United Therapeutics request for review of PTAB decision on Tyvaso patent is denied

According to Liquidia, the US Patent and Trademark Office’s Precedential Opinion Panel (POP) will not review a July 2022 Patent Trial and Appeals Board (PTAB) decision which determined that none of the claims in US Patent No. 10,716,793, which covers United Therapeutics’ Tyvaso inhaled treprostinil, are valid. United Therapeutics had requested both a POP review of the PTAB decision and a rehearing by the PTAB; the PTAB is still considering the rehearing request, Liquidia said. Final approval of Liquidia’s NDA for its Yutrepia treprostinil DPI, which was tentatively approved by the FDA in November 2021, is on hold while litigation continues.

After the FDA accepted Liquidia’s NDA for its Yutrepia treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH) in April 2020, United Therapeutics filed suit, alleging infringement of US Patent No. 9,604,901 and US Patent No. 9,593,066. In July 2020, The ‘793 patent was issued in July 2020, and United Therapeutics added claims related to infringement of that patent at that time. 

In September 2022, the United States District Court for the District of Delaware ruled that Yutrepia would infringe claims contained in the 066 and 793 patents but also found that the claims that would be infringed in the ‘066 patent are invalid and and that the only valid claim in that patent would not be infringed.

Liquidia CEO Roger Jeffs said, “Yesterday’s decision clears the way for the PTAB to make a final decision with respect to UTC’s rehearing request. We believe that the requested clarification of the PTAB’s original decision will help to make the PTAB’s decision even stronger. We remain confident that the rehearing request will be denied and that the PTAB’s favorable decision will be affirmed on appeal, thereby unlocking the path to potential approval of Yutrepia by mid-2024, if not earlier.”

Read the Liquidia press release.