Last Friday, Eagle Pharmaceuticals, Inc. filed a complaint in the District of Delaware against Accord Healthcare Inc. and its affiliates for allegedly filing for drug approval using Eagle’s infringed data and patents of their lymphoma drug Belrapzo.
Eagle, per the complaint, is the creator of Belrapzo, which contains bendamustine hydrochloride and is used to treat a form of leukemia. They hold six patents, all entitled “Formulations of Bendamustine” for their product. In April 2022, Accord notified Eagle that they had submitted a New Drug Application (NDA) to the FDA for approval of their drug which “relies on data from bioavailability and/or bioequivalence studies contained in the approved NDA and/or labeling for BELRAPZO®.” It also has essentially the same shelf-life stability of 24 months.
The complaint detailed how the chemical composition of both drugs are nearly identical and that both promote “administration of a bendamustine-containing composition to patients with chronic lymphocytic leukemia and indolent B-cell non-Hodgkin lymphoma.” This is because they both contain bendamustine as the main ingredient, the same proportion of stabilizers and function in nearly the exact same ways. Eagle wants to stop Accord from “the manufacture, use, offer for sale, sale, marketing, distribution, and/or importation” of their product as they believe it infringes upon all six of their Belrapzo patents which will cause Eagle “irreparable injury.” This is also within Eagle’s legal rights as they have submitted the complaint within 45 days of receiving the Notice Letter.
The plaintiff is seeking a declaration that their patents were infringed upon, injunctive relief enjoining the defendants from producing and selling their infringing products, damages, attorney’s fees and costs, and other relief.
Eagle Pharmaceuticals is represented by McCarter & English, LLP.