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On remand from the Supreme Court, following the Court’s decision that the Federal Circuit should give deference to a district court’s factual findings, but not to legal issues, and following the Court’s decision in Nautilus, Inc. v. Biosig Instruments, Inc. in which the Court modified the indefiniteness standard to be whether the claim, read in light of the specification and the prosecution history, fails to inform, with reasonable certainty, those skilled in the art about the scope of the invention. 

Here, the claims recite a method for manufacturing copolymer-1, wherein the product has “a molecular weight of about 5 to 9 kilodaltons.”  It is undisputed that there are three different measures of molecular weight, each being calculated in a different manner, and that the claim does not specify which measure of molecular weight is to be used.  The district court rejected Sandoz’s argument that the term “molecular weight” was indefinite, finding credible Teva’s expert’s testimony that persons of ordinary skill in the art would have understood the specification to disclose the peak average molecular weight as this is the only type of molecular weight that could be obtained from the method described in Example 1 of the patent.  On appeal, the Federal Circuit reversed, and the Supreme Court remanded to the Federal Circuit with instructions to review the district court’s factual findings for clear error. 

On remand, the Federal Circuit again held that the term “molecular weight” was indefinite, using the indefiniteness standard recited by the Court in Nautilus.  The court held that the district court’s determination of how a person skilled in the art could understand the way in which certain data reflects molecular weight is a question of fact, but such evidence does not suggest that there is a presumption regarding the meaning of the claim term in the art in general or in the context of the patent.  But, the meaning of “molecular weight” in the context of the patents-in-suit is not a question of fact:

A party cannot transform into a factual matter the internal coherence and context assessment of the patent simply by having an expert offer an opinion on it. The internal coherence and context assessment of the patent, and whether it conveys claim meaning with reasonable certainty, are questions of law. The meaning one of skill in the art would attribute to the term molecular weight in light of its use in the claims, the disclosure in the specification, and the discussion of this term in the prosecution history is a question of law. . . . 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. . . . Determining the significance of disclosures in the specification or prosecution history is also part of the legal analysis. Understandings that lie outside the patent documents about the meaning of terms to one of skill in the art or the science or state of the knowledge of one of skill in the art are factual issues.

Thus, the court held that the claim is invalid for indefiniteness by clear and convincing evidence “because read in light of the specification and the prosecution history, the patentee has failed to inform with reasonable certainty those skilled in the art about the scope of the invention.” 

In his dissent, Judge Mayer argues that the district court was wrong to disregard or discount the factual findings made by the district court regarding the understanding of persons of ordinary skill in the art regarding the example in the patent and the prosecution history, which demonstrate that the term would have been understood by persons of ordinary skill in the art.  

Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., Case Nos. 2012-1567, -1568, -1569, -1570 (June 18, 2015); Opinion by: Moore, joined by Wallach, dissenting opinion by Mayer; Appealed From: District Court for the Southern District of New York, Jones, J.  Read the full opinion here.

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