Enzo Life Sciences, Inc. v. Becton, Dickinson and Co. (Holozyme)
Docket No. 2018-1232, -1233 (IPR2016-00820, -00822)
LOURIE, O’MALLEY, CHEN
August 16, 2019 (Non-Precedential)
Brief Summary: Board decisions of invalidity of Enzo’s claims for anticipation and obviousness affirmed; arguments that retroactive application of IPRs is unconstitutional rejected.
Summary: Enzo appealed Board IPR decisions finding various claims of US 7,064,197 invalid for anticipation or obviousness, and challenges the IPRs as a violation of the Fifth Amendment. The FC panel reviewed the Board’s legal determinations de novo and its factual findings underlying those determinations for substantial evidence (that which “a reasonable mind might accept as reasonable”) (Belden, FC 2015; Consol. Edison, US 1938). Representative claim 1 is directed to “[a] non-porous solid support comprising…at lease one single-stranded nucleic acid…fixed or immobilized in hybridizable form” thereto. Representative claim 17 is directed to “[a]n array” of such “hybridizable form[s]” (construed as “capable of binding”, having “bases available for base-pairing”). The Board determined that these claims did not have priority to the earliest claim date because the earliest application “did not provide written description [WD] support for the claimed ‘non-porous solid support’”, which qualified reference “VPK” as prior art (applied in the obviousness context). The Board found that the Fish reference anticipates the claims by teaching single-stranded DNA (ssDNA) bound to…poly-L-lysine (PLL)-coated wells” and “that being capable of hybridizing is the inherent result” therefrom (“hybridizable form”, “actual hybridization” not required). The FC panel agreed with the Board since it “reasonably relied on testimony from both experts”, “an inherent characteristic…is the ‘natural result’ flowing from the reference’s explicitly explicated limitations” (Eli Lilly, FC 2001), and that it did not err “in finding that container with wells or depressions without any nucleic acids would meet the claim language” (also citing In re Kaslow, FC 1983 (without separate arguments regarding the dependent claims, those “stand or fall together with the independent claims”)). The Board also found certain claims to be invalid for obviousness in view of Fish and Gilham (“wherein said fixation or immobilization to said non-porous solid support is covalent”), or with Metzgar and Sato (“wherein said non-porous solid support comprises one or more hydroxyls”), finding the Board’s conclusions to be supported by substantial evidence (e.g., agreeing “with Becton that Enzo’s teaching away arguments improperly attack the references individually” (In re Merck, FC 1986), “it is the combined teachings of Gilham’s chemistry for binding RNA in hybridizable form and Fish’s methods for attaching nucleic acids to non-porous supports”). As it agreed with the Board’s Fish-based obviousness decisions, it did not address those based on the VPK reference. The FC panel also rejected Enzo’s constitutionality arguments “that the IPR process as applied retroactively to patents that issued before the enactment of the AIA violates the Fifth Amendment” as it did in Celgene decision (FC 2019).