Precedential and Key Federal Circuit Opinions

1.  UNITED THERAPEUTICS CORPORATION v. LIQUIDIA TECHNOLOGIES, INC. [OPINION] (22-2217, 7/24/23) (Lourie, Dyk, and Stoll)

Lourie, J. The Court affirmed the district court’s validity and infringement findings. The construction of the claim limitation “treating pulmonary hypertension” did not require a showing of safety and efficacy. And, accordingly, absent incorporation of safety and efficacy requirements in the claims, the Court declined to insert the FDA’s responsibilities into claims by importing requirements where they do not recite such limitations.

As construed, the Court found that the claims were adequately enabled and supported by written description. Despite expert testimony that a physician may have safety concerns in treating some groups of patients, the record also supported that the claimed administration improved conditions even in that group, which is all that was required by the claims as construed. Analogizing a subset of patients having a variant of a particular disease to traditional genus and species claims is inapt. It would be incorrect to fractionate a disease or condition that a method of treatment claim is directed to, and to require a separate disclosure in the specification for each individual variant of the condition (here, an individual group of pulmonary hypertension patients) in order to satisfy the enablement and written description provisions, unless these variants are specified in the claims.

In addition, for induced infringement, the product label did not need to provide hemodynamic data; it merely needs to instruct doctors and patients to administer a therapeutically effective single event dose. And a pending, non-final litigation does not negate an intent to infringe that is otherwise supported by evidence.

Furthermore, in connection with patent owner’s cross-appeal, the Court found that the district court did not clearly err in finding other claims anticipated by a reference which discloses the same product, irrespective of the processes by which they are made, because a product-by-process claim is a product claim, even if claimed by a process by which it can be made. The Court also found that the district court did not clearly err in finding no infringement, which required that treprostinil salt be stored at ambient temperature, based on defendant’s representations to the FDA that it would store treprostinil sodium between 2°C and 8°C and on the lack of any evidence showing otherwise.