Lakeland Regional Medical Center, Inc. v. Astellas US, LLC , 763 F.3d 1280 ( 2014 )


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  •                Case: 13-12709        Date Filed: 08/15/2014      Page: 1 of 23
    [PUBLISH]
    IN THE UNITED STATES COURT OF APPEALS
    FOR THE ELEVENTH CIRCUIT
    _________________________
    No. 13-12709
    _________________________
    D.C. Docket No. 8:10-cv-02008-VMC-TGW
    LAKELAND REGIONAL MEDICAL CENTER, INC., on behalf of itself and all
    others similarly situated,
    Plaintiff – Appellant,
    versus
    ASTELLAS US, LLC and ASTELLAS PHARMA US, INC.,
    Defendants – Appellees.
    __________________________
    Appeal from the United States District Court
    for the Middle District of Florida
    __________________________
    (August 15, 2014)
    Before ANDERSON, Circuit Judge, and EBEL, * Circuit Judge, and UNGARO, **
    District Judge.
    *
    Honorable David M. Ebel, United States Circuit Judge for the Tenth Circuit, sitting by
    designation.
    **
    Honorable Ursula Ungaro, United States District Judge for the Southern District of Florida,
    sitting by designation.
    Case: 13-12709     Date Filed: 08/15/2014   Page: 2 of 23
    EBEL, Circuit Judge:
    Defendants-Appellees Astellas US, LLC and Astellas Pharma US, Inc.
    (collectively “Astellas”) holds patents on a cardiac test and sells its unpatented
    pharmaceutical product, Adenoscan, for use during that test. Plaintiff-Appellant
    Lakeland Regional Medical Center, Inc. (the “Medical Center”), which conducts
    these cardiac tests, alleges that Astellas is able to overcharge the Medical Center
    for the Adenoscan product by unlawfully tying the patented right to perform the
    patented cardiac test to the purchase of the unpatented Adenoscan in violation of
    Section 1 of the Sherman Act, 15 U.S.C. § 1. At issue in this appeal is the district
    court’s refusal to certify the Medical Center’s tying claim as a class action. We
    AFFIRM.
    BACKGROUND
    Healthcare providers often test for coronary artery disease using a procedure
    called myocardial perfusion imaging (“MPI”). This test is most accurate when
    carried out while the heart is stressed by, for example, administering adenosine to
    the patient during the procedure. Adenosine is a naturally occurring chemical
    compound that causes selective blood vessels to dilate. Astellas has held two
    patents for performing an MPI using adenosine; the first patent expired in March
    2009 and the second will expire in March 2015. Astellas does not offer healthcare
    2
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    providers a freestanding license to perform its patented MPI procedure. Instead,
    healthcare providers obtain an implied license to perform the MPI procedure by
    purchasing Astellas’s unpatented adenosine product, Adenoscan, for use during the
    procedure.
    When this litigation began, Adenoscan was the only adenosine product that
    the Food and Drug Administration (“FDA”) had approved for use during an MPI.
    There are other adenosine products available in the market, however, and
    healthcare providers are not bound by the FDA’s approval ruling, but can, instead,
    use any adenosine product during an MPI that the healthcare providers, in their
    medical judgment, deem appropriate. Exercising that prerogative, the Medical
    Center began using chemically-identical adenosine products that were cheaper than
    Adenoscan during MPIs performed at the Medical Center. Astellas responded by
    threatening to sue the Medical Center for performing Astellas’s patented MPI
    procedure without a license.
    The Medical Center sued Astellas first for, among other claims, violating
    federal antitrust laws by illegally tying the implied license to perform MPIs
    involving adenosine to the purchase of Adenoscan. See 15 U.S.C. § 1.1 According
    1
    Section 1, United States Code Title 15, provides in pertinent part that “[e]very contract,
    combination in the form of trust or otherwise, or conspiracy, in restraint of trade or commerce
    among the several States, or with foreign nations, is declared to be illegal.” A tying
    arrangement—“an agreement by a party to sell one product but only on the condition that the
    3
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    to the Medical Center, this unlawful tying arrangement enabled Astellas to charge
    450% more for Adenoscan than the price for other, chemically-identical adenosine
    products. As relief, the Medical Center sought 1) treble damages for the amount
    Astellas had overcharged the Medical Center for Adenoscan, and 2) injunctive and
    declaratory relief. See 15 U.S.C. §§ 15(a), 26.
