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USPTO declares patent related to PAH treatment invalid

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SteadyMed and United Therapeutics announced the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board ruled a patent related to treprostinil, the active ingredient in treatments for pulmonary arterial hypertension, is invalid.

The patent was held by United Therapeutics for purification of prostacyclin derivatives such as treprostinil and was challenged by SteadyMed in October 2015. Treprostinil is the active ingredient in three United Therapeutics products to treat PAH: Orenitram, Remodulin and Tyvaso. It is also the active ingredient in Trevyent, a drug to treat PAH being developed by SteadyMed.

The USPTO found that “all 22 claims in the ... patent [are] unpatentable and cancelled them, rendering the patent invalid,” according to a press release from SteadyMed.

“We are very pleased with this decision by the [Patent Trial and Appeal Board], which confirms our position that the claims in the ... patent were invalid, and the patent should not have been issued to United Therapeutics,” Jonathan Rigby, president and CEO for SteadyMed, said in the release. “We have a growing body of market research data that we believe strongly indicates a significant need for Trevyent that, if approved, has the potential to take a meaningful share of the PAH market.”

SteadyMed expects to file a New Drug Application with the FDA for Trevyent in the second quarter of 2017, Rigby said in the release.

In its press release, United Therapeutics stated it plans on reviewing its options, which include appealing the ruling to the U.S. Court of Appeals for the Federal Circuit or a rehearing with the Patent Trial and Appeal Board. “The ... patent remains valid and enforceable until appeals have been exhausted,” the company stated.

According to its release, United Therapeutics is also defending this patent against other firms attempting to receive approval to market generic versions of Orenitram and Tyvaso.