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In an ANDA case, the district court held that the two patents-at-issue were valid and infringed. On appeal, the court held that: (1) the district court correctly construed the term “buffering agent” by refusing to import a limitation from the specification; (2) the district court correctly determined that claims were infringed under the doctrine of equivalents where the claim, as construed, required that the active ingredient first be dissolved and then the solution be deoxygenated, but the accused process performed the steps in the opposite order, because the court agreed that the difference was insubstantial (based on expert testimony to that effect) and that, as a matter of law, this fact meant that the claim limitation was not “vitiated” [“’Vitation’ is not an exception or threshold determination that forecloses resort to the doctrine of equivalents, but is instead a legal conclusion of lack of equivalence based on the evidence presented and the theory of equivalence asserted.”]; (3) the district court correctly construed the phrase “optionally . . . topped . . . and placed” as requiring that both topping and placing be optional, because statements in the prosecution history were not a clear and unmistakable disavowal; and (4) the district court correctly held that Exela had not met its burden of proving claims obvious.

Cadence Pharmaceuticals Inc. v. Exela Pharmsci Inc., Case No. 2014-1184 (March 23, 2015); Opinion by: Linn, joined by Reyna and Wallach; Appealed From: District Court for the District of Delaware, Stark, J. Read the full opinion here.

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