Massachusetts Laborers' Health & Welfare Fund v. Boehringer Ingelheim Pharmaceuticals, Inc.

UNITED STATES DISTRICT COURT

DISTRICT OF MASSACHUSETTS

_________________________________________

)

MASSACHUSETTS LABORERS’ HEALTH )

& WELFARE FUND, on behalf of itself and )

others similarly situated, )

)

Plaintiff )

)

v. )

) Civil Action No. 24-cv-10565-DJC

)

BOEHRINGER INGELHEIM )

PHARMACEUTICALS, INC. and )

BOEHRINGER INGELHEIM )

INTERNATIONAL GMBH, )

)

Defendants. )

_________________________________________ )

MEMORANDUM AND ORDER

CASPER, J. March 27, 2025

I. Introduction

Plaintiff Massachusetts Laborers’ Health & Welfare Fund (“Massachusetts Laborers”) has

filed this class action against Defendants Boehringer Ingelheim Pharmaceuticals, Inc. and

Boehringer Ingelheim International GMBH (collectively, “Boehringer”) alleging various antitrust-

related violations under state law including monopolization and monopolistic scheme (Count 1

and Count 8), monopolization for wrongful Orange Book listings (Count 2 and Count 9);

monopolization for sham litigation (Count 3 and Count 10), attempted monopolization and

monopolistic scheme (Count 4 and Count 11), unfair methods of competition (Count 5 and Count

12), violations of state consumer protection laws for wrongful Orange Book listings (Count 6 and

Count 13), violations of state consumer protection laws for sham litigation (Count 7 and Count 14)

and unjust enrichment (Count 16). D. 57. Additionally, Massachusetts Laborers seeks injunctive

relief under Section 2 of the Sherman Act and Section 16 of the Clayton Act, 15 U.S.C. § 26 (Count

15). Id. Boehringer has moved to dismiss the amended complaint pursuant to Fed. R. Civ. P.

12(b)(6). D. 65. For the reasons stated below, the Court ALLOWS the motion in part and DENIES

it in part. Id.

II. Standard of Review

On a motion to dismiss for failure to state a claim upon which relief can be granted pursuant

to Fed. R. Civ. P. 12(b)(6), the Court must determine if the facts alleged “plausibly narrate a claim

for relief.” Schatz v. Republican State Leadership Comm., 669 F.3d 50, 55 (1st Cir. 2012) (citation

omitted). Reading the complaint “as a whole,” the Court must conduct a two-step, context-specific

inquiry. García-Catalán v. United States, 734 F.3d 100, 103 (1st Cir. 2013). First, the Court must

perform a close reading of the claim to distinguish the factual allegations from the conclusory legal

allegations contained therein. Id. Factual allegations must be accepted as true, while conclusory

legal conclusions are not entitled credit. Id. Second, the Court must determine whether the factual

allegations present a “reasonable inference that the defendant is liable for the conduct alleged.”

Haley v. City of Bos., 657 F.3d 39, 46 (1st Cir. 2011) (citation omitted). In sum, the complaint

must provide sufficient factual allegations for the Court to find the claim “plausible on its face.”

García-Catalán, 734 F.3d at 103 (citation omitted).

III. Factual Background

The following facts are drawn from Massachusetts Laborers’ amended complaint, D. 57,

and are accepted as true for the purposes of resolving Boehringer’s motion to dismiss.

A. Regulatory Framework

1. Exclusivity

Drug makers can obtain valid patents over their prescription drug products, which provide

limited protection from generic competition by other drug companies for a fixed period (often

called an exclusivity period) set by Congress. D. 57 ¶ 31. A valid, enforceable patent may exclude

others from making the patented invention. Id. ¶ 32. In addition, drug companies may also receive

regulatory exclusivity which runs concurrently to patent exclusivity. Id. ¶ 34. Once a brand name

drug maker’s exclusivity period expires, the company can no longer lawfully block generic

competition. Id. ¶ 37.

2. Orange Book

The Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. §§ 301 et seq., governs the

manufacture, sale, and marketing of prescription drugs in the United States. Id. ¶ 43. A drug

maker seeking to market and sell a new drug must first submit a New Drug Application (“NDA”).

Id. ¶ 45. The patents the applicant identifies as claiming the drug are then listed in the FDA’s

compendium of products and their related patents, the “Approved Drug Products with Therapeutic

Equivalence Evaluation,” also known as the Orange Book. Id. ¶ 10.

From 1983 until 2019, the FDCA required NDA applicants to submit “the patent number and

expiration date of any patent which claims the drug for which the applicant submitted the

application or which claims a method of using such drug and with respect to which a claim of

patent infringement could reasonably be asserted if a person not licensed by the owner engaged in

the manufacture, use, or sale of the drug” to the FDA. Id. ¶ 56. In 1994, the FDA implemented

21 C.F.R. § 314.53, amended in 2003, to specify the types of patents that could be listed in the

Orange Book. Id. ¶¶ 64, 73. The regulation specifies that an applicant may not “submit a patent

unless it claims a drug substance, drug product, or method of using a drug substance or drug

product.” Id. ¶¶ 65, 74. More recently, in 2020, Congress amended the statute by passing the

Orange Book Transparency Act. Id. ¶¶ 114-15. Under this statute, NDA applicants must submit

“the patent number and expiration date of each patent for which a claim of patent infringement

could reasonably be asserted . . . and that (I) claims the drug for which the applicant submitted the

application and is a drug substance (active ingredient) patent or a drug product (formulation or

composition) patent; or (II) claims a method of using such drug for which approval is sought or

has been granted in the application.” Id. ¶ 115.

3. The ANDA Process

Under the Hatch–Waxman Amendment to the FDCA (“Hatch–Waxman”), a generic drug

manufacturer may file an Abbreviated New Drug Application (“ANDA”). Id. ¶ 50. In an ANDA,

a generic drug manufacturer can establish that its product is bioequivalent1 to the brand name drug.

Id. For each patent listed in the Orange Book, the ANDA applicant must include one of four

certifications, including as relevant here, paragraph III certification indicating that “[t]he would-

be competitor will wait for a patent’s expiration before marketing its competing product” or

paragraph IV certification indicating that “[a] listed patent is ‘invalid or will not be infringed by

the manufacture, use, or sale’ of the competitor’s product.” Id. ¶ 122; 21 U.S.C. §

355(j)(2)(A)(vii). If an applicant chooses to pursue a paragraph IV certification, it must notify the

brand-name drug maker and provide a “detailed statement of the factual and legal basis of the

opinion of the applicant that the patent is invalid or will not be infringed.” Id. ¶ 124. Ordinarily,

1 “Bioequivalent” means that the generic drug contains the same active ingredients in the

same amount, administered in the same form, at the same strength; and is absorbed into the body

in the same way, at the same rate, and to the same extent as the brand name drug. Id. ¶ 50. Drugs

that are bioequivalent are also therapeutically equivalent. Id.

a patent holder must wait until a competitor “makes, uses, offers to sell, or sells” an infringing

product before suing. Id. ¶ 133; 35 U.S.C. § 271(a). An ANDA containing a paragraph IV

certification for one or more Orange Book-listed patents, however, provides the brand name drug

maker grounds to sue without needing to wait. Id. ¶ 134. Once such a suit is filed, it imposes an

automatic stay preventing the FDA from granting final approval to the ANDA until (a) the passage

of thirty months or (b) a court decision ruling that the patent is invalid or not infringed by the

ANDA product, whichever happens sooner. Id. ¶ 135; 21 U.S.C. § 355(j)(5)(B)(iii). If an ANDA

satisfies all scientific and procedural conditions for final approval before one of those conditions

occurs, the FDA may grant “tentative approval” for the ANDA. Id. ¶ 136.2

B. Combivent Respimat and Spiriva Respimat

Boehringer’s products, Combivent Respimat and Spiriva Respimat, are both drug-device

combinations. Id. ¶ 4. Combivent Respimat is a combination of two medicines: ipratropium

bromide (an anticholinergic) and albuterol sulfate (a beta2-adrenergic agonist). Id. It is approved

for treatment of chronic obstructive pulmonary disease (“COPD”) that is inadequately controlled

by albuterol alone. Id. Spiriva Respimat, which contains an anticholinergic called tiotropium

bromide, is approved as a once-daily maintenance treatment for the symptoms of COPD, and as a

maintenance treatment for asthma in patients over five years old. Id. Both products are currently

sold in Boehringer’s Respimat inhaler. Id. ¶ 5.

2 While the tentative approval allows a generic drug manufacturer to launch its product

prior to the resolution of the patent infringement case, it does not shield that manufacturer from

liability arising from same. In re Nexium (Esomeprazole) Antitrust Litig. (“Nexium I”), 42 F.

Supp. 3d 231, 245 (D. Mass. 2014), aff'd, 842 F.3d 34 (1st Cir. 2016). Thus, any generic product

launched prior to said resolution is “at-risk,” “that is, with the risk of losing the infringement case

against it hanging over its head.” Id. “Losing an infringement case after launching at risk can

result in significant liability for generic manufacturer, as damages typically are calibrated by the

amount of its at-risk sales.” Id. (citing 32 U.S.C. § 271(e)(4)(C)).

1. Combivent Respimat

As noted, Combivent Respimat is a combination of two active ingredients: ipratropium

bromide and albuterol sulfate. Id. ¶ 174. Albuterol sulfate was patented in 1972; its patents have

since expired. Id. Ipratropium bromide was introduced as a treatment for COPD two years later

in 1974; its original patents have also expired. Id. In 1986, Boehringer introduced Atrovent, a

drug product containing ipratropium bromide, that was covered by a patent that expired in 1991.

Id. ¶ 175. In the mid-1990s, Boehringer introduced a second ipratropium-bromide containing

product, Combivent. Id. ¶ 176. The FDA approved Combivent in 1996 as a combination of

ipratropium bromide and albuterol in a standard inhaler. Id. Because the patents on both

ipratropium bromide and albuterol had expired, Boehringer could not list any patents in the Orange

Book. Id. A regulatory exclusivity protected Combivent from competition, but only until October

24, 1999. Id. Soon thereafter, Boehringer faced several generic competitors. Id.

In April 2010, the FDA announced that it had finalized a rule phasing out seven different

inhaler products that contained chlorofluorocarbons (“CFCs) because CFCs are harmful to the

environment. Id. ¶ 177. Under that rule, Boehringer could no longer sell its original Combivent

formulation after December 31, 2013. Id. In response, Boehringer reformulated its Combivent

product, replacing CFCs with hydrofluoroalkanes (“HFA”). Id. ¶ 178. In so doing, it changed the

Combivent inhaler from a standard inhaler to the Respimat. Id. ¶ 179. The FDA approved

Combivent Respimat on October 7, 2011. Id. ¶ 180. Because Combivent Respimat did not contain

a new chemical entity, Boehringer received only a three-year regulatory exclusivity, which expired

on October 7, 2014. Id.

Boehringer listed twenty-five device patents in the Orange Book claiming Combivent

Respimat, only two of which reference the drugs ipratropium bromide and albuterol sulfate in the

claim. – U.S. Patent No. 6,988,496 (the “‘496 patent”) and U.S. Patent No. 7, 104,470 (the “‘470

patent”). Id. ¶¶ 191–93. The ‘496 patent expired on February 23, 2020 and the ‘470 patent expired

on October 4, 2016. Id. ¶¶ 192, 194.

