Source: http://www.bloomberglaw.com/public/desktop/document/Teva_Pharm_USA_Inc_v_Sandoz_Inc_723_F3d_1363_107_USPQ2d_1655_Fed_?1455195549
Timestamp: 2016-02-11 12:59:12
Document Index: 430196967

Matched Legal Cases: ['§ 271', '§ 1295', '§ 112', '§ 112', '§ 112', '§ 103']

Bloomberg Law - Document - Teva Pharm. USA, Inc. v. Sandoz, Inc., 723 F.3d 1363, 107 U.S.P.Q.2d 1655 (Fed. Cir. 2013), Court Opinion
107 U.S.P.Q.2d 1655
Nos. 2012-1567, 2012-1568, 2012-1569, 2012-1570.
2013 BL 198464
Teva Pharm. USA, Inc. v. Sandoz, Inc., 723 F.3d 1363, 107 U.S.P.Q.2d 1655 (Fed. Cir. 2013) [2013 BL 198464]
TEVA PHARMACEUTICALS USA, INC., Teva Pharmaceutical Industries, Ltd., Teva
Neuroscience, Inc., and Yeda Research and Development Co., Ltd.,
Plaintiffs-Appellants, v. SANDOZ, INC., and Momenta Pharmaceuticals Inc.,
Defendants-Appellants, and Mylan Pharmaceuticals Inc., Mylan Inc., and Natco
Pharma Ltd., Defendants-Appellants, and Sandoz International Gmbh, and
Novartis AG, Defendants.
[**1657] Hide Headnotes
Claims directed to copolymer-1 product used for treating multiple sclerosis, which describe distribution of molecular weight values in given sample in terms of average molecular weights, are invalid for indefiniteness, since plain language of claims does not indicate which average molecular weight measure is intended, since applicants, during prosecution of one patent in suit, stated that term “average molecular weight” refers to peak average molecular weight (Mp), but during prosecution of different patent, stated that same term implies weight average molecular weight (Mw), and since discussion of gel filtration in patents' common specification, which refers to size exclusion chromatography (SEC) method for measuring molecular weight, does not resolve this ambiguity, in that SEC method does not exclusively provide Mp, and peaks of curves shown in figure in specification do not correspond to values denoted as “average molecular weight” in figure’s legend, which makes it difficult to conclude that Mp is intended measure.
[2] Patentability/Validity — Specification — Claim adequacy ►115.1109 [Show Topic Path]
Claims directed to copolymer-1 product used for treating multiple sclerosis, which describe distribution of molecular weight values in given sample in terms of percentage of copolymer-1 molecules in sample falling within arbitrarily set molecular weight range, are not invalid for indefiniteness, since numbers that set boundaries of weight range, expressed in kilodaltons, refer to exact values rather than statistical measures, and scope of claims thus is readily ascertainable.
[3] Patentability/Validity — Specification — Enablement ►115.1105 [Show Topic Path]
Judgment that claims directed to copolymer-1 product used for treating multiple sclerosis are not invalid for lack of enablement is affirmed, since patentees' expert testified that, by calibrating size exclusion chromatography column mentioned in specification, using methods that were well-known at time application was filed, skilled artisan could confirm synthesis of copolymer-1 within molecular weight range recited in claims, since federal district court weighed this testimony against that of infringement defendants' experts and found it to be more convincing, and thus did not err in concluding that using calibration methods discussed by patentees' expert would not require undue experimentation, and since evidence purportedly showing patentees' difficulties with identifying appropriate calibration methods, including their deletion of particular method from draft patent application, do not undermine finding that claims are enabled for making copolymer-1 at claimed molecular weight.
[4] Patentability/Validity — Obviousness — Relevant prior art — Particular inventions ►115.0903.03 [Show Topic Path]
Patentability/Validity — Obviousness — Commercial success ►115.0908 [Show Topic Path]
Judgment that claims directed to copolymer-1 product used for treating multiple sclerosis are not invalid for obviousness is affirmed, since federal district court did not clearly err in finding that prior art expressed preference for higher molecular weight copolymer-1, and therefore taught away from low molecular weight recited in asserted claims, since, with regard to secondary considerations, district court did not err in finding that patentees' multiple sclerosis drug is coextensive with asserted claims, which triggers presumption of nexus between commercial success of drug and claimed invention, and since commercial success of drug is undisputed, and infringement defendants failed to rebut presumption of nexus.
