TORRUELLA, Circuit Judge.
This appeal arises from several pharmaceutical antitrust actions that were consolidated and transferred to the United States District Court for the District of Rhode Island by the United States Judicial Panel on Multidistrict Litigation.
Defendant Warner Chilcott ("Warner") is a brand-name drug manufacturer that owns the patent covering the oral contraceptive Loestrin 24 Fe ("Loestrin 24"). After defendant Watson Pharmaceuticals, Inc. ("Watson") notified Warner that it would seek to introduce a generic version of Loestrin 24, Warner sued Watson for patent infringement. The parties settled on conditions that Watson delay entry of its generic version of Loestrin 24 and, in exchange, Watson entered into favorable promotional deals with Warner and received promises that Warner would not introduce its own generic version of Loestrin 24, among other things. Shortly thereafter, defendant Lupin Pharmaceuticals, Inc. ("Lupin") announced that it would introduce a generic version of Loestrin 24. Warner brought a patent infringement suit against Lupin. Again, the parties settled on terms that Lupin wait to introduce its generic Loestrin 24 in exchange for attorneys'
Two putative classes of plaintiffs—the Direct Purchaser Plaintiffs ("DPPs"), a group comprised of corporate entities that purchased Loestrin 24 directly from Warner, and End Payor Plaintiffs ("EPPs"), which consist of health and welfare benefit plans that have indirectly purchased, paid for, and provided reimbursement for their members' purchase of Loestrin 24, and individuals who purchased or paid for some or all of the purchase price of Loestrin 24-subsequently brought antitrust claims that the settlement agreements were violations of § 1 of the Sherman Act, 15 U.S.C. § 1.
Specifically, this antitrust case queries whether, following Actavis, such settlement agreements are subject to federal antitrust scrutiny where they do not involve reverse payments in pure cash form. The district court found that Actavis only applied to monetary reverse payments and dismissed on the basis that the EPPs and DPPs had alleged the existence of non-cash reverse payments only. Because we disagree with the district court's limited reading of Actavis, we vacate and remand. We begin with the relevant statutory and legal background, which provides the framework for understanding the facts in this appeal.
The Drug Price Competition and Patent Term Restoration Act of 1984, Pub.L. No. 98-417, 98 Stat. 1585, commonly known as the Hatch-Waxman Act, stipulates the process by which pharmaceutical firms may gain approval from the Food and Drug Administration ("FDA") to bring medications to the public marketplace. The Supreme Court in Actavis identified "four key features of the relevant drug-regulatory framework" under the Hatch-Waxman Act. 133 S.Ct. at 2227-29.
First, to market a new prescription drug, a brand-name drug manufacturer must submit a New Drug Application ("NDA") to the FDA and undergo a laborious and expensive approval process. 21 U.S.C. § 355(b)(1); see Actavis, 133 S.Ct. at 2228. Among other things, the NDA must include "the patent number and the expiration date of any patent which claims the drug . . . or which claims a method of using such drug." 21 U.S.C. § 355(b)(1). Upon receiving FDA approval, the brand manufacturer must publish a description of any patents associated with that drug in the Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. See Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S,
Second, the Hatch-Waxman Act promotes the availability of cheaper generic alternatives by allowing generic drug manufacturers to bypass certain aspects of the NDA process. Instead of filing an NDA, a generic manufacturer may file a less cumbersome Abbreviated New Drug Application ("ANDA") "specifying that the generic has the `same active ingredients as,' and is `biologically equivalent' to, the already-approved brand-name drug." Actavis, 133 S.Ct. at 2228 (quoting Caraco Pharm. Labs., Ltd., 132 S.Ct. at 1676); 21 U.S.C. § 355(j)(2). But, "[b]ecause the FDA cannot authorize a generic drug that would infringe a patent, the timing of an ANDA's approval depends on the scope and duration of the patents covering the brand-name drug." Caraco Pharm. Labs., Ltd., 132 S.Ct. at 1676.
