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

United States Court of Appeals

for the Federal Circuit

______________________

TEVA PHARMACEUTICALS USA, INC.,

TEVA PHARMACEUTICAL INDUSTRIES, LTD.,

TEVA NEUROSCIENCE, INC.,

YEDA RESEARCH AND DEVELOPMENT CO., LTD.,

Plaintiffs-Appellees

v.

SANDOZ, INC., MOMENTA PHARMACEUTICALS

INC.,

Defendants-Appellants

MYLAN PHARMACEUTICALS INC., MYLAN INC.,

NATCO PHARMA LTD.,

Defendants-Appellants

SANDOZ INTERNATIONAL GMBH,

NOVARTIS AG,

Defendants

______________________

2012-1567, 2012-1568, 2012-1569, 2012-1570

______________________

Appeals from the United States District Court for the

Southern District of New York in Nos. 08-CV-7611, 09-

CV-8824, Judge Barbara S. Jones.

______________________

Decided: June 18, 2015

______________________

2 TEVA PHARMACEUTICALS USA v. SANDOZ INC.

ELIZABETH HOLLAND, Goodwin Procter LLP, New

York, NY, for plaintiffs-appellees. Also represented by

DAVID M. HASHMALL; JOHN T. BENNETT, HENRY C. DINGER,

JOHN C. ENGLANDER, NICHOLAS K. MITROKOSTAS, DARYL L.

WIESEN, Boston, MA; WILLIAM G. JAMES, II, WILLIAM M.

JAY, Washington, DC.

DEANNE MAYNARD, Morrison & Foerster LLP, Wash-

ington, DC, for defendants-appellants Sandoz, Inc., Mo-

menta Pharmaceuticals Inc. Also represented by MARC A.

HEARRON, BRIAN ROBERT MATSUI; ANDERS T. AANNESTAD,

DAVID CLARENCE DOYLE, BRIAN M. KRAMER, San Diego,

CA.

SHANNON BLOODWORTH, Perkins Coie, LLP, Washing-

ton, DC, for defendants-appellants Mylan Pharmaceuti-

cals Inc., Mylan Inc., Natco Pharma Ltd. Also

represented by BRANDON MICHAEL WHITE; DAVID LEE

ANSTAETT, DAVID E. JONES, Madison, WI; EVAN CHESLER,

Cravath Swaine & Moore LLP, New York, NY.

______________________

Before MOORE, MAYER, and WALLACH, Circuit Judges. 1

Opinion for the court filed by Circuit Judge MOORE.

Dissenting opinion filed by Circuit Judge MAYER.

MOORE, Circuit Judge.

This case comes to us on remand from the Supreme

Court, which vacated our earlier opinion reversing the

1 Pursuant to Fed. Cir. Internal Operating Proce-

dure 15 ¶ 2(b)(ii), Circuit Judges Mayer and Wallach were

designated to replace Circuit Judge Randall R. Rader,

now retired, and District Judge Dee V. Benson, United

States District Court for the District of Utah.

TEVA PHARMACEUTICALS USA v. SANDOZ INC. 3

district court’s judgment that certain claims were not

indefinite (Group I claims), and affirming the district

court’s holdings that other claims (Group II claims) were

valid and infringed. 2 Teva Pharm. USA, Inc. v. Sandoz,

Inc., 723 F.3d 1363 (Fed. Cir. 2013), vacated, Teva Pharm.

USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831 (2015). Relevant

to the Group I claims, the Supreme Court held that the

ultimate construction of a claim term is a question of law,

subject to de novo review, and that underlying subsidiary

fact findings are subject to clear error review. Teva, 135

S. Ct. at 837–38, 841–42. During that same time, the

Supreme Court issued its opinion in Nautilus, Inc. v.

Biosig Instruments, Inc. (Nautilus II), 134 S. Ct. 2120

(2014), addressing the standard for indefiniteness. On

remand, the parties submitted supplemental briefing

explaining how the appeal should be resolved in light of

the Supreme Court’s Teva decision. See Teva Pharm.

USA, Inc. v. Sandoz, Inc., No. 12-1567 (Fed. Cir. Feb. 20,

2015), ECF No. 137. Applying the legal standards set

forth in the Supreme Court’s Teva and Nautilus II deci-

sions, we hold that the Group I claims are invalid for

indefiniteness. 3

2 The asserted patents were: U.S. Patent Nos.

5,800,808; 5,981,589; 6,048,898; 6,054,430; 6,342,476;

6,362,161; 6,620,847; 6,939,539; and 7,199,098. The

Supreme Court decision does not affect our prior holding

with respect to the Group II claims. For the reasons

articulated in our earlier opinion, we adopt those hold-

ings.

3 While the case was pending at the Supreme

Court, all of the patents-in-suit expired, with the excep-

tion of U.S. Patent No. 5,800,808. Thus, claim 1 of the

’808 patent is the sole unexpired Group I claim. Our

analysis will therefore focus on that claim, but to the

extent that issues relating to the expired Group I claims

4 TEVA PHARMACEUTICALS USA v. SANDOZ INC.

BACKGROUND

The facts of this case were recited in this court’s pre-

vious opinion. In summary, Appellants submitted Abbre-

viated New Drug Applications (ANDAs) to the Food and

Drug Administration (FDA) seeking approval to market

generic versions of Copaxone®. Teva, which markets

Copaxone®, sued Appellants for patent infringement

under 35 U.S.C. § 271(e)(2)(A). Claim 1 of the ’808 patent

recites a method of making a product called copolymer-1:

A method of manufacturing copolymer-1, compris-

ing reacting protected copolymer-1 with hydro-

bromic acid to form trifluoroacetyl copolymer-1,

treating said trifluoroacetyl copolymer-1 with

aqueous piperidine solution to form copolymer-1,

and purifying said copolymer-1, to result in copol-

ymer-1 having a molecular weight of about 5 to 9

kilodaltons.