[5] Infringement — Construction of claims ►120.03 [Show Topic Path]
Infringement — Literal infringement ►120.05 [Show Topic Path]
Judgment that accused products literally infringe claims directed to copolymer-1 product used for treating multiple sclerosis is affirmed, since claims recite copolymer-1 containing amino acids alanine, glutamic acid, lisine, and tyrosine in ratio of “approximately 6:2:5:1,” and federal district court did not clearly err in finding that 6:2:5:1 ratio must be converted to percentages to ensure comparison on same scale with amino acid percentages in accused products, since such comparison reveals that, in aggregate, four percentages in accused products differ from “ideal”
percentages of claims by only 4.5 percent, and that no single amino acid differs from its corresponding “ideal” percentage by more than about 2 percent, since examples from prior art show that, even when one of amino acids differs from its “ideal”
percentage by more than 5 percent, material is still considered “copolymer-1,”
and since district court therefore did not clearly err in concluding that these small differences from “ideal” percentages mean that accused products literally infringe.
[6] Patent construction — Prosecution history estoppel ►125.09 [Show Topic Path]
Applicants prosecuting application for claims directed to copolymer-1 product used for treating multiple sclerosis did not clearly and unmistakably disclaim copolymer-1 compositions having weight average molecular weight (Mw)
greater than 10 kilodaltons (kDa) in distinguishing cited prior art reference, since applicants' statement that copolymer-1 of reference had “minimum molecular weight of 10 kilodaltons” did not expressly refer to any specific molecular weight measurement, and connection between this statement and article cited in reference is too attenuated to limit scope of claims to coplymer-1 having Mw less than 10 kDa, and since technique discussed in article cited in reference can yield Mw or different type of molecular weight measure, which fails to resolve ambiguity.
New York, Barbara S. Jones, J., 810 F.Supp.2d 578.
[*1364] [EDITORS' NOTE: THIS PAGE CONTAINED HEADNOTES AND HEADNOTES ARE NOT AN
[*1365] [EDITORS' NOTE: THIS PAGE CONTAINED HEADNOTES AND HEADNOTES ARE NOT AN
[*1366] Elizabeth J. Holland, Kenyon & Kenyon, LLP, of New York, NY, argued for
plaintiffs-appellees. Of counsel on the brief were William G. James, II, of
Washington, DC; David M. Hashmall, Goodwin Procter, LLP, of New York, NY;
John C. Englander, Henry C. Dinger, Daryl L. Wiesen, John T. Bennett, and
Nicholas K. Mitrokostas, of Boston, MA.
Deanne E. Maynard, Morrison & Foerster, LLP, of Washington, DC, argued for
defendants-appellants, Sandoz Inc., et al. With her on the brief were Brian
R. Matsui, and Marc A. Hearron; David C. Doyle, Anders T. Aannestad and
Brian M. Kramer, of San Diego, CA.
Evan R. Chesler, Cravath Swaine & Moore LLP, of New York, NY, argued for
defendants-appellants, Mylan Pharmaceuticals, Inc., et al. On the brief were
Shannon M. Bloodworth and Brandon M. White, Perkins Coie, LLP, of
Washington, DC; and David L. Anstaett and David E. Jones, of Madison, WI. Of
counsel was John Singleton Skilton, Perkins Coie, LLP, of Madison, WI.
Before RADER, Chief Judge, MOORE, Circuit Judge, and BENSON, District
Judge.[fn*]
[fn*] Honorable Dee V. Benson, District Judge, United States District Court
for the District of Utah, sitting by designation.
The defendants in these consolidated patent infringement actions
(collectively, Appellants) appeal from the district court's judgment that
various claims of the nine patents-in-suit asserted by the plaintiffs
(collectively, Teva) are infringed, and from the court's holdings regarding
indefiniteness, nonenablement, and obviousness.[fn1] We hold that Group I
claims are invalid for indefiniteness, but that Group II claims have not
been proven indefinite.[fn2] We also hold that the district court did not
err in its conclusions that the claims are infringed, and that the
Appellants failed to prove that the claims would have been obvious and are
not enabled. Accordingly, we affirm the district court's judgments of
infringement and no invalidity with respect to Group II claims, reverse its
judgment of no invalidity with respect to Group I claims, and remand.
[*1367] BACKGROUND
Appellants submitted Abbreviated New Drug Applications (ANDAs) to the Food
and Drug Administration (FDA) seeking approval to market generic versions of
Copaxone®, a drug used in treating multiple sclerosis. Two proposed generic
products, the Mylan accused product and the Sandoz accused product, are at
issue in this appeal. Teva, which markets Copaxone®, sued Appellants for
patent infringement under 35 U.S.C. § 271(e)(2)(A). The patents-in-suit,
which share a common specification, are listed in the [***2] Approved Drug Products
with Therapeutic Equivalence Evaluations (Orange Book) entry for Copaxone®.
The patents-in-suit include claims reciting a product called copolymer-1 and
claims reciting methods of making copolymer-1.
