Drafting a Pharmaceutical Composition Claim Covering Later-Developed Combination Drugs Without Losing the Disclosure Requirement Challenge: In re Entresto,125 F.4th 1090 (Fed. Cir. 2025)

Abstract

Novartis Pharmaceuticals Corp. has listed U.S. Patent No. 8,101,659 (“659 Patent”) in the Orange Book for Entresto^® used to treat heart failure with reduced ejection fraction. The Federal Circuit in its recent decision, In re Entresto, 125 F.4th 1090 (Fed. Cir. 2025), found the 659 Patent valid under the requirements of enablement and written description. Entresto may indicate that the disclosure requirement does not bar a drug company from asserting patent infringement of a later-developed combination drug not disclosed or implied in its patent. With proper use of “administered in combination” as a claim term, a pharmaceutical composition claim can represent a kit product composed of physically separate active ingredients and cover a combination drug containing the same active ingredients.