In its continuing battle against Indian generic pharmaceutical firms from launching generic versions of its apixaban molecule, used in treatment of thromboembolic diseases, Bristol-Myers Squibb Ireland Unlimited (BMS) has received a favourable injunction order from a Single Bench against Micro Labs. BMS sells apixaban under the brand name Eliquis.
Prior to this, six interim-injunctions were granted by the Court on the alleged infringement of the same patent, against Emcure Pharmaceuticals, Torrent Pharmaceuticals, Cipla Ltd, Alkem Laboratories Ltd, Indoco Remedies Ltd and BDR Pharmaceuticals. Besides, a Court has also issued directions to Natco Pharma Ltd to maintain status quo ante in the same patent matter. Appeals by these Indian companies against the interim-injunctions are expected to be heard by a Division Bench at the end of this month.
BMS, in its petition 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 also will recall the impugned generic products which infringe the suit patent from its distributors, wholesaler’s, said the Order.
Interestingly, the recent Division Bench order in a patent litigation between AstraZeneca Pharma and nine Indian companies, where the Bench refused to give relief to the patent owner, was also brought in for argument by Micro Labs. The Division Bench in that case observed that a single formulation of anti-diabetes drug dapagliflozin is incapable of protection under two separate patents having separate validity periods.
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 in September 17, 2022 - and the Order of Division Bench in the AstraZeneca with Indian firms has to be taken into account.
However, the Single Judge opined that for the purpose of passing of an interim order, the facts and circumstances of each case would be different. The pleas raised by Micro Labs have to be considered either at the time of arguments before the Division Bench or at the time of disposal of the interim injunction of applications that are pending adjudication.
The six orders which were issued earlier related to the same patent noted detailed reasons for granting ex-parte injunction in favour of BMS and against the defendants respectively and the Division Bench did not stay the said orders and the appeals are pending. “Different courts in suits filed for infringement of the same patent by the same plaintiff cannot pass different orders based on somewhat identical submissions raised by the different defendant. Such a step would not be in the interest of justice,” said Justice Jayant Nath.
The oral anticoagulant market is worth Rs. 399 crore and growing at the rate of 17%. Apixaban has the highest CAGR of 56% among all oral anticoagulants available in the market.