# In re Epipen

> District Court, D. Kansas · August 20, 2018 · 336 F. Supp. 3d 1256

URL: https://www.frixlaw.com/law-library/cases/7250288

## Case

- **Full name:** IN RE: EPIPEN (EPINEPHRINE INJECTION, USP) MARKETING, SALES PRACTICES AND ANTITRUST LITIGATION (This Document Applies to Consumer Class Cases)
- **Court:** District Court, D. Kansas
- **Decided:** August 20, 2018
- **Citations:** 336 F. Supp. 3d 1256
- **Precedential status:** Published
- **Opinion:** Opinion of the court by Crabtree
- **Judges:** Crabtree
- **Cited by:** 25 later opinions in the Frix Law Library

## Citator (automated)

- No negative treatment found by the automated citator. That is not the same as a confirmation that the case is good law; read the citing cases.
- Full citator and citing cases: https://www.frixlaw.com/law-library/cases/7250288

## How later opinions describe it (automated extraction)

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- explaining in Illinois Brick, “the Supreme Court held that only direct purchasers may bring claims for damages under the federal antitrust laws”
- discussing the two different standards and identifying the jurisdictions in 27 which they are employed

## Opinion text

Daniel D. Crabtree, United States District Judge
This Order addresses the pending Motions to Dismiss in one of the two separate tracks of this MDL-the consumer class cases track. The consumer class track consists of cases filed by individual consumers or third-party payors who allege they purchased EpiPens for consumption by themselves, their families, or their members, employees, insureds, participants, or beneficiaries. After the Judicial Panel on Multidistrict Litigation *1276 transferred five consumer class cases and one other filed by Sanofi-Aventis U.S. LLC ("Sanofi") to our court for coordinated and consolidated proceedings (Docs. 1, 5, & 9), the consumer class plaintiffs filed a Consolidated Class Action Complaint ("Class Complaint") (Doc. 60). The Class Complaint asserts federal and state antitrust claims, federal RICO Act violations, various state consumer protection law violations, and unjust enrichment claims. The Class Complaint also seeks class action certification.
The Class Complaint asserts its claims against two groups of defendants who are either sellers or manufacturers of the EpiPen. One group consists of defendants Mylan N.V., Mylan Specialty L.P., Mylan Pharmaceuticals, Inc., and Mylan's CEO Heather Bresch (collectively "the Mylan Defendants"). The other group of defendants consists of Pfizer, Inc., King Pharmaceuticals, Inc., and Meridian Medical Technologies, Inc. (collectively "the Pfizer Defendants"). When referring to both sets of defendants, this Order simply calls them, collectively, "defendants."
Defendants have filed separate motions asking the court to dismiss the Class Complaint. Doc. 92 (Pfizer Defendants' Motion to Dismiss Plaintiffs' Consolidated Class Action Complaint); Doc. 94 (Mylan Defendants' Motion to Dismiss Plaintiffs' Consolidated Class Action Complaint). The class plaintiffs have submitted an Omnibus Response to the Motions to Dismiss. Doc. 123. And both sets of defendants have filed Replies. Doc. 216 (Pfizer Defendants' Reply); Doc. 219 (Mylan Defendants' Reply). Also, on March 14, 2018, the Mylan Defendants submitted a Notice of Supplemental Authority under D. Kan. Rule 7.1(f). Doc. 394. The class plaintiffs filed a response, objecting to the supplemental submission. Doc. 403. Then, on July 6, 2018, the class plaintiffs filed a Notice of Supplemental Authority (Doc. 765), and the Mylan Defendants submitted a response to their submission (Doc. 785). On July 11, 2018, the class plaintiffs filed another Notice of Supplemental Authority (Doc. 781), and the Mylan Defendants filed a response to that submission as well (Doc. 803). Finally, on August 12, 2018, the class plaintiffs filed another Notice of Supplemental Authority (Doc. 874), and the Mylan Defendants filed a response to that submission (Doc. 889).
Thus, to say the least, the Motions to Dismiss are now thoroughly and fully briefed. After carefully considering the arguments presented by the parties' filings, the court is prepared to rule. 1 For the reasons explained below, the court grants defendants' motions in part and denies them in part.
I. Factual Background
The following facts come from the Class Complaint. The court accepts the facts asserted in the Class Complaint as true and views them in the light most favorable to the class plaintiffs. Mayfield v. Bethards , 826 F.3d 1252 , 1255 (10th Cir. 2016) (citation omitted).
The EpiPen 2 is a disposable, prefilled automatic injection device that delivers epinephrine *1277 (also known as adrenaline) to treat severe allergic reactions known as anaphylaxis. Anaphylaxis is a life-threatening allergic reaction that can occur rapidly after exposure to an allergen. Anaphylaxis manifests in a variety of symptoms, including swelling of the tongue and throat, vomiting, reduced blood pressure, difficulty breathing, and, if untreated, death. Most commonly, anaphylaxis is caused by food allergens, but medications, latex, insect bites, and other unknown substances also can cause anaphylaxis. About 15 million people have food allergies in the United States. One of every 13 children in the United States has serious food allergies. And, each year, allergic reactions account for some 200,000 emergency room visits. Anaphylaxis is always considered a life-threatening medical emergency.
Epinephrine is used to treat anaphylaxis and is available only by prescription. To treat anaphylaxis effectively, one must administer epinephrine immediately. As little as a thirty minute delay in applying epinephrine can cause death. As a result, patients prone to anaphylaxis are advised to carry an epinephrine auto-injector ("EAI") at all times. By doing so, a patient can use the EAI in an emergency when a risk of a severe allergic reaction presents itself.
In 2007, Mylan acquired the right to market and distribute the EpiPen. Pfizer is the exclusive supplier of EpiPens to Mylan. Pfizer provides Mylan with 100% of its EpiPen supply through two of its wholly owned subsidiaries-King Pharmaceuticals, Inc., and Meridian Medical Technologies, Inc.-who manufacture the epinephrine and hold the EpiPen patents. Since at least 2009, Mylan's market share of EAI devices in the United States EAI market has remained above 80%. Since 2009, Mylan's market share consistently has exceeded 90%, and, in 2012, its share was almost 100%. During the same time-and while the cost of the EpiPen's dose of epinephrine has remained about $1-Mylan has increased the EpiPen's price by more than 600%. In 2007, Mylan priced the EpiPen at $100. By 2016, Mylan was charging more than $600. In 2015, Mylan announced that the EpiPen had reached $1 billion in annual sales for the second consecutive year-up from $200 million in 2007.
The Class Complaint alleges that the Mylan and Pfizer Defendants have maintained a monopoly over the EpiPen market and its profitable revenues by devising an illegal scheme to monopolize the market for EAI devices. The Class Complaint asserts that defendants carried out their illegal scheme through several different avenues. The following paragraphs briefly summarize each one, as the Class Complaint describes them.
The Mylan Defendants Paid Pharmacy Benefit Managers (PBMs) to Exclude Competition
Pharmacy Benefit Managers ("PBMs") are third-party administrators of prescription drug programs for commercial health plans, self-insured employer plans, Medicare Part D plans, the Federal Employees Health Benefits Program, and state government employee plans. More specifically, PBMs administer a health coverage provider's prescription benefit program by developing the coverage provider's formulary (the list of prescription benefits included in the coverage at various pricing "tiers"), processing claims, creating a network of retail pharmacies who provide discounts in exchange for access to a provider's plan participants, and negotiating with manufacturers. The significant majority of patients with prescription drug insurance coverage receive their benefits through a *1278 third-party payor whose drug formulary is determined by a PBM. From 2013 to 2015, commercial third-party payors accounted for about 71% of the EAI drug device market in the United States. So, for a competitor to enter and compete vigorously in the EAI drug device market, it is imperative that it access these third-party payors' drug formularies.
Between 2013 and 2015, the Mylan Defendants took advantage of their monopoly power by imposing significant increases in the EpiPen's price. Mylan then used the additional profit margins to offer PBMs significantly higher rebates and percentage discounts conditioned upon exclusive or preferred placement on the PBMs' drug formularies. For example, when Sanofi launched a rival EAI device-Auvi-Q-in 2013, Mylan began taking steps to block Auvi-Q from drug formularies. It did so by offering large rebates to the PBMs who controlled the formularies for third-party payors-30% or higher-and expressly conditioning those rebates on: (a) granting the EpiPen exclusive position on the formulary; and (b) removing (or severely restricting) access to Auvi-Q. Mylan also targeted another rival EAI device-Adrenaclick-with the exclusionary rebate program. Adrenaclick's market share has ranged from only 2% in 2013 to 8% in 2016. Mylan knew that Adrenaclick-as well as Auvi-Q-could not raise prices to inflate their margins sufficiently to offer rebates or discounts similar to those that Mylan was offering to PBMs. In 2014, CVS Caremark added Adrenaclick to its Formulary Drug Removals List, effectively removing a consumer or other end-payor's opportunity to purchase Adrenaclick as an alternative to the EpiPen.
The class plaintiffs allege that the Mylan Defendants' exclusionary rebate scheme deprives patients of a fair price for EAI devices-the price that would result from normal market forces. Instead of lowering its prices to gain market share, Mylan bargains for its market share by providing ever-larger rebates and other kickbacks to PBMs, conditioned on exclusive relationships with those PBMs. Mylan can position itself on the drug formularies by using its monopoly power to charge consumers higher prices for its product. It then can share these revenues with the PBMs (the ones who create the formularies) through substantially enhanced rebates conditioned on excluding insurance coverage for rival products. This conduct, in turn, inflates the prices that consumers pay for the EpiPens so that Mylan can preserve its net realized price and sales volumes. The class plaintiffs contend that the net effect of this scheme harms both consumers and competitors alike.
The Mylan Defendants Entered into an Exclusive School Access Scheme
The class plaintiffs next assert that the Mylan Defendants leveraged the EpiPen's dominant market position to foreclose competition in an EAI submarket- i.e. , American public schools. They did so by offering to supply a portion of each school's need for EAI devices on a free or discounted basis but conditioning those discounts on the school entering an exclusive dealing contract. The Mylan Defendants created this important submarket by increasing federal lobbying efforts to gain access to parents, educators, and medical professionals in public schools. As part of the lobbying effort, Mylan spent a reported $4 million specifically lobbying to pass the School Access to Emergency Epinephrine Act. The law was enacted in 2013. It gives federal funding priority to schools who stockpile EAIs. Mylan's lobbying efforts proved enormously successful. Now, a majority of states permit their public schools to stockpile EAIs while eleven states require EAI stockpiling. Given the EpiPen's dominant market position, the Act not only *1279 has provided EpiPen access to schools, but also it has mandated some schools to stockpile the product.
After securing the EAI stockpiling requirement, Mylan acted quickly to exclude competing EAIs from this valuable school submarket. As part of the Mylan Defendants' scheme, Mylan launched the "EpiPen4Schools" program. The program gives away free and discounted EpiPens to school districts-ones subject to the new law now requiring (or strongly encouraging) them to stockpile the devices. But Mylan conditioned the free and discounted EpiPens on the schools entering exclusive dealing agreements with Mylan. The purpose of these exclusive dealing agreements was to exclude competitors-like Auvi-Q and Adrenaclick-from the public school submarket. In the fall of 2016, the New York Attorney General and members of the United States Senate announced investigations into the anticompetitive terms of Mylan's EpiPen4Schools program. Later, Mylan eliminated the EpiPen4Schools program's exclusivity requirement.
Defendants, Working Together, Used the Judicial and Regulatory Processes to Protect their Monopoly
The Class Complaint next asserts that the Mylan and Pfizer Defendants worked "hand-in-hand," using patent litigation and the Food and Drug Administration ("FDA") regulatory process to erect barriers to market entry and delay EAI competition. Class Compl. ¶ 314. The Pfizer Defendants own the patents protecting the EpiPen and serve as the contract supplier of the product. The Mylan Defendants own the trademarked brand names and control the worldwide marketing and sale of the product. Together, defendants have a unified interest in protecting the EpiPen monopoly. So, the class plaintiffs allege, defendants collaborated to enhance the EpiPen's sales volume and profitability, fend off competitors, and protect the EpiPen patents by using the judicial and regulatory process to restrain competition.
Defendants did so by adding several more patents to the already-patented EpiPen to prevent the launch of competing generics. Defendants have four patents on the EpiPen. According to the class plaintiffs, none of them are designed to enhance the product. Instead, the patents' purposes are to stop generic competitors. Indeed, Mylan CEO Heather Bresch announced during a public earnings call in 2009 that Mylan was adding another patent to the already-patented EpiPen device that "will also put in another barrier to entry because ... now that market preferential would be the needle protected device and drug of which we have IP and stuff around. So I just think it is a very, very difficult hurdle to get through, and so feel confident that EpiPen is in good shape." Class Compl. ¶ 238. On September 14, 2010, Meridian secured U.S. Patent No. 7,794,432 -less than three weeks before Intelliject (the inventor of Auvi-Q) submitted its New Drug Application ("NDA") to the FDA.
Defendants also worked together to stop generic competition to the EpiPen by filing patent infringement lawsuits. They filed such lawsuits against three generic EpiPen rivals-Sandoz, Teva, and Intelliject-and then entered into anticompetitive settlements with impending generic manufacturers.
