Par Pharmaceutical, Inc. et al. v. Eagle Pharmceuticals, Inc.
Docket No. 2021-2342 (https://cafc.uscourts.gov/opinions-orders/21-2342.OPINION.8-18-2022_1993064.pdf)
MOORE, PROST, HUGHES
August 18, 2022
Brief Summary: DC finding of no infringement under 271(e)(2) affirmed based on Eagle’s ANDA specification to which Eagle is bound, and its denial of DJ affirmed. Summary: Par appealed DC finding that Eagle’s ANDA regarding Par’s Vasostrict® product (a vasopressin injection product used to treat patients with critically low blood pressure) does not infringe the claims of US 9,744,209 or 9,750,785 under 35 USC section 271(e)(2). Eagle’s ANDA was filed before the ‘209 and ‘785 patents expired, and the Orange Book (OB) lists eight patents expiring in 2035 under NDA204485 and ANDA filings by several additional companies. The FC panel opinion explains that the ‘209 patent is directed to methods of treatment and the ‘785 patent is directed to compositions but “[t]he claims of both patents require the vasopressin composition to have a rounded pH between 3.7–3.9, i.e., a pH between 3.65–3.94 before rounding.” Eagle’s ANDA included non-infringement / invalidity certifications. Par sued Eagle in DE for infringement of the patents under 35 USC section 271(e)(2) and sought a declaratory judgment (DJ) that Eagle’s product would infringe under 35 USC section 271(a) and (b). At the DC, “Eagle stipulated that its proposed product would meet all asserted claim limitations except the claimed pH range of 3.7–3.9.” Par argued that “‘real-world’ evidence shows the pH of Eagle’s product drifts up over time”, “sought authority to release products into the marketplace with a pH of 3.64, just 0.01 beneath the infringing range”, and that “these facts taken together compelled a finding that Eagle’s proposed product would more likely than not infringe since a product released at a pH of 3.64 would inevitably drift into Par’s claimed range.” The DC disagreed, finding Par’s “facts ‘neither undisputed nor correct’” (e.g., “the minor fluctuations in pH value identified by Par did not reveal any discernible trend, let alone ‘a steady and inevitable’ upward drift” and “while the release specification alone required a pH range between 3.4–3.6 (i.e., up to 3.64 before rounding) only at the time of distribution, the stability specification imposed an additional constraint that Eagle’s proposed product maintain a pH between 3.4–3.6 from the time of its distribution through the entirety of its shelf life”). The FC panel reviewed the DC’s “conclusions of law de novo and its factual findings for clear error”, deferring to the DC’s findings “in the absence of a definite and firm conviction that a mistake has been made” (Allergan, FC 2015; Scanner Techs., FC 2008; Alza, FC 2006). The FC panel explained that “[u]nder § 271(e)(2), it is an act of infringement to submit an ANDA seeking FDA approval to make and sell a patented drug” (35 USC section 271(e)(2); Warner-Lambert, FC 2003), but also that “courts must conduct an inquiry to determine whether the probable ANDA product would infringe once it is made, used, or sold” (Glaxo, FC 1997) which “is controlled by the ANDA specification itself” (Abbott, FC 2002; Ferring, FC 2014). “Here,” the FC panel wrote, “the inquiry begins and ends with Eagle’s ANDA specification” which “restrict the pH of the proposed product to a pH range between 3.4–3.6 at release and throughout the products’ shelf life—outside the infringing range”, and Par “Par cites no evidence that Eagle would not comply with its stability specification.” The FC panel therefore affirmed the DC’s finding of no infringement under 271(e)(2). The FC panel also affirmed the DC’s denial of Par’s request for DJ and that the finding relied on (i.e., “no upward pH drift in Eagle’s post-release pH data”) “was not clear error” (Teva, FC 2015; “Eagle is bound by its representations to the FDA that it will manufacture its products in accordance with the optimized process and that the pH of its products will remain between 3.4–3.6.”) The DC’s denial of DJ was therefore affirmed.