Sunovion Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc. , 731 F.3d 1271 ( 2013 )


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  •   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
    

Document Info

Docket Number: 2013-1335

Citation Numbers: 731 F.3d 1271, 108 U.S.P.Q. 2d (BNA) 1486, 2013 U.S. App. LEXIS 19656, 2013 WL 5356823

Judges: Lourie, Schall, Reyna

Filed Date: 9/26/2013

Precedential Status: Precedential

Modified Date: 11/5/2024

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