Idenix Pharm. LLC v. Gilead Scis. Inc. - 941 F.3d 1149 (Fed. Cir. 2019)

Rule:

Enablement requires that the specification teach those in the art to make and use the invention without undue experimentation. A claim is not enabled when, at the effective filing date of the patent, one of ordinary skill in the art could not practice their full scope without undue experimentation. Whether a claim satisfies the enablement requirement is a question of law that is reviewed de novo. However, in the context of a jury trial, the factual underpinnings of enablement are reviewed for substantial evidence.

Facts:

Idenix Pharmaceuticals LLC and Universita Degli Studi Di Cagliari (collectively, "Idenix") and Gilead Sciences Inc., ("Gilead") were researching and developing drugs for treatment of the hepatitis C virus ("HCV"). Idenix alleged that the imminent Food and Drug Administration approval, and launch, of Gilead's HCV treatment drug sofosbuvir would infringe Idenix's U.S. Pat. No. 7,608,597 (the “597 patent”). Gilead stipulated to infringement under the district court's claim construction but argued that the '597 patent was invalid for failure to meet the written description and enablement requirements. The jury found for Idenix, upholding the validity of the patent and awarding damages. After trial, Gilead filed a renewed motion for judgment as a matter of law (“JMOL”) with respect to written description and enablement. The district court denied the motion with respect to written description but granted JMOL on enablement, holding the '597 patent invalid. Idenix timely appealed. 

Issue:

Was the ‘597 patent invalid for lack of enablement? 

Answer:

Yes.

Conclusion:

The court affirmed the judgment of the district court, holding that the patent directed to compounds for treatment of the hepatitis C virus (HCV) was invalid for lack of enablement because the patent did 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 (POSA) to determine which nucleosides would or would not be effective against HCV without extensive screening. The immense breadth of screening required to determine which were effective against HCV could only be described as undue experimentation. The court further held that the patent was invalid for lack of written description, under 35 U.S.C.S. § 112, as it failed to provide sufficient blaze marks to direct a POSA to the specific subset of nucleosides that were effective in treating HCV.