2. Spiriva Respimat

In January 2004, the FDA approved Boehringer’s application to make Spiriva, which was

the drug substance tiotropium bromide provided with a standard inhaler. Id. ¶ 187. In November

2007, Boehringer submitted an NDA to the FDA seeking to make, market, and sell Spiriva’s active

ingredient, tiotropium bromide, in the Respimat inhaler as a treatment for COPD. Id. ¶ 188. The

FDA approved Boehringer’s Spiriva Respimat application on September 24, 2014. Id. Because

Spiriva Respimat did not contain a new chemical entity, the FDA granted Boehringer a three-year

regulatory exclusivity, which expired on September 24, 2017. Id.

Boehringer listed nineteen device patents to the Orange Book claiming Spiriva Respimat,

only three of which claim the underlying drug ingredients tiotropium bromide – the ‘470 patent,

the ‘496 patent and U.S. Reissued Patent No. RE39,820 (the “‘820 patent”). Id. ¶¶ 448–51.

Because Boehringer tested the use of Spiriva Respimat in children in February 2017, the FDA

granted it a pediatric exclusivity extension on its listed patents so the ‘470 and ‘496 patents for this

drug expired on August 23, 2020. Id. ¶ 450. The ‘820 patent expired in 2018. Id. ¶ 451.

3. The Disputed Patents

As of the filing of the amended complaint, six of the patents that do not claim the drug

ingredients (the “Disputed Patents”) are still in the Orange Book. Id. ¶ 16. These include U.S.

Patent No. 7,284,474 (the “‘474 patent”); U.S. Patent No. 7,396,341 (the “6‘341 patent”); U.S.

Patent No. 7,837,235 (the “‘235 patent”); U.S. Patent No. 7,896,264 (the “‘264 patent”); U.S.

Patent No. 8,733,341 (the “3‘341 patent”) and U.S. Patent No. 9.027,967 (the “‘967 patent”). Id.

As alleged, the Disputed Patents either claim the Respimat inhaler or a component of it. Id. ¶¶ 9,

16.

C. Lawsuits against Anobri

In March 2023, Anobri Pharmaceuticals US, LLC (along with its parent company,

Shanghai Anovent Pharmaceutical Co., Ltd. and one of Shanghai Anovent’s other subsidiaries,

Nanchang Anovent Pharmaceutical Co., Ltd.) (collectively, “Anobri”) submitted two ANDAs to

the FDA: one for a generic version of Spiriva Respimat and one for a generic version of Combivent

Respimat. Id. ¶ 606. Anobri filed a paragraph IV certification in both ANDAs. Id. ¶¶ 607–08.

On June 29, 2023, Boehringer sued Anobri in the U.S. District Court for the District of New Jersey,

alleging, in two, separate lawsuits, that Anobri’s Combivent Respimat and Spiriva Respimat

ANDAs, respectively, infringed its patents. Id. ¶ 611–12. Anobri answered the complaints and

asserted counterclaims in both cases, arguing that each of Boehringer’s claims of the patents were

invalid. Id. ¶ 613. On July 24, 2024, a stipulation was entered in which Anobri agreed to “no

longer seeking FDA approval” for its ANDAs “prior to the expiration of the ‘474 and ‘264 patents”

and to amend its ANDAs to re-certify them as being submitted under paragraph III. Boehringer

Ingelheim Pharmaceuticals, Inc. et al. v. Anobri Pharmaceuticals U.S., LLC, 23-cv-3530-CCC, D.

77 (D.N.J. 2023); D. 69 at 2-3; D. 69-1.

IV. Procedural History

Massachusetts Laborers filed this action on March 6, 2024, D. 1, and filed the amended

complaint on May 9, 2024. D. 57. Boehringer now has moved to dismiss. D. 65. The Court

heard the parties on the pending motion and took the matter under advisement. D. 89, D. 90.

V. Discussion

Boehringer moves to dismiss the amended complaint on several bases: (1) that

Massachusetts Laborers has failed to allege plausibly a causal relationship between Boehringer’s

alleged wrongful listing of the Disputed Patents in the Orange Book and Massachusetts Laborers’

antitrust injury, D. 66 at 14, (2) that Massachusetts Laborers has failed to allege plausibly that

Boehringer engaged in sham litigation, id. at 19, and (3) that Massachusetts Laborers has failed to

plead many of its state law claims, id. at 24. The Court address these grounds in turn below.

A. Failure to Allege Causation

To bring an antitrust claim, a plaintiff “must not only meet the typical requirements of

Article III standing, but also the requirements of the so-called ‘antitrust standing’ doctrine.”

Vázquez-Ramos v. Triple-S Salud, Inc., 55 F.4th 286, 293 (1st Cir. 2022) (citing Associated Gen.

Contractors of Cal., Inc. v. Cal. State Council of Carpenters, 459 U.S. 519, 535 n.31 (1983)).

Causation is a requisite element of antitrust standing. Id. (quoting RSA Media, Inc. v. AK Media

Grp., Inc., 260 F.3d 10, 14 (1st Cir. 2001)). To plead antitrust causation, “a plaintiff in an antitrust

case must demonstrate that there is a causal connection between the defendant’s illegal practice

and the antitrust injury.” Amphastar Pharms., Inc. v. Momenta Pharms., Inc., 297 F. Supp. 3d 222,

228 (D. Mass. 2018) (citing Sullivan v. Nat'l Football League, 34 F.3d 1091, 1103 (1st Cir. 1994)).

The plaintiff “need not prove that the antitrust violation was the sole cause of their injury, but only

that it was a material cause.” Nexium I, 42 F. Supp. 3d at 267 (quoting Engine Specialties, Inc. v.

Bombardier Ltd., 605 F.2d 1, 14 (1st Cir. 1979)). “An antitrust violation can be the material cause

– often interpreted as proximate cause – ‘even if there are additional independent causes of

injury.’” In re Solodyn (Minocycline Hydrochloride) Antitrust Litig., No. 14-md-02503-DJC,

2018 WL 563144, at *13 (D. Mass. Jan. 25, 2018) (quoting Nexium I, 42 F. Supp. 3d at 267)).

“As in tort law, a plaintiff need not ‘prove a series of negatives’ or ‘offer evidence which positively

exclude[s] every other possible cause’ of the conduct.” Id. (quoting In re Neurontin Mktg. & Sales

Practices Litig., 712 F.3d 21, 45 (1st Cir. 2013)). “‘Once a plaintiff [alleges plausibly] that he

suffered the sort of injury that would be expected consequence of the defendant’s wrongful

conduct,’ the burden shifts to the defendant to rebut this causal inference.” Neurontin, 712 F.3d

at 45 (quoting BCS Servs., Inc. v. Heartwood 88, LLC, 637 F.3d 750, 758 (7th Cir. 2011)).

1. Patent Non-Infringement

Boehringer argues that Massachusetts Laborers cannot allege plausibly a causal link

between Boehringer’s alleged wrongful listing of the Disputed Patents in the Orange Book and its

injury because it cannot allege that a “generic Combivent Respimat or Spiriva Respimat could

have been sold without infringing Boehringer’s patents.” D. 66 at 15. Boehringer contends that

“[b]ecause only one valid patent cuts the chain of causation, [Massachusetts Laborers] must plead

facts showing ‘all’ of Boehringer’s relevant patents are either invalid or would not be infringed by

a generic.” Id. at 16 (citing Mayor & City Council of Baltimore v AbbVie Inc., 42 F.4th 709, 713

(7th Cir. 2022)).

As an initial matter, another session of the Court has declined to adopt this reasoning at the

pleading stage. See Iron Workers Dist. Council of New England Health & Welfare Fund v. Teva

Pharm. Indus. Ltd. (“Iron Workers II”), No. 23-cv-11131-NMG, 2024 WL 4700248, at *5–*6 (D.

Mass. Nov. 6, 2024)) (describing the defendant’s argument that “in claims involving patented and

generic versions of medical products, a plaintiff cannot properly allege causation if the patent at

issue is valid”). The court there held that to the extent that courts in this Circuit have previously

concluded that a plaintiff must demonstrate that a patent for a brand name drug product was invalid

or would not have been infringed to establish antitrust causation, those cases “involved disputes

about causation that arose well-beyond the pleading stage” and as such their applicability is

confined there. See id. at *5 (citing In re Nexium (Esomeprazole) Antitrust Litig. (“Nexium II”),

842 F.3d 34, 63 (1st Cir. 2016); Solodyn, 2018 WL 563144, at *13)). Accordingly, the court

concluded that “because defendant’s motion is at the pleading stage, plaintiff’s allegations of

antitrust standing suffice to survive judgment on the pleadings just as it survived the motion to

dismiss.” Id. at *6.

The same is true here. That is, Boehringer’s argument is insufficient to defeat

Massachusetts Laborers’ antitrust standing because to plead causation, a plaintiff is only required

to allege plausibly that Boehringer’s alleged wrongful listing is a “material cause” of its injury,

not the “sole cause” of same. Nexium I, 42 F. Supp. 3d at 267 (quoting Engine Specialties, Inc.,

605 F.2d at 14). Assuming arguendo that the presence of valid patents in the Orange Book

covering Combivent Respimat and Spiriva Respimat may also deter generic manufacturers from

entering the market for Combivent Respimat and Spiriva Respimat, it is not ground for “dismissing

the complaint now,” In re Actos End-Payor Antitrust Litig., 848 F.3d 89, 101 (2d Cir. 2017) (citing

Zenith Radio Corp. v. Hazeltine Rsch., Inc., 395 U.S. 100, 114 n. 9 (1969)), because the burden is

not on Massachusetts Laborers to “offer evidence to positively exclude” alternative causes or any

“other possible cause” of its injury. Solodyn, 2018 WL 563144, at *13 (quoting Neurontin, 712

F.3d at 45). Accordingly, to the extent that Boehringer’s argument hinges on this pleading

requirement, it cannot prevail.

It is correct, however, “[t]hat a regulatory or legislative bar can break the chain of causation

in antitrust case is beyond fair dispute.” In re Wellbutrin XL Antitrust Litig. Indirect Purchaser

Class (“Wellbutrin II”), 868 F.3d 132, 165 (3d Cir. 2017). Because a “valid patent independently

precludes competition apart from any agreement,” it may interfere with a plaintiff’s chain of

causation and in some circumstances serves “as an independent regulatory bar” to causation.

Nexium II, 842 F.3d at 63 (quoting In re Wellbutrin XL Antitrust Litig. (“Wellbutrin I”), 133 F.

Supp. 3d 734, 764, 767 (E.D. Pa. 2015)). Whether the existence of a valid patent can break the

chain of causation, however, depends on whether the causal theory asserted by the plaintiff hinges

on the invalidity or non-infringement of said patent. See Jazz Pharms., Inc. v. Avadel CNS

Pharms., LLC, No. 22-cv-941-GBW, 2024 WL 2700031, at *9 (D. Del. May 24, 2024) (holding

that the court will assess whether a valid and infringed patent break the causal chain “when a

plaintiff argues that an allegedly blocking patent is invalid, unenforceable, or not infringed”)

(citing Fresenius Kabi USA, LLC v. Par Sterile Prods., LLC, 841 F. App'x 399, 404 (3d Cir.

