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SUPREME COURT OF THE UNITED STATES
_________________
No. 13–854
_________________
TEVA PHARMACEUTICALS USA, INC., et al., PETITIONERS
v. SANDOZ, INC., et al.
on writ of certiorari to the united states court of appeals for
the federal circuit
[January 20, 2015]
Justice Breyer delivered the opinion of the
Court.
In
Markman v.
Westview Instruments, Inc.,517
U. S. 370 (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. 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.
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 (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
Nautilus, Inc. v.
Biosig Instruments,
Inc., 572 U. S. ___, ___, n. 1 (2014) (slip op., at 3, n.
1)). 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 (CA 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 ___ (slip op., at 12) (“[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
Light-ing Ballast Control
LLC v.
Philips Electronics NorthAm. Corp., 744 F. 3d
1272, 1276–1277 (CA 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 (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 (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
(quoting
Zenith Radio Corp. v.
Hazeltine Research,
Inc.,395 U. S. 100,123 (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 author-ity.” 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 (
de novo review of fac-tual
findings “would very likely contribute only negligibly” to accuracy
“at a huge cost in diversion of judicialresources”).
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. We pointed out that history
provides no clear answer.
Id., at 388. The task primarily
involves the construction of written instruments.
Id., at
386, 388, 389. And that task is better matched to a judge’s skills.
Id., at 388 (“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.
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. 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 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; see also
Motion Picture Patents Co. v.
Universal Film Mfg. Co.,243 U. S. 502,510 (1917)
(patent claims are “aptly likened to the description in a deed,
which sets the bounds to the grant which it contains”);
Goodyear
Dental Vulcanite Co. v.
Davis,102 U. S. 222,227
(1880) (analogizing patent construction to the construction of
other written instruments like contracts). Construction of written
instruments 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 (1922). But sometimes, say when a
written instrument uses “technical words or phrases not commonly
understood,”
id., at 292, those words may give rise to a
factual dispute. If so, extrinsic evidence may help to “establish a
usage of trade or locality.”
Ibid. And in that circumstance,
the “determination of the matter of fact” will “preced[e]” the
“function of construction.”
Ibid.; see also 12 R. Lord,
Williston on Contracts §§34:1, p. 2, 34:19, p. 174 (4th ed.
2012) (In contract interpretation, the existence of a “usage”—a
“practice or method” in the relevant industry—“is a question of
fact” (internal quotation marks omitted)). This factual
determination, like all other factual determinations, must be
reviewed for clear error. See
Pullman-Standard,
supra
at 287 (The Rule does not “exclude certain categories of factual
findings” and applies to both “subsidiary” and “ultimate” facts
(internal quotation marks omitted)).
Accordingly, when we held in
Markman that the ultimate
question of claim construction is for the judge and not the jury,
we did not create an exception from the ordinary rule governing
appellate review of factual matters.
Markman no more creates
an exception to Rule 52(a) than would a holding that judges, not
juries, determine equit-able claims, such as requests for
injunctions. A conclusion that an issue is for the judge does not
indicate that Rule 52(a) is inapplicable. See Fed. Rule Civ. Proc.
52 (setting the standard of review for “[Factual] Findings and
Conclusions by the
Court” (emphasis added)).
While we held in
Markman that the ultimate issue of the
proper construction of a claim should be treated as a question of
law, we also recognized that in patent construction, subsidiary
factfinding is sometimes necessary. Indeed, we referred to claim
construction as a practice with “evidentiary underpinnings,” a
practice that “falls somewhere between a pristine legal standard
and a simple historical fact.” 517 U. S., at 378, 388, 390. We
added that sometimes courts may have to make “credibility
judgments” about witnesses.
Id., at 389. In other words, we
recognized that courts may have to resolve subsidiary factual
disputes. And, as explained above, the Rule requires appellate
courts to review all such subsidiary factual findings under the
“clearly erroneous” standard.
Precedent further supports application of the “clearly
erroneous” standard. Before the creation of the Federal Circuit,
the Second Circuit explained that in claim construction, the
subsidiary “question . . . of how the art un-derstood the
term . . . was plainly a question of fact; and unless the
[district court’s] finding was ‘clearly erroneous,’ we are to take”
it “as controlling.”