’808 patent claim 1 (emphases added).

Copolymer–1 consists of four different amino acids

(alanine, glutamic acid, lysine, and tyrosine) combined in

a certain ratio to make a polypeptide product. A sample

of polymeric material like copolymer–1 typically consists

of a mixture of individual polymer molecules that have

varying molecular weights. There are three different

measures of molecular weight relevant to this appeal:

peak average molecular weight (Mp), number average

molecular weight (Mn), and weight average molecular

weight (Mw). Each measure is calculated in a different

manner. The claim does not specify which measure to use

and in a typical polymer sample, Mp, Mn, and Mw have

different values.

remain unresolved, this analysis should be understood to

apply equally to the other Group I claims.

TEVA PHARMACEUTICALS USA v. SANDOZ INC. 5

The district court rejected the Appellants’ argument

that the term “molecular weight” was indefinite. Teva

Pharm. USA, Inc. v. Sandoz, Inc. (Markman Order), 810

F. Supp. 2d 578, 586–93, 596 (S.D.N.Y. 2011). The dis-

trict court found credible Dr. Grant’s testimony that Mp is

the only type of average molecular weight that can be

directly obtained from a chromatogram and calibration

curve obtained by the analytical method described in

Example 1 (Size Exclusion Chromatography or SEC). Id.

at 588, 590. It noted that experts testified that Mn and

Mw can be obtained from the chromatogram and calibra-

tion curve, but doing so would require additional data

manipulation and calculations not disclosed in the specifi-

cation. Id. It therefore credited Dr. Grant’s opinion that

Example 1 implies the use of Mp. Id. The district court

also found that Example 1 corresponds to Figure 1 in the

patent specification. Id. at 588. It considered Appellants’

argument that Figure 1 does not disclose Mp because the

peaks of the depicted curves do not match the molecular

weight values reported in the legend. Id. at 590. The

district court, however, accepted Dr. Grant’s opinion that

a person of ordinary skill would understand that the

process of transferring data from a chromatogram could

cause a shift in the peak of the curves. Id. It therefore

concluded that the fact that the peaks do not match the

listed molecular weights does not dissuade the conclusion

that “molecular weight” means Mp. Id. at 590–91. The

district court determined that “the prosecution history

also indicates [average molecular weight] refers to Mp in

the context of the patents-in-suit.” Id. at 589. It rejected

as irrelevant the patentee’s response to an indefiniteness

rejection during the prosecution of the ’847 patent that

“[o]ne of ordinary skill in the art could understand that

kilodalton unit implies a weight average molecular

weight.” Id. at 591–92. It did so on the basis that the

“statement was incorrect” because each type of average

6 TEVA PHARMACEUTICALS USA v. SANDOZ INC.

molecular weight can use the kilodalton. Id. at 592. It

then concluded that one of ordinary skill would accept the

patentee’s statement during the prosecution of the ’539

patent that average molecular weight means Mp. Id.

Having considered the claims, specification, prosecution

history and extrinsic evidence, the district court deter-

mined that “molecular weight” means Mp in the context of

the claimed invention and held that the claims are not

indefinite. Id.

We reversed the district court’s judgment with respect

to the Group I claims, holding them indefinite. Teva, 723

F.3d at 1368–69. Teva filed a petition for a writ of certio-

rari, arguing to the Supreme Court that in holding the

claims indefinite, we erred by giving no weight to the

district court fact findings. Pet. for Writ of Cert., Teva

Pharm. USA, Inc. v. Sandoz, Inc., No. 13-854, 2014 WL

230926, at *13–14 (2014). Teva argued that this court’s

determinations in Cybor Corp. v. FAS Techs., Inc., 138

F.3d 1448 (Fed. Cir. 1998) (en banc) and Lighting Ballast

Control LLC v. Philips Elecs. North America Corp., 744

F.3d 1272 (Fed. Cir. 2014) (en banc) that we review all

aspects of claim construction de novo was incorrect and

inconsistent with Fed. R. Civ. P. 52(a)(6). Brief for the

Petitioner at 18, Teva Pharm. USA, Inc. v. Sandoz, Inc.,

No. 13-854 (2014). It argued that under Fed. R. Civ. P.

52(a)(6), we should only set aside a district court fact

finding if such finding is clearly erroneous. The Supreme

Court agreed.

The Supreme Court held 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.” Teva, 135 S.

Ct. at 837. The reviewing court, however, should review

subsidiary factual findings under the clearly erroneous

standard. Id. at 838. The Court explained that “when the

TEVA PHARMACEUTICALS USA v. SANDOZ INC. 7

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” which will

be reviewed de novo. Id. at 841. If a district court needs

to consult extrinsic evidence, for example, to understand

the meaning of a term in the relevant art at the relevant

time, the court may need to make subsidiary factual

findings about that extrinsic evidence. Id. The Court

explained that

if a district court resolves a dispute between ex-

perts 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.

Id. Experts may explain terms of art and the state of the

art at any given time, but they cannot be used to prove

the legal construction of a writing. Id. If a district court

resolves a subsidiary factual dispute, it will then interpret

the patent claim in light of the facts as the court found

them. Id. As the Court cautioned, an “issue does not lose

its factual character merely because its resolution is

dispositive of the ultimate legal question.” Id. at 842

(citations and quotation marks omitted). Regardless of

whether a subsidiary factual finding plays a small or

large role in the ultimate conclusion about the meaning of

the patent term, “the ultimate question of construction

will remain a legal question.” Id. at 841–42.

