Wednesday, December 27, 2006

CAFC Rules Zyperxa Patent Valid, Blocks US Generics Penetration!

The U.S. Court of Appeals for the Federal Circuit (CAFC) has upheld the district court decision which earlier in April 2005 found the Eli Lilly’s U.S. Patent # 5,229,382 (the ‘382) to be valid and infringed, after been challenged by generic manufactures under the Hatch-Waxman Law. The ruling would excludes the possibility of generic Zyprexa till April 2011 following the expiry of the ‘382 patent. The CAFC rejected the appeal brought by generics defendants --- Zenith Goldline Pharmaceuticals, Inc. (now known as IVAX Pharmaceuticals, Inc.), Dr. Reddy’s Laboratories Ltd., and Teva Pharmaceuticals Inc. --- after it found no reversible error in the ruling made by the District Court Judge Richard Young. In line to make an early penetration in the US generic Zyprexa market, the generic defendants challenged the validity of the ‘382 patent, claiming that olanzapine was similar to previously disclosed compounds exemplified in the U.S. Patents # 4,115,574 (the ‘574 patent) assigned to Lilly and was in public use before Lilly received the ‘382 patent.

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