HUMANA INC. v. MERCK & COMPANY, INC.

NOT FOR PUBLICATION

UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF NEW JERSEY

HUMANA INC.,

Plaintiff, Case No. 2:23-cv-23023 (BRM) (LDW)

v. OPINION

MERCK & CO., INC. et al.,

Defendants.

MARTINOTTI, DISTRICT JUDGE

Before this Court is Defendants Merck & Co., Inc. (“Merck & Co.”), Merck Sharp &

Dohme LLC (f/k/a Merck Sharp & Dohme Corp.), Schering-Plough Corporation (“Schering-

Plough”), and Schering Corporation (“Schering”) (collectively, “Merck”)1 Partial Motion to

Dismiss (ECF No. 72) Plaintiff Humana Incorporated’s (“Humana”) Third Amended Complaint

1 On February 21, 2025, defendants Glenmark Pharmaceuticals Ltd. and Glenmark

Pharmaceuticals Inc. USA (together, “Glenmark”) were voluntarily dismissed and, as such, are no

longer parties to this action. (ECF No. 67.)

(“Third Amended Complaint”) (ECF No. 61) pursuant to Federal Rule of Civil Procedure 12(b)(6)

(the “Motion”).2 , 3 Humana opposed the Motion (ECF No. 73), and Merck replied (ECF No. 74).

Having reviewed and considered the parties’ submissions filed in connection with the

Motion and having declined to hold oral argument pursuant to Federal Rule of Civil Procedure

78(b), for the reasons set forth below and for good cause having been shown, Merck’s Partial

Motion to Dismiss (ECF No. 72) is GRANTED in part and DENIED in part.

I. BACKGROUND

For the purposes of this Motion, the Court accepts the factual allegations in the Third

Amended Complaint as true and draws all inferences in the light most favorable to Humana. See

Phillips v. Cnty. Of Allegheny, 515 F.3d 224, 228 (3d Cir. 2008). The Court also considers any

“document integral to or explicitly relied upon in the complaint.” In re Burlington Coat Factory

Sec. Litig., 114 F.3d 1410, 1426 (3d Cir. 1997).

The factual and procedural backgrounds of this matter are well-known to the parties and

were previously recounted in depth by the Court in its prior opinion granting in part and denying

in part Defendants’ Partial Motion to Dismiss Humana’s Second Amended Complaint. (ECF No.

57.) Accordingly, the Court will recount only the factual background and procedural history

2 This case is one of two that were originally filed in the District of New Jersey, see Humana Inc.

v. Merck & Co., Inc., et al., Case No. 2:23-cv-23023 (D.N.J. Sept. 22, 2021), and then consolidated

in a Multi-District Litigation (“MDL”) in the Eastern District of Virginia by the JPML pursuant to

29 U.S.C. § 1407, see Humana Inc. v. Merck & Co, et al., Case No. 2:21-cv-01007 (E.D. Va. Oct.

18, 2021); Centene Corp. v. Merck & Co, et al., Case No. 2:21-cv-17363 (E.D. Va. Oct. 18, 2021).

At the time Humana was joined to the MDL, there were at least seven other actions ongoing with

common questions of fact. On December 12, 2023, the JPML remanded both cases to this Court.

(See ECF No. 8.) The two cases are represented by the same attorneys and raise mostly the same

claims against Defendants, who submitted identical briefs in support of their Motions to Dismiss

against the two Plaintiffs.

3 The Motion to Dismiss the Third-Party Complaint or, alternatively, Transfer the Third-Party

action currently pending before the Court will be addressed in a separate opinion. (ECF No. 83.)

associated with this Motion, and will specifically omit discussion of the regulatory structure for

approval of new drugs and the alleged significance of Merck’s cholesterol-reducing drugs, which

were both recounted in this Court’s prior opinion. (Id.) Generally, this case concerns Merck’s

alleged monopolization scheme relating to two of its prescription cholesterol-lowering drugs, Zetia

and Vytorin.

A. The Parties

Humana is a Delaware corporation with its principal place of business in Louisville,

Kentucky, providing healthcare related services, including “insuring risk for prescription drug

costs for more than 8 million members in all 50 States, the District of Columbia, and Puerto Rico.”

(ECF No. 61 ¶ 9.) When a Humana member fills a prescription for Zetia, Vytorin, or generic

equivalents at a pharmacy, Humana pays a large share of the cost; for example, Humana has paid

hundreds of millions of dollars to pharmacies for prescriptions for Zetia, Vytorin, and generic

equivalents dispensed to Humana members. (Id. ¶ 10.) Humana has also spent millions of dollars

on both Zetia and Vytorin dispensed by its own mail-order pharmacy, Humana Pharmacy, Inc.

