Court Opinion

ID: 4676861
Source: CourtListenerOpinion
Date Created: 2021-04-13 19:01:23.193919+00
Date Added: 2024-06-11T08:03:34.980307
License: Public Domain

PUBLISHED

                      UNITED STATES COURT OF APPEALS
                          FOR THE FOURTH CIRCUIT

                                      No. 19-2233

MAYOR AND CITY COUNCIL OF BALTIMORE; GOVERNMENT EMPLOYEES
HEALTH ASSOCIATION, on behalf of itself and all others similarly situated,

                    Plaintiffs - Appellants,

             v.

ACTELION PHARMACEUTICALS LTD.; ACTELION PHARMACEUTICALS US,
INC.; JANSSEN RESEARCH & DEVELOPMENT, LLC,

                    Defendants - Appellees,

             and

ACTELION CLINICAL RESEARCH, INC.,

                    Defendant.

Appeal from the United States District Court for the District of Maryland, at Baltimore.
George L. Russell, III, District Judge. (1:18-cv-03560-GLR)

Submitted: January 29, 2021                                    Decided: April 13, 2021

Before NIEMEYER, WYNN and FLOYD, Circuit Judges.

Vacated and remanded by published opinion. Judge Niemeyer wrote the opinion, in which
Judge Wynn and Judge Floyd joined.
Sharon K. Robertson, David O. Fisher, COHEN MILSTEIN SELLERS & TOLL, New
York, New York, for Appellants. Gregory T. Lawrence, LAWRENCE LAW, LLC,
Baltimore, Maryland; Katherine B. Forrest, Damaris Hernández, CRAVATH, SWAINE &
MOORE LLP, New York, New York, for Appellees.

                                      2
NIEMEYER, Circuit Judge:

       The plaintiffs 1 commenced this antitrust class action against Actelion, 2 alleging that

Actelion extended its patent monopoly for its branded drug Tracleer — a drug to treat

pulmonary artery hypertension — beyond the patent’s expiration date. They alleged that

Actelion did so “through illegitimate means” with the intent of precluding competition

from generic drug manufacturers and charging supracompetitive prices for Tracleer, in

violation of federal and state antitrust laws. They claim that as a result of Actelion’s illegal

monopolization, they were injured by having to pay supracompetitive prices for Tracleer

for some three years after Actelion’s patent for Tracleer expired.

       On Actelion’s motion, the district court dismissed the plaintiffs’ complaint under

Federal Rule of Civil Procedure 12(b)(6), ruling that all but four of the plaintiffs’ claims

were barred by the applicable four-year statutes of limitations because the action was

commenced on November 19, 2018, more than four years after “Actelion’s last overt

anticompetitive act” in February 2014. The court identified that act as the consummation

of settlement agreements between Actelion and several generic manufacturers, resulting in

the dismissal of the manufacturers’ antitrust actions against Actelion. With respect to the

four claims that it held were not barred by limitations — claims made under the laws of

Maine, Minnesota, Vermont, and Wisconsin — the court ruled that the plaintiffs lacked

       1
         Mayor and City Council of Baltimore and Government Employees Health
Association.
       2
         Actelion Pharmaceuticals Ltd.; Actelion Clinical Research, Inc.; Actelion
Pharmaceuticals US, Inc.; and Janssen Research & Development, LLC, collectively,
“Actelion.”
                                               3
standing to assert them because the plaintiffs made no purchases of Tracleer in those States

and thus suffered no harm that implicated their laws.

          On appeal, we vacate and remand, concluding that the plaintiffs’ antitrust claims did

not accrue until the plaintiffs were injured by paying supracompetitive prices for Tracleer

after the patent expired in November 2015.           Therefore, their action commenced in

November 2018 was timely. Moreover, even if the February 2014 date, when Actelion

entered into agreements settling the generic manufacturers’ antitrust claims, marked the

last anticompetitive act, damages could not then have been recovered by plaintiffs because

their claims would not have been ripe for judicial resolution in view of the speculative

nature of future conduct that might have thereafter occurred. Therefore, limitations would

not begin to run until the claims became ripe. And in any event, because the plaintiffs

alleged that Actelion continued with anticompetitive acts after November 2015 in selling

Tracleer at supracompetitive prices, new limitations periods began to run from each sale

that caused the plaintiffs damages. Accordingly, we vacate the district court’s limitations

ruling.

