Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., et al.

Whether the Federal Circuit erred in reviewing district court factual findings of construction of patent claims de novo and Rule 52(a) standard of review accepting findings of fact unless they are clearly erroneous applies to construction of patent claims.

Respondents sought FDA approval of generic versions of a pharmaceutical manufactured by Petitioner. In response, Petitioner claimed that Respondents had infringed on its patents. The district court heard arguments and received evidence and expert testimony construing the definiteness, obviousness, and enablement of the relevant patent claims; it then issued a finding of facts that Respondents had infringed on Petitioner’s claims. Respondents appealed, and a panel of the Court of Appeals for the Federal Circuit reviewed the court’s findings de novo because it held that the construction of the patents claims for definiteness and enablement are not factual finding, but legal conclusions. The Court of Appeals disregarded the findings made by the district court to make its own factual findings construing the patent claims. The panel affirmed the district court’s finding of infringement for one group of claims, and reversed the court’s finding of non-infringement on the second group of claims.

Federal Rule of Civil Procedure 52(a) states that when district courts hear evidence directly that their findings of fact will be accepted upon review unless the findings are clearly erroneous. Since 1998, the Court of Appeals for the Federal Circuit has reviewed district court findings of fact construing patent claims de novo because such findings are of factual and legal issues, and are legal conclusions. The Supreme Court granted certiorari to determine whether the Federal Circuit has erred in reviewing construction of patent claims de novo rather than applying the clearly erroneous standard under Rule 52(a).