Eli Lilly and Company v. Actavis Elizabeth , 435 F. App'x 917 ( 2011 )


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  •    NOTE: This disposition is nonprecedential
    United States Court of Appeals
    for the Federal Circuit
    __________________________
    ELI LILLY AND COMPANY,
    Plaintiff-Appellant,
    v.
    ACTAVIS ELIZABETH LLC,
    Defendant-Appellee,
    AND
    SUN PHARMACEUTICAL INDUSTRIES, LTD.,
    Defendant-Appellee,
    AND
    SANDOZ, INC.,
    Defendant-Appellee,
    AND
    MYLAN PHARMACEUTICALS INC.,
    Defendant-Appellee,
    AND
    APOTEX INC.,
    Defendant-Appellee,
    AND
    AUROBINDO PHARMA LTD.,
    Defendant-Appellee,
    ELI LILLY AND COMPANY   v. ACTAVIS                       2
    AND
    TEVA PHARMACEUTICALS USA, INC.,
    Defendant-Appellee.
    __________________________
    2010-1500
    __________________________
    Appeal from the United States District Court for the
    District of New Jersey in Case No. 07-CV-3770, Judge
    Dennis M. Cavanaugh.
    ___________________________
    Decided: July 29, 2011
    ___________________________
    CHARLES E. LIPSEY, Finnegan, Henderson, Farabow,
    Garrett & Dunner, LLP, of Reston, Virginia, argued for the
    plaintiff-appellant. With him on the brief were L. SCOTT
    BURWELL; ROBERT D. BAJEFSKY, LAURA P. MASUROVSKY, and
    J. DEREK MCCORQUINDALE, of Washington, DC; and
    JENNIFER S. SWAN, of Palo Alto, California. Of counsel on
    the brief were MARK J. STEWART and TONYA L. COMBS, Eli
    Lilly and Company, of Indianapolis, Indiana.
    WILLIAM A. RAKOCZY, Rokaczy Molino Mazzochi Siwik
    LLP, of Chicago, Illinois, argued for defendants-appellees
    Sun Pharmaceutical Industries Ltd, Sandoz Inc. and
    Aurobindo Pharma, Ltd. With him on the brief for defen-
    dant-appellee Aurobindo Pharam Ltd was CHRISTINE J.
    SIWIK. Of counsel were GREGORY A. DUFF and ROBERT M.
    TEIGEN. On the brief were KEITH V. ROCKEY and KATHLEEN
    A. LYONS, Rockey Depke, & Lyons, LLP, of Chicago, Illinois,
    for defendant-appellee Sandoz Inc.; and THOMAS J. PARKER
    and VICTORIA E. SPATARO, Alston & Bird LLP, of New York,
    3                           ELI LILLY AND COMPANY   v. ACTAVIS
    New York for defendant-appellee Mylan Pharmaceuticals
    Inc.; ALAN B. CLEMENT, HUGH S. BALSAM, KEITH D. PARR,
    ANDREA L. WAYDA, SCOTT, B. FEDER, KEVIN M. NELSON and
    MYOKA K. GOODIN, Locke Lord Bissell & Liddell LLP, of
    New York, New York, for defendant-appellee Apotex,Inc. Of
    counsel on the brief was SHASHANK UPADHYE, Apotex, Inc, of
    Toronto, Canada, for defendant-appellee Apotex, Inc. Also
    on the brief were JAMES F. HURST, GAIL STANDISH, PETER E.
    PERKOWSKI and ANDREW C. NICHOLS, Winston & Strawn
    LLP, of Chicago, Illinois, for defendant-appellee Sun
    Pharamaceutical Industries, Ltd. Of counsel was STEFFEN
    JOHNSON.
    CHAD A. LANDMON, Axinn, Veltop & Harkrider lLLP, of
    Hartford, Connecticut, for defendant-appelle Actavis Eliza-
    beth LLC. With him on the brief was MATTHEW J. BECKER.
    __________________________
    Before NEWMAN, FRIEDMAN, ∗ AND LOURIE, Circuit Judges.
    NEWMAN, Circuit Judge.
