Enzo Biochem Inc et al. v. Applera Corp. et al.

Docket No. 2016-1881

August 2, 2017


Brief summary: DC grant of SJ to Applera on remand following Applera’s appeal of a $48.6 million adverse judgment affirmed since, e.g., the DOE “cannot embrace a structure that is specifically excluded from the scope of the claims” (the claims do not include direct detection).

Summary: Enzo appealed DC entry of SJ favoring Applera regarding Enzo’s US 5,449,767 relating to detecting DNA and RNA sequences in samples without using radioisotopes. A jury originally found that Applera infringed the asserted ‘767 claims and awarded Enzo $48.6 million in damages (Enzo I, FC 2010; Enzo II, FC 2015). That decision was appealed and that FC panel agreed with Applera, concluding claim 1 was limited to indirect detection. On remand, the DC “agreed with Applera that [the FC panel’s] decision in Enzo II covered all claims of the ‘767 patent, not just claim 1 as argued by Enzo, and rejected Enzo’s doctrine of equivalents argument relating to claims 1 and 8” and granted Applera’s motion for SJ. The disputed language of claim 1 (upon which the other asserted claims depend) in this appeal “involves the following limitation: ‘wherein A comprises at least three carbon atoms and represents at least one component of a signaling moiety capable of producing a detectable signal’”. Enzo argued the DC erred in its construction of the claims and that “the previously-construed scope of claims 67, 68, and 70, cover[] both direct and indirect detection.” The FC panel determined that Enzo II “consistently refers to the ‘claims’ at issue in that appeal, which extend beyond claim 1 to include claims 8, 67, 68, and 70”, and therefore affirmed this part of the DC’s decision. The DC also granted Applera’s motion for SJ that it did not infringe claims 1 and 8 under the doctrine of equivalents (DOE) (Warner-Jenkinson, US 1997; Graver Tank, US 1950), which Enzo argued was improper “because there is a genuine dispute of material fact” on this point. Infringement under the DOE can be shown “if every limitation of the asserted claim, including a limitation’s ‘equivalent.’ Is found in the accused product, ‘where an ‘equivalent’ differs from the claimed limitation only insubstantially” (e.g., “[w]hether a component in the accused subject matter performs substantially the same function as the claimed limitation in substantially the same way to achieve substantially the same result” (Ethicon, FC 1998)). The FC panel explained that the DOE “cannot embrace a structure that is specifically excluded from the scope of the claims” (Dolly, FC 1994) and “cannot ‘render[] a claim limitation inconsequential or ineffective’” (Akzo Nobel, FC 2016; Warner-Jenkinson). The FC, however, found that Enzo’s DOE argument “runs headfirst into our decision in Enzo II” which found “the inventors were claiming only indirect detection” (“the asserted claims do not include direct detection in part because they excluded direct detection…direct detection cannot be an equivalent of indirect detection” in the ‘767 claims). Thus, the DC decision was affirmed.

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