JOHN M. WALKER, JR., Circuit Judge.
The State of New York brought this antitrust action against Defendant-Appellant Actavis PLC and its wholly-owned subsidiary Forest Laboratories, LLC (collectively, "Defendants"). New York alleges that as Namenda IR, Defendants' twicedaily drug designed to treat moderate-to-severe Alzheimer's disease, neared the end of its patent exclusivity period in July 2015, Defendants introduced a new oncedaily version called Namenda XR. The patents on XR ensure exclusivity, and thus prohibit generic versions of XR from entering the market, until 2029. Faced with the prospect of competition from generic IR, Defendants decided to withdraw virtually all Namenda IR from the market in order to force Alzheimer's patients who depend on Namenda IR to switch to XR before generic IR becomes available. Because generic competition depends heavily
The United States District Court for the Southern District of New York (Robert W. Sweet, Judge) issued a preliminary injunction barring Defendants from restricting access to Namenda IR prior to generic IR entry. We conclude that the district court did not abuse its discretion by granting New York's motion for a preliminary injunction because New York has demonstrated a substantial likelihood of success on the merits of its claim under the Sherman Act, 15 U.S.C. § 2, and has made a strong showing of irreparable injunction. Accordingly, we affirm the district court's order issuing a preliminary injunction.
This case raises a novel question of antitrust law: under what circumstances does conduct by a monopolist to perpetuate patent exclusivity through successive products, commonly known as "product hopping,"
In compliance with the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301-399f, when a pharmaceutical manufacturer seeks to bring a new drug to market, it must submit a New Drug Application ("NDA") for approval by the U.S. Food and Drug Administration ("FDA"). 21 U.S.C. § 355. An NDA must contain scientific evidence that demonstrates the drug is safe and effective, which inevitably requires "a long, comprehensive, and costly testing process." F.T.C. v. Actavis, Inc., ___ U.S. ___, 133 S.Ct. 2223, 2228, 186 L.Ed.2d 343 (2013). NDA-approved drugs are generally referred to as brandname or brand drugs. An approved brand drug enjoys a period of patent exclusivity in the market at the end of which one or more generic drugs,
In 1984, Congress amended the Federal Food, Drug, and Cosmetic Act by enacting the Drug Price Competition and Patent Term Restoration Act (the "Hatch-Waxman Act" or "Hatch-Waxman"), Pub. L.
Hatch-Waxman also promotes competition from generic substitute drugs. It permits a manufacturer that seeks to market a generic version of an NDA-approved drug to file what is known as an Abbreviated New Drug Application ("ANDA"). See 21 U.S.C. § 355(j); see also In re Adderall XR Antitrust Litig., 754 F.3d 128, 130 (2d Cir.2014). An ANDA allows a generic manufacturer to rely on the studies submitted in connection with the already-approved brand drug's NDA to show that the generic is safe and effective, provided that the ANDA certifies that the generic drug has the same active ingredients as and is "biologically equivalent" or "bioequivalent" to the already-approved drug.
A generic drug is bioequivalent to a brand drug if "the rate and extent of absorption" of the active ingredient is the same as that of the brand drug. 21 U.S.C. § 355(j)(8)(B)(i). In other words, two drugs are bioequivalent if they deliver the same amount of the same active ingredient content into a patient's blood stream over the same amount of time. By enabling generic manufacturers to "piggy-back" on a brand drug's scientific studies, Hatch-Waxman "speeds the introduction of lowcost generic drugs to market, thereby furthering drug competition." Actavis, 133 S.Ct. at 2228 (internal quotation marks, alteration, and citation omitted); see also H.R. Rep. No. 98-857, pt. 2, at 9 (1984) (stating the Hatch-Waxman Act's "policy objective" was to "get[] safe and effective generic substitutes on the market as quickly as possible after the expiration of the patent").
By the time Congress enacted the Hatch-Waxman Act, many states had enacted drug substitution laws to further encourage generic competition.
All state drug substitution laws prohibit pharmacists from substituting generic drugs that are not therapeutically equivalent to the brand drug, but state laws do not all define therapeutic equivalence in the same way.