Teva Settlement
In December 2008, Teva filed an Abbreviated New Drug Application ("ANDA") seeking FDA approval to market a generic EpiPen. In August 2009, Pfizer's subsidiaries-King and Meridian-sued Teva for infringing U.S. Patent No. 7,449,012 ("the Teva Litigation"). In November 2010, King and Meridian filed a First Amended Complaint that included a claim for infringing the newly secured '432 patent. Later, King *1280 and Meridian dropped their claims based on infringing the '012 patent, leaving only the claims for infringing the '432 patent.
After discovery and a bench trial in March 2012, the parties settled the Teva Litigation on April 27, 2012. According to the class plaintiffs, defendants and Teva entered an unlawful settlement agreement that required Teva to delay launching its generic EAI for three years-until June 22, 2015-in exchange for defendants providing significant consideration, incentives, and benefits to Teva. The Class Complaint lists several facts about the Teva settlement that, the class plaintiffs contend, show defendants made a substantial "reverse payment" to Teva to convince it to delay bringing its competing product to market. These facts include:
• The court's Markman rulings interpreting the terms of the '432 patent were favorable to Teva.
• The parties settled the litigation after completing a full bench trial, meaning that the parties likely would incur marginal litigation expenses going forward, as compared to the expenses already incurred at settlement.
• No rational economic actor with a viable product (and who had spent millions of dollars developing it) would refrain from entering a lucrative market for 36 months unless it received monetary compensation in exchange for non-entry.
• In 2012, the Federal Trade Commission reported seeing "a record number of settlements involv[ing] potential pay-for-delay agreements," and that, in patent settlements involving a "first-filer" like Teva, the majority of the settlements involved explicit compensation in return for delayed entry (Class Compl. ¶¶ 267-68).
• On the same day of the Teva settlement, Mylan issued a joint press release announcing the settlement on its own behalf and for Pfizer.
• Four days after announcing the Teva settlement, Teva and Mylan settled another lawsuit where Teva had asserted patent infringement claims against Mylan based on Mylan's application to market a generic version of Teva's drug, Nuvigil. With the Nuvigil settlement, Mylan agreed to delay market entry until June 2016. Like the EpiPen, Nuvigil had annual sales hovering near $1 billion. So, procuring delayed entry of generics for both Nuvigil and the EpiPen was valuable to all parties involved.
• The Teva settlement has come under congressional scrutiny as a "pay-for-delay" agreement.
During the same time period, the Teva settlement also prevented competition from any other generic EAI device. Defendants knew that their agreement with Teva would delay market entry because Teva was subject to the Hatch-Waxman Act's 180-day exclusivity award. This provision grants a six-month exclusivity period to the first generic to challenge a brand firm's patent, claiming it is invalid or not infringed. The exclusivity period begins when the first-filing generic enters the market. Here, Teva was the first filer. So, with Teva delaying its market entry under the parties' settlement, Teva's exclusivity period could not begin running until at least three years in the future. As a result, defendants delayed all generics seeking ANDA applications based on the EpiPen.
In a public earnings call, Mylan's CEO Heather Bresch described how the Teva settlement had delayed market competition. Also, she appeared to concede that Mylan had participated in the Teva settlement. In July 2012, she stated publicly: "So we certainly have seen a benefit [to growing the EpiPen market] and obviously, *1281 now with the runway absolutely clear for us through 2015, through our settlement with Teva, I can assure you, we are going to continue as we see [the] response continue to invest in EpiPen as a franchise." Class Compl. ¶ 277 (emphasis added).
Intelliject Settlement
Defendants initiated another patent lawsuit against Intelliject-the inventor of Auvi-Q-when Intelliject sought FDA approval for its competing EAI. In 2009, Sanofi announced it had acquired the rights to Intelliject's EAI and that under its license, Sanofi would manufacture and commercialize the product while Intelliject would continue developing the product and work to secure regulatory approval. On January 11, 2011, defendants-through King-filed a patent infringement lawsuit against Intelliject seeking to block FDA approval of its NDA for its product-one that later became known as Auvi-Q. King's lawsuit alleged that Intelliject's EAI infringed the '432 patent -a patent that Meridian secured more than a year after Intelliject began developing its product and less than three weeks before Intelliject filed its NDA.
On August 1, 2011-less than eight months after King filed its lawsuit-the FDA announced that it was giving Intelliject's EAI tentative final approval, pending resolution of the patent litigation that King filed. Six months later, the parties announced that they had settled the Intelliject litigation. Again, Mylan announced the settlement jointly for itself and Pfizer. Although the parties did not make public the specific terms of the agreement, they announced that the agreement prevented Intelliject and Sanofi from launching their EAI product for another nine months-until November 15, 2012. Intelliject and Sanofi made the agreement not to enter the market until November 15, 2012, in exchange for valuable consideration. Through the Intelliject litigation, defendants effectively blocked competition from Intelliject's competing device for almost two years.
Sandoz Settlement
In 2010, another EAI competitor-Sandoz, Inc. ("Sandoz")-attempted to enter the EAI market by filing an ANDA for its own generic EpiPen alternative. Similar to the other lawsuits against Teva and Intelliject, defendants-through King-filed a patent infringement suit against Sandoz. According to the class plaintiffs, defendants' approach to Sandoz was to stall its ANDA by staying the action. The court administratively terminated the Sandoz litigation, giving the parties the ability to reopen the case by letter request. No party has reopened the case. So, to date, Sandoz's FDA approval and any definitive ruling on the EpiPen patents are stayed indefinitely. The class plaintiffs allege that defendants entered an agreement with Sandoz to stay the case in exchange for valuable consideration paid to Sandoz.
FDA Citizen Petition
The Class Complaint next alleges that, with Teva's generic EAI entry into the market looming, defendants took another step to block generic competition from the market by filing an FDA Citizen Petition. An FDA Citizen Petition provides the public with an avenue to present safety concerns to the FDA. But here, the class plaintiffs allege, defendants used the FDA Citizen Petition process to delay-further-Teva's entry into the market and to prevent Teva's product from competing with the EpiPen.
On January 16, 2015, Mylan filed a Citizen Petition "a mere six months before Teva was scheduled (pursuant to the settlement) to enter the market." Class Compl. ¶ 311. Antitrust scholar Michael Carrier of Rutgers Law School described Mylan's Petition in this fashion:
*1282 In its petition, Mylan contended that Teva should be required to demonstrate that its product was the "same as" Mylan's EpiPen. In other words, even though the parties had already agreed through settlement to delay Teva's generic entry for more than three years, Mylan sought to further delay the entry of Teva's generic through its citizen petition.
In addition to its January 2015 petition, the company waited almost five months after filing and only weeks before the FDA was required to respond, until May 2015, to supplement its petition with a 48-page independent study purportedly showing that patients would not use Teva's generic product correctly.
Given that Teva's generic product had been in development for at least six years before the petition's filing, this late-filing of a supplemental study implicates significant timing questions. Why would such a study be submitted only weeks before the FDA was required to respond under the FDA's 150-day clock?
Id. (quoting Michael A. Carrier & Daryl Wander, Citizen Petitions: An Empirical Study , 34 Cardozo L. Rev. 249 , 279 (2012) ). According to the class plaintiffs, Mylan's submissions to the FDA rested on fundamentally flawed studies and the medical opinions of a doctor whom Mylan had paid some $95,000 in fees.
According to the class plaintiffs, without defendants' use of the FDA Citizen Petition process, Teva would have entered the market much sooner after addressing any FDA concerns and securing FDA approval. The class plaintiffs also assert that, from 2009 to present, defendants' actions deterred not only Teva, but also many more potential generics companies from developing and launching competing products.
Defendants Implement a Pricing Scheme
The Class Complaint next alleges that the Mylan Defendants implemented a pricing scheme that defrauded U.S. consumers into paying an inflated price for the EpiPen-one that climbed by more than 500%. The Mylan Defendants allegedly implemented this pricing scheme working alongside PBMs. Mylan is a generics company that typically makes low margins on drug sales. But the EpiPen-a specialty branded drug-represented a unique and highly profitable revenue stream for Mylan. Recognizing this opportunity, Mylan CEO Heather Bresch and other executives decided to exploit the EpiPen to generate billions of dollars in revenue for Mylan. According to the class plaintiffs, the Mylan Defendants and the PBMs distracted consumers and regulators from the reality that defendants were raising the price of the EpiPen from $100 to $600 by launching a campaign of false and misleading statements and actions.
One of the ways that the Mylan Defendants allegedly implemented their pricing scheme was changing the way Mylan sold the EpiPen. On August 24, 2011, Mylan announced that it no longer would sell individual EpiPens in the U.S. Instead, Mylan forced U.S. consumers to purchase EpiPens in pairs with the EpiPen 2-Pak. The class plaintiffs refer to this change as the "hard switch." And the class plaintiffs allege that the "hard switch" forced consumers and third-party payors to overpay for the EpiPen 2-Pak because the switch, in effect, doubled the EpiPen's price.
From 1987 to 2011, Mylan and others had sold the EpiPen one at a time in the U.S. without incident. Nothing changed in 2011 that required Mylan to sell the EpiPen as a 2-Pak. The EpiPen 2-Pak is just two individual EpiPens connected by a grey piece of plastic. The class plaintiffs *1283 allege that no medical reason exists to force customers to purchase a 2-Pak instead of a single EpiPen. Instead, Mylan deceptively suggested that the 2-Pak was medically required even though EpiPens are sold individually in every other country besides the United States. Also, Mylan's packaging offers no medical instructions or guidelines for patients to know whether, or when, to administer the second back-up EpiPen.
Beginning in 2011, Mylan began raising the price of the EpiPen while forcing customers to buy EpiPens in the 2-Pak. In October 2011, Mylan increased the price of an EpiPen 2-Pak to $181. And by May 2016, the price of an EpiPen 2-Pak jumped to $608.
The Mylan Defendants Have Made Various Misrepresentations and Omissions in an Effort to Conceal Their Anticompetitive Conduct
Finally, the Class Complaint alleges that the Mylan Defendants have spread false and misleading information and omitted material information as part of their scheme to monopolize the EAI market. They spread, the Class Complaint alleges, four broad categories of false and misleading information.
First , the class plaintiffs allege, Mylan created and spread misinformation about a competing EAI device-Auvi-Q. Although the FDA had determined that the epinephrine in Auvi-Q is a bioequivalent to the epinephrine in the EpiPen, Mylan funded and promoted a study entitled, "Auvi-Q versus EpiPen Auto-Injectors: Failure to Demonstrate Bioequivalence of Epinephrine Delivery Based on Partial Area Under the Curve." Class Compl. ¶ 229. Mylan intended the study to undermine the FDA's conclusion that Auvi-Q had demonstrated bioequivalence to the epinephrine in the EpiPen-in direct contradiction to the FDA's conclusion.
The class plaintiffs also allege that Mylan made false and misleading statements about Auvi-Q's formulary status. According to the class plaintiffs, Mylan's anticompetitive conduct caused major health plans either to limit their coverage of Auvi-Q or to exclude Auvi-Q from coverage altogether. Mylan did so by paying formularies to exclude Auvi-Q from coverage. But then, Mylan marketed to physicians the fact that Auvi-Q was not covered by formularies and suggested that the decision to exclude Auvi-Q from coverage was based on clinical recommendations-and not Mylan's large, conditional rebate offers.
Second , the class plaintiffs allege that Mylan made false and misleading statements about the "hard switch" to the EpiPen 2-Pak. On August 24, 2011, Mylan issued a news release entitled "Dey Pharma to Offer EpiPen 2-Pak and EpiPen Jr 2-Pak Exclusively." Class Compl. ¶ 336. The press release's subheadline provided: "Decision aligns with recent clinical guidelines for patients at risk for or who have experienced anaphylaxis to have immediate access to two doses of epinephrine." Id. The Class Complaint alleges that the press release was fraudulent and misleading for several reasons. They include:
• The press release cited a National Institute of Allergy and Infectious Diseases ("NIAID") study that did not apply to the general population. Instead, it applied only to a narrow subset: allergy sufferers who had already (1) been hospitalized for (2) a food allergy.
• Mylan purported to rely on the World Allergy Organization ("WAO") global standard in making the switch, but Mylan did not require sale of the EpiPen 2-Pak globally. Indeed, the press release states that the single EpiPen Auto-Injector *1284 package configuration will remain available outside of the U.S.
• The switch to the 2-Pak did not change patient access to two doses of epinephrine. Doctors could write, and often did write, prescriptions for two EpiPens. So, no need existed for Mylan to mandate something patients could purchase already.
• The medical guidelines recited did not state that providers must sell two doses of epinephrine. Instead, Mylan used the WAO's vague statement as a false pretext for selling only the 2-Pak.
• No mandates required Mylan to sell the EpiPen exclusively as a 2-Pak, or not at all.
• No medical studies support the decision to sell the EpiPen exclusively as a 2-Pak.
• From 1987 until 2011, the EpiPen was sold individually without incident. Nothing changed suddenly in 2011 that required Mylan to sell only the 2-Pak.
• When Mylan switched to the 2-Pak in 2011, it did not order a recall or insist that all U.S. EpiPen patients immediately go buy a second EpiPen.
• Although the press release relies on the WAO, the U.S. is the only country where Mylan required customers to purchase a 2-Pak of the EpiPen.
• According to a study conducted by the American Academy of Allergy, Asthma & Immunology, only a small number of patients require a second dose. The reason for selling the device solely in packs of two is to account for user error due to the imperfect product design, i.e. , 14% of parents accidently stick the needle in their own thumb instead of in their child's leg.
• Mylan offers no medical guidelines or instructions to EpiPen 2-Pak consumers in its packaging or on the device to explain how or when to use (or even how to store) the second EpiPen in the 2-Pak.