Third, the Hatch-Waxman Act establishes procedures for resolving patent disputes between brand and generic drug manufacturers. 21 U.S.C. § 355(j)(2)(A)(vii); Actavis, 133 S.Ct. at 2228. When seeking FDA approval, the generic manufacturer must certify that it will not infringe the brand manufacturer's patents. 21 U.S.C. § 355(j)(2)(A)(vii); Actavis, 133 S.Ct. at 2228. It can make this certification in one of four ways:
Actavis, 133 S.Ct. at 2228 (quoting 21 U.S.C. § 355(j)(2)(A)(vii)(IV)).
The fourth alternative, also known as the Paragraph IV route, "counts as patent infringement and often `means provoking litigation'" by the brand manufacturer. Id. (citation omitted) (quoting Caraco Pharm. Labs., Ltd., 132 S.Ct. at 1677). Should the brand manufacturer bring a patent suit within forty-five days of the generic manufacturer making a Paragraph IV certification, the FDA may not approve the generic manufacturer's ANDA for a thirty-month period. 21 U.S.C. § 355(j)(5)(B)(iii); Actavis, 133 S.Ct. at 2228. Paragraph IV litigation between generic and brand-name drug manufacturers is particularly relevant here as it has led to the settlement arrangements identified in Actavis.
Fourth, the Hatch-Waxman Act provides incentives for the first generic manufacturer to file an ANDA through the Paragraph IV route: the generic will receive a 180-day period of exclusivity during which "no other generic can compete with the brand-name drug." Actavis, 133 S.Ct. at 2229; 21 U.S.C. § 355(j)(5)(B)(iv). This exclusivity period is potentially worth hundreds of millions of dollars to the first-filing generic manufacturer. See Actavis, 133 S.Ct. at 2229.
We turn to Actavis, where the Supreme Court analyzed settlement agreements
The Supreme Court answered in the affirmative. It rejected the argument that a settlement involving reverse payments is immune from antitrust scrutiny so long as any "anticompetitive effects [of the settlement] fall within the scope of the exclusionary potential of the patent," otherwise known as the "scope of the patent" test. Id. at 2230 (quoting FTC v. Watson Pharm., Inc., 677 F.3d 1298, 1312 (11th Cir.2012)).
The Supreme Court acknowledged the "general legal policy" in favor of settlements,
Id. at 2237. While the Supreme Court declined to adopt the Federal Trade Commission's ("FTC") suggestion that reverse payments be considered "presumptively unlawful," it determined that the potential anticompetitive effects of a reverse payment are subject to the rule of reason test. The "rule of reason" is a means of evaluating a restraint on trade and determining "whether under all the circumstances of
Nevertheless, the Supreme Court acknowledged that Actavis left many questions unanswered as to how these cases would be litigated and "le[ft] to the lower courts the structuring of the present rule-of-reason antitrust litigation." Actavis, 133 S.Ct. at 2238.
"In reviewing the grant of a motion to dismiss, we recount the facts as alleged in the operative complaint[s]." Ruivo v. Wells Fargo Bank, N.A., 766 F.3d 87, 88 (1st Cir.2014). This appeal involves two operative complaints that allege substantially the same facts, filed by the EPPs and DPPs, respectively.
Loestrin 24 contains the active ingredients norethindrone acetate and ethinyl estradiol, both of which the FDA has approved as oral contraceptives since the 1970s. Previous versions of Loestrin, including Loestrin 21 and Loestrin 1/20, contain twenty-one tablets taken on a daily basis. The patient would then take a week of placebo pills or skip tablets for a week, depending on the version of Loestrin.
Studies conducted in the 1990s examined whether taking Loestrin tablets for a longer duration than the twenty-one day period decreased the incidence of intermenstrual bleeding, or "spotting," a common side-effect of oral contraceptives. The studies yielded inconsistent results as to whether taking Loestrin tablets for longer periods actually reduced intermenstrual bleeding. Nevertheless, U.S. Patent No. 5,552,394 (the "'394 Patent"), entitled "Low Dose Oral Contraceptives with Less Breakthrough Bleeding and Sustained Efficacy," was granted 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."