[**1658] 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 different ways to describe the
resulting distribution of molecular weight values. One approach uses
statistical measures, including the peak average molecular weight (Mp),
number average molecular weight (Mn), and weight average molecular weight
(Mw). Mp is the molecular weight of the most abundant molecule in the
sample. Mn is the arithmetic mean, or the total mass of all the molecules in
the sample divided by the total number of molecules. Mw is still another
average molecular weight measure that is calculated differently from Mp and
Mn. In a typical polymer sample, Mp, Mn, and Mw have different values.
A second approach describes how many molecules in a polymer sample have
molecular weights that fall within an arbitrarily set range. For example, if
99% of the constituent molecules in a sample have molecular weights between
1 kilodalton (kDa) and 100 kDa, the sample may be described as having 99% of
its mole fraction within the molecular weight range of 1 kDa to 100 kDa.
The claims of the patents-in-suit use both approaches. Claim 1 of the ′589
patent is representative of Group I claims, which use the first approach:
Copolymer-1 having a molecular weight of about 5 to 9 kilodaltons,
reacting protected copolymer-1 . . .; and
purifying said copolymer-1, to result in copolymer-1 having a
molecular weight of about 5 to 9 kilodaltons.
′589 patent claim 1 (emphases added). Claim 1 of the ′430 patent is
representative of Group II claims, which use the second approach:
"Copolymer-1 having over 75% of its mole fraction within the molecular
weight range from about 2 kDa to about 20 kDa. . . ."′430 patent claim 1
In its claim construction order, the district court did not distinguish in
detail between the different contexts in which the term "molecular weight"
is used in Group I and Group II claims. The court rejected the Appellants'
argument that the term "molecular weight" was insolubly ambiguous because it
could refer to Mp, Mn, Mw, or yet another average molecular weight measure.
Teva Pharms. USA, Inc. v. Sandoz, Inc., 810 F.Supp.2d 578, 586-93, 596
(S.D.N.Y.2011) (Markman Order). It construed "molecular weight" as Mp and
held that the claims are not indefinite. Id. After a bench trial, the court
held that the asserted claims are not invalid for obviousness or lack of
enablement, and that the Mylan and Sandoz accused products infringe all of
the asserted claims. Teva Pharms. USA, Inc. v. Sandoz, Inc.,
876 F.Supp.2d 295 (S.D.N.Y.2012) (Opinion).
[*1368] This appeal followed. We have jurisdiction under 28 U.S.C. § 1295(a)(1).
I. Definiteness
A patent's specification "[***3] must conclude with one or more claims
particularly pointing out and distinctly claiming the subject matter which
the inventor . . . regards as the invention." 35 U.S.C. § 112(b) (2012). "A
claim is indefinite only when it is not amenable to construction or
insolubly ambiguous." Biosig Instruments, Inc. v. Nautilus, Inc.,
715 F.3d 891, 898 (Fed.Cir.2013). To prove indefiniteness, "an accused
infringer must demonstrate by clear and convincing evidence that one skilled
in the relevant art could not discern the boundaries of the claim based on
the claim language, the specification, the prosecution history, and the
knowledge in the relevant art." Wellman, Inc. v. Eastman Chem. Co.,
642 F.3d 1355, 1366 (Fed.Cir.2011). Indefiniteness is a question of law that
we review de novo. Id. at 1365-66.
Appellants argue that the term "molecular weight" renders all of the
asserted claims indefinite because it can refer to different measures,
including MPMw, and Mn. They contend that the scope of the claims varies
significantly depending on the measure and that a skilled artisan cannot
ascertain the boundaries of the claims. Appellants argue that Teva
inconsistently defined "molecular weight" as Mw and Mp during prosecution of
two of the familial patents, reinforcing the ambiguity. Further, Appellants
contend that the specification does not resolve which molecular weight
measure is intended.
[**1659] Appellants also contend that their indefiniteness arguments apply equally
to Group I and Group II claims. They argue that even Group II claims, which
refer to a molecular weight range, "necessarily refer to a copolymer-1
percentage above or below a certain average molecular weight." Sandoz Reply
Br. 17. Appellants contend that, because all of the claims recite "molecular
weight," they must be indefinite.
Teva counters that the prosecution history clarifies that "molecular
weight" should be construed as Mp. It contends that its response to an
indefiniteness rejection of the ′539 patent claims unequivocally stated that
a person of skill in the art reading the specification would understand that
the term "molecular weight" refers to Mp. Teva argues that the district
court correctly determined that its response during prosecution of the ′847
patent, where it stated that "[o]ne of ordinary skill in the art could
understand that kilodalton units implies [sic] a weight average molecular
weight," was not contradictory. J.A. 3229. It contends that a skilled
artisan would discount this statement because it does not explicitly define
"molecular weight" as Mw and because it contains an evident scientific error
— any molecular weight measurement, not just Mw, may be expressed in
kilodalton units.