    The Medical Center brought its case as a class action on behalf of all
    healthcare providers who had purchased Adenoscan during a four-year period,
    from September 2006 through September 2010. But the district court refused to
    certify the class, ruling, among other things, that the Medical Center was not a
    viable class representative because 1) the direct purchaser rule, see Illinois Brick
    Co. v. Illinois, 
    431 U.S. 720
    , 729, 736 (1977), precluded the Medical Center’s own
    treble damages claim since the Medical Center had purchased Adenoscan, not
    directly from Astellas, but instead from several independent pharmaceutical
    distributors; and 2) the Medical Center’s requests for declaratory and injunctive
    relief were, or soon would be, moot because, after the initiation of this suit, the
    FDA had approved a generic version of Adenoscan for use during MPIs and
    because the Medical Center insufficiently articulated the class-wide injunctive
    buyer also purchases a different (or tied) product”—may be unlawful under § 1. Eastman Kodak
    Co. v. Image Technical Servs., Inc., 
    504 U.S. 451
    , 461-62 (1992) (internal quotation marks
    omitted). In this case, the Medical Center alleges that the tying product is the implied license to
    perform MPIs involving adenosine, and the tied product is the Adenoscan.
    4
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    relief that it reasonably could obtain.
    Although the district court’s denial of class certification was not a final,
    appealable order, see Coopers & Lybrand v. Livesay, 
    437 U.S. 463
    , 464-65 (1978),
    the ruling effectively foreclosed the Medical Center’s tying claim. The Medical
    Center thus stipulated to the entry of final judgment against it on all of its claims
    while preserving its right to appeal the district court’s denial of class certification.
    See Dorse v. Armstrong World Indus., Inc., 
    798 F.2d 1372
    , 1376-77 (11th Cir.
    1986). Exercising jurisdiction under 28 U.S.C. § 1291, we AFFIRM.
    DISCUSSION
    I. Because the direct purchaser rule precludes the Medical Center’s own
    treble damages claim, the district court did not abuse its discretion in refusing
    the Medical Center’s request to certify a class seeking damages against
    Astellas for unlawful tying
    A. Relevant legal principles
    This appeal involves the interaction between law governing claims for
    unlawful tying and antitrust standing principles. The Medical Center has claimed a
    classic tying arrangement. 2 Its allegations are as follows: Astellas is the source of
    two products. First, Astellas has a patent on performing MPIs that use adenosine
    2
    See Eastman 
    Kodak, 504 U.S. at 460-61
    (“A tying arrangement is an agreement by a party to
    sell one product but only on the condition that the buyer also purchases a different (or tied)
    product,” which violates antitrust laws “if the seller has appreciable economic power in the tying
    product market and if the arrangement affects a substantial volume of commerce in the tied
    market.”) (internal quotation marks omitted); see also Phillip Areeda & Herbert Hovenkamp, IX
    Antitrust Law § 1700a (3d ed. 2011).