Harries v.
Air King Products,
Co., 183 F. 2d 158, 164 (CA2 1950) (L. Hand, C. J.). We
have said the same as to subsidiary factual findings concerning
other patent law inquiries, including “obviousness.”
Dennison
Mfg. Co. v.
Panduit Corp.,475 U. S. 809,811 (1986)
(
per curiam) (“subsidiary determinations of the District
Court” subject to Rule 52(a)’s clear error standard).
Finally, practical considerations favor clear error review. We
have previously pointed out that clear error review is
“particularly” important where patent law is at issue because
patent law is “a field where so much depends upon familiarity with
specific scientific problems and principles not usually contained
in the general storehouse of knowledge and experience.”
Graver
Tank & Mfg. Co. v.
Linde Air Products Co.,339
U. S. 605,610 (1950). A district court judge who has presided
over, and listened to, the entirety of a proceeding has a
comparatively greater opportunity to gain that familiarity than an
appeals court judge who must read a written transcript or perhaps
just those portions to which the parties have referred. Cf.
Lighting Ballast, 744 F. 3d, at 1311 (O’Malley, J.,
dissenting) (Federal Circuit judges “lack the tools that district
courts have available to resolve factual disputes fairly and
accurately,” such as questioning the experts, examining the
invention in operation, or appointing a court-appointed expert);
Anderson, 470 U. S., at 574 (“The trial judge’s major
role is the determination of fact, and with experience in
fulfilling that role comes expertise”).
B
Sandoz argues that claim construction mostly consists of
construing a set of written documents that do not give rise to
subsidiary factual disputes. Tr. of Oral Arg. 39. It adds that
separating “factual” from “legal” questions is often difficult. And
Sandoz, like the Federal Circuit itself, argues that it is simpler
for that appellate court to review the entirety of the district
court’s claim construction
de novo rather than to apply two
separate standards.
Id., at 38; see also
Lighting
Ballast, supra, at 1284 (criticizing clear error review in part
because of the purportedly difficult task of “disentangling” fact
from law).
But even were we free to ignore the Federal Rule (which we are
not), we would not find this argument convincing. Courts of appeals
have long found it possible to separate factual from legal matters.
See,
e.g., First Options of Chicago, Inc. v.
Kaplan,514 U. S. 938–948 (1995) (review of factual
findings for clear error and legal conclusions
de novo
is the “ordinary” standard for courts of appeals). At the same
time, the Federal Circuit’s efforts to treat factual findings and
legal conclusions similarly have brought with them their own
complexities. See
e.g., Cybor Corp. v.
FAS
Technologies, Inc., 138 F. 3d 1448, 1454 (CA Fed. 1998) (en
banc) (claim construction does not involve “factual evidentiary
findings” (citation and internal quotation marks omitted));
Lighting Ballast,
supra, at 1284 (claim construction
has “arguably factual aspects”);
Dow Jones & Co. v.
Ablaise Ltd., 606 F. 3d 1338, 1344–1345 (CA Fed. 2010)
(“[T]his court,” while reviewing claim construction without
deference, “takes into account the views of the trial judge”);
Nazomi Communications Inc., v.
Arm Holdings, PLC, 403
F. 3d 1364, 1371 (CA Fed. 2005) (“[C]ommon sense dictates that the
trial judge’s view will carry weight” (citation and internal
quotation marks omitted));
Lightning Ballast, supra, at 1294
(Lourie, J., concurring) (we should “rarely” overturn district
court’s true subsidiary factfinding; “we should, and do, give
proper informal deference to the work of judges of a subordinate
tribunal”);
Cybor,
supra, at 1480 (opinion of Newman,
J.) (“By continuing the fiction that there are no facts to be found
in claim interpretations, we confound rather than ease the
litigation process”); see also
Anderson,
supra, at
575 (the parties “have already been forced to concentrate their
energies and resources on persuading the trial judge that their
account of the facts is the correct one; requiring them to persuade
three more judges at the appellate level is requiring too much”);
Brief for Peter S. Menell et al. as
Amici Curiae 5 (Federal
Circuit overturns district court claim construction at unusually
high rate).