• Mylan states that between 1-20% of patients might need a second device. But, according to class plaintiffs, the margin of 1-20% is so wide that it is meaningless and provides a false justification for the "hard switch" to the 2-Pak.
Class Compl. ¶ 339. The class plaintiffs also allege that the NIAID panel Mylan relied on to justify the change to the 2-Pak was influenced and tainted by Mylan's financial contributions. The August 24, 2011, press release quotes Dr. Phillip Lieberman, a member of the NIAID panel, as stating that up to 20% of patients will require more than one dose of epinephrine to relieve symptoms. According to the class plaintiffs, Dr. Lieberman's statement does not explain why a 2-Pak is necessary for 100% of patients when only "up to 20%" require more than one dose. Also, his statement never explains why all patients must purchase two EpiPens instead of having a prescription that allows two doses. The class plaintiffs allege that Dr. Lieberman made his statement justifying the switch to the 2-Pak because Mylan paid him to do so.
Third , the class plaintiffs allege, Mylan made false statements about coupons, rebates, and generics. Mylan has stated publicly on its website and to the media throughout at least 2016 that 80% of consumers with insurance pay nothing for the EpiPen. According to the class plaintiffs, this statement is false because third-party payors end up paying the bulk of the cost for the EpiPen and, in turn, the third-party payors pass on the costs to patients with increased premiums. Mylan also announced *1285 recently that it will begin offering a $300 generic version of the EpiPen. The class plaintiffs assert that Mylan's admission that it can make a $300 generic using the same factories and components used to make the $600 EpiPen shows that Mylan is price gouging consumers with its current list price for the EpiPen.
Finally , the Class Complaint alleges that Mylan made false statements to Congress under oath to help cover up its fraud and to deceive the public about the EpiPen price increases. The Class Complaint asserts that CEO Heather Bresch falsely testified to Congress on September 21, 2016, when she: (1) misrepresented Mylan's profit on the EpiPen as $50 per device, but, according to a Wall Street Journal article, Mylan's profits were 60% higher than that amount; (2) misrepresented that Mylan had invested more than $1 billion in the EpiPen when, in fact, Mylan acquired the EpiPen in 2007 without incurring any research and development expenses; (3) misrepresented that Mylan had provided free EpiPens to more than 66,000 U.S. schools with "no strings attached," but Mylan, in fact, did attach strings to the free EpiPens by requiring the schools to sign a contract agreeing not to purchase any products from Mylan's competitors for a twelve-month period; (4) misrepresented that Mylan had reduced U.S. healthcare costs by about $180 billion; and (5) mispresented that 85% of EpiPen patients pay less than $100 for a 2-Pak and a majority pay less than $50.
II. Legal Standard
Fed. R. Civ. P. 8(a)(2) provides that a complaint must contain "a short and plain statement of the claim showing that the pleader is entitled to relief." Although this Rule "does not require 'detailed factual allegations,' " it demands more than "[a] pleading that offers 'labels and conclusions' or 'a formulaic recitation of the elements of a cause of action' " which, as the Supreme Court explained, "will not do." Ashcroft v. Iqbal , 556 U.S. 662 , 678, 129 S.Ct. 1937 , 173 L.Ed.2d 868 (2009) (quoting Bell Atl. Corp. v. Twombly , 550 U.S. 544 , 555, 127 S.Ct. 1955 , 167 L.Ed.2d 929 (2007) ).
When considering a motion to dismiss under Federal Rule of Civil Procedure 12(b)(6), the court must assume that the factual allegations in the complaint are true. Id. (citing Twombly , 550 U.S. at 555 , 127 S.Ct. 1955 ). But the court is " 'not bound to accept as true a legal conclusion couched as a factual allegation.' " Id. (quoting Twombly , 550 U.S. at 555 , 127 S.Ct. 1955 ). " 'Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice' " to state a claim for relief. Bixler v. Foster , 596 F.3d 751 , 756 (10th Cir. 2010) (quoting Iqbal , 556 U.S. at 678 , 129 S.Ct. 1937 ). Also, the complaint's "[f]actual allegations must be enough to raise a right to relief above the speculative level." Twombly , 550 U.S. at 555 , 127 S.Ct. 1955 (citations omitted).
For a complaint to survive a motion to dismiss under Rule 12(b)(6), the pleading "must contain sufficient factual matter, accepted as true, to 'state a claim for relief that is plausible on its face.' " Iqbal , 556 U.S. at 679 , 129 S.Ct. 1937 (quoting Twombly , 550 U.S. at 570 , 127 S.Ct. 1955 ). "A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Id. at 678 , 129 S.Ct. 1937 (citing Twombly , 550 U.S. at 556 , 127 S.Ct. 1955 ). "The plausibility standard is not akin to a 'probability requirement,' but it asks for more than a sheer possibility that a defendant has acted unlawfully." Id. (quoting Twombly , 550 U.S. at 556 , 127 S.Ct. 1955 ); see also Christy Sports, LLC v. Deer Valley Resort Co., Ltd. , 555 F.3d 1188 , 1192 (10th Cir. 2009)
*1286 ("The question is whether, if the allegations are true, it is plausible and not merely possible that the plaintiff is entitled to relief under the relevant law." (citation omitted) ).
In the antitrust context, the Supreme Court observed in Twombly that "proceeding to antitrust discovery can be expensive." Twombly , 550 U.S. at 558 , 127 S.Ct. 1955 (applying the plausibility pleading standard to Sherman Act claims). So, courts must " 'insist upon some specificity in pleading before allowing a potentially massive factual controversy to proceed.' " Id. (quoting Associated Gen. Contractors of Cal., Inc. v. Cal. State Council of Carpenters , 459 U.S. 519 , 528 n.17, 103 S.Ct. 897 , 74 L.Ed.2d 723 (1983) ). But still, antitrust cases are not subject to a standard requiring "heightened fact pleading of specifics." Id. at 570 , 127 S.Ct. 1955 . Instead, an antitrust Complaint must allege "only enough facts to state a claim to relief that is plausible on its face" sufficient to "nudge[ ] the[ ] claims across the line from conceivable to plausible." Id. ; see also In re Urethane Antitrust Litig. , 663 F.Supp.2d 1067 , 1074 (D. Kan. 2009) (explaining on a Rule 12(b)(6) motion to dismiss antitrust claims that "the Court must ensure that plaintiffs have alleged facts to support those elements sufficient to provide the 'heft' to show an entitlement to relief and to 'nudge' plaintiffs' claims over the line from mere[ ] possibility or speculation to plausibility" (quoting Twombly , 550 U.S. at 557 , 570 , 127 S.Ct. 1955 ) ).
The court's analysis, below, applies this governing standard to defendants' Rule 12(b)(6) dismissal arguments.
III. Analysis
The Class Complaint asserts nine claims against the Mylan Defendants: (1) Sherman Act §§ 1 and 2 violations (Count I); (2) Clayton Act § 3 violations (Count II); (3) conspiracy violating state antitrust statutes (Count III); (4) monopolization violating state antitrust statutes (Count IV); (5) attempted monopolization violating state antitrust statutes (Count V); (6) tying violating state antitrust statutes (Count VI); (7) RICO Act violations (Count VII); (8) violation of state consumer protection laws (Count VIII); and (9) unjust enrichment (Count IX). The Class Complaint asserts just Counts I-V and VII jointly against the Mylan and Pfizer Defendants.
Both the Mylan and Pfizer Defendants move the court to dismiss each claim asserted in the Class Complaint. The court addresses each of defendants' arguments in the subsections, below. The first section addresses whether the Class Complaint states plausible claims of federal and state antitrust violations. The second section discusses whether the class plaintiffs have alleged viable RICO claims. The third section addresses whether the Class Complaint states plausible claims for relief under state consumer protection laws. Finally, the fourth section considers whether the class plaintiffs have stated a claim for unjust enrichment.
A. Antitrust Claims
Defendants assert eight different arguments why the class plaintiffs' factual allegations never state a plausible antitrust claim under either federal or state law. The court addresses each one of the eight arguments, in turn, below.
1. Have the class plaintiffs alleged a plausible tying claim based on the EpiPen 2-Pak?
The Mylan Defendants 3 argue that the Class Complaint fails to allege a plausible *1287 tying claim because it never alleges the existence of two distinct products. Instead, the Mylan Defendants contend, the class plaintiffs premise their tying claim on the EpiPen 2-Pak, i.e. selling two EpiPen devices in one package. Defendants assert that this practice-because it involves selling two identical products-is not an unlawful tying arrangement.
Tying is an arrangement involving the sale of "two distinct products or services as a package." Jefferson Parish Hosp. Dist. No. 2 v. Hyde , 466 U.S. 2 , 33, 104 S.Ct. 1551 , 80 L.Ed.2d 2 (1984) (Brennan, J., concurring), abrogated on other grounds by Ill. Tool Works Inc. v. Indep. Ink, Inc. , 547 U.S. 28 , 126 S.Ct. 1281 , 164 L.Ed.2d 26 (2006) (further citation omitted). "[T]he essential characteristic of an invalid tying arrangement lies in the seller's exploitation of its control over the tying product to force the buyer into the purchase of a tied product that the buyer either did not want at all, or might have preferred to purchase elsewhere on different terms." Id. at 12, 104 S.Ct. 1551 . But "a tying arrangement cannot exist unless two separate product markets have been linked." Id. at 21 , 104 S.Ct. 1551 . And "the question whether one or two products are involved turns not on the functional relation between them, but rather on the character of the demand for the two items." Id. at 19 , 104 S.Ct. 1551 ; see also Eastman Kodak Co. v. Image Tech. Servs., Inc. , 504 U.S. 451 , 456, 112 S.Ct. 2072 , 119 L.Ed.2d 265 (1992) ("[T]o be considered two distinct products, there must be sufficient consumer demand so that it is efficient for a firm to provide [one] separately from [the other].").
The class plaintiffs respond that they have alleged a tying arrangement involving two separate product markets-one for the primary EAI device, and the other for a "spare" (or "back-up") EAI device. Class Compl. ¶¶ 575-79. The Class Complaint describes how Mylan and others sold the EpiPen individually in the U.S. from 1987 to 2011 without incident. But, in 2011, Mylan imposed the "hard switch," requiring patients to purchase EpiPens in pairs in the EpiPen 2-Pak. The class plaintiffs allege that, before the "hard switch," "[t]here was sufficient independent demand for some patients to either not purchase a second EpiPen at all or to purchase an EpiPen and a cheaper, alternative back-up." Id. ¶ 577. But, after the hard switch, Mylan forced patients to buy two separate devices-the primary EAI device and back-up EAI device-even though "each EpiPen expires annually and the vast majority of EpiPens expire before they can be used." Id. ¶ 577. As the Class Complaint describes: "Consumers no longer had the choice or ability to purchase a back-up or spare device from another manufacturer, or to decline to purchase a second EpiPen based on whether they needed it, chose to purchase it, or were prescribed it by a doctor." Id. ¶ 579.
Viewing these allegations in the class plaintiffs' favor, the Class Complaint alleges a "sufficient consumer demand" in the U.S. to purchase a primary EAI device separately from a back-up device or none at all "so that it is efficient for a firm to provide [one] separately from [the other]." Eastman Kodak Co. , 504 U.S. at 456 , 112 S.Ct. 2072 ; see also Multistate Legal Studies, Inc. v. Harcourt Brace Jovanovich Legal & Prof'l Pubs., Inc. , 63 F.3d 1540 , 1547-48 (10th Cir. 1995) (holding that the case's summary judgment facts presented a factual dispute whether "enough consumer demand [existed] in Colorado" for one product such that it was efficient to sell the two products separately).
The court recognizes that the class plaintiffs have alleged a tying relationship based on two products that are functionally identical. The Mylan Defendants assert *1288 that the two products thus are interchangeable. For example, a patient could use either one of the two EpiPens in a 2-Pak as the primary device and the other one as the back-up device. The Mylan Defendants thus argue that it is not plausible that the primary EAI device and backup EAI device belong to separate markets. Indeed, the Tenth Circuit has defined the "relevant product market in any given case" as one " 'composed of products that have reasonable interchangeability for the purposes for which they are produced-price, use and qualities considered.' " Buccaneer Energy (USA) Inc. v. Gunnison Energy Corp. , 846 F.3d 1297 , 1313 (10th Cir. 2017) (quoting SCFC ILC, Inc. v. Visa USA, Inc. , 36 F.3d 958 , 966 (10th Cir. 1994) ) (emphasis added). Although the two products here have the same qualities, the Class Complaint defines how patients use them in a functional sense as two separate products. A patient uses one EpiPen as the primary EAI device and the other as the back-up device.
The parties do not cite, and the court's research has not revealed, any tying cases involving identical products with different and distinct uses-what the class plaintiffs allege here. The Mylan Defendants cite two cases where courts refused to find two separate products to support a tying claim, but those cases involved preliminary injunction motions where the factual record failed to demonstrate the existence of two separate product markets. See Metromedia Broad. Corp. v. MGM/UA Entm't Co. , 611 F.Supp. 415 , 422-24 (C.D. Cal. 1985) (recognizing that questions existed whether "the demand for first runs [of TV series] is separate from that for reruns," but refusing to "carve up" a copyright for the purposes of licensing "a single intellectual property" because both the first runs and reruns shared the "same copyright and uniqueness," which "was the product from which market power derives"); Paul v. Pulitzer Publ'g Co. , No 74-327C(A), 1974 WL 887 , at *5 (E.D. Mo. May 24, 1974) (holding that "different issues of the same newspaper are not separate products" but never discussing whether consumer demand existed for selling weekday editions separately from the Saturday edition).
