ET Bureau Jan 10, 2020, 11.24 AM IST
New Delhi: In a setback to major domestic pharma companies like Cipla, Torrent, Emcure, Alkem, the Delhi High Court has granted an injunction restraining them from selling a medicine used for prevention and treatment of thromboembolic diseases, the patent for which is held by Bristol-Myers Squibb (BMS).
BMS filed its claims for patent infringement in Delhi HC, arguing that its anticoagulant product, Apixaban, is patented till September 2022. The drug was granted a patent in 2011. BMS, along with partner Pfizer, has been selling the drug used in the prevention and treatment of blood clots under the brand name Eliquis.
The US firm stated that it came to know on December 6 that Cipla was planning to launch the generic version of Apixaban under the probable brand name Apigy.
BMS carried out an extensive market survey in Delhi to ascertain whether Cipla’s product was launched in the market or not, and it was revealed that the product was not available in the domestic market.
Considering the contentions and the fact that Cipla was yet to launch its product in the market, the court favoured BMS’ plea, stating that if BMS was not granted an ad-interim injunction, it would suffer an “irreparable loss”. Consequently, “an ad-interim injunction is granted in favour of the plaintiffs and against the defendant in terms of prayer –A in the application and the defendant is directed to maintain status quo as on December 12, 2019 qua launching of its product Apigy till the disposal of the application,” the court order of December 2019 said.
While an email sent to Cipla did not elicit any response, BMS said that it was “confident in the value of our innovative science and the strength of our patent position”.
Similarly, on December 17, 2019, BMS came to know that other companies like Alkem, Emcure and Torrent were in the process of launching their generic versions of Apixaban. BMS informed the court that Emcure had already circulated letters to its team for doing the ground work for launching the product under the brand Zapixa.
The court, while granting interim injunctions in favour of BMS, directed these pharma companies to maintain status quo till the disposal of the matter. The next date of hearing is February 5. These companies did not respond to an email sent on December 30.
So far, only Natco Pharma has been given interim relief by the HC, with the court setting aside an injunction petition filed by BMS seeking to protect its anti-coagulant Apixaban against Natco’s Apigat. Natco had launched its generic version in June. BMS had filed its claims for patent infringement at the HC and had secured an injunction on July 5. Natco got the injunction lifted on July 16. The case is pending before the appellate board.
In the same case, pharma company Indoco was also ordered a partial restriction.
An industry expert, on condition of anonymity, mentioned that there are some nuances to the case – for instance, BMS already had an older patent covering the molecule Apixaban in a broad form that has expired in December 2019.
Some of the Indian companies that were restrained have filed appeals against the same in the court. The division bench of the high court is hearing those appeals.