  United States Court of Appeals
      for the Federal Circuit
                ______________________

      SUNOVION PHARMACEUTICALS, INC.,
              Plaintiff-Appellant,

                           v.

      TEVA PHARMACEUTICALS USA, INC.,
          SUN PHARMA GLOBAL, INC.,
   SUN PHARMACEUTICAL INDUSTRIES, INC.,
   SUN PHARMACEUTICAL INDUSTRIES, LTD.,
     ALPHAPHARM PTY. LTD., MYLAN, INC.,
     AND MYLAN PHARMACEUTICALS, INC.,
                 Defendants,

                          AND

     DR. REDDY’S LABORATORIES, LTD. AND
      DR. REDDY’S LABORATORIES, INC.,
              Defendants-Appellees.
             ______________________

                      2013-1335
                ______________________

    Appeal from the United States District Court for the
District of New Jersey in No. 09-CV-1302, Judge Susan D.
Wigenton.
                 ______________________

             Decided: September 26, 2013
               ______________________
2               SUNOVION PHARM.   v. TEVA PHARM. USA, ET AL.



    JOSEPH M. O’MALLEY, JR., Paul Hastings LLP, of New
York, New York, argued for plaintiff-appellant. With him
on the brief were BRUCE M. WEXLER, ERIC W. DITTMANN,
DAVID M. CONCA, ISAAC S. ASHKENAZI, and JASON T.
CHRISTIANSEN. Of counsel on the brief was STEPHEN B.
KINNAIRD, of Washington, DC.

   STUART D. SENDER, Budd Larner, P.C., of Short Hills,
New Jersey, argued for defendants-appellees. With him
on the brief were BRUCE D. RADIN, ALAN H. POLLACK,
FRANK D. RODRIGUEZ, and ELLEN T. LOWENTHAL.
                ______________________

    Before LOURIE, SCHALL, and REYNA, Circuit Judges.
LOURIE, Circuit Judge.
    Sunovion Pharmaceuticals, Inc. (“Sunovion”) appeals
from the decision of the United States District Court for
the District of New Jersey granting summary judgment
that Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s
Laboratories, Inc. (collectively “Reddy”) do not infringe
claims 1, 2, and 8 of Sunovion’s U.S. Patent 6,444,673 (the
“’673 patent”). Sunovion Pharm., Inc. v. Teva Pharm.
USA, Inc., No. 09-1302, 2013 WL 211289 (D.N.J. Jan. 17,
2013). Because we conclude that, although the district
court did not err in construing the asserted claims,
Sunovion was entitled to a judgment of infringement as a
matter of law under 35 U.S.C. § 271(e)(2)(A), we reverse.
                      BACKGROUND
    Sunovion owns the rights to the ’673 patent, which is
directed to pharmaceutical compositions of the single-
enantiomer drug eszopiclone, the active ingredient in the
chiral drug marketed as a sleep medication under the
brand name Lunesta®. Representative claim 1 recites:
    1. 6-(5-chloro-2-pyridyl)-5-[(4-methyl-1-
    piperazinyl)carbonyloxy]-7-oxo-6,7-dihydro-5H-
 SUNOVION PHARM.   v. TEVA PHARM. USA, ET AL.             3



    pyrrolo[3,4-b]pyrazine, or a pharmaceutically
    acceptable salt thereof, in the form of its
    dextrorotatory isomer and essentially free of its
    levorotatory isomer.
’673 patent col. 4 ll. 18–22.
    Eszopiclone is the dextrorotatory or (S)-enantiomer of
the chemical compound specified in the claim, which in its
racemic form is known as zopiclone. * See id. col. 1 ll. 19–
22. In approving the product Lunesta®, the U.S. Food and



