Attempt to Evergreen and Monopolize Invention: Delhi HC allows Indian Pharma Companies to Produce Diabetes Drug Linagliptin [Read Order]

A Single Bench of the Delhi High Court has recently held that there shall be no impediment on the manufacture and sale of products with Linagliptin as the API on account of the suit patent IN '301 and permitted the defendants to manufacture and sell the Diabetes drug subject to necessary approvals. Pursuant to the same, the Delhi High Court vacated the interim orders of the Commercial Court in CS (COMM) 239/2019 and CS(COMM) 240/2019. The pro tem arrangements arrived at between the parties in CS(COMM) 236/2022, CS(COMM) 237/2022 and CS(COMM) 238/2022 vide order dated 19th April, 2022 and in CS(COMM) 296/2022 vide order dated 9th May, 2022, were also vacated. Two Indian pharmaceutical companies, Cadila Healthcare Ltd and West Coast Pharmaceutical Works Ltd, had been restrained earlier this year, from producing and marketing a drug for diabetes, named linagliptin, after the German pharmaceutical company, Boehringer Ingelheim Pharma GmbH & Co, claimed they had violated its patent rights. The commercial court had ruled in favour of Boehringer Ingelheim, as the company held patents for linagliptin, which were registered in February 2002 and August 2003, respectively. Although one of the patents had already expired, the Indian companies were unable to show any authorization to manufacture the drug. The court had ordered Cadila and West Coast Pharma not to infringe on Boehringer Ingelheim's patent rights until the case was resolved. However, in the recent decision by the Delhi High Court, it was observed that, “the suit patent of the plaintiffs, i.e., IN '301 is vulnerable to revocation on the ground of prior claiming in terms of Section 64(1)(a) of the Patents Act.” Section 64(1)(a) of the Patents Act states that, Subject to the provisions contained in this Act, a patent, whether granted before or after the commencement of this Act, may, be revoked on a petition of any person interested or of the Central Government by the Appellate Board or on a counter-claim in a suit for infringement of the patent by the High Court on any of the following grounds, that is to say that the invention, so far as claimed in any claim of the complete specification, was claimed in a valid claim of earlier priority date contained in the complete specification of another patent granted in India. The present suit at the Delhi High Court was brought about by the German pharmaceutical company, Boehringer Ingelheim Pharma GmbH & Company against Vee Excel Drugs and Pharmaceuticals Private Limited, Alkem Laboratories Limited, Micro Labs Limited, Natco Pharma Limited and Mankind Pharma Limited. It was thus observed by the High Court Bench that, by filing multiple patent claims in respect of the same invention, the plaintiffs have made an attempt towards evergreening the invention and re-monopolizing the same. It was also noted by the Single Bench of Justice Amit Bansal that, “the plaintiffs thus had failed to make out a prima facie case for grant of interim injunction. Balance of convenience is in favour of the defendants and against the plaintiffs. Irreparable injury would be caused not only to the defendants but also to the public, if the interim injunction is granted in favour of the plaintiffs.” Resultantly, all the applications in the suits for grant of interim injunction were dismissed with costs of Rs 2,00,000/- to each of the defendants. In addition, costs of Rs. 2,00,000/- was also awarded in favour of Delhi High Court Legal Services Committee on account of detriment caused to the public interest. Support our journalism by subscribing to TaxscanAdFree. Follow us on Telegram for quick updates.