2021)). In third-party payors cases, as here, courts have applied this principle primarily in reverse

payment cases. See e.g. Nexium II, 842 F.3d at 39; Solodyn, 2018 WL 563144, at *3–*4. “A

reverse payment refers to an arrangement in which the brand-name manufacturer and patent holder

compensates the generic manufacturer and alleged patent infringer to settle [a] paragraph IV

litigation and delay the generic’s market entry.” Nexium II, 842 F.3d at 41 (citing F.T.C. v.

Actavis, Inc., 570 U.S. 136, 144–145 (2013)). Because a paragraph IV infringement litigation “put

the patent’s validity at issue,” Actavis, Inc., 570 U.S. at 147, a causal theory based on the allegation

that a defendant has delayed generic entry by settling such a litigation with its generic competitors

necessarily requires a plausible allegation that the patents giving rise to such suits are invalid or

would not be infringed.

Nexium II is illustrative. There, the plaintiffs alleged that the defendant brand name drug

manufacturer engaged in a reverse payment scheme. Nexium II, 842 F.3d at 39. As alleged, the

defendant had sued the generic manufacturers after they filed a paragraph IV certification to market

generic versions of defendant’s brand name drug. Id. at 42–43. The plaintiffs relied upon several

causal theories, including that one of the generic manufacturers “would have incurred the risk of

launching at risk,” i.e. before the paragraph IV litigation has been decided, and another “would

have won its paragraph IV suit against” the defendant. Id. at 62. The First Circuit reasoned that

because both theories “depend[] on the theory that [the defendant’s] patents were invalid or not

infringed by a generic version,” id. at 62, without evidence of same, “the ‘patent[s] serve as an

independent regulatory bar to [a generic’s] launch,’” id. at 63 (alterations in original) (quoting

Wellbutrin I, 133 F. Supp. 3d at 767).

Massachusetts Laborers offers two causal theories, which it refers to as the (1) “No

Wrongful Listing” theory and the (2) “No Sham Litigation” theory. D. 70 at 15-16. Under the

first theory, Massachusetts Laborers alleges that but for Boehringer’s listing of the Disputed

Patents in the Orange Book, prospective generic competitors for Combivent Respimat and Spiriva

Respimat “would not have faced the regulatory barriers to market entry associated with a

[p]paragraph IV certification, specifically the prospect of pre-launch patent litigation and the

automatic 30-month stay of FDA approval of any ANDA” for the drugs. Id. at 16. As a result,

they would have been able to enter the market in or around 2020, when the last of the patents

claiming the drug ingredients in Combivent Respimat and Spiriva Respimat have expired. Id. 15-

16. Under the second theory, Massachusetts Laborers alleges that but for the alleged wrongful

listings,3 Boehringer would have had no ground to file the infringement suit against Anobri and

3 Recent caselaw appears to lend more support to Massachusetts Laborers’ contention that

Boehringer wrongfully listed the patents in the Orange Book. As requested by Massachusetts

Laborers in a supplemental filing, D. 98, the Court took notice of Teva Branded Pharm. Prods.

R&D, Inc. v. Amneal Pharms. of New York, LLC, 124 F.4th 898 (Fed. Cir. 2024). There, the

plaintiff generic drug manufacturer alleged in its counterclaim that the counterclaim defendant

brand name drug manufacturer violated antitrust laws by listing patents for its inhaler relating “to

improvements in [its] device parts[.]” Id. at 908–09. The district court had “concluded that [the

counterclaim defendant’s] patents ‘do not claim the drug for which the applicant submitted the

application’ and thus ordered [the counterclaim defendant] to delist its patents from the Orange

one or both of its ANDAs for Combivent Respimat and Spiriva Respimat would have been

approved and the generic products of same would have entered the market sooner. Id. at 16-17.

Here, neither theory hinges on the issue of patent invalidity or non-infringement. Rather,

each theory depends upon the assertion that Boehringer has misused Hatch-Waxman’s regulatory

mechanism to erect an anticompetitive barrier of entry that either directly prevents prospective

generic competitors from entering the market through patent infringement lawsuits that impose a

“near-automatic injunctive relief, regardless of the merits [the] infringement claims” D. 57 ¶ 147,

as was initially the case for Anobri, or indirectly by deterring generic drug manufacturers from

“even beginning the drug development process,” id. ¶ 11. That is, without being listed in the

Orange Book, the Disputed Patents would not have created a barrier of entry for Combivent

Respimat and Spiriva Respimat generics because Boehringer would not be able to sue for

infringement on those patents until the generic products for them have entered the market. See

Bristol-Myers Squibb Co. v. Ben Venue Lab'ys, 90 F. Supp. 2d 540, 545 (D.N.J. 2000) (explaining

that “[i]n a classic patent infringement case, a patentee may sue an alleged infringer only when the

defendant ‘makes, uses, offers to sell, or sells’ a patented invention – in other words, upon its

actual entry into the market”) (citing 35 U.S.C. § 271(a)). Accordingly, whether the Disputed

Patents are valid or would not be infringed by a generic product is immaterial because, as alleged,

it is not their validity or non-infringement that prevent the entry of the generic products, but their

inclusion in the Orange Book. D. 70 at 15-17.

To support its argument to the contrary, Boehringer relies upon In re Humira

(Adalimumab) Antitrust Litig., 465 F. Supp. 3d 811 (N.D. Ill. 2020) and the Seventh Circuit’s

Book.” Id. at 910 (quoting Teva, 736 F. Supp. 3d at 234, 236). The Federal Circuit affirmed,

holding that that Hatch-Waxman requires brand name drug manufacturers to list only patents that

“claim an invention containing the active ingredient.” Id. at 919.

affirmation in AbbVie, 42 F.4th at 716. There, the defendant brand name drug manufacturer

obtained 132 patents on the brand name drug at issue. Humira, 465 F. Supp. 3d at 822. As the

defendant “pursued new patents, its competitors applied for FDA approval to manufacture

biosimilars.” Id. at 824. The defendant sued these competitors for patent infringement, then settled

with them. Id. at 824–25. The plaintiffs alleged that antitrust causation was shown because, among

other reasons, “if the biosimilar manufacturers had pursued the underlying infringement suits, they

could have prevailed” and entered the market sooner. Id. at 843. Because the plaintiffs asserted a

causal theory premised on the biosimilar manufacturers’ potential victory in the infringement suits,

“it only takes one valid, infringed patent” to undermine it. Id. at 844 (citing Wellbutrin II, 868

F.3d at 165). Given that this is not the causal theory offered by Massachusetts Laborers, the case

has limited applicability here.

2. Intent and Preparedness to Enter the Market

Next, Boehringer argues that antitrust causation is not met because “to meet its burden,

[Massachusetts Laborers] ‘must plead that [a generic competitor] intends to enter the market, that

it is prepared to enter the market, and that it would have entered the market by now but for

[Boehringer] conduct.’” D. 66 at 18 (some alterations in original) (quoting Aventis Pharma S.A.

v. Amphastar Pharms., Inc., 03-cv-00887-MRP-PLA, 2009 WL 8727693, at *14 (C.D. Cal. Feb.

17, 2009)). Boehringer acknowledges that Massachusetts Laborers has identified a potential

generic entrant, Anobri, which had filed ANDAs for both Combivent Respimat and Spiriva

Respimat. Id. Boehringer contends, however, that Massachusetts Laborers has failed to

adequately plead this element because “[t]he complaint says nothing about Anobri, its background

or experience in inhaler products or COPD, its financial capacity to enter, any steps it has taken

to manufacture a generic version of either product, or any other facts that show it would compete

in any relevant markets.” Id. (citing Hecht v. Pro-Football, Inc., 570 F.2d 982, 994 (D.C. Cir.

1977)).

“[I]n assessing the standing of would-be market entrants, courts assess the ‘intent and

preparedness’ of the prospective entrant.” Steward Health Care Sys., LLC v. Blue Cross & Blue

Shield of Rhode Island, 997 F. Supp. 2d 142, 158 (D.R.I. 2014) (quoting Huron Valley Hosp.,

Inc. v. City of Pontiac, 666 F.2d 1029, 1033 (6th Cir.1981)). An entrant’s “[i]ndicia of

preparedness” may include “adequate background and experience in the new field, sufficient

financial capability to enter it, and the taking of actual and substantive affirmative steps toward

entry, such as the consummation of relevant contracts and procurement of necessary facilities and

equipment.” Id. (alteration in original) (quoting Andrx Pharm., Inc. v. Biovail Corp. Int’l, 256

F.3d 799, 807 (D.C. Cir. 2001)). In examining intent and preparedness courts should take a

flexible and holistic approach, taking into account the reality of “the market from which [the

plaintiff] alleges [the entrant] was excluded.” Andrx Pharms. Inc., 256 F.3d at 807.

Here, the allegedly relevant markets include “the ipratropium bromide-albuterol sulfate

HFA inhalation spray market (consisting of Combivent Respimat and its AB-rated generics”4) and

“the tiotropium inhalation spray market (consisting of Spiriva Respimat and its AB-rated

generics),” D. 57 ¶¶ 649, 662. Both are regulated under the regulatory framework set out by Hatch-

Waxman requiring generic drug manufacturers to submit an ANDA to enter the market for a brand

name product. See id. ¶ 50. As clarified by Massachusetts Laborers’ counsel at the motion

hearing, the preparation of an ANDA is a laborious process, requiring Anobri to “develop a

product, perform testing [and] submit those materials to the FDA” to represent that its products

4 “AB-rated” generics are generic drugs that are the bioequivalent to the brand name

drug. D. 57 ¶ 51.

will not infringe Boehringer’s patents. D. 90 at 18. Not only did Anobri undergo this process, but

when sued by Boehringer for patent infringement, it initially defended against the lawsuit. See

generally Boehringer Ingelheim Pharmaceuticals, Inc. et al. v. Anobri Pharmaceuticals U.S., LLC,

23-cv-3530-CCC (D.N.J. 2023). Given these allegations, additional allegations are not required

at this stage. Indeed, courts have held that a plaintiff may adequately plead “intent and

preparedness” even in instances where the identified generic entrants did not have pending

ANDAs. See In re Asacol Antitrust Litig., 323 F.R.D. 451, 488 (D. Mass. 2017), rev'd and

remanded on other grounds, 907 F.3d 42 (1st Cir. 2018) (noting that plaintiffs have “plausibly

allege an injury in the form of lost money fairly traceable to an allegedly unlawful supra-

competitive price”); Xechem, Inc. v. Bristol-Myers Squibb Co., 274 F. Supp. 2d 937, 943 (N.D.

Ill. 2003), rev'd and remanded, 372 F.3d 899, 902 (7th Cir. 2004) (reversing dismissal of complaint

and declining to affirm dismissal on the alternative ground that plaintiff had not shown injury even

when it had not yet filed an ANDA). Accordingly, Massachusetts Laborers’ allegations that

Anobri had filed the ANDAs for Combivent Respimat and Spiriva Respimat are sufficient to

permit a plausible conclusion that the company had the “intent and preparedness” to enter the

generic market for those drugs. See Glaxo Grp. Ltd. v. Apotex, Inc., 130 F. Supp. 2d 1006, 1007

(N.D. Ill. 2001) (citing Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562, 1570–71 (Fed. Cir. 1997))

(explaining, in the declaratory judgment context, that the defendant’s filing of the ANDA “means

that defendant is ready or has at least made meaningful preparations to be ready to market the

allegedly infringing product”).5

5 To the extent that Boehringer relies upon Aventis Pharm., 2009 WL 8727693, at *15 to suggest

that a greater showing of intent and preparedness is required, the Court does not conclude that the

case stands for that proposition where the Court was faulting the drug manufacturer (not a third-

party as Massachusetts Laborers is here) for alleging sufficient facts that were “within [its]

knowledge.”