          As to the district court’s standing ruling, we largely agree with the district court.

But while the plaintiffs cannot for that reason seek relief under the laws of States in which

they made no purchases of Tracleer — i.e., Maine, Minnesota, Vermont, and Wisconsin,

as well as others — they nonetheless might, if a class is certified under Rule 23(c), be able

to advance claims under those laws on behalf of class members who purchased Tracleer in

those States. Accordingly, we conclude that the allegations asserting violations of the laws

in States where plaintiffs did not purchase Tracleer may yet be considered when

                                                4
determining whether the plaintiffs can, based on a Rule 23 analysis, represent class

members who purchased Tracleer in those States, and if they can, then whether the

plaintiffs can include those claims.

                                               I

       The facts alleged in the complaint are, for purposes of this appeal, taken as true, as

the district court’s dismissal order was based on Federal Rule of Civil Procedure 12(b)(6).

       The complaint alleges that Actelion is a pharmaceutical company that obtained an

exclusive license under a patent for Tracleer — U.S. Patent No. 5,292,740 (Patent ’740)

— which was issued in 1994 to Hoffman-LaRoche, Inc. Tracleer, which contains the

compound bosentan, is the only oral treatment for pulmonary arterial hypertension, and

Actelion made billions of dollars in profits from sales of the drug. Patent ’740 expired on

November 20, 2015.

       For some three years after Patent ’740 expired, no competitor brought a generic

version of Tracleer to market, and Actelion was thus able to continue to charge the same

supracompetitive prices for Tracleer that it had charged before the patent expired. In their

complaint, the plaintiffs alleged that this absence of competition was attributable to a multi-

year scheme by Actelion to block at least four generic manufacturers from filing

applications for approval of a generic version of Tracleer with the intent to maintain its

patent monopoly power beyond the expiration date, in violation of the antitrust laws. As

alleged, the generic drug manufacturers sought to obtain from Actelion, beginning in 2009,

samples of Tracleer to enable them to develop a generic drug. This was necessary because

                                              5
a generic manufacturer is not permitted to simply manufacture its own sample, even if it

knows how to; it must create a generic product that is proven to be bioequivalent to the

branded product, which requires that it have samples of that branded product. The four

generic manufacturers — Zydus Pharmaceuticals (USA) Inc., Apotex Inc., Actavis Inc.,

and Roxane Laboratories, Inc. — repeatedly, over the period from 2009 to 2012, requested

to purchase samples from Actelion, and on each occasion Actelion refused, stating that it

“ha[d] the right to choose with whom it d[id] business and to whom it [would] sell its

products.” At the same time, Actelion also, by contract, restricted its own distributors from

selling samples of Tracleer to generic drug manufacturers.

       When the generic drug manufacturers threatened to sue Actelion for violation of the

antitrust laws, Actelion filed a preemptive action in September 2012 against Apotex and

Roxane, seeking a declaratory judgment that it had the right to choose with whom it would

do business and to whom it would sell its products, and that it had no duty to deal with

Apotex or Roxane. Apotex and Roxane filed a counterclaim alleging that Actelion’s

conduct violated the antitrust laws, and Actavis and Zydus intervened to join in that claim.

In denying Actelion’s motion to dismiss the antitrust counterclaim, the district court

indicated that it would be preparing a substantial written opinion to support its ruling. In

so indicating, the court stated, “[W]hat I’m having difficulty [with] is . . . the notion that

[Actelion’s interpretation] somehow would allow a brand name manufacturer who has, I

will call it, Section 2 [of the Sherman Act] intent to . . . confer upon them some kind of

Section 2 immunity where . . . conduct beyond . . . a mere refusal to sell suggests an intent

to extend or maintain a monopoly.” Before the district court could issue its opinion,

                                              6
however, Actelion entered into settlement agreements with the generic drug manufacturers

in February 2014, the terms of which have not been disclosed. The plaintiffs alleged in

their complaint that “[t]he settlements themselves [were] consequences of Actelion’s

anticompetitive actions.”

