Volume 94 Issue 35 | p. 16 | News of The Week
Issue Date: September 5, 2016 | Web Date: September 1, 2016

U. of Minnesota sues Gilead

School says drugmaker’s hepatitis C compound sofosbuvir infringes its patent
Department: Business
News Channels: Biological SCENE
Keywords: intellectual property, litigation, hepatitis C, patent dispute

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.

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The university says its patent covers Gilead’s sofosbuvir. Its complaint states that R1 (above) can be uracil, R2 is a halogen, R3 is a hydroxyl, R4 can by aryl, R5 is an amino acid, R6 and R7 are H or C1 to C6 alkyl, and X can be oxygen.
Two chemical structures.
 
The university says its patent covers Gilead’s sofosbuvir. Its complaint states that R1 (above) can be uracil, R2 is a halogen, R3 is a hydroxyl, R4 can by aryl, R5 is an amino acid, R6 and R7 are H or C1 to C6 alkyl, and X can be oxygen.

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.

 
Chemical & Engineering News
ISSN 0009-2347
Copyright © American Chemical Society
Comments
John Stuart (Fri Sep 02 08:04:30 EDT 2016)
I would like to know who funded the original project to synthesize the anti Hepatitis C heterocyclic compound. If it is the NIH, the compound belongs to the public domain because it was funded by the tax payers of America, and the technology is given, by a process known as "Technology Transfer", to various drug company entities.
I see no reason for a public university to take legal action of a product that came about via the funding of public tax-payer dollars.
Pragati  (Sun Sep 04 07:00:12 EDT 2016)
Let's assume that the "original" work was done at the university. Whether or not the discovery was made using tax dollars, technically the invention/discovery is the intellectual property of the university. They've every right to pursue the case legally. By your logic, public universities shouldn't have tech transfers?
Prof (Wed Sep 07 15:04:45 EDT 2016)
You would do well to educate yourself about the Bayh-Dole act of 1980.
Vicki  (Sat Sep 03 07:46:56 EDT 2016)
Sofosbuvir was invented by Michael Sofia (hence the name) while he was at Pharmasset. Gilead just bought the compound, they didn't invent it at all...
Marco (Tue Sep 06 08:18:51 EDT 2016)
That's also close to Idenix (now Merck) compounds that exist for more than 10 years...
david (Wed Sep 07 16:57:38 EDT 2016)
How do you parse: "R6 and R7 are H or C1 to C6 alkyl"? If R6 and R7 need to be identical, then Sofosbuvir would not be covered (use of and rather than or). If it was written as two clauses, then Sofosbuvir would be covered depending on when Sofosbuvir was patented or disclosed (and thus this patent may be invalid).
david (Thu Sep 08 08:29:41 EDT 2016)
The original patent did not have the wording shown in the figure. It was much broader, so ignore my previous comment. It all goes back to a provisional patent 60/634677 filed on Dec. 9, 2004 by Carston Wagner, which is not readily accessible to me. The US patent on Sofosbuvir (US7964580) has a priority date of Mar 30, 2007. At that time, it was first to invent so the who had priority based on time of invention would be an interesting case. I hope that C&E News continues to follow this development.

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