Fresh From the Bench: Latest Federal Circuit Court Case

CASE OF THE WEEK

Regents of the University of Minnesota v. Gilead Sciences, Inc., Appeal No. 21-2168 (Fed. Cir. Mar. 6, 2023)

The Federal Circuit’s only precedential patent opinion this week focuses on the written description requirement in the context of an anticipation analysis in the chemical arts. Specifically, it concerns whether disclosures in asserted prior art were sufficient to disclose a claimed molecular structure. At issue was Gilead’s flagship drug sofosbuvir, used to treat hepatitis C.

The University of Minnesota owns the ’830 patent, which discloses the following chemical compound:

The claim further specifies that R2 is halo and R3 is hydroxyl, and each of R1, R4, R5, R6, R7, and X were provided in the form of menus of various possible chemical substituents. For example, R5 is “an amino acid,” and each of the chemical substituents of R4, R6, and R7 could include (C1-C-6)alkyl, which could “optionally [be] substituted with one or more” of a laundry list of possible items that literally filled half a page of the Court’s opinion.

Gilead filed an IPR in relation to a number of claims, including independent claim 1, asserting that its own, 2010 patent application anticipated the claims by disclosing sofosbuvir. Minnesota claimed priority to earlier patents in the family tree to attempt to get behind Gilead’s 2010 application. The case turned on whether Minnesota’s earlier patent applications provided sufficient written description support showing it had possession of the claimed molecular compounds at the time of its claimed priority applications. The Patent Office held that it did not, and the university appealed.