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Update on Gilead's Legal Troubles

Zacks Equity Research

Gilead Sciences Inc. (GILD), which boasts of a strong product portfolio, has been facing patent related issues on many of its key drugs. Players like Teva Pharmaceutical Industries Limited (TEVA) are looking to introduce their generic versions of Gilead’s key HIV drugs like Atripla, Truvada and Viread. The entry of generic versions of the company’s HIV drugs would be a major blow to Gilead.

In another patent related issue, Idenix Pharmaceuticals, Inc. (IDIX) filed patent infringement and interference lawsuits in the U.S. against Gilead related to the latter’s high potential hepatitis C virus (:HCV) candidate, sofosbuvir.

We expect sofosbuvir to be approved by the U.S. Food and Drug Administration (:FDA) shortly (target date: Dec 8, 2013) after receiving a positive opinion from an advisory panel of the FDA. The candidate offers significant commercial potential with many HCV patients postponing their treatments awaiting sofosbuvir’s entry into the market. EU approval of the HCV candidate is also on track.

The patent infringement lawsuit has been filed by Idenix with the district court in Boston ,Mass. The lawsuit alleges infringement of a couple of patents (6,914,054 and 7,608,597), co-owned by Idenix, dealing with the methodology of treating HCV patients using 2'-methyl nucleosides.

The patent infringement and interference lawsuit filed with another U.S. district court alleges that Gilead infringes another Idenix co-owned patent (7,608,600). The patent deals with the methodology for treating HCV patients using 2'-methyl-2'-fluoro nucleosides. Moreover, Idenix also claims interference between the above patent and a U.S. patent (8,415,322) of Gilead. Idenix has asked the court to declare Gilead’s patent invalid.

Both biopharmaceutical stocks Gilead and Idenix carry a Zacks Rank #3 (Hold). A better-ranked stock in the biopharma space includes Actelion Ltd. (ALIOF) which carries a Zacks Rank #1 (Strong Buy).

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