Gilead Wins Arbitration Against Roche Over Hepatitis C Drug Sofosbuvir

Gilead Sciences has received a favorable ruling from an arbitration panel regarding a claim made by Roche for Gilead’s sofosbuvir, the active ingredient in Gilead’s Sovaldi, an oral drug to treat chronic hepatitis C virus (HCV) infection, and Gilead’s top-selling drug.

Gilead reported on the ruling in a Form 8-K, filed with the US Securities and Exchange Commission, on August 14, 2014. According to the filing, in March 2013, Roche initiated an arbitration against Gilead Sciences, and Pharmasset, predecessor to Gilead Pharmasset LLC, regarding a 2004 collaboration agreement between Roche and Pharmasset. Gilead acquired Pharmasset in 2012 for $11.2 billion. 

In the arbitration demand, Roche asserted that it had an exclusive license to sofosbuvir pursuant to the collaboration agreement because sofosbuvir, a prodrug of a uridine monophosphate analog, was allegedly a prodrug of PSI-6130, a cytidine analog. Roche further claimed that because it had exclusive rights to sofosbuvir, it also had an exclusive license to a patent covering sofosbuvir, and that Gilead infringed that patent by selling and offering for sale products containing sofosbuvir. Gilead and Gilead Pharmasset LLC filed their response to Roche’s arbitration demand in April 2013. The arbitration hearing was held in New York in June 2014.

On August 14, 2014, the arbitration panel determined that Roche failed to establish any of its claims and ruled in favor of Gilead. As a result, Roche is not entitled to any damages or other relief, according to the filing. 

Gilead received approval from the US Food and Drug Administration (FDA) for Sovaldi in December 2013, making it the first drug approved by the FDA that demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon. For the first-half of 2014, Sovaldi’s sales were $3.480 billion, or 53% of total Gilead’s first-half revenues. 

Sovaldi is a nucleotide analog inhibitor that blocks a specific protein needed by the hepatitis C virus to replicate. Sovaldi is to be used as a component of a combination antiviral treatment regimen for chronic HCV infection. There are several different types of HCV infection. Depending on the type of HCV infection a patient has, the treatment regimen could include Sovaldi and ribavirin or Sovaldi, ribavirin, and peginterferon-alfa

Source: Gilead Sciences 8-K Filing, US Securities and Exchange Commission

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