Defendant Warner
Only several months after the FDA approved Loestrin 24, on June 19, 2006, defendant Watson sent Warner a notice letter that it had filed an ANDA to market a generic of Loestrin 24. The notice letter contained a Paragraph IV certification that the commercial manufacture, use, or sale of Watson's generic Loestrin 24 would not
In January 2009, just before the expiration of the stay, Watson and Warner entered into a stipulation of dismissal and Exclusion Payment Agreement. Under the agreement, Watson agreed that it would delay selling its Loestrin 24 generic until the earliest of the following: (i) January 22, 2014; (ii) 180 days before Warner gave a third party the right to market a Loestrin 24 generic in the United States; (iii) the date another version of a Loestrin 24 generic entered the market; or (iv) the date on which a third party obtained a final, non-appealable judicial order that the '394 patent is invalid, unenforceable, or not infringed by the third party's generic Loestrin 24. In exchange, Warner agreed to several provisions:
Six months after the announcement of Warner and Watson's agreement, on July 30, 2009, defendant Lupin
Before the close of discovery, in October 2010, Warner entered into a non-competition agreement with Lupin and dismissed the suit. Under the agreement, Lupin forfeited its challenge to the '394 Patent and agreed to delay entry of its generic Loestrin 24 until July 22, 2014, the month that the '394 Patent was set to expire and six months after Watson was scheduled to enter the market with its Loestrin 24 generic. In exchange, Warner agreed to the following provisions:
In their complaint, the DPPs allege that Warner and Watson agreed to keep Watson's generic Loestrin 24 off of the market until January 22, 2014, in exchange for payments that Warner made to Watson when, absent the agreement, Watson could have introduced a generic Loestrin 24 as early as 2009. The DPPs contend that this anticompetitive conduct insulated Loestrin 24 from generic competition, which would typically be priced far below the brand and eventually lead to reduced brand prices. In this way, Warner and Watson's conduct allegedly caused antitrust harm by subjecting the DPPs to artificially inflated prices.
The EPPs allege violations of § 1 of the Sherman Act as to both the Warner-Watson and Warner-Lupin agreements. They contend that the agreements required that Warner make payments to Watson and Lupin in exchange for Watson's and Lupin's promise not to market their versions of generic Loestrin 24 until January 22, 2014, and July 22, 2014, respectively. In addition, the EPPs bring state claims for unjust enrichment and allege that the Warner-Watson and Warner-Lupin agreements constituted unlawful restraints of trade in violation of various state antitrust laws.
The defendants filed two motions to dismiss, one as to the DPP complaint and the other as to the EPP complaint, under Federal Rules of Civil Procedure 12(b)(6) and 12(c). The defendants contended that Actavis
The district court granted the motions to dismiss in a single opinion and order on the basis that Actavis was limited to reverse payments in pure cash form. In re Loestrin 24 Fe Antitrust Litig., 45 F.Supp.3d 180 (D.R.I.2014) [In re Loestrin]. Scouring the language of Actavis, the district court noted that "[t]he discussion of patent settlements in Actavis fixates on the one form of consideration that was at issue in that case: cash." Id. at 189. The district court also took into account the five considerations contemplated by the Supreme Court in its determination that subjecting reverse payments to antitrust scrutiny outweighed the benefits of settlement. In the district court's view, these considerations "guide the inquiry as to whether a settlement payment satisfies the rule of reason," and "require[], on the part of the plaintiff, and ultimately the reviewing court (or the jury), an ability to assess or calculate the true value of the payment made by the patentee to the generic competitor." Id. at 190. Whereas a court can measure the value of a cash settlement, "a non-cash settlement, particularly one that is multifaceted and complex. . ., is almost impossible to measure against these five factors." Id. at 191. In addition, the district court noted that "a cautious approach" was warranted as "Actavis marked a dramatic departure from the approach of the courts of appeal, and an important shift in the common law." Id. at 192.