Teva also contends that the specification resolves any ambiguity in the
meaning of "molecular weight." Teva contends that the specification's
reference to the Size Exclusion Chromatography (SEC) method indicates that
"molecular weight" means Mp because determining Mn and Mw requires further
calculations from SEC data that the specification does not describe. It
further argues that Figure 1 confirms this conclusion because only [***4] Mp can be
obtained directly from the molecular weight plot in that figure.
Finally, Teva contends that Group II claims refer to exact molecular
weight values and are therefore not ambiguous. It argues that Group II
claims recite percentages of molecules in a copolymer-1 sample that fall
within a specified molecular weight range, not average values.
[*1369] [1] We agree with Appellants that Group I claims are indefinite and agree with
Teva that Group II claims are not. It is undisputed that Group I claims
contain an ambiguity because their plain language does not indicate which
average molecular weight measure is intended. Teva's attempt to resolve this
ambiguity hinges in part on the prosecution history. But two of its
prosecution statements directly contradict each other and render the
ambiguity insoluble.
During prosecution of the ′539 patent, the Examiner rejected pending
claims as indefinite, stating that "the term 'average molecular weight' . .
. is indefinite since its method of measurement is not specified, i.e. [Mn],
[Mw] . . . etc." J.A. 3245. Teva stated in its response that "[o]ne of
ordinary skill in the art, upon reviewing the specification, would
the peak of the molecular weight distribution curve shown in Figure 1,"
i.e., Mp J.A. 3258. The claims were allowed. During prosecution of the ′847
patent, the Examiner made an analogous rejection over the same claim term,
stating that "the term 'average' molecular weight . . . is meaningless as a
limitation without specifying its basis, e.g., [Mw], [Mn], etc." J.A. 3220.
Teva overcame the rejection by responding that "[o]ne of ordinary skill in
the art could understand that kilodalton units implies [sic] a weight
average molecular weight," i.e., Mw. J.A. 3229. The only basis upon which
the Examiner could have agreed that the ′539 patent claims were not
indefinite was that "molecular weight" means Mp. In contrast, the only basis
for the Examiner's withdrawal of the indefiniteness rejection of the ′847
patent claims was that the same term means Mw. Teva's two definitions cannot
The specification does not resolve the ambiguity. Teva's expert, Dr.
Gregory Grant, testified that after examining the curve depicted in Figure 1
and the accompanying legend, a skilled artisan would know that the claim
terms "molecular weight" and "average molecular weight" denote Mp. Dr. Grant
also testified that Example l's discussion of gel filtration, which refers
to the SEC method for measuring molecular weight, tells a skilled artisan
that "molecular weight" refers to Mp. See ′808 patent, col. 3 ll. 6-8. He
explained that only Mp, which is simply the highest point of a molecular
weight curve, can be read directly from a plot of SEC data.
On de novo review of the district court's indefiniteness holding, we
conclude that Dr. Grant's testimony does not save Group I claims, from
indefiniteness. As Dr. Grant himself opined, SEC does not exclusively
provide [**1660] Mp — both Mn and Mw can also be obtained from the data generated by
the SEC method after some calculations. J.A. 1005. His testimony [***5] is
consistent with that of one of Appellants' experts, who opined that SEC "can
give at least peak average, number average, and weight average 'molecular
weights.'" J.A. 1229. Furthermore, as illustrated in the figure below, the
peaks of the curves in Figure 1 do not correspond to the values denoted as
"average molecular weight" in the figure's legend (Appellants' additions in
color). In fact, the 7.7 kDa value is closer to the Mw than to the Mp of the
corresponding batch, which makes it difficult to conclude that Mp is the
intended measure. J.A. 5285. Thus, we hold that Group I claims are
[*1370] Exhibit
[2] Group II claims, by contrast, do not recite average molecular weight
values. Instead of describing copolymer-1 in terms of a statistical measure,
such as Mw, Group II claims recite the percentage of copolymer-1 molecules
in a sample falling within an arbitrarily set molecular weight range. The
numbers that set the boundaries of that range, such as "2 kDa" and "20 kDa"
in the ′430 patent claim 1, refer to precise points on the "Molecular
Weight" axis, rather than to statistical properties of the polymer molecular
weight curves. Like the numbers 10,000 (i.e., 10 kDa) and 20,000 (i.e., 20
kDa) in the figure above, "2 kDa" and "20 kDa" refer to exact values rather
than statistical measures. The scope of Group II claims is thus readily
ascertainable. We hold that Group II claims are not invalid for
A patent's specification must describe the invention and "the manner and
process of making and using it, in such full, clear, concise, and exact
terms as to enable any person skilled in the art to which it pertains . . .
to make and use the same." 35 U.S.C. § 112(a). "To be enabling, the
specification of a patent must teach those skilled in the art how to make
and use the full scope of the claimed invention without undue
experimentation." MagSil Corp. v. Hitachi Global Storage Techs., Inc.,
687 F.3d 1377, 1380 (Fed.Cir.2012) (internal quotation marks omitted).
Enablement is a question [**1661] of law that we review without deference, based on
underlying factual inquiries that we review for clear error after a bench
trial. Cephalon, Inc. v. Watson Pharm., Inc., 707 F.3d 1330, 1336
(Fed.Cir.2013).