Additionally, Boehringer also argues that Massachusetts Laborers has failed to plead

“intent and preparedness” because it has not alleged that Anobri was prepared to launch “‘at-risk’

in the face of Boehringer’s patents if they were not listed in the Orange Book.” D. 66 at 18 (citing

Wellbutrin I, 133 F. Supp. 3d at 765). As discussed above, if the patents at issue were never listed

in the Orange Book, Anobri would not need to submit a paragraph IV certification for its ANDAs

which means Boehringer would not have been able to sue Anobri for patent infringement until it

has launched its generic versions of Combivent Respimat and Spiriva Respimat. See Bristol-

Myers Squibb Co., 90 F. Supp. 2d at 545. There would not be an at-risk launch in such a scenario.

3. Lack of FDA Approval

Boehringer also argues that Massachusetts Laborers has failed to plead causation because

it has not alleged that Anobri had obtained a tentative approval from the FDA to enter the generic

market for Combivent Respimat and Spiriva Respimat. D. 66 at 19. Boehringer argues that

Anobri’s failure to obtain tentative FDA approval is both indicative of a lack of “intent and

preparedness” and importantly serves as an independent bar to causation. D. 78 at 6, 13. To the

extent that this argument is tied to “intent and preparedness,” it is unavailing for the same reasons

discussed above.

Several courts have addressed tentative FDA approval for pleading antitrust causation.

See, e.g., Andrx Pharms., Inc. 256 F.3d at 808 (holding that the generic drug manufacturer could

have “alleged its intent and preparedness to enter the market by claiming that FDA approval was

probable” and, therefore, dismissal of counterclaim with prejudice was erroneously granted) with

Bristol-Myers Squibb Co., 90 F. Supp. 2d at 545 (declining to tie antitrust standing to a decision

by the FDA to grant conditional approval to an ANDA). There is little relevant authority to

suggest, however, that the lack of FDA approval is an “independent bar” to causation. “Were the

[C]ourt to accept [Boehringer]’s position, antitrust standing under Hatch-Waxman Act would be

wholly contingent on the vagaries of the timing of agency action.” Id. “If the FDA acted

immediately to grant [tentative] approval to an ANDA, the generic applicant would have standing

to bring antitrust claims. But if . . . the [brand name drug maker] beat the applicant to the punch

by filing an [infringement claim] before FDA approval, the generic maker would be denied

antitrust standing.” Id. Given that the purpose of allowing a brand name drug maker to sue when

a generic competitor files an ANDA is to “quickly resolve competing claims in court, before [the

generic] competitors make inroads into the market, . . . [s]uch an anomalous and arbitrary result

[cannot be] intended by the statute.” Id.

Boehringer’s support for its position comes principally from In re Terazosin Hydrochloride

Antirust Lit., 335 F. Supp 2d 1336 (S.D. Fla. 2004); In re Relafen Antitrust Litig., 286 F. Supp. 2d

56 (D. Mass. 2003) and Bristol-Myers Squibb Co. v. Copley Pharm., Inc., 144 F. Supp. 2d 21 (D.

Mass. 2000). As an initial matter, Relafen is inapplicable. In that case, the plaintiffs, a group of

third-party payors, argued that generic alternatives would have become available earlier but for

the defendant brand name drug manufacturer’s filing of paragraph IV patent infringement lawsuits.

Relafen, 286 F. Supp. 2d at 60-61. Boehringer cites a discussion in the case where the court noted

that any damages that flowed from the defendant lawsuit was “entirely speculative” because “no

generic-producing competitor had yet received FDA approval.” Id. at 63. This discussion was

limited, however, to the issue of speculative damages exception to the federal statute of limitations

whereby courts will set the date of accrual on the date the plaintiff suffers an injury if “the damages

flowing from conduct violating the antitrust laws are uncertain at the time the defendant engages

in the conduct.” Id.

Bristol-Myers and Terazosin appear to hold that a lack of tentative FDA approval can serve

as an independent bar to antitrust causation. See Terazosin, 335 F. Supp. 2d at 1368; Bristol-

Myers, 144 F. Supp. 2d at 23-25. Other courts, however, have declined to adopt these holdings.

See e.g. Andrx Pharms., 256 F.3d at 808 (holding that the generic drug manufacturer could allege

“its intent and preparedness to enter the market” even before the FDA approved its ANDA “by

claiming that FDA approval was probable”); Amgen, Inc. v. F. Hoffmann-La Roche Ltd., 480 F.

Supp. 2d 462, 468-69 (D. Mass. 2007) (clarifying that FDA approval is not an independent bar to

causation). Amgen is particularly relevant as it clarified Bristol-Myers, a case that Boehringer

relies upon extensively. There, the Court explained that Bristol-Myers’s holding was based upon

the district court’s holding in Andrx Pharms., Inc. v. Friedman, 83 F. Supp. 2d 179 (D.D.C. 2000)

where the court “appeared to state a broad rule that FDA approval is a necessary requisite to

antitrust standing.” Amgen, 480 F. Supp. 2d at 468. The Court noted that this holding was no

longer applicable, however, because the D.C. Circuit had clarified that “anticipation of FDA

approval,” even without the approval, “may suffice . . . since all that is necessary is demonstration

of intent and preparedness to enter the market.” Id. (citing Andrx Pharms, 256 F.3d at 806-08).

For the foregoing reasons, the Court denies Boehringer’s motion to dismiss the amended

complaint for failure to plead causation.

B. Sham Litigation

Massachusetts Laborers alleges that Boehringer’s lawsuit against Anobri amount to “sham

litigation” because “[a] reasonable drug company in Boehringer’s position would have known they

did not have standing to sue Anobri for infringing Boehringer’s device patents.” D. 57 ¶ 619.

“That is because Boehringer’s standing is founded on having listed its device patents in the Orange

Book – listings that a reasonable brand-name drug company in Boehringer’s position would have

known were improper.” Id. Boehringer argues that its suit against Anobri was not a sham because

(1) Orange Book listings are not necessary for its standing and (2) its suits against Anobri were

protected petitioning activities under Noerr-Pennington. D. 66 at 20-21.

1. Standing

Boehringer contends that its standing to sue Anobri did not “depend on the Orange Book

at all – rather, Boehringer had standing because it alleged the ANDAs infringed its patents.” D.

66 at 20. As explained, under the normal operation of patent laws, a patentee may only sue an

alleged infringer after the allegedly infringing product has entered the market. See Bristol-Myers

Squibb Co., 90 F. Supp. 2d at 545 (citing 35 U.S.C. § 271(a)). Because Anobri’s ANDAs for

Combivent Respimat and Spiriva Respimat were not approved and its generic versions of same

had not entered the market when it was sued, D. 57 ¶¶ 611–12, Massachusetts Laborers is correct

to allege that Boehringer’s standing to sue is “founded on having listed” its patents in the Orange

Book. D. 57 ¶ 619.

2. Noerr-Pennington

Boehringer next argues that its suits against Anobri are protected under Noerr Pennington.

D. 66 at 21. “A party petitioning the government for redress is ‘generally immune from antitrust

liability.’” Iron Workers Dist. Council of New England Health & Welfare Fund v. Teva Pharm.

Indus. Ltd (“Iron Workers I”)., 734 F. Supp. 3d 145, 159 (D. Mass. 2024) (quoting Prof'l Real

Estate Investors, Inc. (“PREI”) v. Columbia Pictures Indus., Inc., 508 U.S. 49, 56 (1993)). This

protection “does not . . . cover ‘sham’ activities or lawsuits.” Id. (citing PREI, 508 U.S. at 56). To

determine whether a lawsuit is a sham, the Court must first examine whether the lawsuit is

“objectively baseless in the sense that no reasonable litigant could realistically expect success on

the merits.” United Food & Com. Workers Unions & Emps. Midwest Health Benefits Fund v.

Novartis Pharms. Corp., 902 F.3d 1, 13 (1st Cir. 2018) (quoting PREI, 508 U.S. at 60). “If an

objective litigant could conclude that the suit is reasonably calculated to elicit a favorable outcome,

the suit is immunized under Noerr, and an antitrust claim premised on the sham exception must

fail.” PREI, 508 U.S. at 60. “If the challenged suit is objectively baseless, [the Court] then

proceeds to consider the alleged monopolist’s ‘subjective motivation under the second part of the

test.’” United Food, 902 F.3d at 13 (quoting PREI, 508 U.S. at 60). “Under this second prong,

the court should focus on whether the baseless lawsuit conceals ‘an attempt to interfere directly

with the business relationship of a competitor’s through the use [of] the governmental process –

as opposed to the outcome of that process – as an anticompetitive weapon.’” Id. (quoting PREI,

508 U.S. at 60-61) (some quotation marks omitted) (alteration and emphasis in original). To

prevail, “a plaintiff must allege that both prongs of the test are met.” Id.

1. Objectively Baseless

The Court cannot say that Boehringer’s lawsuits against Anobri were objectively baseless.

As an initial matter, the Court takes judicial notice of the fact that Anobri has settled with

Boehringer and agreed to that it has removed the Paragraph IV certifications and “is no longer

seeking FDA approval of [ANDAs] with respect to the ‘474 and ‘264 patents.” D. 69-1 at 2; D.

69 at 5; see Boehringer Ingelheim Pharmaceuticals, Inc. et al. v. Anobri Pharmaceuticals U.S.,

LLC, 23-cv-3530-CCC, D. 77 (D.N.J. 2023). These terms are favorable to Boehringer and, at a

minimum, as such suggest that the infringement suits are not objectively baseless. Fed. Trade

Comm'n v. AbbVie Inc, 976 F.3d 327, 367 (3d Cir. 2020) (citations omitted) (stating that

“ordinarily, settlement on terms favorable to a plaintiff suggests a suit is not objectively baseless”

but that even when it is favorable, it is “not dispositive” about the issue).

Even putting that settlement aside, the amended complaint does not contain sufficient,

factual allegations to support an inference of objective baselessness. Massachusetts Laborers

alleges that Boehringer’s suits are objectively baseless because no reasonable pharmaceutical

company in Boehringer’s position should have believed that it had the ability to sue Anobri. D.

57 ¶¶ 614-18. Massachusetts Laborers’ claim is grounded in its interpretation of Hatch-Waxman

and accompanying regulations as requiring each patent listed in the Orange Book to claim the

drug’s active ingredient. D. 57 ¶ 117. To prevail on a showing of the objective baselessness of

the lawsuits, Massachusetts Laborers must allege plausibly that this requirement is so

unambiguous that “no reasonable litigant” in Boehringer’s position could “realistically expect

success on the merits” for infringement claims based on patents listed in the Orange Book that do

not claim a drug’s active ingredient. United Foods, 902 F.3d at 13 (quoting PREI, 508 U.S. at 60).

Massachusetts Laborers argues that there should be no uncertainty on how the statute

should be interpreted given the clear language in both the statute and regulations, D. 70 at 27.

