Antitrust and Unfair Competition Law

Competition: Winter 2017-18, Vol. 27, No. 1


By Michael A. Carrier1

High drug prices have recently been in the news. The media, public, and politicians have lamented significant price increases. At the same time, such developments have been met with explanations that antitrust cannot address price hikes. Critics contend that U.S. courts do not regulate price and that antitrust law is ill-equipped to referee these disputes.

But what if antitrust could address price hikes? What if the price increases were a result of anticompetitive conduct? In that case, antitrust could play a role, addressing the anticompetitive behavior that resulted in high prices. This article focuses on two price hikes that received significant attention, showing how conduct such as settlements, government petitions, exclusive dealing, and restricted distribution systems contributed to the increases.2

The article first introduces Daraprim, which witnessed a 5000-percent price increase shortly after its distribution system was significantly restricted. It then analyzes the EpiPen, which underwent sustained price increases at the same time the company engaged in a patent settlement, citizen petition, and exclusive dealing.


Daraprim received attention for its 5000-percent price increase but not for its restricted distribution system. This section shows how the adoption of this system could constitute monopolization, with the two elements of monopoly power and exclusionary conduct satisfied.

A. Background

Notorious pharmaceutical entrepreneur Martin Shkreli made worldwide headlines in 2015. As CEO of Turing Pharmaceuticals, Shkreli obtained U.S. marketing rights to pyrimethamine (Daraprim) and quickly increased the price 5000 percent, from $13.50 to $750 per pill.3 Pyrimethamine is a decades-old drug used primarily to treat toxoplasmosis, a fatal parasitic brain infection that usually occurs in patients with weakened immune systems, such as those with end-stage HIV infection.4

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Turing’s price hike was met with widespread outrage among the public and in the medical and public health communities, with the episode leading to censure by other drug companies, congressional hearings seeking ways to address the problem, and policy proposals from presidential candidates. Despite the fact that there were no patents or other forms of market exclusivity protecting the drug, Turing was able to raise the price because the relatively small market in the United States for pyrimethamine had attracted no other generic manufacturers. Indeed, Shkreli later lamented that he did not raise the price even higher.5

In addition to increasing price, Turing initiated another less widely understood move—it changed the distribution scheme for the drug. Before its acquisition by Turing, pyrimethamine was available without restriction to patients seeking to fill prescriptions at local pharmacies and to hospitals seeking to stock the product for inpatient use. But in the months before the price hike, apparently as a condition of the sale to Turing, pyrimethamine was switched to a controlled distribution system called Daraprim Direct, in which prescriptions or supplies of the product could be obtained only from a single source: Walgreen’s Specialty Pharmacy.6 As a result, hospitals could no longer obtain the drug from a general wholesaler, and patients could no longer find it at a local pharmacy.

Instead, Turing required institutions and individuals to set up accounts through Daraprim Direct, and outpatients were only able to receive the drug by mail order.7 Comments from Turing executives suggested that a primary goal of the Daraprim Direct system was to make it impossible for anyone other than registered clients to obtain the drug, including generic manufacturers wishing to obtain samples for use in bioequivalence studies needed to obtain Food and Drug Administration (FDA) approval. This behavior could demonstrate monopolization, with the next two sections analyzing evidence of monopoly power and exclusionary conduct.

B. Monopoly Power

Monopoly power has been defined as "the power to control prices or exclude competition."8 It can be shown in one of two ways, each of which appeared to be satisfied in the case of Daraprim. First, monopoly power can be proved indirectly by examining a defendant’s market share along with barriers to entry that could entrench that market position.9 Courts regularly hold that a 90 percent market share supports market power, with several courts finding a 75 percent share to be sufficient.10

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Evidence that Turing has 100 percent of the relevant market is provided by the lack of effective, FDA-approved substitutes. Pyrimethamine is part of all widely accepted first-line therapeutic regimens for toxoplasmosis.11 In fact, the American Society of Microbiology warned that the 5000 percent price increase would "negatively impact both healthcare costs and individual patient treatments."12 Regulatory barriers to entry cement the effect of this high market share as generics can enter the U.S. market only after receiving FDA approval.

Second, monopoly power can be proved directly,13 such as through observable effects on the market, for example, a price increase or output reduction.14 Turing’s conduct has revealed both types of direct evidence.

To begin, Turing significantly increased price. Even though there was not an increase in the costs of producing pyrimethamine (which costs pennies per pill to manufacture15), Turing increased the price 5000 percent. In addition, it was able to maintain this increase despite public outrage and substantial attention from the press and politicians.16 Given the barriers to entry imposed by obtaining FDA review, the high prices likely will be maintained for an extended period of time.17

Documents provided to a congressional committee offer examples of price increases including patient copays in the thousands of dollars. Just to pick one example, one presentation reported that "[p]atients with commercial/private insurance [are] experiencing increased co-pays, delays in claims approval[,] and rejections," with one facing a copay of $16,830.18

Output reductions are another direct indicator of monopoly power. After pyrimethamine’s price increase, hospitals complained that they were not able to obtain the drug,19 with Turing’s own press release conceding that hospitals and clinics "were having trouble accessing the product."20

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In short, Turing appears to have monopoly power in engineering and maintaining a 5000 percent price increase, preventing hospitals from obtaining pyrimethamine, and ensuring the absence of FDA-approved substitutes for the drug.

C. Exclusionary Conduct

To bring a successful monopolization claim, a plaintiff must show not only monopoly power but also exclusionary conduct. Courts often distinguish between the "willful acquisition or maintenance of [monopoly] power" and "growth or development as a consequence of a superior product, business acumen, or historic accident."21 Such a test is easier to state than apply.

