# In re Loestrin 24 Fe Antitrust Litigation

> District Court, D. Rhode Island · August 8, 2017 · 261 F. Supp. 3d 307

URL: https://www.frixlaw.com/law-library/cases/8312376

## Case

- **Full name:** IN RE LOESTRIN 24 FE ANTITRUST LITIGATION This Document Relates To: All Actions
- **Court:** District Court, D. Rhode Island
- **Decided:** August 8, 2017
- **Citations:** 261 F. Supp. 3d 307
- **Precedential status:** Published
- **Opinion:** Opinion of the court by Smith
- **Judges:** Smith
- **Cited by:** 9 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/8312376

## How later opinions describe it (automated extraction)

- holding that it would be more efficient to address questions including whether the plaintiffs had sufficiently alleged intrastate conduct at the class certification, explaining that "[i]t is conceivable, for example, that the Court could deny class certification, which would o…
- holding that where the scheme and injury alleged by the plaintiffs was "the same across the country" and the plaintiffs had "a collective interest in litigating their claims together to attempt to recover," the "question would be appropriately, and more efficiently, addressed …
- holding on a Rule 12(b)(6) motion to dismiss that federal patent law did not preempt plaintiffs' state consumer protection law claims because plaintiffs alleged that defendants enforced their patent in the marketplace with bad faith
- finding that a no-AG Agreement constituted a reverse payment because it transferred payments to the settling generic company that the brand company would have otherwise received by distributing an AG
- stating, in pharmaceutical antitrust case brought by both end payors and direct purchasers, that relevant market must be defined as consisting of commodities reasonably interchanged by consumers for the same purpose

## Opinion text

*314 OPINION AND ORDER
William E. Smith, Chief Judge
The plaintiffs in this multidistrict litigation (“MDL”) seek damages from the defendant-pharmaceutical companies for an allegedly anti-competitive scheme relating to Loestrin 24 FE (“Loestrin 24”), an oral contraceptive comprising 24 norethindrone acetate/ethinyl estradiol (1 mg/20 meg) tablets and four ferrous fumarate tablets.
In June 2013, the United States Supreme Court decided a landmark patent antitrust case, FTC v. Actavis, Inc., 570 U.S. 136 , 133 S.Ct. 2223 , 186 L.Ed.2d 343 (2013), which held that “reverse payments”—settlement payments in patent infringement suits remitted by patent holders to alleged infringers—are subject to the rule of reason under federal antitrust law; In October 2013, the United States Judicial Panel on Multidistrict Litigation consolidated and transferred the instant litigation to this Court. (See Transfer Order, ECF No. 1.) In September 2014, after briefing and argument, the Court dismissed the complaints, holding that Acta-vis applied only to cash payments and reserving judgment on all other issues. See generally In re Loestrin 24 Fe Antitrust Litig., 45 F.Supp.3d 180 (D.R.I. 2014) (“Loestrin 24 (D.R.I.)”). The First Circuit disagreed, vacating the dismissal and remanding for further proceedings. See generally In re Loestrin 24 Fe Antitrust Litig, 814 F.3d 538 (1st Cir. 2016) (“Loestrin 24”).
On remand from the Circuit, the plaintiffs have amended their complaints, and the parties have re-briefed and argued the defendants’ motions to dismiss. Before the Court are two Motions to Dismiss 1 seeking to dismiss the four Operative Complaints 2 in this MDL. For the reasons set forth below, and as previously ordered by this Court on July 21, 2017 (ECF No. 299), the Warner Chilcott Defendants’ Motion to Dismiss (ECF No, 192) is GRANTED with respect to the parent companies; DENIED WITHOUT PREJUDICE with respect to the Énd-Payor Plaintiffs’ (“EPPs”) claims under state law in the twenty-five states and Puerto Rico in which they failed to plead that they have either resided or purchased Loestrin 24 products in the state; DENIED WITHOUT PREJUDICE with respect to arguments that the EPPs failed to state a claim for relief under various state laws for antitrust violations, consumer protection violations, and unjust enrichment; and DENIED in all other respects. The Lupin Defendants’ Motion to Dismiss (ECF No. 191) is DENIED.
*315 I. Background 3
A. The Parties
This MDL litigation consolidates four complaints filed by four sets of plaintiffs. The Direct Purchaser Plaintiffs (“DPPs”) are corporate entities that purchased Loestrin 24 directly from Warner Chilcott, one of the defendants. 4 The Retailers, or the opt-out DPPs, comprise the Walgreen Plaintiffs 5 and the CVS Plaintiffs. 6 The EPPs are “third-party payors” or “indirect purchasers.” They generally comprise employee welfare benefit programs that reimbursed subscribers who purchased Loestrin 24, but also include three individuals who purchased Loestrin 24 for their own use. 7
Defendants are pharmaceutical companies; due to various mergers and acquisitions in the industry, their relationships to one another have changed over the relevant time period, and even during the course of this litigation. (DPP Compl. ¶¶ 18-80.) Warner Chilcott Company, LLC (“Warner Chilcott”) 8 is the current assignee of the patent covering Loestrin 24, U.S. Patent No. 5,552,394 (“the 394 patent”),. and it holds the approved New Drug Application (“NDA”) from the Food and Drug Administration (the “FDA”) for Loestrin 24. (Id. ¶¶ 7,19.) Defendant Watson Laboratories, Inc. is a wholly-owned subsidiary of Watson Pharmaceuticals, Inc., which acquired Actavis, Inc. in 2013 and continued operations under the name Actavis, Inc.; the Court refers to these defendants collectively as “Watson,” except.when explicitly discussing Actavis, Inc. (CVS Compl. ¶30.) Warner Chilcott and Watson are *316 currently both part of Defendant Allergan pic. 9 (EPP Compl. ¶ 27.) The remaining defendants are Lupin Ltd. and Lupin Pharmaceuticals Inc. (collectively, “Lupin” and, together with Warner Chilcott and Watson, “Defendants”). (CVS Compl. ¶¶ 32-34.) Because Warner Chilcott’s and Watson’s interests are now aligned, and they have submitted joint briefing, they are collectively referred to as the “Warner Chilcott" Defendants.” The EPPs, Walgreen Plaintiffs, and CVS Plaintiffs have named Lupin as a defendant; the DPPs have not. (DPP Compl. ¶ 16-30; EPP Compl. ¶¶ 40-41; Walgreens Compl. ¶¶ 36-37; CVS Compl. ¶¶ 32-34.)
B. Generics and the Hatch-Waxman Act Regulatory Framework
The public relies on pharmaceutical companies to develop and bring to market the medical advances that keep us healthy. For this reason, our patent laws afford substantial protection to firms whose innovation leads to the development of new and beneficial medications. Typically, a company that has developed a beneficial and successful medication will enjoy a period of time during which it can sell it exclusively and at a supracompetitive price, thereby recovering its development costs and turning a profit. This period of exclusivity is considered to be an essential incentive for further healthcare and biopharmaceutical research and innovation. See Wendy H. Schacht and John R. Thomas, Cong. Research Serv., RL30756, Patent Law and Its Application to the Pharmaceutical Industry: An Examination of the Drug Price Competition and Patent Term Restoration Act of 1984 (“The Hatch-Waxman Act”) 2-6 (2000).
Once the period of exclusivity expires, however, generic competitors enter the market, severely undercutting the manufacturer’s pricing scheme and eliminating most of the innovator’s profits. (EPP Compl. ¶ 66.) For example, where there is a single generic competitor, the generic tends to be priced approximately 10% lower than the brand name counterpart. (DPP Compl. ¶ 56.) And, where there are multiple generic alternatives, the price of the generics typically falls to 50% to 80% below the brand name product, driving the price close to the marginal cost of production. (Id. ¶¶ 56, 70.) It is no mystery then why a brand and first-filing generic may be motivated to conspire to keep the brand’s monopoly going, splitting the higher profits amongst themselves. (See id. ¶ 74 .)
Because every state has passed a law to either require or permit pharmacies to substitute AB-rated generics for brand name drugs (unless the prescribing doctor orders otherwise), generally within a year of generic market entry, generics will capture 90% of sales and prices will fall by as much as 85%. (DPP Compl. ¶57.) Not surprisingly, then, brand manufacturers view generic competition as a serious threat to profits. (Id.) If there is no generic on the market, the pharmacy must fill the prescription with the branded drug, and supracompetitive pricing may continue. (See id. ¶ 59 .)
*317 The Drug Price Competition and Patent Term Restoration Act of 1984 (more commonly known as the “Hatch-Waxman Act”), Pub. L. No. 98-417, 98 Stat. 1585 (1984), as amended, prescribes the process by which pharmaceutical firms may gain approval from the FDA to. bring medications to market. There are four key features to the Hatch-Waxman Act’s architecture.
First, a drug manufacturer that wishes to market a new product must submit a New Drug Application (“NDA”) to the FDA and undergo a rigorous approval process. See Hatch-Waxman Act, 21 U.S.C. § 355 (b)(1)(A) (requiring, inter alia, that the manufacturer provide “full reports of investigations which have been made to show whether or not such drug is safe for use and whether such, drug is effective in use”). By all accounts, this approval process is arduous and expensive. But, once the FDA has approved an NDA, the manufacturer is entitled to list the drug in the FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations” (also known as the “Orange Book”). (DPP Compl. ¶ 38.) The Orange Book entry provides a measure of protection for the manufacturer by allowing it to list any patents that the manufacturer believes could be asserted against generic competitors. (Id.)
Second, the Hatch-Waxman Act recognized that if manufacturers who have gained FDA approval were allowed to charge supracompetitive prices indefinitely, it would harm consumers. Therefore, the Act creates a mechanism to promote the availability of cheaper generic alternatives by allowing generic manufacturers to bypass many of the onerous aspects of the NDA process. Instead of filing an NDA, a generic manufacturer may instead file an Abbreviated NDA (“ANDA”). See 21 U.S.C. § 355 (j). An ANDA incorporates the findings of safety and effectiveness of the previously-approved NDA, and generally assures that the proposed generic contains the same active ingredients and is otherwise as equally safe and effective as the brand name counterpart. See id. at § 355(j)(2). Thus, the ANDA process allows a generic manufacturer to obtain approval while avoiding the “costly and time-consuming studies” needed to obtain approval for a “pioneer drug.” Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 676 , 110 S.Ct. 2683 , 110 L.Ed.2d 605 (1990), The FDA assigns a rating of “AB” when it determines a generic drug is therapeutically equivalent to its brand-name counterpart. (Walgreen Compl. ¶ 48.) To be therapeutically equivalent, the ANDA must demonstrate that the generic drug is both pharmaceutically equivalent and bioequiva-lent, or in other words, that it “contains the same active ingredient(s), dosage form, route of administration, and strength as the brand drug, and is absorbed at the same rate and to the same extent as the brand drug .... ” (Id.)
Third, the Hatch-Waxman Act sets forth procedures for resolving patent disputes between brand and generic manufacturers. A generic manufacturer filing an ANDA must certify to the FDA that the proposed generic does not infringe any patents listed in the Orange Book. See 21 U.S.C. § 355 (J)(2)(A)(vii). This certification can be made in one of several ways. The generic manufacturer may represent that: (1) the brand manufacturer has not filed any relevant patents; (2) any relevant patents have expired; or (3) a relevant patent is soon to expire and the generic will not be marketed until after the expiration. Id. at §§ 355(j)(2)(A)(vii)(I)-(III). Alternatively, the generic manufacturer may represent that the patent covering' the brand drug is invalid or will not be infringed by the proposed generic (a so-called “Paragraph IV certification”). Id at § 355(j)(2)(A)(vii)(IV).
*318 An ANDA filer who relies on a Paragraph IV certification will almost certainly be sued for patent infringement by the brand manufacturer. Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S. 399, 407 , 132 S.Ct. 1670 , 182 L.Ed.2d 678 (2012) (“Filing a paragraph IV certification means provoking litigation.”). Indeed, if the brand manufacturer brings an infringement suit within 45 days of the generic manufacturer’s filing of the ANDA, the Hatch-Waxman Act provides that the FDA must withhold approval of the generic for a 30-month period during which the parties may litigate the validity of the underlying patent. 21 U.S.C. § 355 (j)(5)(B)(iii).
Finally, in order to incentivize generic manufacturers that incur the costs and risks stemming from Paragraph IV certification litigation, and to encourage generic competition, the Hatch-Waxman Act affords the first successful Paragraph IV ANDA filer a 180-day post-approval exclusivity period during which that manufacturer is the only authorized generic seller. 10 Id at § 355(j)(5)(B)(iv). Because the price of ,a drug drops precipitously as more and more generics enter the market, this initial period of exclusivity can generate substantial profits for the first generic manufacturer. ¿. Scott Hemphill, Paying for Delay: Pharmaceutical, Patent Settlement as a Regulatory Design Problem, 81 N.Y.U. L. Rev. 1553 , 1579 (2006) (describing first-filed ANDA status as “worth several hundred million dollars to a generic firm that successfully challenges the patents bn a major drug”).
. C. Loestrin 24 and the ‘394 Patent
The active ingredients in Loestrin 24, norethindrone acetate and ethinyl estra-diol, were approved by the FDA as a means of oral contraception in 1973 under the brand names Loestrin 1.5/30 and Loestrin 1/20. 11 (DPP Compl. ¶¶ 1,100-01.) Loestrin 1.5/30 and Loestrin 1/20 were generally marketed for use over a 21-day period; women would take the oral contraceptive for 21 consecutive days, followed by a placebo pill containing iron for the following 7 days, before starting the next cycle. (See id. ¶ 102 .) Two additional Loestrin products (viz., Loestrin 21 1.5/30 and Loestrin 21 1/20) were approved by the FDA in 1976; they contained only 21 active tablets of the same composition of Loestrin 1.5/30 and Loestrin 1/20, respectively, and omitted the 7 placebo pills. (Id. ¶¶ 104-060-
On July 22, 1994, a professor at the Eastern Virginia Medical School (“EVMS”), Dr. Gary Hodgen,
applied for a patent for a method of female contraception characterized by a reduced incidence of breakthrough bleeding by administering a combination of estrogen and progestin for 23-25 consecutive days of a 28-day cycle in which the daily amounts of estrogen and pro-gestin are equivalent to about 5-35 meg of ethinyl estradiol and about 0.025 to 10 mg of norethindrone acetate.