The Court vacated our decision, concluding that Teva

identified at least one factual finding by the district court

which we did not review for clear error. Appellants had

argued that “molecular weight” could not mean Mp be-

8 TEVA PHARMACEUTICALS USA v. SANDOZ INC.

cause the molecular weight values in the Figure 1 legend

did not match up with the peak values on the Figure 1

curves. The Supreme Court concluded that the district

court’s finding “about how a skilled artisan would under-

stand the way in which a curve created from chromato-

gram data reflects molecular weights” was a factual

finding. Id. at 843. Distinguishing between the factual

and legal components of the analysis, the Court explained

that “[b]ased on that factual finding, the District Court

reached the legal conclusion that figure 1 did not under-

mine Teva’s argument that molecular weight referred to

the first method of calculation (peak average molecular

weight).” Id. The Court vacated our decision instructing

that the district court fact findings should be reviewed for

clear error. Id. The Court acknowledged that Teva

claimed there were two additional instances in which the

Federal Circuit rejected fact findings without finding

clear error. Expressing no opinion on those arguments,

the Court left these matters for us to consider. Id.

While Teva was pending at the Supreme Court, the

Court issued its opinion in Nautilus II. In Nautilus II,

the Court evaluated our standards for indefiniteness

under 35 U.S.C. § 112, ¶ 2 (2006), 4 rejecting our “not

amenable to construction or insolubly ambiguous” stand-

ard. Those standards were the ones applied in our Teva

decision. The Supreme Court articulated the standard to

be applied: “[W]e hold that a patent is invalid for indefi-

niteness if its claims, read in light of the specification

delineating the patent, and the prosecution history, fail to

4 Paragraph 2 of 35 U.S.C. § 112 was replaced with

newly designated § 112(b) when § 4(c) of the Leahy–Smith

America Invents Act (“AIA”), Pub. L. No. 112–29, took

effect on September 16, 2012. Because this case was filed

before that date, we will refer to the pre-AIA version of §

112.

TEVA PHARMACEUTICALS USA v. SANDOZ INC. 9

inform, with reasonable certainty, those skilled in the art

about the scope of the invention.” Nautilus II, 134 S. Ct.

at 2124 (emphasis added). As we explained on remand,

“[t]he Court has accordingly modified the standard by

which lower courts examine allegedly ambiguous claims;

we may now steer by the bright star of ‘reasonable cer-

tainty,’ rather than the unreliable compass of ‘insoluble

ambiguity.’” Biosig Instruments, Inc. v. Nautilus, Inc.,

No. 2012-1289, slip op. at 8 (Fed. Cir. Apr. 27, 2015).

We therefore reconsider the district court’s claim con-

struction and indefiniteness determination in light of the

Supreme Court’s guidance.

DISCUSSION

A patent’s specification must “conclude with one or

more claims particularly pointing out and distinctly

claiming the subject matter which the applicant regards

as [the] invention” 35 U.S.C. § 112, ¶ 2. A patent is

indefinite “if its claims, read in light of the specification

delineating the patent, and the prosecution history, fail to

inform, with reasonable certainty, those skilled in the art

about the scope of the invention.” Nautilus II, 134 S. Ct.

at 2124. The definiteness requirement must take into

account the inherent limitations of language. “Some

modicum of uncertainty . . . is the ‘price of ensuring the

appropriate incentives for innovation.’” Id. at 2128 (quot-

ing Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co.,

535 U.S. 722, 732 (2002)). On the other hand, “a patent

must be precise enough to afford clear notice of what is

claimed, thereby appris[ing] the public of what is still

open to them.” Id. at 2129 (internal quotation marks and

citations omitted). Indefiniteness is a question of law that

we review de novo. Wellman, Inc. v. Eastman Chem. Co.,

642 F.3d 1355, 1365–66 (Fed. Cir. 2011).

10 TEVA PHARMACEUTICALS USA v. SANDOZ INC.

To determine whether the Group I claim at issue is

indefinite, we look to the patent record—the claims,

specification, and prosecution history—to ascertain if they

convey to one of skill in the art with reasonable certainty

the scope of the invention claimed. We conclude in this

case that they do not convey with reasonable certainty the

measure of molecular weight to be used. Claim 1 of the

’808 patent recites “molecular weight” without specifying

the meaning of that term. The parties agree that “molec-

ular weight” could refer to Mp, Mw, or Mn. And they agree

that each of these measures is calculated in a different

way and would typically yield a different result for a

given polymer sample. But the claim on its face offers no

guidance on which measure of “molecular weight” the

claims cover.

There is no express definition of “molecular weight” in

the ’808 patent specification. Nowhere in the specification

are the terms Mp, Mw, or Mn used. Neither party argues

to the contrary. Instead, in its supplemental briefing to

this court, Teva argues that:

The factual findings establish that to a skilled ar-

tisan, ‘average molecular weight’ has a presumed

meaning in this context, which means that the pa-

tent’s specification resolves any ambiguity; that

the presumed meaning is consistent with Figure 1

of the specification; and that the only statement

causing ambiguity in the prosecution history was

an error. . . . And no intrinsic evidence defeats

that definite meaning—not Figure 1, and not the

prosecution history.

Appellees’ Supp. Br. 1; see also id. at 4–7 (Section 2.

