Federal Circuit Will Not Read Safety and Efficacy Limitations into Pharma Method Claims

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.


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