In contrast here, the Class Complaint asserts facts that plausibly allege two separate product markets-one for EAI primary devices and the other for back-up devices. These allegations are sufficient to state a claim at this stage of the litigation. Ultimately, to prevail on their tying claim, the class plaintiffs must adduce admissible evidence to support a reasonable finding that two separate product markets exist. But, to survive the Motions to Dismiss, plaintiffs need only make plausible factual allegations of two different product markets. They have satisfied that requirement.
2. Have the class plaintiffs alleged plausible exclusive dealing claims based on Mylan's exclusive dealing contracts with PBMs and schools?
The Mylan Defendants assert that the class plaintiffs have failed to allege plausible antitrust claims based on Mylan's exclusive dealing contracts with PBMs and schools. Defendants offer five arguments to support their assertion.
First , the Mylan Defendants argue, the Class Complaint never alleges that Mylan's rebates and discount offers resulted in EpiPen prices below the cost of their production. Six days after the Mylan Defendants filed their Motions to Dismiss the Class Complaint, the court issued a Memorandum and Order in the other of the two separate tracks in this MDL-the Sanofi track. The court's Order granted Mylan's Motion to Dismiss the Sanofi Complaint in part, and denied that motion in part ("the Sanofi Order"). Doc. 98. In the Sanofi Order, the court rejected the same argument asserted here- i.e. , that Sanofi's exclusive dealing claims fail as a matter of *1289 law because the Sanofi Complaint never alleges that Mylan's rebate offers resulted in prices that were below its costs to produce the EpiPen. See id. at 10-15 . The court recognized that the price-cost test does not apply to bar exclusive dealing claims when price itself is not the clearly predominant mechanism of exclusion. Id. at 12-13 (citing ZF Meritor, LLC v. Eaton Corp. , 696 F.3d 254 , 277 (3d Cir. 2012) (further citations omitted) ). And, viewing the allegations in Sanofi's favor, the court concluded that the Sanofi Complaint "does not rely 'solely on the exclusionary effect of [Mylan's] prices' to support its exclusive dealing claim based on Mylan's rebate program." Id. at 13 (quoting ZF Meritor , 696 F.3d at 277 ).
The same is true of the Class Complaint. 4 The Class Complaint alleges that Mylan leveraged its greater-than-90% market share by offering large rebates to PBMs to exclude Auvi-Q from the formularies. Class Compl. ¶ 177. The Class Complaint asserts that no legitimate business reason existed for Mylan's deep conditional rebates except blocking Auvi-Q from the market. Id. ¶ 178. Also, it asserts that Mylan's rebates effectively prevented competitors from accessing formularies of the two largest PBMs-Express Scripts and CVS Caremark-that combine to cover more than 50% of the PBM market in the United States. Id. ¶¶ 162, 168. The Class Complaint alleges that Mylan's conditional rebates unlawfully increased Sanofi's cost to enter the market if it wanted to match Mylan's rebates. Id. ¶ 182. And, the Class Complaint alleges, after Mylan successfully excluded Auvi-Q from coverage, it sent misleading marketing materials to physicians asserting that EpiPen was the "preferred" EAI device for 99% of patients while Auvi-Q was "preferred" for only 2% of patients. According to the class plaintiffs, the marketing materials suggested that the reason for Auvi-Q's exclusion was based on clinical recommendations-and not the large, conditional rebate offers. Id. ¶¶ 232-35. These allegations assert that Mylan's rebate program involved anticompetitive conduct-beyond pricing itself-that was designed to exclude competition in the EAI drug market.
Second , the Mylan Defendants contend that the Class Complaint never alleges that Mylan's rebates harmed the class plaintiffs by excluding Auvi-Q from the market because Sanofi's decision not to compete with the EpiPen was based on other factors, all unrelated to Mylan's conduct. The Mylan Defendants cite a paragraph from the Sanofi Complaint asserting that Sanofi voluntarily recalled Auvi-Q in October 2015 following reports of manufacturing issues. Doc. 95 at 44. But, as the court concluded in the Sanofi Order, the Sanofi Complaint plausibly alleges that Mylan's conduct forced Sanofi to exit the EAI drug market. Doc. 98 at 40. The Class Complaint contains similar allegations. As the court already has held, Mylan's arguments that the voluntary recall-and not Mylan's alleged anticompetitive conduct-caused Sanofi's injuries present a factual dispute that the court cannot resolve on a motion to dismiss. Id. For the same reasons as the Sanofi Order discussed, the court declines to dismiss the class plaintiffs' exclusive dealing claims based on Mylan's argument that Sanofi's decision to exit the EAI market was based on factors other than Mylan's anticompetitive conduct.
*1290 Third , the Mylan Defendants assert that the Class Complaint never alleges that Mylan's exclusive dealing contracts harmed competition. The court rejected this same argument in the Sanofi Order. It rejects it again here for the same reasons. The Class Complaint, construed in favor of the class plaintiffs, plausibly alleges that Mylan's anticompetitive conduct harmed competition. The Class Complaint alleges that defendants implemented a pricing scheme that raised the price of the EpiPen from a little over $100 for two EpiPens in 2007 to more than $600 for the same two EpiPens in 2016. Class Compl. ¶¶ 349-60. According to the class plaintiffs, the price increases allowed Mylan to share its monopoly profits with PBMs through larger rebates for excluding competing products. Id. ¶¶ 165-66. Mylan's exclusionary contracts then prevented consumers in a substantial share of the market from accessing or choosing competing EAI devices such as the Auvi-Q and others. Id. at ¶¶ 168, 491. These allegations, if true, are capable of supporting a finding or inference of harm to competition, and thus, they state a plausible antitrust claim.
Fourth , the Mylan Defendants assert that the class plaintiffs' claims based on discounts or rebates Mylan offered to states or state agencies are barred by the Noerr -Pennington doctrine. The Noerr -Pennington doctrine " 'exempts from antitrust liability any legitimate use of the political process by private individuals, even if their intent is to eliminate competition.' " Tal v. Hogan , 453 F.3d 1244 , 1257 n.13, 1259-60 (10th Cir. 2006) (quoting Zimomra v. Alamo Rent-A-Car, Inc. , 111 F.3d 1495 , 1503 (10th Cir. 1997) ). The scope of the Noerr -Pennington doctrine depends "on the source, context, and nature of the anticompetitive restraint at issue." Allied Tube & Conduit Corp. v. Indian Head, Inc. , 486 U.S. 492 , 499, 108 S.Ct. 1931 , 100 L.Ed.2d 497 (1988).
But " Noerr -Pennington immunity does not apply if the purported effort to influence or obtain government action is in fact only an attempt to interfere with the business relationships of a competitor." Classic Commc'ns, Inc. v. Rural Tel. Serv. Co. , 956 F.Supp. 910 , 917 (D. Kan. 1997) (first citing E. R.R. Presidents Conference v. Noerr Motor Freight, Inc. , 365 U.S. 127 , 144, 81 S.Ct. 523 , 5 L.Ed.2d 464 (1961) ; then citing Cal. Motor Transp. Co. v. Trucking Unlimited , 404 U.S. 508 , 511, 92 S.Ct. 609 , 30 L.Ed.2d 642 (1972) ). "This is the so-called 'sham' exception to the Noerr -Pennington doctrine." Id. The sham exception applies "when 'persons use the governmental process -as opposed to the outcome of that process-as an anticompetitive weapon.' " GF Gaming Corp. v. City of Black Hawk , 405 F.3d 876 , 884 (10th Cir. 2005) (quoting City of Columbia v. Omni Outdoor Advert., Inc. , 499 U.S. 365 , 380, 111 S.Ct. 1344 , 113 L.Ed.2d 382 (1991) ). "The exception thus 'involves a defendant whose activities are not genuinely aimed at procuring favorable government action at all,' such as a defendant who files 'frivolous objections to the license application of a competitor, with no expectation of achieving denial of the license but simply in order to impose expense and delay.' " Id. (quoting City of Columbia , 499 U.S. at 380 , 111 S.Ct. 1344 ).
In the Sanofi Order, the court held that the Noerr -Pennington doctrine barred Sanofi's exclusive dealing claims based on Mylan's discounts or rebates to state-based Medicaid agencies. Doc. 98 at 22-24. The court reasoned that Sanofi's allegations accused Mylan of using the outcome of the government process- i.e. , exclusion of Auvi-Q from the drug formularies- not the process itself , to harm a competitor. Id. at 22. Thus, the court concluded, Noerr -Pennington immunity applied to Sanofi's claims based on discounts or rebates offered to state-based Medicaid agencies. Id.
*1291 The class plaintiffs argue the court should reach a different result here because, they contend, the Class Complaint's allegations differ from Sanofi's. First, the class plaintiffs contend that their antitrust claims are premised on Mylan's misclassification of the EpiPen and that this misclassification influenced decisions by state-based Medicaid agencies to exclude Auvi-Q. The Class Complaint alleges that Mylan's misclassification of the EpiPen allowed it to "amass millions of dollars each year in unpaid rebates to cash-strapped state Medicaid agencies." Class Compl. ¶ 187. And, according to the Class Complaint, these "outstanding underpaid rebates led benefit managers to continue favoring the EpiPen over competitors in the expectation of receiving a large make-up payment if and when Mylan was forced to classify the EpiPen as a brand." Id. ¶ 188. The class plaintiffs assert that the Noerr -Pennington doctrine does not shield Mylan's misrepresentations about the EpiPen's classification from antitrust liability because "[m]isrepresentations, condoned in the political arena, are not immunized when used in the adjudicatory process." Cal. Motor Transp. , 404 U.S. at 513 , 92 S.Ct. 609 .
The court disagrees that the class plaintiffs' allegation about the EpiPen's misclassification-in this one paragraph of their 1,429 paragraph Class Complaint-places the claim outside of Noerr -Pennington immunity. Indeed, "[n]ot every fraudulent misrepresentation during an adjudicative or administrative proceeding can give rise to antitrust liability." Mercatus Grp., LLC v. Lake Forest Hosp. , 641 F.3d 834 , 843 (7th Cir. 2011). "[A] misrepresentation renders an adjudicative proceeding a sham only if the misrepresentation (1) was intentionally made, with knowledge of its falsity; and (2) was material, in the sense that it actually altered the outcome of the proceeding." Id. at 843 ; see also Cheminor Drugs, Ltd. v. Ethyl Corp. , 168 F.3d 119 , 123 (3d Cir. 1999) ("While we do not condone misrepresentations in a judicial setting, neither will we deprive litigants of immunity derived from the First Amendment's right to petition the government if the alleged misrepresentations do not affect the core of the litigant's ... case.").
Here, the class plaintiffs' allegation never asserts explicitly that the misclassification caused any state-based Medicaid agencies to exclude EpiPen rivals from the formularies. Instead, the allegation refers generally to "benefit managers." And it recites that these benefit managers continued to "favor" the EpiPen over competitors. Also, the allegation asserts that the benefit managers knew about the misclassification and thus anticipated a large make-up payment when Mylan was forced to reclassify the EpiPen. Thus, according to the allegation, the benefit managers never made their decisions based on any false representations that Mylan made to them. To the contrary, the allegation asserts that the benefit managers understood that Mylan had misclassified the EpiPen. So, nothing about the misclassification affected the decision-making abilities of benefit managers when they chose which EAI devices to include in the formularies. Construed in the class plaintiffs' favor, the exclusive dealing allegations based on Mylan's discounts or rebates to state-based Medicaid agencies assert that Mylan's conduct violated the antitrust laws by offering the rebates in exchange for exclusivity. The Noerr -Pennington doctrine precludes liability for this type of conduct, even if the intent was to exclude competition. Thus, the Class Complaint fails to allege a plausible antitrust claim based on Mylan's discounts or rebates to state-based Medicaid agencies.
*1292 Finally , the Mylan Defendants argue that the Class Complaint never alleges that Mylan's EpiPen4Schools program foreclosed competitors from a substantial share of the relevant market. 5 To assert a plausible exclusive dealing claim, a plaintiff must plead facts capable of supporting a finding or inference that the "probable effect" of "performance of the contract will foreclose competition in a substantial share of the line of commerce affected." Tampa Elec. Co. v. Nashville Coal Co. , 365 U.S. 320 , 327, 81 S.Ct. 623 , 5 L.Ed.2d 580 (1961) ; see also Perington Wholesale, Inc. v. Burger King Corp. , 631 F.2d 1369 , 1374 (10th Cir. 1979) ("Thus, a complaining trader must allege and prove that a particular arrangement unreasonably restricts the opportunities of the seller's competitors to market their product.").
The Supreme Court has instructed lower courts "[t]o determine substantiality in a given case" by "weigh[ing] the probable effect of the contract on the relevant area of effective competition, taking into account the relative strength of the parties, the proportionate volume of commerce involved in relation to the total volume of commerce in the relevant market area, and the probable immediate and future effects which pre-emption of that share of the market might have on effective competition therein." Tampa Elec. , 365 U.S. at 329 , 81 S.Ct. 623 . When considering whether the contract at issue in Tampa Electric tended to foreclose a substantial volume of competition, the Supreme Court considered several things. Id. at 334-35 , 81 S.Ct. 623 . They include the relative dominance of a seller's position in the market, whether the market has "myriad outlets with substantial sales volume," the prevalence in the industry of exclusive contracts, the duration of the contract, and the existence of any pro-competitive justifications for the contract. Id.
