The US Court of Appeals for the Ninth Circuit denied a petition for panel rehearing and rehearing en banc and issued an amended opinion that reversed a district court’s decision regarding the False Claims Act’s (FCA) public disclosure bar. Silbersher v. Valeant Pharm. Int’l, Inc., Case No. 20-16176 (9th Cir. Aug. 3, 2023; amended Jan. 5, 2024) (Schroeder, Sanchez, Antoon, JJ.)
The FCA imposes civil liability on those who knowingly present a fraudulent claim for payment to the federal government and allows “relators” to bring fraud claims on behalf of the government.
Valeant owns a set of patents that cover a delayed-release formula for a medication prescribed to treat ulcerative colitis. In 2015, a generic drug manufacturer, GeneriCo, challenged one of Valeant’s patents in an inter partes review (IPR) proceeding. Ultimately, the Patent Trial & Appeal Board found Valeant’s patent unpatentable based on two articles co-authored by Valeant’s head of research.
Silbersher was GeneriCo’s lawyer in the IPR proceeding. He discovered that three years before applying for the challenged patent, Valeant had applied for another patent that disclosed the exact opposite of what Valeant would claim in the challenged patent. Silbersher brought an FCA action alleging that Valeant failed to disclose this information in the IPR proceeding. In response, Valeant argued that the public disclosure bar applied. The district court decided that an IPR qualified as an “other Federal hearing”...
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