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

Abstract

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.