    This case arises on the filing by each of the defendants
    of an Abbreviated New Drug Application (ANDA), accompa-
    nied by a Hatch-Waxman Act “Paragraph IV certification”
    challenging the validity and enforceability and asserting
    non-infringement of United States Patent No. 5,658,590 (the
    ’590 patent) owned by Eli Lilly and Company. The ’590
    patent is directed to the use of the drug atomoxetine to treat
    attention-deficit/hyperactivity disorder (ADHD).         Lilly
    obtained federal regulatory approval from the Food and
    Drug Administration (FDA), and markets the product for
    ∗
    Circuit Judge Friedman heard oral argument in this
    appeal, but died on July 6, 2011 and did not participate in
    the final decision. The case was decided by the remaining
    judges of the panel, in accordance with Fed. Cir. Rule 47.11.
    ELI LILLY AND COMPANY   v. ACTAVIS                         4
    this use, with the brand name Strattera®. The defendants
    seek to sell generic counterparts of this drug before the
    expiration date of the ’590 patent.
    The United States District Court for the District of New
    Jersey sustained the ’590 patent against the defendants’
    challenges on the grounds of inequitable conduct, anticipa-
    tion, obviousness, and non-enablement. However, the court
    held the claims invalid for lack of utility, which the court
    called “enablement/utility.” The court also held that if the
    claims were valid the defendants would be liable for in-
    ducement to infringe, but that they would not be liable for
    contributory infringement. The ruling of invalidity for lack
    of utility, and the ruling that contributory infringement
    does not also apply, are reversed. The district court’s other
    rulings are affirmed. 1
    I
    THE PATENTED INVENTION
    The ’590 patent is directed to the use of the compound
    tomoxetine, 2 having the chemical name (R)-(–)-N-methyl-3-
    (2-methylphenoxy)-3-phenylpropylamine, for treatment of
    ADHD. Claim 1 is as follows:
    1. A       method      of     treating    attention-
    deficit/hyperactivity disorder comprising adminis-
    tering to a patient in need of such treatment an ef-
    fective amount of tomoxetine.
    1  Eli Lilly & Co. v. Actavis Elizabeth LLC, 
    676 F. Supp. 2d 352
     (D.N.J. 2009); 
    731 F. Supp. 2d 348
     (D.N.J.
    2010).
    2  The common names “atomoxetine” and “tomoxetine”
    are both used in the record, and are used herein as they
    appear in the record.
    5                           ELI LILLY AND COMPANY   v. ACTAVIS
    Claim 1 was treated by the parties and the district court as
    dispositive of the issues. At the time the ’590 patent appli-
    cation was filed, tomoxetine was a known compound, de-
    scribed and claimed in Lilly’s 
    U.S. Patent No. 4,314,081,
    issued February 2, 1982. Tomoxetine was studied through
    Phase II clinical trials for the treatment of urinary inconti-
    nence, and through Phase III clinical trials for treatment of
    depression. See 
    21 C.F.R. §312.21
     (explaining Phase I,
    Phase II, and Phase III clinical trial criteria). Although the
    clinical trials showed that tomoxetine was safe for human
    use, the product did not provide the medicinal benefits for
    which it was being evaluated.
    In 1993 Lilly scientists Dr. John Heiligenstein and Dr.
    Gary Tollefson suggested that tomoxetine might be effective
    for treatment of ADHD. ADHD is a complex neurobiological
    disorder characterized by developmentally inappropriate
    levels of inattention, hyperactivity, and impulsiveness. The
    district court explained that the occurrence of ADHD is
    wide, the cause is unknown, and the mechanism of drug
    treatment is unclear. Eli Lilly, 
    731 F. Supp. 2d at 352-53, 366
    . It was explained at the trial that research concerning
    ADHD is difficult because there is no animal model for
    experimental evaluation of the effect of any particular
    treatment.
