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

Summarized by:

  • Court: United States Supreme Court
  • Area(s) of Law: Patents
  • Date Filed: January 20, 2015
  • Case #: 13-854
  • Judge(s)/Court Below: Breyer, J., delivered the opinion of the Court, in which Roberts, C. J., and Scalia, Kennedy, Ginsburg, Sotomayor, and Kagan, JJ., joined. Thomas, J., filed a dissenting opinion, in which Alito, J., joined.
  • Full Text Opinion

When reviewing a district court’s analysis of factual matters made in advocation of a patent claim, a court must apply a “clear error” instead of a de novo standard.

Petitioner owned a patent on a manufacturing method for Copaxone, a drug that combats the effects of multiple sclerosis. When Respondent tried to market a generic version of the drug, Petitioner sued for patent infringement. Respondent claimed that the patent was invalid because the drug’s active ingredient was “fatally indefinite” because it did not state which method of calculation was used to determine the weight. After considering contrasting expert evidence, the District Court held that the patent claim was sufficiently definite and was therefore valid.

Federal Rules of Civil Procedure 52(a) provides that for appellate cases, in matters tried to a district court, the court’s “[f]inding of fact . . . must not be set aside unless clearly erroneous.” However, in this case, the Federal Circuit reviewed all aspects of the District Court’s finding using a de novo standard (instead of the clear error standard) and found that the patent was invalid.

On appeal, the question presented to the Court was whether the correct standard of review was used. Specifically, the question was whether a district court’s factual findings in support of its analysis of a patent claim could be reviewed de novo or only for clear error, as required by the Federal Rule of Civil Procedure 52(a).

The Supreme Court held that when reviewing a district court’s analysis of factual matters made in advocation of a patent claim, the Federal Circuit must apply a “clear error” instead of a de novo standard. The Federal Circuit’s decision was therefore vacated and remanded.

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