Finally, the Circuit feared that “clear error” review would
bring about less uniformity.
Lighting Ballast,
supra,
at 1280. Neither the Circuit nor Sandoz, however, has shown that
(or explained why) divergent claim construction stemming from
divergent findings of fact (on subsidiary matters) should occur
more than occasionally. After all, the Federal Circuit will
continue to review
de novo the district court’s ultimate
interpretation of the patent claims. And the attorneys will no
doubt bring cases construing the same claim to the attention of the
trial judge; those prior cases will sometimes be binding because of
issue preclusion, see
Markman, 517 U. S., at 391, and
sometimes will serve as persuasive authority. Moreover, it is
always possible to consolidate for discovery different cases that
involve construction of the same claims. And, as we said in
Markman, subsidiary factfinding is unlikely to loom large in
the universe of litigated claim construction.
Id., at
389–390.
C
The dissent argues that claim construction does not involve any
“factfinding,” or, if it does, claim construction factfinding is
akin to the factfinding that underlies our interpretation of
statutes.
Post, at 1, 5–7 (opinion of Thomas, J.). Its
first, broader contention runs contrary to our recognition in
Markman that claim construction has “evidentiary
underpinnings” and that courts construing patent claims must
sometimes make “credibility judgments” about witnesses. 517
U. S., at 389–390. Indeed, as discussed in Part III,
infra, this case provides a perfect example of the
factfinding that sometimes underlies claim construction: The
parties here presented the District Court with competing
fact-related claims by different experts, and the District Court
resolved the issues of fact that divided those experts.
The dissent’s contention also runs contrary to Sandoz’s
concession at oral argument that claim construction will sometimes
require subsidiary factfinding. Tr. of Oral Arg. 33–34, 38–40. It
is in tension with our interpretation of related areas of patent
law, such as the interpretation of “obviousness,” which we have
said involves subsidiary factfinding subject to Rule 52(a)’s clear
error review. See
Dennison, 475 U. S., at 811. And it fights
the question presented in this case, which
assumes the
existence of such factfinding. See Pet. for Cert. i (whether “a
district court’s factual finding in support of its construction of
a patent claim term may be reviewed
de novo, . . . or
only for clear error”).
Neither do we find factfinding in this context sufficiently
similar to the factfinding that underlies statutory interpretation.
Statutes, in general, address themselves to the general public;
patent claims concern a small portion of that public. Statutes
typically (though not always) rest upon congressional consideration
of general facts related to a reasonably broad set of social
circumstances; patents typically (though not always) rest upon
consideration by a few private parties, experts, and administrators
of more narrowly circumscribed facts related to specific technical
matters. The public, and often an adversarial public, typically
considers and discusses the relevant general facts before Congress
enacts a statute; only private parties, experts, and administrators
likely consider the relevant technical facts before the award of a
patent. Given these differences, it is not surprising that this
Court has never previously compared patent claim construction in
any here relevant way to statutory construction. As discussed
supra, at 5, however, the Court has repeatedly compared
patent claim construction to the construction of other written
instruments such as deeds and contracts. See,
e.g., Markman,
supra, at 384, 386, 388, 389;
Motion Picture Patent
Co., 243 U. S., at 510;
Goodyear, 102 U. S.,
at 227.
D
Now that we have set forth
why the Federal Circuit must
apply clear error review when reviewing subsidiary factfinding in
patent claim construction, it is necessary to explain
how
the rule must be applied in that context. We recognize that a
district court’s construction of a patent claim, like a district
court’s interpretation of a written instrument, often requires the
judge only to examine and to construe the document’s words without
requiring the judge to resolve any underlying factual disputes. As
all parties agree, when the district court reviews only evidence
intrinsic to the patent (the patent claims and specifications,
along with the patent’s prosecution history), the judge’s
determination will amount solely to a determination of law, and the
Court of Appeals will review that construction
de novo. See
Brief for Petitioners 27, Re-ply Brief 16; Brief for Respondents
43; see also Brief for United States as
Amicus Curiae
12–13.
