Plaintiff Bristol Myers Squibb Company (BMS) filed suit against defendant Xspray Pharma AB in New Jersey County on Wednesday. The patent infringement suit seeks to prevent Defendants from making and selling generic versions of Plaintiff’s drug Sprycel.
Sprycel is intended for the treatment of adults and children diagnosed with various types of leukemia. Plaintiffs hold two patents, a ’725 patent and a ’103 patent (patent in suit), entitled “Methods for the preparation of 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors.” The patents were issued in 2009 and 2014 respectively. In addition to the patent in question, the plaintiffs also have a new drug application (NDA) for an oral drug.
According to the complaint, Xspray has submitted a non-disclosure agreement to the FDA in which they seek permission to manufacture and market a generic version of Sprycel. Among other things, Xspray contacted the plaintiffs and informed them that the disputed patent claims were invalid or not infringed by the defendants’ future products.
The Xspray letter to the plaintiffs gave them confidential access to certain parts of the Xspray NDA, but did not give the plaintiffs access to the main drug file. Plaintiffs do not have access to master drug files, which hinders their “ability to review information relevant to their analysis of violations,” the complaint says.
The complaint alleges that Xspray violates at least one claim of each of the patents in question. In addition, Plaintiffs explain that Defendants announced their intention to manufacture and market their NDA products immediately after FDA approval, which Plaintiffs argue would constitute further infringement of the aforementioned patents.
BMS argued that if defendants were not prevented from further infringing the patents in question, they would suffer “substantial and irreparable harm”. The complaint lists two counts of patent infringement. The plaintiffs are seeking a positive decision on each count, an injunction to prevent further infringement, an order ensuring that defendants’ NDA products will not be manufactured before the patent in question expires, monetary relief if defendants promote their NDA products, and more.
Post time: Apr-12-2023