(“HPI”), as well as in retail pharmacy locations. (Id. ¶ 11.) HPI purchases Zetia, Vytorin, and other

drugs relevant to this action from distributors like AmerisourceBergen Drug Corporation

(“ABDC”), who in turn purchases its drugs directly from Defendants. (Id. ¶ 12.) In an agreement

made effective on May 6, 2022, between Humana, HPI, and ABDC, ABDC assigned its rights to

assert claims against Defendants arising out of or relating to ABDC’s purchases of Zetia and

Vytorin which were later resold to HPI from 2011 to present to Humana. (Id.) It is out of this

agreement that Humana’s federal antitrust claims arise. (Id. ¶ 13.)

Merck & Co. is a corporation organized under the laws of New Jersey. (Id. ¶ 14.) Merck

Sharp & Dohme Corp. is a subsidiary of Merck & Co. organized under the laws of New Jersey and

the assignee of patents relevant to this matter. (Id. ¶ 15.) MSP Singapore Co. LLC is also a

subsidiary of Merck & Co., Inc. and formerly the exclusive licensee of the relevant patents. (Id.

¶ 21.) Schering-Plough was also a corporation organized under the laws of New Jersey, as was

Schering, a wholly owned subsidiary of Schering-Plough and the original assignee of the relevant

patents. (Id. ¶¶ 16–17.) Merck & Co. acquired and merged into Schering-Plough in 2009, thereafter

changing its name to Merck & Co., Inc., and the company originally known as Merck & Co., Inc.

became Merck Sharp & Dohme Corp. (Id. ¶ 18.)

Par Pharmaceutical, Inc. is a corporation under the laws of New York. (Id. ¶ 20.) Par

Pharmaceutical, Inc. is a subsidiary of Endo International plc (“Endo”), an Irish corporation with

U.S. headquarters in Malvern, Pennsylvania. (Id.) Endo acquired Par Pharmaceutical Holdings,

Inc. and its subsidiaries (including Par Pharmaceutical, Inc.) and merged it with its existing

generics subsidiary, Qualitest Pharmaceuticals in September 2015. (Id.) The Third Amended

Complaint refers to all of Par’s predecessors and successors, collectively, as “Par.” (Id.)

B. Defendants’ Allegedly Anticompetitive Conduct

Humana alleges Defendants engaged in an overarching scheme to monopolize the

distribution of Zetia and Vytorin in the U.S., including a purportedly anticompetitive settlement

agreement (“Zetia Settlement Agreement”) between Merck and Glenmark and alleged unlawful

business arrangements between Merck, Par, and Glenmark, in violation of federal and state

antitrust laws, and state consumer protection and unjust enrichment laws. (Id. ¶ 8.)

1. Merck’s Allegedly Inequitable Conduct During FDA Approval

Process of the ’115 and RE ’721 Patents, and Glenmark’s ANDA

Application for a Generic Version of Zetia

The Third Amended Complaint alleges Schering, through its attorney Anita W. Magatti

(“Magatti”), prosecuted a family of patents, including U.S. Patent No. 5,767,115 (the “’115”

patent), from the 1990s through the 2000s, during which time Schering, Merck4 , and MSP

Singapore had a duty to disclose “all information known . . . to be material to patentability” to the

U.S. Patent and Trademark Office (“USPTO”). (Id. ¶¶ 67–68 (quoting 37 C.F.R. § 1.56).) This

continued prosecution allowed Merck to obtain reissue to correct two “mistakes” in the patents,

first with respect to the RE ’721 patent and then with U.S. Reissue Patent No. RE 42,461 (the

“’461” patent). (Id. ¶ 67.) However, Schering, Merck, and MSP Singapore allegedly did not

disclose potentially relevant publications, such as one concerning laboratory experiments that

resulted in the metabolization of compounds SCH48461 and SCH58235, also known as ezetimibe

(generic Zetia), using well-known methods. (Id. ¶¶ 69–71.) Therefore, Defendants were allegedly

able to obtain patent claims that impermissibly covered naturally occurring, widely known

compounds. (Id. ¶ 71.)

Two sets of alleged inequitable conduct are particularly relevant here. (See id. ¶¶ 74–84.)

The first relates to the ’115 patent prosecution. On July 21, 1992, Schering filed International

Patent Application No. PCT/US92/05972, later published as “WO ’048,” which included data from

experimental testing of compounds like SCH48461 administered in vivo to hamsters. (Id. ¶¶ 74–

75.) Humana alleges at least two inventors (namely, Duane Burnett (“Burnett”) and John Clader

(“Clader”)) “were aware . . . that metabolites within the scope of one or more claims of the ’115

patent were necessarily produced when SCH48461 was administered to hamsters, as described in

WO ’048” because they are named inventors on the patent. (Id. ¶¶ 74, 76.) Additionally, Burnett

and Clader were allegedly aware “that metabolites within the scope of the ’115 patent were

necessarily produced when SCH48461 was administered to hamsters,” after a manuscript entitled

4 Humana does not identify the specific Merck entity here or elsewhere, and generally refers to

“the Merck Defendants” throughout the Third Amended Complaint. (See, e.g., ECF No. 61 ¶ 26.)