In determining whether Turing’s refusal to provide samples constitutes exclusionary conduct, consideration of the regulatory background is essential. The Supreme Court in Verizon Communications v. Trinko22 explained that "antitrust analysis must always be attuned to the particular structure and circumstances of the industry at issue."23 In particular, courts must take "careful account" of "the pervasive federal and state regulation characteristic of the industry," and the analysis must "recognize and reflect the distinctive economic and legal setting of the regulated industry to which it applies."24

A central objective of the Hatch-Waxman Act is to encourage generic entry.25 Congress sought to achieve this goal through several mechanisms, including formalizing the expedited pathway and allowing generics to experiment on brand drugs before the end of the patent term.26 Most relevant for our purposes, the scheme allows generics to earn abbreviated approvals if they can show that their drugs are bioequivalent to the brand’s drug.27 But this crucial element of competition is possible only if the generic has access to the brand firm’s samples.28 Restricted distribution systems threaten this access.

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Most prescription drugs are available through a standard pharmaceutical distribution chain: from manufacturer to wholesaler, then to retail or mail-order pharmacy, and then to consumer.29 The goal is to distribute the drug as widely as possible, as widespread distribution tends to increase manufacturers’ revenues by making drugs available to be prescribed to as many people as possible.

Drugs with limited distribution schemes, by contrast, are not available through standard retail or mail-order pharmacies. Instead, the manufacturer eliminates the wholesaler and distributes the drug only through specialty pharmacies selected by the manufacturer. Funneling sales through one wholesaler gives the manufacturer complete control over the distribution chain, which could prevent generics from having the access to samples they need to conduct bioequivalence studies and reach the market.

Restricting the typical expansive distribution scheme also tends to involve conduct that makes no sense, other than stifling generic entry. The no-economic-sense analysis asks whether conduct allegedly maintaining a monopoly by excluding nascent competition "likely would have been profitable if the nascent competition flourished and the monopoly was not maintained."30 The test focuses on the conduct’s "reasonably anticipated impact" (according to "objective economic considerations for a reasonable person") when undertaken rather than its actual impact.31 Such conduct provides a simple way to determine whether a company’s sole motive is to impair competition. If a firm undertakes conduct that makes no economic sense, then its "anticompetitive intent" can be "unambiguously . . . inferred."32

In the regulatory context, and considering behavior that does not make business sense, the leading monopolization cases foreshadow liability. For example, in Aspen Skiing Co. v. Aspen Highlands Skiing Corp.,33 the owner of three downhill skiing facilities failed to offer a justification for withdrawing from a joint ticketing arrangement with the owner of the only other facility in the area.34 Just as the Supreme Court found liability where the defendant was "willing to sacrifice short-run benefits and consumer goodwill in exchange for a perceived long-run impact on its smaller rival,"35 a generic that offers to purchase samples at the full retail price can claim that a brand refuses sales that would have been profitable.

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In a second example, Otter Tail Power Co. v. United States,36 the Supreme Court required a company to share electric power transmission with rivals. Similar to the facts in that case, in which the defendant was able to "sell[] power at wholesale to those towns that wanted municipal plants" but refused to sell "solely to prevent municipal power systems from eroding its monopolistic position," the brand in this context already is voluntarily selling the drug but restricting its distribution system so that it would not need to sell to others.37

In addition, the concerns the Court raised in Trinko are less relevant because the brand already sells at retail (reducing problems with "forced sharing" and differing from the "brand new" service Verizon was required to create) and makes only a one-time sale (limiting judicial involvement).38 At the same time, Turing’s change to the distribution scheme did not resemble the setting in Trinko, where "[t]he complaint d[id] not allege that Verizon voluntarily engaged in a course of dealing with its rivals," but instead was similar to that in Aspen Skiing, where "[t]he unilateral termination of a voluntary (and thus presumably profitable) course of dealing suggested a willingness to forsake short-term profits to achieve an anticompetitive end."39

The 2015 switch of pyrimethamine to a restricted distribution scheme as a condition of its sale to Turing threatened to result in fewer sales. Drug manufacturers typically have expansive distribution systems. Absent medical necessity, there is no reason to voluntarily restrict these systems. In this case in particular, there was no apparent rationale for limiting distribution 62 years after the FDA approved pyrimethamine and with no recent safety concerns.

If there were any doubt as to the reason for the change in the distribution system, it was dispelled by Turing itself. Jon Haas, the director of patient access, admitted that he "would block [a] purchase" of pyrimethamine if a generic manufacturer sought to order the pill and conceded that Turing "would like to do our best to avoid generic competition" and was "certainly not going to make it easier" for the generics.40 Turing’s insistence on behavior that lacks rational business sense provides strong evidence of blocking generic rivals. This is a powerful illustration of exclusionary conduct that appears to violate the antitrust laws.

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Nor, finally, are these the only examples of potentially anticompetitive restrictive-distribution systems. Two precursors arose with Shkreli’s previous start-up company, Retrophin. In the first case, the company made rare genetic disorder-treating Chenodal available only through a restricted system that allowed it to increase the drug’s price from $9,460 to $47,300 per 100 pills41 and to prevent generics from "access[ing] product for bioequivalence study."42 In the second, it restricted distribution for cystinuria-treating (predisposing patients to kidney stones) Thiola, which allowed it to raise the price from $1.50 per pill to $30 per pill,43 recognizing that "[e]xclusivity (closed distribution) creates a barrier and pricing power."44 In short, Turing’s Daraprim-related behavior provides evidence of monopoly power and exclusionary conduct, which could satisfy the requirements of a monopolization case.

II. EpiPen: Settlement, Petition, Exclusive Contracts

Conduct related to the EpiPen also threatens anticompetitive behavior, albeit through a different combination of activity: settlements, citizen petitions, and exclusive contracts.

