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BMS enters into amicable settlement with two companies in Apixaban patent dispute

Our Bureau, New Delhi
Thursday, April 13, 2023, 08:00 Hrs  [IST]

Bristol Myers Squibb Holdings Ireland Unlimited (BMS) has entered into an amicable settlement with a couple of Indian pharma companies in connection to the patent dispute on the former’s oral anticoagulant drug Apixaban, as the patent expired on September 17, 2022.

The dispute between Bristol Myers Squibb Holdings Ireland Unlimited and Indoco Remedies, and another between the originator company and Metrochem API Pvt Ltd, were amicably settled, the companies informed the Delhi High Court.

According to the terms of settlement, Indoco Remedies submitted that it acknowledge the validity of BMS’ claim in India related to the suit patent, without prejudice to its rights and the contentions raised by the company in the litigation and solely with the view to amicably and expeditiously resolve the dispute.

It confirmed that subsequent to the interim order in December 24, 2019 on the said litigation, it has discontinued manufacturing and selling or exporting Apixaban or any of its pharmaceutically acceptable salts in any form until the expiry of the suit patent in September, 2022. The company manufactured 55,728 numbers of Apixabid 2.5 mg and 5 mg strengths prior to the interim order in December, 2019 and the stock expired in October, 2021 and the expired stock has been destroyed by the company.

Indoco agreed to withdraw the counter claims in the matter, since the patent has expired. BMS agreed to forgo certain prayers related to damages.

In the terms of settlement, Metrochem has submitted that it acknowledges the validity of BMS’ patent for Apixaban during its term which expired in September, last year and the company has discontinued manufacturing, selling or exporting of Apixaban or any of its pharmaceutically acceptable salts in the form of Active Pharmaceutical Ingredients or finished formulation under any brand name, subsequent to filing of the proceedings with the Delhi High Court.

The activities undertaken by the company with respect to Apixaban, in form till the expiry of the patent was in accordance with the Section 107A of the Patents Act, 1970, which exempts certain acts as not to be considered as an infringement. It also agreed to pay Rs. 1,50,000 as token cost to BMS. BMS agreed to forgo various prayers it has made into suit against Metrochem, as part of the settlement agreement.

In two different orders on April 10, 2023, Justice C Hari Shankar decreed the suits in terms of the settlement agreement by which the parties shall remain bound. The Court also ordered that BMS shall be entitled to refund of court fees, if any, deposited by it.

As reported earlier, BMS has been in litigation with at least 14 Indian generics manufacturers including Natco Pharma, Emcure Pharmaceuticals, Torrent Pharmaceuticals, Cipla Ltd, Alkem Laboratories, Indoco Remedies, BDR Pharmaceuticals, Micro Labs, Triveni Interchem, Consern Pharma Ltd, Zee Laboratories, Metrochem API Pvt Ltd, Angle Biopharma and Jigs Chemical Ltd related to the patent rights of Apixaban. Micro Labs, BDR Pharmaceuticals, MSN Laboratories and Natco Pharma have filed revocation applications against the patent.


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