    At the time of this invention, all of the products that
    were being used to treat ADHD exhibited deficiencies. The
    ’590 patent explains that the stimulants that were being
    used require multiple doses per day, produce a rebound
    effect between doses, and cause undesirable side effects; and
    the tricyclic antidepressants that were being used also
    produce undesirable side effects, and require careful super-
    vision and dosage titration. The record states that the
    suggestion of Drs. Heiligenstein and Tollefson that tomoxet-
    ine might be an effective treatment for ADHD was met with
    ELI LILLY AND COMPANY   v. ACTAVIS                         6
    skepticism. However, arrangements were made to conduct
    clinical tests at Massachusetts General Hospital, and on
    December 1, 1994 the investigators submitted to the FDA
    an Investigational New Drug (IND) application for treat-
    ment of ADHD with tomoxetine. On January 3, 1995 the
    FDA authorized the investigation. The ’590 patent applica-
    tion was filed on January 11, 1995, and the clinical investi-
    gation commenced. By May 1995 initial positive results
    were obtained, and in October 1995 the investigators re-
    ported their preliminary results at a meeting of the Ameri-
    can Association of Child and Adolescent Psychiatry.
    Clinical investigation continued over the next seven
    years, including treatment of patients of various ages and
    ADHD severity, determination of possible side effects and of
    the cumulative effect of treatment, the development and
    evaluation of formulations, schedules, and dosages, and
    other studies relevant to determination of efficacy and
    safety. On November 26, 2002 the FDA approved the use of
    tomoxetine for treatment of ADHD in adults, children, and
    adolescents, at dosages of 10, 18, 25, 40, and 60 mg/day of
    oral administration; on February 14, 2005 the FDA also
    approved dosages of 80 and 100 mg/day. The record states
    that the product has achieved wide use.
    II
    OBVIOUSNESS
    The defendants challenged patent validity on the ground
    of obviousness, arguing that atomoxetine was a known
    norepinephrine inhibitor and thus that it would have been
    obvious to test this product for treatment of ADHD. The
    defendants argued that the inventors simply “substituted
    one potent selective norepinephrine reuptake inhibitor
    (atomoxetine) for another (desipramine) known to be effec-
    7                           ELI LILLY AND COMPANY   v. ACTAVIS
    tive in treating ADHD.” Eli Lilly, 
    731 F. Supp. 2d at 356
    (quoting Defendants’ Post-Trial Brief, at 7).
    The district court, discussing this argument, referred to
    the reports of sudden death of children taking desipramine,
    and found that these “negative reports concerning desip-
    ramine. . . . must weigh to some extent away from using
    atomoxetine as a potential ADHD treatment” although
    “desipramine was functionally a similar compound to ato-
    moxetine.” 
    Id. at 365
    . The court found that “while the prior
    art demonstrated that norepinephrine reuptake inhibition
    was relevant to ADHD treatment, the literature does not
    appear to indicate that it was alone sufficient.” 
    Id. at 362
    .
    The court stated that “it is impermissible to pick and choose
    from any one reference only so much of it as will support a
    given position, to the exclusion of other parts necessary to
    the full appreciation of what such reference fairly suggests
    to one of ordinary skill in the art.” 
    Id. at 365-66
     (quoting In
    re Weslau, 
    353 F.2d 238
    , 241 (CCPA 1965)).
    The district court observed that the entirety of the prior
    art must be considered in determining obviousness. There
    was no evidence that the advantageous and effective proper-
    ties of atomoxetine to treat ADHD, devoid of the negative
    effects of known and similar products, would have been
    obvious from the prior art. The district court found that
    treatment of ADHD with atomoxetine would not have been
    predicted by skilled artisans with a reasonable degree of
    certainty, and concluded that there was not clear and con-
    vincing evidence that the effective use of atomoxetine to
    treat ADHD would have been obvious to a person of ordi-
    nary skill in the field of the invention.
    The defendants argue that, at the very least, it would
    have been “obvious to try” atomoxetine for this use. How-
    ever, applying the guidance of KSR International Co. v.
    ELI LILLY AND COMPANY   v. ACTAVIS                           8
    Teleflex Inc., 
    550 U.S. 398
     (2007), there was no evidence
    that use of atomoxetine had been identified as a possible
    solution to the problems of treating ADHD, nor that the
    exercise of common sense would have led a person of ordi-
    nary skill to test atomoxetine for treatment of ADHD. See
    
    id. at 420-21
    . The evidence was contrary to the likelihood
    that atomoxetine would be effective to treat ADHD, for
    atomoxetine was known not to be an effective antidepres-
    sant, and the known norepinephrine inhibitor despiramine
    was associated with sudden death in children. The experts
    for both sides were in agreement that they would not have
    expected that atomoxetine would be a successful treatment
    of ADHD.
