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.

The new drug product in the Photocure case was METVIXIA®, a prodrug (methyl ester) of a previously approved active moiety of LEVULAN KERASTICK®. The new drug product LEVAQUIN® in the Lupin case was a single enantiomer of a previously approved racemate sold as FLOXIN®. These holdings represent a shift in how the Federal Circuit views unique pharmaceutical compounds and appear to open the door to extending patent term for new drug products that are related to previously approved drugs, such as polymorphs, protected forms, and different stereoisomeric combinations.

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