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Patent Term Extension Under H-W Act Covers Alternative Forms Of Approved Product.(Hatch-Waxman Act)(Pfizer Inc. v. Dr. Reddy's Laboratories, Ltd., Case Nos. 03-1227, -1258 (Fed. Cir. Feb. 27, 2004))

Publication: Mondaq Business Briefing
Publication Date: 02-APR-04
Format: Online
Delivery: Immediate Online Access

Article Excerpt
Construing portions of the Hatch-Waxman Act (H-W), the U.S. Court of Appeals for the Federal Circuit held that the patent term restoration provision encompasses alternative salt and ester forms of an approved drug product, but clarifying that the term restoration provision is limited to registered uses of the approved product. Pfizer Inc. v. Dr. Reddy's Laboratories, Ltd., Case Nos. 03-1227, -1258 (Fed. Cir. Feb. 27, 2004) (Newman, J.).

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