      Thereafter, Actelion continued — up to and beyond the expiration date of Patent

’740 — to refuse to sell samples to different generic companies who requested them.

      The complaint alleged, “But for Actelion’s refusal to allow the generic[]

[manufacturers] to purchase samples, one or more generics would have been available in

November 2015” to provide competition and competitive prices. It contended further that

Actelion’s refusal to do business with the generic manufacturing companies was

      irrational but for its anticompetitive effects. . . . There is no legitimate, non-
      pretextual, procompetitive business justification for Actelion’s refusal to sell
      samples of Tracleer to generic manufacturers. . . . Actelion’s scheme was
      intended to impede generic competition to Tracleer, and it succeeded in
      doing so.

Thus, it alleged that Actelion possessed monopoly power and that,

      [t]hrough its overarching anticompetitive scheme . . . willfully maintained its
      monopoly power in the relevant market using restrictive or exclusionary
      conduct . . . . Actelion’s anticompetitive conduct was done with the specific
      intent to maintain its monopoly in the market for bosentan in the United
      States.

The complaint summarized that Actelion’s anticompetitive scheme was successful in

“extend[ing] its dominance in [the relevant] market, maintain[ing] Tracleer’s prices at

supracompetitive levels,” and “depriv[ing] the market of competition.” According to the

complaint, this illegal monopolization not only harmed competition but caused the

                                              7
plaintiffs to pay supracompetitive prices for some three years after Actelion’s patent

expired. As alleged:

       Actelion’s anticompetitive scheme has been 100% effective. Nearly three
       years after the expiration of the Tracleer patent, no generic Tracleer is
       available in the United States.

       Actelion’s scheme has forced Plaintiffs and other purchasers to pay higher
       prices for bosentan for far longer than they otherwise would have. Without
       Actelion’s years-long blockade, at least one generic version of Tracleer
       would have been available in the [United States] at or around the expiration
       of Tracleer’s patent protection in November 2015. [Actelion’s] unlawful
       conduct has barred generic versions of Tracleer from the market, prevented
       competition, and cost purchasers hundreds of millions of dollars in
       overcharge damages.

       More particularly, the complaint alleged that the plaintiff City of Baltimore

“purchased, paid, and/or provided reimbursement for some or all of the purchase price of

Tracleer in Maryland” and “[a]bsent the unlawful conduct alleged herein, the City of

Baltimore would have purchased less expensive generic alternatives rather than branded

Tracleer.” And it alleged the same for the plaintiff Government Employees Health

Association, which was providing benefits to 1.5 million people residing in all 50 States as

well as the District of Columbia and Puerto Rico.

       The complaint concluded with allegations that Actelion violated § 2 of the Sherman

Act, 15 U.S.C. § 2, as made privately enforceable through §§ 4 and 16 of the Clayton Act,

id. §§ 15, 26. It also alleged violations of 25 state antitrust statutes and 20 state consumer

protection statutes.

       Actelion filed a motion to dismiss the complaint under Federal Rule of Civil

Procedure 12(b)(6), raising several arguments for dismissal, including the two that are at

                                              8
issue in this appeal. It contended that all but four of the plaintiffs’ claims were time-barred

by four-year statutes of limitations because the last overt act alleged by the plaintiffs

occurred in February 2014, when the settlement agreements were reached, and the

plaintiffs’ complaint was filed more than four years later, in November 2018. It also

contended that the plaintiffs lacked standing to pursue claims under the laws of States in

which they themselves had not purchased Tracleer.

       The district court granted Actelion’s motion to dismiss, relying on both grounds. It

characterized the plaintiffs’ complaint as a refusal-to-deal case in which Actelion’s alleged

refusals spanned from 2009 to February 2014. And it concluded that “when [a] plaintiff

charges a continual refusal to deal, the statute of limitations commences to run from the

last overt act causing injury to the plaintiff’s business” (quoting Charlotte Telecasters, Inc.

v. Jefferson-Pilot Corp., 546 F.2d 570, 572 (4th Cir. 1976)), which it identified as the

February 2014 settlements. The court rejected the plaintiffs’ argument that their claims

accrued on November 20, 2015, because the “expiration of the Patent is not an overt act by

Actelion.” It also rejected the plaintiffs’ alternative argument that Actelion was engaged

in a continuing violation such that the statutes of limitations began to run from each sale

of Tracleer at supracompetitive prices. In doing so, the court concluded — mistakenly —

that the complaint did not allege that Actelion “actually” charged supracompetitive prices

or that it engaged in “illegal price fixing or predatory pricing,” which traditionally have

involved continuing violations.

