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

135 S. Ct. 45, 189 L. Ed. 2d 895, 2014 U.S. LEXIS 4897
CourtSupreme Court of the United States
DecidedJanuary 20, 2015
Docket13-854
StatusPublished

This text of 135 S. Ct. 45 (Teva Pharmaceuticals USA, 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.

Bluebook
Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., 135 S. Ct. 45, 189 L. Ed. 2d 895, 2014 U.S. LEXIS 4897 (U.S. 2015).

Opinion

(Slip Opinion) OCTOBER TERM, 2014 1

Syllabus

NOTE: Where it is feasible, a syllabus (headnote) will be released, as is being done in connection with this case, at the time the opinion is issued. The syllabus constitutes no part of the opinion of the Court but has been prepared by the Reporter of Decisions for the convenience of the reader. See United States v. Detroit Timber & Lumber Co., 200 U. S. 321, 337.

SUPREME COURT OF THE UNITED STATES

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 in­ fringement. Sandoz countered that the patent was invalid. Specifi­ cally, 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 meth­ ods 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 conflict­ ing expert evidence, the District Court concluded that the patent claim was sufficiently definite and the patent was thus valid. As rel­ evant here, it found that in context a skilled artisan would under­ stand 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 construc­ tion, 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. Pp. 4–16. (a) Federal Rule of Civil Procedure 52(a)(6) states that a court of appeals “must not . . . set aside” a district court’s “[f]indings of fact” unless they are “clearly erroneous.” It sets out a “clear command,” 2 TEVA PHARMACEUTICALS USA, INC. v. SANDOZ, INC.

Anderson v. Bessemer City, 470 U. S. 564, 574, and “does not make exceptions or . . . exclude certain categories of factual findings” from the court of appeals’ obligation, Pullman-Standard v. Swint, 456 U. S. 273, 287. The Rule thus applies to both subsidiary and ulti­ mate facts. Ibid. And the function of an appeals court reviewing the findings of a “ ‘district court sitting without a jury . . . is not to decide factual issues de novo.’ ” Anderson, supra, at 573. Even if exceptions to the Rule were permissible, there is no convincing ground for creat­ ing an exception here. Markman v. Westview Instruments, Inc., 517 U. S. 370, neither created, nor argued for, such an exception. There, the Court held that the ultimate question of claim construction is for the judge, not the jury, id., at 372, but it did not thereby create an ex­ ception from the ordinary rule governing appellate review of factual matters. Instead, the Court pointed out that a judge, in construing a patent claim, is engaged in much the same task as the judge would be in construing other written instruments, such as deeds, contracts, or tariffs. Id., at 384, 386, 388, 389. Construction of written instru­ ments often presents a “question solely of law,” at least when the words in those instruments are “used in their ordinary meaning.” Great Northern R. Co. v. Merchants Elevator Co., 259 U. S. 285, 291. But if a written instrument uses “technical words or phrases not commonly understood,” id., at 292, those words may give rise to a fac­ tual dispute. If so, extrinsic evidence may help to “establish a usage of trade or locality.” Ibid. And in that circumstance, the “determina­ tion of the matter of fact” will “preced[e]” the “function of construc­ tion.” Ibid. The Markman Court also recognized that courts will sometimes have to resolve subsidiary factual disputes in patent construction; Rule 52 requires appellate courts to review such disputes under the “clearly erroneous” standard. Application of this standard is further supported by precedent and by practical considerations. Clear error review is “particularly” important in patent cases because a district court judge who has presided over, and listened to, the entire pro­ ceeding has a comparatively greater opportunity to gain the neces­ sary “familiarity with specific scientific problems and principles,” Graver Tank & Mfg. Co. v. Linde Air Products Co., 339 U. S. 605, 610, than an appeals court judge who must read a written transcript or perhaps just those portions referenced by the parties. Pp. 4–8. (b) Arguments to the contrary are unavailing. Sandoz claims that separating “factual” from “legal” questions may be difficult and, like the Federal Circuit, posits that it is simpler for the appellate court to review the entirety of the district court’s claim construction de novo than to apply two separate standards. But courts of appeals have long been able to separate factual from legal matters, see, e.g., First Cite as: 574 U. S. ____ (2015) 3

Options of Chicago, Inc. v. Kaplan, 514 U. S. 938, 947–948, and the Federal Circuit’s efforts to treat factual findings and legal conclu­ sions similarly have brought with them their own complexities. As for Sandoz’s argument that “clear error” review will bring about less uniformity, neither the Circuit nor Sandoz has shown that divergent claim construction stemming from divergent findings of fact on sub­ sidiary matters should occur more than occasionally. Pp. 8–11. (c) This leaves the question of how the clear error standard should be applied when reviewing subsidiary factfinding in patent claim construction. When the district court reviews only evidence intrinsic to the patent, the judge’s determination is solely a determination of law, and the court of appeals will review that construction de novo. However, where the district court needs to consult extrinsic evidence in order to understand, for example, the background science or the meaning of a term in the relevant art during the relevant time peri­ od, and where those subsidiary facts are in dispute, courts will need to make subsidiary factual findings about the extrinsic evidence. The district judge, after deciding the factual dispute, will then interpret the patent claim in light of the facts as he has found them. The ulti­ mate construction of the claim is a legal conclusion that the appellate court can review de novo. But to overturn the judge’s resolution of an underlying factual dispute, the appellate court must find that the judge, in respect to those factual findings, has made a clear error. Pp. 11–14. (d) Here, for example, the District Court made a factual finding, crediting Teva’s expert’s account, and thereby rejecting Sandoz’s ex­ pert’s contrary explanation, about how a skilled artisan would under­ stand the way in which a curve created from chromatogram data re­ flects molecular weights.

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Bluebook (online)
135 S. Ct. 45, 189 L. Ed. 2d 895, 2014 U.S. LEXIS 4897, Counsel Stack Legal Research, https://law.counselstack.com/opinion/teva-pharmaceuticals-usa-inc-v-sandoz-inc-scotus-2015.