In some cases, however, the district court will need to look
beyond the patent’s intrinsic evidence and 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 period. See,
e.g., Seymour v.
Osborne,
11 Wall. 516, 546 (1871) (a patent may be “so interspersed with
technical terms and terms of art that the testimony of scientific
witnesses is indispensable to a correct understanding of its
meaning”). In cases where those subsidiary facts are in dispute,
courts will need to make subsidiary factual findings about that
extrinsic evidence. These are the “evidentiary underpinnings” of
claim construction that we discussed in
Markman, and this
subsidiary factfinding must be reviewed for clear error on
appeal.
For example, if a district court resolves a dispute between
experts and makes a factual finding that, in general, a certain
term of art had a particular meaning to a person of ordinary skill
in the art at the time of the invention, the district court must
then conduct a legal analysis: whether a skilled artisan would
ascribe that same meaning to that term
in the context of the
specific patent claim under review. That is because “[e]xperts
may be examined to explain terms of art, and the state of the art,
at any given time,” but they cannot be used to prove “the proper or
legal construction of any instrument of writing.”
Winans v.
New York & Erie R. Co., 21 How. 88, 100–101 (1859); see
also
Markman,
supra, at 388 (“ ‘Where technical
terms are used, or where the qualities of substances
. . . or any similar data necessary to the comprehension
of the language of the patent are unknown to the judge, the
testimony of witnesses may be received upon these subjects, and any
other means of information be employed.
But in the actual
interpretation of the patent the court proceeds upon its own
responsibility, as an arbiter of the law, giving to the patent its
true and final character and force’ ” (quoting 2 W.
Robinson, Law of Patents §732, pp. 482–483 (1890); emphasis in
original)).
Accordingly, the question we have answered here concerns review
of the district court’s resolution of a subsidiary factual dispute
that helps that court determine the proper interpretation of the
written patent claim. The district judge, after deciding the
factual dispute, will then interpret the patent claim in light of
the facts as he has found them. This ultimate interpretation is a
legal conclusion. The appellate court can still review the district
court’s ultimate construction of the claim
de novo. But, to
overturn the judge’s resolution of an underlying factual dispute,
the Court of Appeals must find that the judge, in respect to those
factual findings, has made a clear error. Fed. Rule Civ. Proc.
52(a)(6).
In some instances, a factual finding will play only a small role
in a judge’s ultimate legal conclusion about the meaning of the
patent term. But in some instances, a factual finding may be close
to dispositive of the ultimate legal question of the proper meaning
of the term in the context of the patent. Nonetheless, the ultimate
question of construction will remain a legal question. Simply
because a factual finding may be nearly dispositive does not render
the subsidiary question a legal one. “[A]n issue does not lose its
factual character merely because its resolution is dispositive of
the ultimate” legal question.
Miller v.
Fenton,474
U. S. 104,113 (1985). It is analogous to a judge (sitting
without a jury) deciding whether a defendant gave a confession
voluntarily. The answer to the legal question about the
voluntariness of the confes-sion may turn upon the answer to a
subsidiary factual question, say “whether in fact the police
engaged in the intimidation tactics alleged by the defendant.”
Id., at 112. An appellate court will review the trial
judge’s factual determination about the alleged intimidation
deferentially (though, after reviewing the factual findings, it
will review a judge’s ultimate determination of voluntariness
de
novo). See
id., at 112–118. An appellate court similarly
should review for clear error those factual findings that underlie
a district court’s claim construction.
III
We can illustrate our holding by considering an instance in
which Teva
, with the support of the Solicitor General,
argues that the Federal Circuit wrongly reviewed the District
Court’s factual finding
de novo. See Brief for Petitioners
54–56; Brief for United States as
Amicus Curiae 31–32.
Recall that Teva’s patent claim specifies an active ingredient with
a “molecular weight of about 5 to 9 kilodaltons.” Recall Sandoz’s
basic argument, namely that the term “molecular weight” is
indefinite or ambiguous. The term might refer to the weight of the
most numerous molecule, it might refer to weight as calculated by
the average weight of all molecules, or it might refer to weight as
calculated by an average in which heavier molecules count for more.