       As to the plaintiffs’ four remaining claims — those alleging violations of the laws

of Maine, Minnesota, Vermont, and Wisconsin (which have six-year statutes of limitations)

                                              9
— the district court held that the plaintiffs lacked standing to bring those claims because

they failed to allege that they “suffered any specific harm in Maine, Wisconsin, Minnesota,

and Vermont” so as to implicate those States’ statutes.

       From the district court’s order of dismissal dated September 30, 2019, the plaintiffs

filed this appeal.

                                              II

       With respect to the district court’s statute-of-limitations ruling, the plaintiffs

contend that the district court committed “three serious errors.” First, the court erroneously

concluded that “the statute of limitations began to run against [the plaintiffs] before [they]

suffered any injury, in clear contravention of the standard antitrust accrual rule.” Under

that rule, the statute of limitations would begin to run once the plaintiffs were actually

injured — that is, once Actelion’s patent expired and the plaintiffs paid supracompetitive

prices for Tracleer. Second and similarly, the court failed to accept that an action “does

not accrue with respect to a plaintiff’s damages until those damages become more than

speculative,” citing Zenith Radio Corp. v. Hazeltine Rsch., Inc., 401 U.S. 321, 339 (1971).

And third, the court “failed to apply the continuing-violation doctrine,” under which the

statutes of limitations would begin to run from each sale after November 2015 that Actelion

made at supracompetitive prices.

       Addressing the limitations issues requires an understanding of the nature of the

plaintiffs’ causes of action and when they accrued. The plaintiffs’ principal cause of action

is brought under § 4 of the Clayton Act, which provides that “any person who shall be

                                             10
injured in his business or property by reason of anything forbidden in the antitrust laws

may sue therefor,” 15 U.S.C. § 15(a) (emphasis added), and § 2 of the Sherman Act, which

prohibits the willful maintenance of monopoly power, see id. § 2. Section 4B of the

Clayton Act provides that any such action is “barred unless commenced within four years

after the cause of action accrued.” Id. § 15b (emphasis added). 3 The Supreme Court has

held that “[g]enerally, a cause of action accrues and the statute begins to run when a

defendant commits an act that injures a plaintiff’s business.” Zenith, 401 U.S. at 338

(emphasis added). Because a cause of action under § 4 of the Clayton Act vindicates one

who is injured by a violation of the antitrust laws, it accrues when the plaintiff first suffers

injury. See id. at 339. Thus, when “a plaintiff feels the adverse impact of an antitrust

conspiracy on a particular date, a cause of action immediately accrues to him.” Id. Indeed,

without injury, a cause of action does not exist and therefore cannot accrue. Following this

principle, the Zenith Court described its task as determining “whether Zenith could have

recovered . . . damages [it suffered during the 1959–1963 period] if it had brought suit for

them in 1954, for if it could not, it would follow for the reasons stated above that it must

be permitted to recover them now.” Id. at 340.

       In this case, according to the plaintiffs’ complaint, the plaintiffs had no cause of

action as of February 2014 — when, according to the district court, the last overt act took

place. The district court reasoned that this was a refusal-to-deal case and all refusals took

place before the 2014 settlements, which were more than four years before suit was filed.

       3
        We proceed with the understanding that analysis of the statute of limitations under
the Clayton Act is the same for each relevant state statute.
                                              11
But the court did not address whether those refusals on or before the February 2014

settlements injured the plaintiffs at that time. The district court’s reasoning resulted from

a misunderstanding of the nature of the causes of action alleged in the plaintiffs’ complaint

and of the nature of the injury alleged.

       The plaintiffs’ federal antitrust claims rest on § 2 of the Sherman Act, 15 U.S.C.

