Court delivers split ruling in lung drug dispute
Lengthy opinion invalidated plaintiff’s patent but ruled that defendant’s would still infringe | Patents at issue related to treatment for high blood pressure in the lungs.
A Delaware court handed a splintered ruling in a dispute between Liquidia and United Therapeutics (UTC) centring on lung treatments.
District Judge Richards invalidated a UTC patent for the treatment Tyvaso (treprostinil) inhalation solution, which treats high blood pressure in the lungs.
But he also found Liquidia’s Yutrepia will cause doctors and patients to infringe in a 54-page opinion issued on August 31 in the US District Court for the District of Delaware.
In June 2020, UTC filed a lawsuit against Liquidia under the Hatch-Waxman Act for infringement of a trio of patents covering Tyvoso, US patent numbers 9,593,066, 9,604,901, and 10,716,793.
The dispute arose when Liquidia submitted an ANDA number 213005 under§ 505(b)(2) of the Federal Food, Drug, and Cosmetic Act seeking US Food and Drug Administration (FDA) approval for the manufacture, use, and sale of its proposed product LIQ861 (Yutrepia).
In October 2021, the US Patent Trial and Appeal Board ruled in Liquidia’s favour in the inter partes proceeding against the 901 patent owned by UTC and listed in the Orange Book for Tyvaso.
The judgment this week related to the infringement and validity of claims 1, 2, 3, 6, 8, and 9 of the '066 patent and claims 1, 4, 6, 7, and 8 of the '793 patent.
In conclusion, Judge Andrews found that UTC failed to prove by a preponderance of the evidence that Liquidia will infringe claim 8 of the ' 066 patent and Liquidia “proved by clear and convincing evidence that claims 1, 2, 3, 6, and 9 of the '066 patent are invalid”.
However, he also held that UTC proved by a preponderance of the evidence that Liquidia will induce infringement of claims 1, 4, 6, 7, and 8 of the '793 patent.
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