United Therapeutics Corp. v. Liquidia Technologies, Inc.
Docket No. 2022-2217, 2023-1021 (https://cafc.uscourts.gov/opinions-orders/22-2217.OPINION.7-24-2023_2161663.pdf)
LOURIE, DYK, STALL
July 23, 2023
Brief Summary: DC decisions regarding infringement, that a pending IPR proceeding has no bearing on this appeal, infringement but anticipation, and non-infringement affirmed.
Summary: This appeal relates to the DC’s holdings regarding certain claims of UT’s US 10,716,793 and US 9,593,066 relating to UT’s Tyvasol® (“an inhaled solution formulation of treprostinil approved for the treatment of pulmonary hypertension (‘PH’)”; two of seven OB patents listed for UT’s NDA 022387). Liquidia appealed the DC’s decision that certain ‘793 claims are not invalid and are infringed, and that certain ‘066 claims are invalid as anticipated “but are otherwise infringed”. UT cross-appealed the DC’s decision the invalidity decision and that claims 6, 8 and 9 of the ‘066 patent are not infringed by Liquidia’s 505(b)(2) NDA 213005 for YutrepiaTM which “is a dry powder inhalation formulation of treprostinil but is not a generic version of any currently marketed drug.” In July 2022, the USPTO Board issued a Final Written Decision (FWD) finding all the ‘793 claims invalid for obviousness (confirmed in a rehearing), and UT’s appeal is currently pending (not this appeal). The ‘793 patent claims methods for treating PH using “a therapeutically effective single event dose” that “comprises from 15 micrograms to 90 micrograms of treprostinil…delivered in 1 to 3 breaths” with dependent limitations related to dry powder formulations and inhalers.
The DC concluded UT showed by a preponderance of the evidence that Liquidia would directly infringe, found “Liquidia’s argument that it lacked specific intent to induce infringement” of the “treating [PH]” limitation” “lacked merit” as a label “merely needs to instruct doctors and patients to administer a therapeutically effective single event dose”, the claims were not invalid for lack of enablement or written description, and stayed approval of Liquidia’s NDA until expiration of the ‘793 patent. The FC panel noted the DC “gave the phrase ‘therapeutically effective’ a limiting construction” but did not address the issue as Liquidia did not raise it here. The FC panel also explained that “[q]uestions of safety and efficacy in patent law have long fallen under the purview of the FDA” (In re Brana, FC 1995; Scott, FC 1994; In re Anthony, CCPA 1969), and “decline[d] to insert the FDA’s responsibilities into claims by importing requirements where they do not recite such limitations.” The FC panel also found the claims to be enabled and described (Ariad, FC 2010; “[a] subset of unresponsive patients is not analogous to unsupported species in a generic claim to chemical compounds”) as construed by the DC. The FC panel also found no error with the DC’s finding of infringement as Liquidia’s label “merely needs to instruct doctors and patients to administer a therapeutically effective single event dose, which it does”, and the DC’s conclusion that “a single administration of Yutrepia will be therapeutically effective”. Regarding the ‘793 IPR, the FC panel wrote that “[a] pending, non-final litigation does not negate an intent to infringe that is otherwise supported by evidence” and “an IPR decision does not have collateral estoppel effect until that decision is affirmed or the parties waive their appeal rights” (XY, FC 2018; 35 USC 318(b)). The ‘066 patent is directed to treprostinil pharmaceutical compositions, storage of the same at ambient temperature, and processes of preparing the compositions. The DC found Liquidia would infringe certain claims (not the ambient temperature or process claims), met the “lower impurity” limitations, but also found all of the alleged claims invalid for anticipation. The FC panel agreed with the DC that the claims were anticipated and explained that “unpatentable or invalid claims cannot be infringed” (Commil, US 2015). Regarding anticipation, the FC panel explained that while the prior art reference referred to Treprostinil “as a product-by-process claim”, that “is a product claim, even if claimed by a process by which it can be made” and the claim recites impurities. The FC panel also agreed with the DC that Liquidia does not infringe ‘066 “ambient temperature” storage claims 6 and 8 (e.g., “Liquidia’s NDA requires the treprostinil salt to be stored at a temperature of 2–8°C”).