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Teva Pharms. USA, Inc. v. Sandoz, Inc.

Supreme Court of the United States

October 15, 2014, Argued; January 20, 2015, Decided

No. 13-854


 [*321]   [**835]  [1272]   Justice Breyer delivered 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, 134 L. Ed. 2d 577. 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, 134 L. Ed. 2d 577.

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  [*322]  when it reviews a trial judge’s resolution of an underlying factual dispute. Should the Court of Appeals review  [***727]  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.

The basic dispute in this case concerns the meaning of the words [****8]  “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 (SDNY 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  [**836] Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 902-903, n. 1, 572 U.S. 898, 134 S. Ct. 2120, 189 L. Ed. 2d 37, 44 (2014). The phrase “molecular weight of 5 to 9 kilodaltons,” said Sandoz, did not satisfy this requirement.

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574 U.S. 318 *; 135 S. Ct. 831 **; 190 L. Ed. 2d 719 ***; 2015 U.S. LEXIS 628 ****; 113 U.S.P.Q.2D (BNA) 1269; 83 U.S.L.W. 4055; 90 Fed. R. Serv. 3d (Callaghan) 1244

TEVA PHARMACEUTICALS USA, INC., et al., Petitioners v. SANDOZ, INC., et al.

Notice: The Lexis pagination of this document is subject to change pending release of the final published version.

Subsequent History: Request denied by Teva Pharms. United States, Inc. v. Sandoz, Inc., 2015 U.S. Dist. LEXIS 17396 (S.D.N.Y., Feb. 10, 2015)

On remand at Teva Pharms. USA, Inc. v. Sandoz Inc., 2015 U.S. App. LEXIS 10618 (Fed. Cir., Feb. 20, 2015)

On remand at Teva Pharms. USA, Inc. v. Sandoz, Inc., 789 F.3d 1335, 2015 U.S. App. LEXIS 10229 (Fed. Cir., June 18, 2015)


Teva Pharms. USA, Inc. v. Sandoz, Inc., 723 F.3d 1363, 2013 U.S. App. LEXIS 15208 (Fed. Cir., 2013)

Disposition: 723 F.3d 1363, vacated and remanded.


patent, subsidiary, molecular weight, district court, factfinding, factual findings, molecules, determinations, fact finding, calculated, written instrument, evidentiary, construing, court of appeals, clear error, de novo, contracts, skilled, deeds, kilodaltons, invention, appellate court, factual dispute, artisan, parties, curve, words, clearly erroneous, question of law, peak

Civil Procedure, Trials, Jury Trials, Province of Court & Jury, Patent Law, Claims & Specifications, Claims, Infringement Actions, Claim Interpretation, General Overview, Jurisdiction & Review, Standards of Review, Clearly Erroneous Review, De Novo Review, Fact & Law Issues, Bench Trials, Specifications, Definiteness, Appeals, Constitutional Law, Bill of Rights, Fundamental Rights, Trial by Jury in Civil Actions, Contracts Law, Contract Interpretation, Parol Evidence, Custom & Usage, Questions of Fact & Law, Aids & Extrinsic Evidence, Evidence, Admissibility, Expert Witnesses, Ultimate Issue