Plaintiff Veloxis Pharmaceuticals, Inc. filed suit on Thursday in the District of Delaware against defendants Accord Healthcare, Inc. and Intas Pharmaceuticals LTD. The complaint alleges that the defendants engaged in patent infringement when they submitted an Abbreviated New Drug Application (ANDA) to the FDA seeking approval to produce and market .075 mg, 1 mg, and 4 mg extended-release tablets of tacrolimus (ANDA products).
The plaintiff cites six patents-in-suit, four titled “Tacrolimus for Improved Treatment of Transplant Patients,” and two titled “Stabilized Tacrolimus Composition.” Each of the patents-in-suit cover Veloxis’ tacrolimus extended-release tablets, which are sold under the name ENVARSUS XR. ENVARSUS XR is described in the complaint as a “calcineurin-inhibitor immunosuppressant” intended to treat kidney transplant patients.
All of the patents-in-suit are listed in the FDA’s orange book, a publication officially titled “Approved Drug Products with Therapeutic Equivalence Evaluations.” ENVARSUS XR’s prescribing information recommends that the tablets be administered using one of the methods listed in the patents-in-suit.
Defendant Accord provided the plaintiff with a notice letter on May 23, 2022, in which they informed them of the ANDA they had submitted to the FDA. The ANDA seeks approval from the FDA to produce and market the defendant’s ANDA products prior to the expiration of each of the patents-in-suit. The notice letter also expressed the defendant’s belief that the claims of the patents-in-suit will not be infringed by the defendant’s ANDA products.
The plaintiff asserts that the defendant’s ANDA products will be bioequivalent to ENVARSUS XR and will have “the same active ingredient, the same dosage form, the same route of administration, and the same strengths as ENVARSUS XR,” therefore infringing on the patents-in-suit.
The claim cites six separate counts of infringement for each of the patents-in-suit. Veloxis is seeking favorable judgment regarding the alleged infringement, an order preventing the defendants from manufacturing their ANDA products prior to the expiration of the patents-in-suit, damages in the event that the defendants go forward with their ANDA products, litigation fees, and more.The plaintiff is represented by Morris, Nichols, Arsht & Tunnell LLP.
