Teva Pharmaceuticals Usa, Inc. v. Sandoz, Inc.

135 S.Ct. 831 (2015)

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Nature of the Case

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Facts

Teva (P) owns the relevant patent for a manufacturing method for Copaxone, a drug used to treat multiple sclerosis. The drug’s active ingredient, called “copolymer-1,” is made up of molecules of varying sizes. The relevant claim describes that ingredient as having “a molecular weight of 5 to 9 kilodaltons.” Sandoz (Ds) tried to market a generic version of Copaxone. P sued D for patent infringement. D argued that the patent was invalid under §112 ¶2. D argued that the term “molecular weight” might mean any one of three different things. The phrase might refer (1) to molecular weight as calculated by the weight of the molecule that is most prevalent in the mix that makes up copolymer-1. (The scientific term for molecular weight so calculated is, we are told, “peak average molecular weight.”) The phrase might refer (2) to molecular weight as calculated by taking all the different-sized molecules in the mix that makes up copolymer-1 and calculating the average weight, i.e., adding up the weight of each molecule and dividing by the number of molecules. (The scientific term for molecular weight so calculated is, we are told, “number average molecular weight.”) Or, the phrase might refer (3) to molecular weight as calculated by taking all the different-sized molecules in the mix that makes up copolymer-1 and calculating their average weight while giving heavier molecules a weight-related bonus when doing so. (The scientific term for molecular weight so calculated, we are told, is “weight average molecular weight.”). Since P does not say which method of calculation should be used, the claim’s phrase “molecular weight” is indefinite, and the claim fails §112 ¶2. The Court held that the claim was sufficiently definite in the context of a skilled artisan where the term “molecular weight” referred to molecular weight as calculated by the first method. The Federal Circuit reversed using de novo review of all aspects of the District Court’s claim construction, including the District Court’s determination of subsidiary facts. The Supreme Court granted certiorari.