Hatch-Waxman and state substitution laws were enacted, in part, because the pharmaceutical market is not a well-functioning market. In a well-functioning market, a consumer selects and pays for a product after evaluating the price and quality of the product. In the prescription
Fed. Trade Comm'n Bureau of Consumer Prot., Drug Product Selection 2-3 (1979), available at http://bit.ly/1JqKd4G. ("FTC, Drug Product Selection"). State substitution laws are designed to correct for this price disconnect by shifting drug selection, between brand drugs and their corresponding generics from doctors, to pharmacists and patients, who have greater financial incentives to make price comparisons.
The relevant market, undisputed on appeal, is the memantine-drug market in the United States. Defendants manufacture Namenda, a memantine hydrochloride based
Namenda IR and Namenda XR have the same active ingredient and the same therapeutic effect. The relevant medical difference between the two is that IR, which is released immediately into the bloodstream, is taken twice a day while XR, which is released gradually, is taken once a day.
The non-medical difference between IR and XR relates to their patent protection. Defendants' patents on Namenda IR prohibit any manufacturer from marketing a generic version of IR until July 11, 2015 (Namenda IR's "exclusivity period").
Namenda IR and Namenda XR currently occupy the entire memantine-drug market. However, five generic versions of IR have tentative FDA approval to enter the market on July 11, 2015, and seven others may enter the market as early as October 2015. Because Namenda XR has a different strength and daily dosage regimen—Namenda IR involves two immediate-release tablets of 10mg each and Namenda XR involves one 28mg extended-release capsule
When Defendants brought Namenda XR to market in July 2013 (approximately three years after it was approved), they
In early 2014, Defendants decided on a more direct approach. They were concerned that they would be unable to convert a significant percentage of Alzheimer's patients dependent upon memantine therapy from IR to XR prior to the entry of generic IR. Defendants' internal projections estimated that only 30% of Namenda IR users would voluntarily switch prior to July 2015. On February 14, 2014, Defendants publicly announced that they would discontinue Namenda IR on August 15, 2014, notified the FDA of their plans to discontinue Namenda IR, and published letters on their websites urging caregivers and healthcare providers to "discuss switching to Namenda XR" with their patients. S.A. 51-52. Defendants also sought to convert Namenda IR's largest customer base, Medicare patients, to XR by sending a letter to the Centers for Medicare & Medicaid Services requesting that the agency remove IR from the formulary list, so that Medicare health plans would not cover it. Their planned discontinuance was delayed by a disruption in XR production, and in June 2014, Defendants announced that Namenda IR would be available until the fall of that year.
But before Defendants withdrew IR entirely, intervening events again prompted them to modify their plans. In September 2014, New York State filed a complaint alleging that Defendants' planned withdrawal of Namenda IR violated the antitrust laws. Defendants subsequently entered into an agreement with Foundation Care, a mail-order-only pharmacy, to provide for limited access to Namenda IR if medically required. Under the terms of the agreement, Foundation Care is authorized to dispense Namenda IR tablets only after receiving a form from a doctor stating that it is "medically necessary" for the patient to take Namenda IR. Defendants estimated internally that less than 3% of current Namenda IR users would be able to obtain IR through Foundation Care. S.A. 67. Although the agreement with Foundation Care makes IR available to a limited number of patients, Defendants' actions effectively withdrew Namenda IR from the market. The parties have referred to Defendants' efforts to withdraw Namenda IR from the market as the "hard switch" or "forced switch," terms we also adopt. The hard switch began on February 14, 2014 with the announcement of Defendants' intention to withdraw Namenda IR and was suspended in September 2014 when Defendants agreed to a "standstill" during the litigation proceedings described below. Because a manufacturer does not simply withdraw a drug at once, absent pressing safety concerns, announcing the imminent discontinuation of a drug is tantamount to withdrawal.
In September 2014, New York State filed a complaint in the District Court for the Southern District of New York (Robert W. Sweet, Judge) alleging that Defendants were violating the Sherman Antitrust Act, 15 U.S.C. §§ 1 and 2, as well as New York's Donnelly Act, N.Y. Gen. Bus. Law § 340 et seq., and seeking a permanent injunction and damages. New York also sought a preliminary injunction barring Defendants from restricting access to Namenda IR during the course of the litigation.
