- The University of Minnesota on Monday sued Gilead, claiming the big biotech infringed on a patent held by the school on sofosbuvir, a key compound at the heart of the big biotech's lucrative hepatitis C franchise.
- The lawsuit claims Gilead's drugs Harvoni, Sovaldi and Epclusa incorporate discoveries made by Dr. Carston Wagner, currently the endowed chair in medicinal chemistry at the university's College of Pharmacy.
- Wagner received a patent for his work on nucleotide prodrugs in 2014, and rights were subsequently transferred to the university.
Gilead's hepatitis C drugs have been the target of a number of patent challenges, most notably a suit brought by Merck which claimed damages for infringement and royalties on future sales. A federal jury had ruled in favor of Merck, awarding $200 million in damages. But the verdict was overturned after a judge found a former Merck lawyer had lied.
In its suit, the University of Minnesota claims Gilead willfully and deliberately on the patent awarded to Wagner by the U.S. Patent Office in August 2014. The so-called '830 patent covers a genus of compounds invented by Wagner, one of which is sofosbuvir, the lawsuit claims.
"Gilead has infringed, and continues to infringe, the University’s intellectual property rights by, among other things, selling medicines containing the drug sofosbuvir, including brand name drugs Sovaldi, Harvoni, and Epclusa," the lawsuit reads.
The university apparently informed Gilead of its alleged infringement in July 2015 and met with the biotech a month later to discuss the '830 patent.
Since approval of Sovaldi in 2013, sales of the three drugs have combined to earn Gilead nearly $40 billion in worldwide sales, with roughly 68% of that revenue coming from the U.S. market. The mega-blockbuster sales of both Sovaldi and Harvoni (Epclusa just won approval) rapidly propelled Gilead to the top of the biotech food chain.
As more and more hepatitis C patients are treated with the near-curative therapies, however, sales have begun to ebb. Harvoni sales in the U.S. were down by roughly half over the first six months of 2016.
It is unclear if the University of Minnesota's suit will gain much traction in the courts. Jefferies analysts, writing in a recent note, view the lawsuit as having a "low probability of success."