A. Background

In the summer of 2016, Mylan found itself under fire for high EpiPen prices. Between 2009 and 2016, Mylan raised the price of this life-saving device, which delivers epinephrine to treat anaphylactic shock, 15 times, resulting in an increase of more than 400%.45 The medicine in an EpiPen costs only pennies per dose.46 But a pack of two, which needs to be replaced each year and which families buy multiples of for various locations, costs more than $600.47 The consequences of these prices are felt in all corners, as life-threatening allergies from peanuts, shellfish, and other substances affect fifteen million Americans and one in thirteen children.48

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In the summer and fall of 2016, the uproar over the price increases thundered across the spectrum. Politicians from both parties expressed concern,49 including through vigorous criticism at a September 2016 hearing.50 The company was accused of "corporate greed,"51 with particular ire directed towards CEO Heather Bresch.52

Many reasons were offered for the price hike. Some blamed the FDA for a slow-moving generic approval process.53 Others lamented a broken healthcare system.54 Bresch indicted a convoluted distribution chain, with multiple parties each taking a portion of the profits.55

Little attention was paid, however, to Mylan’s role in clearing the field of competitors through potentially anticompetitive actions. The next three sections show how Mylan engaged in an expansive and aggressive array of actions that exploited (1) the litigation process through settlement, (2) the administrative process through FDA citizen petitions, and (3) the laws requiring auto-injectors in schools through exclusive contracts.

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B. Settlement

The first activity involved settlement. In August 2009, Meridian Medical Technologies (a Pfizer subsidiary that manufactures the EpiPen) and King Pharmaceuticals (which acquired Meridian) sued Teva for patent infringement.56 After a four-day bench trial in early 2012,57 the parties settled in April 2012,58 only weeks before post-trial briefings were due in late May 2012.59 While the terms of the settlement are confidential, a Mylan press release confirms that Teva agreed to delay entering the market for more than three years, until June 20 1 5.60 During the period in which Teva could not enter the market, EpiPen prices more than doubled, from (roughly) $220 to $460.61

One cannot know with certainty how the court would have decided the patent litigation. But ominous tea leaves on the patents’ validity are revealed by the court’s Markman62 claim construction hearing, which signaled greater success for Teva than for the patent owners.63 The settlement also was concerning not just because it delayed a successful generic from the market but also because of its effects on other, later-filing generics. The Hatch-Waxman Act awards 180 days of exclusivity to the first generic to challenge a brand firm’s patent claiming that it is invalid or not infringed.64 This period does not begin until the first-filing generic enters the market, in this case three years in the future. Because Teva was the first filer,65 as a result of delaying Teva’s entry into the market, Mylan and its partners delayed all generics that sought to file applications based on the EpiPen.66

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Settlements of patent litigation threaten potential landmines of anticompetitive effects. The Supreme Court made clear in FTC v. Actavis67 that a settlement by which a brand pays a generic to delay entering the market could have "significant adverse effects on competition" and violate the antitrust laws.68

Although the Actavis decision post-dated the settlement, the parties could not have been unaware at the time they settled in April 2012 that potentially rigorous scrutiny was on the horizon. Any appeal of the Delaware court’s decision would be heard by the Third Circuit. And the settlement was signed shortly after that court’s December 2011 oral argument in In re K-Dur Antitrust Litigation, in which the judges expressed skepticism of arguments for minimal antitrust scrutiny.69 In July 2012, the court adopted a test of presumptive illegality.70 Because the terms of the settlement are confidential, it is not possible to know whether there was a transfer of consideration to Teva.71 But the generic-friendly claim construction bolstering Teva’s leverage, together with the vast scale of the market,72 increased the likelihood that Meridian delayed Teva’s entry through payment.73

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C. Citizen Petition

In addition to delayed-entry settlements, Mylan sought to forestall Teva’s entry by employing a "citizen petition," which is meant to raise safety concerns with the FDA but which has been used by brand firms to delay generic entry. As I have shown, "citizen" petitions are filed mostly by brand firms, and are almost always (92%) denied.74

Mylan filed its citizen petition against Teva’s Abbreviated New Drug Application (ANDA or generic application) in January 2015.75 A response from the FDA was anticipated no later than June 201576—only weeks before Teva was permitted to enter the market pursuant to its settlement. As my study revealed, Mylan’s petition appears to have been filed as a delay tactic to avoid generic approval and the loss of its overwhelming share of the market.77

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Just as concerning, in May 2015, four months after filing the petition, Mylan filed a supplemental study asserting that patients would not be able to operate Teva’s proposed device without retraining.78 Experts explained, however, that Mylan’s supplemental study "had a lot of problems" as it "lacked a control group; did not study the actual generic but a prototype instead; used a small number of participants; failed to provide them with proper instructions for use; and told participants to watch a video rather than actually use the Teva device."79

Shedding even more light on the questionable petition and supplemental study is its timing. In a development of which the industry would be keenly aware, Teva filed its ANDA against the Epi-Pen in 2008.80 And court documents show that Teva produced its ANDA filing in the course of litigation in September 2010.81 This material included "detailed product descriptions, drawings, and instructions for use" for Teva’s proposed generic.82

At the time (and to this day), Mylan was working hand-in-hand with Meridian/King, with the former taking over Orange Book sponsorship of the drug application and the latter targeting rivals in litigation83 It thus seems exceedingly likely that Mylan would have been aware of Teva’s ANDA in 2008 and aware of documents explaining Teva’s product in 2010. In fact, it was Mylan that announced the settlement of the litigation, confirming its close connection to the case.84 This connection raises significant concerns that Mylan waited more than four years to file its citizen petition in 2015.

Even though Teva’s ANDA was ultimately denied in February 2016,85 Mylan would not have known this when it filed its petition in January 2015. And my comprehensive study of citizen petitions found that in 2015, the FDA approved three ANDAs on the same day it denied a petition, suggesting that generic approval was at least partially delayed until the petition was resolved.86

It is reasonable to conclude that Mylan’s (1) filing of a petition years after invariably knowing about Teva’s generic; (2) filing of a petition calculated to delay entry after settlement; and (3) late-filing of a supplemental study together comprised a strategy to delay Teva’s ANDA approval beyond the already-delayed agreed entry date of June 2015. Although the FDA is required to respond to petitions within 150 days, on numerous occasions the agency offers only an interim response explaining that it requires more time due to "complex issues raised" in the petition.87 As a result, a strategy similar to the one Mylan used easily could have pushed a petition’s disposition (and thus generic approval) past 150 days. For a billion-dollar drug product like the EpiPen, each day of delay meant an extra $3 million.