(Id. ¶ 117 (emphasis omitted).) Dr. Hodgen assigned the patent application to EVMS. (Id.) Occasional intermenstrual bleeding, also referred to as “breakthrough bleed *319 ing” or “spotting,” is vaginal bleeding that occurs mid-cycle, as opposed to during menstruation, and can be a common occurrence associated with many oral contraceptives. (Id. ¶ 119.)
Dr. Hodgen, in support of his application, submitted data, from a 1992 study conducted with ten monkeys. (Id. ¶¶ 122, 124.) In that study, scientists from EVMS administered Loestrin 1/20 active tablets (ground up and adjusted to account for lower body weight) to monkeys and ostensibly found that the monkeys had a decrease in the incidence of breakthrough bleeding when they received active ingredient tablets for 24 days, rather than 21 days. (Id. ¶¶ 124-25.)
According to Plaintiffs’ allegations, “[beginning on or around January 1993” scientists at EVMS conducted a human study in which two groups comprising fifteen women each followed one of two low dose oral contraceptive regimens for three months. (See, e.g., id. ¶¶ 127 , .129.) The first group received a regimen of 25 days of Loestrin 1/20 tablets followed by 3 placebo tablets; the second group followed a monthly regimen of 21 Loestrin 1/20 tablets followed by 7 placebo tablets. (Id. ¶ 129.) The study participants in the first group knew they were following a regimen of 25 days of Loestrin 1/20 tablets followed by 3 placebo tablets; participants were not required to keep the study design or methods confidential. (Id. ¶ 130.) The scientists found no significant differences between the two groups in the women’s incidence of breakthrough bleeding. (Id. ¶ 132.) The study was published in the Journal of the Society for Gynecologic Investigation in March 1996. (Id. ¶ 133.) .
Dr. Hodgen submitted an application to the Patent and Trademark Office (“PTO”) in July 1994. 12 , (Walgreen Compl. ¶ 3.) Within the application, he included “minimal data” from the monkey study, and did not disclose .the results of the human study to the PTO. (DPP, Compl. ¶¶ 122, 126.) According to Plaintiffs’ Complaints, “the patent examiner focused on two issues: [ (1) ] the amount of ethinyl estradiol and norethindrone acetate in oral contraceptives disclosed in the prior art; and [(2)] whether the invention decreased breakthrough bleeding.” (See, e,g., id. ¶ 135 .) With respect to the first issue, the examiner noted that a prior art reference (namely, the Craft reference) disclosed a contraceptive regimen of 50 meg of ethinyl estradiol and 3 mg of norethindrone acetate. (Id. ¶ 136.) The examiner further noted that a second prior art reference, EPO 253,607, also known as the “Upton reference,” disclosed a contraceptive regimen of administering 15 meg ethinyl estradiol with progestin each day, with a 24-day dosing regimen. (Id.) With this information, the patent examiner made an initial determination that the Craft and Upton ■references rendered all claims obvious. (Id.) The applicants responded, in pertinent part, as follows:
[T]he claimed regimen leaves the patient with a total estrogen exposure per an-num which is well below the total annual dose of estrogen in all other combination formulations commercially available in this country. Those all contain at least 30 meg EE (Craft uses 50 meg) and a regimen of 21 dosing day plus a 7-day pill free interval.... In contrast to Craft, the present invention employs a *320 lower estrogen dosage which does not participate in this contraceptive efficacy but instead controls unscheduled bleeding.
(Id. ¶ 137 (alteration and emphasis in original).) The applicants did not disclose that Loestrin 1/20 contains 20 meg of ethinyl estradiol and that it had been publicly available since the 1970s. (Id.)
With respect to the second issue, in response to the applicants’ rejoinder, the patent examiner addressed whether the invention reduced breakthrough bleeding. (Id. ¶ 138.) The examiner again rejected the claims because the amount of ethinyl estradiol disclosed in the claims (35 meg) was similar to that taught by the Craft reference (50 meg) and the applicants had not shown “that a dosage regimen different by only 15 meg less of estrogen has unexpected contraceptive and reduced breakthrough bleeding results.” (Id. (emphasis omitted).)
The EPPs allege in their Complaint that two U.S Patents and one publication teach of doses of ethinyl estradiol that “fall within the claimed ranges and weight rations of the ’394 patent,” as well as European Patent No. 253,607, which discloses a 24-day dosing regimen. (See EPP Compl. ¶¶ 132, 134 (citing the WO 93/17686 publication, U.S. Patent No. 5,108,995, and U.S. Patent No. 4,826,831 ).) They also allege that the prior art was such that “[o]ne of ordinary skill would thus have expected that administering a combination of estrogen and progestin for 23-25 days, or specifically 24 days, would be safe and effective.” (Id. ¶ 136; see also id. ¶¶ 131-42 .)
On February 5,1996, the patent examiner issued a Notice of Allowability for all claims. The patent issued in September 1996. (DPP Compl. ¶ 134.) The resulting patent, the ’394 patent, is titled “Low Dose Oral Contraceptives with Less Breakthrough Bleeding and Sustained Efficacy.” (Id. ¶ 118.) As mentioned, Loestrin 24 has 24 tablets containing 1 mg of norethin-drone acetate and 20 meg of ethinyl estradiol, as well as 4 placebo tablets containing iron. (Id ¶ 109.) Thus the active tablets mimic Loestrin 1/20 and Loestrin 21. Warner Chilcott owned the ’394 patent from 2003, when its predecessor acquired it, through Watson’s generic entry in July 2014. 13 (EPP Compl. ¶¶ 155,172.)
In April 2005, Warner Chilcott submitted an NDA and, in February 2006, received FDA approval to market the dosing regimen that would become Loestrin 24. (DPP Compl. ¶ 108.) At approximately the same time, Warner Chilcott listed Loestrin 24 in the Orange Book. (See id. ¶¶ 113-16 .) According to the DPPs, “[bjefore listing the ’394 patent, Warner Chilcott knew that it was invalid and/or unenforceable.” (Id ¶ 116.) Warner Chilcott earned over $1.75 billion in revenue between 2006 and 2012 from sales of branded Loestrin 24, and its sales were approximately $247 million annually in 2009. (Id. ¶ 112; CVS Compl. ¶ 126.)
D. Watson Challenges the ‘394 Patent
In June 2006, just several months after Warner Chilcott’s NDA was approved, Watson notified Warner Chilcott that it had filed an ANDA to market a generic version of Loestrin 24 based on a Paragraph IV certification that the generic would not infringe the ’394 patent. 14 (DPP *321 Compl. ¶¶ 168, 171.) Not unpredictably, Warner Chilcott responded by filing suit against Watson. 15 (Id ¶ 172.) By doing so, Warner Chilcott triggered the 30-month stay provision of the Hatch-Waxman Act, preventing the FDA from approving Watson’s ANDA for at least 30 months. (See id. ¶ 172 .)
In January 2009, at approximately the same time that the 30-month stay would have expired (that would have allowed the FDA to move forward on Watson’s ANDA), and before the parties briefed the substantive issues in the case, the parties filed a dismissal stipulation and entered into a settlement agreement (the “Watson Agreement”). (Id. ¶¶ 183-84, 187.) Pursuant to the Watson Agreement, Watson agreed to delay the launch of a Loestrin 24 generic until the earliest of: (1) January 2014, approximately six months prior to the expiration of the ’394 patent; (2) “180 days before a date on which Warner Chil-cott grants rights to a third party to market a generic version of Loestrin 24 in the United States”; or (3) “the date on which another generic version of Loestrin 24 enters the market.” (Id ¶ 188.) In exchange for this, Warner Chilcott and Watson entered into a series of deals that, in the DPPs’ calculation, were worth at least $66 million. (Id ¶¶ 9, 189-218.) Specifically, the Watson Agreement provided that Warner Chilcott (1) would not launch an authorized generic Loestrin 24 within Watson’s first 180 days on the market, 16 which the DPPs estimate to be worth at least $41.34 million to Watson; 17 (2) would not grant a license to any other generics for at least the first six months Watson had entered the market; 18 (3) agreed to pay Watson annual fees and a percentage of net sales in connection with the co-promotion of a separate Warner Chilcott drug called Femring, a deal valued by the DPPs to be worth about $25 million to Watson; 19 and (4) would give Watson the exclusive right to market and sell a separate Warner Chilcott oral contraceptive known as Generess Fe, memorialized in a patent license and finished product supply agreements, in exchange for Warner Chilcott receiving 15% of net sales until the launch of a generic Gener-ess product or if Watson exercised a buyout right; this was valued by the DPPs to be worth tens of millions to Watson. (DPP *322 Compl. ¶¶ 9, 206, 210-11.) The EPPs value the sum of -these deals as worth at least $216.67 million to Watson; the DPPs value it as worth tens or hundreds of millions to Watson; and the Retailers value the sum of the deals at approximately $266 million to Watson. (EPP Compl. ¶ 4; DPP Compl. ¶¶ 9, 192, 199; CVS Compl. ¶¶124, 131-32.) Plaintiffs allege that these “side deals”, occurred contemporaneously with the settlement of the ’394 patent infringement suit. (See, e.g., DPP Compl. ¶ 206.)
Plaintiffs allege that Warner Chilcott entered into agreements, or “reverse payments,” as a quid pro quo for-Watson’s agreement to abandon its invalidity, unen-foreeability, and infringement claims, as well as Watson’s agreement to delay generic competition to Loestrin 24. (DPP Compl. ¶¶ 189, 191.) They further allege that Watson could not have obtained these payments if it had prevailed in the patent infringement suit against Warner Chilcott. (Id. ¶190.) Plaintiffs plead that litigation costs for similar patent infringement suits cost approximately $6 to $10 million, from complaint to verdict. (Id. ¶¶ 192,199 (citing American Intellectual Property Lawyers Association, 2013 Report of the Economic Survey 34 (2013)); EPP Compl. ¶197 (‘Warner Chilcott’s future expected litigation costs at the time of the settlement with Watson were much less than that because, among other reasons, the patent case had been pending for years.”).)
The DPPs point to a 2002 FTC report suggesting that generic manufacturers won 73% of the Hatch-Waxman patent litigation suits decided on the merits from 1992 to 2002. (DPP Compl. ¶49 (citing FTC, Generic Drug Entry Prior to Patent Expiration: An FTC Study, at vi-vii (July 2002)); John R. Allison, Mark A. Lemley & David L. Schwartz, Understanding the Realities of Modern Patent Litigation, 92 Tex. L. Rev. 1769 , 1787 (2014) (noting that generic challengers prevailed in 74%. of patent infringement suits filed in 2008 and 2009 and decided on the merits).)
E. Lupin Challenges the ‘394 Patent
Six months after Warner Chilcott and Watson announced the Watson Agreement, in June 2009, Lupin notified Warner Chilcott that it too had filed an ANDA seeking to market a generic alternative to Loestrin 24. (DPP Compl. ¶220.) Like Watson, Lupin based its ANDA on a Paragraph IV certification that Lupin’s generic would not infringe the ’394 patent. (Id.) And, as before, Warner Chilcott responded by filing suit. 20 (Id. ¶ 221 & h.44.) Again, merely by filing suit, Warner Chilcott triggered a 30-month stay of the Lupin generic under the Hatch-Waxman Act. (See id. ¶ 222 .)
In October 2010, Warner Chilcott dismissed the suit, and Warner and Lupin entered into an agreement (the “Lupin Agreement”). (Id. ¶ 225.) Pursuant to that agreement, Lupin agreed not to market its Loestrin 24 generic Until July 2014, the same month the ’394 patent was to expire and six months after Watson had been authorized to market its generic. (Id. ¶ 226.)
Like Watson, Lupin is alleged to have benefitted from its agreement to delay the introduction of its generic. First, Warner Chilcott granted Lupin a license to market Femcon Fe, a separate oral contraceptive manufactured by Warner Chilcott, beginning on the earlier of 180 days after Teva Pharmaceutical Industries, Ltd (the first filer) entered the market with a generic equivalent, or January 1, 2013. (EPP Compl. ¶214.) The EPPs value this at approximately $15 -million to Lupin. (Id, ¶5⅛).) Plaintiffs allege that, but for this agreement, Lupin would "not have been *323 able to enter the market until, at a minimum, January 31, 2012, at the end of the 80-month stay. (See, e.g., EPP Compl. ¶ 214.) Second, Lupin was given the right to sell a generic version of Asacol 400, an anti-inflammatory drug to be supplied by Warner Chilcott, if a generic version of Asacol 400 was launched by another generic manufacturer in the United States. (DPP Compl. ¶ 228.) The EPPs value this deal as being worth at least $50 million to Lupin. (EPP Compl. ¶ 5(b).) Third, Warner Chilcott agreed to pay $2 million in attorneys* fees to Lupin. (DPP Compl. ¶ 229.) 21
The EPPs and the Retailer Plaintiffs challenge the Lupin Agreement as a reverse payment. (See, e.g., EPP Compl. ¶¶ 355-63; Walgreen Compl. ¶¶ 146-47.) The DPPs do not.
F. Mylan Challenges the ’394 Patent
In April 2011, six months after the Lu-pin Agreement was announced, Mylan Pharmaceuticals Inc. (“Mylan”), together with Famy Care Ltd., notified Warner Chilcott that Mylan and Famy Care Ltd. had filed an ANDA for a generic Loestrin 24 and included in its notice letter a Paragraph IV certification. (DPP Compl. ¶ 233; EPP Compl. ¶ 227.) In June 2011, Warner Chilcott filed suit against Mylan alleging infringement of the ’394 patent. (DPP Compl. ¶ 234 & n.45; EPP Compl. ¶228.) The 30-month stay was triggered, and the case proceeded through claim construction. (DPP Compl. ¶¶ 235-36.) While this suit was pending, the Federal Circuit ruled in a similar patent suit that the patent covering another low-dose, extended-regimen oral contraceptive was invalid for obviousness. (EPP Compl. ¶¶ 234-36.) Warner Chilcott and Mylan entered into a settlement agreement and dismissed the case just weeks before it was scheduled for trial. (DPP Compl. ¶ 239.) Mylan agreed to dismiss its suit challenging the ’394 patent, and delay entry of its generic version of Loestrin 24 until July 22, 2014—the month the ’394 patent was set to expire. (EPP Compl. ¶ 241.)