The district court held that Appellants failed to prove that the asserted
claims are not enabled for making copolymer-1 at the claimed molecular
weight because a person of skill in the art would be able to measure it
using either of two known calibration methods, "self-standards" or
"universal calibration." See Opinion, 876 F.Supp.2d at 382-99. The court
determined that polymer literature at the time of filing described both
methods in detail, and that those methods could be adapted to copolymer-1.
The court also found that Teva's own extensive post-filing experimentation
with measurement methods did not
[*1371] conclusively establish lack of enablement. The court thus rejected
Appellants' experts' testimony that undue experimentation would be required,
holding instead that the specification and background knowledge in the art
provided sufficient guidance on measuring the molecular weight.
Appellants argue that the district court erred in its enablement analysis.
They contend [***6] that the specification states only that the SEC column should
be "calibrated" and does not disclose which calibration standards should be
used to measure the molecular weight. ′808 patent, col. 3 ll. 6-8.
Appellants argue that general SEC calibration methods do not readily apply
because copolymer-1 is complex and exhibits unpredictable behavior. They
further point to expert testimony that the commercially available standards
that a skilled artisan would have been most likely to pick are in fact
unreliable for measuring the molecular weight of copolymer-1.
Appellants also argue that the evidence of Teva's own difficulties with
identifying appropriate calibration methods, which they contend the district
court disregarded, confirms that the claims are not enabled. Appellants
contend that Teva's various internal documents show the allegedly
challenging development of calibration standards for measuring the molecular
weight of copolymer-1, and point out that Teva deleted references to the
standards from the patent application before filing. They argue that Teva's
problems with molecular weight measurements continued after filing, noting
that Teva switched calibration standards during the FDA approval process.
Appellants thus contend that the asserted claims are not enabled because the
specification does not teach which standards a skilled artisan must use to
calibrate copolymer-1 molecular weight measurements.
[3] We perceive no clear error in the fact findings on which the district
court based its enablement conclusion. Dr. Grant testified at length that it
would have been routine for a skilled artisan to measure the molecular
weight of copolymer-1. See, e.g., J.A. 19671, 20474, 20752-54. He explained
that, by calibrating the SEC column mentioned in the specification using
methods that were well known at the time of filing, a skilled artisan could
confirm the synthesis of copolymer-1 within the claimed molecular weight
range. Id. The district court weighed this testimony against that of
Appellants' experts and found it to be more convincing. See, e.g., Opinion,
876 F.Supp.2d at 398 (Appellants' expert "failed to address the extensive
literature that existed [at the time of filing] regarding SEC,
self-standards, and universal calibration."); see also id. at 392. We thus
agree with Teva that the district court did not err in concluding that
utilizing the calibration methods discussed by Dr. Grant would not require
undue experimentation.
Appellants' arguments relating to Teva's own alleged calibration struggles
also fail to demonstrate that the district court committed a reversible
error. Appellants' assertion that the district court ignored Teva's internal
experimentation is simply inaccurate. See id. at 391. Moreover, Appellants
point to no evidence that undermines the district court's understanding that
"it is entirely plausible that Teva experimented with different methods to
deal with regulatory and other scale-up issues, rather than to correct
faulty measurements." Id.; see also Edwards Lifesciences [***7] AG v. CoreValve,
Inc., 699 F.3d 1305, 1309-10 (Fed.Cir.2012) (explaining that failure to
enable a commercial embodiment does not demonstrate nonenablement under
35 U.S.C. § 112(a)). Nor do Appellants adequately explain why the claimed
invention cannot be practiced without the calibration method that Teva
deleted from its draft patent application.
[*1372] We therefore affirm the district court's conclusion of no invalidity for
lack of enablement.