Heading: “The District Court Did Not Clearly Err in

Finding That The Key Term Has A Presumed Meaning In

The Art”). Teva’s recitation of what was found below is

inaccurate. The district court did not find that the term

TEVA PHARMACEUTICALS USA v. SANDOZ INC. 11

molecular weight or average molecular weight had a

presumed meaning in the art. And if there were such a

finding, it would not have been supported by the record in

this case. All parties agree that the term “molecular

weight” or “average molecular weight” in the Group I

claims could refer to any of the three weight measures Mp,

Mn, or Mw. Even Teva’s expert Dr. Grant repeatedly

admitted that the term molecular weight has no default

meaning to one of skill in the art. J.A. 3096-97. And

while it is true that the district court used the word

“presumed” once in its indefiniteness section, the use was

in characterizing Teva’s argument, not in making a fact

finding: “Thus, Teva (and Dr. Grant) conclude, Mp can be

read from the chromatogram generated by SEC without

any ‘further calculation’ and would be understood by a

person of ordinary skill in the art to be the presumed

meaning of [average molecular weight] in the context of

the patents-in-suit.” Markman Order at 588.

The district court’s determination about how a skilled

artisan would understand the way in which SEC-

generated chromatogram data reflects molecular weight is

a question of fact. And we see no clear error in that fact

finding—that one of skill in the art could read Mp from a

chromatogram without further calculation and that Mw or

Mn would both require further calculations. We see no

clear error in the district court’s decision to credit Dr.

Grant’s testimony that Figure 1 was created by trans-

forming data from a chromatogram to the curves depicted

in Figure 1. Nor do we see clear error in its acceptance of

Dr. Grant’s opinion that a person of ordinary skill would

understand that the process of transforming such data

could cause the peaks of each curve to shift slightly such

that a person of skill would understand that the listed

molecular weights fall approximately at the peaks of the

curves, i.e., Mp. While Dr. Grant’s argument that the

peak positions on the curves are within a margin of error

12 TEVA PHARMACEUTICALS USA v. SANDOZ INC.

(which he admits is as high as an error of 16.7%) is rela-

tively cursory and unexplained, see J.A. 1016–17, none-

theless we do not find the district court’s reliance on it

clearly erroneous. But accepting these fact findings does

not, as Teva suggests, mean that there now exists a

presumption regarding the meaning of the claim term in

the art in general or in the context of this patent.

To the extent that Teva argues that the meaning of

“molecular weight” in the context of patents-in-suit is

itself a question of fact, it is wrong. See Teva, 135 S. Ct.

at 841–42. A party cannot transform into a factual mat-

ter the internal coherence and context assessment of the

patent simply by having an expert offer an opinion on it.

The internal coherence and context assessment of the

patent, and whether it conveys claim meaning with

reasonable certainty, are questions of law. The meaning

one of skill in the art would attribute to the term molecu-

lar weight in light of its use in the claims, the disclosure

in the specification, and the discussion of this term in the

prosecution history is a question of law. The district court

should not defer to Dr. Grant’s ultimate conclusion about

claim meaning in the context of this patent nor do we

defer to the district court on this legal question. To the

extent that Teva argues that this ultimate determination

deserves deference, it is in error. To the extent that Teva

or the dissent suggests that the specification’s disclosure

of SEC would “infer” that this claim term, molecular

weight, in this patent refers to Mp, such an inference is

part of the legal analysis, not a fact finding to be given

deference. Determining the meaning or significance to

ascribe to the legal writings which constitute the intrinsic

record is legal analysis. The Supreme Court made clear

that the factual components include “the background

science or the meaning of a term in the relevant art

during the relevant time period.” Id. at 841. Teva cannot

transform legal analysis about the meaning or signifi-

TEVA PHARMACEUTICALS USA v. SANDOZ INC. 13

cance of the intrinsic evidence into a factual question

simply by having an expert testify on it. Id. at 841 (“ex-

perts 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” (citation omitted)). Determining

the significance of disclosures in the specification or

prosecution history is also part of the legal analysis.

Understandings that lie outside the patent documents

about the meaning of terms to one of skill in the art or the

science or state of the knowledge of one of skill in the art

are factual issues. Even accepting as correct the district

court’s factual determinations about SEC and the transfer

of chromatogram data to create Figure 1, these facts do

not resolve the ambiguity in the Group I claim about the

intended molecular weight measure.

To determine whether one of skill in the art would be

reasonably certain that the claim’s use of molecular

weight is Mp, we consider as well the prosecution history.

Statements made during prosecution history are relevant

to claim construction. See Teva, 135 S. Ct. at 841; Phil-

lips v. AWH Corp., 415 F.3d 1303, 1317 (Fed. Cir. 2005).

Applicants can define (lexicography), explain, or disavow

claim scope during prosecution. And whether their

statements or disclaimers impact the meaning of a claim

term in a given patent is a legal question, not a factual

one. A statement made during prosecution of related

patents may be properly considered in construing a term

common to those patents, regardless of whether the

statement pre- or post-dates the issuance of the particular

patent at issue. Microsoft Corp. v. Multi-Tech Sys., Inc.,

357 F.3d 1340, 1350 (Fed. Cir. 2004). The parties do not

point to any portion of the ’808 patent’s prosecution

history that is relevant to the construction of “molecular

weight.” However, they point to, and the district court

considered, statements about the meaning of “molecular

14 TEVA PHARMACEUTICALS USA v. SANDOZ INC.

weight” made during the prosecution of the ’847 and ’539

patents which are both continuations of the ’808 patent. 5

Such statements are legally relevant to the meaning one

of skill in the art would attribute to the identical term in

the ‘808 patent. In the prosecution of both patents, the

examiner rejected the claims as indefinite because the

term average molecular weight was meaningless without

specifying whether Mp, Mn, or Mw should be used. See

J.A. 3220 (“The term ‘average’ molecular weight . . . is

meaningless as a limitation without specifying its basis,

e.g. weight average molecular weight, number average

molecular weight, etc.”); J.A. 3245 (“[T]he term ‘average

molecular weight’ . . . is indefinite since its method of

measurement is not specified, i.e. number average molec-

ular weight, weight average molecular weight, average

molecular weight as determined by light scattering, etc.”).