§ 2, which requires them to show (1) that Actelion possessed monopoly power in a relevant

market — i.e., the power to control prices or exclude competition — and (2) that it willfully

acquired or maintained that power. See United States v. Grinnell Corp., 384 U.S. 563,

570–71 (1966). They would also have to show under § 4 of the Clayton Act that they were

directly — not proximately — injured by the violation. See 15 U.S.C. § 15; Associated

Gen. Contractors of Cal., Inc. v. Cal. State Council of Carpenters, 459 U.S. 519, 540–46

(1983).

       While the plaintiffs’ complaint acknowledged that Actelion possessed legal

monopoly power during the period of its patent license, it alleged that monopolization in

violation of § 2 of the Sherman Act occurred following the expiration of the patent in

November 2015 and continued for at least three years thereafter, during which Actelion

was able to control prices. The complaint alleged that Actelion was able to do so by

deliberately delaying competition from generic manufacturers by blocking their ability to

develop generic drugs by refusing to sell them the needed samples. While Actelion’s

refusals might have amounted — at least as claimed by the generic manufacturers — to an

abuse of patent monopoly power that injured the generic manufacturers, patent abuse is not

the nature of the plaintiffs’ alleged claims. The plaintiffs alleged that Actelion willfully

                                             12
maintained illegal monopoly power beginning in November 2015 (after the patent expired)

by having excluded competition.

        Thus, the antitrust violations alleged by the plaintiffs are that Actelion maintained

monopoly power beginning in November 2015, as manifested by the supracompetitive

prices it charged them for Tracleer beginning at that point. And as important, the plaintiffs

did not allege that Actelion’s refusals to provide samples to the generic manufacturers

caused them their injury. Rather, that was the means by which Actelion was able to extend

illegally its patent monopoly following the patent’s expiration. Stated differently, the

complaint alleged that Actelion began its anticompetitive scheme before the expiration of

its patent, when it still had legal monopoly power over sales of Tracleer, but that the scheme

had no illegal effect until it exercised its monopoly power beyond November 2015, when

the patent expired and it was yet able to charge monopoly prices. Accordingly, it was also

only then — in November 2015 — that the plaintiffs could have been injured as a result of

Actelion’s monopolistic prices. In short, because the plaintiffs were not injured in 2014,

they had no cause of action in 2014, and thus limitations could not have begun to run in

2014.

        Even were we to assume that in February 2014 the plaintiffs had some form of action

— which they did not allege — their claim at that time could only have been for future

damages occurring after November 2015, and those damages would have been too

speculative to recover. In that situation, as Zenith teaches, the cause of action would accrue

only when such damages occurred:

                                             13
       In antitrust . . . actions, refusal to award future [damages] as too speculative
       is equivalent to holding that no cause of action has yet accrued for any but
       those damages already suffered. In these instances, the cause of action for
       future damages, if they ever occur, will accrue only on the date they are
       suffered; thereafter the plaintiff may sue to recover them at any time within
       four years from the date they were inflicted.

Zenith, 401 U.S. at 339; see also Charlotte Telecasters, 546 F.2d at 573 (“[A] cause of

action for future damages does not accrue until the damages become reasonably

ascertainable and, therefore, capable of proof”); South Carolina v. United States, 912 F.3d

720, 726, 730 (4th Cir. 2019) (“[A] plaintiff’s claim is not ripe for judicial review ‘if it

rests upon contingent future events that may not occur as anticipated, or indeed may not

occur at all’” (quoting Scoggins v. Lee’s Crossing Homeowners Ass’n, 718 F.3d 262, 270

(4th Cir. 2013))).

       To avoid the consequences of applying these principles, Actelion argues that in

February 2014, the plaintiffs “suffered an injury to their future economic interests”

(emphasis added), thus causing limitations to begin running in 2014. Such an argument,

however, would require anticipation of (1) a future antitrust violation, as the plaintiffs

alleged, (2) the continued exclusion of generic manufacturers after November 2015, and

(3) Actelion’s continuing ability to charge supracompetitive prices. Relying on “future

economic interests” that were dependent on such future events would simply be untenable.

If merely an overt act in 2014 without injury were to be the starting gate for limitations to

run, then all those who would first suffer antitrust injury more than four years after that

overt act “would be forever incapable of recovery.” Zenith, 401 U.S. at 340. Such a

proposition makes no sense, as recognized in Zenith.