“In Vivo Metabolism-Based Discovery of a Potent Cholesterol Absorption-Inhibitor, SCH58235,

in the Rat and Rhesus Monkey through the Identification of the Active Metabolites of SCH48461”

was published in the Journal of Pharmacology and Experimental Therapeutics on June 30, 1997

(“June 1997 manuscript”). (Id. ¶ 76.) Despite Schering’s submitted disclosure statement to the

USPTO listing WO ’048 as “provid[ing] additional background information,” Burnett and Clader,

and potentially others, were aware that it “did significantly more than simply provide ‘background’

for the pending application” but, rather, described that the metabolites claimed in the application

that became the ’115 patent were “naturally occurring metabolites of the SCH48461 compound[.]”

(Id. ¶ 77.)

The second set of misrepresentations concerns the allegation that Schering scientists

intentionally concealed the true inventorship of the ’115 and RE ’721 patents. (Id. ¶ 78.) Humana

alleges that, “[i]n an apparently magnanimous gesture,” Schering scientist Dr. Adriano Afonso

(“Afonso”) “removed his name from the list of inventors during preparation of the patent

application to help promote [Dr. Stuart] Rosenblum’s [(“Rosenblum”)] career[,]” even though it

was actually Afonso who invented the compounds 4E and 4F (discussed in claim 7 of the patents),

which are “arguably the most important compound[s] for purposes of developing ezetimibe[.]”

(Id. ¶¶ 78–79, 81–82.) In addition to Rosenblum, Schering’s attorneys, including Schering’s Chief

Patent Counsel James Nelson (“Nelson”), allegedly knew by around 2005 of the incorrect

inventorship problem but did not correct it. (Id. ¶¶ 72, 78–79.)

Under 21 U.S.C. § 355(b)(1)(A), manufacturers are required to inform the FDA by listing

in their Orange Book any patents covering, as well as those not covering, the product, so generic

companies can “assess whether to challenge infringement and/or validity of the patents.” (Id. ¶ 85.)

A patent is considered to “cover” a product when that product “meet[s] all the elements of at least

one ‘claim’ in the patent.” (Id. ¶ 86.) Merck allegedly violated this statutory duty by listing some

patents that did not cover Zetia and improperly asserting other patents against pharmaceutical

companies seeking generic approval for the drug. (Id. ¶¶ 85, 87–89.) Specifically, Merck listed

U.S. Patent No. 5,846,966 (the “’966” patent) as containing a combination of ezetimibe and a

statin, despite knowing the product did not contain a statin. (Id. ¶ 87.) Therefore, “Merck knew

that the ’966 patent could not be infringed by the manufacture, use, offer to sell, sale, or

importation of Zetia.” (Id.) Merck also listed the RE ’721 in both the Orange Books for Zetia and

Vytorin, despite allegedly knowing RE ’721 could only have covered Zetia. (Id. ¶ 88.) In doing

so, Merck allegedly “knew or should have known that the patent was invalid” or otherwise

unenforceable due to its “inequitable conduct[,]” as described above (Id. ¶ 89.)

Additionally, before its NDA was approved, Merck attempted to extend its Zetia patent

protection. (Id. ¶ 90.) In particular, Merck filed U.S. Patent Application No. 10/136,968 (issued as

U.S. Patent No. 7,030,106 (the “’106” patent)), which did not claim priority to the RE ’721 patent

and therefore “constituted prior art to the ’106 patent.” (Id. ¶¶ 91–92.) Merck purportedly listed

the ’106 patent in the Orange Book for Zetia, extending the drug’s expiration date to July 25, 2022,

through that patent’s pediatric extension. (Id. ¶ 93.) However, because the ’106 patent’s “Field of

the Invention” states, in part, “[t]he present invention relates to compositions and therapeutic

combinations,” and the ’106 patent claims do not refer to combination use, “Merck knew that the

’106 patent was invalid in view of at least the RE ’721 patent.” (Id. ¶¶ 93–95.)

Finally, with FDA approval for Zetia, Merck had a five-year exclusivity grant and an

additional grant of pediatric exclusivity of six months for the RE ’721 patent. (Id. ¶¶ 96–97.) On

October 25, 2006—the first date on which other generic companies could file ANDAs for Zetia—

Glenmark filed an ANDA for a generic version of Zetia. (Id. ¶ 98.) Glenmark’s ANDA application

included a Paragraph IV Certification asserting the patents listed in Zetia’s Orange Book, along

with the RE ’721, ’966, and ’106 patents, but the FDA could not approve the ANDA until the

following year because of Merck’s regulatory exclusivity. (Id.)