Neither the statute nor regulations, however, unambiguously limits patents listed in the Orange

Book to only those claiming drug’s active ingredients. D. 57 ¶ 117. Pursuant to FDCA, a patent

listed in the Orange Book must “1) ‘claim[] the drug for which the applicant submitted the

application;’ and 2) the patent must be directed to a drug substance or a drug product.” Teva

Branded Pharm. Prod. R&D, Inc. v. Amneal Pharms. of New York, LLC, 736 F. Supp. 3d 227,

234 (D.N.J. 2024) (alteration in original) (citing 21 U.S.C. § 355(b)(1)(A)(viii)(I)), aff'd, 124 F.4th

898 (Fed. Cir. 2024). The term “drug” means, among other things, an “article[] intended for use

in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals,” id.

(quoting 21 U.S.C. § 321(g)(1)) which, as Teva noted, includes inhalers, id. at 235. The phrase

“drug product” is defined to mean “a finished dosage form, e.g., tablet, capsule, or solution, that

contains a drug substance, generally, but not necessarily, in association with one or more

ingredients.” 21 C.F.R. § 314.3(b). The regulation further defines “dosage form” as “the physical

manifestation containing the active and inactive ingredients that delivers a dose of the drug

product.” Id. Because neither the statute nor regulation unambiguously requires a company to list

only patents claiming the drug ingredients in the Orange Book, D. 57 ¶ 117, an objective litigant

in Boehringer’s position could reasonably believe that it had standing to challenge Anobri and

succeed “on the merits.” United Foods, 902 F.3d at 13 (quoting PREI, 508 U.S. at 60).

Massachusetts Laborers also alleges that In re Lantus Direct Purchaser Antitrust Litig., 950

F.3d 1 (1st Cir. 2020), should have notified Boehringer that it lacked standing to challenge Anobri.

D. 57 ¶ 633. This argument is similarly unavailing. First, Lantus was not binding authority in the

Anobri litigation because the suits were filed in outside of this Circuit and because they were patent

infringement suits, D. 57 ¶¶ 611–12, and as such were mainly bound by Federal Circuit

precedents.6 See Wang Lab'ys, Inc. v. Applied Computer Scis., Inc., 926 F.2d 92, 94 (1st Cir.

6 To the extent that Massachusetts Laborers relies upon the recent decision, Teva Branded

Pharm. Prods. R&D, Inc., 124 F.4th at 919, to support its argument that Boehringer’s lawsuits

were objectively baseless, the timing of that decision makes it challenging to do so. Although the

Federal Circuit’s holding appears to confirm Massachusetts Laborers’ interpretation of Hatch-

Waxman, it was decided after Boehringer had already filed its patent infringement suits against

Anobri, D. 57 ¶¶ 611–12.

It also does not lend support to Massachusetts Laborers’ claim that Boehringer’s suit

against Anobri also qualify for the Walker Process fraud exception to Noerr-Pennington. D. 70 at

28. The exception “allows for a plaintiff to bring an antitrust suit against a defendant when that

defendant fraudulently obtains its patent and seeks to maintain a monopoly over a product by

bringing patent infringement suits against competitors based on that fraudulently-obtained patent.”

Jazz, 2024 WL 2700031, at *6 (citing Walker Process Equipment, Inc. v. Food Machinery &

Chemical Corp., 382 U.S. 172, 176–77 (1965)). Like any fraud claim, to invoke the Walker

Process fraud exception Massachusetts Laborers must allege plausibly that Boehringer acted with

“the intent to deceive or, at least, a state of mind so reckless as to the consequences that it is held

to be the equivalent of intent[].” Metris U.S.A., Inc. v. Faro Techs., Inc., 882 F. Supp. 2d 160, 174

(D. Mass. 2011) (quoting Hydril Co. LP v. Grant Prideco LP, 474 F.3d 1344, 1349 (Fed. Cir.

2007)). Massachusetts Laborers, however, has not made any additional allegations to permit an

1991) (noting that the Federal Circuit has exclusive jurisdiction over district court cases involving

patent disputes).

Second, contrary to Massachusetts Laborers’ assertion, Lantus does not unambiguously

interpret Hatch-Waxman as requiring patents listed in the Orange Book to claim drug ingredients.

In Lantus, the plaintiffs, similar to this case, alleged that the defendant brand name drug

manufacturer had “artificially restricted competition in the market for insulin glargine” by

improperly listing a patent that did not claim “insulin glargine or any method of using it.” Lantus,

950 F.3d at 6-7. The defendant argued that the listing was proper because the product at issue, an

injector pen device, qualifies as drug product “because it is a ‘finished dosage form[.]’” Id. at 7.

The court reasoned that although there was some support for the defendant’s position, id. at 7, the

disputed patent should not have been listed in the Orange Book because it does not claim either

the drug ingredients or the injector pen itself but only a “drive mechanism” inside the pen, id. at

6, 8–10. Here, even assuming arguendo that Lantus applies, since the Disputed Patents claim the

Respimat inhaler, D. 57 ¶ 9, Boehringer could reasonably believe that it had standing to challenge

Anobri and succeed on the merits of its infringement claims.7

inference that Boehringer knew that its listing was improper, much less that Boehringer acted with

the “intent to deceive.” Metris, 882 F. Supp. 2d at 174 (quoting Hydril Co. LP, 474 F.3d at 1349).

To the extent that this argument is based on Massachusetts Laborers’ assertion that Boehringer

should have known that it lacked standing to sue Anobri, it fails for the same reasons discussed

above.

7 Since the Court concludes that the first prong under Noerr-Pennington is satisfied, the

Court does not need to reach the second prong about subjective motivation. PREI, 508 U.S. at 60

(noting that “[i]f an objective litigant could conclude that the suit is reasonably calculated to elicit

a favorable outcome, the suit is immunized under Noerr, and an antitrust claim premised on the

sham exception must fail”).

For the reasons stated above, Massachusetts Laborers has failed to allege plausibly that

Boehringer had engaged in sham litigation. Accordingly, the Court allows the motion to dismiss

as to Massachusetts Laborers’ sham litigation claims.

C. Failure to Plead State Law Claims

1. Antitrust claims

Boehringer argues that Massachusetts Laborers has failed to plead its antitrust state law

claims for three reasons. First, Boehringer argues that the antitrust claims asserted under the laws

of Illinois, Montana and New Jersey should be dismissed because, under these laws, indirect

purchasers like Massachusetts Laborers are barred from bringing antitrust class actions claims. D.

66 at 25. Generally, “only direct purchasers of goods produced by firms engaged in

anticompetitive conduct could be regarded as injured within the meaning of the Clayton Act.” In

re Solodyn (Minocycline Hydrochloride) Antitrust Litig., No. 14–md–02503–DJC, 2015 WL

5458570, at *15 (D. Mass. Sept. 16, 2015) (citing Illinois Brick Co. v. Illinois, 431 U.S. 720, 746–

47 (1977)). “While some states have passed laws known as ‘Illinois Brick-repealers’ which

expressly grant [indirect purchasers] the right to sue for antitrust violations, ‘[indirect purchasers]

cannot assert antitrust claims under the law of states which have not passed such laws.’” Id.

(quoting In re Nexium (Esomeprazole) Antitrust Litig. (“Nexium”), 968 F. Supp. 2d 367, 409 (D.

Mass. 2013)).

a. Illinois, Montana and New Jersey

Illinois. Under the Illinois Antitrust Act (“IAA”), “no person shall be authorized to

maintain a class action in any court of this State for indirect purchasers asserting claims under this

Act, with the sole exception of this State’s Attorney General.” 740 Ill. Comp. Stat. § 10/07 (2010).

Relying upon the Supreme Court’s holding in Shady Grove Orthopedic Assocs., P.A. v. Allstate

Ins., 559 U.S. 393 (2010), Massachusetts Laborers argues that the IAA does not prohibit indirect

purchasers from bringing class actions in federal courts because it is preempted by Fed. R. Civ. P.

23. D. 70 at 29 (citing Shady Grove Orthopedic Assocs, 559 U.S. at 407). In Nexium, the court

explained the Supreme Court in Shady Grove has held that Rule 23 preempted a “New York

procedural law governing the prerequisites for class action” because that law “purported to govern

procedure” and since “federal procedural rules apply in federal court . . . where state laws conflict

with Rule 23, Rule 23 governs.” Nexium, 968 F. Supp. 2d at 408 (citing Shady Grove, 559 U.S.

at 399). The court noted, however, that Shady Grove is inapplicable to the IAA because unlike

the aforementioned New York law, the statute is “contained in the state’s antitrust statute, which

confers substantive rights upon its citizens.” Id. at 409. Because the IAA is a substantive law, the

court concluded that Shady Grove’s holding was inapplicable and held that Rule 23 does not

preempt the statute. Id. Accordingly, given that Rule 23 does not preempt the IAA, the Court

allows the motion to dismiss as to the antitrust claims raised under Illinois law.

Montana. The Montana’s Unfair Trade Practices Act (“MUTPA”) prohibits unlawful

restraint of trade and anticompetitive conduct. Mont. Code Ann. § 30-14-205. The statute

provides that “[a] person who is or will be injured . . . may bring an action to enjoin an act” that is

in violation of the statute. Id. § 30-14-222(1). The term “person” is defined to include “any person,

partnership, firm, corporation, joint-stock company, or other association engaged in business

within [Montana].” Id. § 30-14-202(7). Noting the plain language of the statute, as well as

Montana’s strong policy favoring access to the courts, a state court has held that “Illinois Brick

rule does not apply to the [MPTA].” Olson v. Microsoft Corp., No. CDV-2000-219, 2001 WL

36083237, at *1 (Mont. Dist. Feb. 15, 2001). Relying on this holding, this Court has likewise

declined to apply the Illinois Brick rule to the MUPTA. See In re Asacol Antitrust Litig., No. 15-

cv-12730-DJC, 2016 WL 4083333, at *13 (D. Mass. July 20, 2016) (citing Olson, 2001 WL

36083237, at *1). Accordingly, the Court denies the motion to dismiss antitrust claims raised

under Montana law.

New Jersey. Under the recently amended New Jersey Antitrust Act (“NJAA”), “any person

who shall be injured in his business or property by reason of anticompetitive conduct . . . may sue.”

N.J. Stat. Ann. § 56:9-12(a). The statute further states that “the fact that . . . any person who has

sustained damages . . . has not dealt directly with the defendant shall not bar or otherwise limit

recovery.” Id. § 56:9-12(c). The language specifically contemplates indirect purchasers, noting

that in cases where “claims are asserted against a defendant by both direct and indirect purchasers,

the court may take such steps as the court deems appropriate to avoid duplicate recovery of

damages.” Id. Accordingly, the Court denies the motion to dismiss as to the antitrust claims under

New Jersey law.

b. Massachusetts and Mississippi

Second, Boehringer argues that Massachusetts Laborers has failed to state a claim under

Massachusetts and Mississippi’s antitrust laws because it has not alleged any “wholly intrastate

conduct by Boehringer” in these states. D. 66 at 25.

Massachusetts. Under Massachusetts law, any person injured by unfair or deceptive

practices may bring suit. Mass. Gen. L. c. 93A, §§ 9, 11. Whether said person must allege a

wholly intrastate conduct depends on whether the claim is raised under Section 9 or 11 of the

statute. See Iron Workers I, 734 F. Supp. 3d at 162 (quoting Fishman Transducers, Inc. v. Paul,

684 F.3d 187, 197 (1st Cir. 2012)). “Section 9 of that statute provides a cause of action for

individual consumers who have suffered a loss due to an unfair trade practice whereas section 11

pertains to persons acting in a business context.” Id. (citing In re Pharm. Indus. Average

Wholesale Price Litig. (“PIAWP”), 582 F.3d 156, 191 (1st Cir. 2009)). “Unlike actions pursuant

to section 9, section 11 claims must concern conduct that occurred ‘primarily and substantially’

within the Commonwealth.” Id. (quoting Fishman Transducers, Inc., 684 F.3d at 197).