    *   Stereoisomers are molecules that have the same
molecular formula or atomic composition, but which are
arranged differently in space. Enantiomers are a pair of
stereoisomers that are non-superimposable mirror images
of each other and often have distinct physical proper-
ties. In organic chemistry, enantiomeric pairs include
compounds that have one or more stereogenic centers, i.e.,
carbon atoms with four different substituent atoms or
groups of atoms. Those compounds are thus said to be
chiral.
    To distinguish between different enantiomers of the
same compound, chemists use various naming conven-
tions. Enantiomers are sometimes called optical isomers
because a pure enantiomer rotates plane-polarized light
in a particular direction. If the light rotates clockwise,
then that enantiomer is labeled as dextrorotatory; its
counterpart will rotate the light counterclockwise and is
labeled levorotatory. A different nomenclature system
labels each stereogenic center “(R)” or “(S)” according to a
set of scientific rules. A racemate (or racemic mixture) is
an equal mixture of two enantiomers and therefore is not
optically active (i.e., will not rotate plane-polarized light
in either direction because its constituent enantiomers
cancel each other out).
4                SUNOVION PHARM.   v. TEVA PHARM. USA, ET AL.



Drug Administration (the “FDA”) required that each
tablet of Lunesta® contain not more than (“NMT”) 0.3% of
eszopiclone’s corresponding levorotatory enantiomer, (R)-
zopiclone.
     Pursuant to 21 U.S.C. § 355(b)(1), the ’673 patent is
listed as referenced to Lunesta® in the FDA’s Approved
Drug Products with Therapeutic Equivalence Evaluations
publication (commonly known as the “Orange Book”).
Reddy consequently submitted to the FDA Abbreviated
New Drug Application (“ANDA”) 091024, which included
a so-called paragraph IV certification with respect to the
’673 patent under the Hatch-Waxman Act, 21 U.S.C.
§ 355(j)(2)(A)(vii)(IV), seeking approval to manufacture,
use, and sell 1 mg, 2 mg, and 3 mg eszopiclone tablets as
generic versions of Lunesta® prior to the expiration of the
’673 patent. Sunovion then initiated the instant suit,
asserting that Reddy’s ANDA submission constituted an
act of infringement of claims 1, 2, and 8 of the ’673 patent
according to 35 U.S.C. § 271(e)(2)(A).
    Following a Markman hearing, the district court
construed the claim term “essentially free” to mean “less
than 0.25% of [the] levorotatory isomer.”         Sunovion
Pharm., Inc. v. Teva Pharm. USA, Inc., No. 09-1302
(D.N.J. Apr. 10, 2012), ECF No. 417 (“Markman Opin-
ion”). The court found that there was no plain meaning
for the disputed term and thus focused on intrinsic evi-
dence, including the prosecution history of the patent,
because it was undisputed that neither the claims nor the
written description defined what degree of enantiomeric
purity of the dextrorotatory isomer was “essentially free”
of the levorotatory isomer. Id. at 5–6. The court held that
Sunovion was bound by its own definition of the invention
as containing less than 0.25% of the levorotatory enanti-
omer through a declaration submitted by named co-
inventor Roussel and through amendments and argu-
ments made during prosecution. Id. at 9–11. The court
also rejected the conclusions of Sunovion’s expert as
 SUNOVION PHARM.   v. TEVA PHARM. USA, ET AL.           5



extrinsic evidence and “limited by the fact that he did not
read the entire file history of the patent” in finding that
his proposed construction was overcome by Sunovion’s
own repeated characterizations of Example 1 of the pa-
tent as demonstrating less than 0.25% of the levorotatory
isomer. Id. at 12.
    Reddy’s original ANDA specification, submitted to
the FDA on December 15, 2008, requested regulatory
approval for generic eszopiclone products with “[n]ot less
than 0.3% and [n]ot more than 1.0%” levorotatory isomer.
J.A. 4136. On June 24, 2010, the FDA communicated to
Reddy deficiencies in its ANDA specification, particularly
that the requested “limit for [levorotatory]-isomer is not
acceptable,” and consequently required Reddy to “tighten
the [levorotatory]-Zopiclone limit in the drug substance
and drug product to NMT 0.30%.” J.A. 4968–69. In
response, Reddy submitted an amendment to the FDA on
April 26, 2012, revising its ANDA specification to request
approval for generic eszopiclone products restricted to
“NMT 0.6%” (i.e., 0.0–0.6%) of the levorotatory isomer.
J.A. 5669.
    Reddy then moved for summary judgment of nonin-
fringement. The district court initially denied Reddy’s
motion without prejudice, but permitted Reddy to file a
renewed motion for summary judgment of noninfringe-
ment accompanied by a so-called “certification” that
Reddy would not market an eszopiclone product contain-
ing less than 0.3% of the levorotatory isomer. Sunovion,
2013 WL 211289, at *2. Reddy subsequently submitted a
declaration to the district court from one of its employees
vowing to the court, but not to the FDA, that Reddy would
only market generic eszopiclone tablets containing 0.3–
0.6% levorotatory isomer, notwithstanding that Reddy
had not (and still has not) gained regulatory approval for
products with that level of impurity. Id.; J.A. 5665–67
(the “Cappuccino certification”); see also Sunovion
6                SUNOVION PHARM.   v. TEVA PHARM. USA, ET AL.