Nevertheless, the district court candidly conceded that it had significant reservations about its holding: if antitrust scrutiny is limited to reverse payments in cash, "non-cash pay for delay arrangements are likely to evade Sherman Act scrutiny so long as pharmaceutical companies take the obvious cue to structure their settlements in ways that avoid cash payments." Id. at 193. The district court noted that "the Plaintiffs have asserted, in two robust complaints, facts demonstrating illegal contracts or combinations in restraint of trade undertaken by the Defendants." Id. However, because the district court dismissed the case on the basis that the reverse payments were not in cash form, it 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.
The district court entered final judgment as to the DPPs' claim under Rule 58 of the Federal Rules of Civil Procedure, noting that their case was "immediately appealable" as their complaint has been dismissed in its entirety. The district court entered final judgment as to the EPPs' federal antitrust claims under Rule 54(b) of the Federal Rules of Civil Procedure and stayed their remaining claims. The DPPs and EPPs timely appealed the
We review a dismissal under Rule 12(b)(6) de novo. Ocasio-Hernández v. Fortuño-Burset, 640 F.3d 1, 7 (1st Cir. 2011). "For the purposes of our review, we accept as true all well-pled facts alleged in the complaint and draw all reasonable inferences in [the plaintiffs'] favor." Evergreen Partnering Grp., Inc. v. Pactiv Corp., 720 F.3d 33, 36 (1st Cir.2013). "A motion for judgment on the pleadings [under Rule 12(c)] is treated much like a Rule 12(b)(6) motion to dismiss," with the court viewing "the facts contained in the pleadings in the light most favorable to the nonmovant and draw[ing] all reasonable inferences therefrom." Pérez-Acevedo v. Rivero-Cubano, 520 F.3d 26, 29 (1st Cir. 2008) (quoting R.G. Fin. Corp. v. Vergara-Núñez, 446 F.3d 178, 182 (1st Cir.2006)).
"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.'" Iqbal, 556 U.S. at 678, 129 S.Ct. 1937 (quoting Twombly, 550 U.S. at 570, 127 S.Ct. 1955). The pleadings need not contain "detailed factual allegations" but must provide "more than labels and conclusions, and a formulaic recitation of the elements of the cause of action will not do." Twombly, 550 U.S. at 555, 127 S.Ct. 1955. Although the pleading standards articulated in Twombly are now ubiquitous in the legal world, 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," id. at 554-55, 127 S.Ct. 1955, and this court 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, Evergreen Partnering Grp., 720 F.3d at 46-47.
As the district court addressed only the question of whether Actavis reached non-cash reverse payments, today we choose to limit ourselves to that query as well. For the reasons discussed herein, we conclude that the district court erred in determining that non-monetary reverse payments do not fall under Actavis's scope.
The district court reasoned that the reverse payments alleged in Actavis involved only cash payments, but that is not so: in Actavis, it was alleged that the reverse payments involved side deals in which the generic manufacturers agreed to promote the brand name drug at issue in exchange for multi-million dollar payments from the brand manufacturer. 133 S.Ct. at 2229; Watson Pharm., Inc., 677 F.3d at 1305 (describing the terms of the settlement agreements). This fact alone 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 and militates against limiting the Supreme Court's decision to pure cash payments.
The district court also analyzed the language of Actavis, noting that the Supreme Court was "fixated" on cash. But the district court overstates its case. Indeed, the Court in Actavis explained that, "in substance, the plaintiff agreed to pay the
In re Loestrin, 45 F.Supp.3d at 194 (footnote and citation omitted).
True, Actavis does contain references to money. See Actavis, 133 S.Ct. at 2233 (describing reverse payment settlements as an arrangement "in which A, the plaintiff, pays money to defendant B purely so B will give up the patent fight"); id. (explaining that, in reverse payment settlements, a party "walks away with money simply so it will stay away from the patentee's market"). But the key word used throughout the opinion is "payment," which connotes a much broader category of consideration than cash alone. Black's Law Dictionary (10th ed.2014) (defining "payment" as the "performance of an obligation by the delivery of money or some other valuable thing accepted in partial or full discharge of the obligation" and "the money or other valuable thing so delivered in satisfaction of an obligation" (emphases added)). As the Third Circuit observed,
King Drug Co. of Florence, Inc. v. Smithkline Beecham Corp., 791 F.3d 388, 406 (3d Cir.2015); see also id. at 409 (holding, post-Actavis, that a no-AG agreement "is subject to antitrust scrutiny under the rule of reason").
