Bristol Myers Squibb Sues Biocon For Patent Infringement Over Leukemia Drug

Plaintiff Bristol Myers Squibb Company (BMS) filed suit against defendant Biocon Pharma Limited (Biocon) on Monday in the District of New Jersey. The complaint for patent infringement explains that the defendant filed an abbreviated new drug application (ANDA) with the FDA that sought approval to produce and market a generic version of the plaintiff’s drug Sprycel prior to the expiration of the two patents protecting the drug.

The plaintiff’s website describes the drug as intended to treat adults with a newly diagnosed form of leukemia. The patents-in-suit, the ‘725 patent and the ‘103 patent, were assigned in 2009 and 2019, respectively. Both patents, which are assigned to BMS, protect the process by which the drug works.

The ANDA filed by the defendant is said in the complaint to demonstrate “the bioavailability or bioequivalence of the Biocon ANDA Products to SPRYCEL.” The ANDA also alleges that the patents-in-suit held by the plaintiff are invalid, unenforceable, or will not be infringed upon when the defendant begins to manufacture and sell their generic version of Sprycel.

In April of 2022, the defendant mailed the plaintiff a letter informing them of the ANDA they had filed with the FDA. The complaint asserts that if Biocon is not enjoined from infringing the patents-in-suit, BMS will be “substantially and irreparably harmed.”

The complaint cites two separate counts of infringement. The plaintiff is seeking favorable judgment on each count of infringement, an injunction preventing the defendant from producing their generic version of the drug, monetary relief in the event that the defendant goes forth with the manufacturing of the generic, litigation fees, and any other relief deemed appropriate by the court.

The plaintiff is represented by Walsh Pizzi O’Reilly Falanga LLP.