G. Warner Chilcott Introduces Minastrin 24
Before generic Loestrin 24 could enter the market, Warner Chilcott created a second, similar product. According to Plaintiffs, this second product had no safety, efficacy, or other benefit of any sort for consumers, and it was formulated as a step in the broader anticompetitive scheme. (See, e.g., EPP Compl. ¶¶ 244-45.) In July 2012, Warner Chilcott submitted an NDA for a second oral contraceptive comprised of 24 norethindrone acetate/ethinyl estra-diol (1 mg/20 meg) tablets arid four ferrous fumarate tablets; this drug was later marketed under the brand name Minastrin 24. (DPP Compl. ¶ 252.) Minastrin 24 was different from Loestrin 24 in two ways: Warner Chilcott added spearmint and a sweetener to the inactive pills (there was no change to the active pills), and its proposed labeling instructed women to chew the pill before swallowing. (Id. ¶253.) In essence, the only differences between the active pills in Loestrin 24 and Minastrin 24 were their method of use (chew vs. swallow) and markings. (Id. ¶¶ 255-56 (quoting the FDA as stating that, “[t]he NA and EE tablets *324 of the proposed product [Minastrin 24] have the same components, composition, doses, and dosing regimen as the NA and EE tablets of Loestrin 24 Fe[ ]”); see also EPP Compl. ¶250 (quoting the FDA as stating “vvith the exception of tablet de-bossing and insignificant manufacturing changes, the proposed drug product [Mi-nastrin 24] is identical to approved Loestrin 24 Fe[ ]”) (internal citation omitted).) The inactive pills solely serve as reminder pills, there is no medical reason to take the pills, and they may be discarded. (DPP Compl. ¶ 254; EPP Compl. ¶248.)
The FDA approved, the Minastrin 24 NDA in May 2013. (DPP Compl. ¶252.) Minastrin 24 and Loestrin 24 are not AB-rated and, therefore, pharmacies cannot substitute Minastrin 24 for generic Loestrin 24. (Id. ¶ 268.) Warner Chilcott launched Minastrin 24 in July 2013, sending its sales force out to “aggressively switch” Loestrin 24 prescriptions to those for Minastrin 24. (Id. ¶¶ 266, 273.) It stopped promoting Loestrin 24 and promoted Minastrin 24 instead. (Id. ¶273.)
In August 2013, Warner Chilcott withdrew branded Loestrin 24 from the market. (Id. ¶ 267.) The DPPs’ Complaint states that ‘Warner Chilcott did not remove existing Loestrin 24 supplies from the market but instead ceased manufacturing and distributing Loestrin 24.” (Id.) In June 2014, after receiving new three-year marketing exclusivity, Warner Chilcott changed the Minastrin 24 labeling to state that women could either chew or swallow the pills. (Id. ¶¶ 270, 282.)
Plaintiffs allege that Warner Chilcott’s sole motivation in this alleged “product hop” was to impair generic competition. (Id. ¶¶ 277, 280.) But for its impairing genetic competition, it would have been a money-losing endeavor for Warner Chil-cott. (EPP Compl. ¶ 270; DPP Compl. ¶280.) Plaintiffs claim that the Minastrin 24 product hop involved extra costs (developing, patenting, gaining FDA approval of, and marketing Minastrin 24) and lost revenue (from branded sales of Loestrin 24), at least in the short run, for Warner Chilcott. (DPP Compl. ¶¶ 278-80.) Warner Chilcott’s motivation is further revealed by its withdrawal of the request for FDA approval for Minastrin 24 on two occasions,' at least once for “business reasons,” that corresponded with settlement negotiations with Watson and Lupin. (EPP Compl. ¶¶ 273-75.)
The Complaints allege that “Warner Chilcott successfully converted virtually all of Loestrin 24 prescriptions to Minastrin 24 before Watson’s geneiic entered in January 2014.” (DPP Compl. ¶ 288.)
H. Harm to Consumers
According to Plaintiffs, the net effect of the alleged anticompetitive scheme, from the ’394 patent application to the Minastrin 24 product hop, was to delay generic competition until at least January 2014. (See, e.g., EPP Compl. ¶¶ 281-85; DPP Compl. ¶ 288.) Absent these various efforts, Plaintiffs allege, Loestrin 24 would have' faced generic competition as early as September 2009, when the FDA approved Watson’s ANDA. (DPP Compl. ¶¶ 15, 325.) At that time, Warner Chilcott would have lost its monopoly—other generic versions of Loestrin 24, including an authorized generic would have entered the market—and consumers would have paid less for oral contraceptives comprising 24 norethin-drone acetate/ethinyl estradiol (1 mg/20 meg) and four ferrous fumarate tablets by:
(i) substituting purchases of less-expensive AB-rated generic Loestrin 24 for their purchases of more-expensive branded Loestrin 24; (ii) receiving discounts on their remaining branded Loestrin 24 purchases; (iii) purchasing generic Loestrin 24 at lower prices sooner; and (iv) purchasing less expensive *325 generic Loestrin 24 instead of more expensive branded Minastrin 24.
(DPP Compl. ¶¶ 325, 328, 331.) As a result, Plaintiffs were injured by paying overcharges for the oral contraceptive. (Id. II15.)
Plaintiffs argue that Defendants’ scheme and unlawful payments harmed Plaintiffs by allowing Defendants to:
(a) delay the entry of less expensive generic versions of Loestrin 24 in the United States; (b) fix, raise, maintain or stabilize the price of Loestrin 24; and (c) allocate 100% of the U.S. market for Loestrin 24 and its generic equivalents to Warner Chilcott.
(Walgreen Compl. ¶ 163.)
I. Claims for Relief
The DPPs bring claims against Defendant Warner Chilcott for violating § 1 of the Sherman Antitrust Act (the “Sherman Act”), 15 U.S.C. § 1 , by entering into the Watson Agreement, and § 2 of the Sherman Act for engaging in an exclusionary, anticompetitive scheme designed to create and maintain a monopoly in the market for Loestrin 24 drugs. (DPP Compl. ¶¶ 346, 353-55.) Under this latter claim, Plaintiffs attack Warner Chilcott’s listing of the drug in the Orange Book; filing a “sham” lawsuit against generic manufacturers of Loestrin 24; the reverse payment to Watson; reformulating Loestrin 24 into Mi-nastrin 24; aggressively switching sales from Loestrin 24 to Minastrin 24; and removing Loestrin 24 from the market months before expected generic entry. (Id. ¶ 346.)
The EPPs bring seven claims sounding in state antitrust law, state consumer protection l&w, and unjust enrichment against Warner Chilcott, Watson, and Lupin. More specifically, the EPPs allege: (1) a monopolization and monopolistic scheme under state law, or state antitrust claims under state law (EPP Compl. ¶¶ 338-52); (2) conspiracy and combination in restraint of trade under state law against Warner Chilcott and Watson (id. ¶¶ 346-54); (3) conspiracy and combination in restraint of trade under state law against Warner Chilcott and Lupin (id. ¶¶ 355-63); (4) conspiracy and combination in restraint of trade under state law against all Defendants (id. ¶¶ 364-73); (5) unfair or unconscionable acts and practices under state law against all Defendants (id. ¶¶ 374-79); (6) unjust enrichment against all Defendants (id. ¶¶ 380-91); and (7) grounds for declaratory and injunctive relief pnder federal law against Warner Chilcott (id. ¶¶ 392-97).
The Walgreen and CVS Plaintiffs, separately, bring claims against Warner Chil-cott for violating § 2 of the Sherman Act by monopolization and attempt to monopolize (Walgreen Compl. ¶¶ 197-208; CVS Compl. ¶¶ 195-206); against Warner Chilcott and Watson, as well as Warner Chilcott and Lupin, for violating § 1 of the Sherman Act by conspiring to restrain trade through the reverse payments (Walgreen Compl. ¶¶ 209-24; CVS Compl. ¶¶ 207-22); and against all Defendants for conspiring to restrain trade in violation of § 1 of the Sherman Act (Walgreen Compl. ¶ 225-29; CVS Compl. ¶¶ 223-27).
II. Legal Standard
“To survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’ ” 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, 570 , 127 S.Ct. 1955 , 167 L.Ed.2d 929 (2007)). “[N]aked assertion[s],” “[t]hreadbare recitals of the elements of a cause of action,” and “mere eonclusory statements” are insufficient to survive dismissal. Id. (internal citations omitted). That being said, “the pleadings need not contain ‘detailed factual allegations’ but must provide ‘more than *326 labels and conclusions, and a formulaic recitation of the elements of the cause of action will not do.’ ” Loestrin 24, 814 F.3d at 549 (quoting Twombly, 550 U.S. at 555 , 127 S.Ct. 1955 ). As the First Circuit has stated in this very case,
it -is important to note that Twombly addressed the specific question of “what a plaintiff must plead in order to state a claim under § 1 of the Sherman Act,” and [the First Circuit] has cautioned against converting Twombly* s mandates into a requirement that antitrust plaintiffs provide evidentiary support or set forth other “plus factors” to demonstrate the plausibility of their Sherman Act claims[.]
Id. at 649 (internal citations omitted). Plaintiffs must plead facts sufficient, “to raise a reasonable expectation that discovery will reveal evidence” of the Sherman Act violations. Twombly, 550 U.S. at 556 , 127 S.Ct. 1955 .
III. Discussion
A. Market Power
Defendants argue that Plaintiffs have failed to plausibly allege that Warner Chilcott exercised market power in a relevant economic market, taking particular aim at Plaintiffs’ narrowly defined market comprising only Loestrin 24, Minastrin 24, and their AB-rated generic equivalents. (See Warner Chilcott & Watson Defs.* Omnibus Mem. Supporting Dismissal of all Claims in all Pls.’ Compls. (“Warner Chilcott Mot. to Dismiss”) 3-5, ECF No. 198.) Defendants argue that the relevant market is properly defined as the wider oral contraceptive market—which they characterize as a “fragmented and highly competitive” market. (See id. at 10.) In this broader market, they contend Loestrin 24 did .pot enjoy sufficient market power to exercise a monopoly. But Defendants concede, as they must, that courts generally treat this fact-intensive issue as one to be decided on a motion for summary judgment (if no genuine issue of material fact exists) or at trial. (See Warner Chilcott & Watson Defs.’ Omnibus Reply Mem. (“Warner Chilcott Reply”) 8 & n.6, ECF No. 212 (citing, for example, In re Nexium (Esomeprazole) Antitrust Litig., 968 F.Supp.2d 367, 389 (D. Mass. 2013) (Nexium I); Andrx Pharm., Inc, v. Elan Corp., 421 F.3d 1227, 1235 (11th Cir. 2005)).)
To state a claim for relief under § 1 of the Sherman Act, a plaintiff must plead sufficient facts to demonstrate that “the defendant had market power, in the relevant market, and the specific intent to restrain competition.” CVD, Inc, v. Raytheon Co., 769 F.2d 842, 851 (1st Cir. 1985). Under § 2 of the Sherman Act, similarly, a plaintiff must demonstrate that “the defendant had the specific intent to monopolize the relevant market, and a dangerous probability of success.” Id.
Market power, sometimes called monopoly power, “is the abilities (1) to price substantially above the competitive level and. (2) to persist in doing so for a significant period without erosion by new entry or expansion.” In re Aggrenox Antitrust Litig., 199 F.Supp.3d 662, 665 (D. Conn. 2016) (“Aggrenox II”) (quoting IIB Areeda & Hovenkamp, Antitrust Law, ¶501, at 111 (3rd ed. 2007) (emphasis in original)). 22 A plaintiff may demonstrate *327 market power in two ways: “[a] plaintiff can either show direct evidence of market power (perhaps by showing actual supra-competitive prices and restricted output) or circumstantial evidence of market pow-er Coastal Fuels Inc. v. Caribbean Petroleum Corp., 79 F.3d 182, 196-97 (1st Cir. 1996) (citing Rebel Oil Co., Inc. v. Atlantic Richfield Co., 51 F.3d 1421, 1434 (9th Cir. 1995)); see also In re Aggrenox Antitrust Litigation, 94 F.Supp.3d 224, 246 (D. Conn. 2015) (“Aggrenox I”) (“[W]hen direct evidence is available that a party profitably charges supracompetitive prices, the existence of market power can be established from that fact alone.” (citing Tops Markets, Inc. v. Quality Markets, Inc., 142 F.3d 90, 97-98 (2d Cir. 1998))); accord Actavis, 133 S.Ct. at 2236-37 (“[T]he size of the [reverse] payment from a branded drug manufacturer to prospective generic is itself a strong indicator of power ....” If a large reverse payment is demonstrated it “may well” suggest “market power derived from the patent.”) (quotation and citation omitted).
A “relevant market” is properly defined as consisting of “commodities reasonably interchangeable by consumers for the same purposes.” Nexium I, 968 F.Supp.2d at 395 (quotation omitted); see also Brown Shoe Co. v. United States, 370 U.S. 294, 325 , 82 S.Ct. 1502 , 8 L.Ed.2d 510 (1962) (“The outer boundaries of a product market are determined by the reasonable interchangeability of use or the cross-elasticity of demand between the product itself and substitutes for it.”). Products are not reasonably interchangeable merely because they share similar forms or functions, but rather “[s]uch limits are drawn according to the cross-elasticity of demand for the product in question—the extent to which purchasers will accept substitute products in instances of price fluctuation and other changes.” Nexium I, 968 F.Supp.2d at 387 -88 (quoting George R. Whitten, Jr., Inc. v. Paddock Pool Builders, Inc., 508 F.2d 547, 552 (1st Cir. 1974)).
There is no strict prohibition on defining a relevant market as a single-drug market. See, e.g., Eastman Kodak Co. v. Image Tech. Servs., Inc., 504 U.S. 451, 482 , 112 S.Ct. 2072 , 119 L.Ed.2d 265 (1992) (“This Court’s prior cases support the proposition that in some instances one brand of a product can constitute a separate market.”); Geneva Pharms. Tech. Corp. v. Barr Labs., Inc., 386 F.3d 485 , 496-500 (2d Cir. 2004) (defining the relevant market as the generic versions of a particular drug, excluding the branded version of the drug); In re Terazosin Hydrochloride Antitrust Litig., 352 F.Supp.2d 1279 , 1319 n.40 (S.D. Fla. 2005) (defining a relevant market as a branded drug and its generic counterpart); In re Cardizem CD Antitrust Litig., 105 F.Supp.2d 618, 680-81 (E.D. Mich. 2000), aff'd, 332 F.3d 896 (6th Cir. 2003) (holding a branded drug and its generic version to be a plausible relevant market); Nexium I, 968 F.Supp.2d at 388 (holding a single branded drag and its generic to be a plausible relevant market).