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Parties filing petitions with government agencies often can rely on the immunity from the antitrust laws provided by the Noerr-Pennington doctrine, as "[t]hose who petition [the] government for redress are generally immune from antitrust liability."88 But this defense is not absolute. In particular, there is a well-established "sham" exception, whose requirements of subjective motivation and objective baselessness could conceivably be satisfied in this case from Mylan’s likely longstanding knowledge of Teva’s generic, the timing of the petition in relation to the settlement, and the questionable nature of the supplemental study.89 On a broader level, the petition could be viewed as an integral part of an overall scheme of monopolization, together with settlement and (as discussed immediately below) exclusive dealing.90

D. Exclusive Dealing

In addition to delaying future generic entry from Teva (and others waiting in line behind it) through settlement and petition, Mylan blocked present competitors through its program for distributing the EpiPen to schools.91

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In November 2013, in response to a seven-year-old girl at a Virginia school dying from an allergic reaction to peanuts,92 Congress passed the School Access to Emergency Epinephrine Act.93 Under this law, the Secretary of Health and Human Services is authorized to give preferential funding to states with schools that maintain an emergency supply of epinephrine for students.94 The law has had a significant effect: 11 states require95 and 38 encourage96 schools to stock epinephrine.97 This federal legislation has been supplemented by state laws that mandate that public schools obtain auto-injectors.98

On one hand, such an arrangement could increase access to a life-saving device. But on the other, it could exclude competitors. As a condition of receiving discounted EpiPens,99 schools were required to agree that they would "not in the next twelve (12) months purchase any products that are competitive to EpiPen® Auto-Injectors."100 The language appeared in order forms in August 2014, June 2015, and April 2016,101 and Mylan has admitted such a practice.102

In antitrust terms, this conduct offers a discount price based on exclusivity. As the leading treatise explains, such an arrangement "should generally be treated as no different from an orthodox exclusive-dealing arrangement."103 Exclusive dealing case law stems from Section 3 of the Clayton Act, which prohibits a "discount . . . or rebate . . . on the condition, agreement, or understanding that the . . . purchaser . . . shall not use or deal in the goods . . . of a competitor" where there is an adverse effect on competition.104 Exclusive dealing also can constitute monopolization under Section 2 of the Sherman Act if the defendant has monopoly power.105 The general concern with exclusive dealing arrangements is that they block competitors from the market and result in higher prices and lower output.

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In evaluating the antitrust aspects of such arrangements, courts have historically focused on the share of the market foreclosed by the arrangement, requiring plaintiffs to show roughly 30% to 40% foreclosure.106 Assuming this threshold is cleared, courts then analyze other factors, such as the duration of the contracts, prevalence in the industry, existence of entry barriers, distribution alternatives, and other competitive effects.107

Recent cases have shifted the emphasis away from foreclosure. One commentator has found that courts "have looked beyond foreclosure to focus instead on the effect of exclusive dealing in creating, enhancing, or preserving the defendant’s market power."108 Recent cases "have . . . found exclusive dealing and similar arrangements unlawful despite minimal, or even zero, levels of percentage foreclosure from access to the ultimate consumer."109

Applying antitrust law to Mylan’s EpiPen contracts, the first question is whether distribution through schools constitutes its own market. An expansive view would treat together distribution in varied settings including schools, hospitals, amusement parks, and families. According to such an interpretation, the share distributed to schools would likely be a modest subset of the total number of devices.

But a more justified interpretation is that schools constitute their own separate market. While each state law differs on the particular age through which students are required to attend school, it is generally accepted that children up to the age of eighteen must do so.110 After the passage of the 2013 legislation, schools are either required, or receive significant incentives, to stock epinephrine auto-injectors. Schools’ decisions on which devices to purchase are not tied to those of parents and hospitals. And given the number of children that do not carry EpiPens with them, school nurses play an irreplaceable role during school hours on the front lines of treating anaphylactic shock, buttressing the conclusion of a market for distribution through schools.111

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In the market of school distribution for epinephrine auto-injectors, the precise extent of foreclosure is unclear.112 There are roughly 129,000 elementary, middle, and high schools in the U.S. today: 98,000 public113 and 31,000 private.114 While more than half of these schools, over 65,000, receive free EpiPens, the number of schools that have bought EpiPens at a discount is less clear, which prevents definitive conclusions on foreclosure.115

Regardless of the percentage of the market foreclosed, other factors favor antitrust liability.116 For competitors not yet on the market, there are high entry barriers in the form of FDA approval. It is particularly difficult for companies to obtain approval of epinephrine auto-injectors as the FDA is cautious given the potentially fatal consequences from misapplication.117 Barriers also applied to alternatives on the market like Adrenaclick and Auvi-Q, as the Mylan contracts made it more difficult to gain a foothold. Nurses would be trained on the EpiPen, and caregivers whose children’s lives were saved by a nurse using an EpiPen—or even who merely knew that the devices were present at the school—would tend to purchase (and tell relatives and others to buy) EpiPens.

In addition, the competitive effects are as clear as they ever are in these cases: a 400% surge from 15 price increases between 2009 and 2016. For each of those increases, Mylan hiked the EpiPen’s price at least 9%, and as much as 15%.118 In short, Mylan’s exclusive dealing agreements appeared to block competitors from the market and to increase price.

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Depending on Mylan’s market share (which was 94% in August 2016119 but 71% in March 2017120), this analysis may form the basis for not only a Clayton Act Section 3 claim but also a monopolization claim.121

III. Conclusion

A greater number of price increases than is commonly recognized can be explained by anticompetitive behavior like that outlined in this article. As the Daraprim and EpiPen examples showed, in these cases antitrust can address price hikes. In the years ahead, antitrust enforcers and observers should carefully scrutinize price increases to determine if they are accompanied by anticompetitive behavior.