The class plaintiffs assert that the Class Complaint plausibly alleges facts capable of supporting a finding or inference of substantial market foreclosure. The Class Complaint alleges that Mylan's exclusionary contracts with PBMs prevented competitors from accessing formularies covering more than 50% of the PBM market in the U.S. Also, the Class Complaint alleges that Mylan created a substantial, additional need for EpiPens by adding school districts to the market for EAI devices. Class Compl. ¶ 208. More than 67,000 school districts now purchase EpiPens, and the districts usually are "bulk" purchasers. Id. For example, the public schools in Fairfax County, Virginia, order about 1,100 EpiPen 2-Paks annually to have them on hand for their 180,000 students. Id. The Class Complaint also alleges that Mylan gained another advantage by opening up the school market-gaining access to nursing staff and creating familiarity with the EpiPen among parents. Id. ¶ 209.
Although these allegations never assert definitively that the EpiPen4Schools program's exclusionary contracts foreclosed a substantial share of the market, the court declines to conclude at the motion to dismiss *1293 stage that these facts fail to plead adequate foreclosure. Indeed, our court has recognized that Tampa Electric provides a "number of other factors which may be relevant to a rule of reason analysis in an exclusive dealing claim," and thus it has refused to "decide at the pleading stage that plaintiff had failed to plead adequate foreclosure levels" to state an exclusive dealing claim. Suture Express, Inc. v. Cardinal Health 200, LLC , 963 F.Supp.2d 1212 , 1229 (D. Kan. 2013) (Rogers, J.). The court comes to the same conclusion here. To determine whether the EpiPen4Schools program's exclusionary contracts foreclosed a substantial share of the market, the court must weigh the various factors outlined in Tampa Electric . The court cannot engage in such an analysis at the pleading stage. Instead, the court considers the Class Complaint's allegations in the light most favorable to the class plaintiffs. And it concludes that the class plaintiffs plausibly have alleged facts supporting a finding or inference that the probable effect of Mylan's exclusionary contracts in the EpiPen4Schools program substantially foreclosed competition. The court thus concludes that the class plaintiffs have stated a plausible exclusive dealing claim based on Mylan's EpiPen4Schools program.
3. Have the class plaintiffs alleged causation to support their antitrust claims based on the patent litigation settlements?
Next, defendants argue that the class plaintiffs lack standing to assert their antitrust claims based on the patent litigation settlements with potential competitors. This argument asserts that the class plaintiffs have alleged no facts capable of supporting a finding or inference of causation. To establish antitrust standing, a plaintiff must allege "(1) an 'antitrust injury'; and (2) a direct causal connection between that injury and a defendant's violation of the antitrust laws." Tal v. Hogan , 453 F.3d 1244 , 1253 (10th Cir. 2006) (citations and internal quotation marks omitted); see also Sharp v. United Airlines, Inc. , 967 F.2d 404 , 406 (10th Cir. 1992) (explaining that antitrust standing requires "the causal connection between the antitrust violation and the plaintiff's injury").
Defendants contend that the class plaintiffs have not alleged plausibly that they caused any delay in the sale of potential competitors' EAI devices by initiating the patent lawsuits and entering into settlement agreements with potential competitors. 6 Instead, defendants provide two reasons-unrelated to the patent litigation and settlements-that prevented potential competitors Teva, Intelliject, and Sandoz from entering the EAI market. First, defendants assert, Teva and Sandoz never entered the market because they never secured FDA approval for their EAI devices. Second, defendants contend, these potential competitors could not enter the market lawfully without infringing Pfizer's EpiPen device patents-ones that don't expire until 2025. The class plaintiffs respond, asserting that both arguments require *1294 the court to make factual determinations-something it cannot do on a motion to dismiss. Instead, the class plaintiffs argue, the Class Complaint alleges facts from which one could infer plausibly that defendants' conduct prevented potential competitors from entering the EAI market. The court agrees with them, for reasons explained below.
In response to defendants' first argument, the class plaintiffs concede that the Class Complaint recites that Teva and Sandoz never secured FDA approval for their competing EAI devices. Class Compl. ¶¶ 302, 319. But it also alleges that Teva and Sandoz were anticipating imminent launches into the EAI market and taking the steps to gain FDA approval of their generic, competing products so that they could enter the market. See id. ¶¶ 251-52 (reciting that defendants' alleged "pay-for-delay" settlements were designed "to stop Teva's imminent generic competition" after Teva had filed an ANDA in December 2008 seeking approval to market a generic EpiPen); see also id. ¶ 302 (reciting that "[i]n 2010, Sandoz ... made a similar attempt to enter the market through a generic alternative to EpiPen" by filing an ANDA). And, the Class Complaint alleges, defendants' unlawful conduct- i.e. , filing the lawsuits and entering into reverse payment settlements for purposes of delaying these potential competitors' entry into the market-caused Teva and Sandoz's failure to secure FDA approval.
Indeed, the Class Complaint recognizes that the "FDA ultimately rejected Teva's generic product when it was under review." Id. ¶ 319. But it also alleges that "it is likely that Teva may have been able to fix those problems if the patent lawsuit had not delayed its ability to enter the market." Id. (citation and internal quotation marks omitted). The Class Complaint also alleges: "But for Mylan's anti-competitive assault campaign, Teva would have entered the market much sooner and fixed the deficiencies that led to the FDA's rejection of Teva's generic." Id. ¶ 322. And it contends: "By sidelining Teva from 2012 to 2015, Mylan, King, and Meridian disrupted Teva's trajectory toward FDA approval and also gained a three-year guaranteed monopoly period in which Mylan could raise prices on consumers without any fear of generic competition from Teva." Id.
Also, the Class Complaint alleges that Sandoz never secured FDA approval because defendants' litigation has resulted in "the court entering an order staying the FDA process and administratively terminating the action, to be reopened upon letter request by any of the parties." Id. ¶ 302. And, to date, "[n]o party has reopened the case." Id.
The class plaintiffs argue that these allegations plausibly assert causation because the delay for potential competitors entering the market "was a foreseeable consequence of the original antitrust violation." In re Flonase Antitrust Litig. , 798 F.Supp.2d 619 , 630 (E.D. Pa. 2011) ; see also id. at 629-33 (denying summary judgment against antitrust claims because, among other things, plaintiffs presented sufficient evidence to raise genuine issues of material fact whether the FDA's deficiency notices sent to a potential competing generic "was indeed proximately caused by, or was the foreseeable consequences of, [defendant's] alleged antitrust violations"). The court agrees with this argument. Viewing the allegations in the class plaintiffs' favor, the Class Complaint asserts that defendants' alleged unlawful reverse payment settlements caused both the potential competitors' delay in entering the EAI device market and their delay in securing FDA approval.
Defendants cite several cases where district courts have dismissed antitrust claims *1295 based on reverse payment settlements for lack of causation because, those courts held, the absence of FDA approval had caused the generic's delay in entering the market-not defendants' alleged conduct. Defendants urge the court to apply the same reasoning here. But these cases differ from this one because the complaints in those cases never alleged that defendants had caused the delay to secure FDA approval. See, e.g. , In re Asacol Antitrust Litig. , No. 15-cv-12730-DJC, 2016 WL 4083333 , at *7 (D. Mass. July 20, 2016) (dismissing antitrust claim based on alleged reverse payment settlements because "the amended complaint contains no plausible allegation that [defendants] sought to delay or sabotage FDA approval" and, instead, "the lack of FDA approval today remains 'the limiting factor' in [the generic's] ability to bring its generic drug to market"); In re Sologyn (Minocycline Hydrochlorine) Antitrust Litig. , No. 14-md-02503-DJC, 2015 WL 5458570 , at *9 (D. Mass. Sept. 16, 2015) (holding that plaintiffs' allegations that a reverse payment settlement delayed entry of a competing product never asserted a "plausible allegation of delay by defendants" because the competing product never received FDA approval to launch its product before the parties' agreed entry date under the settlement); Brotech Corp. v. White Eagle Int'l Tech. Grp., Inc. , No. Civ.A.03-232, 2004 WL 1427136 , at *6 (E.D. Pa. June 21, 2004) (holding that a counterclaim alleged no antitrust injury when it "[did] not allege facts establishing" [a competitor's] intent and preparedness to enter the market for its [competing] product, that it would be prepared to enter the market for said product in the absence of the instant lawsuit, or that FDA approval of said products is probable). The facts alleged here differ. The class plaintiffs have alleged that defendants' reverse payment settlements delayed competing products-not only from entering the market but from securing FDA approval. See Class Compl. ¶¶ 302, 319, 322. These allegations suffice to state a claim for relief at the pleading stage.
In response to defendants' second argument-that a generic competitor could not enter the market lawfully without infringing Pfizer's patents-the class plaintiffs assert the Class Complaint plausibly alleges that Pfizer's patent rights were not sufficient to preclude generic competition (even though the patents did not expire until 2025). The class plaintiffs contend that, without defendants' alleged unlawful settlements, defendants faced a high probability of generic competition because it was likely that the courts would find the patents invalid or conclude that the generic competing devices were non-infringing. Indeed, the Class Complaint alleges that "given the trial court's previous rulings [in the Teva Litigation] it requires no great leap to infer that, had the parties waited for a decision, the '432 patent would have been found invalid." Id. ¶ 284 . It goes on to allege: "That, in turn, would have removed the most significant barrier to entry for Teva-or any other putative generic manufacturer, making it more likely that at least one would have entered or attempted to enter the market." Id. The Class Complaint also alleges facts about the trial court proceedings that allow a plausible finding or inference of invalidity or non-infringement. These alleged facts include: (1) the trial court issued Markman rulings interpreting the '432 patent favorable to Teva; (2) the parties settled after the trial court had held a full bench trial, meaning that the parties' additional litigation expenses were minimal compared to the expenses they already had incurred when they settled; and (3) "[n]o rational economic actor with a viable product (and who had spent millions of dollars developing it) would refrain from entering a lucrative 'blockbuster' market for 36 months unless *1296 it received monetary compensation in exchange for non-entry." Id. ¶ 265 .
Defendants assert that these allegations fail to state a plausible claim because they merely speculate that a generic would have proved invalidity or non-infringement in a patent lawsuit. For support, defendants cite two cases where district courts dismissed antitrust claims based on alleged unlawful reverse payments because the plaintiffs never asserted plausible allegations about a generic's ability to prevail in patent litigation with the patent holders. See, e.g. , FTC v. AbbVie, Inc. , 107 F.Supp.3d 428 , 437 (E.D. Pa. 2015) (holding that plaintiff's allegations that the patent litigation was a sham "is merely speculation" because "[n]o judicial determination of the sham issue had been made when the parties settled the case"); In re Ciprofloxacin Hydrochloride Antitrust Litig. , 261 F.Supp.2d 188 , 201-02 (E.D.N.Y. 2003) (holding that plaintiff's allegations that a generic would have prevailed in patent litigation were too speculative, especially because of judicially noticed facts about "post-settlement affirmations of the ... [p]atent's validity").
The court disagrees that the class plaintiffs' allegations here are merely speculative. In contrast to defendants' cited cases, the class plaintiffs here allege facts capable of supporting a finding or inference that a potential generic competitor could have shown that Pfizer's patents were invalid, or that its competing device did not infringe the patents. These factual allegations include ones about what transpired in the Teva Litigation- i.e. , that the trial court issued a Markman ruling that was allegedly favorable to Teva and that the timing of the parties' settlement suggests the patent holders recognized the risk of the trial court finding the patents invalid or the competing product non-infringing.
Recently, the Massachusetts federal district court denied summary judgment against an antitrust claim based on a reverse payment settlement. Analyzing the causation issue, that court noted, "the Supreme Court [has] explained that 'it is normally not necessary to litigate patent validity to answer the antitrust question (unless, perhaps, to determine whether the patent litigation is a sham)' because '[a]n unexplained large reverse payment itself would normally suggest that the patentee has some serious doubts about the patent's survival.' " In re Sologyn (Minocycline Hydrochlorine) Antitrust Litig. , No. 14-md-02503-DJC, 2018 WL 563144 , at *14 (D. Mass. Jan. 25, 2018) (quoting FTC v. Actavis, Inc. , 570 U.S. 136 , 157, 133 S.Ct. 2223 , 186 L.Ed.2d 343 (2013) ). Also, the court recognized "as a general matter, '[i]t is well established that the burden of proving infringement generally rests upon the patentee.' " Id. (quoting Medtronic, Inc. v. Mirowski Family Ventures, LLC , 571 U.S. 191 , 198, 134 S.Ct. 843 , 187 L.Ed.2d 703 (2014) ). The Massachusetts court thus concluded that, on summary judgment, "the standard requiring Plaintiffs to produce 'some evidence' of invalidity or noninfringement does not require Plaintiffs 'to prove that the generic defendant would have won, only that it could have.' " Id. (quoting United Food & Commercial Workers Local 1776 v. Teikoku Pharma USA , 296 F.Supp.3d 1142 , 1155 (N.D. Cal. 2017) ).
Applying that reasoning here, 7 the class plaintiffs need not allege that Teva would have prevailed in the patent litigation-it merely needs to allege that it could have.
*1297 The Class Complaint's allegations assert plausibly that Teva could have prevailed in the patent litigation if the parties has not resolved the case through an alleged reverse payment settlement. These allegations thus sufficiently assert that Pfizer's patents did not bar a generic competitor from entering the market. And the class plaintiffs have stated a plausible antitrust claim based on the alleged unlawful reverse payment settlements. See In re Niaspan Antitrust Litig. , 42 F.Supp.3d 735 , 755 (E.D. Pa. 2014) (denying motion to dismiss antitrust claim for lack of an injury caused by a patent litigation settlement because, the court concluded, plaintiffs "plausibly alleged that, but for the anticompetitive settlement agreements, [the generic] would have prevailed in the underlying patent litigation against [the patent holder]").
