Bristol Myers Squibb Sues Xspray Pharma Over Alleged Patent Infringement Regarding Leukemia Drug

A suit was filed on Wednesday in the District of New Jersey by plaintiff Bristol Myers Squibb Company (BMS) against defendant Xspray Pharma AB. The complaint for patent infringement seeks to enjoin the defendant from producing and marketing a generic version of the plaintiff’s drug Sprycel.

Sprycel seeks to treat adults and children who are diagnosed with varying types of leukemia. The plaintiff holds two patents, the ‘725 patent and the ‘103 patent (the patents-in-suit), which are entitled “process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors.” The patents were issued in 2009 and 2014 respectively. In addition to the patents-in-suit, the plaintiff holds a New Drug Application (NDA) for the oral use of the drug.

According to the complaint, Xspray submitted an NDA to the FDA in which they sought approval to manufacture and market a generic version of Sprycel. In addition to this, Xspray contacted the plaintiff and informed them that the claims of the patents-in-suit were either invalid or would not be infringed upon by the defendant’s forthcoming products.

Xspray’s letter to the plaintiff offered them confidential access to certain portions of the Xspray NDA but did not offer the plaintiff access to the Drug Master File. The complaint notes the lack of the plaintiff’s access to the Drug Master File has hindered their “ability to consider information that is relevant to its infringement analysis” of the patents-in-suit.

The complaint alleges that Xspray has infringed on at least one claim of each of the patents-in-suit. Further, the plaintiff explains that the defendant has announced their intent to manufacture and sell their NDA products immediately upon gaining FDA approval, which the plaintiff argues will constitute further infringement of the aforementioned patents.

BMS contends that if the defendant is not blocked from further infringement on the patents-in-suit, they will be “substantially and irreparably harmed.” The complaint cites two counts of patent infringement. The plaintiff is seeking favorable judgment on each count, an injunction preventing further infringement, an order guaranteeing that the defendant’s NDA products will not be manufactured prior to the expiration of the patents-in-suit, monetary relief in the event that the defendant goes forward with their NDA products, and more.

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