New Jersey Pharma Cos. Allege Patent Infringement Against Macleods Pharmaceuticals

On Wednesday in the District of New Jersey, Mitsubishi Tanabe Pharma Corporation (MTPC), Janssen Pharmaceuticals Inc. (JPI), Janssen Pharmaceutica NV, Janssen Research and Development LLC, and Cilag GMBH International filed a complaint for patent infringement against Macleods Pharmaceuticals LTD (Macleods India) and Macleods Pharma USA Inc. (Macleods USA) concerning drug product Invokamet XR, used to improve glycemic control in adults with type-2 diabetes.

The complaint explained that JPI holds the new drug application (NDA) No. 205879 for “extended-release canagliflozin and metformin tablets,” a generic description of Invokamet XR, and is the owner of both U.S. Patent Nos. 7,943,582 (the ’582 patent) and 8,513,202 (the ’202 patent), as of May 17, 2011, and Aug. 20, 2013, respectively, for Invokamet.

Macleods India, of which Macleods USA is a subsidiary, sent a letter to JPI and MTPC dated Nov. 30, 2020, alerting JPI of Macleods India’s submission of an abbreviated new drug application (ANDA) to the Food and Drug Administration (FDA) seeking approval to market a generic version of JPI’s product. The plaintiffs alleged patent infringement by the very fact of the ANDA filing and that the defendants have “had knowledge of” both the ’582 and ’202 patents since at least the Nov. 30, 2020, letter.

“On information and belief, discovery/testing will show that if Macleods India and/or Macleods USA commercially makes, uses, offers to sell, or sells the Macleod s ANDA Products within the United States, or imports the Macleods ANDA Products into the United States, or induces or contributes to any such conduct during the term(s) of the ’582 patent” and the ’202 patent, Macleods India will infringe at least claims 1, 6, and 7 and at least 1 and 3 through 5, respectively, according to the complaint.

The plaintiffs requested judgment affirming the alleged infringements, a permanent injunction restraining and enjoining the defendants from marketing, manufacturing, and selling the ANDA products until after the patents-in-suit expire, and an award for damages and reasonable relief.

The plaintiffs are represented by Saul Ewing Arnstein & Lehr.