Nor are we the first court to determine that Actavis should reach non-monetary reverse payments. Of the many district courts and the single court of appeals to have addressed this question, the overwhelming majority have declined to limit Actavis to cash payments. See King Drug Co. of Florence, Inc., 791 F.3d at 403 ("We do not believe Actavis's holding can be limited to reverse payments of cash."); In
To be sure, the district court was correct that the language of Actavis emphasizes that the value of a reverse payment is a key component in determining whether it is unlawful. In discussing how to apply the rule of reason analysis to reverse payments, the Supreme Court explained, "the likelihood of a reverse payment bringing about anticompetitive 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. Such language emphasizes that the size of the reverse payment, particularly as it relates to potential litigation expenses, is central to the antitrust query and requires that the reviewing court or factfinder assess the value of the payment.
Similarly, as the district court noted, the five considerations set forth by the Supreme Court
On this basis, the district court determined that it was "almost impossible" to measure non-cash settlements such as those at issue here. In re Loestrin, 45 F.Supp.3d at 191. Although the value of non-cash reverse payments may be much more difficult to compute than that of their cash counterparts, antitrust litigation often requires an "elaborate inquiry into the reasonableness of a challenged business practice" and, as a result, is "extensive and complex." Maricopa Cty. Med. Soc'y, 457 U.S. at 343, 102 S.Ct. 2466. In other words, antitrust litigation already requires courts to make intricate and complex judgments about market practices.
We agree with those courts that, rather than rejecting wholesale Actavis's applicability to non-cash payments, have required 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.'" In re Actos End Payor Antitrust Litig., 2015 WL 5610752, at *13. Consistent with Twombly, which declined to "require heightened fact pleading of specifics," Twombly, 550 U.S. at 570, 127 S.Ct. 1955, we do not require that the plaintiffs provide precise figures and calculations at the pleading stage, In re Actos End Payor Antitrust Litig., 2015 WL 5610752, at *13. 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." In re Aggrenox Antitrust Litig., 94 F.Supp.3d at 244-45. 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. See In re Niaspan Antitrust Litig., 42 F.Supp.3d at 753 (describing Twombly's applicability to the Actavis inquiry).
On appeal, the defendants do not strenuously argue that Actavis should be limited to cash payments, instead focusing their briefing on whether the plaintiffs adequately pled that the provisions at issue in the Warner-Watson and Warner-Lupin settlement agreements are unlawful reverse payments under Actavis. As the district court did not address these issues, we remand for the district court to evaluate these remaining questions in the first instance. The Supreme Court acknowledged that Actavis had opened the door to a new landscape of litigation and "le[ft] to the lower courts the structuring of the present rule-of-reason antitrust litigation." Actavis, 133 S.Ct. at 2238. At this juncture, we feel that the most prudent course is to proceed one step at a time, and we therefore leave for another day
For the foregoing reasons, the judgment is vacated and the case is remanded for further proceedings consistent with this opinion. No costs are awarded.
15 U.S.C. § 1.
We note, however, that there is overlap between the five considerations and the preexisting elements of the rule of reason. For example, the First Circuit's rule of reason analysis queries, among other things, whether the "agreement involved the exercise of power in a relevant economic market." Stop & Shop Supermarket Co., 373 F.3d at 61. In that same vein, Actavis explains how to evaluate the market power question: "the size of the payment from a branded drug manufacturer to a prospective generic is itself a strong indicator of power." Actavis, 133 S.Ct. at 2236 (internal quotation marks omitted). Similarly, the First Circuit rule of reason includes as an element the anticompetitive consequences of the alleged agreement, and the first of the five considerations articulated by the Supreme Court explains that a reverse payment may have significant anticompetitive effects where it "amounts to a purchase by the patentee of the exclusive right to sell its product." Id. at 2234.