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1. Distinguished Professor, Rutgers Law School. Copyright © 2017 Michael A. Carrier. Parts of this article are adapted from Michael A. Carrier, Nicole Levidow & Aaron S. Kesselheim, Using Antitrust Law to Challenge Turing’s Daraprim Price Increase, 31 BERK. TECH. L. J. 1379 (2017) and Michael A. Carrier & Carl J. Minniti III, The Untold EpiPen Story: How Mylan Hiked Prices by Blocking Rivals, 102 Cornell L. Rev. Online 53 (2017).

2. Antitrust also plays a role when price remains elevated longer than it should, for example, when a brand pays a generic to settle patent litigation and delay entering the market. See, e.g., FTC v. Actavis, 133 S. Ct. 2223 (2013).

3. Andrew Pollack, Drug Goes From $13.50 a Tablet to $750, Overnight, N.Y. Times, Sept. 21, 2015, at B1.

4. Sara Fazio, Toxoplasmosis, New Eng. J. Med. Blog (Feb. 23, 2012), index.php/toxoplasmosis/2012/02/23/.

5. Kate Gibson, Martin Shkreli: "I Should’ve Raised Prices Higher," CBS News (Dec. 4, 2015), http://

6. Andrew Pollack & Julie Creswell, The Mercurial Man Behind the Drug Price Increase that Went Viral, N.Y. Times, Sept. 23, 2015, at B1.

7. Monica V. Mahoney, New Pyrimethamine Dispensing Program: What Pharmacists Should Know, Pharm. Times (July 17, 2015),

8. United States v. E.I. duPont de Nemours & Co., 351 U.S. 377, 391 (1956).

9. Herbert Hovenkamp, Federal Antitrust Policy: The Law of Competition and its Practice ¶ 6.2b, at 359-60 (5th ed. 2016).

10. Id. ¶ 6.2a, at 357.

11. Sara Fazio, Toxoplasmosis, New Eng. J. Med. Blog (Feb. 23, 2012), php/toxoplasmosis/2012/02/23/.

12. Memorandum from the Democratic Staff to Democratic Members of the Full House Comm. on Oversight and Gov’t Relations, at 5 (Feb. 2, 2016),

13. ABA Section of Antitrust Law, Antitrust Law Developments 69-70 (7th ed. 2012) (noting that "direct proof has provided the basis for findings of substantial anticompetitive effects in some prominent cases").

14. Broadcom Corp. v. Qualcomm Inc., 501 F.3d 297, 307 (3d Cir. 2007).

15. See Karthick Arvinth, Daraprim: Generic Version of Drug Costs Less than £0.07 in India, International Business Times (Sept. 25, 2015),

16. Pollack, supra note 2.

17. See, e.g., Star Fuel Marts, LLC v. Sam’s E., Inc., 362 F.3d 639, 654 (10th Cir. 2004).

18. Comm. Memorandum, supra note 11, at 5.

19. Letter from Stephen B. Calderwood & Adaora Adimora to Tom Evegan & Kevin Bernier (Sept. 8, 2015), FINAL.pdf.

20. Press Release: Important News about Daraprim (pyrimethamine), Turing Pharmaceuticals (Sept. 18, 2015),

21. United States v. Grinnell Corp., 384 U.S. 563, 570-71 (1966).

22. 540 U.S. 398 (2004).

23. Id. at 411.

24. Id.

25. See, e.g., Michael A. Carrier, Unsettling Drug Patent Settlements: A Framework for Presumptive Illegality, 108 Mich. L. Rev. 37, 41-43 (2009).

26. See 35 U.S.C. § 271(e)(1) (2012); Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 669-70 (1990) (allowing experimentation before end of patent term would prevent "unintended distortion" of patent laws that would extend "de facto monopoly"); FTC, Generic Drug Entry Prior to Patent Expiration: An FTC Study 5 (2002), reports/generic-drug-entry-prior-patent-expiration-ftc-study/genericdrugstudy_0.pdf.

27. See Generic Drug Study, supra note 25, at 5; Lauren Battaglia, Risky Conduct with Risk Mitigation Strategies? The Potential Antitrust Issues Associated with REMS, Antitrust Health Care Chronicle 26, 28 (Mar. 2013).

28. Aaron S. Kesselheim & Jonathan J. Darrow, Hatch-Waxman Turns 30: Do We Need a Re-designed Approach for the Modern Era?, 15 Yale J. Health Pol’y L. & Ethics 293, 340-41 (2015).

29. Kaiser Family Foundation, Follow the Pill: Understanding the U.S. Commercial Pharmaceutical Supply Chain (2005),

30. Gregory J. Werden, Identifying Exclusionary Conduct Under Section 2: The "No Economic Sense" Test, 73 Antitrust L.J. 413, 415 (2006). For conduct allegedly creating a monopoly, the test asks "whether the conduct likely would have been profitable if the existing competitors were not excluded and monopoly was not created." Id.

31. Id. at 416.

32. A. Douglas Melamed, Exclusive Dealing Agreements and Other Exclusionary Conduct—Are There Unifying Principles?, 73 Antitrust L.J. 375, 393 (2006).

33. 472 U.S. 585 (1985).

34. Id.

35. Id. at 610-11.

36. 410 U.S. 366 (1973).

37. Id. at 378.

38. 540 U.S. at 408-09.

39. Id. at 409.

40. Ed Silverman, How Martin Shkreli Prevents Generic Versions of his Pricey Pill, Pharmalot (Oct. 5, 2015),

41. Retrophin, Inc. Report, U.S. Sec. ExcH. Comm’n (Apr. 3, 2014), ID = 1193805-14-689&CIK=1438533.

42. Derek Lowe, The Most Unconscionable Drug Price Hike I Have Yet Seen, In the Pipeline (Sept. 11, 2014), price_hike_i_have_yet_seen.

