The U.S. Patent and Trademark Office's Patent Trial and Appeal Board ruled that United Therapeutics Corp.'s patent claims for the active pharmaceutical ingredient in its hypertension drug were unpatentable and cancelled them.
The patent was challenged by SteadyMed Ltd. in an inter partes review started in October 2015 and instituted in April 2016.
The patent claims, among other things, treprostinil produced using an improved method. Treprostinil is the active pharmaceutical ingredient in United Therapeutics' Remodulin and SteadyMed's lead drug candidate, Trevyent. The two drugs treat pulmonary arterial hypertension. SteadyMed plans to seek FDA approval for Trevyent in the second quarter of 2017.
United Therapeutics is evaluating its options for the ruling, including filing an appeal in the U.S. Court of Appeals for the Federal Circuit, or requesting a rehearing.
The biotechnology company is currently asserting the patent in two other cases that are scheduled for trial in September and February 2018.