    We discern no error in the district court’s ruling that the
    claims had not been proved invalid on the ground of obvi-
    ousness.
    III
    ENABLEMENT/SCOPE
    The defendants argue that the ’590 specification does
    not enable the full scope of claim 1, pointing out that the
    claim’s words “administering to the patient an effective
    amount” are not limited to the formulations that are specifi-
    cally exemplified in the specification. The defendants argue
    that the patent enables only the immediate release products
    and dosages in the specific examples, and that claim 1 is
    invalid because it is not so limited. The defendants’ expert
    witness testified that formulations and dosages for treat-
    ment of ADHD are not routine, and thus that undue ex-
    perimentation would be required to determine the specific
    formulation and effective amount to be administered to a
    specific patient.
    9                           ELI LILLY AND COMPANY   v. ACTAVIS
    The ’590 patent describes the formulation and admini-
    stration of tomoxetine as follows:
    Since tomoxetine is readily orally absorbed and
    requires only once/day administration, there is little
    or no reason to administer it in any other way than
    orally. It may be produced in the form of a clean,
    stable crystal, and thus is easily formulated in the
    usual oral pharmaceutical forms, such as tablets,
    capsules, suspensions, and the like. The usual
    methods of pharmaceutical scientists are applicable.
    It may be usefully administered, if there is any rea-
    son to do so in a particular circumstance, in other
    pharmaceutical forms, such as injectable solutions,
    depot injections, suppositories and the like, which
    are well known to and understood by pharmaceuti-
    cal scientists. It will substantially always be pre-
    ferred, however, to administer tomoxetine as a
    tablet or capsule and such pharmaceutical forms are
    recommended.
    ’590 patent, col. 2 ll.20-33. The patent’s description of
    dosages for treatment of ADHD with tomoxetine includes:
    The effective dose of tomoxetine for ADHD is in
    the range from about 5 mg/day to about 100 mg/day.
    The preferred adult dose is in the range from about
    10 to about 80 mg/day, and a more highly preferred
    adult dose is from about 20 to about 60 mg/day. The
    children’s dose of course is smaller, in the range
    from about 5 to about 70 mg/day, more preferably
    from about 10 to about 50 mg/day. The optimum
    dose for each patient, as always, must be set by the
    physician in charge of the case, talking into account
    the patient’s size, other medications which the pa-
    ELI LILLY AND COMPANY    v. ACTAVIS                            10
    tient requires, severity of the disorder and all of the
    other circumstances of the patient.
    
    Id.
     at col. 2 ll.7-19.
    The district court found that “the various conceivable
    formulations are standard—and they were not part of the
    basis for the invention’s patentability.” Eli Lilly, 
    731 F. Supp. 2d at 375
    . The court observed that the particular
    dosage form is not the invention, and is routinely deter-
    mined:
    a dosage formulator as defined by the parties—a
    scientist with at least a bachelor’s degree in phar-
    macy or some closely related field, at least three to
    five years of work experience in developing a par-
    ticular pharmaceutical dosage form, and the ability
    to consult with others skilled in other particular
    disciplines (e.g., physicians, analytical chemists,
    and biopharmaceutical scientists)—would be able to
    do so without undue experimentation.
    
    Id. at 376
    . In In re Wands, 
    858 F.2d 731
     (Fed. Cir. 1988),
    this court identified several factors that may assist in
    determining whether experimentation is “undue”:
    (1) the quantity of experimentation necessary, (2)
    the amount of direction or guidance presented, (3)
    the presence or absence of working examples, (4) the
    nature of the invention, (5) the state of the prior art,
    (6) the relative skill of those in the art, (7) the pre-
    dictability or unpredictability of the art, and (8) the
    breadth of the claims.
    
    858 F.2d at 737
    . The district court applied this precedent,
    and concluded that “reliance on formulation-related disclo-
    11                           ELI LILLY AND COMPANY   v. ACTAVIS
    sures in the prior art [is] appropriate.” Eli Lilly, 
    731 F. Supp. 2d at 375
    .