Pharm., Inc. v. Teva Pharm. USA, Inc., No. 09-1302
(D.N.J. Apr. 10, 2013), ECF No. 507 (“Final Judgment”).
     The district court accordingly granted Reddy’s re-
newed motion for summary judgment of noninfringement.
Sunovion, 2013 WL 211289, at *6. The court found that
the eszopiclone products that Reddy presumes to market
would likely be “outside the infringing range of less than
0.25% of levorotatory isomer” because of Reddy’s internal
manufacturing guidelines and the Cappuccino certifica-
tion in which it pledged to constrain the amount of levoro-
tatory isomer to not less than 0.3%, despite the contrary
representations made to the FDA in Reddy’s amended
ANDA specification. Id. at *4–5.
    Sunovion timely appealed. To facilitate appeal, the
parties stipulated to the validity and enforceability of the
asserted claims of the ’673 patent. Final Judgment at 2.
We have jurisdiction pursuant to 28 U.S.C. § 1295(a)(1).
                       DISCUSSION
    Summary judgment in this case was premised in part
on the district court’s interpretation of the “essentially
free” limitation of the asserted claims. We address claim
construction as a matter of law, which we review without
deference on appeal. Cybor Corp. v. FAS Techs., Inc., 138
F.3d 1448, 1454–56 (Fed. Cir. 1998) (en banc).
    Summary judgment is appropriate if the movant
“shows that there is no genuine dispute as to any material
fact and the movant is entitled to judgment as a matter of
law.” Fed. R. Civ. P. 56(a). We review the grant of sum-
mary judgment under the law of the regional circuit in
which the district court sits, here, the Third Circuit.
Lexion Med., LLC v. Northgate Techs., Inc., 641 F.3d
1352, 1358 (Fed. Cir. 2011). The Third Circuit reviews
the grant of summary judgment without deference, draw-
ing all reasonable inferences in favor of the nonmovant.
Nicini v. Morra, 212 F.3d 798, 805–06 (3d Cir. 2000) (en
 SUNOVION PHARM.   v. TEVA PHARM. USA, ET AL.           7



banc); see also Anderson v. Liberty Lobby, Inc., 477 U.S.
242, 255 (1986).
    Infringement is a question of fact. Move, Inc. v. Real
Estate Alliance Ltd., 709 F.3d 1117, 1121 (Fed. Cir. 2013).
But on appeal from a grant of summary judgment of
noninfringement, we determine whether, after resolving
reasonable factual inferences in favor of the patentee, the
district court correctly concluded that no reasonable jury
could find infringement. Id.
                              I
    Sunovion argues that the claim limitation “essentially
free” should be defined as “largely but not wholly free” of
the levorotatory isomer, which encompasses greater than
approximately 90% dextrorotatory isomer by weight of the
total weight of zopiclone. Appellant Br. 34, 49–50. Reddy
maintains that the district court’s construction was cor-
rect in defining “essentially free” as “less than 0.25% of
[the] levorotatory isomer.” Appellee Br. 34. We agree
with Reddy and the district court concerning this claim
construction.
    When construing claim terms, we first look to, and
primarily rely on, the intrinsic evidence, including the
claims themselves, the specification, and the prosecution
history of the patent, which is usually dispositive. Phil-
lips v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005)
(en banc); Vitronics Corp. v. Conceptronic, Inc., 90 F.3d
1576, 1582 (Fed. Cir. 1996) (stating that prosecution
history may be critical in interpreting disputed claim
terms because it “contains the complete record of all the
proceedings before the Patent and Trademark Office,
including any express representations made by the appli-
cant regarding the scope of the claims”).
    Claim terms “are generally given their ordinary and
customary meaning,” Phillips, 415 F.3d at 1312 (quoting
Vitronics, 90 F.3d at 1582), but we agree with the district
8                SUNOVION PHARM.   v. TEVA PHARM. USA, ET AL.



