Hoffman Warnick Helps Vanda Protect Drug Treatment Patent

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Jayme Torelli and Steve Swinton

ALBANY, NY (01/16/2020) (readMedia)-- We are proud to have assisted our client, Vanda Pharmaceuticals, in an important patent case that allows the company to retain market exclusivity for one of their important drug products until 2027. On January 13, 2020, the US Supreme Court denied Hikma Pharmaceuticals' petition for a writ of certiorari in the matter of Hikma Pharmaceuticals USA Inc., et al. v. Vanda Pharmaceuticals Inc., No. 18-817.

Hikma sought review of a recent Federal Circuit Court of Appeals decision in which Vanda's US Pat. 8,586,610 was found both valid and infringed by West-Ward Pharmaceuticals international Ltd., a wholly owned subsidiary of Hikma Pharmaceuticals PLC. The question presented in Hikma's petition for certiorari "is whether patents that claim a method of medically treating a patient automatically satisfy Section 101 of the Patent Act, even if they apply a natural law using only routine and conventional steps."

In denying cert, SCOTUS leaves the Federal Circuit's decision undisturbed, confirming Vanda's '610 patent is valid and was infringed by West-Ward's filing of an Abbreviated New Drug Application (ANDA) for iloperidone. It also leaves undisturbed the USPTO's June 7, 2018 memorandum on Recent Subject Matter Eligibility Decision: Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, which provides guidance to patent examiners, practitioners, and stakeholders on subject matter eligibility for patent protection.

About the '610 Patent

The '610 patent relates to methods for the administration of iloperidone, a treatment for adults with schizophrenia. The patent protects Vanda's FANAPT® iloperidone tablets, and is expected to remain in force through November 2, 2027.

About Vanda Pharmaceuticals Inc.

Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients.

About Hoffman Warnick's Counsel

Hoffman Warnick, LLC is an intellectual property law firm specializing in patents, copyrights, trademarks, transactions, due diligence, opinions, licensing and pre-litigation negotiations. Located in Albany, New York, it is known for excellent patent work within the life sciences industry. Firm members Steve Swinton and Jayme Torelli drafted and prosecuted the '610 patent on behalf of Vanda.

Everyone at Hoffman Warnick congratulates Vanda, as well as patent litigation counsel, Paul, Weiss, Rifkind, Wharton & Garrison LLP on this important legal decision!