The University of Minnesota filed a complaint in federal court on Aug. 29 charging that Gilead Sciences’ multi-billion-dollar hepatitis C drugs Sovaldi, Harvoni, and Epclusa infringe on a two-year-old patent the university owns.
Each of the hepatitis C drugs contains sofosbuvir, an antiviral agent that the university claims is covered by a patent awarded to Carston R. Wagner, a medicinal chemistry professor in the school’s College of Pharmacy. Wagner is also executive editor of the ACS journal Molecular Pharmaceutics. ACS is the publisher of C&EN.
Despite meeting with the university a year ago concerning the claim, Gilead “has continued its infringing conduct,” the complaint says. The university is seeking unspecified compensatory damages and royalties to be determined in a jury trial.
In a statement, Gilead contends that the university “did not invent sofosbuvir, nor did they contribute to its development. We believe their patent to be invalid and not infringed by the sale of Gilead’s medicines for chronic hepatitis C.”
The university’s patent, US 8815830, was issued in August 2014 and builds on Wagner patents going back a decade. Called “Nucleosides with Antiviral and Anticancer Activity,” it is the result of Wagner’s research into the role of human histidine triad nucleotide-binding protein 1 (hHint1), according to the complaint.
That work led Wagner to develop a family of compounds that act as antiviral agents against the hepatitis C virus, the complaint says. “Gilead’s sofosbuvir medicines incorporate these contributions of Dr. Wagner,” notes the complaint.
The university’s case against Gilead is not the first time intellectual property rights to sofosbuvir have been disputed. In March, a federal jury in California ordered Gilead to pay Merck & Co. $200 million for infringing on a patent that Merck says led to the development of sofosbuvir. However, a federal judge recently overturned the suit.