In the instant case, Plaintiffs’ Complaints allege the following. Warner Chilcott had monopoly power in the relevant market and, at relevant times, enjoyed a market share of 100%. (DPP Compl. ¶¶ 300, 309.) Plaintiffs define the relevant market as oral contraceptives with 24 active tablets containing 1 mg norethindrone acetate and 20 meg ethinyl estradiol and *328 four inactive iron tablets. As defined, this market comprises Loestrin 24, Loestrin 24’s AB-rated generic equivalents, Minastrin 24, and Minastrin 24’s AB-rated generic equivalents (collectively, the “Loestrin 24 drugs”), as well as narrower markets therein. (Id. ¶¶ 300-01.)
In support of their allegation that Warner Chilcott had market power sufficient to exclude competitors and control prices of Loestrin 24 drugs, Plaintiffs rely on direct evidence of market power. They allege that direct evidence shows that:
(i) generic versions of each [of the Loestrin 24 drugs] would have entered the market at substantial discounts to the brand versions but for the defendants’ anticompetitive conduct; (ii) the gross margin on each drug was at all times at least 60%; and (iii) the defendants never lowered the price of the drugs to the competitive level in response to the pricing of other branded or generic drugs.
(Id. ¶302.) According to Plaintiffs, this resulted in Warner Chilcott selling branded Loestrin 24 drugs in excess of marginal costs and in excess of the competitive prices, thereby allowing them to enjoy high profit margins. (Id. ¶ 306.) Plaintiffs further allege that, “[a]t competitive prices, Loestrin 24 drugs do not exhibit significant, positive, cross-elasticity of demand with respect to price with any other oral contraceptive other than AB-rated generic versions of those Loestrin 24 drugs.” (Id. ¶304.) Plaintiffs say that only the entry of AB-rated generic Loest-rin 24 drugs would have undercut Warner Chilcott’s ability to maintain supra-competitive prices for Loestrin 24 drugs. (Id. ¶ 305.) This market had high barriers to entry due to patent protection; the high cost of entry and expansion; the cost of marketing and physician detailing; and AB-rated generic substitution laws. (Id. ¶ 308.) Loestrin 24 and Minastrin 24 are not reasonably interchangeable with other drugs, according to Plaintiffs, other than their AB-rated generic versions, due to “attributes [that] significantly differen-tiat[e] them from other oral contraceptives and mak[e] them unique as against other oral contraceptives”; indeed, according to Plaintiffs, “[t]he FDA does not consider Loestrin 24 drugs and other oral contraceptives interchangeable,” in light of variations in their active ingredients and dosages. (Id. ¶310.) Moreover, oral contraceptives differ in their efficacy, safety, and side effect profiles. These differences drive a doctor’s recommendation, as well as a woman’s decision, to continue taking a particular oral contraceptive. (Id. ¶ 312.)
While there are many oral contraceptives on the market, this is not a typical market because the consumer generally neither fully chooses nor pays for the product. In the typical case, a doctor chooses the oral contraceptive her patient will buy and the patient’s insurer pays for it. (See id. ¶ 313.) As a result, the pharmaceutical marketplace exhibits a disconnect between the product selection and the payment obligation, with the consequence that price does not drive prescriptions for oral contraceptives, as it would in most other markets. (Id. ¶313.) Even though other oral contraceptives were available on the market, including lower-priced generics that were not AB-rated to Loestrin 24, Loestrin 24’s sales increased from 2008 to 2011, and its price increased each year. (Id. 11319.)
Thus, in these circumstances, and at this preliminary stage of the case, the Court concludes that Plaintiffs have met their burden by plausibly alleging that Warner Chilcott charged supracompetitive prices for Loestrin drugs without losing sales, and thus Warner Chilcott had market power in the relevant market. Having said *329 this, it may very well turn out, after discovery, that the Loestrin drugs are in fact reasonably economically interchangeable with other oral contraceptives, or some subset of oral contraceptives. But, this is a fact-sensitive issue that is not appropriately decided on a motion to dismiss. See Eastman Kodak Co., 504 U.S. at 482 , 112 S.Ct. 2072 (noting that “[t]he proper market definition” required “factual inquiry into the ‘commercial realities’ faced by consumers”); Nexium I, 968 F.Supp.2d at 388 (stating that the interchangeability of the drug with other drugs is “such a factually intensive determination [it] is better left for resolution by a jury”). 23
B. Reverse Payment
All Plaintiffs allege that the terms of the Watson Agreement constituted a large and unjustified reverse payment made in exchange for Watson’s promise to delay entry of its AB-rated generic version of Loestrin 24 for almost five years. (See, e.g., DPP Compl. ¶218.) The EPPs and Retailer Plaintiffs also challenge the Lupin Agreement as an unlawful reverse payment. (EPP Compl. ¶¶ 215-19; Walgreen Compl. ¶¶ 144-45; CVS Compl. ¶ 141-42.) Defendants move to dismiss these claims.
Reverse payments are subject to the rule of reason. Actavis, 133 S.Ct. at 2237-38 . The rule of reason is applied in a three-step process: a plaintiff must first “prove anticompetitive effects,” by demonstrating “a payment for delay, or, in other words, payment to prevent the risk of competition.” King Drug Co. of Florence v. Smithkline Beecham Corp., 791 F.3d 388, 412 (3d Cir. 2015) (“Lamictal”), cert. denied, — U.S. -, 137 S.Ct. 446 , 196 L.Ed.2d 328 (2016) (citing Actavis, 133 S.Ct. at 2235-36 ). “[T]he likelihood of a reverse payment bringing about anticom-petitive effects depends upon 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.” Actavis, 133 S.Ct. at 2237 . Second, if the plaintiffs satisfy the first step, “the burden then shifts to the [defendants to show that a challenged payment was justified by some precompet-itive objective”; and third, “the burden shifts back to the [plaintiffs to establish, under the rule of reason, that the settlement is' nevertheless anticompetitive on balance.” In re Nexium (Esomeprazole) Antitrust Litig., 42 F.Supp.3d 231, 262-63 (D. Mass. 2014) (“Nexium II”).
Before the Court sets out to address whether Plaintiffs have plausibly alleged a large and unjustified reverse payment, there are several threshold issues to address.
*330 ■ First, the parties disagree about the significance of the- “five sets of considerations” addressed in Actavis. 133 S.Ct. at 2234 . In the instant case, the First Circuit expressly rejected a reading of the five considerations as “guid[ing] the inquiry as to whether a settlement payment satisfies the rule of reasont.]” Loestrin 24, 814 F.3d at 551 n.12. Rather, the First Circuit agreed with the DPPs that the Supreme Court proffered these considerations “only as justifications for why subjecting reverse payments to antitrust scrutiny outweigh the public policy in favor of settlements' .,. [and, thus,] the five considerations should not overhaul the rule of reason, nor should they create a new five-part framework in antitrust cases.” Id. at 551 n.12 (internal citation omitted) (emphasis added); see also id. at ‘544 (“The Supreme Court acknowledged the ‘general legal policy in favor of settlements, but determined that ‘five sets of considerations’ weighed in favor of subjecting reverse payment settlements to antitrust scrutiny.” (quoting Ac-tavis, 133 S.Ct. at 2234-37 )). As a result, the Court meets the Warner Chilcott Defendants’ argument that the five guideposts discussed in Actavis “set[ ] forth key considerations [that the Court must address here] for discerning between traditional settlements (as to which there is no concern) -and unusual settlements (as to which further scrutiny may be required),’’ with a healthy dose of skepticism. (See Warner Chilcott Reply 15; see also Warner Chilcott Mot. to Dismiss 36.) The Warner Chilcott Defendants seize the Supreme Court’s statement that “[w]here a reverse payment reflects traditional settlement considerations, such as avoided litigation costs or fair value for services, there is not the same concern that a patentee is using its monopoly profits to avoid the- risk of patent invalidation or a finding of nonin-fringement.” Actavis, 133 S.Ct. at 2236 . Rather than adopting-the Warner Chilcott Defendants’ emphasis on the distinction between traditional and nontraditional settlement terms, however, the Court adheres to the First Circuit’s guidance in Loestrin 24.
Second, the Court must choose a'framework within which to analyze the alleged unlawful reverse payments under the Watson and Lupin Agreements, given their complexity. On this, the parties seem to agree that the Court must look at each component of the two deals, as well as each settlement agreement as a whole, to determine whether plausible claims have been set forth that the Watson and Lupin Agreements, constitute large and unjustified reverse payments. 24
-This is well supported by the case law. On the one hand, there is support for analyzing each component of a complex, non-cash reverse payment settlement to determine whether it is cognizable under Actavis. See, e.g„ In re Actos End Payor Antitrust Litig., No, 13-CV-9244 (RA), 2015 WL 5610752 , at *12-13, 18 (S.D.N.Y. Sept. 22, 2015) (“Actos”), affd in part, vacated in part on other grounds 848 F.3d 89 (2d Cir. 2017) (holding that an acceleration clause is not subject to antitrust scrutiny where Plaintiffs conceded that they *331 could be procompetitive in some circumstances, but noting that no-AG clauses are subject to antitrust scrutiny), Indeed, the First Circuit, in the instant case, directed this Court to address on remhnd the subsequent issue of "whether the individual provisions of the settlement agreements .,. would have been adequately alleged as unlawful reverse payments.” Loestrin 24, 814 F.3d at 548 ; see also id. C‘[T]he district court ,., did not address the subsequent question of whether the individual provisions of the settlement agreements— including the no-AG agreement, the acceleration clause, and the various side deals— would have been adequately alleged as unlawful reverse payments were Actavis to extend to non-cash -payments.”). There is similar support for looking at the whole' of the settlement to determine its alleged effect on competition. See Aggrenox I, 94 F.Supp.3d at 243 (“A settlement agreement may be very simple or tremendously complex, and it may involve all manner of consideration; and if, when viewed holistically, it effects a large and unexplained net transfer of value from the patent-holder to the alleged patent-infringer, it may fairly be called a reverse-payment settlement.”); see also In re Opana ER Antitrust Litig., 162 F.Supp.3d 704, 718 (N.D. Ill. 2016) ("Opana”) (declining the defendants’ invitation to assess the components of the settlement in a “piecemeal fashion” to determine whether “each individual payment fails to rise to the level of a large and unjustified payment” and choosing instead to “determine whether, when taken as a whole, the total payment ... was large and unjustified”); In re Niaspan Antitrust Litigation, 42 F.Supp.3d 735, 752 (E.D. Pa. 2014) (“Niaspan”) (“[D]efendants may not improperly ‘dismember’ plaintiffs’ Consolidated Amended Complaints by examining each of the three settlement agreements in isolation. Rather, the Licensing Agreement must be read in conjunction with the Co-Promotion and Manufacturing Agreements executed that same day.”) (internal citations omitted).
Here, because the Operative Complaints set forth plausible allegations that the Watson and Lupin Agreements were global, complex settlement agreements, the Court proceeds in two steps. First, the Court looks at each component of the Watson and Lupin Agreements to determine whether they were “adequately alleged as unlawful reverse payments,” Loestrin 24, 814 F.3d at 548 ; that is, whether they are appropriately part of the calculus when the Court proceeds to the second step. For example, a reasonable cash payment exchanged to cover litigation expenses would be excluded from any further antitrust scrutiny, but such a payment would of course factor into the -second step of the analysis in as much as it specifically addresses litigation costs, which, in turn, means that other components of the settlement agreement do not. Second, the Court takes a broad and holistic look at the deal to determine whether the entire deal, taken as a whole, amounted to a large and unjustified reverse payment. Specifically, the Court gives the arrangement a careful look with an eye toward “the likelihood of a reverse payment bringing about anticom-petitive effects” in light of “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.” Actavis, 133 S.Ct. at 2237 ; see also id. at 2236 (“Where a reverse payment reflects traditional settlement considerations, such as fair value for services, there is not the same concern[.]”); In re Lipitor Antitrust Litig., 46 F.Supp.Sd 523, 546 (D.N.J. 2014) (“Even if the reverse payment is shown, any traditional settlement considerations or services provided by the generic are deducted to determine whether there is a net positive *332 payment flowing from the patentee to the alleged infringer.”) 25
Third, much of the parties’ briefing addresses the level of particularity with which a reverse payment must be pleaded. On this, the First Circuit has been clear; all that is required is:
that the plaintiffs plead information sufficient “to estimate the value of the term, at least to the extent of determining whether it is ‘large’ and ‘unjustified.’ ” Consistent with Twombly, which declined to “require heightened fact pleading of specifics,” we do not require that the plaintiffs provide precise figures and calculations at the pleading stage. Requiring such a high burden would impose a nearly insurmountable bar for plaintiffs at the pleading stage because “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.” Nevertheless, 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.
Loestrin 24, 814 F.3d at 552 (internal citations omitted). Though the First Circuit does not require Plaintiffs to attach a dollar figure to the value of the alleged unlawful reverse payment, for most of the settlement components, Plaintiffs have nevertheless done so by placing relatively specific valuations on each of the components as well as the whole.
Fourth, the Court must determine whether it should value the alleged reverse payment from the perspective of the patent holder, the alleged infringer, or both, for this inquiry. 26 (See, e.g., Retailer Mem. in Opp’n to the Warner Chilcott/Watson Mot. to Dismiss Brief (“Retailers Brief’) 26, ECF No. 207.) The text of Actavis suggests that the Court should consider both in considering an alleged unlawful reverse payment. See Actavis, 133 S.Ct. at 2235 (“The payment may instead provide strong evidence that the patentee seeks to induce the generic challenger to abandon its claim with a share of its monopoly profits that would otherwise be lost in the competitive market.”). The Court’s use of the word “induce” suggests that the value to the alleged infringer is paramount, whereas the emphasis on the “share of its monopoly profits” supports the notion that the brand must be alleged to have sacrificed some amount of its anticipated profits in order to maintain its monopoly.
With these principles in mind, the Court turns to the Watson and Lupin Agreements.
1. The Watson Agreement
As outlined above, the Watson Agreement provided Watson with a no-AG provision; a six-month period of generic exclusivity; the Femring promotional deal; and the Generess promotional deal.
