Teva v. Sandoz Revisited

June 25, 2015
Post by Blog Staff

Teva v. Sandoz Revisited

On June 18, 2015, a Federal Circuit panel reaffirmed that the key claim of the patent at issue inTeva v. Sandoz, was invalid as indefinite. The procedural posture and technical background leading up to this decision is discussed in aprior blog post.  The Federal Circuit ultimately concluded that they are still allowed to address if the question of law regarding indefiniteness is properly determined although deference must be given to a district court's fact finding.

The Supreme Court had held that the "ultimate construction of a claim term is a question of law, subject to de novo review, and the underlying subsidiary fact findings are subject to clear error review."During the time in which the Court was deliberating Teva, they also issued a decision in Nautilus, Inc. v. Biosig Instruments, Inc. (Nautilus II), which addressed the standard for indefiniteness. On remand, the Federal Circuit reconsidered the claims in light of these Supreme Court decisions.

The question of law was whether or not a person of ordinary skill in the art would understand "molecular weight"to be "peak average molecular weight.‚¬ The district court concluded this term was definite in light of the prosecution history and Teva's expert's opinion. Though the Federal Circuit concluded that the district court's reliance on expert opinions was not clearly erroneous, they also concluded that "Teva cannot transform legal analysis about the meaning or significance into a factual question simply by having an expert testify on it."Even considering this testimony with deference, the Federal Circuit concluded that the facts did not resolve the ambiguity in claim and turned to the prosecution history. In light of this, the Federal Circuit that the findings there did not rise to the level required by Nautilus as each molecular weight can be represented in the same units as required by average peak molecular weight. Therefore, the Federal Circuit concluded that the claim in question was in valid.  

The full opinion can be found here

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