On Wednesday in the District of Delaware, Amgen Inc. and Les Laboratoires Servier filed a complaint against Alembic Pharmaceuticals Ltd. and a subsidiary, alleging infringement of the patents corresponding to the active ingredient in the plaintiffs’ Corlanor, a product used to treat chronic heart failure.
The patents-in-suit ’649, ’650, ’996, and ’842, exclusively licensed to Amgen, correspond to different “crystalline” forms of active ingredient ivabradine hydrochloride, which constitute Corlanor. Amgen, a developer, manufacturer, and seller of therapeutic drug products, holds the new drug application (NDA) 20-6143 for the product. The patents-in-suit also are assigned to Les Laboratoires Servier, a company based in France.
On Dec. 7, 2020, Alembic — a developer, seller, and distributor of pharmaceutical products — sent a letter to the plaintiffs saying that they submitted ANDA No. 215238 to the Food and Drug Administration (FDA) “to commercially manufacture, use, offer for sale, sell, and/or import” the ANDA product, a generic version of Corlanor, intending to do so before the patents-in-suit were to expire, the plaintiffs claimed. In their letter, the defendants also claimed to have a Paragraph IV certification accompanying their ANDA that said “the Patents-in-Suit are invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use, offer for sale, sale, and/or importation” of the proposed generic ANDA product, the plaintiffs said.
According to the plaintiffs, the defendants knew about the patents-in-suit at the time they submitted their ANDA, and the ANDA “refers to and relies upon” Corlanor’s NDA “and contains data that, according to Defendants, demonstrate(s) the bioequivalence” between the NDA and ANDA products.
The plaintiffs alleged four counts of infringement, one for each patent-in-suit, arguing they “will be substantially and irreparably harmed” if the defendants continue in their intent to manufacture and sell the proposed ANDA product.
Requests by the plaintiffs include an order that the effective date of approval by the FDA be no earlier than the patents-in-suit’s expiration date, an order enjoining the defendants and any of their employees and affiliates from pursuing the manufacture and sale of the ANDA product until after the expiration date, and other reasonable relief.
The plaintiffs are represented by Morris, Nichols, Arsht & Tunnell.