                                             14
       At bottom, the plaintiffs’ cause of action, as defined by 15 U.S.C. §§ 2 and 15,

accrued when they were injured, and, as they alleged, they were first injured in November

2015. As we have stated, “the four-year statute of limitations began to run [from] the date

of the injury.” Detrick v. Panalpina, Inc., 108 F.3d 529, 540 (4th Cir. 1997) (emphasis

added); see also Pocahontas Supreme Coal Co. v. Bethlehem Steel Corp., 828 F.2d 211,

220 (4th Cir. 1987); Klehr v. A.O. Smith Corp., 521 U.S. 179, 198, 201 (1997) (Scalia, J.,

concurring).

       Quite apart from application of the standard antitrust accrual rule and the correlative

speculative-damages doctrine, which render the plaintiffs’ action timely, the continuing-

violation doctrine would also entitle the plaintiffs to recover damages for each

supracompetitive sale that Actelion made after November 2015. As explained in Zenith,

“[i]n the context of a continuing conspiracy to violate the antitrust laws,” the statute of

limitations begins to run from “each time a plaintiff is injured by an act of the defendants.”

401 U.S. at 338. Specifically, in cases “involving allegations of ‘a price-fixing conspiracy

that brings about a series of unlawfully high priced sales over a period of years, each overt

act that is part of the violation and that injures the plaintiff, e.g., each sale to the plaintiff,

starts the statutory period running again.’” In re Cotton Yarn Antitrust Litig., 505 F.3d

274, 290–91 (4th Cir. 2007) (emphasis added) (quoting Klehr, 521 U.S. at 189); see also

Berkey Photo, Inc. v. Eastman Kodak Co., 603 F.2d 263, 295 (2d Cir. 1979) (“[E]ach time

a plaintiff is injured by an act of the defendants a cause of action accrues to him to recover

the damages caused by that act”). Similarly, according to the complaint in this case, each

time that Actelion sold Tracleer at a supracompetitive price after its patent expired, it

                                                15
illegally exercised monopoly power — i.e., willfully maintained monopoly power,

Grinnell, 384 U.S. at 570–71 — thus committing an overt act that caused injury and

violated the antitrust laws. Accordingly, a new limitations period began to run from each

such sale.

       Actelion argues, nonetheless, that these “sales at supracompetitive prices” were

merely a holdover “effect” of its earlier settlements in February 2014 and that the sales

themselves were not unlawful acts that gave rise to new causes of action. It maintains, as

the district court did, that this is a refusal-to-deal case and that post-patent sales to the

plaintiffs were not refusals to deal and therefore did not provide the plaintiffs with new

causes of action. This, however, does not respond to the plaintiffs’ complaint as written.

The plaintiffs did not allege that Actelion’s refusals to deal excluded them “from

participation in an industry,” as they would have to allege to state a refusal-to-deal claim;

they alleged that they are customers of Actelion, not competitors. Charlotte Telecasters,

546 F.2d at 572; see also Berkey Photo, 603 F.2d at 295 (“Although the business of a

monopolist’s rival may be injured at the time the anticompetitive conduct occurs, a

purchaser, by contrast, is not harmed until the monopolist actually exercises its illicit power

to extract an excessive price”). The plaintiffs’ complaint, instead, alleged conduct more

closely analogous to what has been termed a pay-for-delay scheme. See, e.g., FTC v.

Actavis, Inc., 570 U.S. 136 (2013). They alleged that Actelion engaged in an “illegal

scheme to maintain its monopoly” by “delay[ing] the start of generic drug competition” so

that it could “continue [after November 2015] to profitably charge supra-competitive

prices.” Thus, each time that Actelion sold Tracleer to the plaintiffs at monopoly prices

                                              16
after the patent’s expiration, it engaged in a new injurious overt act that commenced a new

limitations period. See Charlotte Telecasters, 546 F.2d at 572.

       Virtually every court faced with similar allegations has held, citing the continuing-

violation doctrine, “that a new cause of action accrues to purchasers upon each overpriced

sale of the drug.” Malla Pollack, 6 Callmann on Unfair Competition, Trademarks, and

Monopolization § 23:32 (4th ed. 2019); see, e.g., In re Buspirone Patent Litig., 185 F. Supp.

