Lovenox Patent Invalidity Ruling Could Open Door To Near-Term Generics
This article was originally published in The Pink Sheet Daily
Executive Summary
California court invalidates Sanofi-Aventis’ patent due to inequitable conduct. The court’s ruling will lead to lifting of 30-month stay on ANDA approvals. Amphastar and Teva said they would await FDA approval of their enoxaparin generics before deciding whether to launch prior to an appellate court ruling.
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A California federal court ruling invalidating Sanofi-Aventis' Lovenox patent could open the door to enoxaparin generics in the near term. A Riverside, Calif. federal court ruled in favor of generic companies June 15 in finding that a Sanofi-Aventis patent for the antithrombotic was invalid due to inequitable conduct. The patent at issue (no. 5,389,618) covers low molecular weight polysaccharides, methods of use and manufacturing processes. The '618 patent was reissued by the Patent & Trademark Office, and both the original and reissued patents expire in February 2012 (1 (Also see "Lovenox Patent Could Be Reissued In Mid-2005, Sanofi-Aventis Says" - Pink Sheet, 20 Dec, 2004.)). The invalidity ruling came in Sanofi's patent litigation against Amphastar and Teva over the generic companies' Paragraph IV challenges to the '618 patent. Both companies' ANDAs are currently subject to a 30-month stay of approval, and neither has received tentative approval yet. However, formal entry of the court's invalidity ruling as a final judgment would result in a lifting of the 30-month stay, Sanofi said. Sanofi said it will appeal the ruling and will "vigorously defend" its property rights covering Lovenox. Amphastar and Teva said they would await FDA approval of their ANDAs before determining whether to launch their generics prior to an appellate court ruling. Andrx holds marketing rights for Amphastar's enoxaparin generic (2 (Also see "Andrx Picks Up Lovenox Generic Marketing Rights From Amphastar" - Pink Sheet, 6 May, 2005.)). - Jessica Merrill |