43. Id.; see also Lydia Ramsey, The CEO Who Jacked up the Price of a Drug by 5,000% Has Done This Before, Business Insider (Sept. 23, 2015),

44. Memorandum from the Democratic Staff to Democratic Members of the Full House Comm. on Oversight and Gov’t Relations, at 3 (Feb. 2, 2016), See also Carrier, Levidow & Kesselheim, supra note *, at 1407-08 (discussing Namenda drug at heart of New York Attorney General’s product-hopping case, for which manufacturer imposed restricted distribution system for original, but not reformulated, version).

45. Sy Mukherjee, How Mylan Got Away With Its Enormous Price Hike for the EpiPen, Fortune, Aug. 22, 2016,; Matt Egan, How EpiPen Came to Symbolize Corporate Greed, CNN Money, Aug. 29, 2016, http://money.cnn. com/2016/08/29/investing/epipen-price-rise-history/; Anna Edney & Cynthia Koons, Mylan Plans Generic EpiPen to Quell Outcry Over $600 Cost, Bloomberg, Aug. 29, 2016, com/news/articles/2016-08-29/mylan-to-sell-generic-epipen-to-quell-outcry-over-600-cost.

46. Letter from Jason Chaffetz (R-UT) & Elijah E. Cummings (D-MD) to Heather Bresch, Aug. 29, 2016, documents/2016-08-29%20JC%20and%20EEC%20%20to%20Bresch-Mylan%20EpiPen%20 Pricing.pdf (questioning price increase and commencing congressional investigation).

47. Id.

48. Mukherjee, supra note 44, at 1.

49. Chaffetz & Cummings Letter, supra note 45; Letter from Charles E. Grassley (R-IA) to Heather Bresch, Aug. 22, 2016, upload/2016-08-22%20CEG%20to%20Mylan%20(EpiPen).pdf.

50. Full House Comm. on Oversight & Gov’t Reform, Hearing on Reviewing the Rising Price of EpiPens (Sept. 21, 2016), available at; Anna Edney & Robert Langreth, Mylan Blasted for Raising EpiPen Prices to Get "Filthy Rich," Bloomberg (Sept. 21, 2016), mylan-criticized-on-profits-and-pay-at-house-oversight-hearing.

51. Egan, supra note 44.

52. Andrew B. Polumbo, To the EpiPen CEO: My Daughters Will Be Nothing Like You, Huffington Post, Aug. 31, 2016,

53. Rand Paul, Sen. Rand Paul: EpiPen Scandal Is a Perfect Example of Crony Capitalism, Time (Sept. 7, 2016),; A Drug Cartel at the FDA, Wall St. J. (Sept. 26, 2016) (criticizing FDA’s generic label regulations and commenting that "next t ime you hear a political sermon on the scandalous expense of treatments, remember this government collusion to keep drug prices high"),

54. E.g., Charley Grant, The EpiPen Controversy Isn’t About Mylan, Wall St. J., Aug. 25, 2016, http://; Aaron E. Carroll, The EpiPen, a Case Study in Health System Dysfunction, N.Y. Times, Aug. 23, 2016, http://www. html?_r=0.

55. Dan Mangan & Anita Balakrishnan, Mylan CEO Bresch: ‘No One’s More Frustrated Than Me’ About EpiPen Price Furor, CNBC, Aug. 25, 2016,

56. Complaint, King Pharm, Inc. v. Teva Parenteral Med. Inc., Case No. 09-652-GMS (D. Del. Aug. 28, 2009). At the time of this suit, the 2009 Orange Book listed Meridian as EpiPen’s sponsor. Mylan Specialty took over as EpiPen’s sponsor in the 2014 Orange Book. Even though Meridian and King formally filed the lawsuit, this article connects the conduct to Mylan given (1) its wholly-aligned interests as exclusive marketer and distributor, (2) the division of responsibility by which Meridian/ King filed lawsuits and Mylan listed patents in the Orange Book, and (3) Mylan’s announcement of the settlement, which quotes executives not from Meridian or Pfizer but only from Mylan. See infra note 57 and accompanying text (quoting CEO Heather Bresch: "We are pleased with this settlement, and are confident that the EpiPen® Auto-Injector will continue to be a market leader.").

57. Case No. 09-652, D.I. 150-54 (D. Del. July 25, 2012) (transcript of trial held on Feb. 16, 2012 and Mar. 7-9, 2012).

58. See Mylan and Pfizer Announce Epinephrine Auto-injector Settlement Agreement with Teva, Mylan (Apr. 26, 2012),

59. Case No. 09-652-GMS, D.I. 146 (D. Del. Apr. 12, 2012).

60. Id. The West Virginia Attorney General has opened an antitrust investigation of the settlement. Chris Morran, West Virginia Investigating EpiPen Maker Mylan For Alleged Medicaid Fraud, Antitrust Violations, Consumerist, Sept. 20, 2016,

61. See Dan Mangan, This Chart Shows Why Everyone’s Angry About Soaring Price of Lifesaving EpiPen, CNBC, Aug. 23, 2016, (providing figures from July 2012 and May 2015).

62. See generally Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996) (holding that claim construction is a matter of law and that judges are to construe the meaning of patent claims).

63. See Carrier & Minniti, supra note *, at 61-62.

64. 21 U.S.C. §355(j)(5)(B)(iv) (2012).

65. Update: Teva and Antares’s Generic Challenge to Epi-Pen, SeekingAlpha, Feb. 23, 2012, http://

66. See Michael A. Carrier, Payment After Actavis, 100 IowA L. Rev. 7, 15 (2014) (noting that the 2003 Medicare Amendments, which were designed to encourage expedited entry by specifying events that led to a forfeiture of the exclusivity period, were ineffective).

67. 133 S. Ct. 2233 (2013).

68. Id. at 2231.

69. Oral Argument, In re K-Dur Antitrust Litig., Nos. 10-2077, 10-2078, 10-2079, & 10-4571, at 25, 36, 37 (3d Cir. Dec. 12, 2011) (noting that "Senator Hatch himself has said that he thinks these reverse payments are anti-competitive" and questioning arrangement by which brand purchased generic product on grounds that it "le[]d to the presumption that [it] could have been buying off the generic from entering the market earlier" and that "what [the parties] ended up [with] was an allocation of the market—which violates the antitrust laws").

