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By Tony Dutra
Aug. 31 — The University of Minnesota is taking a shot at Gilead Sciences Inc.'s revenues from hepatitis C drugs Sovaldi, Harvoni and Epclusa ( Regents of the Univ. of Minnesota v. Gilead Scis., Inc., D. Minn., No. 0:16-cv-02915, complaint filed Aug. 29, 2016).
Merck & Co.’s $200 million jury verdict against Gilead for patent infringement for its hepatitis treatment was thrown out because of misconduct by a Merck witness. Now university professor Carston R. Wagner has revived a 10-year-old patent application on the genus of “prodrugs” that, the university says, includes the species sofosbuvir, the active agent in Gilead's products.Source Material:
The university claims that Gilead “has reaped tens of billions of dollars” while infringing Wagner's U.S. Patent No. 8,815,830. Around 170 million people in the world, and 3.2 million to 3.5 million people in the U.S., have hepatitis C, according to the district court judge in Merck's case.
Foster City, Calif.-based Gilead's pricing of the drugs has been highly controversial. The company charges $84,000 for a 12-week treatment cycle of Sovaldi, or $1,000 per pill; Harvoni is priced at $94,500. The FDA just approved Epclusa June 28, and pricing is not yet available.
Medicare spent more on Sovaldi in 2014 than on any other drug. The Senate Finance Committee issued a report in December critical of Gilead's model of maximizing revenue with little concern for access or affordability.
Gilead cited 17 patents in its New Drug Application for sofosbuvir in April 2013, but the earliest claimed invention date on the patents was in March 2007. The Food and Drug Administration granted approval for Sovaldi first, on Dec. 6, 2013.
In the interim, on Aug. 30, 2013, Gilead filed a lawsuit for a declaration that Merck's patents—which claimed priority to 2001—were either invalid or would not be infringed by Sovaldi and Harvoni.
The U.S. District Court for the Northern District of California ruled in favor of Merck on the merits. But Judge Beth Labson Freeman ultimately negated a jury award of $200 million because of dishonest and duplicitous testimony by a retired Merck scientist before and during trial. Gilead Scis., Inc. v. Merck & Co., No. 13-cv-04057-BLF, 2016 BL 179960 (N.D. Cal. June 6, 2016) (110 PTD, 6/8/16).
Meanwhile, on March 28, 2014, the University of Minnesota's Wagner submitted a new patent application, seeking “Track One” expedited processing. U.S. Patent No. 8,815,830 was issued just five months later, on Aug. 26, 2014. The university is assignee. The National Institutes of Health has rights in the patent as a licensee, as Wagner's related work was supported under a government grant.
Prodrugs are pharmacologically inactive until administered, metabolized into an active form inside the human body. The patent claims are directed to therapeutic nucleotide prodrugs and histidine triad nucleotide-binding proteins (HINTs). Sofosbuvir is a prodrug that, according to the university's complaint, “is one of the compounds included in the genus of compounds invented by Professor Wagner and claimed in the ’830 patent.”
Gilead combines sofosbuvir with anti-viral agents ribavirin, ledipasvir and velpatasvir in Sovaldi, Harvoni and Epclusa, respectively.
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