Par Pharmaceutical, Inc. et al. v. Hospira, Inc.
Docket No. 2020-1273 (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/20-1273.OPINION.11-23-2020_1689851.pdf)
DYK, TARANTO, STOLL
November 23, 2020
Brief Summary: DC finding that Hospira’s ANDA infringed Par’s claims affirmed (e.g., “[w]hat a generic asks for an receives approval to market, if within the scope of a valid claim, is an infringement”).
Summary: Hospira appealed DC finding that its generic (ANDA) of Par’s Adrenalin® epinephrin injection infringed Par’s US Pat. Nos. 9,119,876 and 9,295,657 directed to compositions and methods of treatment, respectively. The DC construed several claim terms and “determined that the sodium chloride permitted by Hospira’s ANDA comes within the claim limitation requiring ‘about 6 to 8 mg/mL’ of a tonicity regulating agent”, “the ANDA covered a product having citric acid that would serve as a transition metal complexing agent” (“about 0.01 to 0.4 mg/mL”) and “covered a product having citric acid that served as a pH lowering agent in an amount that comes within the claim-required range” (“about 0.001 to 0.010 mg/mL”). The FC panel explained that “whether an ANDA is ‘for’ a patent-claimed drug or patent-claimed use of a drug under 35 U.S.C. § 271(e)(2), is an issue of fact…reviewed for clear error.” Referring to its Cohesive (FC 2008) and Monsanto (FC 2018) decisions, the FC panel wrote that “[t]he authorized extension” of the term “about” “beyond the stated numbers in the range is cabined to what ‘a person having ordinary skill in the art…would reasonably consider ‘about…’ to encompass”, “[t]he extension effected by ‘about’ must be tied to ‘the purpose of the limitation in the claimed invention-not the purpose of the invention itself”, and “requires examination of whether the extension is by a ‘modest amount,’…considering the ‘criticality of the [numerical limitation] to the invention’”. In front of the DC, Par and Hospira “agreed that ‘about’ should be construed to have its ‘plain and ordinary meaning’ of ‘approximately’”, and the FC panel found that the DC “reasonably concluded” (e.g., based on expert testimony) that “‘about 8’ encompasses 9, considering the purpose of the upper limit”, without considering “statements suggesting that 8.5 mg/ml might be too high to be ‘about 6 to 8’” made “years after the ‘876 and ‘657 patents issued” during prosecution of “a continuation-in-part application that named a different inventor group, that had different claims, and that Par eventually abandoned”. Regarding the “transition metal complexing agent” limitation, which the DC found the citric acid of Hospira’s product meets, Hospira argued that the DC’s “analysis should have focused entirely on the characteristics of the composition that Hospira was likely to sell, not on what compositions the ANDA, if approved, would allow Hospira to market.” The FC panel disagreed with Hospira, explaining that “[i]t is not necessary that Hospira intended the citric acid to function as a chelating agent if, as the [DC] could readily find, the citric acid actually does so” (Global-Tech, US 2011) and that “[w]hat a generic asks for an receives approval to market, if within the scope of a valid claim, is an infringement” (“representations about the ANDA’s scope control the infringement analysis”) (Sunovion, FC 2013; Glaxo, FC 1997; Ferring B.V., FC 2014 (“When an ANDA is silent with respect to a claim limitation, Sunovion does not govern; it is the product that the generic company is likely to sell that guides the infringement analysis.”)) The FC panel also concluded the DC correctly found Hospira’s ANDA product included the claimed pH lowering agent. The DC decision was therefore affirmed.