SteadyMed receives favorable ruling in inter partes review against United Therapeutics patent.
SteadyMed Ltd., a specialty pharmaceutical company focused on the development of drug product candidates to treat orphan and high-value diseases with unmet parenteral delivery needs, announced that the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO) ruled in its favor in the Inter Partes Review (IPR) proceeding against U.S. Patent No. 8,497,393 (the ‘393 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.
The IPR was instituted by PTAB in April 2016 after SteadyMed challenged the ‘393 patent’s validity. 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).
“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,” said Jonathan Rigby, President and Chief Executive Officer of SteadyMed. “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.”
(Source: SteadyMed Ltd.)