Otsuka Pharmaceutical Co. Alleges Patent Infringement Against Hetero Drugs Ltd.

Otsuka Pharmaceutical Co. Ltd. (Otsuka) and H. Lundbeck A/S filed a complaint Friday in Delaware District Court against Hetero Labs Ltd., Hetero Labs Ltd. Unit-V, Hetero USA Inc., and Hetero Drugs Ltd. alleging infringement of the plaintiffs’ patent for drug Rexulti.

The United States Patent and Trademark Office (PTO) issued a patent for the drug, deemed the ’362 patent, on Feb. 15, 2011, which would have expired on April 12, 2026. The FDA approved Otsuka’s new drug application (NDA) for Rexulti, approved for adjunctive treatment of major depressive disorder and treatment of schizophrenia, on July 10, 2015.

The defendants filed an abbreviated new drug application (ANDA) seeking FDA approval to commercially manufacture, use or sell generic versions of Otsuka’s Rexulti in the U.S. before the expiration of the ’362 patent. Hetero notified Otsuka on Sept. 11, 2019, that it had filed the ANDA. In response, the plaintiffs filed a complaint in this Court against Hetero alleging patent infringement, as the patent had not reached expiration.

The PTO reissued Rexulti’s patent, now RE’059, on June 23, 2020, after which the plaintiffs notified the FDA. The RE’059 patent will expire Dec. 23, 2028. Hetero alleged in its ANDA that “the claims of the RE’059 patent are invalid, unenforceable and/or would not be infringed by the commercial manufacture, use, sale, offer for sale and/or importation of Hetero’s generic products.”

According to the complaint, “Hetero has infringed one or more claims of the RE’059 patent by submitting, or causing to be submitted, to the FDA ANDA No. 213669, seeking approval to commercially manufacture, use, import, offer to sell or sell Hetero’s generic products before the expiration date of the RE’059 patent,” unless this Court orders that the FDA does not approve Hetero’s ANDA to be effective until after RE’059’s expiration.

The plaintiffs’ requests are as follows: that the Court enter judgment that Hetero has infringed the RE’059 patent through its ANDA submission; that any manufacture, use, sale or import of the generic drug before RE’059’s expiration would be considered infringement; that the Court issue an order that if the FDA does approve Hetero’s ANDA, it shall be no earlier than RE’059’s expiration; a preliminary and/or permanent injunction ordering Hetero from manufacturing, using or selling the generic products and from trying to further push the ANDA’s approval until after RE’059’s approval; as well as appropriate compensatory relief.

The plaintiffs are represented by Ashby & Geddes.