Favorable ruling for SteadyMed v United Therapeutics

Pharmaceutical company SteadyMed Ltd said the Patent Trial and Appeal Board (PTAB) of the US Patent and Trademark Office (USPTO) ruled in its favor in the Inter Partes Review (IPR) proceeding against a patent owned by United Therapeutics.

“In its ruling, the PTAB found all 22 claims in the ‘393 patent unpatentable and cancelled them, rendering the patent invalid,” said SteadyMed.

“The ‘393 patent claims a product made by a process to further purify prostacyclin derivatives, such as treprostinil.

“Treprostinil is the active pharmaceutical ingredient used in United Therapeutics’ Remodulin and SteadyMed’s lead drug candidate, Trevyent, which is in development for the treatment of pulmonary arterial hypertension (PAH).”

SteadyMed CEO Jonathan Rigby said: “We are very pleased with this decision by the PTAB, which confirms our position that the claims in the ‘393 patent were invalid and the patent should not have been issued to United Therapeutics.

“We continue to focus on completing the final steps ahead of submitting our New Drug Application (NDA) for Trevyent, for the treatment of PAH, by the end of the second quarter.

“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.”

United Therapeutics said it was evaluating its options “including the possibility of immediately exercising its right of appeal to the US Court of Appeals for the Federal Circuit or first requesting a rehearing before the PTAB.”

United Therapeutics added: “The ‘393 patent remains valid and enforceable until appeals have been exhausted …

“United Therapeutics intends to continue vigorously defending the ‘393 patent, but even if the ultimate result is unfavorable, United Therapeutics has other patents claiming subject matter similar to the ‘393 patent and with the same expiration date (December 2028).”