Cases & Deals

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Takeda trial win in Hatch-Waxman case involving diabetes products upheld by Federal Circuit

Client(s) Takeda Pharmaceuticals U.S.A., Inc.

Jones Day successfully represented Takeda Pharmaceutical Company Ltd. in a Hatch-Waxman Act dispute against companies seeking to market generic versions of three diabetes products prior to the expiration of Takeda's patents. Torrent Pharmaceuticals Ltd., Torrent Pharma Inc., and Indoco Remedies Ltd. submitted Abbreviated New Drug Applications ("ANDAs") seeking FDA approval of their proposed generic versions of three Takeda drug products (NESINA®, KAZANO®, and OSENI®) indicated for the treatment of type-2 diabetes. After receiving notice of the ANDAs, Takeda filed a lawsuit for patent infringement in the United States District Court for the District of New Jersey. The defendants ultimately were forced to concede infringement of Takeda's asserted patent, but challenged the patent as legally invalid. Trial on this issue was held before the Honorable Stanley Chesler, who ruled in favor of Takeda on all issues and ordered that FDA approval of the proposed generic products can be no earlier than the date of expiration of Takeda's patent in 2028. Torrent and Indoco appealed the district court decision, which the Federal Circuit affirmed on February 16, 2021.

Takeda Pharmaceutical Company Ltd., et al. v. Torrent Pharmaceuticals Ltd., et al., No. 2-17-cv-03186 (D.N.J.); Appeal Nos. 2020-1552, 2020-1598 (Fed. Cir.)