How a Treatment Claim Without Reciting Safety and Efficacy Requirements May Survive the Disclosure Requirement Challenge: <i>United Therapeutics Corp. v. Liquidia Technologies, Inc.</i>

This article analyzes a case representing an issue of the disclosure requirement under 35 U.S.C. § 112 where the claimed invention used a single active ingredient to treat several variants of the targeted disease. In United Therapeutics Corp. v. Liquidia Techs., Inc. , 74 F.4th 1360 (Fed. Cir. 2023), one disputed treatment patent survived the disclosure requirement challenge. United Therapeutics indicates that a treatment claim without reciting a safety or efficacy limitation is generally not construed to include safety and efficacy requirements. This case also suggests a strategy of patent drafting where the specification of a treatment patent should focus on how the patented treatment improves targeted subjects’ biological data rather than their symptoms, functions, or survival rates.