4. Have the class plaintiffs alleged a plausible conspiracy between Mylan and Pfizer?
Defendants next assert that the class plaintiffs have failed to allege a plausible conspiracy between the Mylan and Pfizer Defendants under the antitrust laws. Defendants concede that the Class Complaint alleges that "[b]eginning in 2012 with the settlement of the Teva Litigation, Defendants [Mylan, King, Meridian] engaged in a continuing illegal contract, combination, and conspiracy in restraint of trade, the purpose and effect of which was to prevent the sale of a generic version of the EpiPen in the United States...." Class Compl. ¶ 543 (Count III alleging state law antitrust violations); see also id. ¶ 530 ("By their agreement, Defendants intentionally and wrongfully conspired and combined in an unreasonable restraint of trade in a per se violation of § 1 of the Sherman Act...." (Count I, alleging violations of federal antitrust law) ). But, defendants contend, the Class Complaint alleges no facts capable of supporting a finding or inference of an agreement or conspiracy to exclude competing devices in the EAI market. 8
To state a claim under Sherman Act § 1, a complaint must allege "enough factual matter (taken as true) to suggest that an agreement was made." Bell Atl. Corp. v. Twombly , 550 U.S. 544 , 556, 127 S.Ct. 1955 , 167 L.Ed.2d 929 (2007) ; see *1298 also TV Commc'ns Network, Inc. v. Turner Network Television, Inc. , 964 F.2d 1022 , 1027 (10th Cir. 1992) ("To state a claim for a violation of section one [of the Sherman Act] the plaintiff must allege facts which show: the defendant entered a contract, combination or conspiracy that unreasonably restrains trade in the relevant market.").
"An agreement or conspiracy under federal antitrust laws is said to exist when 'there is a unity of purpose, a common design and understanding, a meeting of the minds, or a conscious commitment to a common scheme.' " Suture Express, Inc. v. Cardinal Health 200, LLC , 963 F.Supp.2d 1212 , 1223 (D. Kan. 2013) (quoting W. Penn Allegheny Health Sys. v. UPMC , 627 F.3d 85 , 99 (3d Cir. 2010) ). " 'A plaintiff may plead an agreement by alleging direct or circumstantial evidence, or a combination of the two,' but allegations of direct evidence, that are adequately detailed, are sufficient alone." Id. (quoting W. Penn Allegheny , 627 F.3d at 99 ). However, "[b]are bones accusations of a conspiracy without any supporting facts are insufficient to state an antitrust claim." Tal v. Hogan , 453 F.3d 1244 , 1261 (2006) (citation omitted).
Here, the class plaintiffs contend that they have alleged facts which one can use to infer plausibly that defendants conspired to exclude competing EAI devices from the market. The Class Complaint asserts that defendants engaged in a "multi-faceted, fraudulent scheme to obtain and maintain a monopoly" in the EAI market. Class Compl. ¶ 6. The Class Complaint alleges that defendants effectuated their scheme by combining and conspiring to: assert and prosecute invalid patents to dissuade competitors from entering the EAI market; intervene in regulatory proceedings to delay competitors' entry in the EAI market; and enter into unlawful "pay-for-delay" settlement agreements with competitors to maintain Mylan's power. Id. 9
The Class Complaint alleges that the Mylan and Pfizer Defendants engaged in this scheme to fend off EpiPen competitors because they had a "unified interest" to protect their monopoly. Id. ¶ 241. It asserts that the Pfizer Defendants (as the EpiPen patent holders and suppliers) and the Mylan Defendants (as the EpiPen sellers) worked collaboratively to enhance the EpiPen's sales volume and profitability because their related revenues rise and fall together. Id. ¶ 241.
The Class Complaint, construed in the class plaintiffs' favor, also alleges that defendants worked together to secure patents solely for the purpose of preventing generic competition. Id. ¶¶ 236-39. It describes how Mylan CEO Heather Bresch announced during a public earnings call in 2009, that Mylan was adding another patent to the already-patented EpiPen device that "will also put in [place] another barrier to entry...." Id. ¶ 238 (emphasis added). Shortly afterward, Meridian-not Mylan-secured the '432 patent. Also, the Class Complaint alleges that Mylan Specialty *1299 LP took over as sponsor of the EpiPen patents in the Orange Book 10 from Meridian. Id. ¶ 247. The Class Complaint asserts that this sponsorship change shows "concerted action by Mylan and Pfizer to share the burdens and rewards of their EpiPen monopoly." Id. ¶¶ 247, 314.
The Class Complaint also alleges that the Mylan Defendants and Pfizer Defendants worked together to prevent competitors from entering the market by filing patent infringement lawsuits and entering into "pay-for-delay" settlement agreements. Id. ¶¶ 236-303. While Mylan was not a party to the patent litigation lawsuits, one can infer plausibly from the Class Complaint's allegations that Mylan was participating in the concerted action. Indeed, the class plaintiffs allege that Mylan CEO Heather Bresch appeared to concede that Mylan participated in the Teva settlement by publicly referring to it as " our settlement with Teva." Id. ¶ 277 (emphasis added). Mylan also issued joint press releases with Pfizer announcing the Teva and Intelliject settlements. Id. ¶¶ 270, 298. The Class Complaint also quotes an antitrust scholar who has concluded "[a]t 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 litigation." Id. ¶ 314. The Class Complaint also describes that Congress has questioned whether the Teva settlement is an unlawful "pay-for-delay" settlement. Id. ¶ 280. In the inquiry, Congress directed questions about the settlement to Mylan, even though Mylan was not a party to the lawsuit. Id.
Defendants assert that all of class plaintiffs' allegations merely amount to "loosely parallel conduct" that cannot state a plausible conspiracy claim. Doc. 95 at 53 (citing Twombly , 550 U.S. at 556 , 127 S.Ct. 1955 ("[A]n allegation of parallel conduct and a bare assertion of conspiracy will not suffice.") ). Defendants assert that the allegations about patent infringement lawsuits and settlements involve different cases with different patents and different parties-and sometimes different products. Defendants contend that one cannot infer plausibly from these allegations that defendants agreed to join a conspiracy. Instead, defendants assert, these allegations just show unilateral and independent conduct-not a horizontal agreement-and thus, defendants argue, the allegations do not suffice to state a conspiracy claim.
Indeed, the Supreme Court requires: "[W]hen allegations of parallel conduct are set out in order to make a § 1 claim, they must be placed in a context that raises a suggestion of preceding agreement, not merely parallel conduct that could just as well be independent action." Twombly , 550 U.S. at 557 , 127 S.Ct. 1955 . This is so because "lawful parallel conduct fails to bespeak unlawful agreement." Id. at 556 , 127 S.Ct. 1955 . See also Mitchael v. Intracorp, Inc. , 179 F.3d 847 , 859 (10th Cir. 1999) ("While consciously parallel behavior may contribute to a finding of antitrust conspiracy, it is insufficient, standing alone, to prove conspiracy."); Cayman Exploration Corp. v. United Gas Pipe Line Co. , 873 F.2d 1357 , 1361 (10th Cir. 1989) ("[C]onscious parallel business behavior, standing alone, is insufficient *1300 to prove conspiracy."). Thus, "an allegation of parallel conduct and a bare assertion of conspiracy will not suffice. Without more, parallel conduct does not suggest conspiracy, and a conclusory allegation of agreement at some unidentified point does not supply facts adequate to show illegality." Twombly , 550 U.S. at 556 , 127 S.Ct. 1955 . Instead, a plaintiff must allege "conspiracy evidence [that] tend[s] to rule out the possibility that the defendants were acting independently." Id. at 554 , 127 S.Ct. 1955 .
The Tenth Circuit has held that "parallel behavior may, however, support the existence of an illegal agreement 'when augmented by additional evidence from which an understanding among the parties may be inferred.' " Mitchael , 179 F.3d at 859 (quoting Monument Builders of Greater Kansas City, Inc. v. Am. Cemetery Ass'n , 891 F.2d 1473 , 1481 (10th Cir. 1989) (further citation and internal quotation marks omitted) ). " 'Such evidence may include a showing that the parties are acting against their own individual business interests, or that there is motivation to enter into an agreement requiring parallel behavior.' " Id. (quoting Monument Builders , 891 F.2d at 1481 (further citation and internal quotation marks omitted) ); see also In re Ins. Brokerage Antitrust Litig. , 618 F.3d 300 , 321-22 (3d Cir. 2010) (explaining that "[s]ome courts have denominated these [additional] facts, the presence of which may indicate the existence of an actionable agreement, as 'plus factors' " and identifying "at least three such plus factors: (1) evidence that the defendant had a motive to enter into a price fixing conspiracy; (2) evidence that the defendant acted contrary to its interests; and (3) evidence implying a traditional conspiracy" (citations and internal quotation marks omitted) ).
Here, the Class Complaint alleges parallel conduct by asserting, plausibly, that both the Mylan and Pfizer Defendants participated in a scheme to secure invalid EpiPen patents, initiate patent infringement litigation, and then settle those lawsuits with reverse payment settlements. The court also concludes that the Class Complaint, construed in the class plaintiffs' favor, alleges sufficient "plus factors" and thus allows one to infer plausibly that an actionable agreement existed. The class plaintiffs allege facts supporting a plausible inference that defendants were motivated to enter an agreement to exclude competitors from entering the EAI market. See Class Compl. ¶¶ 241 (alleging that defendants' EpiPen-related revenues rise and fall together), 244 (alleging that, when Pfizer acquired King and Meridian, "Mylan was rightly concerned that Pfizer might try to compete with Mylan by marketing the same device to consumers under a different trade name. But rather than compete with Mylan, Pfizer agreed to continue supplying the device to Mylan under terms that are not publicly available."). The class plaintiffs also allege that defendants worked together to effectuate this scheme by securing patents, litigating patent infringement lawsuits, and entering into reverse payment settlements. Id. ¶¶ 238-39, 247, 270, 277, 298, 314, 632. The court recognizes that "each of [these] allegations of circumstantial agreement standing alone may not be sufficient to imply agreement," but, "taken together, they provide a sufficient basis to plausibly contextualize the agreement necessary for pleading a § 1 claim." Evergreen Partnering Grp., Inc. v. Pactiv Corp. , 720 F.3d 33 , 47 (1st Cir. 2013).
Defendants argue that the Class Complaint asserts no allegations supporting at least one of the plus factors- i.e. , that defendants acted against their own economic interest. Defendants assert that the Class Complaint alleges that the Mylan and Pfizer Defendants had a "unified interest"
*1301 in protecting the EpiPen monopoly and "work[ed] collaboratively to enhance the product['s] sales volume and profitability." Class Compl. ¶ 241. According to defendants, these allegations allow only an inference of lawful parallel conduct-not an unlawful agreement. But the class plaintiffs respond that the Class Complaint alleges that Pfizer also participates in the EAI market through its generic division Greenstone's distribution of the Adrenaclick generic EAI. Id. ¶ 101 n.16. So, the class plaintiffs contend, Pfizer was able to control a portion of the small amount of the EpiPen's competition. From these allegations, one could reasonably infer that Pfizer acted against its own interests by conspiring with Mylan to exclude EpiPen competition-competition that includes the generic Adrenaclick that Pfizer also distributes through its Greenstone division.
The court thus concludes that the Class Complaint sufficiently alleges facts capable of supporting a finding or inference of requisite "plus factors." Combined with defendants' alleged parallel business behavior, they state a plausible antitrust claim. The court thus denies defendants' Motions to Dismiss on this basis.
Finally, in a footnote, defendants assert that the Copperweld doctrine bars the class plaintiffs' conspiracy claims because the Mylan and Pfizer Defendants are parties with a unified interest and thus incapable of conspiring with each other for purposes of Sherman Act § 1. See Copperweld Corp. v. Indep. Tube Corp. , 467 U.S. 752 , 777, 104 S.Ct. 2731 , 81 L.Ed.2d 628 (1984) (holding that a parent and its wholly owned subsidiary are incapable of conspiring with each other under the Sherman Act); see also Shionogi Pharma, Inc. v. Mylan, Inc. , No. 10-1077, 2011 WL 2174499 , at *5 (D. Del. May 26, 2011) (recognizing that "district courts have held that other parties with unified interests, such as a patent holder and licensee, are incapable of conspiring"). But Copperweld does not hold that a patent holder and licensee never can conspire to violate the antitrust laws. Indeed, as other courts have recognized, a patent holder and its licensee can conspire in violation of the antitrust laws "only if [the conspiracy] deprives the marketplace of independent actors." Levi Case Co., Inc. v. ATS Prods., Inc. , 788 F.Supp. 428 , 431 (N.D. Cal. 1992) ; see also In re Suboxone (Buprenorphine Hydrochloride & Naloxone) Antitrust Litig. , No. 13-MD-2445, 2017 WL 4910673 , at *8-9 (E.D. Pa. Oct. 30, 2017) (rejecting argument that alleged co-conspirators were "a single economic entity as patent licensor and licensee" and refusing to apply the Copperweld doctrine because the complaint alleged "two separate entities that engaged in concerted action to jointly advance their economic interests"); Townshend v. Rockwell Int'l Corp. , No. C99-0400SBA, 2000 WL 433505 , at *6 (N.D. Cal. Mar. 28, 2000) (denying Rule 12(b)(6) motion to dismiss conspiracy claims because the case law did not establish that patent holder and licensee are "legally incapable of entering into a conspiracy" and concluding that defendants' capability of entering a conspiracy was a "question of fact" that the court could not resolve on a motion to dismiss).
