the Supreme Court in the matter of granting ad interim injunction. Per contra, Senior Advocate Amit Sibal appearing for Bristol Myers supported the order and submitted that it was dishonest on the part of Natco Pharma to risk introducing its product in the market without pursuing its revocation application pending before the IPAB. 

The High Court referred to a conspectus of judicial precedents where legal principals in relation to orders of interim injunction were enunciated and explained. Reliance was placed on Supreme Court decisions including Wander v. Antox, 1990 (Supp) SCC 727; Dorab Cawasji Warden v. Coomi Sorab Warden, (1990) 2 SCC 117; Tek Singh v. Shashi Verma, 2019 SCC OnLine SC 168Seema Arshad Zaheer v. Municipal Corporation of Greater Mumbai, (2006) 5 SCC 282; etc. Reliance was further placed upon Mahadeo Savlaram Shelke v. Pune Municipal Corporation, (1995) 3 SCC 33, where the Supreme Court explained that the expressions “prima facie” case, “balance of convenience”, “irreparable hardship” were not rhetorical phrases for mere incantation. 

The High Court was of the view that matters involving alleged infringement of patents constitute a separate species of litigation. A further sub-species would be those concerning pharmaceutical patents. This is because the law concerning them under the Patents Act, 1970 and other related legislation has peculiar elements that would have to be kept in view by the Court. On facts of the case, it was noted that there was no formation of an opinion by the Single Judge of the Bristol Myers having made out a prima facie case in their favour for grant of an interim injunction. Furthermore, as regards the other two elements, viz., balance of convenience and irreparable hardship, there was no mention of these, even impliedly in the impugned order. 

The Court observed: “Although, there are special features in litigation involving infringement of patents, that still would not obviate the Court dealing with the question of grant of interim injunction to record the three important elements as have been stressed in a large number of decisions of the Supreme Court. It is not necessary that the order granting or refusing interim injunction should expressly state about the above elements but a reading of the order should indicate the forming of an opinion by the Court on the said aspects”. In Court’s opinion, a reading of the impugned order did not reflect that the Single Judge had formed such an opinion on the aforementioned elements. Further: “The decision in the application of interim injunction has to necessarily indicate the view of the Court on the three elements mentioned hereinbefore and the additional features when it involves a case of alleged infringement of a patent, and in particular, a pharmaceutical patent. It is not the length of the order or its precise wording that matters. It is necessary, however, that the factors mentioned hereinbefore must be discernible from the order which comes to a conclusion one way or the other regarding the grant of an interim injunction”.  

In such view of the matter, the Court held that the impugned interim order be set aside and the application for interim injunction be decided afresh by the Single Judge. It was directed that until then, the status quo as on 5-7-2019, prior to the passing of the impugned order shall be maintained. [Natco Pharma Ltd. v. Bristol Myers Squibb Holdings Ireland Unlimited, 2019 SCC OnLine Del 9164, decided on 16-07-2019] 

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