    The defendants cite ALZA Corp. v. Andrx Pharmaceuti-
    cals LLC, 
    603 F.3d 935
     (Fed. Cir. 2010), in which this court
    found that the patent did not “provide sufficient guidance
    for a person of ordinary skill in the art to make the non-
    osmotic dosage forms as claimed.” 
    Id. at 940
    . However, in
    that case the court described the field of ascending release
    dosage forms as “not mature” and “a ‘breakaway’ from the
    prior art.” 
    Id. at 941
    . Such characteristics were not here
    demonstrated. There was no evidence that known proce-
    dures for determination of dosages and formulation did not
    apply. See Spectra-Physics, Inc. v. Coherent, Inc., 
    827 F.2d 1524
    , 1534 (Fed. Cir. 1987) (“A patent need not teach, and
    preferably omits, what is well known in the art.”).
    Enablement is not negated if a reasonable amount of
    experimentation is required to establish dosages and formu-
    lation of an active ingredient. See Enzo Biochem, Inc. v.
    Calgene Inc., 
    188 F.3d 1362
    , 1371 (Fed. Cir. 1999). Lack of
    enablement must be proved by clear and convincing evi-
    dence. Auto. Tech. Int’l, Inc. v. BMW of N. Am., Inc., 
    501 F.3d 1274
    , 1281 (Fed. Cir. 2007). Error has not been shown
    in the district court’s finding and conclusion that the scope
    of the claims is enabled. That ruling is affirmed.
    IV
    ENABLEMENT/UTILITY
    The district court held all of the ’590 patent claims inva-
    lid for lack of “enablement/utility.” The court held that
    utility was not established because experimental data
    showing the results of treatment of ADHD were not in-
    cluded in the specification. The court held that “the court
    ELI LILLY AND COMPANY   v. ACTAVIS                            12
    cannot conclude that a person of skill in the art would have
    recognized the method of treatment’s utility in view of the
    specification and prior art.” Eli Lilly, 
    731 F. Supp.2d at 389
    .
    The patent statute requires that the specification “dis-
    close as a matter of fact a practical utility for the invention.”
    In re Ziegler, 
    992 F.2d 1197
    , 1201 (Fed. Cir. 1993). Lilly
    points out that the utility to treat ADHD was fully disclosed
    and correctly described and enabled in the specification.
    The ’590 patent describes the use of tomoxetine to treat
    ADHD in humans, and states that “tomoxetine is a notably
    safe drug, and its use in ADHD, in both adults and children,
    is a superior treatment for that disorder because of im-
    proved safety.” Col.1 ll.66 to col.2 l.1. The patent refers to
    the two recognized types of ADHD, inattentive type and
    hyperactive-impulsive type, and states: “Treatment with
    tomoxetine is effective in patients who are primarily suffer-
    ing from either component or from the combined disorder.”
    Col.3 ll.38-40. The patent states:
    The method of the present invention is effective in
    the treatment of patients who are children, adoles-
    cents or adults, and there is no significant difference
    in the symptoms or the details of the manner of
    treatment among patients or different ages.
    Col.4 ll.14-18. No criticism of the correctness of these
    statements has been offered. The defendants do not dispute
    that the ’590 patent describes the utility of tomoxetine for
    treatment of ADHD, and that the utility is correctly de-
    scribed. Lilly agrees that human test data were not avail-
    able at the time the patent application was filed, because
    human tests were prohibited without FDA authorization.
    13                          ELI LILLY AND COMPANY   v. ACTAVIS
    Dr. Heiligenstein, one of the inventors, testified about
    his uncertainty whether this treatment of ADHD would be
    effective, when he and Dr. Tollefson suggested experimental
    testing for this purpose:
    Q: At the time of this filing, did you have a reason-
    able expectation that tomoxetine would work to
    treat ADHD?
    A: It was a hypothesis.
    Q: Did you have a reasonable expectation?
    A: Reasonable? Can you define reasonable?
    Q: Did you believe it was going to work for ADHD?
    A: No, I wasn’t sure at all that it would work.
