CAFC favored innovator Sanofi Aventis in a patent dispute on generic form of Riluzole by Impax. Following is the only orange book listed patent for Riluzole:
US5527814 (Expiry: Jun 18, 2013): Which covers Riluzole as product
Impax tried to prove invalidation on the grounds that ‘814 patent is anticipated and obvious in light of prior art disclosure.
Also, Impax tried to prove inequitable conduct. However, CAFC upheld District court’s decision that selection of Riluzole is not anticipated by the prior art (Aventis’s patent US5236940). Court found that ‘940 patent although discloses Riluzole as a Markush structure, but do not discloses its effectiveness in treating RLS. Furthermore, court concluded that
Opinion
Monday, 6 October 2008
Riluzole 50 mg tablet (Rilutek): CAFC favored innovator sanofi Aventis, generic launch after expiry of product patent
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