2d 363, 380 (S.D.N.Y. 2002) (finding that the purchaser plaintiffs’ claims were timely

“based on allegations of injury arising from purchases of [a drug] at allegedly inflated

prices beginning four years prior to the filings of their respective Complaints” where

purchasers alleged that a settlement agreement kept generic competition out of the market);

In re K-Dur Antitrust Litig., 338 F. Supp. 2d 517, 551 (D.N.J. 2004) (finding claims timely

where the plaintiffs “alleged that they were overcharged and paid supra-competitive prices

for [a drug] as a result of Defendants’ settlement agreements . . . within the applicable time

limitations”); In re Nexium (Esomeprazole) Antitrust Litig., 968 F. Supp. 2d 367, 400 (D.

Mass. 2013) (“[E]very time the Direct Purchasers were overcharged for brand [drug], they

suffered a cognizable injury” that accrued a new cause of action); In re Niaspan Antitrust

Litig., 42 F. Supp. 3d 735, 746 (E.D. Pa. 2014) (“[A]lleged ongoing sales of [the drug] at

a supracompetitive price constitute a continuing violation”); In re Skelaxin (Metaxalone)

Antitrust Litig., No. 1:12-MD-2343, 2013 WL 2181185, at *29 (E.D. Tenn. May 20, 2013)

(“Plaintiffs have sufficiently alleged those acts resulted in Plaintiffs being overcharged for

[the drug] well into the limitations period”); In re Aggrenox Antitrust Litig., 94 F. Supp. 3d

224, 238 (D. Conn. 2015) (holding that “a purchaser suing a monopolist for overcharges is

                                             17
injured anew by each overcharge”); In re: EpiPen (Epinephrine Injection, USP) Mktg.,

Sales Pracs. & Antitrust Litig., 336 F. Supp. 3d 1256, 1329 (D. Kan. 2018) (“Defendants

engaged in new and additional acts each time they charged the allegedly inflated prices

. . . . And each of those acts inflicted a new and accumulating injury on the class

plaintiffs”); In re Effexor Antitrust Litig., 357 F. Supp. 3d 363, 385 (D.N.J. 2018) (“[T]he

Court finds [the plaintiffs’] claims are timely, under the continuing-violation doctrine,” for

overcharges “as a result of Defendants’ settlement agreement”).

       In sum, we conclude that the plaintiffs have alleged adequate facts in their complaint

to demonstrate that their claims were timely filed.

                                              III

       The plaintiffs also challenge the district court’s dismissal of Counts 6, 10, 33, and

44 of the complaint — involving class members’ claims against Actelion under the laws

of Maine, Minnesota, Vermont, and Wisconsin — based on a lack of standing. The court

explained that the plaintiffs never purchased Tracleer in those States and so never suffered

any specific injury entitling them to sue under those States’ laws. The district court

addressed only those four counts because it had dismissed all other counts of the complaint

on limitations grounds. But Actelion’s motion to dismiss for lack of standing was directed

to all 42 counts of the complaint in which the plaintiffs alleged that class members, not the

plaintiffs themselves, purchased Tracleer at supracompetitive prices.           Our analysis,

therefore, applies not only to the dismissal of the four counts, but to all other counts of the

complaint that were included in Actelion’s motion to dismiss for lack of standing.

                                              18
       In its motion to dismiss, Actelion contended that the “plaintiffs’ 42 claims arising

under the laws of various states (but . . . not California, Florida, and Maryland) must be

dismissed for lack of Article III standing.” It also contended that those same counts must

be dismissed for a lack of “statutory standing.” Both arguments were based on the ground

that the plaintiffs did not purchase or pay for Tracleer in any of the States involved and

therefore that those States’ laws were not implicated.

       In its ruling, the district court set aside Actelion’s argument for lack of Article III

standing and grounded its dismissal on “Actelion’s standing arguments through the lens of

statutory standing” only. It explained that the “Plaintiffs fail[ed] to allege . . . that [they]

suffered any specific harm” in those States; they alleged only that they purchased Tracleer

“in Maryland, California, and Florida.” Actelion has not challenged the district court’s

approach on appeal, although it also has not abandoned any lack-of-standing argument it

has.

