SETBACK: Delhi HC restricts Cipla from launching generic version of Apixaban
New Delhi: The Delhi High Court has granted an order restraining drug majors- Cipla from selling generic versions of Bristol-Myers Squibb's (BMS) anticoagulant drug Apixaban.
The order comes as a major setback to the pharma giant as well as several others including Emcure pharma, Torrent as well as Alkem which are reportedly planning to introduce this drug in the Indian market.
Apixaban is sold by BMS in collaboration with Pfizer under the trade name Eliquis. It is indicated for the prevention and treatment of thromboembolic diseases. BMS claimed that the product was granted a patent in April 2011 and the patent would expire on 17th September 2022.
Presently, the patent for the drug has not been subjected to any pre-grant or post-grant opposition in India except by Natco Pharma, that filed a petition seeking revocation of the patent on 9th May 2016 which is currently pending before the appellate board.
On December 6 2019, Bristol-Myers was informed that Cipla was planning to launch a generic version of APIXABAN under the probable brand name APIGY and was promoting its generic APIXABAN product in two potencies, that is, 2.5mg and 5mg tablets. Similarly, on December 17, 2019, BMS further came to know that other companies like Alkem, Emcure and Torrent were also in the process of launching their generic versions of Apixaban.
BMS carried out an extensive market survey was conducted in Delhi to ascertain whether the infringing APIXABAN products were launched in the market or not and it was revealed that the product was not available in the domestic market.
The court observed that admittedly till date the drug has not reached the market and Cipla has not yet commercialised its product APIGY.
Considering the contentions of the parties, Justice Mukta Gupta noted;
"it is clear that the validity of the suit patent IN-381 is till 17th September 2022 which suit patent specifically discloses APIXABAN, BMS has made out a strong prima facie case in their favour and in case BMS is not granted an ad-interim injunction, it would suffer an irreparable loss. The balance of convenience also lies in favour of BMS and against Cipla for the reason admittedly the Cipla is yet to launch its product in the market."
The court while restricting Cipla from manufacturing generic Apixaban finally held;
"Consequently, an ad-interim injunction is granted in favour of BMS and against Cipla in terms of prayer –A in the application and Cipla is directed to maintain status quo as on 12th December 2019 qua launching of its product APIGY till the disposal of the application."