A Patent Does Not Guarantee the Patent Owner Will Be First to Market

Written by: Daniel Kiang and Kurt M. Jacobs

INCYTE CORPORATION V. SUN PHARMACEUTICAL INDUSTRIES, LTD.

Before Moore, Prost and Hughes. Appeal from the United States District Court for the District of New Jersey.

Summary: A district court erred in issuing a preliminary injunction against an alleged infringer under a theory that the patentee would have been first to market, when it was inevitable that the alleged infringer would have been first to market.

Sun Pharmaceuticals secured FDA approval in July 2024 for a drug used to treat autoimmune disorders and was set to launch the drug in October 2024.  Before the launch, Incyte Corporation sued Sun for patent infringement and moved for a preliminary injunction.  The district court granted the preliminary injunction based on its finding that, but for Sun's drug, Incyte's patent would allow it to be the first to market, and thus Incyte would be irreparably harmed absent an injunction.

On appeal, the Federal Circuit held that the district court’s finding of irreparable harm was clearly erroneous because (1) Sun was prepared to launch, (2) Incyte’s patent expires in December 2026, and (3) Incyte would not launch its product, under the best-case scenario, until several years after the expiration of its patent.  Thus, an injunction would only shorten an otherwise inevitable head start for Sun’s allegedly infringing product. Accordingly, the Federal Circuit reversed the district court’s grant of the preliminary injunction.

Editor: Sean Murray