       To begin, it is important to note that the plaintiffs sued on their own behalf and

purportedly, under Rule 23, on behalf of all others similarly situated. But that putative

class has not been certified, and therefore, Actelion’s motion to dismiss for lack of standing

could only be directed to the plaintiffs’ claims under the laws of States other than Maryland,

California, and Florida. It is undisputed that the plaintiffs alleged purchases of Tracleer in

only those three States and did not allege that it made purchases of Tracleer in the other

States. In those other States, the plaintiffs asserted claims based on class members’

purchases of Tracleer.

                                              19
       To have Article III standing, the plaintiffs “must allege and show that they

personally have been injured, not that injury has been suffered by other, unidentified

members of the class.” Lewis v. Casey, 518 U.S. 343, 357 (1996) (emphasis added)

(quoting Simon v. E. Ky. Welfare Rts. Org., 426 U.S. 26, 40 n.20 (1976)); Spokeo, Inc. v.

Robins, 136 S. Ct. 1540, 1547 (2016) (requiring that plaintiffs show injury, causation, and

redressability). But even when plaintiffs have suffered such a necessary injury, they must

also have so-called statutory standing. Steel Co. v. Citizens for a Better Env’t, 523 U.S.

83, 97 & n.2 (1998) (stating that unlike Article III standing, statutory standing considers

“whether [a] cause of action exists under a particular statute”).

       To demonstrate statutory standing, the plaintiffs must show that they satisfy the

statutory requirements of the laws of the States they are invoking. See CGM, LLC v.

BellSouth Telecomms., Inc., 664 F.3d 46, 52 (4th Cir. 2011); see also Lexmark Int’l, Inc.

v. Static Control Components, Inc., 572 U.S. 118, 128 & n.4 (2014) (noting that the

statutory standing “label” can be “misleading” because it “does not implicate [a court’s]

subject-matter jurisdiction” (cleaned up)). In this case, the plaintiffs did not allege facts to

show that they satisfied the statutory requirements of States other than Maryland,

California, and Florida. Consequently, the plaintiffs may not seek relief for their own

injuries under those States’ statutes, and the district court’s determination as to the

plaintiffs’ own statutory standing was proper. CGM, 664 F.3d at 52 (“A dismissal for lack

of statutory standing is effectively the same as a dismissal for failure to state a claim”

(cleaned up)).

                                              20
       Nonetheless, the claims that the plaintiffs made on behalf of class members who

purchased Tracleer in States other than Maryland, California, and Florida need not be

stricken or disregarded. Since those counts of the complaint define class members’ claims,

they may be considered in determining whether the plaintiffs’ claims raise “questions of

law or fact common to the class” and whether these are “typical of the claims or defenses

of the class,” Fed. R. Civ. P. 23(a), and also whether the common questions “predominate,”

Fed. R. Civ. P. 23(b)(3); see also Langan v. Johnson & Johnson Consumer Cos., 897 F.3d

88, 93 (2d Cir. 2018) (“[W]hether it is proper for a class to include out-of-state, nonparty

class members with claims subject to different state laws is a question of predominance

under Rule 23(b)(3)”); In re Asacol Antitrust Litig., 907 F.3d 42, 49–51 (1st Cir. 2018). If

the Rule 23 requirements are met, the plaintiffs could then represent the class members

who sustained damages under those laws. See Wal-Mart Stores, Inc. v. Dukes, 564 U.S.

338, 348–49 (2011).

                                         *       *      *

       In vacating the district court’s order of dismissal, we do not suggest any outcome

on the plaintiffs’ claims. Their complaint contains only allegations that have yet to be

proven or tested. Indeed, even a statute-of-limitations defense, if pleaded as an affirmative

defense, may yet be vindicated. See Goodman v. Praxair, Inc., 494 F.3d 458, 466 (4th Cir.

2007) (en banc). And it goes without saying that class certification will present complex

issues, none of which have, at this point, been addressed or resolved. So we now tell the

parties to return to the district court and go to it.

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         VACATED AND REMANDED
        FOR FURTHER PROCEEDINGS
     CONSISTENT WITH THIS OPINION

22