August 4, 2023
Authored and Edited by Christina Ji-Hye Yang; Elizabeth D. Ferrill; Michael Nielsen†
In United Therapeutics Corp. v. Liquidia Techs., Inc., No. 22-2217 (Fed. Cir. July 24, 2023), the Federal Circuit affirmed a District of Delaware decision addressing claim construction, validity, and infringement.
United Therapeutics (UT) filed a lawsuit against Liquidia for infringement of the ’793 and ’066 patents directed to methods of treating pulmonary hypertension and pharmaceutical compositions comprising Treprostinil. Liquidia filed an IPR against the ’793 patent, and the Board found all claims unpatentable as obvious. The district court found that the ’793 patent is valid and infringed and that claims 6 and 9 of the ’066 patent are invalid as anticipated and claim 8 is valid but not infringed. Liquidia appealed.
The Federal Circuit affirmed. The term “treating pulmonary hypertension” in the ’793 patent claims includes all five groups of pulmonary hypertension patients and does not require any additional efficacy or safety limitations. Applying this construction, the claims are adequately enabled and supported by written description because disease-specific requirements are issues for the FDA and not relevant to validity. The Federal Circuit also affirmed the district court’s finding of induced infringement, holding that the accused infringer only needs to instruct doctors and patients to administer a therapeutically effective single dose. The Board’s IPR decision finding claims unpatentable does not negate an intent to infringe because the claims are cancelled only after the time for appeal has expired or any appeal has terminated. Turning to the ’066 patent, the Federal Circuit affirmed the district court’s findings of anticipation and non-infringement.
†Michael Nielsen is a Law Clerk at Finnegan.
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