    5
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    to stress the patient’s heart during the procedure. Healthcare providers wanting to
    perform that procedure, therefore, need a license from Astellas to do so. Second,
    Astellas sells Adenoscan which, at the time this litigation began, was the only
    adenosine product that the FDA had approved for use during the patented MPI
    procedure, although there were other adenosine products available on the market
    that could perform the same function as Adenoscan. According to the Medical
    Center’s allegations, Astellas leveraged its power in the testing market to
    overcharge for Adenoscan. The Medical Center contends that it was injured by
    this tying arrangement because the only way it could obtain the tying product that
    it needed—a license from Astellas to perform MPIs involving adenosine—was to
    overpay for Adenoscan. The Medical Center further contends that, by requiring it
    to buy the overpriced Adenoscan in order to get the process license it wanted,
    Astellas foreclosed the Medical Center from purchasing other adenosine products
    at much lower prices for use during the MPIs. The Medical Center measures its
    tying damages, then, by the amount it overpaid for Adenoscan when compared
    with the amount it could have paid to purchase another adenosine product.3
    3
    The appropriate measure of damages in a tying case is the amount the purchaser overpaid for
    the unlawfully tied bundle of products or services when compared to the amount the purchaser
    would have paid to purchase those products or services separately. See Kypta v. McDonald’s
    Corp., 
    671 F.2d 1282
    , 1285 (11th Cir. 1982). Here, however, the Medical Center alleges that
    Astellas charged nothing for the implied use license it tied to the sale of Adenoscan, and further
    alleges that, even if Astellas had offered a stand-alone license separate from the Adenoscan,
    6
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    But it is well-settled that not everyone who is injured by an antitrust
    violation can recover (treble) damages. 4 Under the direct purchaser rule, only the
    customer who purchased the goods or services at issue directly from the alleged
    antitrust violator can recover damages. See Illinois 
    Brick, 431 U.S. at 729
    , 736;
    see also Kansas v. UtiliCorp United, Inc., 
    497 U.S. 199
    , 203-04 (1990). In other
    words, even if Astellas’s alleged tying arrangement injured purchasers all along the
    distribution chain for either the tying (implied process license) or the tied
    (Adenoscan) product, the direct purchaser rule only permits the first purchaser to
    recover damages from Astellas for any unlawful overcharge. The reasons for this
    rule are threefold, see 
    UtiliCorp, 497 U.S. at 208-16
    : permitting only the direct
    purchaser to recover damages 1) “eliminate[s] the complications of apportioning
    overcharges between direct and indirect purchasers,” 
    id. at 208;
    2) eliminates the
    possibility that direct and indirect purchasers could seek duplicative recoveries
    against the antitrust violator, 
    id. at 212;
    and 3) best “promote[s] the vigorous
    enforcement of the antitrust laws” by permitting only the best-situated purchaser to
    sue for damages, 
    id. at 214.
    Astellas would have charged nothing for that license. In this tying case, then, the Medical Center
    is measuring its damages by the amount Astellas was able to overcharge the Medical Center for
    the Adenoscan, by tying it to the implied license, as compared to the price at which the Medical
    Center could have obtained other, comparable adenosine products.
    4
    Because this tying claim is before us on standing, we do not reach its merits and so we
    do not express any opinion regarding the claim’s merits.
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    B. The district court correctly determined that the direct purchaser
    rule bars the Medical Center’s damages claim
    We review de novo the district court’s application of the direct purchaser
    rule to the Medical Center’s damages claim. See Sunbeam Television Corp. v.
    Nielsen Media Research, Inc., 
    711 F.3d 1264
    , 1270 (11th Cir. 2013). Applying
    that rule here, there is no doubt that the distributors who purchased Adenoscan
    from Astellas and then resold it to the Medical Center are the direct purchasers
    and, therefore, the only parties under Illinois Brick that can recover tying damages
    from Astellas. Because, according to the Medical Center, neither the distributors
    nor the Medical Center ever paid Astellas anything for the implied license to
    perform the patented MPI procedure, it was the distributors who first bore all the
    damages from the alleged unlawful tying, which was the overcharged price of
    Adenoscan.
    Although the distributors may have passed on to the Medical Center some or
    all of the overcharge that they paid to Astellas, the Medical Center cannot recover
    damages from Astellas for that overcharge because it was the second purchaser of
    that tied product. Indeed, to allow the Medical Center to maintain a damages claim
    for this particular tying arrangement would give rise to the very problems that the
    direct purchaser rule seeks to avoid. It would complicate the calculation of
    damages resulting from any overcharge by Astellas by requiring an apportionment
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    of that overcharge throughout the Adenoscan distribution chain, between the direct
    purchasers (the distributors) and the indirect purchasers (like the Medical Center);
    it would create the possibility that both the distributors and the indirect Adenoscan
    purchasers like the Medical Center could recover from Astellas for the same
    allegedly unlawful tying arrangement; and it would discourage vigorous private-
    citizen enforcement of the antitrust laws by making it more difficult for the best-
    suited plaintiffs, the distributors, to bring an unlawful tying claim. 5 See 
    UtiliCorp, 497 U.S. at 208-16
    . For these reasons, then, only the distributors, as the direct
    purchasers of Adenoscan who first paid the inflated tied price for that product, can
    recover damages from Astellas for that alleged overcharge resulting from
    Astellas’s alleged tying behavior.