*333 a. No AG-Agreement
The Warner Chilcott Defendants argue that a no-AG agreement is not an unlawful reverse payment as a matter' of law. (See generally Warner Chilcott Mot. to Dismiss 59-82.) The Court disagrees. Here, Plaintiffs value the no-AG deal at more than $40 million to Watson. (See, e.g., DPP Compl. ¶¶ 194-99; Walgreen Compl. ¶ 127.) The Complaints plausibly allege that a no-AG agreement is both very valuable to a generic manufacturer (and thus may induce it to stay out of the market) and amounts to a sacrifice by a brand manufacturer, rendering the potential anticompetitive effect plain. On a 12(b)(6) motion to dismiss, this is sufficient. See Aggrenox I, 94 F.Supp.3d at 245 (“If some particular transfer of money would be unlawful—for whatever reason— its unlawfulness is not cured merely because the value is transferred in the form of exclusive licenses instead of cash, irrespective of whether the grant of an exclusive license would otherwise be valid.... The issue is not whether the form of the payment was legal, but whether the purpose of the payment was legal.”); see also Lamictal, 791 F.3d at 409 (holding that a no-AG agreement, “because it may represent an unusual, unexplained transfer of value from the patent holder to the alleged infringer that cannot be adequately justified—whether as compensation for litigation expenses or services, or otherwise—is subject to antitrust scrutiny under the rule of reason.” (internal footnote omitted)); Opana, 162 F.Supp.3d at 718 ; In re Solodyn (Minocycline Hydrochloride) Antitrust Litig., No. CV 14-MD-02503-DJC, 2015 WL 5458570 , at *7-9 (D. Mass. Sept. 16, 2015) (“Solodyn”); Niaspan, 42 F.Supp.3d at 752-53 .
The Warner Chilcott Defendants argue that this theory is inconsistent with Plaintiffs’ product hop theory (Warner Chilcott Reply 26-27); even if that is so, Plaintiffs may plead alternative theories. See Fed. R. Civ. P. 8(d). But it is also plausible on the face of the Operative Complaints that the two theories are not inconsistent at all. Plaintiffs plausibly allege that Warner Chilcott, faced with the realities of the no-AG provision in the Watson Agreement and with generic entry looming, opted to roll but its product hop, presumably to stem its looming losses. Had the Watson Agreement not existed, perhaps it would not have used the product hop to alter the competitive landscape, or would have done so at a different point in time. But the fact that a product hop would have been less lucrative with an authorized generic on the market does not render the scheme implausible.
b. Acceleration Clause
The EPPs challenge the acceleration clause in the Watson Agreement as part of the unlawful reverse payment. (EPP Compl. ¶¶ 177-79, 188-90.) They allege that', with the acceleration clause in place, other generics' did not have the opportunity, and thus the incentive to try, to enter the market before Watson’s scheduled entry of January 22, 2014. “By eliminating the possibility of obtaining a period of de facto exclusivity, the clause very substantially diminished, if not altogether eliminated, the incentive for later generic filers to enter before January 22, 2014.” (Id. ¶¶ 189-90.) The EPPs further allege that “[b]ut for the anticompetitive effects of the acceleration clause, later filing generics, such as Mylan and Lupin, would have entered or obtained licensed entry dates earlier than” Watson’s entry date of January 22, 2014; Watson would not have settled for an entry date as late as it did; and Watson would have entered earlier than January 2014. (Id. ¶ 194.) The EPPs do not attach a dollar figure to the acceleration clause. The Warner Chilcott Defendants challenge this assertion, arguing that *334 acceleration clauses are procompetitive and thus not subject to antitrust scrutiny. (Warner Chilcott Mot. to Dismiss 82-87.)
The Court concludes that the EPPs have plausibly alleged that the acceleration clause had.anticompetitive effects. It may be that with more factual and expert discovery, . the Warner Chilcott. .Defendants can establish that there were no anticom-petitive effects, or that, on the second prong of the rule of reason analysis, the “challenged payment was justified by some precompetitive objective.” Nexium II, 42 F.Supp.3d at 262-63. But at this juncture, the Court is not prepared to hold that an acceleration clause like the one in the Watson Agreement may never be cognizable as a component of a complex settlement agreement amounting to a large and unjustified reverse payment. Accordingly, the acceleration clause may be considered, a least for the time being, as a component in the greater calculus. But see Actos, 2015 WL 5610752 , at *16 (holding that the acceleration clause was not cognizable as a large and unjustified payment).
c. Promotional Deals
Defendants contend that Plaintiffs failed to allege that four promotional or license agreements within the Watson and Lupin Agreements (viz., the Femring, Generess, Asacol, and Femcon deals) 27 are unlawful reverse payments under Actavis. (Warner Chilcott Mot. to Dismiss 25.) They argue that (1) these agreements represent paymentp from the generic to the brand; (2) they are “traditional and commonplace;” (3) they allow for the entry of new competition; (4) they do not represent a sacrifice by Warner Chilcott; (5) they are not plausibly alleged to be for anything but fair "value; and (6) it is not plausible that they were entered into in exchange for the genéric’s delay in entering the market. (Id. at 45-46, 55-59.) After careful consideration, these arguments do not carry the day.
. Of importance, Defendants miss the mark on their plaint that promotional deals of this sort cannot constitute reverse payments. If brand manufacturer A offers generic manufacturer B a licensing deal that is valued at $100 million to B over five years and represents a sacrifice .of $80 million to A over- five years, in exchange for which B agrees-to not enter the market with its generic drug, it is of no moment that B is expected to pay A $10 million in royalties over five years. Such a deal does not reflect the fair value of the license agreement; it represents a sacrifice of A’s potential monopoly profits; and represents a payment to B in order to induce it to stay out of the market. Indeed, Actavis itself dealt with a reverse payment consisting of a cash payment and promotional deals to • generics, which demonstrates “that the Supreme Court recognized that a disguised above-market deal, in which a brand manufacturer 'effectively overpays a generic manufacturer for services rendered, may qualify as a reverse payment subject to antitrust scrutiny .... ” Loestrin 24, 814 F.3d at 549 .
Plaintiffs have also sufficiently alleged that each of the promotional deals was not for fair value. While Defendants spill much ink here, under the rule of reason framework, once Plaintiffs have alleged facts supporting a not-for-fair-value, large, and unjustified payment, the burden shifts to Defendants “to produce evidence to justify the payment by showing it was no more than the brand-name manufacturer’s own saved litigation costs or was fair value for sendees the generic manufacturer promised to perform and was not a payment for *335 delay.” Solodyn, 2015 WL 5458570 , at *7. “Such justifications, as with any affirmative defense, cannot be resolved on a motion to dismiss unless the facts establishing the defense are clear on the face of the plaintiffs’ complaint, which they are not in this case.” Id (citing Blackstone Realty LLC v. FDIC, 244 F.3d 193, 197 (1st Cir. 2001)).
With respect to- the Femring Deal, the DPPs value the deal to be worth approximately $25, million to Watson. (DPP Compl. ¶¶ 214-16.) They further allege that, “[t]he Femring deal provided substantial compensation to Watson that was, in and of itself, in excess of the fair value of Watson’s cost of performance[,]” and it served no other purpose than to induce Watson’s delayed entry of generic competition. (DPP Compl. ¶¶ 216, 218.) The EPPs allege that the Femring deal “provided compensation to Watson that was in excess of the fair value of the promotional services that Watson was required to perform.” (EPP Compl. ¶ 186.) The Retailers allege the “payments were far in excess of Watson’s cost of performance or the fair market value of that performance.” (Walgreen Compl. ¶ 134; CVS Compl. ¶ 131.) That Plaintiffs do not expressly plead that it amounted to lost monopoly profits to Warner Chilcott is not dispositive on a motion to dismiss; such a reasonable inference may be drawn.
With respect to the Generess Fe Deal, the Watson Agreement provided Watson with the exclusive right to market and sell another Warner Chilcott oral contraceptive, Generess Fe. Under the deal, Watson had the right to retain 85% of the net sales from Generess, as well as the right to retain 100% of net sales either upon the launch of a generic Generess product or if Watson exercised a buy-out right; the DPPs value this piece of the deal at “tens of millions” to Watson. (DPP Compl. ¶¶ 9, 205, 210-11.) There can be no serious question that Plaintiffs have alleged that the deal was not for fair value. For example, the DPPs allege that “[t]his transfer of value from Warner Chilcott to Watson ha[d] no rational explanation other than to provide additional compensation to Watson for delaying its generic Loestrin 24.” (DPP Compl. ¶ 207; see also id. ¶ 211.) The EPPs allege that the royalty rate was “below market,” and the deal cannot “be justified solely as compensation for the services to be performed by Watson under the deal” because the deal “made no business or economic sense for Warner Chilcott absent Watson’s agreement to preserve” Warner Chilcott’s Loestrin 24 mqnopoly. (EPP Compl. ¶¶ 4, 185.)
The Warner Chilcott Defendants argue that “there is a disconnect between Actavis’s discussion of reverse payments and Plaintiffs’ allegations of forward payments, i.e., payments from the generic settler to the brand.” (Warner Chilcott Reply 22; see also Warner Chilcott Mot, to Dismiss 45-49.) The Warner Chilcott Defendants’ argument misses the mark. It is not the form but the purpose of a reverse payment that renders it subject to antitrust scrutiny. See generally Loestrin 24, 814 F.3d 538 ; Aggrenox I, 94 F.Supp.3d at 245 (“The issue is not whether the form of the payment was legal, but whether the purpose of the payment was legal,”). Plaintiffs have plausibly alleged facts that set forth a deal in which the Generess Fe promotional deal was one component of a. larger, complex settlement agreement in which this exclusive right to market and sell Gener-ess may have been offered to Watson in excess of the fair value cost of Watson’s performance. In other words, though the actual payment may be in the form of Watson’s right to retain 85% of the net sales of the Generess product, if it were customary under .such .an agreement for Watson to retain a lower percentage of the *336 net sales for its marketing and sales efforts, it nonetheless may signal a large and unjustified reverse payment. That Plaintiffs have not expressly pleaded an exact value to Watson for this promotional deal is, again, not dispositive.
2. Lupin Agreement
The Lupin Agreement comprises three components: the Femcon deal, the Asacol deal, and a cash payment of $4 million by Warner Chilcott to Lupin toward attorneys’ fees and litigation expenses for both the Loestrin 24 and Fem-con patent infringement suits. The EPPs and Retailer Plaintiffs challenge the Lupin Agreemént as an unlawful reverse payment. Defendants defend these side deals as separate from Lupin’s settlement in the Loestrin 24 litigation, noting that the side deals contain “a number of contingencies reflecting complicated business judgments as to their strategic value to either company and require significant future performance by both parties.” (Omnibus Mem. of Law in Supp. of Lupin Defs.’ Mot. to Dismiss the End Payor and Retailer Pls.’ Compls. (“Lupin Mot. to Dismiss”) 1, ECF No. 199-1.)
a. Causation
Lupin argues that the reverse payment claim should be dismissed as to the Lupin Agreement because Lupin did not obtain FDA approval to sell a generic version of Loestrin 24 until October 28, 2015. (Mot. Hr’g Tr. 54:1-55:18, Jan. 13, 2017, ECF No. 266.) Accordingly, it argues, the EPPs and Retailer Plaintiffs have not pleaded that its delayed generic entry was the result of the Lupin Agreement reverse-paymént settlement. This argument was not raised in Lupin’s memorandum in support of its motion to dismiss, and appears for the first time in its reply brief. See DRI LR Cv 7(b)(3) (“A reply memorandum shall consist only of a response to an objection and shall not present additional grounds for granting the motion, or rear-gue or expand upon the arguments made in support of the motion.”);- see also Pratt v. United States, 129 F.3d 54, 62 (1st Cir. 1997) (noting that arguments not advanced in the appellant’s opening brief are deemed waived).
The Operative Complaints do not establish, as a matter of law, that a delay in FDA approval caused the delay in generic entry to the exclusion of the reverse payment. Assuming arguendo that the Court took judicial notice of the fact that the FDA did not grant Lupin approval to sell a generic version of Loestrin 24 until October 2015, the facts alleged in the Operative Complaints do not preclude the possibility that the Lupin Agreement contributed to the October 2015 entry date. It is plausible that the entry date provided for in the Lupin Agreement affected the FDA’s and Lupin’s behavior during the approval process. If the Lupin Agreement had provided for, an earlier entry date, Lupin may have been able to obtain FDA approval earlier. Because Lupin’s arguments are not conclusive on the face of the Operative Complaints, and reasonable inferences can be made in Plaintiffs’ favor, the. Court declines to dismiss these claims on this basis,
b. Femcon Deal
The Femcon deal granted Lupin a license to market Femcon Fe, a separate oral contraceptive manufactured by Warner Chilcott, beginning the earlier of 180 days after the first filer, Teva Pharmaceutical Industries, Ltd, entered the market with a generic equivalent, or January 1, 2013. (EPP Compl. ¶ 214.) The EPPs value this at approximately $15 million to Lupin. (Id. ¶ 5(a),) The EPPs and Retailers allege that, but for this agreement, Lupin would not have been able to enter the Femcon market until at least January 31, 2012, at the end of the 30-month stay, and as late as March 23, 2016, when Lupin received *337 final FDA approval for its ANDA. (See, e.g., id. ¶ 214.) The EPPs allege that the royalty payment, which would flow from Lupin to Warner Chilcott, would be “below market rates” and that the “usual and customary” rate for similar agreements is 80-90% of the gross margin for units sold, which is higher than the royalty of 50% of gross margin for units sold provided in the Femcon and Asaeol deals. (Id. ¶¶5, 216, 220.) With these allegations, the EPPs and Retailers have set forth “information sufficient to estimate the value of the term, at least to the extent of determining whether it is large and unjustified.” Loestrin 24, 814 F.3d at 552 (internal quotations and citation omitted).
