Gilead Again Defends Against Lawsuits Over Patents for Hepatitis C Treatments

The University of Minnesota filed a lawsuit against Gilead Sciences, maintaining that the pharmaceutical company infringed on a patent when it marketed 3 medications for the treatment of the hepatitis C virus (HCV) containing the drug sofosbuvir, including the company’s brand-name drugs Sovaldi, Harvoni, and Epclusa, reported STAT.

The university’s lawsuit states that all 3 drugs are covered by patent rights assigned to the university by Carston Wagner, PhD, professor and endowed chair of the Department of Medicinal Chemistry at the university’s college of pharmacy. The University of Minnesota says that Wagner received the patent in August 2014, and the lawsuit states that the structural formula of sofosbuvir falls within the scope of its patent.

The university’s lawsuit states that the patent covers antiviral compounds and methods for using those compounds to treat viral infections, such as that caused by hepatitis C virus. It contends that Gilead’s medications incorporate the contributions of Dr. Wagner that are disclosed and claimed in the patent.

“Gilead has reaped tens of billions of dollars in the sales of those drugs, without the University’s authorization and without compensating the University,” the lawsuit states.

The lawsuit is Regents of the University of Minnesota v. Gilead Sciences, Inc., filed in the US District Court for the District of Minnesota, case number 0:16-cv-02915. It was filed August 30, 2016.

Gilead has responded that it believes the university’s patent is invalid and not infringed by the sale of the company’s medicines for HCV. Gilead strongly believes that it has the sole right to commercialize Sovaldi in the United States.

The University of Minnesota’s lawsuit is the second against Gilead with respect to its HCV treatments. Previously, Merck sued Gilead for more than $3 billion in a patent dispute, and sought royalties from the company. Merck claimed that compounds Gilead acquired when it purchased another company (Pharmassset, Inc.) closely copied hepatitis C compounds that Merck researched years earlier. Gilead’s countersuit against Merck argued that the Merck patents were invalid.

Merck initially won the case against Gilead, winning $200 million in damages based on findings that Merck’s patents were valid, but 2 months ago the verdict was overturned because a judge determined there had been misconduct by a Merck attorney.

Sofosbuvir generated approximately $19 billion in sales in 2015 for Gilead, with list prices from $84,000 for a 12-week course of treatment to $94,500 before discounts. Activist groups have raised concerns that patents covering expensive HCV treatments have restricted access to more affordable generic drugs. Harvoni’s list price is $1125 per pill before discounts and $94,000 for a 12-week regimen.

Epclusa, which was approved recently, is indicated to fight all 6 strains of HCV, and is priced below the older treatments. Epclusa combines the older Sovaldi medication with the company’s newer velpatasivir, and costs $74,760 for a 12-week course of treatment (before any rebates), less than the list prices for Sovaldi and Harvoni.