    C. The Medical Center’s argument to the contrary is unavailing
    The Medical Center’s primary argument against applying the direct
    purchaser rule to preclude its damages claim is that the distributors are not the best
    plaintiffs to assert the tying claim at issue here because they have no use for the
    tying product, which is the implied license to perform an MPI using adenosine;
    5
    Applying the direct purchaser rule here serves all of the purposes underlying that rule. See
    
    UtiliCorp, 497 U.S. at 208-16
    . But even if the rule’s application in this particular case did not
    serve the rule’s underlying purposes, the Supreme Court has directed courts to apply the rule
    nonetheless: “even assuming that any economic assumptions underlying the Illinois Brick rule
    might be disproved in a specific case, we think it an unwarranted and counterproductive exercise
    to litigate a series of exceptions.” 
    Id. at 216.
    9
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    indeed, according to the Medical Center, the distributors never even receive that
    license.6 According to the Medical Center, in other words, Astellas does not exert
    tying pressure on the distributors, coercing them to buy the tied product
    (Adenoscan) in order to get the tying product (the implied license) because the
    distributors have no use for the implied license. And if there is no pressure on the
    distributors to buy the tied product, so argues the Medical Center, the distributors
    have no incentive to bring the tying claim.
    We are unpersuaded. While admittedly the distributors have no need for a
    license that permits them to perform MPIs, that license has economic value for the
    distributors who seek to resell Adenoscan to their healthcare customers, who do
    need that license. In fact, because the distributors could only market and sell
    Adenoscan for its FDA-approved use—that is, in conjunction with an MPI
    involving adenosine—the distributors needed to be able to assure their
    6
    No one questions that Astellas tied the implied process license to the purchase of Adenoscan.
    But there are two ways to view that arrangement. One way is to suppose that the implied license
    came directly from the purchase of Adenoscan and thus flowed down the Adenoscan distribution
    chain, from Astellas to the distributor to the Medical Center. This is what Astellas contends, and
    that is consistent with its, Astellas’s, own assertions in letters it sent to healthcare providers,
    including the Medical Center. The other way to view the arrangement is that Astellas linked the
    right to obtain an implied license to the purchase of Adenoscan, even though healthcare
    providers like the Medical Center, in exercising that right, actually obtained the implied license
    directly from Astellas. That is the Medical Center’s contention. As we see it, it does not matter
    because, either way, Astellas undoubtedly conditioned its granting of the implied license on the
    purchase of Adenoscan, and here the entire tying damages came from the enhanced price of
    Adenoscan, the tied product, which was first paid by the distributors to Astellas.
    10
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    customers—the hospitals—that they could use the Adenoscan that the distributors
    were selling. Thus, Adenoscan, tied to the implied license, had a greater resale
    value for the distributors than other adenosine products which Astellas would not
    allow to be used with its patented MPI process. Therefore, regardless of whether
    or not the distributors themselves actually received or used the implied license,
    they were still susceptible to the coercion of the tying arrangement and were still
    injured by any unlawful overcharge that Astellas was able to command for
    Adenoscan. To conclude otherwise would be to ignore the economic realities of
    the transactions at issue here. See United States v. Concentrated Phosphate Export
    Ass’n, 
    393 U.S. 199
    , 208 (1968) (“In interpreting the antitrust laws, . . . [w]e must
    look at the economic reality of the relevant transactions.”); see also Eastman
    
    Kodak, 504 U.S. at 466-67
    (“Legal presumptions that rest on formalistic
    distinctions rather than actual market realities are generally disfavored in antitrust
    law.”).
    Our conclusion is bolstered by several cases from other circuits which,
    although not controlling here, are helpful. Though not a tying case, Kloth v.