New York's theory of antitrust liability, in substance, is as follows. As Namenda IR neared the end of its exclusivity period, Defendants introduced Namenda XR and, before generic IR was available, withdrew Namenda IR in order to force patients to switch from IR to XR (for which generic IR will not be substitutable under most states' laws). In doing so, Defendants intended to thwart generic entry into and competition in the memantine-drug market in order to maintain their monopoly in that market.
The district court held a five-day hearing on the preliminary-injunction motion, during which it received testimony from 24 witnesses and reviewed over 1,400 exhibits. After considering that evidence, the district court made several key findings. (1) Withdrawing Namenda IR from the market prior to generic entry forces Alzheimer's patients dependent on memantine therapy to switch to Namenda XR because it is the only available alternative; (2) The generic versions of IR poised to enter the market in July and October of 2015 will not be AB-rated to XR because they have different strengths and dosages; (3) Pharmacists will not be permitted to substitute generic IR for Namenda XR under New York and Many other states' substitution laws because generic IR is not therapeutically equivalent to Namenda XR; (4) If Defendants forced Alzheimer's patients to switch to Namenda XR prior to generic entry, those patients would be very unlikely to switch back to twice-daily IR therapy even after less-expensive generic IR becomes available, due to the high transaction costs associated with Alzheimer's patients first switching from one formulation of a drug to a new formulation and then back to the original formulation ("reverse commuting"); (5) Preventing generic IR from competing under state drug substitution laws would likely thwart generic entry into and competition in the memantine-drug market; and (6) In withdrawing Namenda IR from the market, Defendants' explicit purpose was to impede generic competition and to avoid the patent cliff—which occurs at the end of a drug's exclusivity period when generics gain market share through state substitution laws.
Based on those findings, the district court granted New York's request for a preliminary injunction. The district court concluded that New York raised serious questions regarding the merits of its claims under Sections 1 and 2 of the Sherman Act and the Donnelly Act, demonstrated the potential for irreparable harm, and concluded that the balance of the equities favored an injunction. The injunction states:
S.A. 137-38. The injunction is effective from the date of issuance, December 15, 2014, until "thirty days after July 11, 2015 (the date when generic memantine will first be available) (the `Injunction Term')." S.A. 138. Defendants timely appealed the grant of the preliminary injunction, and we granted expedited review.
We review a district court's grant of a preliminary injunction for abuse of discretion. Faiveley Transp. Malmo AB v. Wabtec Corp., 559 F.3d 110, 116 (2d Cir.2009). A district court has abused its discretion if it based its ruling on an error of law or a clearly erroneous assessment of the evidence, or if its "decision . . . cannot be located within the range of permissible decisions." Id. (internal quotation marks omitted). We review legal conclusions, such as the appropriate standard for relief, de novo. See Somoza v. N.Y.C. Dep't of Educ., 538 F.3d 106, 112 (2d Cir.2008).
On appeal, Defendants argue that (1) the district court applied the wrong legal standard for a preliminary injunction; (2) product hopping is not anticompetitive or exclusionary under § 2 of the Sherman Act; (3) Defendants' patent rights foreclose antitrust liability; (4) the agreement with Foundation Care does not violate § 1 of the Sherman Act; (5) New York failed to show irreparable harm; and (6) the injunction is vague and overbroad.
Defendants argue that the district court erred by applying the ordinary standard for a preliminary injunction, rather than a heightened standard, because the injunction provides New York with "substantially all the relief sought." Defendants' Brief ("Defs. Br.") at 25. We agree that a heightened standard applies.
Section 16 of the Clayton Act entitles a party to obtain injunctive relief "against threatened loss or damage by a violation of the antitrust laws." California v. Am. Stores Co., 495 U.S. 271, 280, 110 S.Ct. 1853, 109 L.Ed.2d 240 (1990) (quoting 15 U.S.C. § 26). A party seeking a preliminary injunction must ordinarily establish (1) "irreparable harm"; (2) "either (a) a likelihood of success on the merits, or (b) sufficiently serious questions going to the merits of its claims to make them fair ground for litigation, plus a balance of the hardships tipping decidedly in favor of the moving party"; and (3) "that a preliminary injunction is in the public interest." Oneida Nation of New York v. Cuomo, 645 F.3d 154, 164 (2d Cir.2011) (internal quotation marks omitted).