court that there is no plain or ordinary meaning to the
claim term “essentially free” because terms of approxima-
tion such as “essentially” are capable of multiple mean-
ings. Deering Precision Instruments, L.L.C. v. Vector
Distrib. Sys., Inc., 347 F.3d 1314, 1322–23 (Fed. Cir.
2003); Ecolab, Inc. v. Envirochem, Inc., 264 F.3d 1358,
1369 (Fed. Cir. 2001). Turning therefore to the intrinsic
record of the patent, we likewise find no reason to disturb
the district court’s interpretation because the specification
of the ’673 patent offers no guidance on the issue and the
prosecution history shows that the applicants repeatedly
defined their invention as the dextrorotatory isomer of
zopiclone containing less than 0.25% of the levorotatory
isomer.
    The term “essentially free” appears only in the claims
of the ’673 patent and does not appear anywhere in the
written description. Except for the claims, the specifica-
tion is devoid of any reference to the degree of enantiopu-
rity of the claimed dextrorotatory isomer of zopiclone.
The written description refers to the subject of the
claimed invention merely as the dextrorotatory isomer of
zopiclone, distinguished from the racemate, which is by
definition a 50/50 mixture of the two enantiomers. ’673
patent col. 1 ll. 24–35. However, the prosecution history
of the application that matured into the ’673 patent
demonstrates that the applicants repeatedly and consist-
ently defined their claimed invention to be as exhibited by
Example 1. The only other example in the patent, Exam-
ple 2, briefly describes a pharmaceutical formulation of
the active product, id. col. 4 ll. 5–15, not another example
of the dextrorotatory isomer.
    At one point, the applicants relied on the disclosure of
Example 1 as “evidence of the fact that the material of the
instant invention consists essentially of the [dextrorotato-
ry]-isomer of zopiclone.” J.A. 2174. In overcoming an
obviousness rejection at another point, the applicants
again identified their invention as Example 1, arguing
 SUNOVION PHARM.   v. TEVA PHARM. USA, ET AL.            9



that there was “no suggestion in the prior art which
would lead one of ordinary skill [to] achieve the claimed
result, namely, resolution of the racemate to yield the
[dextrorotatory]-isomer. See Example 1.” J.A. 1845–46.
To make their meaning clear, the applicants also submit-
ted a declaration by named co-inventor Roussel, which
stated that the “pure form” of the dextrorotatory isomer of
zopiclone “as described in Example 1” contained “lower
than 0.25%” of the levorotatory isomer. J.A. 2185–86.
The Roussel declaration further stated that the data of
Example 1, i.e., less than 0.25% levorotatory isomer
content, “demonstrate the purity of the [dextrorotatory]-
isomer of the invention and show[] that the instant inven-
tion consists essentially of the [dextrorotatory]-isomer of
zopiclone.” Id.
    Moreover, concurrent with that prosecution, the ap-
plicants requested an interference with another patent
that disclosed and claimed an enantiomerically purified
form of zopiclone. J.A. 2235–36. In that request, the
applicants invoked the Roussel declaration and its char-
acterization of the invention as establishing a “convinc-
ing” argument for patentability, specifically identifying
Example 1 as support for the particular term “essentially
free,” and directly equated the term “essentially free” to
the dextrorotatory isomer of zopiclone containing less
than 0.25% levorotatory isomer. J.A. 2244–45.
     The totality of the record evidence thus supports the
interpretation of the term “essentially free” as less than
0.25% levorotatory isomer. The definition of a claim term
can be affected through “repeated and definitive re-
marks,” Computer Docking Station Corp. v. Dell, Inc., 519
F.3d 1366, 1374 (Fed. Cir. 2008); Honeywell Int’l, Inc. v.
ITT Indus., Inc., 452 F.3d 1312, 1318 (Fed. Cir. 2006), and
it is also appropriate to rely on the record of interference
proceedings in construing claim terms. Phillips Petrole-
um Co. v. Huntsman Polymers Corp., 157 F.3d 866, 872
(Fed. Cir. 1998); Young Dental Mfg. Co. v. Q3 Special
10               SUNOVION PHARM.   v. TEVA PHARM. USA, ET AL.



