A US appeals court has revived a class action lawsuit alleging Sanofi-Aventis improperly delayed generic versions of its diabetes treatment Lantus from entering the market by misleading the US Food and Drug Administration (FDA) about its patent rights.
Reversing a lower court judge, the US Circuit Court of Appeals for the 1st Circuit on Thursday, February 13, stated a putative class of direct purchasers had plausibly alleged Sanofi violated antitrust law by improperly submitting a patent for inclusion in an important FDA database.
The court held that the complaint adequately alleged that Sanofi shouldn’t have submitted the patent, which neither claims nor even mentions insulin glargine or the Lantus SoloSTAR.
According to Bloomberg, the opinion provides clarity on what patents are appropriately listed in the Orange Book—and which ones have been providing unfair cover for drugmakers seeking to drag out litigation and delay market entry by generic drugs, Zachary Silbersher, an intellectual property lawyer with Kroub Silbersher & Kolmykov in New York, said.
“For a drug manufacturer, the more patents you list, the longer it takes to litigate them, and the greater the chances that one of them will keep out a generic,” Silbersher said. “Because of that prior history, the implications of this opinion could be significant.”
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