Defendants point out that Lupin and Warner Chilcott were settling two distinct patent suits—one concerning Loestrin 24 and the other concerning Femcon. The Loestrin 24 and Femcon settlement agreements were documented in a single agreement, with the Asaeol deal attached, and they were executed on the same day. The Asaeol and Femcon deals were both contingent upon the date for entry into the Loestrin 24 market. (Warner Chilcott Mot. to Dismiss 53-54 (citation omitted).) But, as noted above, the complexity of a settlement agreement is no reason to escape antitrust scrutiny. Ultimately, a jury may need to parse out the Femcon settlement and the Loestrin 24 settlement. But for now, Plaintiffs have plausibly alleged sufficient facts to establish that the Femcon promotional deal was part of an unlawful reverse payment to Lupin to induce it to stay out of the Loestrin 24 market, perhaps as well as the Femcon market,
c. Asaeol Deal
The Asaeol deal, or the second component of the larger Lupin Agreement, gave Lupin the right to sell a generic version of Asaeol 400, an anti-inflammatory drug, to be supplied by Warner Chilcott, if a generic version of Asaeol 400 was launched by another generic manufacturer in the United States. (EPP Compl. ¶ 217.) The EPPs value this deal as being worth at least $50 million to Lupin; the Retailers allege that Lupin expected to earn $100 million annually from the Asaeol agreement. (EPP Compl. ¶ 5(b); Walgreen Compl. ¶ 144.) Defendants argue that because the deal was contingent upon the success of a third-party generic securing FDA approval to enter the market, the agreement “was highly contingent” and “[a]ny claimed ‘value’ to Lupin would have to account for this uncertainty.” (Warner Chilcott Mot. to Dismiss 51.)
As an initial matter, that the FDA has not approved a generic version of Asaeol is, in itself, irrelevant. The deal must be valued at the time the parties entered the deal, and it must have been worth something to Lupin, or else they would not have invested the effort and legal fees in the matter. 28 On the other hand, it is implausible that the parties to the Lupin Agreement were unaware of the possibility that the contingency may never be met. On the face of the Operative Complaints, however, it is plain that the Asaeol deal represented á sacrifice by Warner Chilcott and a bene *338 fit to Lupin in order to induce it to stay-out of the generic market. On these facts, Plaintiffs adequately pleaded their claim and the Asacol deal will be considered when assessing the Lupin Agreement as a whole.
3. The Sum of the Whole(s)
In their-Operative Complaints, Plaintiffs plausibly allege-that the Watson and Lupin Agreements, viewed as two complex settlement agreements, amounted to both a payment to the generic manufacturers to induce a- generic-entry delay, as well as a sacrifice of monopoly profits, on the whole, to protect a perceived weakness in the ’394 patent. For. the Watson Agreement, the DPPs value the sum of the deals at tens or hundreds of millions to Watson (DPP Compl. ¶¶ 9, 192, 199); the Retailers value them to be worth $266 million to Watson (e.g., CVS Compl. ¶¶ 124, 131-32); the EPPs value the sum at $216.67 million to Watson (EPP Compl. ¶ 4). With respect to the Lupin Agreement, the EPPs value the Femcon deal to be worth approximately $16 million, and the Asacol deal approximately $50 million, to Lupin. (EPP Compl. ¶¶ 5(a)-(b).) These represent rather, precise estimates of the value of each component of the deal, given Plaintiffs have not had the benefit of discovery, accompanied by a step-by-step calculation of how they reached those figures. See Loestrin 24, 814 F.3d at 552 (stating that Plaintiffs must “plead, information sufficient.to estimate the value of the term, at least to the extent of determining whether it is large and unjustified,” but “not requir[ing] that [Plaintiffs provide precise figures and calculations” (citation and quotation marks omitted)). Moreover, Plaintiffs have sufficiently alleged that the Agreements were not otherwise justified by “avoided litigation costs or fair value for services.” Actavis, 133 S.Ct. at 2236 .
‘ In light of the standard for dismissal on a 12(b)(6) motion, the Court concludes that Plaintiffs have met their burden and have adequately alleged that the sum total of the Watson Agreement constituted a large and unjustified payment, as did the Lupin Agreement (challenged by the EPPs and Retailers only). Plaintiffs have satisfied their burden to allege facts that, with the benefit of fact and expert discovery, have the reasonable expectation of proving their prima facie case under the rule of reason. See Twombly, 550 U.S. at 556 , 127 S.Ct. 1955 (holding that a complaint must plead facts sufficient “to raise a reasonable expectation that discovery will reveal evidence” of a Sherman Act violation).
C. Fraud on the PTO, Sham Litigation, and Orange Book Claims
Generally, under the Noerr-Pen-nington doctrine, “a Sherman Act violation cannot be ‘predicated upon mere attempts to influence the passage or enforcement of laws,’ ” Amphastar Pharm. Inc. v. Momenta Pharm., Inc., 850 F.3d 52, 66 (1st Cir. 2017) (quoting E.R.R. Presidents Conference v. Noerr Motor Freight, Inc., 365 U.S. 127, 135 , 81 S.Ct. 523 , 5 L.Ed.2d 464 (1961) . (“Noerr”))(citing United Mine Workers v. Pennington, 381 U.S. 657, 670 , 85 S.Ct. 1585 , 14 L.Ed.2d 626 (1965) (“Pennington”)). Though Noerr and Pennington addressed citizen activity in the executive and legislative branches,. the Supreme Court has extended the protection to patent holders filing suit in federal court. See Amphastar Pharm. Inc., 850 F.3d at 56 (citing Cal. Motor Transp. Co. v. Trucking Unlimited, 404 U.S. 508, 510 , 92 S.Ct. 609 , 30 L.Ed.2d 642 (1972)).
But as with most rules, there are exceptions. A patent holder may be subject to antitrust, liability for the anticompetitive effects of-bringing a patent infringement suit where a plaintiff demonstrates “(1) that the asserted patent was obtained through knowing and willful fraud within the meaning of Walker Process Equipment, *339 Inc. v. Food Machinery & Chemical Corp., 382 U.S. 172, 177 , 86 S.Ct. 347 , 15 L.Ed.2d 247 (1965), or (2) that the infringement suit was. ‘a mere sham to cover what is actually nothing more than an attempt to interfere directly with the business relationships of a competitor,’ Noerr Motor Freight, Inc., 365 U.S. at 144 , 81 S.Ct. 523 .” Nobelpharma AB v. Implant Innovations, Inc., 141 F.3d 1059, 1068 (Fed. Cir. 1998) (additional citations omitted). Plaintiffs assert both- theories here.
1. Walker Process Claims
To plead a claim for relief under § 2 of the Sherman Act on a Walker Process theory, a plaintiff must allege two conditions. “First, the plaintiff must -show that the defendant procured the relevant patent by knowing, and willful fraud on the PTO or (in the case of an assignee) that the defendant maintained and enforced the patent with knowledge of the fraudulent manner in which it was obtained.” Ritz Camera & Image, LLC v. SanDisk Corp., 700 F.3d 503, 506 (Fed. Cir. 2012). Notably it is the enforcement of a patent procured by fraud that may give rise to a Sherman Act claim; mere procurement without more does not “affect the welfare of the consumer and cannot in itself violate the antitrust laws.” FMC Corp. v. Manitowoc Co., 835 F.2d 1411 , 1418 & n.16 (Fed. Cir. 1987); see also Walker Process, 382 U.S. at 174 , 86 S.Ct. 347 . “Second, the plaintiff must prove all the elements otherwise necessary to establish a Sherman Act monopolization charge.” Ritz Camera & Image, LLC, 700 F.3d at 506 (citations omitted). Under the second condition, “[t]he ‘other elements’ necessary to establish an attempted monopolization claim are: ‘(1) that the defendant has engaged in predatory or anticompetitive conduct with (2) a specific intent to monopolize and (3) a dangerous probability of achieving monopoly power.’ ” TransWeb, LLC v. 3M Innovative Properties Co., 812 F.3d 1295, 1306 (Fed. Cir. 2016) (quoting Spectrum Sports, Inc, v. McQuillan, 506 U.S. 447, 456 , 113 S.Ct. 884 , 122 L.Ed.2d 247 (1993)).
a. Plaintiffs’ Allegations of Fraud on the PTO
Plaintiffs allege that the applicants for the ’394 patent, including Dr. Hodgen and others involved with its patent prosecution, breached their duty under 37 C.F.R. § 1.56 and common law “by intentionally misrepresenting material facts, failing to disclose material information, and submitting false information to the PTO with the intent to deceive.” (See, e.g., EPP Compl. ¶ 144.) Broadly speaking, this includes: (1) the fraudulent omission of the 1993 human study, either because its findings undercut patentability " or because it constituted invalidating public use (DPP Compl. ¶¶ 126, 141; EPP Compl. ¶¶ 147-56; CVS Compl. ¶ 78; Walgreen Compl. ¶ 81); (2) the intentional withholding of prior art that teaches a regimen of more than 21 days for oral contraceptives (EPP Compl. ¶¶ 166-69); and (3) false statements and material withholding of information.about the amount of estrogen in prior art oral contraceptives (id ¶¶ 157-65).
To state a claim for fraud on the PTO, a plaintiff must allege “(1) a false representation or deliberate omission of a fact material, to patentability, (2) made with the intent- to deceive the patent examiner, (3) on which the examiner justifiably relied in granting the patent, and (4) but for which misrepresentation or deliberate omission the patent would not have been granted.” C.R. Bard, Inc. v. M3 Sys., 157 F.3d 1340, 1364 (Fed. Cir. 1998). 29 “Such a misrepresentation or omission must evi *340 dence a clear intent to deceive the examiner and thereby cause the PTO to grant an invalid patent.” Nobelpharma AB, 141 F.3d at 1070 . To establish Walker Process fraud there must be “independent and clear evidence of deceptive intent together with a clear showing of reliance, he., that the patent would not have issued but for the misrepresentation or omission.” Id. at 1071 . And to satisfy Rule 9(b) of the Federal Rules of Civil Procedure, a plaintiff must plead the “who, what, when, where, and how of the material misrepresentation or omission committed before the PTO.” Exergen Corp. v. Wal-Mart Stores, Inc., 575 F.3d 1312, 1328 (Fed. Cir. 2009). The Warner Chilcott Defendants move to dismiss all Plaintiffs’ Walker Process fraud claims. The Court addresses their arguments in turn.
b. Specific Individual with Intent to Defraud the PTO
The Warner Chilcott Defendants first argue that Plaintiffs failed to plead that any specific individual prosecuting the ’394 patent intended to deceive the PTO. This argument gets no traction. With respect to the failure to disclose the 1993 human study, the DPPs allege that: “Hod-gen’s omission and misrepresentations were made with knowledge that they were false and misleading, and with the specific intent that the PTO rely on the monkey study and issue a patent. There is no other reasonable explanation for the failure to report a failed human study that the inventor personally conducted. The failed study was intentionally withheld because it undercut patentability.” (DPP Compl. ¶ 141.) Dr. Hodgen and the applicants are alleged to have known also that the human study constituted invalidating public use, as Dr. Hodgen was aware of the study and it took place more than one year prior to the patent application. (Id. ¶ 126; EPP Compl. ¶¶ 148-56.)
Plaintiffs further allege that the ’394 applicants withheld material prior art from the PTO in failing to disclose the so-called *341 Molloy reference (see infra, at 75). (See, e.g., EPP Compl. ¶¶ 166-68.) Plaintiffs allege that a December 1990 letter by Dr. Hodgen to Warner-Lambert reveals that both Dr. Hodgen and Roger Boissoneault, who later became CEO of Warner Chilcott, had knowledge of the Molloy reference, but that the applicants did not disclose the Molloy reference to the PTO during the ’394 patent prosecution because it undercut patentability. (EPP Compl. ¶¶ 155, 168.)
Plaintiffs further allege that the applicants defrauded the PTO by withholding or misrepresenting the fact that there were commercially available oral contraceptives that contained at least 30 meg of ethinyl estradiol and that the claimed invention would reduce total estrogen exposure per annum. (See, e.g., EPP Compl. ¶ 165.) They allege that Dr. Hodgen and the other applicants knew their statement was false because Loestrin 1/20 was commercially available in the United States, oral contraceptives with a similar composition of estrogen were available in Europe, and Loestrin 1/20 exposes women to half as much estrogen as the dosing regimen claimed in the ’394 patent. (Id. ¶ 162.)
The facts underlying each set of fraud allegations support a reasonable inference that a specific individual, namely, Dr. Hod-gen, “(1) knew of the withheld material information or of the falsity of the material misrepresentation, and (2) withheld or misrepresented this information with a specific intent to deceive the PTO.” Exergen Corp., 575 F.3d at 1328-29 . 30 While Plaintiffs may still have ground to cover in order to prove that the applicants had the intent to deceive the PTO, courts have cautioned that “[s]cienter or intent to defraud is usually an issue of fact that should not typically be resolved on a pretrial motion.” See In re Effexor XR Antitrust Litig, No. CIV.A. 11-5479 PGS, 2014 WL 4988410 , at *26 (D.N.J. Oct. 6, 2014). There is little question that Plaintiffs’ pleadings are adequate on this score.
c. Omission of the 1993 Human Study
Plaintiffs allege that the applicants’ failure to disclose a 1993 human study conducted by Dr. Hodgen was a material omission, either because it failed to show a statistically significant reduction in breakthrough bleeding (DPP Compl. ¶¶ 126, 141) or because it represented invalidating use (EPP Cqmpl. ¶ 153; CVS Compl. ¶ 78; Walgreen Compl. ¶ 81). They further allege the patent «would not have been issued but for the material omission and the applicants omitted' the information with the intent to deceive the PTO. (See, e.g., DPP Compl. ¶¶ 141, 147.) In support of its allegations that the failure to disclose the 1993 human study was a material omission, Plaintiffs detail the ’394 patent prosecution as follows.
During the patent examination, the examiner focused on two issues: the amount of the ethinyl estradiol and norethindrone acetate in oral contraceptives disclosed in the prior art, and whether the invention decreased breakthrough bleeding. (DPP Compl. ¶135.) After initially concluding that prior art rendered all claims obvious in light of the references disclosing similarly low amounts of ethinyl estradiol and norethindrone acetate, the examiner focused on whether the invention demonstrated an unexpected decrease in breakthrough bleeding. (DPP Compl. ¶¶136, 138.) The examiner again rejected the claims because of the similar amount of ethinyl estradiol in the prior art and be *342 cause “the applicants [had not] shown that it was unexpected that decreasing the amount of ethinyl estradiol reduces the incidence of. breakthrough bleeding[.]” (Id. ¶ 138.) The examiner stated:
The applicant’s remarks have been considered but are unpersuasive. Claim 1 recited a possible dosage of 35 meg of estrogen which is only 15 meg lower than the 50 meg dosage taught by Craft et al. It has not been demonstrated that a'dosage regjmen different by only 15 meg less of estrogen has unexpected contraceptive and reduced breakthrough bleeding results.
(Id. (emphasis ojnitted).)