Prods., Inc., 112 F.3d 1137, 1143 (Fed. Cir. 1997) (using
arguments made in request for interference to interpret
disputed claim limitation).
    The applicants’ repeated and consistent attribution of
the purity level of less than 0.25% levorotatory isomer to
“the invention” and “the instant invention” thus gives
meaning to the term “essentially free.” Verizon Servs.
Corp. v. Vonage Holdings Corp., 503 F.3d 1295, 1308
(Fed. Cir. 2007) (“describ[ing] the features of the ‘present
invention’ as a whole . . . limits the scope of the
invention”); Microsoft Corp. v. Multi-Tech Sys., Inc., 357
F.3d 1340, 1348 (Fed. Cir. 2004) (limiting claim terms to
an embodiment that was “repeatedly and consistently
describe[d]”).        In   particular,    the    applicants’
representations regarding the Roussel declaration “inform
the meaning of the claim language by demonstrating how
the inventor understood the invention.” Phillips, 415
F.3d at 1317. Sunovion asserted the less than 0.25%
levorotatory isomer purity measurements as an
expression of its invention in order to secure its patent
rights. See Southwall Techs., Inc. v. Cardinal IG, Co., 54
F.3d 1570, 1576 (Fed. Cir. 1995) (“[C]laims may not be
construed one way in order to obtain their allowance and
in a different way against accused infringers.”); see also
Biogen Idec, Inc. v. GlaxoSmithKline LLC, 713 F.3d 1090,
1095–96 (Fed. Cir. 2013) (determining scope of claims in
view of statements made during prosecution in response
to enablement rejection); Ethicon Endo-Surgery, Inc. v.
U.S. Surgical Corp., 93 F.3d 1572, 1580–81 (Fed. Cir.
1996) (relying on patentee’s prosecution history to
interpret claim because specification provided minimal
guidance).
     Accordingly, we affirm the district court’s construc-
tion of the claim term “essentially free” as containing less
than 0.25% levorotatory isomer.
 SUNOVION PHARM.   v. TEVA PHARM. USA, ET AL.           11



                             II
    Following its decision on claim construction, the
district court ruled on summary judgment that Reddy did
not infringe claims 1, 2, and 8 of the ’673 patent.
Sunovion, 2013 WL 211289, at *4–5.
     Sunovion argues that the district court erred in con-
cluding that Reddy would not infringe by making and
selling its product approved by the FDA. It contends that
a judgment of infringement is appropriate even under
what it characterizes as the erroneous construction that
“essentially free” means less than 0.25% levorotatory
isomer. Sunovion argues that Reddy’s amended ANDA
specification itself controls the issue of infringement
because it expressly defines Reddy’s product in a way that
directly addresses the infringement question (i.e., eszopi-
clone with 0.0–0.6% levorotatory isomer), which includes
the “less than 0.25%” purity range that would allow
Reddy to sell infringing products. Appellant Br. 53–54.
     Reddy responds that it does not infringe because, de-
spite conceding that it is “bound by its ANDA specifica-
tion,” its internal manufacturing guidelines require its
generic eszopiclone products to contain at least 0.3%
levorotatory isomer. Appellee Br. 50. Reddy also argues
that the Cappuccino certification assured the district
court that Reddy would only market generic eszopiclone
tablets containing 0.3–0.6% levorotatory isomer, asserting
that “literal non-infringement is as simple as 0.3 is more
than 0.25.” Id. at 48. Reddy further contends that
“[a]fter [Reddy] sells generic eszopiclone commercially, if
Sunovion tests and believes it infringes, Sunovion is free
to bring suit against [Reddy] under 35 U.S.C. § 271(a).”
Id. at 50.
    We agree with Sunovion. Although no traditional pa-
tent infringement has occurred until a patented product is
made, used, or sold, under the Hatch-Waxman frame-
work, the filing of an ANDA itself constitutes a technical
12               SUNOVION PHARM.   v. TEVA PHARM. USA, ET AL.