We have held the movant to a heightened standard where: (i) an injunction is "mandatory," or (ii) the injunction "will provide the movant with substantially all the relief sought and that relief cannot be undone even if the defendant prevails at a trial on the merits." Tom Doherty Assocs., Inc. v. Saban Entm't, Inc., 60 F.3d 27, 33-34 (2d Cir.1995). When either condition is met, the movant must show a "clear" or "substantial" likelihood of success on the merits, Beal v. Stern, 184 F.3d 117, 123 (2d Cir.1999), and make a "strong showing" of irreparable harm, Doe v. N.Y. Univ., 666 F.2d 761, 773 (2d Cir.1981), in addition to showing that the preliminary injunction is in the public interest.
The injunction issued by the district court in this case remains in place until 30 days after generics enter the market, and therefore "grant[s] plaintiffs substantially all the relief they ultimately sought, in effect, as if the injunction had
That conclusion, however, is of little import in this case because New York has satisfied the heightened standard. The district court did not abuse its discretion in granting a preliminary injunction because New York has demonstrated a substantial likelihood of success on the merits of its monopolization and attempted monopolization claims under § 2 of the Sherman Act, see Beal, 184 F.3d at 123, and has made a strong showing that Defendants' conduct would cause irreparable harm to competition in the memantine-drug market and to consumers, Doe, 666 F.2d at 773. The district court's factual findings, which were based, for the most part, on Defendants' own internal documents, cannot be said to be clearly erroneous, and its injunction prohibiting Defendants from withdrawing Namenda IR prior to generic entry was not an abuse of discretion as being outside the range of permissible decisions.
Section 2 of the Sherman Act makes it an offense to "monopolize, or attempt to monopolize . . . any part of the trade or commerce among the several States." 15 U.S.C. § 2; see also Geneva Pharm. Tech. Corp. v. Barr Labs. Inc., 386 F.3d 485, 495 (2d Cir.2004). To establish monopolization in violation of § 2, a plaintiff must prove not only that the defendant possessed monopoly power in the relevant market, but that it willfully acquired or maintained that power "as distinguished from growth or development as a consequence of a superior product, business acumen, or historic accident." Verizon Commc'ns Inc. v. Law Offices of Curtis V. Trinko, LLP, 540 U.S. 398, 407, 124 S.Ct. 872, 157 L.Ed.2d 823 (2004) (quoting United States v. Grinnell Corp., 384 U.S. 563, 570-71, 86 S.Ct. 1698, 16 L.Ed.2d 778 (1966)). "To safeguard the incentive to innovate, the possession of monopoly power will not be found unlawful unless it is accompanied by an element of anticompetitive conduct." Id. In order to show attempted monopolization, the plaintiff must prove: "(1) that the defendant has engaged in predatory or anticompetitive conduct with (2) a specific intent to monopolize and (3) a dangerous probability of achieving monopoly power." Spectrum Sports, Inc. v. McQuillan, 506 U.S. 447, 456, 113 S.Ct. 884, 122 L.Ed.2d 247 (1993). Attempted monopolization, unlike monopolization, requires a finding of specific intent. See, e.g., Delaware & Hudson Ry. Co. v. Consol. Rail Corp., 902 F.2d 174, 180 (2d Cir.1990).
Defendants' patents on Namenda IR indisputably grant them a legal monopoly in the U.S. memantine-drug market until July 11, 2015.
Given that Defendants' monopoly power has been established, this case turns on whether Defendants willfully sought to maintain or attempted to maintain that monopoly in violation of § 2. In United States v. Microsoft Corp., 253 F.3d 34, 58-60 (D.C.Cir.2001) (en banc), the D.C. Circuit, sitting en banc, established a helpful framework for determining when a product change violates § 2 based on the rule-of-reason test articulated by the Supreme Court in Standard Oil Co. v. United States, 221 U.S. 1, 31 S.Ct. 502, 55 L.Ed. 619 (1911), and generally applied to antitrust claims. See also Paycom Billing Servs., Inc. v. Mastercard Int'l, Inc., 467 F.3d 283, 289-90 (2d Cir.2006) (explaining that courts analyze most antitrust claims under the rule of reason).