70. In re K-Dur Antitrust Litig., 686 F.3d 197, 218 (3d Cir. 2012), cert. granted and judgment vacated by Upsher-Smith Lab., Inc. v. La. Wholesale Drug Co., 133 S. Ct. 2849 (2013).

71. See Notice of Removal of Action from State Court Pursuant to 28 U.S.C. §§ 1331, 1332, 1338, 1367, 1441, 1446 & 1454 at Exhibit A at ¶¶ 34-35, Teamsters v. King Pharms., No. 1:15-cv-04666-LAK (N.Y. filed June 16, 2015) (requesting access to settlement agreement and stating that "[u]pon information and belief, Teva received unjustifiable consideration, incentives, and benefits in exchange for their collusion" since "[n]o rational economic actor with a viable product would refrain from entering a lucrative ‘blockbuster’ market unless they received some form of valuable consideration").

72. One analyst anticipated that a Teva victory could have resulted in it "captur[ing] 40% of the Epi-Pen unit market and roughly 20% of current sales, or about $54 million, in the first year of introduction." Larry Smith, The Promise of the Antares Pipeline is the Basis of My Buy Recommendation, Smith On Stocks, Jan. 25, 2012,

73. In the midst of the EpiPen price-hike saga, Teva has declined to comment on whether payment was made in exchange for the settlement. Chris Glorioso & Evan Stulberger, I-Team: Company Behind EpiPen Fought to Keep Cheaper Generic off Market, NBC New York, Aug. 30, 2016, http:// As of this writing, Teva has not received FDA approval. But that is the result of a history in which it delayed entering for several years, and which conceivably lessened its incentives to enter the market.

Nor was this the only settlement. In January 2011, King commenced litigation against Intelliject (now Kaleo) for infringement after the company sought approval for Auvi-Q. Complaint, King Pharm, Inc. v. Intelliject Inc., Case No. 1:11-cv-00065-UNA (D. Del. Jan. 19, 2011). In February 2012, the parties settled on terms allowing Auvi-Q to enter the market in November 2012 (three months after receiving FDA approval). Mylan and Pfizer Announce Epinephrine Auto-Injector Settlement Agreement, FiercePharma, Feb. 16, 2012, mylan-and-pfizer-announce-epinephrine-auto-injector-settlement-agreement; Phil Milford, Pfizer, Mylan Settle With Sanofi Over Epinephrine Injector, Bloomberg, Feb. 16, 2012, http://www.; NDA 201739, Drugs@FDA: FDA Approved Drug Products, http:// (enter 201739 into the Search by Drug Name, Active Ingredient, or Application Number field).).

74. Michael A. Carrier & Carl Minniti, Citizen Petitions: Long, Late-Filed and At-Last Denied, 66 Am. U. L. Rev 305, 333 (2016) (examining all 505(q) petitions (which ask the FDA to take action against a pending generic application) filed between 2011 and 2015); see also Michael A. Carrier & Daryl Wander, Citizen Petitions: An Empirical Study, 34 Cardozo L. Rev. 249, 274 (2012) (finding that the FDA denied 81% of petitions filed between 2001 and 2010).

75. Citizen Petition from Mylan Specialty, L.P., Docket No. FDA-2015-P-0181-0001 at *1 (posted on Jan. 16, 2015).

76. See 21 U.S.C. § 355(q)(F) (2012) ("The Secretary shall take final agency action on a petition not later than 150 days after the date on which the petition is submitted.").

77. See Carrier & Minniti, supra note 73, at 350-51.

78. Supplement from Mylan Specialty, L.P., Docket No. FDA-2015-P-0181-0007 at *10 (posted on May 5, 2015).

79. Ed Silverman, How Mylan Tried to Keep Teva from Selling a Generic EpiPen, Stat, Aug. 31, 2016, https:// The petition also included a statement from Dr. Eli Meltzer—who received roughly $95,000 from Mylan between 2014 and 2015—that users trained on the EpiPen would not "be able to reliably use a different operational platform in an emergency situation as safely and effectively." Id.

80. Smith, supra note 71.

81. Defendants’ Brief in Support of their Motion to Dismiss at 6, King Pharm, Inc. v. Teva Parenteral Med. Inc., Case No. 09-652-GMS at *6 (D. Del., filed Dec. 13, 2010).

82. Id.

83. See supra note 57.

84. See supra note 57.

85. Carly Helfand, FDA Swats Down Teva’s EpiPen Copy, Putting Mylan in Cruise Control, FiercePharma (Mar. 1, 2016),

86. See Carrier & Minniti, supra note 73, at 341-44.

87. E.g., Interim Response Letter from FDA CDER to Cubist Pharm., Inc., Docket No. FDA-2015-P-1595-0004 (posted on Oct. 26, 2015) (interim response from FDA, 173 days after petition filing, stating that "FDA has been unable to reach a decision on your petition because it raises complex issues requiring extensive review and analysis by Agency officials").

88. Prof”l Real Estate Investors, Inc. v. Columbia Pictures Indus., 508 U.S. 49, 56 (1993).

89. E.g., Tyco Healthcare Group v. Mutual Pharm., 762 F.3d 1338, 1348 (Fed. Cir. 2014); In re DDAVP Direct Purchaser Antitrust Litig., 585 F.3d 677, 694 (2d Cir. 2009); In re Flonase Antitrust Litig., 795 F. Supp. 2d 300, 317 (E.D. Pa. 2011); In re Prograf Antitrust Litig., 2012 WL 293850, at *5 (D. Mass. Feb. 1, 2012); see also Tyco Healthcare Group v. Mutual Pharm., 2015 WL 3460790, at *9 (D.N.J. May 29, 2015) (denying summary judgment because generic offered evidence that petition delayed entry).

