Otsuka Pharmaceutical Alleges Infringement of Patent Covering Rexulti Against Sandoz

Otsuka Pharmaceutical Co. Ltd. and H. Lundbeck A/S filed a complaint Monday against Sandoz Inc. and Sandoz International GmbH, alleging that a product made by the defendants infringes on the plaintiff’s patent covering drug Rexulti.

According to the complaint, Japanese company Otsuka and Danish company Lundbeck are the owner and licensee, respectively, of U.S. Reissue Patent No. RE48,059, which covers major depressive disorder and schizophrenia treatment Rexulti in 0.25, 0.5, 1, 2, 3 and 4 mg tablets. The patent-in-suit was reissued June 23, 2020, the complaint said, and thus will expire Dec. 23, 2028.

New Jersey-based Sandoz, a generic pharmaceutical manufacturer, submitted Abbreviated New Drug Application (ANDA) No. 213570, allegedly seeking approval from the Food and Drug Administration (FDA) to circulate brexpiprazole tablets — the generic version of Rexulti — in the same strengths that the plaintiffs manufacture. According to the complaint, Sandoz sent a letter in September 2019 to notify the plaintiffs that it had filed the ANDA, and this prompted an initial lawsuit disputing various other patents belonging to the plaintiffs, which later was dismissed.

The defendants later sent a second letter, dated March 12, claiming that the plaintiffs’ reissued patent was “invalid, unenforceable, and/or would not be infringed” by Sandoz’s products; the plaintiffs disagreed, claiming that, by Sandoz’s ANDA, it “has represented to the FDA that Sandoz’s generic products are pharmaceutically and therapeutically equivalent to Otsuka’s REXULTI® Tablets.”

According to the plaintiffs, if the defendants’ ANDA is approved, they will begin manufacturing, selling, and distributing an allegedly infringing product. If the defendants are not enjoined from continuing their allegedly infringing conduct, the plaintiffs claim they will be “irreparably harmed,” also requesting a judgment that the defendants’ proposed products are infringing and that any FDA approval of the ANDA products must come after the expiration date of the plaintiffs’ patent, as well as monetary relief.

Ashby & Geddes P.A. represents the plaintiffs.