In United Therapeutics Corporation v. Liquidia Technologies, the Federal Circuit ruled that safety and efficacy are not necessary for pharmaceutical method claims to be valid. This decision came after Liquidia filed a New Drug Application for a dry powder inhalation formulation of treprostinil for the treatment of pulmonary hypertension. United Therapeutics sued Liquidia in response.
https://www.jdsupra.com/legalnews/federal-circuit-will-not-read-safety-5515722/
https://www.jdsupra.com/legalnews/federal-circuit-will-not-read-safety-5515722/