Likewise, here, the court finds that the Class Complaint sufficiently alleges facts capable of supporting a finding or inference that the Mylan and Pfizer Defendants are "two separate entities that engaged in concerted action to jointly advance their economic interests." In re Suboxone , 2017 WL 4910673 , at *9. Although the Class Complaint alleges that the Mylan and Pfizer Defendants shared a "unified interest" in protecting the EpiPen monopoly (Class Compl. ¶ 241), it also alleges that defendants had separate interests-Mylan through its sale of the EpiPen and *1302 Pfizer with its control of a portion of the small amount of the EpiPen's competition through its Greenstone division's distribution of the generic Adrenaclick. Indeed, the Class Complaint alleges that both compete in the EAI market. The Class Complaint also alleges "anticompetitive conduct at the heart of the alleged conspiracy"- i.e. , the concerted effort to procure patents, initiate patent infringement litigation, and enter into reverse payment settlements in an effort to prevent EpiPen competitors from entering the EAI market-that is "ancillary" to the patentee/licensee relationship. In re Suboxone , 2017 WL 4910673 , at *9. For these reasons, the court refuses to apply the Copperweld doctrine here.
5. Have the class plaintiffs alleged a viable antitrust claim based on the "reverse" patent litigation settlements?
Next, defendants argue that the class plaintiffs have failed to allege plausible antitrust claims based on alleged reverse payment settlements. The Supreme Court has held that reverse payment settlements "can sometimes violate the antitrust laws." FTC v. Actavis, Inc. , 570 U.S. 136 , 141, 133 S.Ct. 2223 , 186 L.Ed.2d 343 (2013). A reverse payment settlement refers to an agreement by a brand-name manufacturer and patent holder to compensate a generic manufacturer and alleged patent infringer in exchange for settling patent infringement litigation, thus delaying the generic's market entry. In re Nexium (Esomeprazole) Antitrust Litig. , 842 F.3d 34 , 41 (1st Cir. 2016) (citing Actavis , 570 U.S. at 145 , 133 S.Ct. 2223 ). "When a brand-name manufacturer pays to delay the first filer's generic launch, that reverse payment postpones not only the first filer's product but also those of all other generic manufacturers, who must wait out the 180-day exclusivity period before going to market." Id. Because a reverse payment settlement effectively delays generic competition in the market, Actavis recognized that "a reverse payment, where large and unjustified, can bring with it the risk of significant anticompetitive effects." Actavis , 570 U.S. at 158 , 133 S.Ct. 2223 .
To determine whether a reverse payment settlement has anticompetitive effects, the Supreme Court has instructed that "a detailed exploration of the validity of the patent itself" is not necessary. Id. at 158 , 133 S.Ct. 2223 . Instead, the anticompetitive effects of a reverse payment depend on "its size, its scale in relation to the payor's anticipated future litigation costs, its independence from other services for which it might represent payment, and the lack of any other convincing justification." Id. at 159 , 133 S.Ct. 2223 . The Supreme Court also recognized that "[t]he existence and degree of any anticompetitive consequence may also vary as among industries." Id. Because of "[t]hese complexities," the Supreme Court has held that courts must analyze alleged unlawful reverse payment settlements under the rule of reason. Id.
Here, defendants assert that the Class Complaint fails to plead facts showing that defendants actually made any payments in the patent litigation settlements with Teva, Intelliject, and Sandoz. Thus, defendants contend, the class plaintiffs fail to state a plausible claim based on any of these settlements. The court addresses each of the three settlements separately, below.
a. Teva Settlement
The class plaintiffs assert that one plausibly can infer from the Class Complaint's allegations that defendants made a large and unjustified reverse payment settlement in the Teva Litigation. The Class Complaint alleges that one reasonably can infer "[f]rom the facts surrounding the settlement" that "King and Meridian made a *1303 substantial 'reverse payment' to Teva to convince it to delay bringing its competing generic auto-injector to market." Class Compl. ¶ 265. According to the Class Complaint, these facts include: (1) the district court in the Teva Litigation had issued a Markman ruling interpreting the '432 patent favorable to Teva; (2) the parties settled after a full bench trial, meaning that the parties already had expended significant litigation expenses compared to the marginal ones they would incur going forward; and (3) it makes little sense that a "rational economic actor with a viable product (and who had spent millions of dollars developing it) would refrain from entering a lucrative 'blockbuster' market for 36 months unless it received monetary compensation in exchange for non-entry." Id.
The Class Complaint never alleges the amount of the alleged settlement payment, but it explains that the terms of the Teva settlement are confidential and not publicly available. Id. ¶ 264. At least one court has held that a plaintiff need not plead a precise monetary settlement amount, recognizing that "very precise and particularized estimates of fair value and anticipated litigation costs may require evidence in the exclusive possession of the defendants, as well as expert analysis, and that these issues are sufficiently factual to require discovery." In re Aggrenox Antitrust Litig. , 94 F.Supp.3d 224 , 244 (D. Conn. 2015). Instead, to plead that a large and unjustified reverse payment occurred, a plaintiff must assert "specific allegations about the terms of the settlement and their relative value that are plausible on their face." Id. ; see also King Drug Co. of Florence, Inc. v. Smithkline Beecham Corp. , 791 F.3d 388 , 410 (3d Cir. 2015) (reversing a district court's Rule 12(b)(6) dismissal of antitrust claims because "plaintiffs' allegations, and the plausible inferences that can be drawn from them, are sufficient to state a rule-of-reason claim under Twombly and Iqbal for violation of the Sherman Act on the ground that [defendant] sought to induce [a generic] to delay its entry into the lamotrigine tablet market by way of an unjustified no-AG agreement"); In re Loestrin 24 Fe Antitrust Litig. , 814 F.3d 538 , 552 (1st Cir. 2016) (declining to "require heightened fact pleading of specifics" such as "precise figures and calculations at the pleading stage" but holding that "the plaintiffs must allege facts sufficient to support the legal conclusion that the settlement at issue involves a large and unjustified reverse payment under Actavis ").
Defendants assert that the class plaintiffs' allegations here fall short of this pleading standard. For support, defendants rely on FTC v. AbbVie, Inc. , 107 F.Supp.3d 428 (E.D. Pa. 2015), where the court held that plaintiff had failed to state a plausible antitrust claim because the patentees "did not make any payment, reverse or otherwise, to the claimed infringer...." Id. at 436 . AbbVie 's facts differ significantly from the ones alleged here. The class plaintiffs specifically allege that defendants "provided significant consideration, incentives, and benefits to Teva to delay bringing their competing product to market." Class Compl. ¶ 263. And, the court concludes, the allegations assert specific facts-described above-that are capable of supporting a reasonable inference that the consideration provided as part of the Teva settlement constituted a substantial reverse payment. Id. ¶ 265.
Defendants disagree. They argue that the asserted facts cannot support a plausible inference of a reverse payment settlement. But their arguments invite the court to weigh the Class Complaint's factual allegations-something it cannot do on a motion to dismiss. For example, defendants assert that the Teva settlement was not the product of an unlawful reverse payment *1304 but, instead, a settlement that the trial court expressly encouraged. Doc. 93 at 14. Defendants also disagree with the class plaintiffs' assertion that the parties settled after they had already incurred the most significant attorney's fees through a bench trial. Defendants argue that the Teva Litigation was "subject to the uncertainty, expense, and burden of protracted appeals and possible remands." Id. at 15. And, defendants contend, the Markman ruling was not favorable to Teva but instead was more of a "mixed conclusion," with the court rejecting two of Teva's proposed constructions. Id. (citations and internal quotations omitted).
All these arguments require the court to consider disputed factual allegations. And that function is not a proper one on a Rule 12(b)(6) motion to dismiss. See In re Cardizem CD Antitrust Litig. , 332 F.3d 896 , 900 (6th Cir. 2003) (affirming district court's denial of a motion to dismiss because "[t]he defendants' claim that [the generic manufacturer's] decision to stay off the market was motivated not by the [reverse payment], but by its fear of damages in the pending patent infringement litigation, merely raise[d] a disputed issue of fact that cannot be resolved on a motion to dismiss"). Instead, viewing the allegations in the class plaintiffs' favor, the court concludes that the Class Complaint alleges "enough facts" to allow a reasonable inference that the Teva settlement constituted an unlawful reverse payment and thus is sufficient to "nudge[ ] the[ ] claims across the line from conceivable to plausible." Twombly , 550 U.S. at 570 , 127 S.Ct. 1955 .
b. Intelliject Settlement
Defendants next argue that the class plaintiffs assert conclusory allegations to support their theory that the Intelliject settlement constitutes an unlawful reverse payment settlement. Thus, defendants contend, the class plaintiffs fail to state a plausible claim for relief based on it. For the same reasons already discussed, the court rejects defendants' argument.
Viewing the Class Complaint's allegations in the class plaintiffs' favor, one can infer plausibly that defendants made a reverse payment in the Intelliject settlement. The Class Complaint alleges that, in February 2012, Mylan and Pfizer jointly announced settlement of the Intelliject litigation. Class Compl. ¶ 298. Like the Teva settlement, the terms of the Intelliject settlement are confidential. Id. But Mylan and Pfizer publicly stated that "the agreement prevented Intelliject and Sanofi from launching their e-cue device for another nine months, until November 15, 2012." Id. The Class Complaint asserts that "[t]he relatively short duration of delay before entry of the e-cue likely indicates the strength of Intelliject's defenses to the patent litigation." Id. The Class Complaint also contends, "on information and belief, Intelliject and Sanofi agreed not to enter the market until November 15, 2012[,] in exchange for valuable consideration." Id. ¶ 299. These allegations can support a plausible inference that defendants settled the Intelliject litigation by making a reverse payment.
Defendants contend that these facts won't allow such an inference because the settlement granted Intelliject a market entry date that was 13 years before the EpiPen patents expire. Defendants argue that this allegation shows just that the Intelliject settlement is a traditional settlement agreement involving a negotiated early entry date. And that type of settlement agreement is not subject to antitrust scrutiny. Actavis , 570 U.S. at 158 , 133 S.Ct. 2223 . With this argument, defendants again ask the court to weigh disputed factual allegations. The court cannot engage in such fact-finding on a motion to dismiss. For these reasons, the court finds that the Class Complaint plausibly asserts that the *1305 Intelliject settlement constituted a large and unjustified reverse payment settlement sufficient to support an antitrust claim.
c. Sandoz Settlement
Finally, defendants assert that the Class Complaint fails to allege that the Sandoz settlement involved a large and unjustified reverse payment settlement. The Class Complaint alleges that, in 2010, Sandoz attempted to enter the EAI market with a generic alternative to the EpiPen. Class Compl. ¶ 302. The Class Complaint asserts that "defendants conspired to have King file a patent infringement suit against Sandoz in response to its ANDA filing." Id. Pfizer filed a Form 10-Q with the SEC in 2016. Id. It recited that Sandoz's ANDA is ongoing and the litigation is stalled because the court had entered an order staying the FDA process and administratively terminating the action, subject to the parties seeking to reopen the case by letter request. Id. To date, no party has reopened the case. Id. The Class Complaint describes how staying the litigation also stays a definitive ruling on any challenge to the EpiPen patents. Id. And it asserts "[o]n information and belief" that defendants "entered into an agreement with Sandoz to stay the case indefinitely in exchange for valuable consideration to Sandoz." Id. at ¶ 303.
Although the class plaintiffs cannot provide the precise terms of the Sandoz agreement without the benefit of discovery, one plausibly can infer from Sandoz's actions that it received significant consideration in exchange for its actions- i.e. , agreeing to stay its ANDA application for its generic product. Indeed, one also could infer the opposite conclusion-that Sandoz agreed to stay its ANDA application because it considered the patent infringement claims valid and appreciated the risk that it would lose the patent infringement litigation. But, at the pleading stage, the court cannot make that determination. Instead, the court must consider the facts alleged in the class plaintiffs' favor and draw reasonable inferences from them. Applying that standard here, the court concludes that the class plaintiffs have asserted a plausible antitrust claim based on their allegations that the Sandoz settlement involved an unlawful reverse payment settlement.
6. Have the class plaintiffs stated a plausible antitrust claim based on the FDA Citizen Petition?
Next, the Mylan Defendants argue that the class plaintiffs' allegations about the FDA Citizen Petition fail to state a plausible antitrust claim. The Mylan Defendants assert two arguments supporting dismissal.
First , the Mylan Defendants contend, the Class Complaint never alleges that the Citizen Petition caused any delay in the FDA approval process. The Mylan Defendants explain that a federal statute requires the FDA to take final agency action on a Citizen Petition within 150 days (about five months). 21 U.S.C. § 355 (q)(1)(F). And, 21 U.S.C. § 355 (q)(1)(A) provides that the Secretary "shall not delay approval" of a pending ANDA based on the filing of a Citizen Petition. But, as Mylan concedes, this statute also contains an exception. It authorizes "the Secretary, upon reviewing the petition," to determine whether a further delay is necessary to protect public health. 21 U.S.C. § 355 (q)(1)(A)(ii). And, as the Class Complaint alleges, legal scholars and Congress have recognized the "dangerous potential" of Citizen Petitions (such as Mylan's) to extend brand monopolies and delay approval of generics. Class Compl. ¶¶ 306, 308.