"As a general rule, courts are properly very skeptical about claims that competition has been harmed by a dominant firm's product design changes." Microsoft, 253 F.3d at 65; see also Foremost Pro Color, Inc. v. Eastman Kodak Co., 703 F.2d 534, 544-45 (9th Cir.1983). Product innovation generally benefits consumers and inflicts harm on competitors, so courts look for evidence of "exclusionary or anticompetitive effects" in order to "distinguish `between conduct that defeats a competitor because of efficiency and consumer satisfaction'" and conduct that impedes competition through means other than competition on the merits. Trans Sport, Inc. v. Starter Sportswear, Inc., 964 F.2d 186, 188-89 (2d Cir.1992) (quoting U.S. Football League v. Nat'l Football League, 842 F.2d 1335, 1359 (2d Cir.1988)).
Well-established case law makes clear that product redesign is anticompetitive when it coerces consumers and impedes competition.
In this case, Defendants argue that withdrawing a product is not anticompetitive or exclusionary conduct, especially when the new product is superior to the old product.
Defendants' hard switch crosses the line from persuasion to coercion and is anticompetitive. As long as Defendants sought to persuade patients and their doctors to switch from Namenda IR to Namenda XR while both were on the market (the soft switch) and with generic IR drugs on the horizon, patients and doctors could evaluate the products and their generics on the merits in furtherance of competitive objectives.
By effectively withdrawing Namenda IR prior to generic entry, Defendants forced patients to switch from Namenda IR to XR—the only other memantine drug on the market.
Defendants argue that courts should not distinguish between hard and soft switches. But this argument ignores one of Berkey Photo's basic tenets: the market
As the district court concluded, Defendants' hard switch would likely have anticompetitive and exclusionary effects on competition in the memantine market, creating a "dangerous probability" that Defendants would maintain their monopoly power after generics enter the market. Spectrum Sports, 506 U.S. at 456, 113 S.Ct. 884. Based on careful consideration of the unique characteristics of the pharmaceutical market, the district court found that "[p]rice competition at the pharmacy, facilitated by state substitution laws, is the principal means by which generics are able to compete in the United States." S.A. 26.
We agree with the district court's analysis. Forcing patients to switch to XR would prevent generic substitution because generic versions of IR are not AB-rated to Namenda XR. And if, as Defendants' own internal predictions estimate, the hard switch successfully converted 80 to 100% of IR patients to XR prior to generic entry, there would be "few to no prescriptions" left for which generics would be eligible to compete. S.A. 82. Because Defendants' forced switch "through something other than competition on the merits[] has the effect of significantly reducing usage of rivals' products and hence protecting its own . . . monopoly, it is anticompetitive." Microsoft, 253 F.3d at 65.
Defendants and their amici argue that generics can successfully compete by persuading third-party payors and prescription-benefit managers to promote generic IR through the use of formularies, tiered drug structures, step programs, and prior authorization requirements.
Although in theory, Alzheimer's patients would be free to switch back to IR therapy after generic entry, the district court found that, in practice, such a reverse commute would be a highly unlikely occurrence. As one of Defendants' own executives explained during a January 21, 2014 earnings call: "if we do the hard switch and we convert patients and caregivers to once-a-day therapy versus twice a day, it's very difficult for the generics then to reverse-commute back." S.A. 51. This is because there are high transaction costs associated with reverse commuting. Any patient who wants to switch back to twice daily IR therapy must first obtain a new prescription from a doctor. But, as the district court found, the nature of Alzheimer's disease makes moderate-to-severe Alzheimer's patients especially vulnerable to changes in routine, and makes doctors and caregivers very reluctant to change a patient's medication if the current treatment is effective. As a result, if Defendants forced patients to switch from twice-daily Namenda IR to once-daily XR, those patients would be very unlikely to switch back to twice-daily generic IR even if generic IR is more cost-effective.
Defendants and their amici argue that the district court's focus on AB-ratings is misplaced because up to 20 states do not impose an AB-rating requirement and thus "may let pharmacists unilaterally substitute generic IR for Namenda XR."
