According to Liquidia, the US Patent Trial and Appeal Board (PTAB) has found that none of the claims included in US Patent No. 10,716,793, covering Tyvaso inhaled treprostinil, are valid. The company said that the PTAB ruling would have to be upheld on appeal before it can affect a court ruling holding up final approval of Liquidia’s NDA for Yutrepia treprostinil DPI, which was tentatively approved by the FDA in November 2021. The FDA recently approved United Therapeutics’ Tyvaso treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
United Therapeutics filed suit against Liquidia in June 2020, alleging infringement of US Patent No. 9,604,901 and US Patent No. 9,593,066 after the FDA accepted Liquidia’s NDA for Yutrepia (LIQ861) for the treatment of pulmonary arterial hypertension (PAH) in April 2020. In July 2020, the ‘793 patent was issued, and United Therapeutics added claims related to infringement of that patent to the suit.
A previous PTAB ruling in October 2021 found that 7 of 9 claims in the ‘901 patent were invalid, and in December 2021, United Therapeutics agreed to a judgment that Liquidia had not infringed on the ‘901 patent. The ‘793 patent, which expires in 2027, and the ‘066 patent, which expires in 2028, continue to stand in the way of final approval of Yutrepia at this time.
Liquidia CEO Roger Jeffs commented, “We are very pleased with this decision by the PTAB. Today’s decision is another step down the path towards Yutrepia’s potential final regulatory approval. We will continue to vigorously defend our right to commercialize Yutrepia as soon as possible and look forward to hearing the final decision from the district court in the Hatch-Waxman litigation.”
Read the Liquidia press release.
