CoreRx Sued Over Alleged Patent Infringement and Breach of Contract

A suit was filed on Friday in the Middle District of Florida Tampa Division by plaintiff Azurity Pharmaceuticals, Inc. against defendant CoreRx, Inc. The complaint details alleged patent infringement on the behalf of the defendant in the manufacturing and marketing of their CoreRx formulation product.

The plaintiff, per the complaint, manufactures and markets a product called Epaned, which is a ready-to-use oral solution intended to treat hypertension in people under six years of age. Epaned also treats “hypertension in adults, heart failure, and asymptomatic left ventricular dysfunction.” The two patents-in-suit were issued to Azurity for their Epaned product in 2021 and do not expire until March 25, 2036, the complaint said.

CoreRx, the complaint explains, manufactures the aforementioned CoreRx formulation, while Bionpharma, Inc. markets the product. When Bionpharma filed an abbreviated new drug application (ANDA) seeking approval of the CoreRx formulation, Azurity brought an action against them, claiming that the new product is already covered in the claims of the patents-in-suit. Despite this action, the Food and Drug Administration (FDA) approved the ANDA. After this approval, Bionpharma and CoreRx began manufacturing and marketing the CoreRx formulation, which the plaintiff asserts was “in blatant disregard for Azurity’s patent rights.”

The plaintiff later brought action against CoreRx, the complaint explained; in a settlement, Azurity agreed to absolve CoreRx of all infringement liability if they refrained from further infringement of the patents-in-suit through the CoreRx formulation. Because CoreRx continues to infringe upon Azurity’s claims, the complaint says, Azurity maintains that the settlement is null and that they are able to bring suit against CoreRx.

The complaint cites six counts of infringement and one count of breach of contract. The plaintiff is seeking a declaration that the patents-in-suit are both valid and enforceable, favorable judgment on all counts, damages, an injunction preventing further infringement, and any other relief deemed proper by the court.

The plaintiff is represented by Shutts & Bowen LLP and Wilson Sonsini Goodrich & Rosati.