Teva Pharm. United States, Inc. v. Sandoz, Inc.

135 S. Ct. 831, 190 L. Ed. 2d 719, 113 U.S.P.Q. 2d (BNA) 1269, 90 Fed. R. Serv. 3d 1244, 83 U.S.L.W. 4055, 2015 U.S. LEXIS 628
CourtSupreme Court of the United States
DecidedJanuary 20, 2015
DocketNo. 13–854.
StatusPublished
Cited by632 cases

This text of 135 S. Ct. 831 (Teva Pharm. United States, Inc. v. Sandoz, Inc.) is published on Counsel Stack Legal Research, covering Supreme Court of the United States primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

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Teva Pharm. United States, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 190 L. Ed. 2d 719, 113 U.S.P.Q. 2d (BNA) 1269, 90 Fed. R. Serv. 3d 1244, 83 U.S.L.W. 4055, 2015 U.S. LEXIS 628 (U.S. 2015).

Opinion

Justice BREYERdelivered the opinion of the Court.

In Markman v. Westview Instruments, Inc.,517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996), we explained that a patent claim is that "portion of the patent document that defines the scope of the patentee's rights." Id.,at 372, 116 S.Ct. 1384. We held that "the construction of a patent, including terms of art within its claim," is not for a jury but "exclusively" for "the court" to determine. Ibid. That is so even where the construction of a term of art has "evidentiary underpinnings." Id., at 390, 116 S.Ct. 1384.

Today's case involves claim construction with "evidentiary underpinnings." See Part III, infra. And, it requires us to determine what standard the Court of Appeals should use when it reviews a trial judge's resolution of an underlying factual dispute. Should the Court of Appeals review the district court's factfinding de novo as it would review a question of law? Or, should it review that factfinding as it would review a trial judge's factfinding in other cases, namely by taking them as correct "unless clearly erroneous?" See Fed. Rule Civ. Proc. 52(a)(6). We hold that the appellate court must apply a "clear error," not a de novo, standard of review.

I

The basic dispute in this case concerns the meaning of the words "molecular weight" as those words appear in a patent claim. The petitioners, Teva Pharmaceuticals (along with related firms), own the relevant patent. The patent covers 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. App. 1143a. And the relevant claim describes that ingredient as having "a molecular weight of 5 to 9 kilodaltons." Id., at 1145a.

The respondents, Sandoz, Inc. (and several other firms), tried to market a generic version of Copaxone. Teva sued Sandoz for patent infringement. 810 F.Supp.2d 578, 581 (S.D.N.Y.2011). Sandoz defended the suit by arguing that the patent was invalid. Ibid. The Patent Act requires that a claim "particularly poin[t] out and distinctly clai[m] the subject matter which the applicant regards as his invention." 35 U.S.C. § 112¶ 2 (2006 ed.); see *836Nautilus, Inc. v. Biosig Instruments, Inc.,572 U.S. ----, ----, n. 1, 134 S.Ct. 2120, 2125, n. 1, 189 L.Ed.2d 37 (2014). The phrase "molecular weight of 5 to 9 kilodaltons," said Sandoz, did not satisfy this requirement.

The reason that the phrase is fatally indefinite, Sandoz argued, is that, in the context of this patent claim, 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.") See 723 F.3d 1363, 1367 (C.A.Fed.2013); App. 124a. In Sandoz's view, since Teva's patent claim does not say which method of calculation should be used, the claim's phrase "molecular weight" is indefinite, and the claim fails to satisfy the critical patent law requirement.

The District Court, after taking evidence from experts, concluded that the patent claim was sufficiently definite. Among other things, 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, i.e., "peak average molecular weight." 810 F.Supp.2d, at 596; see Nautilus, supra,at ----, 134 S.Ct., at 2130("[T]he definiteness inquiry trains on the understanding of a skilled artisan at the time of the patent application"). In part for this reason, the District Court held the patent valid. 810 F.Supp.2d, at 596.

On appeal, the Federal Circuit held to the contrary. It found that the term "molecular weight" was indefinite. And it consequently held the patent invalid. 723 F.3d, at 1369. In reaching this conclusion, the Federal Circuit reviewed de novo all aspects of the District Court's claim construction, including the District Court's determination of subsidiary facts. Id.,at 1369, 1373; see also Lighting Ballast Control LLC v. Philips Electronics North Am. Corp.,

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135 S. Ct. 831, 190 L. Ed. 2d 719, 113 U.S.P.Q. 2d (BNA) 1269, 90 Fed. R. Serv. 3d 1244, 83 U.S.L.W. 4055, 2015 U.S. LEXIS 628, Counsel Stack Legal Research, https://law.counselstack.com/opinion/teva-pharm-united-states-inc-v-sandoz-inc-scotus-2015.