The claim, Sandoz argues, does not tell us which way we should
calculate weight. See Part I,
supra.
To illustrate, imagine we have a sample of copolymer-1 (the
active ingredient) made up of 10 molecules: 4 weigh 6 kilodaltons
each, 3 weigh 8 kilodaltons each, and 3 weigh 9 kilodaltons each.
Using the first method of calculation, the “molecular weight” would
be 6 kilodaltons, the weight of the most prevalent molecule. Using
the second method, the molecular weight would be 7.5 (total weight,
75, di-vided by the number of molecules, 10). Using the third
method, the molecular weight would be more than 8, depend-ing upon
how much extra weight we gave to the heavier molecules.
Teva argued in the District Court that the term “molecular
weight” in the patent meant molecular weight calculated in the
first way (the weight of the most prevalent molecule, or peak
average molecular weight). Sandoz, however, argued that figure 1 of
the patent showed that Teva could not be right. 810 F. Supp.
2d, at 590. (We have set forth figure 1 in the Appendix,
infra). That figure, said Sandoz, helped to show that the
patent term did
not refer to the first method of
calculation. Figure 1 shows how the weights of a sample’s molecules
were distributed in three different samples. The curves indicate
the number of molecules of each weight that were present in each of
the three. For example, the figure’s legend says that the first
sample’s “molecular weight” is 7.7. According to Teva, that should
mean that molecules weighing 7.7 kilodaltons were the most
prevalent molecules in the sample. But, look at the curve, said
Sandoz. It shows that the most prevalent molecule weighed, not 7.7
kilodaltons, but slightly less than 7.7 (about 6.8) kilodaltons.
See App. 138a–139a. After all, the
peak of the first
molecular weight distribution curve (the solid curve in the figure)
is not at precisely 7.7 kilodaltons, but at a point just before
7.7. Thus, argued Sandoz, the figure shows that the patent claim
term “molecular weight” did not mean molecular weight calculated by
the first method. It must mean something else. It is indefinite.
810 F. Supp. 2d, at 590.
The District Court did not accept Sandoz’s argument. Teva’s
expert testified that a skilled artisan would understand that
converting data from a chromatogram to molecular weight
distribution curves like those in figure 1 would cause the peak on
each curve to shift slightly; this could explain the difference
between the value indicated by the peak of the curve (about 6.8)
and the value in the figure’s legend (7.7). App. 138a–139a.
Sandoz’s expert testified that no such shift would occur. App.
375a–376a. The District Court credited Teva’s expert’s account,
thereby rejecting Sandoz’s expert’s explanation. 810 F. Supp.
2d, at 589; Brief for Respondents 61. The District Court’s finding
about this matter was a factual finding—about how a skilled artisan
would understand the way in which a curve created from chromatogram
data reflects molecular weights. Based on that factual finding, the
District Court reached the legal conclusion that figure 1 did not
undermine Teva’s argument that molecular weight referred to the
first method of calculation (peak average molecular weight). 810
F. Supp. 2d, at 590–591.
When the Federal Circuit reviewed the District Court’s decision,
it recognized that the peak of the curve did not match the 7.7
kilodaltons listed in the legend of figure 1. 723 F. 3d, at
1369. But the Federal Circuit did not accept Teva’s expert’s
explanation as to how a skilled artisan would expect the peaks of
the curves to shift. And it failed to accept that explanation
without finding that the District Court’s contrary determination
was “clearly erroneous.” See
ibid. The Federal Circuit
should have accepted the District Court’s finding unless it was
“clearly erroneous.” Our holding today makes clear that, in failing
to do so, the Federal Circuit was wrong.
Teva claims that there are two additional instances in which the
Federal Circuit rejected the District Court’s factual findings
without concluding that they were clearly erroneous. We leave these
matters for the Federal Circuit to consider on remand in light of
today’s opinion.
We vacate the Federal Circuit’s judgment, and we remand the case
for further proceedings consistent with this opinion.
It is so ordered.
APPENDIX
FIG. 1 (with minor additions to emphasize that the peak of the
solid curve does not correspond precisely to 7.7kDa)
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