SUPREME COURT OF THE UNITED STATES Syllabus TEVA PHARMACEUTICALS USA, INC., ET AL. v. SANDOZ, INC., ET AL.

CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT No. 13–854.

Argued October 15, 2014—Decided January 20, 2015

Petitioners, Teva Pharmaceuticals (and related firms), own a patent that covers a manufacturing method for the multiple sclerosis drug Copaxone.

When respondents, Sandoz, Inc. (and other firms), tried to market a generic version of the drug, Teva sued them for patent infringement. Sandoz countered that the patent was invalid. 

Specifically, Sandoz argued that the claim that Copaxone’s active ingredient had “a molecular weight of 5 to 9 kilodaltons” was fatally indefinite, see 35 U. S. C. §112 ¶2, because it did not state which of three methods of calculation—the weight of the most prevalent molecule, the weight as calculated by the average weight of all molecules, or weight as calculated by an average in which heavier molecules count for more—was used to determine that weight.

 

After considering conflicting expert evidence, the District Court concluded that the patent claim was sufficiently definite and the patent was thus valid. As relevant here, it found that in context a skilled artisan would understand that the term “molecular weight” referred to molecular weight as calculated by the first method.

In finding the “molecular weight” term indefinite and the patent invalid on appeal, the Federal Circuit reviewed de novo all aspects of the District Court’s claim construction, including the District Court’s determination of subsidiary facts.

 

Held

When reviewing a district court’s resolution of subsidiary factual matters made in the course of its construction of a patent claim, the Federal Circuit must apply a “clear error,” not a de novo, standard of review.

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US Supreme Court: TEVA et al., v. Sandoz for Copaxone
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