Defendants argue that their conduct was not anticompetitive because preventing "free riding" is a legitimate business purpose. But what Defendants call "free riding"—generic substitution by pharmacists following the end of Namenda IR's exclusivity period—is authorized by law; is the explicit goal of state substitution laws; and furthers the goals of the Hatch-Waxman Act by promoting drug competition, Actavis, 133 S.Ct. at 2228, and by preventing the "practical extension of [brand drug
Defendants also argue that antitrust law is not a vehicle for enforcing the "spirit" of drug laws. Defs. Br. at 46. But the Supreme Court has made clear that "[a]ntitrust analysis must always be attuned to the particular structure and circumstances of the industry at issue." Trinko, 540 U.S. at 411, 124 S.Ct. 872. Leading antitrust authorities have encouraged courts to acknowledge market defects, such as a price disconnect and the exclusivity of patents, in their antitrust analysis.
All of Defendants' procompetitive justifications for withdrawing IR are pretextual. The record is replete with evidence showing that Defendants were, in the words of Defendants' own CEO, "trying to . . . put up barriers or obstacles" to generic competition. J.A. 132; see also S.A. 49 ("We need to transition volume to XR to protect our Namenda revenue from generic penetration in 2015 when we lose IR patent exclusivity."); J.A. 155 ("[W]hat we're trying to do is make a cliff disappear and rather have a long—a prolonged decline. And we believe that by potentially doing a forced switch, we will hold on to a large share of our base users."); S.A. 49 ("Our mission is to convert to Namenda XR and lift the franchise. . . . We need to convert as much IR business to Namenda XR as quickly as possible."). Based largely on Defendants' own documents, New York has rebutted Defendants' procompetitive justifications.
Because we have determined that Defendants' procompetitive justifications are pretextual, we need not weigh them against the anticompetitive harms. But in any event, New York has shown that whatever procompetitive benefits exist are out weighed by the anticompetitive harms.
Defendants argue that withdrawing IR was procompetitive because it would maximize their return on their investment in XR. But in deciding to take IR off the market, Defendants were willing to give up profits they would have made selling IR—Forest's best-selling drug. This "willingness to forsake short-term profits to achieve an anticompetitive end" is indicative of anticompetitive behavior. In re Adderall, 754 F.3d at 135 (internal quotation marks omitted). Moreover, Defendants fail to explain why the potential [redacted] in additional XR sales that they stood to earn—which is less than the approximately $1.5 billion in annual sales they have made from Namenda IR in recent years—makes economic sense in the absence of the benefit derived from eliminating generic competition. See id. at 133 (stating that anticompetitive effects could be shown where defendants' conduct "makes sense only because it eliminates competition"). As a result, we agree with the district court that:
S.A. 74.
Finally, Defendants have presented no evidence to support their argument that antitrust scrutiny of the pharmaceutical industry will meaningfully deter innovation. To the contrary, as the American Antitrust Institute amici argue, immunizing product hopping from antitrust scrutiny may deter significant innovation by encouraging manufacturers to focus on switching the market to trivial or minor product reformulations rather than investing in the research and development necessary to develop riskier, but medically significant innovations.
In sum, we conclude that the combination of withdrawing a successful drug from the market and introducing a reformulated version of that drug, which has the dual effect of forcing patients to switch to the new version and impeding generic competition, without a legitimate business justification, violates § 2 of the Sherman Act.
Defendants argue that their patent rights under Namenda IR and Namenda XR shield them from antitrust liability. To be sure, there is tension between the antitrust laws' objective of enhancing competition by preventing unlawful monopolies and patent laws' objective of incentivizing innovation by granting legal patent monopolies. See In re Adderall, 754 F.3d at 133; see also SCM Corp. v. Xerox Corp., 645 F.2d 1195, 1205 (2d Cir.1981).
