Liquidia Technologies said that the US Patent Trial and Appeal Board (PTAB) has issued decisions on two patents related to Tyvaso treprostinil inhalation solution, which is marketed by United Therapeutics for the treatment of pulmonary arterial hypertension (PAH). Liquidia filed petitions with the US Patent and Trademark Office seeking to invalidate the two patents in March 2020. The PTAB declined to review US Patent No. 9,593,066, saying that it was unlikely that a challenge would succeed, but instituted an inter partes review of Patent No. 9,604,901.
In April 2020, the FDA accepted Liquidia’s 505(b)(2) NDA for its LIQ861 treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH), which cited Tyvaso as the reference drug, and United Therapeutics filed a patent infringement suit the next month. In July 2020, United Therapeutics amended its suit to include an additional patent covering Tyvaso.
Liquidia CEO Neal Fowler commented, “The PTAB’s decision to institute an IPR proceeding against the ‘901 patent for Tyvaso is another important step forward for Liquidia’s ongoing effort to bring LIQ861, a convenient and well tolerated treatment option, to the PAH community. We believe PTAB’s decision on ‘066 to be in error and while there are options for reconsideration, we remain confident in the arguments of non-infringement and invalidity to be made in district court.”
Fowler continued, “The Liquidia management team and our board are committed to providing PAH patients with alternative treatment options, like LIQ861, that we believe they need and deserve. We will not be deterred by any effort to limit our ability to deliver on this goal for patients and are confident in our options to bring LIQ861 to commercialization.”
Read the Liquidia Technologies press release.
