Opinion following remand from SCOTUS: Teva Pharmaceuticals USA, Inc. et al. v. Sandoz Inc. et al.

Docket Nos. 2012-1567, -1568, -1569, -1570

June 18, 2015

Update: Prior FC decision (723 F.3d 1363 (Fed. Cir. 2013) vacated by SCOTUS (135 S.Ct. 831 (2015); FC remand opinion June 18, 2015

Brief summary: The term “molecular weight” was (again) found indefinite, this time in view of Teva (US 2015) and Nautilus II (SC 2014 (indefiniteness determined under “reasonable certainty” standard).

Summary: This appeal was reconsidered in light of SCOTUS’ Teva ((135 S.Ct. 831 (2015)(ultimate construction of a claim term is a question of law reviewed de novo, underlying fact findings review for clear error (but decisions based solely on intrinsic evidence reviewed de novo…experts may explain terms/state of art but “cannot be used to prove the legal construction of a writing”) and Nautilus II (134 S.Ct. 2120 (2014) (rejecting the FC’s “not amenable to construction or insolubly ambiguous” standard for indefiniteness in favor of “reasonable certainty” standard, the FC explaining in the remand opinion that it can “now steer by the bright star of ‘reasonable certainty’, rather than the unreliable compass of ‘insoluble ambiguity’”)) decisions. In the previous FC opinion, the term “molecular weight” in a claim directed to a method of manufacturing “copolymer-1” was determined to be indefinite as “which measure to use…Mp, Mn [or] Mw” was not specified (reversing the DC) and the claims found enabled and not obvious. This opinion is focused on indefiniteness. The SC concluded the DC finding “about how a skilled artisan would understand the way in which a curve created from chromatogram data reflects molecular weight” was a factual finding subject to review for clear error, and was not reviewed as such by the FC. The FC concluded after reviewing the patent record (claims, specification, prosecution history) that the unexpired claims at issue “do not convey with reasonable certainty the measure of molecular weight to be used” (“Claim 1…recites ‘molecular weight’ without specifying the meaning…The parties agree [it] could refer to Mp, Mw or Mn…[and each] would typically yield a different result for a given polymer sample…the claim on its face offers no guidance on which measure of ‘molecular weight’ the claims cover…There is no express definition of ‘molecular weight’ in the ‘808 specification. Nowhere in the specification are the terms Mp, Mw or Mn used.”) Teva argued “[t]he factual findings establish that to a skilled artisan, ‘average molecular weight’ has a presumed meaning in this context, which means the patent’s specification resolves any ambiguity”, “the presumed meaning is consistent with Figure 1”, and “the only statement causing ambiguity in the prosecution history was an error” (however, patentees have been held “to statements containing errors…where, for example, nothing in the statement was at odds with the plain language of the claims or the specification” (Springs Window, FC 2003)). The FC disagreed, concluding the DC did not find the term had a presumed meaning in the art (“Even Teva’s expert Dr. Grant repeatedly admitted that the term…has no default meaning to one of skill in the art.”) “[a]nd if there were such a finding, it would not have been supported by the record in this case.” “[T]he meaning…in the context of [the] patents-in-suit” was determined not to be a question of fact; whether “the specification’s disclosure…would infer” a meaning is “not a fact finding to be given deference” but “part of the legal analysis” (“Teva cannot transform legal analysis about the meaning or significance of the intrinsic evidence into a factual question simply by having an expert testify on it.”) The opinion explains that the prosecution histories of two continuation applications are relevant to the identical term in the parent ‘808 patent. And in one of those applications, the applicant responded to an indefiniteness rejection that Mw was implied by the use of kilodalton units and this decision, the majority explained, “is part of the legal analysis, not as the dissent claims, one of the fact findings to which we owe deference.” Thus, the DC’s decision of no indefinitness was again reversed. Judge Mayer’s dissent argued the DC decision was based on factual findings and the FC was “not free to disregard or discount them in assessing whether the ‘808 patent withstands scrutiny” (“We must be ‘mindful that we are a court of review, not of first view…” (Cutter, US 2005)).

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