But in its recent landmark antitrust case, F.T.C. v. Actavis, Inc., the Supreme Court made clear that "patent and antitrust policies are both relevant in determining the scope of the patent monopoly—and consequently antitrust law immunity—that is conferred by a patent." 133 S.Ct. at 2231 (internal quotation marks omitted); see also United States v. Gypsum Co., 333 U.S. 364, 390-91, 68 S.Ct. 525, 92 L.Ed. 746 (1948) (indicating that courts must "balance the privileges of [the patent holder]
The Court's decision in Actavis reaffirmed the conclusions of circuit courts that a patent does not confer upon the patent holder an "absolute and unfettered right to use its intellectual property as it wishes," Microsoft, 253 F.3d at 63, and "[i]ntellectual property rights do not confer a privilege to violate the antitrust laws," In re Indep. Serv. Orgs. Antitrust Litig., 203 F.3d 1322, 1325 (Fed.Cir.2000). See also Allied Orthopedic Appliances Inc. v. Tyco Health Care Grp. LP, 592 F.3d 991, 998 (9th Cir.2010) ("[C]hanges in product design are not immune from antitrust scrutiny and in certain cases may constitute an unlawful means of maintaining a monopoly under Section 2.").
Defendants argue that their conduct does not violate antitrust law because they have merely "exercised rights afforded by the Patent Act." Defs. Br. at 34. But patent law gives Defendants a temporary monopoly on individual drugs—not a right to use their patents as part of a scheme to interfere with competition "beyond the limits of the patent monopoly." United States v. Line Material Co., 333 U.S. 287, 308, 68 S.Ct. 550, 92 L.Ed. 701 (1948). Defendants have essentially tried to use their patent rights on Namenda XR to extend the exclusivity period for all of their memantine-therapy drugs. As explained above, it is the combination of Defendants' withdrawal of IR and introduction of XR in the context of generic substitution laws that places their conduct beyond the scope of their patent rights for IR or XR individually.
In light of New York's substantial likelihood of success on the merits of its monopolization and attempted monopolization claims, we need not address the merits of its Sherman Act § 1 or Donnelly Act claims, which are based on the agreement between Defendants and Foundation Care. We do note, however, that an agreement related to a party's violation of § 2 does not trigger liability under § 1 unless the agreement itself unreasonably restrains trade, Geneva Pharm., 386 F.3d at 506, and there is mutual anticompetitive intent, see id. at 507 ("[L]ack of intent by one party . . . precludes a conspiracy to monopolize."). Conduct that satisfies the unreasonable restraint prong under § 2 does not necessarily violate § 1 absent evidence that the agreement furthers the anticompetitive conduct. Id. at 506.
New York has made a "strong" showing that competition and consumers will suffer irreparable harm in the absence of the injunction. Doe, 666 F.2d at 773. Irreparable harm is "injury that is neither remote nor speculative, but actual and imminent and that cannot be remedied by an award of monetary damages." Forest City Daly Hous., Inc. v. Town of N. Hempstead, 175 F.3d 144, 153 (2d Cir.1999) (internal quotation marks omitted). To obtain injunctive relief under § 16 of the Clayton Act, that injury must be an injury "of the type the antitrust laws were designed to prevent and that flows from that which makes defendants' acts unlawful." Consol. Gold Fields PLC v. Minorco, S.A., 871 F.2d 252, 257 (internal quotation marks omitted), amended by 890 F.2d 569 (2d Cir.1989).
As the district court concluded, "[p]ermanent damage to competition in the memantine market can . . . result from Defendants' planned hard switch
The district court also found that, in addition to harming consumer choice, Defendants' hard switch would cause economic harm to consumers. Based on Defendants' own data, the district court found that consumers would pay almost $300 million more and third-party payors would pay almost $1.4 billion more for memantine therapy if Defendants were permitted to switch patients to Namenda XR before generic IR entry. And HHS reports that Defendants' withdrawal of Namenda IR prior to generic entry would cost Medicare and its beneficiaries a minimum of $6 billion over the next ten years.
Defendants argue that the district court erred in finding irreparable harm because any increase in costs to consumers and third-party payors is "compensable and readily quantifiable." Defs. Br. at 26. But compensating the approximately 500,000 Alzheimer's patients who take Namenda IR tablets, and an unknown number of public and private third-party payors, for an ongoing harm would impose "the task of disentangling overlapping damages claims [which] is not lightly to be imposed upon potential antitrust litigants, or upon the judicial system." Blue Shield of Va. v. McCready, 457 U.S. 465, 475 n. 11, 102 S.Ct. 2540, 73 L.Ed.2d 149 (1982); see also Salinger v. Colting, 607 F.3d 68, 81 (2d Cir.2010) ("Harm might be irremediable, or irreparable, for many reasons, including that a loss is difficult to replace. . . .").