The ’808, ’847, and ’539 patents share a nearly identical

specification, and all three patents identically include

Example 1 and Figure 1, discussed above. That these

applications containing the same Example 1 and Figure 1

as the ’808 patent were rejected for indefiniteness sug-

gests that, contrary to Teva’s position, the specification

does not conclusively establish that in the context of these

patents a person of ordinary skill in the art would con-

clude that the meaning of “molecular weight” is Mp.

5 Prior to the expiration of the other patents-in-suit,

Teva did not dispute the relevance of the prosecution

history of related patents to the construction of the term

“molecular weight.” See Markman Order at 592; J.A.

1018. Now Teva argues that “the prosecution history of

later patents . . . cannot override the specification or

invalidate the patent.” Appellees’ Supp. Br. 1; see also id.

at 12. But we have said before, and reaffirm today, that

past and future prosecution of related patents may be

relevant to the construction of a given claim term.

TEVA PHARMACEUTICALS USA v. SANDOZ INC. 15

In response to the indefiniteness rejection concerning

the meaning of “molecular weight” during the prosecution

of the ’847 patent, the earlier of the two continuations, the

applicants argued that the term “molecular weight” was

not indefinite because “[o]ne of ordinary skill in the art

could understand that kilodalton units implies a weight

average molecular weight,” i.e., Mw. J.A. 3229. To be

clear, this was the only basis which the applicant argued

in response to the indefiniteness rejection. And the

applicant was successful. Defining “molecular weight” as

Mw, as the applicant did in response to the rejection, was

what overcame the rejection. The district court heard

testimony that the statement made during the prosecu-

tion of the ’847 patent was scientifically erroneous be-

cause each type of “molecular weight” can be expressed in

kilodaltons. Markman Order at 592. The fact finding by

the district court—that one of skill in the art would un-

derstand that each type of “molecular weight” could be

expressed in kilodaltons—is not clearly erroneous. How-

ever, the fact that Mw, Mn, and Mp can each be expressed

in kilodaltons does not erase the confusion created by the

patentee about its claim scope. Regardless of the scien-

tific accuracy of the statement, a person of ordinary skill

in the art would have understood that the applicants

defined the term “molecular weight” as Mw to gain allow-

ance of the claims. This is a legal conclusion unaffected

by the scientific error made during prosecution. To the

extent that the dissent claims that the significance to be

given to the patentee’s express definition of molecular

weight as Mw, made to overcome a rejection, is a question

of fact, the dissent is wrong. The determination of the

significance of statements made during prosecution to the

claim construction is a question of law.

The examiner required the applicants to provide a

meaning for “molecular weight” and they provided one:

Mw. The fact that their explanation contained further

16 TEVA PHARMACEUTICALS USA v. SANDOZ INC.

elaboration which itself included a scientific error does

not undermine the statement’s legal import. “The public

notice function of a patent and its prosecution history

requires that a patentee be held to what he declares

during the prosecution of his patent.” Springs Window

Fashions LP v. Novo Indus., L.P., 323 F.3d 989, 995 (Fed.

Cir. 2003). We have held patentees to statements con-

taining errors made during prosecution where, for exam-

ple, nothing in the statement was at odds with the plain

language of the claims or the specification. See id. at

995–96; see also Hockerson-Halberstadt, Inc. v. Avia Grp.

Int’l, Inc., 222 F.3d 951, 957 (Fed. Cir. 2000) (rejecting

patentee’s “request for a mulligan that would erase from

the prosecution history the inventor’s disavowal of a

particular aspect of a claim term’s meaning” despite

patentee’s argument that a person of ordinary skill would

have understood the statement during prosecution to be

erroneous); cf. Biotec Biologische Naturverpackungen

GmbH v. Biocorp, Inc., 249 F.3d 1341, 1348 (Fed. Cir.

2001) (declining to limit claims by erroneous statement

made during prosecution that was contrary to the plain

language of the claims, the specification, and other state-

ments made during prosecution). Given the role of the

statement in gaining allowance of the claims, a person of

ordinary skill in the art would have understood the appli-

cants to have defined “molecular weight” to mean Mw, and

the fact that any of the measures (Mw, Mn or Mp) can be

expressed in kilodaltons, does not change the significance

of the choice made by the patentee, Mw, to overcome the

rejection. And importantly, this determination is part of

the legal analysis, not as the dissent claims, one of the

fact findings to which we owe deference.

During the prosecution of the ’539 patent, the appli-

cants responded to a nearly identical indefiniteness

rejection to the term “molecular weight” by arguing that a

person “of ordinary skill in the art, upon reviewing the

TEVA PHARMACEUTICALS USA v. SANDOZ INC. 17

specification, would understand that ‘average molecular

weight’ refers to the molecular weight at the peak of the

molecular distribution curve in Figure 1,” i.e., Mp. J.A.