    Heiligenstein Dep. 127:4-12, August 7, 2008. It was not
    disputed that persons experienced in this field would re-
    quire actual human tests to verify the effectiveness of this
    use. As the Court discussed in Daubert v. Merrell Dow
    Pharmaceuticals, Inc., 
    509 U.S. 579
    , 593 (1993): “Scientific
    methodology today is based on generating hypotheses and
    testing them to see if they can be falsified; indeed, this
    methodology is what distinguishes science from the other
    fields of human inquiry.” (quoting Michael D. Green, 
    86 Nw. U. L. Rev. 643
    , 645 (1992)).
    Although it was recognized that Dr. Heiligenstein’s hy-
    pothesis required testing, Lilly points out that support for
    the testing was provided, patent procedures were initiated,
    and the FDA authorized proceeding with human clinical
    trials. The Manual of Patent Examining Procedure in-
    structs examiners to give presumptive weight to the utility
    for which human trials have been initiated:
    ELI LILLY AND COMPANY   v. ACTAVIS                            14
    MPEP §2107.03 (8th ed. 2008). IV. . . . Before a
    drug can enter human clinical trials, the sponsor, of-
    ten the applicant, must provide a convincing ration-
    ale to those especially skilled in the art (e.g., the
    Food and Drug Administration) that the investiga-
    tion may be successful. Such a rationale would pro-
    vide a basis for the sponsor’s expectation that the
    investigation may be successful. In order to deter-
    mine a protocol for phase I testing, the first phase of
    clinical investigation, some credible rationale of how
    the drug might be effective or could be effective
    would be necessary. Thus, as a general rule, if an
    applicant has initiated human clinical trials for a
    therapeutic product or process, Office personnel
    should presume that the applicant has established
    that the subject matter of that trial is reasonably
    predictive of having the asserted therapeutic utility.
    (Emphases in original.) During examination of the ’590
    application, the patent examiner did not require the sub-
    mission of data showing treatment of ADHD with atomoxet-
    ine, although it is not disputed that such data were obtained
    shortly after the patent application was filed. The utility of
    this product to treat ADHD is not so incredible as to war-
    rant the special procedures that are authorized for use when
    the examiner doubts the described utility, as in In re
    Swartz, 
    232 F.3d 862
     (Fed. Cir. 2000) (cold fusion); Newman
    v. Quigg, 
    877 F.2d 1575
    , modified 
    886 F.2d 329
     (Fed. Cir.
    1987) (perpetual motion); and for subject matter in once
    notoriously intractable areas such as cures for baldness or
    cancer. In deciding whether additional information is
    required for examination purposes, deference is owed to the
    “qualified agency presumed to have properly done its job.”
    Am. Hoist & Derrick Co. v. Sowa & Sons, Inc., 
    725 F.2d 1350
    , 1359 (Fed. Cir. 1984).
    15                           ELI LILLY AND COMPANY   v. ACTAVIS
    In this case, evidence of the described utility of tomoxet-
    ine was not requested by the patent examiner, although
    experimental verification was obtained soon after the filing
    of the patent application. The examination of the ’590
    patent was in accordance with the rules, as the court has
    explained:
    [A] specification which contains a disclosure of util-
    ity which corresponds in scope to the subject matter
    sought to be patented must be taken as sufficient to
    satisfy the utility requirement of §101 for the entire
    claimed subject matter unless there is reason for
    one skilled in the art to question the objective truth
    of the statement of utility or its scope.
    In re Langer, 
    503 F.2d 1380
    , 1391 (CCPA 1974) (emphases
    in original). In In re Brana, 
    51 F.3d 1560
     (Fed. Cir. 1995)
    the court again explained that:
    A specification disclosure which contains a teaching
    of the manner and process of making and using the
    invention in terms which correspond to those used
    in describing and defining the subject matter sought
    to be patented must be taken as in compliance with
    the enabling requirement of the first paragraph of
    §112 unless there is reason to doubt the objective
    truth of the statements contained therein which
    must be relied on for enabling support.
    
    51 F.3d at 1566
     (quoting In re Marzocchi, 
    439 F.2d 220
    , 223
    (CCPA 1971)) (emphases in original). In Brana, where the
    utility was antitumor activity in humans, the court reaf-
    firmed the practice that: “Only after the PTO provides
    evidence showing that one of ordinary skill in the art would
    reasonably doubt the asserted utility does the burden shift
    to the applicant to provide rebuttal evidence sufficient to
    ELI LILLY AND COMPANY   v. ACTAVIS                           16
    convince such a person of the invention’s asserted utility.”