Presumably after additional correspondence, the application’s claims were thereafter allowed. Tjie ’394 patent specification states, “[i]t is the object of the present invention to provide a new estrogen-pro-gestin combination and regimen for oral contraceptive use which maintains the efficacy and provides enhanced control of endometrial bleeding.” (Id. ¶ 120 (emphasis in original).) Claim 1 of the ’394 patent, upon which Claims 2-12 depend, recites:
A method of female contraception which is characterized by a reduced incidence of breakthrbugh bleeding after the first cycle-which comprises monophasicly administering a combination of estrogen and progestin for 23-25 consecutive days of a 28 day cycle in which the.daily amounts of estrogen and progestin are equivalent to about 1-35 meg of ethinyl estradiol and about 0.025 to 10 mg of norethindrone acetate, respectively, and in which the weight ratio of estrogen to progestin is at least 1:45 calculated as ethinyl estradiol to norethindrone acetate.
(Id. ¶ 121 (emphasis altered).)
The Warner Chilcott Defendants move to dismiss Plaintiffs’ Walker Process fraud claims concerning the 1993 human study on the basis that the patent examiner did not consider breakthrough bleeding to be an independent ground for patentability, and thus, would have issued the patent even if she -had known about the 1993 human study. In other words, the omission was not material. (See Warner Chilcott Mot. to Dismiss 94 (“[T]he -’394 applicants focused on the differences in the dosage amounts and length of administration, not the intended efficacy in reducing breakthrough bleeding.”).) In support of their argument, the Warner Chilcott Defendants point to two sets of documents beyond the scope of the Operative Complaints: the prosecution history -for the ’394 patent and the Loestrin 24 patent infringement suit between Warner Chilcott and Mylan, which commenced after. Warner Chilcott settled with Watson and Lupin.
The Warner Chilcott Defendants ask the Court to consider the patent prosecution history as incorporated by -reference into the Operative Complaints for purposes of deciding this motion. The Warner Chilcott Defendants argue that the patent examiner’s response that “it has not been demonstrated that a dosage regimen differing by only 15 meg less of estrogen [has unexpected] reduced breakthrough bleeding” shows the examiner was not persuaded that the lower dosage of estrogen reduced breakthrough bleeding. (See id. at 100 .) If she was not persuaded, evidence further undermining Loestrin 24’s ability to reduce breakthrough bleeding cannot be material. In rejoinder, the DPPs contend that the bracketed text (“has unexpected”), omitted from the Warner Chilcott Defendants’ opening brief, reveals that the examiner was addressing the patent’s claim and proposed estrogen dosage in relation to higher estrogen dosages taught by prior art. The DPPs argue that the examiner accepted the false representation that a lower dosage reduced breakthrough bleeding but questioned whether it was unexpected.
*343 The Warner Chilcott Defendants further ask the Court to delve into the suit between Warner Chilcott and Mylan, in which the U.S. District Court for the District of New Jersey held a Markman hearing on claim construction and concluded that the ’394 patent’s reference to reduced breakthrough bleeding was a non-limiting preamble term. See Opinion 8, Warner Chilcott Co. LLC v. Mylan Inc., et al., 3:11-cv-03262-JAP-TJB, 2013 WL 1410005 , ECF No. 81 (D.N.J. Apr. 8, 2013) (stating that “Mylan has 'not identified anything in the prosecution history that the Court considers to be evidence of clear reliance on reduced breakthrough bleeding as patentably significant,” and concluding that the reduced incidence of breakthrough bleeding was a non-limiting preamble term). If reduced breakthrough bleeding did not provide an independent basis for patentability, the Warner Chilcott Defendants argue, the study’s omission was not material. (See Warner Chilcott Mot. to Dismiss 100.)
To establish Walker Process fraud, Plaintiffs must establish that the fraudulent omission or fraudulent misrepresentation was material, ie., “that the patent would not have issued but for the patent examiner’s justifiable reliance on the pat-entee’s misrepresentation or omission.” Dippin’ Dots, Inc. v. Mosey, 476 F.3d 1337, 1346-47 (Fed. Cir. 2007). The Court declines to consider the patent prosecution file or take judicial notice of the claim construction decision in the Mylan suit. It is clear from the parties’ arguments that the issue of materiality is replete with issues of fact that would require the Court to decide, as a matter of law, whether the patent examiner would not have allowed the patent but for the omission of the 1993 human study. Such a decision is better reserved for summary judgment or trial, on a full record after fact and expert discovery. See In re DDAVP Direct Purchaser Antitrust Litig., 585 F.3d 677, 692 (2d Cir. 2009) (“Even if the district judge was correct that the earlier record did not show fraud, the record in this case could be different following discovery.”). Here, on the face of the Operative Complaints, it is plausible that the patent examiner would have determined an unsuccessful human study suggesting that Loestrin 24 provides no statistically significant reduction of breakthrough bleeding material and, as a result, would have declined to issue the patent. This is so even if a clinical study was not required to patent the invention. “[E]ven if one was skeptical .about the truth of the facts, they survive on a motion to dismiss.” See Effexor, 2014 WL 4988410 , at *25. :
d. 1993 Human Study Constituted Invalidating Public Use
The Warner Chilcott Defendants also challenge the EPPs’ and Retailers’ claim that the 1993 human study constituted invalidating public use. (Warner Chil-cott Mot. to Dismiss 100-02,),They argue that Plaintiffs failed to plead the dates of the 1993 human study to show that it was more than a. year before the patent application, that the mere fact that there was no confidentiality agreement is not enough to render it public use, and that Plaintiffs have failed to plead sufficient facts outlining the alleged invalidating public use. (Id.)
Under . 35 U.S.C. § 102 (b), public use of an invention in the United States more than one year before the date of the patent application renders the invention unpatentable. “The proper test for the public use prong of the § 102(b) statutory bar is whether the purported use: (1) was accessible to the public; or (2) was commercially exploited.” Invitrogen Corp. v. Biocrest Mfg., L.P., 424 F.3d 1374, 1380 (Fed. Cir. 2005). The public policy supporting the public use bar to patentability is to avoid “the removal, from the public domain, of *344 inventions that the public reasonably has come to believe are freely available.” Delano Farms Co. v. Cal. Table Grape Comm’n, 778 F.3d 1243, 1247 (Fed. Cir. 2015) (quoting Tone Bros. v. Sysco Corp., 28 F.3d 1192, 1198 (Fed. Cir. 1994)). The issue at play is “whether the actions taken by the inventor [or some other third party] create a reasonable belief as to the invention’s public availability.” Id.
‘ Courts and juries examine the following factors to resolve this issue: “the nature of the activity that occurred in public; the public access to and knowledge of the public use; [and] whether there was any confidentiality obligation imposed on persons who observed the use.” Id (quoting Bernhardt, L.L.C. v. Collezione Europa USA, Inc., 386 F.3d 1371, 1379 (Fed. Cir. 2004)). This last factor centers on “the commonsense notion that whether an invention is ‘accessible to the public’ ... depends, at least in part, on the degree of confidentiality surrounding its use: ‘[A]n agreement of confidentiality, or circumstances creating a similar expectation of secrecy, may negate a public use where there is not commercial exploitation.’” Id. (quoting Dey, L.P. v. Sunovion Pharm,, Inc,, 715 F.3d 1351, 1355 (Fed. Cir. 2013)).
As thése factors reveal, this is a fact-intensive inquiry. Though Defendants are correct that courts do not require “a formal confidentiality agreement to show nonpublic use[,]” courts and juries must weigh the specific facts of each case to determine “whether there were circumstances creating a similar expectation of secrecy.” Delano Farms, 778 F.3d at 1248 (citations omitted).
Here, Plaintiffs have alleged that scientists at EVMS conducted a human study “[b]eginning on or around January 1993.” (DPP Compl. ¶ 127.) Fifteen of the thirty participants followed a regimen of twpnty-five days of Loestrin 1/20 tablets followed by three placebo tablets. The treatment spanned three months, and “[p]articipants were not obligated to keep the study design or methods confidential.” (Id. ¶¶ 129-30.) In July 1994, more than one year after the study commenced, Dr. Hodgen applied for what we know to be the ’394 patent. (Id. ¶ 117.) While Plaintiffs do not provide exhaustive allegations directly addressing each of the factors supporting public use, these facts sufficiently allege a claim that invalidating public use, more than one year before the patent application, had rendered the invention unpatentable. Claims of this sort are typically highly fact-dependent and not likely to be disposed of on a motion to dismiss, and that is the case here. Cf. Dey, 715 F.3d at 1360 & n.5 (reversing grant of summary judgment for party arguing invalidating public use, declining to grant summary judgment for the non-moving party, and remanding for further proceedings).
e. Failure to Disclose the Molloy Reference
The EPPs and Retailer Plaintiffs also assert that the applicants’ failure to disclose prior invalidating art amounted to fraud on the PTO in procuring the ’394 patent. (See, e.g., EPP Compl. ¶¶ 166-67; Walgreen Compl. ¶¶ 88-89.) Specifically, they allege that the applicants intentionally concealed an article referred to as the “Molloy reference.” (See, e.g., EPP Compl. ¶¶ 138, 166-68 (citing B.G. Molloy et al, “Missed Pill” conception: fact or fiction?, 290 Brit. Med. J. 1474, 1475 (1985)).) The Molloy reference observed: “To reduce the risk of missed pill conception a 28 day pack containing 23 pills and 5 blanks could be substituted for the current 21 day pack. This would still permit a withdrawal bleed without the risk of significant follicular development.” (EPP Compl. ¶ 138; see also id. (quoting two other references proposing a regimen of 24 oral contraceptive pills followed by 4 placebo pills).) Accord *345 ing to the EPP Complaint, “[t]he prior art’s direct recommendations to use 24/4 and 23/5 dosing regimens to minimize the risks of escape ovulation would have motivated one of ordinary skill in the art to implement such a shortened pill-free interval for use with known low-dose products” as set forth in the ’394 patent. (EPP Compl. ¶ 139.) Thus, the EPPs and Retailers allege that, given the “plain disclosures and clear motivation to combine those disclosures in the prior art,” the ’394 patent was invalid for obviousness. (Id, ¶ 142; see also Walgreen Compl. ¶ 89 (“Molloy is material to the patentability of the claims of the ’394 Patent because the claims of the patent extend the 21-day schedule to 23-25 days.”).)
To round out the fraud allegations, Plaintiffs allege that Dr. Hodgen and Warner Chilcott were aware of the Molloy reference when they applied for the patent and later enforced it, respectively, as evidenced by a December 1990 letter from Dr. Hodgen to Warner-Lambert; the applicants did not disclose the reference to the PTO during the patent prosecution; and the applicants intended to deceive the PTO by withholding the reference. (EPP Compl. ¶ 168.)
The Warner Chilcott Defendants move to dismiss the fraud allegations, contending that the EPPs and Retailers fail to allege intent to deceive the PTO and but-for materiality in light of the applicants’ disclosure of other, cumulative references. 31 (Warner Chilcott Mot. to Dismiss 92,102-04.)
To support a claim of Walker Process fraud, there must be “independent and clear evidence of deceptive intent together with a clear showing of reliance, i.e., that the patent would not have issued but for the misrepresentation or omission.” Nobelpharma AB, 141 F.3d at 1070-71 . “Therefore, for an omission such as a failure to cite a piece of prior art to support a finding of Walker Process fraud, the withholding of the reference must show evidence of fraudulent intent.” Id. at 1071 . It is rare to have direct evidence of deceptive intent,' especially at the pleading stage, and thus “a district court may infer intent from indirect and circumstantial evidence.” Therasense, 649 F.3d at 1290. “A reasonable inference is one that is plausible and that flows logically from the facts alleged, including any objective indications of candor and good faith.” Exergen Corp., 575 F.3d at 1329 n.5 (citing Greenstone v. Cambex Corp., 975 F.2d 22, 26 (1st Cir. 1992)).
To plead that a withheld reference is material, a pleading should “identify the particular claim limitations, or combination of claim limitations, that are supposedly absent from the information of record.” Exergen Corp., 575 F.3d at 1329 . “Such allegations are necessary to explain both “why^ the withheld information is material and not cumulative, and ‘how an examiner would have used this information in assessing the patentability of the claims.” Id. at 1329-30 .
The EPPs and Retailers here plainly plead that the Molloy reference teaches to increase the oral contraceptive regimen from 21 days to 23 days, and the ’394 patent claims “extend the 21-day schedule to 23-25 days.” (See, e.g., Walgreen Compl. ¶ 89.) The Molloy reference is not *346 so dearly’ cumulative on the face of the Operative Complaints, nor lacking in mate--riality, that the Court may say that Plaintiffs have not alleged a plausible basis for relief. See Digital Control, Inc. v. Charles Mach. Works, 437 F.3d 1309, 1319 (Fed. Cir. 2006) (“As this court has previously noted, the scope'and content of prior art and what the prior art teaches are questions of fact.”).
Notably, all the. cases cited by Defendants in support of their argument that the EPPs and Retailers have failed to adequately allege intent to deceive the-PTO were decided on post-trial motions. See, e.g., Nobelpharma AB, 141 F.3d at 1059 ; C.R. Bard, 157 F.3d at 1340 ; Hebert v. Lisle Corp., 99 F.3d 1109 (Fed. Cir. 1996); Smith & Nephew, Inc, v. Interlace Med., Inc., 955 F.Supp.2d 69 (D. Mass. 2013).
For purposes of surviving a motion to dismiss, the EPPs and Retailers have pleaded that the Molloy reference was material and the applicants had the fraudulent intent to deceive the PTO in withholding that reference, '
f. Amount of Estrogen
Plaintiffs allege that the applicants fraudulently misrepresented the amount of estrogen in other commercially available oral contraceptives. Specifically, in response to the examiner’s initial determination that all claims were obvious, the applicants responded with a letter stating, in part, that “the claimed regimen leaves the patient with a total estrogen exposure per annum which is well below the total annual dose of estrogen in all other combination formulations commercially available in this country. Those all contain at least 30 meg EE (Craft uses 50 meg) .... ” (DPP Compl. ¶ 1370 Despite the applicants’ statement to the patent examiner, Plaintiffs allege, Hodgen and the other applicants knew of a commercially available oral contraceptive that “exposed women to half as much estrogen as claimed in the ’394 -Patent”—-namely, Loestrin 1/20— but failed to disclose it. (Walgreen Compl. ¶ 86.)