“Although the ‘dividing line between a consumer claim and a business claim . . . is not

always clear,’ it ‘appears to turn on whether a given party has undertaken the transaction in

question for business reasons or has engaged in it for purely personal reasons (such as the purchase

of an item for personal use).’” Asacol, 2016 WL 4083333, at *13 (alterations in original) (quoting

Frullo v. Landenberger, 61 Mass. App. Ct. 814, 821 (2004)). Here, Massachusetts Laborers

“cannot bring a claim under [Section] 9 as [it] cannot [plausibly allege] that [it] undertook the

relevant transactions,” namely the purchasing and/or reimbursement for purchases of Combivent

Respimat and Spiriva Respimat on behalf of its members, D. 57 ¶ 21, “for purely personal reasons.”

Asacol, 2016 WL 4083333, at *3 (quoting Frullo, 61 Mass. App. Ct. at 821). Accordingly,

Massachusetts Laborers may only bring its claim under Section 11, which requires it to allege

plausibly that Boehringer’s alleged misconduct occurred “primarily and substantially” within

Massachusetts. PIAWP, 582 F.3d at 194 (quoting Kuwaiti Danish Computer Co. v. Digital Equip.

Corp., 483 Mass. 459, 781 (2003)). Because Massachusetts Laborers has not done so here, the

Court allows the motion to dismiss as to antitrust claims raised under Massachusetts law.

Mississippi. In State ex rel. Fitch v. Yazaki N. Am., Inc., the court held that a party raising

a suit under the Mississippi Antitrust Act (“MAA”), Miss. Code. Ann. § 75-21-1 et seq., must

allege a wholly intrastate conduct. State ex rel. Fitch v. Yazaki N. Am., Inc., 294 So. 3d 1178,

1190 (Miss. 2020). In so holding, the court rejected the state’s argument that it has satisfied this

requirement by alleging that the defendant engaged in intrastate commerce in Mississippi through

its interstate commercial activities. Id. at 1188–90. Here, because Massachusetts Laborers has

not alleged that Boehringer’s alleged antitrust activities occurred wholly within Mississippi, the

Court allows the motion to dismiss as to antitrust claims raised under Mississippi law.

c. Utah

Boehringer argues that Massachusetts Laborers cannot state a claim under Utah law

because it is not a citizen or resident of Utah. D. 66 at 25. The Utah Antitrust Act (“UAA”) allows

“[a] person who is a citizen . . . or a resident of [Utah] who is injured or is threatened with injury

in his business or property by violation of the [UAA] may bring an action for injunctive relief and

damages.” Utah Code Ann. 1953 § 76-10-3109(1)(a). This requirement also applies to indirect

purchasers. In re Liquid Aluminum Sulfate Antitrust Litig., No. 16-cv-2687-MD-JLL, 2017 WL

3131977, at *28 (D.N.J. July 20, 2017) (citing Utah Code Ann. 1953 § 76-10-3109(1)(a)).

Massachusetts Laborers argues that it has fulfilled this requirement by alleging that some

members of the class made purchases in Utah which “presumably include Utah citizens and

residents.” D. 70 at 30. Although a minority of courts have held that the UAA’s citizenship or

residency requirement may be satisfied in a class action because members of the putative class

“presumably include citizens and residents of Utah,” most courts have held that “UAA claims must

be dismissed if the only named plaintiffs do not allege that they are citizens or residents of Utah.”

In re Amitiza Antitrust Litig., No. 21-cv-11057-MJJ, 2024 WL 4250224, at *13 (D. Mass. Aug.

21, 2024) (citing Blue Cross & Blue Shield of Vermont v. Teva Pharm. Indus., Ltd., 712 F. Supp.

3d 499, 549 (D. Vt. 2024) and other cases), report and recommendation adopted as modified, No.

21-cv-11057-MJJ, 2024 WL 4344887 (D. Mass. Sept. 30, 2024).

Here, given that the UAA’s text indicates that only a person who is the citizen or resident

may bring suit under the UAA, see Utah Code Ann. 1953 § 76-10-3109(1)(a), the majority’s

reasoning is more persuasive. Accordingly, because Massachusetts Laborers has not plausibly

alleged that it is a citizen or resident of Utah, the Court allows the motion to dismiss as to the

antitrust claims raised under Utah law.

2. Consumer Protection Claims

Boehringer raises three grounds to dismiss Massachusetts Laborers’ consumer protection

claims. First, Boehringer argues that the consumer protection statutes of Arkansas, Illinois,

Maryland and Utah do not apply in an antitrust context. D. 66 at 25. Second, Boehringer also

argues that the consumer protection statutes of New Jersey and Oklahoma do not provide for

consumer protection claims based on antitrust allegations by indirect purchasers. Id. Third,

Boehringer argues that Massachusetts consumer protection law does not apply to indirect

purchaser antitrust claims. Id. Lastly, Boehringer contends that Massachusetts Laborers cannot

raise a consumer protection claim under Indiana, Maryland, South Dakota, Vermont and Wyoming

laws because “it has not alleged that it relied on some statement or conduct by Boehringer, as is

[allegedly] required under these state laws.” Id at 25-26 (emphasis in original).

a. Arkansas, Illinois, Maryland and Utah

Arkansas. The Arkansas Deceptive Trade Practices Act (“ADTPA”) broadly prohibits

“deceptive and unconscionable trade practices.” Ark. Code Ann. § 4-88-107(a). Most courts have

construed the statute’s language to include anticompetitive conduct. See Iron Workers I, 734 F.

Supp. 3d at 163 (citing In re Packaged Seafood Prods. Antitrust Litig., 242 F. Supp. 3d 1033, 1072

(S. D. Cal. 2017)) (noting that “the Arkansas Supreme Court has held that the [statute’s]

proscription of ‘unconscionable’ trade practices is broad and that the statute is to be broadly

construed”); In re Pork Antitrust Litig., 495 F. Supp. 3d 753, 780–81 (D. Minn. 2020) (holding

that the ADTPA applies to anticompetitive behavior). Although the ADTPA allows private

individuals injured by the deceptive or unconscionable trade practices to bring suit, Ark. Code

Ann. § 4-88-113(f)(1)(A), it bars private class actions “unless the claim is being asserted for a

violation of Arkansas Constitution, Amendment 89,” id. § 4-88-113(f)(1)(B). Here, Massachusetts

Laborers is bringing a class action that does not assert any violation of the Arkansas Constitution.

Accordingly, the motion to dismiss is allowed as to consumer protection claims raised under

Arkansas law.

Illinois. The Supreme Court of Illinois has held that under the Illinois Consumer Fraud

and Deceptive Businesses Practices Act (“ICFA”), 815 Ill. Comp. Stat. § 505/1 et seq., a plaintiff

may not “state a cause of action that [is] a typical antitrust allegation under the ICFA, where the

legislature had declined to include such cause of action under the [IAA].” In re Flonase Antitrust

Litig., 692 F. Supp. 2d 524, 538 (E.D. Pa. 2010) (citing Laughlin v. Evanston Hosp., 133 Ill. 2d

374, 391 (1990)). Thus, a plaintiff may raise an antitrust claim under the ICFA only if the claim

would be viable under the IAA. See Iron Workers I, 734 F. Supp. 3d at 163 (denying a motion to

dismiss because “[n]either party ha[d] addressed whether the antitrust claims at issue are actionable

under the [IAA]”). Here, as discussed, Massachusetts Laborers cannot bring an antitrust action

under the IAA where indirect purchasers are prohibited from bringing such an action under that

statute. See Solodyn, 2015 WL 5458570, at *16 (citing 740 Ill. Comp. Stat. § 10/7 (2010)).

Accordingly, Massachusetts Laborers cannot now bring an identical claim under the ICFA. The

Court allows the motion to dismiss as to consumer protection claims brought under Illinois law.

Maryland. The Maryland Consumer Protection Act (“MCPA”) “forbids any ‘unfair or

deceptive trade practice,’” and includes a “nonexclusive list of prohibited acts.” In re New Motor

Vehicles Canadian Exp. Antitrust Litig., 350 F. Supp. 2d 160, 187 (D. Me. 2004) (quoting Md.

Code Ann., Com. Law, §§ 13-301, 13-303). Because Maryland “has separate statutory schemes

addressing antitrust and unfair or deceptive trade practices,” and because “antitrust allegations do

not ‘fit within the MCPA framework,’” courts in Maryland have held that anticompetitive conducts

are not actionable under the MCPA. See Washington Cnty. Bd. of Educ. v. Mallinckrodt ARD,

Inc., 431 F. Supp. 3d 698, 711 (D. Md. 2020) (quoting Davidson v. Microsoft Corp., 143 Md. App.

43, 57 (2002)). Accordingly, the Court allows the motion to dismiss as to consumer protection

claims raised under Maryland law on this ground.

Utah. “The Utah Consumer Sales Practices Act (“UCSPA”) . . . prohibits deceptive or

unconscionable acts or practices by a supplier in connection with a consumer transaction.” Wade

v. Jobe, 818 P.2d 1006, 1013-14 (Utah 1991). (quoting Utah Code Ann. §§ 13-11-1 et seq.).

Courts are split on whether the UCSPA applies in antitrust context. Some, emphasizing the

statute’s requirement that the UCSPA be construed liberally, have held that the statute can be

applied against antitrust violations. See e.g., In re Cattle Antitrust Litig., No. 19-cv-1129-JRT-

HB, 2021 WL 7757881, at *14 (D. Minn. Sept. 14, 2021) (citing Utah Code Ann. § 13-11-2); In

re Namenda Indirect Purchaser Antitrust Litig., No. 115-cv-6549C-MRWL, 2021 WL 2403727,

at *33 (S.D.N.Y. June 11, 2021). Others, noting that the UCSPA was meant to be interpreted in

accordance with the Federal Trade Commission Act (“FTCA”), 15 U.S.C. § 45, have held that the

UCSPA cannot be applied to antitrust violations because the statute lacks an anticompetition

provision similar to the FTCA. See e.g., Iron Workers I, 734 F. Supp. 3d at 163 (citing Utah Code

Ann. § 13-11-2(4)); In re Dynamic Random Access Memory (Dram) Antitrust Litig., 516 F. Supp.

2d 1072, 1117 (N.D. Cal. 2007) (citing Utah Code Ann. § 13-11-2(4)). Here, the Court finds the

latter cases’ reasoning more persuasive. Although the text of the UCSPA emphasizes that the

statute is to be construed liberally, it also notes that the statute must be construed to “promote”

specific policies, among which is to “make state regulations of consumer sales practices not

inconsistent with the policies” of the FTCA. Utah Code Ann. § 13-11-2(4). Because the USCPA

was modelled after and is meant to be read in accordance with the FTCA, the lack of an

anticompetition provision in the USCPA indicates that the legislature did not intend for such a

provision to be read into the statute. See Dynamic Random Access Memory, 516 F. Supp. 2d at

1117. Accordingly, the Court allows the motion to dismiss as to consumer protection claims raised

under Utah law.

b. New Jersey and Oklahoma

New Jersey. Federal and state courts have previously held that the New Jersey Consumer

Fraud Act (“NJCFA”), N.J. Stat. Ann. 56:8-1 et seq. prohibits indirect purchasers from pursuing

antitrust actions, noting that doing so would undermine the NJAA’s prohibition of same. See In

re New Motor Vehicles Canadian Exp. Antitrust Litig., 350 F. Supp. 2d 160, 195 (D. Me. 2004);

Island Mortg. of New Jersey & Perennial Lawn Care, Inc. v. 3M, 860 A.2d 1013, 1017-18 (N.J.

