A complaint for patent infringement was filed in the District of Delaware on Monday by Exelixis, Inc. against MSN Laboratories Private Limited and MSN Pharmaceuticals, Inc.
The defendants filed an abbreviated new drug application (ANDA) with the Food and Drug Administration (FDA) in which they sought approval to produce and market a generic version of the plaintiff’s drug Cabometyx (the ANDA product) prior to the expiration of its related patent, the ‘349 patent.
The complaint explains that the plaintiff is in the business of “creating, developing, and bringing to market new medicines for difficult-to-treat cancers.” Their product Cabometyxis used to treat advanced renal cell carcinoma, which is a type of kidney cancer, as well as patients with liver cancer and differentiated thyroid cancer. Specifically, the complaint explains that Cabometyx is a “tyrosine kinase inhibitor.” The plaintiff’s product has been cited in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations publication.
Similarly to the plaintiff, MSN “develops, manufactures, distributes, and/or imports pharmaceutical products for sale and use throughout the United States.”
The ‘349 patent is titled “Processes for Preparing Quinoline Compounds and Pharmaceutical Compositions Containing Such Compounds.” The patent-in-suit was issued to the plaintiff on April 12 of 2022, meaning it will expire in February of 2032. The plaintiff contends that the claims of the patent-in-suit are valid, enforceable, and not expired.
The defendants informed the plaintiff of the ANDA they had filed with the FDA through a notification letter dated June 6, 2022. MSN alleged in the letter that the plaintiff’s patent was not valid, unenforceable or would not be infringed by the defendants ANDA product.
The plaintiff asserts their belief that if MSN’s ANDA is approved by the FDA, they will immediately begin the production and marketing of their ANDA product, which the plaintiff alleges would constitute patent infringement. The plaintiff notes that MSN’s product will have the same active ingredients, same dosage forms and strengths, and be bioequivalent to Cabometyx.
The complaint cites one count of infringement. The plaintiff is seeking judgment that the patent is not invalid, is not unenforceable, and are infringed by MSN’s ANDA submission, as well as damages and monetary in the event that MSN goes forward with their ANDA product, favorable judgment on the count of infringement, and an injunction preventing MSN from future infringement.
The plaintiff is represented by Morris, Nichols, Arsht & Tunnell LLP.