Teva Pharm. USA, Inc. v. Sandoz, Inc.

• Citation: 135 S.Ct. 831,574 U.S. 318,190 L.Ed.2d 719
• Decision Date: 20 January 2015
• Docket Number: No. 13–854.,13–854.
• Parties: TEVA PHARMACEUTICALS USA, INC., et al., Petitioners v. SANDOZ, INC., et al.
• Court: United States Supreme Court

574 U.S. 318

135 S.Ct. 831

190 L.Ed.2d 719

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

v.SANDOZ, INC., et al.

No. 13–854.

Supreme Court of the United States

Argued Oct. 15, 2014.

Decided Jan. 20, 2015.

William M. Jay, Washington, DC, for Petitioners.

Carter G. Phillips, Washington, DC, for Respondents.

Ginger D. Anders, for the United States as amicus curiae, by special leave of the Court.

Jay P. Lefkowitz, P.C., John C. O'Quinn, Jason M. Wilcox, Kirkland & Ellis LLP, Washington, DC, William M. Jay, Counsel of Record, William G. James, II, Goodwin Procter LLP, Washington, DC, David M. Hashmall, Elizabeth J. Holland, Steven J. Bernstein, Goodwin Procter LLP, New York, NY, Alan M. Dershowitz, Cambridge, MA, Daryl L. Wiesen, Henry C. Dinger, John C. Englander, Nicholas K. Mitrokostas, Todd Marabella, Jaime A. Santos, Goodwin Procter LLP, Boston, MA, for Petitioners.

Carter G. Phillips, Counsel of Record, Ryan C. Morris, Adam Hallowell, Sidley Austin LLP, Washington, DC, Deanne E. Maynard, Brian R. Matsui, Marc A. Hearron, Morrison & Foerster LLP, Washington, DC, Steven J. Horowitz, Sidley Austin LLP, Chicago, IL, Eric D. Miller, Shannon M. Bloodworth, David L. Anstaett, Brandon White, Perkins Coie LLP, Washington, DC, Evan R. Chesler, Richard J. Stark, Cravath, Swaine & Moore LLP, New York, NY, David C. Doyle, Anders T. Aannestad, Brian M. Kramer, Elizabeth Cary Miller, James J. Cekola, Morrison & Foerster LLP, San Diego, CA, for Respondents.

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. 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 Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 900-903, 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 911, 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., 744 F.3d 1272, 1276–1277 (C.A.Fed.2014) (en banc) (reaffirming de novo review of district court claim construction).

Teva filed a petition for certiorari. And we granted that petition. The Federal Circuit reviews the claim construction decisions of federal district courts throughout the Nation, and we consequently believe it important to clarify the standard of review that it must apply when doing so.

II

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." In our view, this rule and the standard it sets forth must apply when a court of appeals reviews a district court's resolution of subsidiary factual matters made in the course of its construction of a patent claim. We have made clear that the Rule sets forth a "clear command." Anderson v. Bessemer City, 470 U.S. 564, 574, 105 S.Ct. 1504, 84 L.Ed.2d 518 (1985).

"It does not make exceptions or purport to exclude certain categories of factual findings from the obligation of a court of appeals to accept a district court's findings unless clearly erroneous." Pullman–Standard v. Swint, 456 U.S. 273, 287, 102 S.Ct. 1781, 72 L.Ed.2d 66 (1982). Accordingly, the Rule applies to both subsidiary and ultimate facts. Ibid. And we have said that, when reviewing the findings of a " ‘district court sitting without a jury, appellate courts must constantly have in mind that their function is not to decide factual issues de novo. ’ " Anderson, supra, at 573, 105 S.Ct. 1504 (quoting Zenith Radio Corp. v. Hazeltine Research, Inc., 395 U.S. 100, 123, 89 S.Ct. 1562, 23 L.Ed.2d 129 (1969) ).

Even if exceptions to the Rule were permissible, we cannot find any convincing ground for creating an exception to that Rule here. The Rules Advisory Committee pointed out that, in general, exceptions "would tend to undermine the legitimacy of the district courts ..., multiply appeals ..., and needlessly reallocate judicial authority." Advisory Committee's 1985 Note on subd. (a) of Fed. Rule Civ. Proc. 52, 28 U.S.C.App., pp. 908–909; see also Anderson, supra, at 574–575, 105 S.Ct. 1504 (de novo review of factual findings "would very likely contribute only negligibly" to accuracy "at a huge cost in diversion of judicial resources").

Our opinion in Markman neither created, nor argued for, an exception to Rule 52(a). The question presented in that case was a Seventh Amendment question: Should a jury or a judge construe patent claims? 517 U.S., at 372, 116 S.Ct. 1384. We pointed out that history provides no clear answer. Id., at 388, 116 S.Ct. 1384. The task primarily involves the construction of written instruments. Id., at 386, 388, 389, 116 S.Ct. 1384. And that task is better matched to a judge's skills. Id., at 388, 116 S.Ct. 1384 ("The construction of written instruments is one of those things that judges often do and are likely to do better than jurors unburdened by training in exegesis"). We consequently held that claim construction falls "exclusively within the province of the court," not that of the jury. Id., at 372, 116 S.Ct. 1384.

When describing claim construction we concluded that it was proper to treat the ultimate question of the proper construction of the patent as a question of law in the way that we treat document construction as a question of law. Id., at 388–391, 116 S.Ct. 1384. But this does not imply an exception to Rule 52(a) for underlying factual disputes. We used the term "question of law" while pointing out that a judge, in construing a...