Super. 2004). Given that the NJAA has been amended to allow indirect purchasers to bring

antitrust actions, N.J. Stat. Ann. § 56:9-12(a)–(c), this reasoning is no longer persuasive. Because

“states remain free to permit recovery by indirect purchasers,” Massachusetts Laborers may seek

antitrust recovery under NJCFA “so long as [its] allegations are enough to plead the relevant

consumer protection violation.” In re Generic Pharms. Pricing Antitrust Litig., 368 F. Supp. 3d

814, 840 (E.D. Pa. 2019) (citations omitted). Accordingly, the Court denies the motion to dismiss

Massachusetts Laborers’ consumer protection claims raised under New Jersey law.

Oklahoma. Courts generally agree that the Oklahoma Consumer Protection Act

(“OCPA”), Okla. Stat. Ann. 15, § 751 et seq., does not permit indirect purchasers from bringing

actions for antitrust violations. See California v. Infineon Techs. AG, 531 F. Supp. 2d 1124, 1149

(N.D. Cal. 2007); Major v. Microsoft Corp., 60 P.3d 511, 517 (Okla. Civ. App. 2002).

Accordingly, the Court allows the motion to dismiss as to Massachusetts Laborers’ consumer

protection claims raised under Oklahoma law.

c. Massachusetts

Even assuming arguendo that a Chapter 93A § 11 claim survived the failure to allege

conduct that occurred “primarily and substantially” in Massachusetts as required, see pp. 28-29,

supra, Section 11 “includes a specific provision that in any action brought under that section, the

court shall be guided in its interpretation of unfair methods of competition by the provisions of the

[Massachusetts] Antitrust Act [Mass. Gen. L. c. 93].” Ciardi v. F. Hoffmann-La Roche, Ltd., 436

Mass. 53, 62-63 (2002). Because “the Antitrust Act is to be construed in harmony with judicial

interpretations of comparable federal antitrust statutes, the rule of law established in [Illinois

Brick] would apply with equal force to preclude claims brought under G. L. c. 93 by indirect

purchasers in Massachusetts.” Id. at 57-58. Accordingly, the Court allows the motion to dismiss

as to claims raised under Massachusetts consumer protection laws on this basis as well.

d. Indiana, Maryland, South Dakota, Vermont and Wyoming

Indiana. Under the Indiana Deceptive Consumer Sales Act (“IDCSA”), a person who

“rel[ies] upon an uncured or incurable deceptive act may bring an action for the damages actually

suffered.” Ind. Code Ann. § 24-5-0.5-4(a). At issue is whether the IDCSA applies where

Massachusetts Laborers did not directly rely upon Boehringer’s alleged deception. In In re Actiq

Sales & Mktg. Pracs. Litig., the court held that a plaintiff may assert a claim under the IDCSA

where there is no direct, first-party reliance. In re Actiq Sales & Mktg. Pracs. Litig., 790 F. Supp.

2d 313, 322-24 (E.D. Pa. 2011). There, the plaintiffs, third-party payors, alleged that they were

forced to pay excessive prescription costs for the defendant’s drug due to the defendant’s illegal

marketing scheme directed at physicians. Id. at 317. The court explained that the statutory text

covers deceptive practices by “a supplier,” which is defined as “a manufacturer, wholesaler, or

retailer, whether or not the person deals directly with the consumer.” Id. at 323 (quoting Ind. Code.

Ann. §§ 24-5-0.5-2(a)(3)(A)). As such, the court held that “it is evident that the Indiana legislature

intended the law to encompass deceptive acts that cause damages not only to direct consumers,

but also third parties who would lack direct reliance on the supplier’s deceptive acts.” Id. Thus,

“reasonable reliance will suffice, not only that of a first-party nature.” Id. The Court finds the

Actiq court’s reasoning persuasive. Here, as alleged, Boehringer’s Orange Book listing scheme

and sham litigation have caused Massachusetts Laborers injury in the form of higher prices for

purchases of Combivent Respimat and Spiriva Respimat. D. 57 ¶¶ 676, 685. Thus, Massachusetts

Laborers may raise a claim under the IDCSA notwithstanding the lack of direct reliance on any of

Boehringer’s statements or conduct. Accordingly, the Court denies the motion to dismiss as to

consumer protection claim raised under Indiana law.

Maryland. Even if anticompetitive conduct was actionable under the MCPA, see pp. 32-

33, supra, Massachusetts Laborers have still failed to state a claim under the MCPA. To state such

a claim, “a plaintiff must adequately plead that (1) the defendant engaged in an unfair or deceptive

practice or misrepresentation, (2) the plaintiff relied upon the representation, and (3) doing so

caused the plaintiff actual injury.” Bowman v. Select Portfolio Servicing, Inc., 704 F. Supp. 3d

633, 652 (D. Md. 2023) (quoting Turner v. JPMorgan Chase, N.A., No. 14-cv-0576-TDC, 2015

WL 5021390, at *4 (D. Md. Aug. 21, 2015)). “A consumer relies on a misrepresentation when

the misrepresentation substantially induces the consumer’s choice.” Bank of Am., N.A. v. Jill P.

Mitchell Living Tr., 822 F. Supp. 2d 505, 532 (D. Md. 2011) (citations omitted). Because the

reliance element of the MCPA requires a plaintiff to allege plausibly that its behavior was induced

by the defendant’s alleged misrepresentations, a plaintiff may only satisfy this element by alleging

direct reliance. See In re ZF-TRW Airbag Control Units Prod. Liab. Litig., 601 F. Supp. 3d 625,

777 (C.D. Cal. 2022) (concluding that the plaintiffs have failed to show reliance because the

plaintiffs “have not shown that they were exposed to or relied on [the defendants’] alleged

misrepresentations”), opinion clarified sub nom. In re ZF-TRW Airbag Control Units Prod., No.

19-cv-02905-JAK, 2022 WL 19425927 (C.D. Cal. Mar. 2, 2022). Here, although Massachusetts

Laborers has plausibly alleged that it suffered an injury due to Boehringer’s alleged

anticompetitive conduct which as alleged include falsely certifying to the FDA that its listed

patents claim a drug product, D. 57 ¶ 676, it failed to allege any facts to permit an inference that it

directly relied upon that alleged misrepresentation to its detriment. Accordingly, the Court allows

the motion to dismiss as to consumer protection claims under Maryland law.

South Dakota. The South Dakota Deceptive Trade Practices and Consumer Protection Act

(“SDDTPA”) provides that “[a]ny person who claims to have been adversely affected by any act

of a practice declared to be unlawful by [the SDDTPA] shall be permitted to bring a civil action”

for recovery of damages. Moss v. Guttormson, 551 N.W.2d 14, 17 (S.D. 1996) (some alterations

in original) (emphasis in original) (quoting S.D. Codified Law § 37-14-31). Because the statute

applies to any person who was adversely affected, its scope extends beyond direct consumers. Id.

Accordingly, “[d]efendants cannot escape liability to plaintiffs for their alleged misrepresentations

simply because they did not make statements directly to plaintiffs.” Brookings Mun. Utilities, Inc.

v. Amoco Chem. Co., 103 F. Supp. 2d 1169, 1178 (D.S.D. 2000). Because Massachusetts

Laborers has plausibly alleged that it suffered from Boehringer’s alleged anticompetitive conducts,

it may raise a claim under the SDDTPA. According, the Court denies the motion to dismiss as to

consumer protection claims under South Dakota law.

Vermont. The Vermont Consumer Protection Act (“VCPA”) provides that “[a]ny

consumer who contracts for goods or services in reliance upon false or fraudulent representations

or practices prohibited . . . , or who sustain damages or injury as a result of any false or fraudulent

representations or practices prohibited . . . may sue for appropriate equitable relief and may

recover . . . the amount of his or her damages.” Vt. Stat. Ann. Tit. 9, § 2461(b). “To maintain a

private action under § 2461(b), a plaintiff must ‘[allege plausibly] either (1) reliance on a deceptive

act in contracting goods or services or (2) damages or injury from an unfair or deceptive act.”

Mansfield v. Heilmann, Ekman, Cooley & Gagnon, Inc., 308 A.3d 533, 543 (Vt. 2023) (quoting

Dernier v. Mortg. Network, Inc., 87 A.3d 465, 481 (Vt. 2013)). Thus, so long as Massachusetts

Laborers could allege some injury resulting from Boehringer’s alleged unlawful conduct, it needs

not to also allege reliance. See id. (quoting Dernier, 87 A.3d at 481). As discussed, Massachusetts

Laborers has done so here. Accordingly, Massachusetts Laborers has stated a claim under the

VCPA and the Court denies the motion to dismiss as to consumer protection claims raised under

Vermont law.

Wyoming. The Wyoming Consumer Protection Act (“WYCPA”) provides that “[a] person

relying upon an uncured unlawful deceptive trade practice may bring an action under this act for

the damages he has actually suffered as a consumer as a result of such unlawful deceptive trade

practice.” Wyo. Stat. Ann. § 40–12–108(a). At least one court has indicated that the statute

requires an allegation of direct reliance. See Allen v. Conagra Foods, Inc., 331 F.R.D. 641, 669

(N.D. Cal. 2019) (observing that the plaintiffs “acknowledge[d] that the statute explicitly requires

reliance”). The Court agrees with this assessment. By its plain terms the statute limits its scope

to only persons “relying upon” unlawful and deceptive trade practices “for the damages he has

actually suffered.” Wyo. Stat. Ann. § 40–12–108(a). Here, Massachusetts Laborers has not

alleged that it directly relied upon any of Boehringer’s alleged misconducts to its detriment.

Accordingly, the Court allows the motion to dismiss as to consumer protection claims raised under

Wyoming law.

3. Unjust enrichment claims

In general, “there are only a few differences in the description of unjust enrichment claims

as between states.” Iron Workers I, 734 F. Supp. 3d at 161 (quoting Overka v. Am. Airlines, Inc.,

265 F.R.D. 14, 21 (D. Mass. 2010)). “First, each state requires enrichment of the defendant at the

expense of plaintiff.” Overka, 265 F.R.D. at 21. “Second, all states require that the defendant

retain the benefit.” Id. “Third, all jurisdictions require that retention of the benefit without

payment would create injustice.” Id. Boehringer argues that Massachusetts Laborers has failed to

state a claim for unjust enrichment the laws of Alabama, Florida, New York, North Carolina,

Michigan, North Dakota and Ohio because it has failed to allege plausibly that it has conferred a

direct benefit to Boehringer, which. D. 66 at 26.

a. Alabama

“In Alabama, ‘the essence of . . . unjust enrichment . . . is that a plaintiff can prove facts

showing that defendant holds money which, in equity and good conscience, belongs to plaintiff or

holds money which was improperly paid to defendant because of mistake of fraud.’” Danny Lynn

Elec. & Plumbing, LLC v. Veolia ES Solid Waste Se., Inc., No. 09-cv-192-MHT, 2011 WL

2893629, at *6 (M.D. Ala. July 19, 2011) (emphasis in original) (alterations in original)

(quoting Hancock–Hazlett General Const. Co., Inc. v. Trane Co., 499 So.2d 1385, 1387

(Ala.1986)). Courts have generally agreed that Alabama law requires a plaintiff to have conferred

a direct benefit to the defendant to state a claim for unjust enrichment. See e.g. In re Atlas Roofing

Corp. Chalet Shingle Prod. Liab. Litig., No. 13-cv-MD-2495-TWT, 2018 WL 2929831, at *6

(N.D. Ga. June 8, 2018) (quoting Opelika Prod. Credit Ass'n, Inc. v. Lamb, 361 So. 2d 95, 99 (Ala.