The Class Complaint asserts that Mylan filed a Citizen Petition on January 16, 2015, "a mere six months before Teva was *1306 scheduled (pursuant to the settlement) to enter the market." Id. ¶ 311 . It also alleges that Mylan waited until May 2015-almost five months after filing its Citizen Petition and only weeks before the FDA was required to respond-to supplement its Petition with a 48-page independent study purportedly showing that patients would not use Teva's generic product correctly. Id. ¶ 311 . The Class Complaint quotes a legal scholar who has questioned the timing of Mylan's Citizen Petition and suggested that it was part of a strategy to delay Teva's ANDA approval. Id. ¶¶ 311, 314 . And, the Class Complaint asserts, "[b]ut for Mylan's anti-competitive assault campaign" that included the FDA Citizen Petition, "Teva would have entered the market much sooner and fixed the deficiencies that led to the FDA's rejection of Teva's generic." Id. ¶ 322 .
At least one court has concluded that allegations similar to those asserted here-ones that asserted, generally, that citizen petitions can delay the FDA approval process, and, more specifically, that a defendant had delayed approval of a generic competitor-"plausibly pleads that the citizen petition resulted in delay of the FDA's approval of the generic ANDAs." In re Suboxone (Buprenorphine Hydrochloride and Naloxone) Antitrust Litig. , No. 13-MD-2445, 2017 WL 3967911 , at *18 (E.D. Pa. Sept. 8, 2017) (denying a Rule 12(b)(6) motion to dismiss antitrust claims based on alleged delay caused by FDA citizen petition because the Amended Complaint plausibly pleaded delay and "[w]hether such a delay actually occurred in this case is a subject more properly left for resolution after discovery"). For the same reasons, the court finds that the class plaintiffs plausibly have alleged that Mylan's Citizen Petition delayed the FDA approval process. 11
Second , the Mylan Defendants assert that the Noerr -Pennington doctrine bars the class plaintiffs' claims based on the FDA Citizen Petition. As discussed, the Noerr -Pennington doctrine "exempts from antitrust liability any legitimate use of the political process by private individuals, even if their intent is to eliminate competition." Tal v. Hogan , 453 F.3d 1244 , 1259 (10th Cir. 2006) (citation and internal quotations marks omitted). But Noerr -Pennington immunity does not apply to "sham" activities. Prof'l Real Estate Inv'rs, Inc. v. Columbia Pictures Indus., Inc. , 508 U.S. 49 , 60-61, 113 S.Ct. 1920 , 123 L.Ed.2d 611 (1993). Petitioning the government is a "sham" activity if: (1) it is "objectively baseless in the sense that no reasonable litigant could realistically expect success on the merits," and (2) it "uses the governmental process -as opposed to the outcome of that process-as an anticompetitive weapon." Id. (citations and internal quotation marks omitted).
The Mylan Defendants assert that the Class Complaint's allegations don't satisfy these two requirements to plead adequately that Mylan's Citizen Petition falls within the sham exception to the Noerr -Pennington doctrine. First, the Mylan Defendants argue that the allegations don't plead facts capable of supporting a finding or inference *1307 that Mylan's Citizen Petition was objectively baseless. Some courts have found that the question "[w]hether petitioning activity is a sham is generally [one] for the jury." In re Suboxone (Buprenorphine Hydrochloride and Naloxone) Antitrust Litig. , 64 F.Supp.3d 665 , 689 (E.D. Pa. 2014) (citing In re Flonase Antitrust Litig. , 795 F.Supp.2d 300 , 310 (E.D. Pa. 2011) ). But " 'a court may decide probable cause as a matter of law' where 'there is no dispute over the predicate facts of the underlying ... proceeding.' " Id. (quoting Prof'l Real Estate Inv'rs, Inc. , 508 U.S. at 63 , 113 S.Ct. 1920 ).
The Class Complaint asserts facts supporting a plausible inference that the Citizen Petition was objectively baseless because of its timing and contents. Mylan waited until January 2015-six months before Teva was scheduled to enter the market-to file the Citizen Petition even though Teva had been developing the drug for six years, the parties had litigated the patent infringement suit for three years, and the parties settled that litigation three years before the Petition's filing. Class Compl. ¶¶ 311, 314. The Class Complaint also asserts that Mylan's Citizen Petition relied on a medical statement from a doctor who Mylan paid to render the opinion. Id. ¶¶ 317, 318. And Mylan's Citizen Petition never disclosed that it had made such a payment. Id. ¶ 318.
The Class Complaint also alleges that Mylan waited just weeks before the FDA was required to respond to the ANDA to supplement its Citizen Petition by submitting a study. Id. ¶ 311. The Class Complaint asserts that this study had "numerous flaws that demonstrate that Mylan was not acting in good faith" by submitting it to the FDA. Id. ¶ 313. The Class Complaint identifies specific flaws: the study lacked a control group; it did not use the actual generic device, but a prototype; it used a small number of participants; the researchers failed to provide proper instructions to the study's participants for using the prototype; and the researchers told the participants to watch a video instead of actually use the prototype. Id.
The Mylan Defendants respond with various arguments attacking these allegations. They explain the legitimacy of the filings' timing, the doctor's medical statement, the payments the doctor received (noting that the doctor received payments from other pharmaceutical companies, including Teva), and the supplemental study. But these arguments present disputed fact issues that the court cannot decide at the pleading stage. On a motion to dismiss, the court considers the allegations in the class plaintiffs' favor and concludes they sufficiently allege that Mylan's FDA Citizen Petition was objectively baseless. See In re Suboxone Antitrust Litig. , 2017 WL 3967911 , at *17 (explaining that federal antitrust claims "based on the filing of a sham citizen petition survived dismissal" because the complaint "sets forth multiple facts which could create an inference that the petition was objectively baseless"); see also La. Wholesale Drug Co. v. Sanofi-Aventis , No. 07 Civ.7343(HB), 2008 WL 169362 , at *5 (S.D.N.Y. Jan. 18, 2008) (denying motion to dismiss antitrust claims based on an alleged sham petition because plaintiff alleged triable fact issues about "the reasonability and viability" of the citizen petition and was entitled to additional discovery to prove the allegations).
The court also finds that the Class Complaint plausibly alleges that Mylan used the process of filing the FDA Citizen Petition-not the outcome of that proceeding-to restrain competition. The Class Complaint repeatedly alleges that Mylan used the FDA Citizen Petition process as a means to delay Teva's market entry. Class Compl. ¶¶ 304, 310, 311, 316, 319, 321. These allegations suffice to state an antirust *1308 claim based on Mylan's Citizen Petition that falls within the sham exception to the Noerr -Pennington doctrine.
7. Have the class plaintiffs alleged a plausible antitrust claim based on allegedly misleading statements?
The Mylan Defendants next argue that the Class Complaint fails to allege plausible antitrust claims based on the Mylan Defendants' misrepresentations about Auvi-Q's bioequivalence and not-covered status. 12 Deceptive speech can support Sherman Act claims because "in some cases, such defamation, which plainly is not competition on the merits, can give rise to antitrust liability, especially when it is combined with other anticompetitive acts." W. Penn Allegheny Health Sys., Inc. v. UPMC , 627 F.3d 85 , 109 n.14 (3d Cir. 2010) ; see also Caldera, Inc. v. Microsoft Corp. , 87 F.Supp.2d 1244 , 1249 (D. Utah 1999) (holding that alleged misleading statements about the plaintiff's product viewed with other anticompetitive behavior supported a Sherman Act § 2 claim sufficient to survive summary judgment).
The Tenth Circuit presumes that allegedly false speech "bears only a de minimis effect on competition." Lenox MacLaren Surgical Corp. v. Medtronic, Inc. , 762 F.3d 1114 , 1127 (10th Cir. 2014) ; see also Nat'l Ass'n of Pharm. Mfrs., Inc. v. Ayerst Labs. , 850 F.2d 904 , 916 (2d Cir. 1988) ("[A] plaintiff asserting a monopolization claim based on misleading advertising must overcome a presumption that the effect on competition of such a practice was de minimis." (citation and internal quotation marks omitted) ). 13 An antitrust plaintiff "may rebut this presumption by satisfying a six-factor test, showing that the disparagement was: (1) clearly false, (2) clearly material, (3) clearly likely to induce reasonable reliance, (4) made to buyers without knowledge of the subject matter, (5) continued for prolonged periods, and (6) not readily susceptible to neutralization or other offset by rivals." Lenox , 762 F.3d at 1127 (citing Am. Prof'l Testing Serv., Inc. v. Harcourt Brace Jovanovich Legal & Prof'l Publ'ns, Inc. , 108 F.3d 1147 , 1152 (9th Cir. 1997) ); see also Ayerst Labs. , 850 F.2d at 916 (quoting III P. Areeda & D. Turner, Antitrust Law *1309 ¶ 738a, at 278-79 (1978) ). The Tenth Circuit has not decided whether a plaintiff must satisfy all six factors to overcome the de minimis presumption. Lenox , 762 F.3d at 1128 n.9 ; see also Duty Free Ams., Inc. v. Estee Lauder Cos. , 797 F.3d 1248 , 1269 (11th Cir. 2015) (holding that it need not determine whether a plaintiff must allege all six factors because the complaint failed to allege falsity).
In Ayerst , the Second Circuit held that a district court had erred by dismissing a Sherman Act § 2 claim. Plaintiff there based its claim on an allegedly false and deceptive letter that defendant had sent to customers. The court found that plaintiff's Complaint alleged several of the factors required to overtake the de minimis presumption-including that the letter was clearly false, clearly material, and clearly likely to induce reasonable reliance. Id. But the court also agreed with defendant: plaintiff had not alleged other certain factors because the Complaint asserted that defendant sent the letter to pharmacists-persons likely to have knowledge about the subject matter-and that defendant only could have made the misrepresentations for a short time period. Id. at 917. Nevertheless, the court concluded, "several factors ... cannot be adequately evaluated until the discovery process has moved forward to a greater extent than it has thus far." Id. The court thus held that the Complaint pleaded a Sherman Act § 2 claim sufficient to survive Rule 12(b)(6) dismissal.
Viewing the facts alleged here in the light most favorable to the class plaintiffs, the Class Complaint alleges several of the factors required to overcome a presumption that deceptive statements have had a de minimis effect on competition. The class plaintiffs allege that Mylan: (1) created and spread misinformation about the Auvi-Q and its bioequivalence to the EpiPen; (2) funded and promoted a study that was intended to undermine the FDA's conclusion that Auvi-Q demonstrated bioequivalence to the epinephrine in the EpiPen; and (3) made misleading statements to physicians that the EpiPen was the "preferred" brand based on Auvi-Q's coverage exclusions when Mylan itself produced the exclusion with its large, conditional rebate offers. Class Compl. ¶¶ 229, 232-34. The class plaintiffs assert that these allegedly false and misleading statements blocked Auvi-Q from competing in the market, thus excluding competition. Id. ¶¶ 229-31, 235.
The Mylan Defendants contend that the class plaintiffs' allegations fail to assert that Mylan's allegedly deceptive statements were "clearly false," as the first factor of the six-factor test requires. The court disagrees. One plausibly can infer from the Class Complaint's allegations that Mylan's statements about Auvi-Q were clearly false. Although the Class Complaint does not use those precise words, it calls the statements "misinformation" and so "misleading" that they "ensur[ed] that physicians would think that the EpiPen was the only realistic choice for their patients." Id. ¶¶ 229, 234-35. Of course, to prevail on their speech-based claims, the class plaintiffs must come forward with evidence showing that these alleged statements produced anticompetitive effects in violation of the antitrust laws. But, at the pleading stage, the court applies Ayerst 's rationale and concludes that the class plaintiffs "should be allowed to go forward with the discovery process to substantiate [their] claim" that Mylan's allegedly deceptive speech violated the antitrust laws. Ayerst Labs. , 850 F.2d at 917 .
Also, following Ayerst , the court need not decide whether the Class Complaint alleges facts capable of supporting each factor before it could overtake the de minimis presumption. The Ayerst plaintiff did *1310 not satisfy such an obligation at the pleading stage. The court finds persuasive Ayerst 's conclusion that these factors require factual development through the discovery process. Here, the court cannot evaluate several of the factors adequately without the facts that discovery may or may not produce. So, the court denies the motion to dismiss the class plaintiffs' deceptive speech claim at the pleading stage. See id. at 917 .
8. Have the class plaintiffs stated plausible claims for relief under state antitrust laws?
Finally, defendants argue that the Class Complaint fails to allege any plausible claims under all the state antitrust laws invoked by the Class Complaint. Defendants contend that the state antitrust claims fail for the same reasons that the federal claims fail. But, as discussed above, the court concludes that the Class Complaint states plausible claims for relief under the federal antitrust laws. It reaches the same conclusion about defendants' repackaged arguments attacking the state law claims.
Also, defendants advance three other arguments that, they say, warrant dismissal of certain state antitrust claims. First , defendants argue that the court should dismiss state antitrust claims asserted under the laws of Alaska, Arizona, 14 the District of Columbia, Iowa, New Mexico, North and South Dakota, Oregon, 15 Puerto Rico, Rhode Island, Vermont, 16 and Wisconsin 17 because the Class Complaint includes no named plaintiff who resides in any of these states. Our court has recognized that "[s]everal courts, including other district courts in the Tenth Circuit, have determined that the plaintiffs in

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Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/7250288. Public record. Not legal advice.