Hospira, Inc. v. Fresenius Kabi USA, LLC
Docket Nos. 2019-1329, -1367
NEWMAN, LOURIE, TARANTO
January 9, 2020
Brief Summary: DC obviousness judgment of affirmed as “wherein” clause only describes “a result that was inherent in the prior art”.
Summary: Hospira appealed DC judgment finding claim 6 of US 8,648,106 relating to the Precedex Premix product (including the sedative dexmedetomidine; NDA N021038 also listing five other non-expired US patents (see FN1 re: ‘049 patent) invalid for obviousness. Sole independent ‘106 claim 1 is directed to “[a] ready to use liquid” dexmedetomidine in “a sealed glass container, wherein the liquid pharmaceutical composition when stored in the glass container for at least five months exhibits no more than about 2% decrease in the concentration of dexmedetomidine.” Dependent ‘106 claim 6, at issue in this appeal, is dependent on claim 1 “wherein the dexmedetomidine…is at a concentration of about 4 [micrograms]/ml.” The FC panel explained that the ‘106 patent states “[t]he present invention is based in part on the discovery that” the “premixed formulation…does not require reconstitution or dilution prior to administration” and “remains stable and active after prolonged storage.” The DC concluded that at least one embodiment of ‘106 claim 6 was obvious based in part on its determination that the “about 2% limitation…is inherent” in prior art “expressly” teaching 4 [micrograms]/ml compositions and post-‘106 patent filing date “stability data for more than 20 tested samples” (e.g., DC found “Fresenius’s expert’s analysis…more reliable than that of Hospira’s expert”; citing In re Cuozzo, FC 2015 (“to prove that a claim covering multiple alternative embodiments is invalid, a defendant need only prove that one of the embodiments is invalid”); the DC noting that it was found not to be inherent in a separate decision (D. Del. 2018, aff’d Fed. Cir. 2019)). Hospira argued that the DC “incorrectly considered the inherency of the about 2% limitation in non-prior art embodiments rather than the allegedly obvious prior art combination” and “applied a lower ‘reasonable expectation of success standard’ rather than the higher ‘necessarily present’ standard to the inherency question.” Hospira argued that the tested samples were “manufactured using the…process described in Example 5 of the ‘106 patent, and thus the stability data…cannot suffice to prove that all samples of the allegedly obvious combination…would ‘necessarily’ meet the about 2% limitation.” The FC panel first explained that reliance on post-filing date data is acceptable (Monsanto, Fed. Cir. 2018), and that the claim is not a method or product-by-process claim so how the samples were manufactured is not relevant. The FC panel also found that although the DC “conflated the standards for inherency and reasonable expectation of success”, it was “harmless error” (Vanderbilt, Fed. Cir. 2010), and concluded the “wherein” clause only describes “a result that was inherent in the prior art” (Atlas Powder, FC 1999 (“unappreciated property”)); In re Kubin, FC 2009; Persion, FC 2019 (PK claims inherent); Alcon, FC 2012; In re Kao, FC 2011 (“‘food effect’ in an inherent property”); see also Schering, FC 2003 (“the prior art need not recognize the inherent property”)). The DC decision was therefore affirmed.