Legal Alert: Unique Active Ingredient in Drug Product Can Mean Patent Term Extension


Unique Active Ingredient in Drug Product Can Mean Patent Term Extension

The U.S. Court of Appeals for the Federal Circuit recently affirmed two separate district court decisions finding that patents on newly approved pharmaceutical active ingredients are eligible for patent term extension under 35 U.S.C. § 156(a)(5)(A), to account for time lost during Food and Drug Administration (FDA) regulatory review. In both Photocure ASA v. Kappos and Ortho-McNeil Pharm., Inc. v. Lupin Pharm., Inc., the Federal Circuit reasoned that new active ingredients that are separately patentable and subject to regulatory review over related compounds may satisfy the § 156 requirement as the first permitted commercial marketing of the drug product following regulatory approval.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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