infringement for jurisdictional purposes.         35 U.S.C.
§ 271(e)(2)(A); Eli Lilly & Co. v. Medtronic, Inc., 496 U.S.
661, 676 (1990). But the ultimate infringement question
is determined by traditional patent law principles and, if
a product that an ANDA applicant is asking the FDA to
approve for sale falls within the scope of an issued patent,
a judgment of infringement must necessarily ensue. See
Abbott Labs. v. TorPharm, Inc., 300 F.3d 1367, 1373 (Fed.
Cir. 2002).
     What Reddy has asked the FDA to approve as a regu-
latory matter is the subject matter that determines
whether infringement will occur, and the fact that Reddy
either tells the court that its manufacturing guidelines
will keep it outside the scope of the claims or has even
filed a declaration in the court stating that it will stay
outside the scope of the claims does not overcome the
basic fact that it has asked the FDA to approve, and hopes
to receive from the FDA, approval to market a product
within the scope of the issued claims. In this case, Red-
dy’s request for approval of levorotatory amounts from
0.0–0.6% is within the scope of the “less than 0.25%”
limitation of the ’673 patent claims.
    Reddy’s amended ANDA specification seeking FDA
approval for generic eszopiclone products with 0.0–0.6%
levorotatory isomer mandates a finding of infringement.
It is a stipulated fact that Reddy has not yet received
regulatory approval, Final Judgment at 2, and it is un-
disputed that the FDA has required Reddy to “tighten the
[levorotatory]-Zopiclone limit in [Reddy’s] drug substance
and drug product to NMT 0.3%” in response to Reddy’s
original ANDA specification. Reddy’s own Cappuccino
certification itself recognizes that its promise to the court
was based on “what will be the presumed FDA-approved
specification of ‘not more than 0.6%’ [levorotatory]-
isomer.” Cappuccino certification at 4 (emphasis added).
 SUNOVION PHARM.   v. TEVA PHARM. USA, ET AL.            13



     Reddy’s focus on its so-called certification to the dis-
trict court—pledging to follow internal manufacturing
guidelines that may produce a drug composition for which
the FDA has indicated it will not grant approval—as
“other evidence” dispositive of the infringement inquiry is
misplaced, as was the court’s reliance on it in granting
summary judgment of noninfringement. The Hatch-
Waxman framework was established to deal with situa-
tions in which a generic drug manufacturer seeks an
ANDA to copy an approved product, and it therefore must
comply with the definition of the approved product. 21
U.S.C. § 355(j)(4)(F); see Pfizer Inc. v. Shalala, 182 F.3d
975, 977 (D.C. Cir. 1999). Allowing Reddy to avoid in-
fringement based on its unconventional and unenforcea-
ble “guarantee” when it is asking for and may receive
FDA approval to market a product within the scope of the
innovator’s patent, would be incompatible with the basic
principles of patent law.
    What a generic applicant asks for and receives ap-
proval to market, if within the scope of a valid claim, is an
infringement. See Abbott, 300 F.3d at 1373 (“[b]ecause
drug manufacturers are bound by strict statutory provi-
sions to sell only those products that comport with the
ANDA’s description of the drug, an ANDA specification
defining a proposed generic drug in a manner that direct-
ly addresses the issue of infringement will control the
infringement inquiry.”). If it had no intent to infringe,
Reddy should not have requested, or should not accept,
approval to market a product within the scope of the
claim. The possibility that Sunovion could later test any
of Reddy’s commercially available generic eszopiclone
products, when approved, and bring an infringement
action under § 271(a), as Reddy argues, unnecessarily
defers resolution of the infringement issue that the
Hatch-Waxman framework was intended to address
earlier, generally before ANDA approval. Reddy does not
dispute that it would be practically impossible for Sunovi-
14              SUNOVION PHARM.   v. TEVA PHARM. USA, ET AL.