The Warner Chilcott Defendants, in rejoinder, say that we do not have the full story here. Rather, at another point during the’prosecution, the applicants disclosed Loestrin 1/20 and its estrogen content to the PTO (which they say is appareht on the face of the patent), as well as prior art references disclosing formulations with less than 30 meg of ethinyl estradiol. (Warner Chilcott Mot. to Dismiss 105.) Defendants further point the Court to a rejection letter dated November 28, 1995 as proof that the omission could not have been material. (Id.) In that letter, the examiner announced that she had found the applicants’ remarks “unpersuasive/’ (Id. (citation omitted).)
“A false or clearly misleading prosecution statement may permit an inference that the statement was made with deceptive intent.” Pippin’ Dots, Inc., 476 F,3d at 1347, “For. instance, evidence may establish that a patent applicant knew one fact and presented another, thus allowing the factfinder to conclude that the -applicant intended by the misrepresentation to deceive the examiner.” Id.
The Warner -Chilcott Defendants’,arguments are not sustainable merely on the face-' of Plaintiffs’ Operative Complaints, and are better reserved for either summary judgment or trial. On the face of the Operative Complaints, the Plaintiffs plead sufficient underlying facts to support a reasonable inference of intent to deceive the PTO and materiality, and accordingly, these issues will need to be resolved after the benefit of discovery.
g. Warner Chilcott’s Purported Knowledge of Fraud
The Warner Chilcott, Defendants argue that Plaintiffs have not ade *347 quately alleged that Warner Chilcott had knowledge of any fraud on the PTO. (Warner Chilcott Mot. to Dismiss 106.) To establish fraud on the PTO, a plaintiff must plead, and ultimately prove, “no less than ... intentional fraud involving, affirmative dishonesty.” Tyco Healthcare Grp. LP v. Mut. Pharm. Co., 762 F.3d 1338, 1350 (Fed. Cir. 2014) (quoting C.R. Bard, Inc., 157 F.3d at 1364 ). With an assignee, like Warner Chilcott, a plaintiff must establish, then, “that the defendant maintained and enforced the patent with knowledge of the fraudulent manner in which it was obtained.” Ritz Camera & Image, LLC, 700 F.3d at 506 ; see also Walker Process, 382 U.S. at 179 , 86 S.Ct. 347 (Harlan, J., concurring) (“[I]f the defendant was not the original patent applicant, he had been enforcing the patent with knowledge of the fraudulent manner in which it was obtained .... ”).
Plaintiffs here allege that Warner Chil-cott knew about the fraudulent omissions and misrepresentations during the ’894 patent prosecution because of letters Dr. Hodgen wrote to Warner-Lambert and Roger Boissonneault in 1990 and 1993, respectively. (DPP Compl. ¶¶ 142-44; Walgreen Compl. ¶ 90; EPP Compl. ¶ 168.) At the time of this contact; Mr. Boissonneault was the Vice President of Female Health Care at Parke Davis, which was owned by Warner Lambert; Mr. Boissonneault later served as Warner Chileott’s CEO from 2005 to 2013, during the enforcement of the ’394 patent. (DPP Compl. ¶ 144.) “Bois-sonneault and Hodgen exchanged information about plans to study whether administering Loestrin 1/20 for more than 21 days would reduce the incidence of bleeding and possibly provide additional patent coverage years before Hodgen conducted his studies and applied for a patent.” (Id. ¶ 143; see also Walgreen Compl. ¶ 90 (“The Applicants were aware of the Molloy reference, as shown by a letter Hodgen wrote to Warner-Lambert during December 1990.”).) Dr. Hodgen also sent a letter to Mr. Boissonneault in 1993 in an effort to persuade Parke Davis to pay EVMS for the “technology” used in the 1993 human study. (DPP Compl. ¶144.) The DPPs allege that this letter supports their allegation that Mr. Boissonneault knew of Dr. Hodgen’s human study in 1993 and provides the basis for a reasonable inference that Mr. Boissonneault knew the study had not shown a decrease in the incidence of breakthrough bleeding. (Id.) Following the letter, Mr. Boissonneault negotiated the terms of an agreement; the DPPs allege that the agreement, dated October 2,1994, “included a $1 million payment to EVMS in exchange for an assignment of EVMS’s interest in the patent application and any resulting patents to Warner Lambert.” (Id. ¶ 145.) Plaintiffs allege that Warner Chil-cott and Mr. Boissonneault knew that Dr. Hodgen’s 1993 human study had not been disclosed to the PTO during the ’394 patent prosecution and that they knew it was a material omission when the ’394 patent was listed and enforced. (DPP Compl. ¶¶ 139, 142, 147.)
This is enough upon which to make a reasonable inference that Mr. Boisson-neault had knowledge of the 1993 human study at the time of the patent enforcement. Reasonable inferences may further be drawn that Mr. Boissonneault, in light of his position at Warner Chilcott, had actual knowledge that the applicants misrepresented the amount of estrogen available in other commercially available oral contraceptives and that tüe applicants had fraudulently omitted the Molloy reference, (See, e.g., Walgreens Compl. ¶ 90; EPP Compl. ¶ 168.)
The sum of all this is that Plaintiffs have sufficiently alleged Walker Process fraud on the PTO, and those claims survive Defendant Warner Chilcott’s motion to dismiss.
*348 2. Sham Litigation
To survive a motion to dismiss on a sham litigation theory, a plaintiff must plausibly allege that the litigation was (1) “objectively baseless in the sense that no reasonable litigant could realistically expect success on the merits;” and (2) subjectively motivated by a desire to “conceal[ ] an attempt to interfere directly with the business relationships of a competitor through the use [of] the governmental process ... as an anticompetitive weapon.” Prof'l Real Estate Investors, Inc. v. Columbia Pictures Indus., 508 U.S. 49, 60-61 , 113 S.Ct. 1920 , 123 L.Ed.2d 611 (1993) (internal citation omitted). Only then does the suit fall within Noerr’s exception to immunity from liability. Nobelpharma AB, 141 F.3d at 1071 . To be sure, this is a high burden to meet; ,“[g]iven the presumption of patent validity and the burden on the patent challenger to prove invalidity by clear and convincing evidence, it will be a rare case in which a patentee’s assertion of its patent in the face of a claim of invalidity will be so unreasonable as to support a claim that the patentee has engaged in sham litigation.” Tyco Healthcare Grp. LP, 762 F.3d at 1345 .
Here, Plaintiffs allege that “[a] reasonable pharmaceutical company in Warner Chilcott’s position” would not have had a reasonable expectation of success on the merits in its infringement suit against Watson. (See DPP Compl. ¶ 179 (challenging only the Watson suit); see also EPP Compl. ¶¶ 173-76; 199-206; 230-81 (challenging the Watson, Lupin, and Mylan suits); Walgreen Compl. ¶¶ 100, 110, 115 (challenging the Watson, Lupin, and Mylan suits).) In its suit against Warner Chilcott, Watson had attacked the ’394 patent on three separate grounds: invalidity; unenforceability; and non-infringement. (DPP Compl. ¶ 181.) According to the DPPs’ Operative Complaint, discovery in the Warner Chilcott-Watson litigation revealed that Mr. Boissonneault learned of the 1993 human study. (See, e.g., id.) The FDA’s medical review of Loestrin 24, made public on March 24, 2008, further confirmed that Loestrin 24 did not provide for a significant reduction in the incidence of breakthrough bleeding. (Id.) The Operative Complaints allege that Watson would have prevailed in that litigation for the reasons alleged by Watson in its suit with Warner Chilcott and due to the defects alleged by Plaintiffs in this suit. (See, e.g., id. ¶ 182.) 32 In sum, the allegations state that “Warner Chilcott knew that the applicants procured the ’394 patent fraudulently before it listed the ’394 patent in the Orange Book for Loestrin 24, and before it asserted the patent in lawsuits filed against Watson, Lupin, and Mylan.” (EPP Compl. ¶ 169)
Accepting all facts alleged in the Operative Complaints as true, drawing all reasonable inferences in favor of Plaintiffs, and in light of the Court’s conclusion that Plaintiffs have alleged facts sufficient to conclude that Warner Chilcott had actual knowledge that the ’394 patent was fraudulently procured, Plaintiffs have stated a plausible claim for sham litigation. The *349 facts support the conclusion that the suits against the generic manufacturers were “objectively baseless” and that no reasonable litigant could have expected to succeed on the merits where it understood the ’394 patent to have been fraudulently procured. Prof'l Real Estate Investors, 508 U.S. at 60 , 113 S.Ct. 1920 . In other words, Warner Chilcott could not have expected to prove that the generics infringed a valid ’394 patent. Moreover, the facts support a conclusion that the patent infringement suits were litigation subjectively motivated by a desire to “conceal[] an attempt to interfere directly with the business relationships of a competitor through the ‘use of the governmental process ... as an anticompetitive weapon.’ ” Id at 60-61,113 S.Ct. 1920 (internal citation omitted).
3. Orange Book Listing
Plaintiffs allege that Warner Chil-cott further committed - fraud on the PTO by listing the ’394 patent in the Orange Book as the only patent covering Loestrin 24 or a method of using Loestrin 24, even though individuals at Warner Chilcott, including but not limited to then-CEO Roger Boissonneault, knew the ’394 patent was invalid or unenforceable. (See, e.g., Walgreen Compl. ¶¶ 72-73.) Plaintiffs allege that, ‘Warner Chilcott listed the ’394 patent in the Orange Book even though it knew that patent could not reasonably be asserted against generic manufacturers because it knew the patent was procured fraudulently, and also that the patent was invalid and unenforceable.” (Id. ¶ 93.) They allege that this constituted fraud and inequitable conduct on the PTO. In addition, Plaintiffs allege that Warner Chilcott knew that the ’394 patent was not valid, as it was “anticipated and obvious in light of the prior art” before listing the patent in the Orange Book. (Id. ¶ 94.) Plaintiffs allege that “Warner Chilcott’s listing of the ’394 [p]atent was objectively and subjectively baseless because Warner Chilcott did not believe and could not reasonably have believed that the ’394 [pjatent could be asserted against manufacturers of generic versions of Loestrin 24.” (Id. ¶ 97.) It was listed to create an obstacle to generic competition. (Id.) Defendants argue that this claim only survives if Plaintiffs’ Walker Process fraud or sham litigation claims survive. See Solodyn, 2015 WL 5458570 , *12 (holding that “listing presumptively valid patents in the Orange Book and enforcing them against infringers are not bases for an antitrust claim” (quoting In re Lipitor Antitrust Litig., No. 3:12-CV-2389 (PGS), 2013 WL 4780496 , at *21 (D.N.J. Sept.- 5, 2013))). Because the underlying conduct has survived' Defendants’ motion to dismiss, Plaintiffs have pleaded fraud on the PTO vis-á-vis Warner Chilcott’s Orange Book listing..
D. Product Hop
The Warner Chilcott Defendants move to dismiss Plaintiffs’ product hop claims. They argue that courts should not recognize a product hop theory under antitrust law so as to avoid being in the business of prohibiting “a company from deciding to stop manufacturing and marketing a product.” (Warner Chilcott Mot. to Dismiss 118; see also Warner Chilcott Reply 57-58.) If the Court does recognize a product hop theory, the. Warner Chilcott Defendants further argue that the facts alleged in the instant case do not state a claim for relief. (Warner Chilcott Mot. to Dismiss 113.) They contend that generic versions of Loestrin 24 have since entered the market and have been profitable. (See Warner Chilcott Reply 64 (“[T]he very fact that-six generics have been approved, to the tune of as many as 5 million generic prescriptions per month .... belies any claim that generics did not see a ‘cost efficient’ means of distribution ....” (citing DPP Compl. 76, Fig. 6)).)
Plaintiffs’ allegations are succinctly summarized as follows:
*350 (1) Minastrin 24 Fe is chemically and pharmaceutically identical to Loestrin 24 Fe—the only differences. are the addition of flavoring to the placebo pills and an instruction in the labeling to chew the tablets (the tablets themselves were already chewable); (2) in or about August 2013, Warner Chilcott stopped manufacturing and distributing Loestrin 24 Fe and started distributing Minastrin 24 Fe; (3) physicians substantially decreased the number of Loestrin 24 Fe prescriptions they wrote and* began prescribing Minastrin 24 Fe instead; and (4) the result was to substantially reduce the number of prescriptions that could be filled with generic Loestrin 24 Fe when it became available,in early 2014.
(Retailers’ Mem. in Opp’n to Warner Chilcott/Watson Mof. to Dismiss 55, EOF No. 207.) Plaintiffs further allege that, in executing the product hop, Defendants intended to suppress competition, and make monopoly profits. (See DPP Compl. ¶¶287-90.) .
A procjuct hop occurs when a brand-name drug manufacturer tweaks the drug “to prevent pharmacists from substituting a generic equivalent when presented with a prescription for the newly modified brand-name drug.” In re Asacol Antitrust Litig., No. 15-CV-12730-DJC, 2016 WL 4083333 , at *2 (D. Mass. July 20, 2016) (“Asacol”); see also New York ex rel. Schneiderman v. Actavis PLC, 787 F.3d 638 , 643 & n.2 (2d Cir. 2015) (“Namenda”) (noting that “conduct by a monopolist to perpetuate patent exclusivity through successive products” is “commonly known as ‘product hopping ”). To more effectively stymie generic competition with a product hop, “a brand-name manufacturer often removes the original drug from the market entirely, known as a ‘hard switch,’ right before patent expiration to deprive potential generic manufacturers a prescription base -for, their generic drugs.” Asacol, 2016 WL 4083333 , at *2.
Product hop claims are analyzed under § 2 of the Sherman Act, which “makes it illegal to ‘monopolize, or attempt to monopolize ... any part of the trade or commerce’ among the several States.” Diaz Aviation Corp. v. Airport Aviation Servs., Inc., 716 F.3d 256, 265 (1st Cir. 2013) (quoting 15 U.S.C. § 2 ). “To prove a violation of this statute, a plaintiff must demonstrate (1) that the defendant possesses ‘monopoly power in the relevant market,’ and (2) that the defendant has acquired or maintained that power by improper means.” Town of Concord v. Boston Edison Co., 915 F.2d 17, 21 (1st Cir. 1990) (quoting United States v. Grinnell Corp., 384 U.S. 563, 570-71 , 86 S.Ct.

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Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/8312376. Public record. Not legal advice.