    Microsoft Corp., 
    444 F.3d 312
    (4th Cir. 2006), is perhaps most helpful. In Kloth,
    Microsoft sold computer manufacturers a license to “pre-install” Microsoft
    software onto the manufacturers’ computers and the right to charge consumers for
    11
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    the option to purchase licenses to use the software from Microsoft. 
    Id. at 318-19,
    321-22. After consumers bought the computers from the manufacturer or a
    retailer, the consumers had the option of either accepting Microsoft’s license to use
    the software already installed on the computer or rejecting the license and
    receiving a refund directly from Microsoft. 
    Id. at 318,
    320. Applying Illinois
    Brick, the Fourth Circuit held that the consumers were indirect purchasers of
    Microsoft’s software licenses, even if the consumers actually acquired the software
    licenses directly from Microsoft, because the consumers paid the computer
    manufacturers or retailers (and not Microsoft) for the licenses as part of the
    computer’s purchase price. 
    Id. at 320-21.
    In reaching that conclusion, the Fourth
    Circuit rejected the consumers’ contrary suggestion that they were direct
    purchasers, stating that they
    fail[ed] to recognize both the role of the [computer manufacturer] or
    the retailer in the licensing chain and the economic realities of the
    transaction. Although Microsoft does not sell title to its software, it
    does sell licenses to use its software, and plaintiffs [consumers] could
    have acquired licenses directly from Microsoft. . . . But the plaintiffs
    in this case acquired their licenses by purchases from [computer
    manufacturers] and retailers, paying them, not Microsoft, for their
    licenses at prices set by the [manufacturers] and retailers. Because the
    plaintiffs purchased their products from intermediaries and not
    Microsoft, they are indirect purchasers within the meaning of that
    term as defined in Illinois Brick and UtiliCorp, and the recoveries they
    would have from Microsoft would present the very problems that
    those cases sought to avoid.
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    Id. The situation
    in Kloth is analogous to the circumstances presented here and
    supports our conclusion that the direct purchaser rule precludes the Medical
    Center’s damages claim. 7 As in Kloth, here the distributor paid Astellas for the
    Adenoscan and the license (or the right to obtain the license); and the Medical
    Center then, in turn, paid the distributor (and not Astellas) for both the Adenoscan
    and the license (or the right to obtain the license). The Medical Center, therefore,
    was only an indirect purchaser of both from the alleged antitrust violator, Astellas. 8
    In a second case supporting our decision, Warren General Hospital v.
    Amgen Inc., 
    643 F.3d 77
    (3d Cir. 2011), the Third Circuit applied the direct
    purchaser rule to preclude a hospital’s tying claim against a pharmaceutical
    company. There, the hospital claimed that the drug manufacturer, Amgen, was
    unlawfully tying the sale of two drugs over which Amgen had a monopoly (the
    “tying” products) to the sale of a third, more expensive Amgen drug (the “tied”
    product). 
    Id. at 80-81.
    The alleged tying scheme specifically involved Amgen
    7
    The Medical Center attempts to distinguish Kloth because, in that case, 1) both the computer
    hardware and software came together from the computer manufacturers to the consumer; and
    2) Microsoft leveraged its power in the computer operating system market to compel the
    manufacturers to install its software onto the computers. But those facts do not meaningfully
    distinguish Kloth from the circumstances presented here.
    8
    Recall that under the Medical Center’s theory, no one actually paid anything for the implied
    license.
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    offering healthcare providers price rebates on the tying drugs based upon the
    volume of purchases that healthcare providers made of the tied drug. 
    Id. Even though
    Warren General Hospital bought all three drugs through independent
    distributors, the plaintiff hospital claimed that it had directly purchased the drugs
    from Amgen because it contracted with Amgen directly for the rebates and it
    received those rebates directly from Amgen. 
    Id. at 87-88.
    The Third Circuit
    rejected that argument, concluding that the hospital was still only an indirect
    purchaser of Amgen’s drugs because the hospital ordered the drugs from
    independent distributors and paid those distributors for the drugs at a price set by
    the distributors. 
    Id. at 88-89.