3258. Here too the specification was identical to the ’808

and ’847 patents in all respects relevant to the molecular

weight question, and the examiner found the specification

did not provide the reasonable certainty required for

definiteness. The patentee overcame that rejection by

again defining which measure of molecular weight to use,

in that case Mp.

To summarize, it is undisputed that “molecular

weight” or average molecular weight can be ascertained

by any of three possible measures: Mp, Mn, and Mw. The

claims do not indicate which measure to use. The specifi-

cation never defines molecular weight or even mentions

Mp, Mw, or Mn. And the term “average molecular weight”

does not have a plain meaning to one of skill in the art.

The district court fact findings regarding how one of skill

in the art would understand the way in which a curve

created with chromatogram data reflects molecular

weights was not clearly erroneous. Its fact findings about

the additional calculations that would be required to

determine Mw or Mn are not clearly erroneous. Its fact

findings about how a skilled artisan would accept a curve

“shift” when converting chromatogram data to a curve

such as that illustrated in Figure 1 are not clearly errone-

ous. A skilled artisan, knowing a shift might occur, would

still not be reasonably certain in light of the entire record

as to which type of average was intended. During prose-

cution of the related ’847 and ’539 patents, which with

respect to molecular weight have identical specifications,

examiners twice rejected the term “molecular weight” as

indefinite for failing to disclose which measure of molecu-

lar weight to use (Mp, Mn, or Mw). And the patentee in

one instance stated that it was Mw and in the other stated

it was Mp. We find no clear error in the district court’s

18 TEVA PHARMACEUTICALS USA v. SANDOZ INC.

fact finding that one of the statements contained a scien-

tifically erroneous claim. We hold that claim 1 is invalid

for indefiniteness by clear and convincing evidence be-

cause read in light of the specification and the prosecution

history, the patentee has failed to inform with reasonable

certainty those skilled in the art about the scope of the

invention. On this record, there is not reasonable certain-

ty that molecular weight should be measured using Mp.

This is the legal question—and on this question—we

reverse the district court.

AFFIRMED-IN-PART, REVERSED-IN-PART

COSTS

No costs.

United States Court of Appeals

for the Federal Circuit

______________________

TEVA PHARMACEUTICALS USA, INC.,

TEVA PHARMACEUTICAL INDUSTRIES, LTD.,

TEVA NEUROSCIENCE, INC., YEDA RESEARCH

AND DEVELOPMENT CO., LTD.,

Plaintiffs-Appellees

v.

SANDOZ, INC., MOMENTA PHARMACEUTICALS

INC.,

Defendants-Appellants

MYLAN PHARMACEUTICALS INC., MYLAN INC.,

NATCO PHARMA LTD.,

Defendants-Appellants

SANDOZ INTERNATIONAL GMBH,

NOVARTIS AG,

Defendants

______________________

2012-1567, 2012-1568, 2012-1569, 2012-1570

______________________

MAYER, Circuit Judge, dissenting.

“[I]n some instances, a factual finding may be close to

dispositive of the ultimate legal question of the proper

meaning of [a claim] term in the context of [a] patent.”

Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831,

841–42 (2015). This is such a case. After carefully evalu-

ating the testimony of the parties’ experts, the district

2 TEVA PHARMACEUTICALS USA v. SANDOZ INC.

court made a factual finding that an artisan skilled in the

art of polypeptide synthesis would have inferred from the

use of an analytic technique known as size exclusion

chromatography (“SEC”) in U.S. Patent No. 5,800,808 (the

“’808 patent”) that the term “molecular weight” referred

to peak average molecular weight. Teva Pharm. USA,

Inc. v. Sandoz Inc., 810 F. Supp. 2d 578, 588 (S.D.N.Y.

2011) (“District Court Decision”). The court further found

that a person of ordinary skill in the art would have

accepted a statement made by the patentee during prose-

cution of U.S. Patent No. 6,939,539 (the “’539 patent”) as

“proof” of what was meant by the term “molecular

weight.” Id. at 592. * Because neither of these factual

findings is clearly erroneous, we are not free to disregard

or discount them in assessing whether the ’808 patent

withstands definiteness scrutiny. See Pullman-Standard

v. Swint, 456 U.S. 273, 287 (1982) (emphasizing that

Federal Rule of Civil Procedure 52(a) “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 errone-

ous”). I therefore respectfully dissent.

I.

In some cases, a trial court can decide an indefinite-

ness dispute based solely on the intrinsic evidence. When

a district court’s review is confined to the intrinsic record,

its conclusion on indefiniteness will be a legal determina-

tion which we can appropriately review de novo. See

Teva, 135 S. Ct. at 841. In many instances, however,

* Teva Pharmaceuticals USA, Inc. and related par-

ties (collectively “Teva”) own the ’808 patent, which is the

sole patent at issue in this appeal. The ’808 patent is

related to both the ’539 patent and U.S. Patent No.

6,620,847 (the “’847 patent”), and the three patents share

substantially identical specifications.

TEVA PHARMACEUTICALS USA v. SANDOZ INC. 3

particularly where complex technology is at issue, a trial

court will be required to look outside a patent and its

prosecution history in order to fully apprehend matters

such as “the background science or the meaning of a term

in the relevant art during the relevant time period.” Id.;

see Seymour v. Osborne, 78 U.S. 516, 546 (1871) (empha-

sizing that a patent may be “so interspersed with tech-

nical terms and terms of art that the testimony of

scientific witnesses is indispensable to a correct under-

standing of its meaning”). Those laboring in different

fields of scientific endeavor often speak with words drawn

from specialized lexicons, and in many cases it is only by

delving into the background science and thoroughly

evaluating the testimony of competing experts that a trial

court can make an informed determination as to whether

a claim provides a skilled artisan with reasonable certain-

ty as to the scope of an invention. See Loom Co. v. Hig-

gins, 105 U.S. 580, 585 (1881) (explaining that skilled

artisans “understand the language of their brother scien-

tist[s]”).