Additionally, we agree with the district court, and the parties do not dispute, that the preliminary injunction serves the public's interest in a competitive market for memantine drugs. See United States v. Siemens Corp., 621 F.2d 499, 506 (2d Cir. 1980) (finding that the government represents the public's interest in a competitive marketplace in seeking to enjoin a merger under § 7 of the Clayton Act); see also Register.com, Inc. v. Verio, Inc., 356 F.3d 393, 424 (2d Cir.2004) ("[G]overnment action taken in furtherance of a regulatory or statutory scheme . . . is presumed to be in the public interest").
Defendants argue that the injunction provision requiring them to make Namenda IR tablets available on the same terms and conditions applicable since July 21, 2013 is vague because the terms and conditions have shifted over the past 17 months. We disagree. The injunction plainly prohibits Defendants from charging more for Namenda IR than it did during the specified timeframe and from restricting access to IR. If Defendants need additional clarification, they can seek it in the district court.
Defendants also argue that the injunction is overbroad because there is no antitrust violation in the 20 states in which drug substitution laws might allow pharmacists to substitute generic IR for Namenda XR. Defendants did not raise this argument before the district court, and therefore have forfeited it. See, e.g., Zalaski v. City of Hartford, 723 F.3d 382, 395 (2d Cir.2013) ("[P]laintiffs failed to raise the argument in the district court, thereby forfeiting it on appeal."). In any event, that argument is not persuasive because, as explained above, it exaggerates the extent to which state substitution laws differ. Defendants have not brought to our attention a single state in which drug substitution laws will definitively allow pharmacists to submit generic IR for Namenda XR, and have thus failed to identify any state for which there is no antitrust violation.
For the reasons stated above, we AFFIRM the District Court's order granting New York's motion for a preliminary injunction.
S.A. 16. Memantine-based drugs, like Namenda, partially block the brain's NMDA receptor in order to prevent "overexcitation" of that receptor, "which can cause toxicity to neurons in the brain." S.A. 17.
In contrast, the three other FDA-approved drugs on the market to treat Alzheimer's disease—Aricept, Exelon, and Razadyne—are all acetylcholinesterase inhibitors ("CIs"). CIs reduce the breakdown of acetylcholine, a chemical messenger that transmits information between nerve cells, in the brain. Rather than work on the glutamate pathway, like Namenda, CIs work on the acetylcholine pathway. CIs are generally prescribed to patients experiencing the early stage of Alzheimer's disease, and are prescribed in conjunction with—but not independently of—Namenda during the moderate-to-severe stages of Alzheimer's disease.
HHS, Office of the Assistant Sec'y for Planning and Evaluation, Some Observations Related to the Generic Drug Market 5 (2015), available at http://aspe.hhs.gov/sp/reports/2015/GenericMarket/ib_GenericMarket.pdf (HHS, Some Observations).
Defendants argue that they will be injured if they cannot convert patients to Namenda XR prior to July 2015, but that argument begets the question of whether their conduct is lawful. Certainly, courts do not consider the harm a party suffers from being prevented from violating the law.
Defendants also argue that they "had stopped making IR batches and ha[d] been implementing plans to limit distribution for months." Defs. Br. at 25. Ordering Defendants to manufacture IR, Defendants argue, impedes production of XR and delays the development of Namzaric, an even newer Alzheimer's drug, because the FDA has only certified one plant to produce IR, XR, and Namzaric. This argument is belied by the record. At the preliminary injunction hearing, one of Defendants' executives testified that the plant could manufacture IR while manufacturing XR. J.A. 533. Defendants also informed the district court that there was no cap on the amount of IR that would be supplied through Foundation Care and that the supply could be "adjusted as necessary based on demand." J.A. 904. Another of Defendants' experts testified that the "biggest problem [Defendants] have with [manufacturing both IR and XR] is the labor force," but "the equipment is completely different equipment." J.A. 202. Defendants' expert clarified that they need skilled labor but, at most, he explained that there might be some delay caused by training employees to use the new XR equipment where employees who had manufactured IR would be able to transition more quickly. J.A. 203.
