On Thursday in the District of Delaware, United Therapeutics Corporation (UTC) and Supernus Pharmaceuticals Inc. filed a complaint against a generic pharmaceutical company, alleging infringement of the plaintiffs’ patents covering the hypertension drug Orenitram.
UTC holds New Drug Application No. 203496 for extended-release treprostinil tablets under brand name Orenitram, initially approved by the United States Food and Drug Administration (FDA) in 2013. Either UTC or Supernus is the owner of each patent covering the drug: United States Patent Nos. 7,417,070; 7,544,713; 8,252,839; 8,349,89; 8,410,169; 8,747,897; 9,050,311; 9,278,901; 9,393,203; 9,422,223; 9,593,066; and 9,604,901. These patents all are listed in the FDA’s approved drug product database, the Orange Book, the complaint said.
According to the complaint, the defendant, ANI Pharmaceuticals Inc., submitted Abbreviated New Drug Application (ANDA) No. 215667 to the FDA seeking approval of treprostinil, the generic version of Orenitram. The defendant notified the plaintiffs of this action in a letter dated Feb. 19, received by the plaintiffs on Feb. 23, which set forth its argument that the plaintiffs’ patents are “invalid, unenforceable, and/or not infringed” by ANI’s ANDA product.
However, the plaintiffs contended that ANI’s attempted defense that its ANDA product is noninfringing did not mention various claims of certain patents.
The plaintiffs claimed that ANI’s submission of its ANDA and the potential commercial manufacture and sale of its ANDA product, pending FDA approval, has already infringed and will directly infringe its patents or induce infringement of the plaintiffs’ patents covering Orenitram. They argued that the defendant’s conduct has been knowing and willful given it should have been aware of the plaintiffs’ patents.
Unless the court prevents the defendant from continuing its allegedly infringing actions, the plaintiffs purported that they will be “substantially and irreparably damaged.”
The plaintiffs are represented by Morris, Nichols, Arsht & Tunnell LLP.