[**1662] III. Obviousness
A patent claim is invalid under 35 U.S.C. § 103 "if the differences
between the claimed invention and the prior art are such that the claimed
invention as a whole would have been obvious before the effective filing
date of the claimed invention to a person having ordinary skill in the art
to which the claimed invention pertains." "Obviousness . . . is a legal
conclusion based on underlying facts." Allergan, Inc. v. Sandoz Inc.,
___ F.3d ___, 2013 WL 1810852, at *4 (Fed.Cir.May 1, 2013). "The underlying
factual considerations in an obviousness analysis include the scope and
content of the prior art, the differences between the prior art and the
claimed invention, the level of ordinary skill in the art, and any relevant
secondary considerations," which include "commercial success, long-left but
unsolved needs, failure of others, and unexpected results." Id. (citations
The district court held that the asserted claims would not have been
obvious in view of copolymer-1 compounds with a molecular weight higher than
10 kDa disclosed in U.S. Patent No. 3,849,550 (Teitelbaum) and other prior
art references. Opinion, 876 F.Supp.2d at 401-19. It found that Teitelbaum
disclosed a preference for copolymer-1 compositions having molecular weights
of 18-20 kDa and greater, and that other references explicitly taught away
from the claimed lower molecular weight copolymer-1. The court also
determined that various secondary considerations supported the conclusion of
Appellants argue that the asserted claims would have been obvious because
the claimed copolymer-1 differs from known copolymer-1 by only one
kilodalton unit and behaves similarly to the prior art material.
Specifically, they contend that there is no evidence that copolymer-1 with a
molecular weight less than 10 kDa exhibits an improved toxicity profile over
the prior art copolymer-1. Appellants also dispute the district court's
conclusion that the prior art taught away from the claimed invention. They
acknowledge that one paragraph in a 1974 prior art reference stated that
copolymer-1 with a molecular weight lower than 17 kDa was ineffective for
treating multiple sclerosis. See J.A. 49058-59. But they counter that more
recent art taught that copolymer-1 of lower molecular weight yielded
promising results in human trials. See J.A. 36696-702. With regard to
secondary considerations, Appellants urge that Teva failed to prove a nexus
between lower molecular weight and Copaxone®'s commercial success. They
further contend that there was no long-felt need for the claimed material
because higher molecular weight copolymer-1 was known to be effective.
[4] We see no error in the district [***8] court's obviousness analysis. The court
did not clearly err when it found that the prior art expressed a preference
for higher molecular weight copolymer-1, and therefore taught away from the
claimed invention. See, e.g., Teitelbaum, col. 1 ll. 61-62, col. 2 ll.
19-32; see also J.A. 20391-93, 49058-59. The court also did not clearly err
in the fact findings relevant to secondary considerations, which further
support the conclusion of nonobviousness. For example, the court found that
"Copaxone® is coextensive with the asserted claims," Opinion,
876 F.Supp.2d at 406, triggering a presumption of a nexus between the drug's
commercial success and the claimed invention, see Brown & Williamson Tobacco
Corp. v. Philip Morris, Inc., 229 F.3d 1120, 1130 (Fed.Cir.2000). Because
Copaxone®'s commercial success is undisputed and Appellants have not
rebutted the
[*1373] presumption of a nexus, this consideration favors Teva. We affirm the
district court's determination that Appellants failed to establish that the
claimed invention would have been obvious.
Claim construction is an issue of law that we review de novo. Cybor Corp.
v. FAS Techs., Inc., 138 F.3d 1448, 1454-55 (Fed.Cir.1998) (en bane). In
construing a claim term, we look at the term's plain meaning. Phillips v.
AWH Corp., 415 F.3d 1303, 1313 (Fed.Cir.2005) (en bane). "There are only two
exceptions to this general rule: 1) when a patentee sets out a definition
and acts as his own lexicographer, or 2) when the patentee disavows the full
scope of a claim term either in the specification or during prosecution."
Thorner v. Sony Computer Entm't Am., LLC, 669 F.3d 1362, 1365
(Fed.Cir.2012). In order for the doctrine of prosecution disclaimer to
apply, a statement in prosecution must constitute a clear and unmistakable
disclaimer of claim scope. Omega Eng'g, Inc. v. Raytek Corp., 334 F.3d 1314,
1326 ([**1663] Fed.Cir.2003). Infringement is a question of fact reviewed for clear
error after a bench trial. Alza Corp. v. Mylan Labs., Inc., 464 F.3d 1286,
1289 (Fed.Cir.2006).
The district court construed "copolymer-1" to mean "a mixture of
polypeptides composed of alanine, glutamic acid, lysine, and tyrosine in a
molar ratio of approximately 6:2:5:1." Markman Order, 810 F.Supp.2d at 585;
see ′808 patent, col. 1 ll. 32-43. This construction is not in dispute. The
court explained after trial that, in order to facilitate a comparison with
the accused products, it converted the 6:2:5:1 ratio into percentages (42.9%
alanine, 14.3% glutamic acid, 35.7% lysine, and 7.1% tyrosine). Opinion,
876 F.Supp.2d at 336, 339-40. Based on various examples of copolymer-1
disclosed in the references cited in the specification, the court determined
that an accused product meets the "approximately 6:2:5:1" limitation as long
as its amino acid composition does not vary from the "ideal" percentages by
an aggregate of more than 12%. Id. at 340. The court found that the Mylan
accused product and the Sandoz accused product differ from the "ideal"
percentages by an aggregate of 4.4% and 4.5% respectively, and thus infringe
literally. Id. at 335-44, 356-63. The court also found that Mylan and Sandoz
infringe under the doctrine of equivalents because the overall differences
between the amino acid amounts in the claims and the accused products are
insubstantial. Id. at 345-49, 358.
