Idenix Pharmaceuticals LLC v. Gilead Sciences Inc., No. 18-1691 (Fed. Cir. 2019)Annotate this Case
Index and Gilead were developing drugs for treating the hepatitis C virus (HCV). Idenix alleged that the imminent FDA approval, and launch, of Gilead’s HCV treatment drug sofosbuvir would infringe Idenix’s 597 patent. After a jury trial, Gilead stipulated to infringement under the district court’s claim construction but argued that the patent was invalid for failure to meet the written description and enablement requirements. The jury found for Idenix, upheld the patent and awarded damages. The district court denied Gilead’s motion with respect to written description but granted judgment as a matter of law on enablement, holding the 597 patent invalid. The Federal Circuit affirmed as to non-enablement and held that the patent is also invalid for lack of written description. Although the level of skill in the art is high, the patent does not provide enough meaningful guidance or working examples, across the full scope of the claim, to allow a person of ordinary skill in the art to determine which nucleosides would be effective against HCV without extensive screening. The immense breadth of screening required amounts to "undue experimentation." Given the conspicuous absence of that compound, a person of ordinary skill in the art would not “visualize or recognize the members of the genus” as including 2'-fluoro-down, and the specification could not demonstrate that the inventor had possession of that embodiment at the time of filing.