The Court of Appeals for the Federal Circuit has upheld rulings by the United States District Court for the District of Delaware in a patent infringement suit filed by United Therapeutics against Liquidia Corporation alleging that Liquidia’s Yutrepia treprostinil DPI infringes patents covering Tyvaso inhaled treprostinil. The FDA tentatively approved Liquidia’s NDA for Yutrepia in November 2021.
The rulings in question concerned US patents No. 9,593,066 and No. 10,716,793. In August 2022, the court ruled that Yutrepia would infringe some claims contained in the ‘066 and ‘793 patents; however, the judge also ruled that the claims in the ‘066 patent were either invalid or not infringed. While the judge ruled that Liquidia infringed on claims in the ‘793 patent, the US Patent Trial and Appeal Board (PTAB) had ruled the previous month that none of the claims in ‘793 are patentable and upheld that ruling earlier this year. United Therapeutics has appealed the PTAB ruling, and Liquidia said that the case is expected to be heard by early next year.
Liquidia CEO Roger Jeffs commented, “With today’s decision, only one of the three patents asserted against Liquidia stands in the way of seeking final approval for Yutrepia. We remain confident that this single patent will no longer be at issue upon conclusion of the on-going appeal of the ‘793 IPR decision, which invalidated all claims in the patent. We will continue to prepare for the potential launch of Yutrepia to treat pulmonary arterial hypertension (PAH) and will work with regulatory authorities to add the indication to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD).”
United Therapeutics VP and Associate General Countel Shaun Snader said, “Today’s decision vindicates our position, as confirmed earlier by the district court, that Yutrepia is an infringing product. We will continue to vigorously defend our intellectual property.”
Read the Liquidia press release.
Read the United Therapeutics press release.