The parties dispute [***9] whether the district court's consideration of the
percentages in conjunction with its consideration of the "approximately
6:2:5:1" limitation constitutes a "derivative" claim construction or a part
of its infringement analysis. The former is a question of law; the latter is
a question of fact. We hold that whether the amino acid percentages in the
accused products meet the "approximately 6:2:5:1" limitation is a part of
the district court's infringement analysis. Thus, we review the district
court's conclusions for clear error.
B. "Approximately 6:2:5:1"
Appellants, argue that the district court erred in its analysis of
"approximately 6:2:5:1." They contend that the 6:2:5:1 ratio captures
relative proportions of the four amino acids in copolymer-1 to one another.
Appellants argue that the court "eviscerated" these relationships by
analyzing "approximately 6:2:5:1" in terms of an aggregate amount of percent
variation in the amino acid content. Mylan Br. 30. Appellants urge that
examples of copolymer-1 in the references cited in the
[*1374] specification define the scope of "approximately 6:2:5:1," and argue that
these examples allow for at most 16% variation of any particular amino acid
from the "ideal" 6:2:5:1 ratio.
Appellants point out that their products contain the four amino acids in
the ratios 4.6: 1.6: 3.7: 1.0 (Mylan product) and 4.6: 1.5: 3.7: 1.0 (Sandoz
product). They argue that the accused products do not literally infringe the
asserted claims because, for example, the ratio of lysine to tyrosine, 3.7:
1, deviates by more than 16% from the "ideal" ratio of 5:1. Appellants
further contend that the district court erred in its finding of infringement
under the doctrine of equivalents because its analysis vitiated the
"6:2:5:1" requirement.
Teva counters that the district court rightly decided, based on the
intrinsic record and expert testimony, that "approximately 6:2:5:1" covers
compositions that differ from the "ideal" percentages by an aggregate of at
most 12%. Teva argues that Appellants improperly seek to limit the scope of
the claims to prior art examples of copolymer-1. It also contends that
Appellants fail to adequately explain why the district court's analysis
should have focused on the relative ratios of the four amino acids to one
another rather than their proportions relative to the whole.
Teva further contends that Appellants perform a "mathematical sleight of
hand" by normalizing the ratio relative to tyrosine, the least abundant
amino acid in copolymer-1. Teva Br. 32. Teva points out that, while the
6:2:5:1 ratio sets the scale at 14 (= 6 + 2 + 5 + 1), Appellant Mylan's
expression of the ratio in its product bases the scale on the incommensurate
value of 10.9 (= 4.6 + 1.5 + 3.7 + 1.0).[fn3] Teva argues that, in order to
properly compare the Mylan accused product to the claims, the correct way to
express the accused amino acid ratio is 6.0: 2.0: 4.7: 1.3 (i.e., a total [**1664] of
14) or to perform the comparison in terms of percentages. Teva contends that
either of these approaches demonstrates that the accused products meet the
"copolymer-1" limitation as construed by the district court. Teva further
argues that, [***10] when rounding error is taken into account, it becomes clear
that the accused products contain the four amino acids in the 6:2:5:1 ratio.
Finally, it contends that the district court correctly determined that
Appellants infringe under the doctrine of equivalents because the
differences between the claims and the accused products are insubstantial.
[5] We agree with Teva that the district court did not clearly err in
concluding that the accused products literally infringe the asserted claims.
We see no basis for overturning the district court's finding that the
6:2:5:1 ratio must be converted to percentages to ensure a comparison on the
same scale with the amino acid percentages in the accused products. That
comparison reveals that, in the aggregate, the four percentages in1 Mylan's
product (42.7%, 14.4%, 33.6%, and 9.2%) differ from the "ideal" percentages
(42.9%, 14.3%, 35.7%, and 7.1%) by only 4.5%.[fn4] Furthermore, no single
amino acid differs from its corresponding "ideal" percentage by more than
about 2%. Id. at 338.
The district court did not clearly err in determining that these small
differences from the "ideal" percentages mean that the accused products
literally infringe. The court's conclusion is supported by its findings
regarding prior art examples of copolymer-1. See id. at 339-40. These
[*1375] examples show that, even when one of the amino acids (lysine) differs from
its "ideal" percentage by more than 5%, the material is still considered
"copolymer-1." Id. (discussing "Batch 2"); J.A. 49042. The district court's
conclusion is reinforced by the undisputed testimony of Teva's expert, Dr.