    According to the court, it was irrelevant that the
    rebates came directly from Amgen: while there “were some direct interactions
    between Amgen and the hospital relating to the rebate program and the volume of
    Amgen drugs the hospital required,” those interactions were insufficient to make
    the hospital a direct purchaser of the drugs from Amgen when the drugs
    themselves were in fact purchased from the independent distributors. 
    Id. at 88.
    The same could be said about the products here: even if the license might be
    viewed as coming directly from Astellas, see supra n. 4, that does not change the
    fact that the Medical Center purchased Adenoscan, which carried the right to
    obtain permission to use it in MPIs and which constituted the entire overcharge
    14
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    forming the basis of the treble damages claim, directly from the distributors, not
    Astellas.
    Finally, the Tenth Circuit’s decision in Sports Racing Services, Inc. v. Sports
    Car Club of America, Inc., 
    131 F.3d 874
    (10th Cir. 1997) lends further support to
    our decision. In Sports Racing Services, an amateur car racer, Freeman, sued
    Sports Car Club of America, alleging that Sports Car Club illegally tied its sale of
    the right to race in Club-sponsored races to the purchase of cars and parts for the
    races from Sports Car 
    Club. 131 F.3d at 878-79
    , 886. Although Freeman bought
    the tying product, the right to race, directly from Sports Car Club, he had to buy
    the tied products, Sports Car Club’s cars and parts, from an independent
    distributor. 
    Id. at 878,
    883, 887. The Tenth Circuit held that the direct purchaser
    rule may not bar Freeman’s tying claim against Sports Car Club, 9 even though he
    was only an indirect purchaser of the tied products (the cars and parts), because
    Freeman was the first party in either distribution chain (of the tied and tying
    products) that was “the direct victim of the anticompetitive activity [the tying
    arrangement] and the first person with a cause of action” for tying. 
    Id. at 889.
    That reasoning is consistent with our conclusion here: the distributors were the first
    entities in the Adenoscan distribution chain subjected to the tying arrangement’s
    9
    The case came to the Tenth Circuit on a summary judgment decision. See Sports Racing
    
    Servs., 131 F.3d at 878
    . Ultimately the court remanded the case to the district court for further
    factual finding. 
    Id. at 890-91.
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    coercive force because they were compelled to pay the overcharge for Adenoscan,
    which was the source of the alleged tying damages claim and the Medical Center
    was downstream of that tying damage.
    The Tenth Circuit, in Sports Racing Services, concluded that the cars/parts
    distributor in that case did not have a tying claim because the distributor was not
    subjected to the coercive effect of the tying arrangement since it had no connection
    to, and no use for, the tying product—the right to race in Club-sponsored races. 10
    While the distributor in Sports Racing Services paid for the tied products, the cars
    and parts it resold to the racers, the distributor did not pay for the tying product, the
    right to race. Because it was the racer who first paid for both, therefore, he was the
    only party who could claim tying damages, measured as the difference between the
    price the racer paid for the bundled products and services against the price he
    would have paid for them separately, had Sports Car Club not unlawfully tied them
    together.
    Here, on the other hand, the Adenoscan distributors, as we have already
    explained, were subject to the coercive effect of Astellas’s allegedly unlawful tying
    arrangement because both the tying product, the implied license, and the tied
    10
    The distributor was not itself buying the cars to race them and, when it resold the cars, it did
    not do so with a license that the buyer could race them in a Club-sponsored race. The buyer
    independently had to qualify and pay directly to Sports Car Club for the right to race in a
    sponsored race. There was no suggestion that when the distributor bought the car from Sports
    Car Club, that it was also buying an implied right to race that car in a Club-sponsored race.
    16
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    product, Adenoscan, were valuable to the distributors and useful to them on resale.
    Moreover, the purchase of the Adenoscan automatically conveyed an implied
    license to perform the patented MPI procedure using adenosine. Furthermore,
    according to the Medical Center, neither it nor the distributors paid anything for
    the automatically conveyed implied license. Unlike in Sports Racing Services,
    then, the distributors in this case bore the full brunt of the tying arrangement and
    they were the first entities who suffered the full amount of the tying damages,
    measured in this case as the overcharge Astellas was able to demand for
    Adenoscan. Unlike in Sports Racing Services, then, it follows that the distributors
    in this case were injured by the tying arrangement in the same manner as the
    Medical Center and they, rather than the Medical Center, are the first entities in the
    Adenoscan distribution chain to have a tying damages claim against Astellas. It
    follows, therefore, that only the distributors, as the direct purchasers of Adenoscan,
    can recover damages from Astellas; the Medical Center cannot.