The court here is once again led astray by its failure

to afford sufficient deference to the trial court’s findings of

fact. See Teva, 135 S. Ct. at 842. The district court

engaged in extensive fact-finding about the background

science reflected in the ’808 patent. See id. at 840 (“[T]his

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 re-

solved the issues of fact that divided those experts.”).

After considering expert declarations and deposition

testimony—and holding two hearings—the court deter-

mined that the term “molecular weight” was not indefi-

nite because a skilled artisan would have understood its

meaning. See District Court Decision, 810 F. Supp. 2d at

587–95. Relying in significant measure on the testimony

of Dr. Gregory Grant, Teva’s expert, the trial court made

4 TEVA PHARMACEUTICALS USA v. SANDOZ INC.

three key factual determinations: (1) a person of ordinary

skill in the art of polypeptide synthesis would infer from

the use of the SEC method disclosed in the specification of

the ’808 patent that the term “molecular weight” referred

to peak average molecular weight, id. at 589–90; (2) a

skilled artisan would not rely upon a statement Teva

made when prosecuting the ’847 patent that the expres-

sion of molecular weight in kilodalton units “implie[d] a

weight average molecular weight,” because that state-

ment rested on obvious scientific error, id. at 591–92; and

(3) that artisan would instead rely on Teva’s affirmative

statement, made while prosecuting the ’539 patent, that

“molecular weight” meant peak average molecular weight,

id. at 592.

We must be “mindful that we are a court of review,

not of first view,” Cutter v. Wilkinson, 544 U.S. 709, 718

n.7 (2005), and that our duty is to evaluate each case in

light of the facts as the trial court has found them. This

court’s conclusion that the ’808 patent is fatally indefinite

hinges on the fact that Teva made divergent statements

as to the meaning of “molecular weight” when prosecuting

the ’847 and ’539 patents. Ante at 17. That conclusion,

however, cannot be reconciled with the district court’s

express factual finding that a skilled artisan would not

rely on the statement Teva made as to the meaning of

“molecular weight” when prosecuting the ’847 patent

because it was scientifically incorrect. Peak average

molecular weight, weight average molecular weight, and

number average molecular weight are all expressed in

kilodaltons. See District Court Decision, 810 F. Supp. 2d

at 592. Accordingly, Teva’s statement that the use of

kilodalton units implied that “molecular weight” meant

weight average molecular weight was a non sequitur and,

as the district court correctly found, a skilled artisan

would not have relied upon it. See id.

As this court has repeatedly made clear, obviously er-

roneous statements in the prosecution file carry little

TEVA PHARMACEUTICALS USA v. SANDOZ INC. 5

weight in determining claim meaning. See, e.g., Rambus

Inc. v. Infineon Techs. AG, 318 F.3d 1081, 1090 (Fed. Cir.

2003) (emphasizing that an “incorrect statement in the

prosecution history [did] not govern the meaning of the

claims”); Biotec Biologische Naturverpackungen GmbH v.

Biocorp, Inc., 249 F.3d 1341, 1348 (Fed. Cir. 2001) (“An

error in the prosecution record must be viewed as are

errors in documents in general; that is, would it have been

apparent to the interested reader that an error was made,

such that it would be unfair to enforce the error.”). Fur-

thermore, a single statement by Teva during prosecution

of the ’847 patent—made years after the ’808 patent

issued—should not be deemed dispositive on the question

of whether the ’808 patent is sufficiently definite. See

Athletic Alternatives, Inc. v. Prince Mfg., Inc., 73 F.3d

1573, 1580 (Fed. Cir. 1996) (emphasizing that the ambi-

guity of the prosecution history made it “unhelpful as an

interpretive resource” for determining the meaning of a

claim term). While the prosecution history of one patent

in a chain may be used to construe the same term in both

earlier and later issued related patents with the same

specification, see Microsoft Corp. v. Multi-Tech Sys., Inc.,

357 F.3d 1340, 1350 (Fed. Cir. 2004), the court is unable

to cite to a single case in which a statement made in

prosecuting a later related patent was deemed sufficient,

standing alone, to render an earlier issued patent indefi-

nite. The prosecution history of the ’847 patent cannot

trump the disclosure in the specification of the ’808 patent

which, by describing the use of the SEC method, indicates

to a skilled artisan that “molecular weight” means peak

average molecular weight. See Vederi, LLC v. Google,

Inc., 744 F.3d 1376, 1382 (Fed. Cir. 2014) (emphasizing

that “the specification is the single best guide to the

meaning of a claim term” and that “the prosecution histo-

ry often lacks the clarity of the specification” (citations

and internal quotation marks omitted)).

6 TEVA PHARMACEUTICALS USA v. SANDOZ INC.

According to the court, although Teva’s statement

that the use of kilodalton units “implie[d] a weight aver-

age molecular weight” was scientifically incorrect, a

skilled artisan would nonetheless have understood that

the applicants defined the term “molecular weight” as

weight average molecular weight to gain allowance of the

claims. Ante at 16. This argument is unconvincing. Read

as a whole, Teva’s statement that the use of kilodalton

units “implie[d] a weight average molecular weight” is

nonsensical, and a skilled artisan would not rely upon any

part of it. This is particularly true given that Teva con-

firmed, when subsequently prosecuting the ’539 patent,

that—consistent with the use of the SEC method dis-

closed in the specification—the term “molecular weight”

meant peak average molecular weight. See Elbex Video,

Ltd. v. Sensormatic Elecs. Corp., 508 F.3d 1366, 1372–73

(Fed. Cir. 2007) (concluding that an earlier, incorrect

statement in the prosecution history did not override a

later, correct statement as to claim scope).

