Court Strikes Down FDA's Delisting of Drug
When Patentee Has Not Sued Generic Maker
The U.S. Food and Drug Administration's policy of delisting a drug from the Orange Book at the request of the patentee when the patentee has not sued the generic drug maker that has challenged the patent through an abbreviated new drug application is inconsistent with the relevant federal statutory provision, the U.S. Court of Appeals for the District of Columbia Circuit ruled Nov. 14 (Ranbaxy Laboratories Ltd. v. Leavitt, D.C. Cir., No. 06-5154, 11/14/06).
1 comment:
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