George Gokel, that the amino acid content in copolymer-1 is uncertain due to
experimental variations and measurement errors. Id. at 339; J.A. 19825-28.
We need not decide whether a material that differs by 12% from the 6:2:5:1
ratio (expressed in percentages) infringes the asserted claims because the
Mylan and Sandoz accused products deviate from the ratio by less than 5%. We
see no clear error in the district court's determination that these
products, which differ from the "ideal" percentages by less than 5% in the
aggregate, meet the "approximately 6:2:5:1" limitation. Given this
conclusion, we do not need to reach the parties' arguments regarding
infringement under the doctrine of equivalents.
3. Prosecution Disclaimer
The district court also rejected Appellants' argument that Teva disclaimed
copolymer-1 compositions having Mw greater than 10 kDa during prosecution.
Markman Order, 810 F.Supp.2d at 596-98. Appellants challenge this conclusion
on appeal. They contend that their proposed products have Mw less than 10
kDa and thus do not infringe.
During prosecution of several of the asserted patents, Teva overcame
rejections based on the Teitelbaum patent by arguing that, in contrast to
Teitelbaum's copolymer-1 with a "minimum molecular weight of 10
kilodaltons," the pending claims cover "copolymer-1 having a molecular
weight of about 5 to 9 kilodaltons." E.g., J.A. 34747. Teitelbaum does not
explain whether its references to "molecular weight" mean Mp or Mw, but
cites an article that describes the measurement process [***11] in more detail.
Teitelbaum, col. 4 ll. 31-32 (citing J.A. 49043).
Appellants argue that Teva's statements constitute a disclaimer of
copolymer-1 compositions with Mw greater than 10 kDa. They contend that the
article cited in Teitelbaum describes a technique that can measure only Mw.
Appellants argue that an ordinary artisan would thus understand the
prosecution history statements to refer to Mw and to surrender coverage of
any copolymer-1 with Mw greater than 10 kDa.
[6] We agree with Teva that its prosecution history statements do not
constitute a clear and unmistakable disclaimer. The phrase "molecular weight
of 10 kilodaltons" does not expressly refer to any specific molecular weight
measurement — indeed, Group I claims are indefinite due in part to the
ambiguity in the meaning of "molecular weight." The connection between this
statement and the article cited in Teitelbaum is too attenuated to limit the
scope of the claims to copolymer-1 with Mw less than 10 kDa. Moreover, the
technique discussed in that article can yield Mw or a different type of
molecular weight measure, which fails to resolve the ambiguity.
[**1665] CONCLUSION
We have considered the parties' remaining arguments and do not find them
to be persuasive. We hold that the district court did not err in its
conclusions that the claims are infringed, that Appellants failed to prove
that the claims would have been obvious and are not enabled, and that
Appellants failed to prove that Group II claims are indefinite. We also hold
that the district court erred in concluding that Group I claims have not
been proven indefinite. Accordingly, we affirm the district court's
judgments of infringement and no invalidity with respect to Group II
[*1376] claims, reverse its judgment of no invalidity with respect to Group I
claims, and remand.[fn5]
AFFIRMED-IN-PART, REVERSED-IN-PART AND REMANDED
[fn1] The asserted patents are: U.S. Patent Nos. 5,800,808 (′808 patent),
5,981,589 (′589 patent), 6,048,898 (′898 patent), 6,054,430 (′430 patent),
6,342,476 (′476 patent), 6,362,161 (′161 patent), 6,620,847 (′847 patent),
6,939,-539 (′539 patent), and 7,199,098 (′098 patent).
[fn2] The six Group II claims are: claims 1 and 2 of the ′430 patent, claim
1 of the ′476 patent, claim 1 of the ′161 patent, and claims 1 and 8 of the
′098 patent. The remaining claims are collectively referred to as Group I
[fn3] These arguments apply equally to Sandoz's accused product.
[fn4] In Sandoz's product, the corresponding percentages are 43.6%, 14.7%,
33.4%, 8.3%, amounting to an aggregate difference of 4.5% from the "ideal"
[fn5] We note that, according to the Orange Book, all of Teva's Copaxone®
patents expire on the same date: May 24, 2014. We remand for the district
court to determine whether there exists any need to modify its injunction.
Judgment vacated and case remanded by
Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 113 U.S.P.Q.2d 1269, 83 U.S.L.W. 4055 (2015)
Judgment Reversed (In Part), Judgment Affirmed (In Part), Case Remanded
12-01567 (Fed. Cir.)
12-01568 (Fed. Cir.)
12-01569 (Fed. Cir.)
12-01570 (Fed. Cir.)