In assessing obviousness, what the prior art teaches is

a question of fact. See Graham v. John Deere Co., 383

U.S. 1, 17 (1966); see also Lighting Ballast Control LLC v.

Philips Elecs. N. Am. Corp., 744 F.3d 1272, 1307 (Fed.

Cir. 2014) (en banc) (O’Malley, J., dissenting), judgment

vacated sub nom. Lighting Ballast Control LLC v. Univer-

sal Lighting Techs., Inc., 135 S. Ct. 1173 (2015) (“Im-

portantly, one of the key fact questions in an obviousness

inquiry is what a prior art reference teaches—often, what

is claimed and described in a previously issued patent.

And, all findings regarding the scope and content of the

prior art are subject to clear error review.” (citation omit-

ted)). In assessing indefiniteness, likewise, a trial court’s

determination, based on expert testimony, as to what a

skilled artisan would glean from subsequently issued

patents and their prosecution histories is a factual finding

which can be set aside only for clear error. See Bose Corp.

v. Consumers Union of U.S., Inc., 466 U.S. 485, 498 (1984)

TEVA PHARMACEUTICALS USA v. SANDOZ INC. 7

(“It surely does not stretch the language of [Rule 52(a)] to

characterize an inquiry into what a person knew at a

given point in time as a question of ‘fact.’” (footnote omit-

ted)). We cannot substitute our assessment of the testi-

mony for that of the trial court simply because from our

appellate perch we might assess that testimony different-

ly. If we credit—as we must because it is not clearly

erroneous—the district court’s explicit finding that a

skilled artisan would not rely on the facially incorrect

statement made during prosecution of the ’847 patent,

there is no reasonable basis for concluding that the prose-

cution history of patents related to the ’808 patent would

create, in the mind of the skilled artisan, ambiguity

regarding the meaning of the term “molecular weight.”

The court’s approach here contravenes binding prece-

dent. In Enzo Biochem Inc. v. Applera Corp., we held that

under Teva a trial court’s conclusion, based on expert

testimony, as to whether an example in the specification

disclosed “direct detection” was a “factual finding” which

was subject to clear error review. 780 F.3d 1149, 1156

(Fed. Cir. 2015). Likewise, in EON Corp. IP Holdings

LLC v. AT&T Mobility LLC, we held that a district court’s

determination, based on the testimony from experts, that

claims disclosed “complicated, customized computer soft-

ware” was a “factual finding[].” 785 F.3d 616, 624 (Fed.

Cir. 2015). Here, however, the court insists that the

determination, based on extensive expert testimony, that

a skilled artisan would not rely on a facially incorrect

statement made during prosecution of the ’847 patent was

“part of the legal analysis, not as the dissent claims, one

of the fact findings to which we owe deference.” Ante at

16. The court’s view that the universe of factual findings

to which we owe deference includes only

“[u]nderstandings that lie outside the patent documents,”

ante at 13, simply cannot be squared with Enzo and EON.

Although the ultimate conclusion of indefiniteness

under 35 U.S.C. § 112 is a legal question, see Eidos Dis-

8 TEVA PHARMACEUTICALS USA v. SANDOZ INC.

play, LLC v. AU Optronics Corp., 779 F.3d 1360, 1364-65

(Fed. Cir. 2015), Teva mandates that the trial court’s

factual findings are to be respected, barring clear error,

and that the required legal analysis must be performed in

view of those findings, 135 S. Ct. at 841. Here, however,

the court takes the opposite tack, first embarking on an

independent review of the record and then considering, as

an afterthought, the important and carefully considered

factual findings made by the trial court.

II.

In Nautilus, Inc. v. Biosig Instruments, Inc., the Su-

preme Court rejected this court’s view that a claim met

definiteness requirements so long as it was “amenable to

construction,” and, as construed, was not “insolubly

ambiguous.” 134 S. Ct. 2120, 2124 (2014) (citations and

internal quotation marks omitted). Because the district

court here relied on the now discarded “insolubly ambigu-

ous” standard when it held that the ’808 patent was not

invalid for indefiniteness, see District Court Decision, 810

F. Supp. 2d at 582, this case should be remanded so that

the court can take additional evidence as it deems appro-

priate and assess in the first instance whether the ’808

patent meets the more stringent Nautilus definiteness

standard. See 134 S. Ct. at 2124 (explaining “that a

patent is invalid for indefiniteness if its claims, read in

light of the specification delineating the patent, and the

prosecution history, fail to inform, with reasonable cer-

tainty, those skilled in the art about the scope of the

invention”).

The ’808 patent will expire in September 2015. This

looming expiration date does not, however, permit us to

overstep our appellate role or feign first-hand experience

with the testimony or the technology. We are neither

equipped nor authorized to make the predicate factual

determinations necessary to assess whether the ’808

patent withstands definiteness scrutiny under the Nauti-

TEVA PHARMACEUTICALS USA v. SANDOZ INC. 9

lus standard. See Anderson v. Bessemer City, 470 U.S.

564, 574 (1985) (emphasizing that “[t]he trial judge’s

major role is the determination of fact, and with experi-

ence in fulfilling that role comes expertise”).