United Therapeutics announced that it has been issued a new US patent covering Tyvaso treprostinil inhalation solution for the treatment of pulmonary arterial hypertension and that it has subsequently amended its recently filed suit against Liquidia Technologies to include infringement of the new patent.
The patent infringement suit initially referenced two US patents — 9,604,901 and 9,593,066 — both titled “Process to prepare treprostinil, the active ingredient in Remodulin” and both expiring in December 2028. The new patent, No. 10,716,793 (“Treprostinil administration by inhalation”) was filed in January 2020 and expires in May 2027.
United Therapeutics filed suit after the FDA accepted Liquidia’s submission of a 505(b)(2) NDA for its LIQ861 treprostinil DPI for the treatment of PAH in April 2020. In March 2020, Liquidia had filed petitions with the US Patent and Trademark Office seeking to invalidate the 901 and 066 patents.
Read the United Therapeutics press release.