Liquidia says Federal Circuit affirms district court rulings in patent fight

Liquidia Corporation (LQDA) announced that the Court of Appeals for the Federal Circuit has affirmed all rulings by the United States District Court for the District of Delaware in litigation filed by United Therapeutics (UTHR) under the Drug Price Competition and Patent Term Restoration Act, or Hatch-Waxman litigation, which alleged that Liquidia’s YUTREPIA inhalation powder infringes U.S. Patent No. 9,593,066 and U.S. Patent No. 10,716,793. The District Court had previously ruled in August 2022 that five of the six asserted claims of the ‘066 patent are invalid, that the only valid asserted claim of the ‘066 patent is not infringed by Liquidia, and that Liquidia would induce infringement of the five asserted claims in the ‘793 patent based on the arguments presented at the District Court. Dr. Roger Jeffs, CEO of Liquidia, said: “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 and will work with regulatory authorities to add the indication to treat pulmonary hypertension associated with interstitial lung disease.”