Plaintiff Abraxis Bioscience, LLC (Abraxis) filed suit against defendant Jiangsu Hengrui Pharmaceuticals Co. Ltd. (Hengrui) on Wednesday in the District of New Jersey over claims that the defendant infringed on a patent held by Abraxis that protects its signature drug Abraxane.
Abraxane, the complaint says, is used to treat specific forms of breast and lung cancer
The plaintiff obtained a patent from the U.S. Patent and Trademark Office in late 2010, titled “Compositions and Methods of Delivery of Pharmacological Agents.” Abraxis also holds a New Drug Application for “paclitaxel protein-bound particles for injectable suspension, which it sells under the trade name Abraxane.”
Hengrui filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) in an effort to gain approval to manufacture and produce a generic version of the plaintiff’s drug Abraxane prior to the expiration of the patent-in-suit. They also provided the FDA and the plaintiff with a written certification that the claims of the patent-in-suit were invalid, unenforceable, or will not be infringed by the activities described in their corresponding ANDA. The letter addressed to the plaintiff also informed Abraxis of their intent to seek approval from Abraxis to market the generic version of Abraxane prior to the expiration of the patent-in-suit.
The plaintiff explains that it has reason to believe that if the FDA approves Hengrui’s ANDA, the defendant will begin the manufacturing and selling of the generic version of Abraxane despite the validity of the patent-in-suit.
The complaint cites one count of patent infringement. The plaintiff is seeking judgment that the patent is valid and enforceable, costs and expenses resulting from the action, and any other relief deemed proper by the court.
The plaintiff is represented by Saul Ewing Arnstein & Lehr LLP.
