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www.fdanews.com/articles/166651-gilead-wins-dispute-with-rival-roche-over-rights-to-sovaldi

Gilead Wins Dispute with Rival Roche Over Rights to Sovaldi

August 25, 2014

Gilead Sciences may continue marketing its blockbuster hepatitis C drug Sovaldi after winning a dispute with rival drugmaker Roche over rights to the expensive new therapy.

A U.S. arbitration panel last week disagreed with Roche’s March 2013 claims that its previous research collaboration with manufacturer Pharmasset, which Gilead bought in 2011, entitled the Swiss drugmaker to an exclusive license of Sovaldi’s active ingredient sofosbuvir. Roche also claimed that it had an exclusive license to a patent covering sofosbuvir, and that Gilead infringed on that patent.

An arbitration panel, however, determined that Roche failed to establish any of its claims, Gilead said in an SEC filing. As a result, Roche is not entitled to any damages or other relief, it added.

Roche is not the only company attempting legal action to thwart Gilead’s dominance of the hepatitis C market. AbbVie filed suit in February, claiming rights to the combination of sofosbuvir and ledipasvir. Just before the FDA approved Sovaldi in December 2013, Idenix Pharmaceuticals attempted to ground it, claiming that the drug infringes on some of its patents.

The drug, which costs roughly $84,000 for a 12-week treatment, generated $5.75 billion in sales in the first half of 2014. The UK’s National Institute for Health and Care Excellence last week recommended the drug for the treatment of three types of hepatitis C infection. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.