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The Delhi High Court has issued directions to consolidate all the 14 suits and four revocation petitions pending related to pharma major Bristol Myers Squibb Holdings Ireland Unlimited’s (BMS) oral anticoagulant drug apixaban, to hold the trials together even as the term of the patent under dispute came to an end almost two months back.
The Order was issued while hearing a petition filed by MSN Laboratories Pvt Ltd seeking revocation and removal of the patent titled, “Lactam-containing compounds and derivatives thereof as factor Xa inhibitors” which was granted in favour of BMS. The patent relates to the brand apixaban, which is used for the treatment of ailments including deep vein thrombosis and Factor Xa reduction, which came to an end on September 17, 2022.
BMS has been entangled 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. Micro Labs, BDR Pharmaceuticals, MSN Laboratories and Natco Pharma have filed revocation applications against the patent.
The suits were listed for hearing on separate dates in November and December, 2022.
“Admittedly, there are various suits and revocation petitions which are pending before this Court in respect of the said patent. The trial of the said suits and revocation could be held in a consolidated manner so as to ensure that there are no contradictory orders passed in respect of the same patent,” observed Justice Prathiba M Singh.
“Accordingly, the Registry is directed to consolidate all these suits and revocation petitions and place them before the Hon’ble Judge-in-charge so that they can be marked before one Bench and listed together,” said the Judge. The hearing of the consolidated list of litigations is listed on January 13, 2023, now.
Earlier, BMS and Micro Labs informed the High Court that they were in discussion for amicable resolution of the patent dispute in the backdrop of the expiry of the patent in the middle of September.
Earlier, in its petition against Micro Labs, BMS alleged that while it has received interim injunction against six firms on the patent, Micro Labs filed a revocation petition with the Court against the Patent No. 247381, and the latter has admitted its intention to launch the generic apixaban in June 2021.
Further, it alleged that Micro Labs has already listed the apixaban product in 2.5 mg and 3 mg tablet strengths under the probable brand name Apivas on various third party websites and has also applied for registration of the trade mark Apivas before the Indian Trade Mark Registry. In an order issued on August 16, Justice Jayant Nath passed an ex-parte ad-interim injunction restraining Micro Labs, and the people related to it, from using, making, selling, distributing, advertising, marketing, exporting offering for sale in any generic apixaban product under any brand name, including but not limited to Apivas, which infringes the suit patent IN 247381.
Micro Labs argued that in this case, BMS has two patents - IN 243917 as a Markush patent expired on December 17, 2019 and IN 247381 specifically discloses the molecule, which expires on September 17, 2022.
The oral anticoagulant market is worth Rs. 399 crore and growing at the rate of 17%. Apixaban enjoyed the highest CAGR of 56% among all oral anticoagulants available in the market.
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