    
    Id.
     at 1566 (citing In re Bundy, 
    642 F.2d 430
    , 433 (CCPA
    1981)). Such evidence was not here provided by the PTO,
    and rebuttal evidence was not required.
    The district court’s statement that “there was no credi-
    ble disclosure of utility to begin with,” Eli Lilly, 
    731 F. Supp. 2d at
    386 n.18, does not comport with the specifica-
    tion’s extensive disclosure of utility. The district court
    appears to have accepted the defendants’ argument that in
    view of the absence of experimental data in the specifica-
    tion, the disclosed utility must be deemed incredible. The
    district court apparently also accepted the defendants’
    position that such data were required to be included in the
    specification. However, the purported authority cited by the
    defendants concerned quite different issues, where, for
    various reasons, it was appropriate to offer experimental
    evidence. For example, the district court relied on patent
    “interference” cases, as in Rasmusson v. SmithKline
    Beecham Corp., 
    413 F.3d 1318
    , 1324 (Fed. Cir. 2005), where
    evidence of actual reduction to practice was required to
    establish a priority date earlier than that of an adverse
    claimant.
    When priority is not at issue, generally the applicant
    may provide data obtained either before or after the patent
    application was filed. With reference to demonstration of
    utility, in Brana, 
    51 F.3d at
    1567 n.19 the court noted that
    post-filing evidence “can be used to substantiate any doubts
    as to the asserted utility since this pertains to the accuracy
    of a statement already in the specification.” Here, the
    utility of tomoxetine is accurately stated in the specification;
    there is no allegation of falsity in the disclosed utility, and
    the patent examiner did not require the presentation of
    additional data. In In re Marzocchi, 
    439 F.2d 220
     (CCPA
    1971) the court had explained that:
    17                           ELI LILLY AND COMPANY   v. ACTAVIS
    The only relevant concern of the Patent Office under
    these circumstances should be over the truth of any
    such assertion. The first paragraph of §112 requires
    nothing more than objective enablement. How such
    a teaching is set forth, either by the use of illustra-
    tive examples or by broad terminology, is of no im-
    portance.
    
    439 F.2d at 223
    . The ’590 patent describes and enables the
    utility of tomoxetine to treat ADHD. The disclosure is not
    “on its face, contrary to generally accepted scientific princi-
    ples.“ 
    Id. at 223
    . Lilly’s expert testified that the utility of
    tomoxetine to treat ADHD “had not been ruled out,” Trial
    Tr. 1099:4, and even the defendants’ expert testified that “it
    could work.” Trial Tr. 200:22.
    The defendants rely on Janssen Pharmaceutica N.V. v.
    Teva Pharmaceuticals USA, Inc., 
    583 F.3d 1317
     (Fed. Cir.
    2009) where the court held that the use of galantamine to
    treat Alzheimer’s disease was a “mere research proposal.”
    The specification summarized six scientific articles on the
    properties of galantamine to raise blood levels of cortisol
    and ACTH, and reporting brain effects in mammals, and the
    court held that because the animal tests were “not finished .
    . . by the time the ‘318 patent was allowed,” enablement was
    not shown. The court held that there was not “a reasonable
    correlation between a compound’s activity and its asserted
    therapeutic use,” in the words of MPEP §2107.03. In the
    case of atomoxetine, however, the norepinephrine relation-
    ship was known, safety for antidepressant activity had been
    established, the specification contained a full description of
    the utility, experimental verification had been obtained
    before the patent was granted, and the examiner had not
    requested additional information. There was no evidence
    that the disclosure is “on its face, contrary to generally
    accepted scientific principles.” Marzocchi, 
    439 F.2d at 223
    .
    ELI LILLY AND COMPANY   v. ACTAVIS                          18
    As stated in Brana, 
    51 F.3d 1566
    -67: “Even if one skilled in
    the art would have reasonably questioned the asserted
    utility, i.e., even if the PTO met its initial burden thereby
    shifting the burden to the applicants to offer rebuttal evi-
    dence, applicants proffered sufficient evidence to convince
    one of skill in the art of the asserted utility.”