on, the FDA, or any court to monitor Reddy’s compliance,
particularly in view of the status of eszopiclone as a
controlled substance.
    Reddy relies on Bayer AG v. Elan Pharmaceutical Re-
search Corp., 212 F.3d 1241 (Fed. Cir. 2000) and Glaxo,
Inc. v. Novopharm, Ltd., 110 F.3d 1562 (Fed. Cir. 1997) to
support its noninfringement argument. We find the facts
of those cases, however, to be significantly different from
those present here. In Bayer, we upheld a summary
judgment of no literal infringement because the generic
manufacturer’s ANDA specification itself required that
the proposed product have a specific surface area outside
of the range claimed by the innovator’s asserted patent.
Bayer, 212 F.3d at 1250. In Glaxo, we likewise upheld a
judgment of no literal infringement because the ANDA
application specified only that the generic product would
have one crystalline form with certain purity, but did not
reveal whether a different crystalline form claimed by the
asserted patents would be present at all. Glaxo, 110 F.3d
at 1569. In that case, we endorsed the district court’s
reference to evidence including biobatch data and actual
samples of the generic composition, which Novopharm
had submitted to the FDA, as relevant to the infringe-
ment inquiry because the ANDA specification itself did
not resolve the question of infringement in the first in-
stance. See also Abbott, 300 F.3d at 1373 (noting that
“there may well be genuine disputes as to whether the
ANDA specification defines the compound with sufficient
particularity to answer the infringement inquiry.”). In
both Bayer and Glaxo, we thus held that approved com-
pounds outside the scope of the relevant claims did not
infringe.
    However, the converse must also be true: if an ANDA
specification defines a compound such that it meets the
limitations of an asserted claim, then there is almost
never a genuine issue of material fact that the claim is
infringed. Id. Unlike the circumstances in Bayer and
 SUNOVION PHARM.   v. TEVA PHARM. USA, ET AL.            15



Glaxo, that is the case before us.        Reddy’s ANDA
specification clearly describes a product that meets the
limitations of the asserted claims.
    We therefore hold that any so-called certification
pledging not to infringe cannot override the conclusion
that when a drug manufacturer seeks FDA approval to
market a generic compound within the scope of a valid
patent, it is an infringement as a matter of law. Simply
saying “But I won’t do it” is not enough to avoid
infringement.
     Accordingly, in view of the district court’s correct
construction that the asserted claims of the ’673 patent
are directed to the dextrorotatory isomer of zopiclone
containing less than 0.25% levorotatory isomer, we
conclude that Reddy’s ANDA specification for generic
eszopiclone products with 0.0–0.6% levorotatory isomer
literally infringes claim 1 as a matter of law. Reddy’s
ANDA       specification   indisputably    includes   the
dextrorotatory isomer of zopiclone with a purity in the
range of less than 0.25% levorotatory isomer, which is
covered by claim 1 of Sunovion’s ’673 patent.
                       CONCLUSION
    In view of the foregoing, we conclude that the district
court’s construction of the asserted claims was correct, but
we also conclude that the court erred in granting sum-
mary judgment of noninfringement to Reddy. Therefore,
because Reddy’s ANDA specification infringes claim 1 of
Sunovion’s ’673 patent as a matter of law, the judgment of
the district court is reversed.
                       REVERSED
