USITC to investigate Novartis patent complaint against Regeneron

The  US International Trade Commission (USITC) will investigate  Regeneron Pharmaceuticals for the alleged infringement of a patent owned by its rival  Novartis, it announced in a notice posted yesterday, July 21.

The investigation is based on a complaint filed by Swiss multinational pharmaceutical company Novartis Pharma AG, and its US subsidiaries Novartis Pharmaceuticals Corporation and Novartis Technology, on June 19. Novartis filed a supplementary letter with the commission on July 10.

Novartis alleges that  Regeneron infringed its ’631 patent and violated  section 337 of the Tariff Act of 1930 by importing into the US and selling “certain pre-filled syringes for intravitreal injection” or “syringes that are pre-filled with ophthalmic medication, and components of such syringes, including barrels, plungers, and stoppers”. The company has requested that the USITC issue Regeneron with “a limited exclusion order” along with a “cease and desist” order.

The USITC’s chief administrative law judge will assign the case to one of the USITC’s administrative law judges (ALJ), who will schedule and hold a hearing. The ALJ will decide whether there has been a violation of section 337, to be reviewed by the commission.

The USITC sets a target date for the completion of an investigation within 45 days of its announcement. USITC remedial orders in section 337 cases become final 60 days after being issued, unless they are disapproved for policy reasons by Robert Lighthize, the US Trade Representative, within that period.