    On the entirety of the evidence, invalidity for lack of en-
    ablement/utility was not shown by clear and convincing
    evidence. The district court’s holding of invalidity on this
    ground is reversed.
    V
    INFRINGEMENT
    The district court held that the defendants would be li-
    able for inducement to infringe the ’590 patent by providing
    atomoxetine bearing the FDA-approved label authorizing
    use to treat ADHD. The defendants argue that “the mere
    distribution of generic atomoxetine products cannot estab-
    lish inducement liability, even though the labeling includes
    the legally required statement of FDA-approved use.” Lilly
    responds that the label use to treat ADHD is the only le-
    gally approved use, and the only use for which the defen-
    dants are authorized to provide the product.
    The defendants rely on Warner-Lambert Co. v. Apotex
    Corp., 
    316 F.3d 1348
     (Fed. Cir. 2003), for its finding of non-
    infringement, although in that case the patent on the only
    FDA-authorized use had expired, and the court held that
    the provider of the generic product, labeled for the author-
    ized use on which the patent had expired, did not infringe a
    different (unexpired) patent on an unauthorized use:
    19                          ELI LILLY AND COMPANY   v. ACTAVIS
    [T]he request to make and sell a drug labeled with a
    permissible (non-infringing) use cannot reasonably
    be interpreted as an act of infringement (induced or
    otherwise) with respect to a patent on an unap-
    proved use, as the ANDA does not induce anyone to
    perform the unapproved acts required to infringe.
    
    316 F.3d at 1364-65
    .
    The defendants also argue that there are off-label uses
    of atomoxetine, stated by the defendants to be as high as
    29% of the total, and conceded by Lilly as possibly as high as
    8% of the total. However, the product sold by the defen-
    dants is labeled solely for the patented use to treat ADHD.
    We have long held that the sale of a product specifically
    labeled for use in a patented method constitutes inducement
    to infringe that patent, and usually is also contributory
    infringement. See Astrazeneca LP v. Apotex, Inc., 
    633 F.3d 1042
    , 1060 (Fed. Cir. 2010) (finding intent to induce in-
    fringement based on the product label authorizing the
    patented use, which “would inevitably lead some consumers
    to practice the claimed method”); see also DSU Med. Corp. v.
    JMS Co. Ltd., 
    471 F.3d 1293
    , 1305-06 (Fed. Cir. 2006) (en
    banc in relevant part) (finding liability for induced in-
    fringement when an entity “offers a product with the object
    of promoting its use to infringe, as shown by clear expres-
    sion or other affirmative steps taken to foster infringe-
    ment”).
    No clear error has been shown in the district court’s
    findings and conclusion regarding inducement. We affirm
    the judgment that the provision of atomoxetine labeled
    solely for use to treat ADHD constitutes inducement to
    infringe the ’590 patent.
    ELI LILLY AND COMPANY   v. ACTAVIS                          20
    As for contributory infringement, the district court held
    that liability is avoided if the product has any “frequent”
    non-infringing use. Lilly argues that atomoxetine is not a
    “staple article of commerce suitable for substantial non-
    infringing use,” the words of 
    35 U.S.C. §271
    (c), for the only
    authorized use of atomoxetine is the patented use to treat
    ADHD. The defendants are restricted from selling a feder-
    ally regulated drug for unapproved uses. See 
    21 C.F.R. §202.1
    (e)(4). The defendants respond that physicians may
    nonetheless prescribe atomoxetine for unauthorized use.
    Such unauthorized activity does not avoid infringement by a
    product that is authorized to be sold solely for the infringing
    use.
    We conclude that the district court erred in its applica-
    tion of the law of contributory infringement. That aspect of
    the district court’s decision is reversed.
    SUMMARY
    The judgment that the ’590 patent claims are invalid for
    lack of “enablement/utility” is reversed. The district court’s
    rulings of validity on other grounds, and the judgment of
    infringement, are affirmed. We remand for further proceed-
    ings.
    AFFIRMED-IN-PART, REVERSED-IN-PART, and
    REMANDED