90. See, e.g., In re Neurontin Antitrust Litig., 2009 WL 2751029, at *15 (D.N.J. Aug. 28, 2009) ("Courts have routinely upheld the validity of ‘overall monopolization scheme’ claims in the patent context, even in the absence of allegations that any one of the scheme’s predicate actions was independently violative of antitrust laws." (quoting Abbott Labs v. Teva Pharm. USA, Inc., 432 F. Supp. 2d 408, 428 (D. Del 2006))).

91. The New York Attorney General launched an antitrust investigation of this conduct. Press Release, N.Y. Attorney General, A.G. Schneiderman Launches Antitrust Investigation into Mylan Pharmaceuticals Inc., Maker of EpiPen, Sept. 6, 2016,

92. Cynthia Koons & Robert Langreth, How Marketing Turned the EpiPen into a Billion-Dollar Business, BloombergBusinessweek, Sept. 23, 2015, how-marketing-turnedthe-epipen-into-a-billion-dollar-business.

93. Pub. L. No. 113-48, 127 Stat. 575 (2013) (codified at 42 U.S.C. § 280g(d)(1)(F)-(G)).

94. Id.

95. School Access to Epinephrine Map, Food Allergy Res. & Educ. epinephrine/map (last updated July 6, 2016).

96. Id. Hawaii is the only state that does not require or allow schools to stock epinephrine.

97. Koons & Langreth, supra note 91.

98. See Aimee Nienstadt, Comment, The Insufficiency of the Law Surrounding Food Allergies, 36 Pace L. Rev. 595, 611 (2016) (providing analysis on state epinephrine auto-injector laws). For a discussion of Mylan’s role in the enactment of the 2013 Act, see Carrier & Minniti, supra note *, at 67-68.

99. Ike Swetlitz & Ed Silverman, Mylan May Have Violated Antitrust Law in its EpiPen Sales to Schools, Legal Experts Say, Stat, Aug. 25, 2016, (noting that the "discounted price was $112.10," roughly "a quarter of the cost charged to pharmacies at the time").

100. Id.

101. Id.

102. Full House Comm., supra note 49 (pt. 1, at 1:44:00) (in testimony to House Committee, Bresch responded to Representative Duckworth’s question about whether "schools purchasing discounted EpiPens had to make any representations or warranties to Mylan that they would adhere to certain conditions in order to access the discount price by conceding: "For people that wanted to buy it at the discounted rate, yes").

103. XI Herbert Hovenkamp, Antitrust Law: An Analysis of Antitrust Principles and Their Application ¶ 1807b, at 133 (3d ed. 2006).

104. 15 U.S.C. § 14 (2012); see id.

105. 15 U.S.C. § 2.

106. Herbert Hovenkamp, Federal Antitrust Policy: The Law of Competition and its Practice 596 (5th ed. 2016).

107. Id. at 597.

108. See Jonathan M. Jacobson, Exclusive Dealing, "Foreclosure," and Consumer Harm, 70 Antitrust L.J. 311, 311 (2002).

109. Id. at 363; see also id. ("precise percentage of the market asserted to be foreclosed . . . appears to be a wasteful exercise" as "[f]ew serious cases today are based on assertions that foreclosure alone is the source of the asserted competitive harm").

110. See 78A C.J.S. School and School Districts § 988 (2016).

111. See David Stukus, New Epinephrine Study Shows Alarming Results, Kids With Food Allergies: KFA Medical Advisory Team (July 14, 2014), http://community.kidswithfoodallergies. org/blog/new-epinephrine-study-shows-alarming-results (study showed that only 40% of families carried self-injectable epinephrine with them).

112. E.g., EpiPen4Schools Program, Mich. Ass’N of Intermediate Sch. Admins., http://www.gomaisa. org/epipens-4-schools-program (last visited Oct. 20, 2016) (covering "qualifying public and private kindergarten, elementary, middle and high schools in the U.S.").

113. Jill Barshay, The Hechinger Report, Number of U.S. Charter Schools Up 7 Percent, Report Shows, U.S. News &World Rep. (Nov. 3, 2014), number-of-us-charter-schools-up-7-percent-report-shows.

114. Facts and Studies, Council for Am. Priv. Educ.,

115. Swetlitz & Silverman, supra note 98; Mylan Letter to Sen. Elizabeth Warren et al., Sept. 12, 2016, at 7-8 (noting that 1,348 schools purchased EpiPens at a discount between September 2015 and September 2016 but not explaining whether restrictive contracts were in place for entire period or whether such figures were representative of earlier periods); Ed Silverman, Lawmakers Call for FTC Probe into Potential Antitrust Violations in EpiPen School Program, Stat, Nov. 8, 2016, https://www. (noting that "700,000 free pens have been distributed to schools" and that "another 45,000 pens" were distributed at a discount).

116. The 12-month duration of the contract would present the sole factor that would counsel against liability, but would likely be significantly outweighed by the other factors.

117. See Helfand, supra note 84 ("regulators flagged ‘certain major deficiencies’"); see generally Pauline Bartolone, EpiPen’s Dominance Driven by Competitors’ Stumbles and Tragic Deaths, NPR: Shots Health News from NPR (Sept. 7, 2016), epipen-s-dominance-driven-by-competitors-stumbles-and-tragic-deaths.

118. Jayne O’Donnell et al., EpiPen’s Steady Price Increases Masked Until Deductibles Rose, USA Today, Aug. 25, 2016,

119. E.g., Matt Egan, EpiPen Outrage May Fuel Cheap Generic in 2017, CNNMoney: The Buzz (Aug. 26, 2016),

120. Sy Mukherjee, Mylan’s EpiPen Is Bleeding Market Share to Its Rivals, Fortune, Mar 6, 2017, http://

121. In fact, courts have accepted lower foreclosure figures in the context of monopolization. See United States v. Microsoft Corp., 253 F.3d 34, 70 (D.C. Cir. 2001) ("[A] monopolist’s use of exclusive contracts, in certain circumstances, may give rise to a § 2 violation even though the contracts foreclose less than the roughly 40% or 50% share usually required in order to establish a § 1 violation.").

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