Monday 6 October, 2008

Riluzole 50 mg tablet (Rilutek): CAFC favored innovator sanofi Aventis, generic launch after expiry of product patent

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
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Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
 
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