1978)) (concluding that unjust enrichment under Alabama law requires that the benefit conferred

“must be realized as a direct result of the transaction”); Danny Lynn, 2011 WL 2893629, at *6

(M.D. Ala. July 19, 2011) (dismissing plaintiffs’ unjust enrichment claim under Alabama law

because the plaintiffs “did not confer a direct benefit” on the individual defendants”). Because

Massachusetts Laborers has not alleged plausibly a direct conferral of benefits, the Court allows

the motion to dismiss as to the unjust enrichment claim under Alabama law.

b. Florida

Courts in Florida have held that to prevail on an unjust enrichment claim, the plaintiff must

have conferred a direct benefit to the defendant. See Kopel v. Kopel, 229 So. 3d 812, 818 (Fla.

2017) (citing Peoples Nat'l Bank of Commerce v. First Union Nat'l Bank of Fla. N.A., 667 So.2d

876, 879 (Fla. 3d DCA 1996)); Cape, LLC v. Och-Ziff Real Est. Acquisitions LP, 370 So. 3d 1010,

1016 (Fla. Dist. Ct. App. 2023) (citing Am. Safety Ins. Serv., Inc. v. Griggs, 959 So. 2d 322, 331

(Fla. 5th DCA 2007)). “A direct benefit is not conferred on a manufacturer where a consumer

buys a product from a retailer, rather than directly from the manufacturer.” In re Evenflo Co., Inc.

Mktg., Sales Pracs. & Prod. Liab. Litig., 707 F. Supp. 3d 103, 136 (D. Mass. 2023) (citing

Marrache v. Bacardi U.S.A., Inc., 17 F.4th 1084, 1102 (11th Cir. 2021)). Here, Massachusetts

Laborers alleges that it “purchased, paid, and/or provided reimbursement for some or all of the

purchase price of Combivent Respimat and Spiriva Respimat” for its members “from pharmacies

in multiple states.” D. 57 ¶ 21. Because Massachusetts Laborers has not alleged that it purchased

the medications directly from Boehringer, the Court allows the motion to dismiss as to the unjust

enrichment claim under Florida law.

c. New York

To state a claim for unjust enrichment under New York law, “‘a plaintiff need not be in

privity with the defendant to state a claim for unjust enrichment,’ but their relationship cannot be

‘too attenuated.’” In re Processed Egg Prods. Antitrust Litig., 851 F. Supp. 2d 867, 930 (E.D. Pa.

2012) (quoting Sperry v. Crompton Corp., 8 N.Y.3d 204, 215–16 (2007)). At least one federal

court has explained that this means “a product’s indirect purchaser” can assert the claim “against

the manufacturer of the product itself.” Waldman v. New Chapter, Inc., 714 F. Supp. 2d 398, 403-

04 (E.D.N.Y. 2010) (citing Cox v. Microsoft Corp., 778 N.Y.S.2d 147, 149 (1st Dep't 2004)).

Thus, Massachusetts Laborers may assert this unjust enrichment claim against Boehringer here

without needing to allege plausibly that it had conferred a direct benefit on Boehringer. See

Processed Egg Prods., 851 F. Supp. 2d at 930 (holding that the complaint’s lack of allegations

“suggesting the conferral of a direct benefit . . . is not in and of itself fatal to a New York unjust

enrichment claim as a matter of law”). Accordingly, the Court denies the motion to dismiss as to

the unjust enrichment claim under New York law.

d. North Carolina

“North Carolina law requires that a plaintiff seeking recovery for unjust enrichment ‘must

have conferred a benefit on the other party.’” Metric Constructors, Inc. v. Bank of Tokyo-

Mitsubishi, Ltd., 72 F. App'x 916, 920 (4th Cir. 2003) (quoting Booe v. Shadrick, 322 N.C. 567,

556 (1988)). “Under North Carolina law, it is sufficient for a plaintiff to [allege plausibly] that it

has conferred some benefit on the defendant, without regard to the directness of the transaction.”

Id. at 921. Because North Carolina law does not impose a “direct benefit” requirement, the Court

denies the motion to dismiss as to the unjust enrichment claim under North Carolina law.

e. Michigan

In Michigan, unjust enrichment is only available “in cases where the defendant directly

receives a benefit from the plaintiff.” Smith v. Glenmark Generics, Inc., USA, No. 315898, 2014

WL 4087968, at *1 (Mich. Ct. App. Aug. 19, 2014) (citing Kammer Asphalt Paving Co. v. E.

China Twp. Sch., 443 Mich. 176, 187–88 (1993)). Thus, the Michigan Court of Appeals has held

that unjust enrichment is unavailable where the plaintiff and defendant have no direct contact with

one another. See A & M Supply Co. v. Microsoft Corp., No. 274164, 2008 WL 540883, at *2

(Mich. Ct. App. Feb. 28, 2008). Here, Massachusetts Laborers does not allege that it has had any

direct contacts or transactions with Boehringer. Accordingly, the Court allows the motion to

dismiss as to the unjust enrichment claim under Michigan law.

f. North Dakota

Under North Dakota law, “[f]or a complainant to recover” for unjust enrichment, “it is

sufficient if another ‘has, without justification, obtained a benefit at the direct expense of the

complainant, who then has no legal means of retrieving it. . . . The essential element in recovering

under the theory of unjust enrichment is the receipt of a benefit by the defendant from the plaintiff

which would be inequitable to retain without paying for its value.” McColl Farms, LLC v. Pflaum,

837 N.W.2d 359, 367 (N.D. 2013) (internal citation and quotation marks omitted). Courts in this

Circuit have generally held that a plaintiff must allege plausibly the conferral of a direct benefit to

the defendant to state a claim for unjust enrichment under North Dakota law. See Amitiza, 2024

WL 4250224, at *34-35 (citations omitted); In re Loestrin 24 FE Antitrust Litig., 410 F. Supp. 3d

352, 384 (D.R.I. 2019) (citing Solodyn, 2015 WL 5458570, at *18). Here, because Massachusetts

Laborers has not alleged any conferral of direct benefits to Boehringer and accordingly the Court

allows the motion to dismiss as to the unjust enrichment claim under North Dakota law.

g. Ohio

Under Ohio law, a plaintiff must allege plausibly that they have conferred a benefit directly

to the defendant to state a claim for unjust enrichment. See In re Whirlpool Corp. Front-Loading

Washer Products Liab. Litig., 684 F. Supp. 2d 942, 951-52 (N.D. Ohio 2009). Therefore, “an

indirect purchaser cannot assert a common law claim for restitution and unjust enrichment against

a defendant without establishing that a benefit had been conferred upon that defendant by the

purchaser.” Johnson v. Microsoft Corp., 834 N.E.2d 791, 799 (Ohio 2005). Accordingly, the

Court allows the motion to dismiss as to the unjust enrichment claim under Ohio law.

D. Injunctive Relief Claim Pursuant to the Clayton Act, 15 U.S.C. § 26

Under the Clayton Act,8 “[a]ny person, firm, corporation, or association shall be entitled to

sue for and have injunctive relief, in any court of the United States having jurisdiction over the

parties, against threatened loss or damage by a violation of the antitrust laws.” 15 U.S.C. § 26.

“In other words, plaintiffs ‘must [allege plausibly] a significant threat of injury from an impending

violation . . . or from a contemporary violation likely to continue or recur.” In re DDAVP Indirect

Purchaser Antitrust Litig., 903 F. Supp. 2d 198, 209 (S.D.N.Y. 2012) (quoting In re New Motor

Vehicles Canadian Exp. Antitrust Litig., 522 F.3d 6, 13 (1st Cir. 2008)). Such an injury must be

“both ‘real and immediate,’ not ‘conjectural’ or ‘hypothetical.’” New Motor Vehicles, 522 F.3d

at 14 (quoting O'Shea v. Littleton, 414 U.S. 488, 494 (1974)).

8 Although Massachusetts Laborers references both the Sherman Act and the Clayton Act

in the heading of Count 15, it only “requests that the Court grant injunctive relief pursuant to

Section 16 of the Clayton Act, 15 U.S.C. § 26.” D. 57 ¶ 836. Accordingly, the Court construes

this claim as requesting injunctive relief only under the Clayton Act.

Boehringer argues that the Court should dismiss this claim because Massachusetts Laborers

has “failed to allege a ‘real and immediate’ threat of injury requiring injunctive relief. D. 78 at 16

(citing New Motor Vehicles, 522 F.3d at 14). But Massachusetts Laborers’ alleged injury, having

to pay higher prices for drugs it otherwise would not need to but for Boehringer’s allegedly

wrongful listing, D. 57 ¶ 685, is the precisely the kind of “[t]hreaten[ed] economic harm to . . .

consumers . . . [that] is plainly sufficient to authorize injunctive relief.” New York ex rel.

Schneiderman v. Actavis PLC, 787 F.3d 638, 661 (2d Cir. 2015) (some alterations in original)

(quoting California v. Am. Stores Co., 495 U.S. 271, 283 (1990)). Accordingly, the Court denies

the motion to dismiss as to Massachusetts Laborers’ claim for injunctive relief on this ground.

VI. Conclusion

For the foregoing reasons, the Court ALLOWS in part and DENIES in part Boehringer’s

motion to dismiss, D. 65, as follows:

1. The motion to dismiss is ALLOWED with respect to Massachusetts Laborers’

sham litigation claims.

2. The motion to dismiss is ALLOWED with respect to Massachusetts Laborers’

antitrust claims (monopolization and attempted monopolization) raised under

Illinois, Massachusetts, Mississippi and Utah laws.

3. The motion to dismiss is ALLOWED with respect to Massachusetts Laborers’

consumer protection claims raised under Arkansas, Illinois, Maryland, Utah,

Oklahoma, Massachusetts and Wyoming laws.

4. The motion to dismiss is ALLOWED with respect to Massachusetts Laborers’

unjust enrichment claims raised under the laws of Alabama, Florida, Michigan,

North Dakota and Ohio.

5. The motion to dismiss is DENIED in all other respects. The remaining claims are

as follow:

a. Counts 1, 2, 4, 8, 9 and 11 excluding claims raised under Illinois,

Massachusetts, Mississippi and Utah laws.

b. Counts 5, 6, 12 and 13 excluding claims raised under Arkansas, Illinois,

Maryland, Utah, Oklahoma, Massachusetts and Wyoming laws.

c. Counts 15, the claim for injunctive relief under § 16 of the Clayton Act.

d. Count 16 excluding claims raised under Alabama, Florida, Michigan,

North Dakota and Ohio laws.

So Ordered.

/s Denise J. Casper

United States District Judge