University of Minnesota Sues Gilead Sciences for Infringement of Hepatitis C Patents

| Michael L. FullerRobert J. Hilton, Ph.D.

On August 29, 2016, the Regents of the University of Minnesota (“the University”) filed suit against Gilead Sciences (“Gilead”) for patent infringement in the District Court for the District of Minnesota. According to the complaint, the University alleges that Gilead’s sale of drugs containing the nucleotide analog sofosbuvir infringes their U.S. Patent No. 8,815,830 (the ’830 patent).

Gilead Sciences is a biopharmaceutical company that sells antiviral drugs for the treatment of HIV, hepatitis B (HBV), hepatitis C (HCV), and influenza. Gilead’s HCV drugs generated more than $19 billion in sales in 2015, and accounted for more than 60% of Gilead’s revenue. Gilead markets its HCV drugs as Sovaldi®, Harvoni®, and Epclusa®, each of which contains the nucleotide analog, sofosbuvir. Sofosbuvir is used for the treatment of HCV infections, and has a reduced therapeutic duration as compared to other treatments. Sofosbuvir is an RNA-dependent RNA viral polymerase inhibitor, and thereby inhibits RNA-dependent RNA viral replication.

The ’830 patent was issued on August 24, 2014 and listed University professor Carston Wagner as the inventor. The ‘830 patent claims specific compounds and methods for treating a viral infection. In the complaint, the University alleges that Gilead infringes literally, and under the doctrine of equivalents, at least claims 1-9 and 11-12 of the ’830 patent by selling Sovaldi®, Harvoni® and Epclusa®. The University also alleges that Gilead infringes claims 13-21 and 23-28 by actively and intentionally inducing others to infringe.

In response to the complaint, a Gilead spokesperson stated that the company strongly believes that it has the sole right to commercialize (Sovaldi®) in the U.S. and that the University of Minnesota’s patent is invalid and is not infringed by the sale of Gilead’s medicines for chronic hepatitis C.