    D. Conclusion as to the district court’s refusal to certify a class for
    purposes of the Medical Center’s damages claim
    For these reasons, then, we agree with the district court that the direct
    purchaser rule precludes the Medical Center, as an indirect purchaser of
    Adenoscan, from recovering damages from Astellas for its allegedly unlawful
    tying arrangement. As such, the Medical Center would not be an adequate
    17
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    representative for a class seeking damages for the alleged unlawful tying and the
    district court, therefore, did not abuse its discretion in denying the Medical
    Center’s request to certify a class for the damages claim, see Ault v. Walt Disney
    World Co., 
    692 F.3d 1212
    , 1216 (11th Cir. 2012), cert denied, 
    133 S. Ct. 1806
    (2013).
    II. The district court also did not abuse its discretion in refusing to certify the
    class for purposes of seeking injunctive and declaratory relief
    The direct purchaser rule does not apply to claims for injunctive and
    declaratory relief. See In re Beef Indus. Antitrust Litig., 
    600 F.2d 1148
    , 1167 (5th
    Cir. 1979).11 Nevertheless, the district court also declined to certify the class for
    purposes of seeking injunctive and declaratory relief against Astellas because
    1) such relief in this case would soon be moot; and 2) the Medical Center did “not
    sufficiently brief[] the Court as to the substance of its claims for declaratory or
    injunctive relief to justify class certification pursuant to [Fed. R. Civ. P.] 23(b)(2).”
    (Doc. 150 at 13.) We disagree with the first reason, but affirm on the second.
    A. The Medical Center’s claims are not moot
    We review questions of mootness de novo. See Doe v. Wooten, 
    747 F.3d 1317
    , 1321-22 (11th Cir. 2014). It was Astellas’s burden, as the party asserting
    11
    This court, in Bonner v. City of Prichard, 
    661 F.2d 1206
    , 1207 (11th Cir. 1981) (en banc)
    adopted as binding precedent all decisions of the former Fifth Circuit issued prior to October 1,
    1981.
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    Case: 13-12709        Date Filed: 08/15/2014        Page: 19 of 23
    that the Medical Center’s claims would soon be moot, to come forward with
    information to support that assertion. See Cardinal Chem. Co. v. Morton Int’l,
    Inc., 
    508 U.S. 83
    , 98 (1993) (addressing mootness on appeal).
    Astellas grounded its mootness argument on its prediction that a generic
    version of Adenoscan would be available in October 2012, just a week after the
    district court denied class certification. But that prediction proved wrong, and
    generic Adenoscan did not become available during the time this case remained
    pending in the district court.12 Moreover, the record does not indicate what effect,
    if any, the presence of this single generic might have on the Adenoscan market.
    We cannot conclude, therefore, that the controversy at issue here is at an end, see
    Atheists of Fla., Inc. v. City of Lakeland, 
    713 F.3d 577
    , 593-94 (11th Cir. 2013), or
    that it is currently impossible to provide the Medical Center with meaningful
    injunctive or declaratory relief, see Rich v. Sec’y, Fla. Dep’t of Corr., 
    716 F.3d 525
    , 531 (11th Cir. 2013). Indeed, on appeal, Astellas does not argue to the
    contrary. The district court thus erred in denying class certification on the ground
    that the Medical Center’s declaratory and injunctive claims might soon become
    12
    Astellas now asserts that the FDA approved a generic form of Adenoscan a year later, in
    August 2013, after the Medical Center initiated this appeal, but that information is not part of the
    appellate record.
    19
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    moot. 13
    B. The district court did not abuse its discretion in refusing to certify
    the class because the Medical Center failed to justify certification
    In addition to mootness, the district court also refused to certify the class for
    purposes of declaratory and injunctive relief because the Medical Center failed to
    justify certification. We review that determination for an abuse of discretion. See
    
    Ault, 692 F.3d at 1216
    . “As long as the district court’s reasoning stays within the
    parameters of Rule 23’s requirements for the certification of a class, the district
    court decision will not be disturbed.” Heffner v. Blue Cross & Blue Shield of Ala.,
    Inc., 
    443 F.3d 1330
    , 1337 (11th Cir. 2006) (internal quotation marks omitted).
    Rule 23(b)(2) provides that a class can be certified for purposes of seeking
    injunctive or declaratory relief if “the party opposing the class has acted or refused
    to act on grounds that apply generally to the class, so that final injunctive relief or
    corresponding declaratory relief is appropriate respecting the class as a whole.”
    “The key to the (b)(2) class is the indivisible nature of the injunctive or declaratory
    remedy warranted.” Wal-Mart Stores, Inc. v. Dukes, 
    131 S. Ct. 2541
    , 2557 (2011)
    (internal quotation marks omitted). Thus, “Rule 23(b)(2) applies only when a
    single injunction or declaratory judgment would provide relief to each member of
    13
    It may be that the district court did not conclude as a jurisdictional matter that the Medical
    Center’s claims were, or soon would be, moot. Instead, the district court may have decided not
    to exercise its discretion to certify the class under these circumstances. If so, the denial of class
    certification was an abuse of discretion, for the same reasons stated above.
    20
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    the class.” 
    Id. It was
    the Medical Center’s burden to “affirmatively demonstrate”
    that class certification was appropriate under Rule 23(b)(2). 
    Id. at 2551.
    The
    Medical Center failed to meet that burden, in two ways.
    First, it never identified exactly what injunctive or declaratory relief it was
    seeking. In its complaint, the Medical Center requested only “such declaratory and
    injunctive relief as appropriate in order to compel and ensure defendant Astellas’
    future compliance with law.” (Doc. 11 at 19.) In the twenty-two months between
    the time the Medical Center filed its complaint and the time it moved for class
    certification, Astellas tried unsuccessfully to pin the Medical Center down as to
    exactly what declaratory and injunctive relief it was seeking. Specifically, Astellas
    wanted to know whether the Medical Center was seeking an order requiring it to
    offer healthcare providers a stand-alone license to perform MPIs involving
    adenosine. When the Medical Center moved for class certification, it suggested
    only that the district court “could” order Astellas to provide access to and use of its
    patent without threat of litigation and without requiring the purchase of a product
    from Astellas. (Doc. 115 at 13.) This statement was insufficient to permit the
    district court to assess adequately whether the injunctive and declaratory relief the
    Medical Center was seeking could provide relief to each member of the class, see
    Wal-Mart 
    Stores, 131 S. Ct. at 2557
    .
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    Second, even if the Medical Center adequately explained the injunctive and
    declaratory relief it sought, and assuming that relief included an injunction
    requiring Astellas to offer healthcare providers a stand-alone license to perform
    MPIs involving adenosine, the Medical Center failed to prove that such an order
    would provide relief to each class member. See 
    id. at 2551,
    2557. Astellas
    asserted that no other member of the putative class had ever asked for a stand-
    alone license; that, according to Astellas, it was likely a stand-alone license
    combined with generic adenosine would cost class members at least as much, if not
    more, than the implied license currently bundled with Adenoscan; and that, even if
    it would be less expensive to purchase a stand-alone license and generic adenosine,
    healthcare providers might still choose to use Adenoscan because the FDA had
    approved only Adenoscan for use during MPIs and Medicare would reimburse
    providers only for using Adenoscan but not for using the generic version of
    adenosine. The Medical Center failed to offer any evidence to counter Astellas’s
    assertions. The district court, therefore, did not abuse its discretion in refusing to
    certify the class for purposes of seeking declaratory and injunctive relief against
    Astellas.
    CONCLUSION
    For the foregoing reasons, we AFFIRM the district court’s decision denying
    22
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    the Medical Center class certification on its claims seeking treble damages and
    injunctive and declaratory relief.
    23