2. Merck Purportedly Patents Vytorin Using Same Zetia Patents, and

Sues Generic Competitors for Alleged Infringement

In response to the looming expiration of Zocor’s patent and regulatory exclusivity in 2006,

Merck allegedly decided to combine Zocor and Zetia into a single tablet, with the aim of stretching

Zetia’s still-active patent protection over Zocor. (Id. ¶¶ 157–58.) In 2003, MSP Singapore filed an

NDA for this new combination product, Vytorin, and received FDA approval on July 23, 2004,

which gave Merck exclusivity until October 25, 2007. (Id. ¶ 158.) Merck marketed Vytorin as a

“unique dual-inhibition therapy,” even though Vytorin prescriptions contained the same

combination of doses as Zocor and Zetia, which were often prescribed in tandem. (Id. ¶ 159.)

According to Humana, Vytorin became a highly successful drug and generated billions of dollars

in sales. (Id. ¶ 160.) After March 21, 2014, Merck’s exclusive right over Vytorin was based on the

RE ’461 patent alone. (Id. ¶¶ 160–61.)

3. Schering’s Lawsuit Against Glenmark Alleging Infringement of the

RE ’721 Patent

On March 22, 2007, Schering and MSP Singapore, as the patent’s assignee and exclusive

licensee, respectively, sued Glenmark in the U.S. District Court for the District of New Jersey

alleging infringement of the RE ’721 patent.5 (Id. ¶ 99.) This lawsuit was allegedly meritless

because Merck “effectively admitted” the ’966 and ’106 patents were invalid, unenforceable,

and/or did not cover Zetia by failing to assert claims the patents would be infringed by the

5 Humana alleges Schering was a plaintiff in several other patent actions relating to Zetia and

Vytorin and, in filing this and other actions alongside Merck, Schering “had a vested economic

interest” in Merck’s efforts to maintain its monopolies over the two drugs. (Id. ¶ 99 n.11.)

Glenmark generic. (Id.) However, merely by initiating the suit, Schering and MSP Singapore

triggered an automatic 30-month stay, during which time the FDA was prevented from approving

Glenmark’s ANDA until expiration of the 30 months or entry of a final judgement that the RE

’721 patent was invalid, unenforceable, and/or not infringed. (Id.) In its responsive pleadings,

Glenmark asserted various affirmative defenses and counterclaims “based on the invalidity and

unenforceability of the RE ’721 patent[,]” arguing Schering engaged in inequitable conduct and

violated its duty of disclosure to the USPTO in its filing of the RE ’721 patent with respect to the

mischaracterization of WO ’048 and Schering’s failure to identify material scientific publications.

(Id. ¶¶ 100–07.) While the lawsuit was ongoing, the FDA tentatively approved Glenmark’s

ANDA, giving it a 180-day exclusivity period as the first filer for a Zetia generic. (Id. ¶ 109.)

4. Schering and Glenmark Sign a Settlement Agreement, Which

Includes an Alleged Reverse Payment Scheme

Less than four months after the FDA granted tentative approval to Glenmark’s ANDA for

Zetia, and while the parties were in settlement talks, Glenmark’s lead negotiator sent Glenmark

executives an email summary with key points from a meeting with Schering’s general counsel.

(Id. ¶ 111.) In that email, he noted “I . . . reminded [Schering’s general counsel] of the fact that

[the] court decision in favor of Glenmark will impact Vytorin product.” (Id.)

On May 10, 2010, Schering, MSP Singapore, and Glenmark settled, agreeing that

Glenmark would not release its generic Zetia drug until December 12, 2016. (Id. ¶ 112; see ECF

No. 46-6, Ex. C.) The Zetia Settlement Agreement allegedly ensured the RE ’721 patent would

not be invalidated by the suit and protected “both Zetia and Vytorin from generic competition.”

(Id. ¶ 113.)

Under sections 5.2 and 5.4 of the Zetia Settlement Agreement, Glenmark would not launch

its generic drug before December 12, 2016, and under section 5.3, Merck would not launch an

authorized generic version of its own “[d]uring any period of exclusivity to which Glenmark [wa]s

entitled under 21 U.S.C. § 355(j)(5)(B)(iv) [180-day exclusivity], and through the expiration of

[Merck’s] rights under the RE ’721 Patent and Ezetimibe Pediatric Exclusivity.” (Id. ¶ 127.) In

other words, Glenmark was free to launch its generic drug on December 12, 2016, Merck’s

exclusivity period for the RE ’721 patent ended on April 25, 2017, and Glenmark’s exclusivity

expired on June 10, 2017. (Id.) Humana alleges this settlement was effectively a reverse payment

scheme where Merck paid Glenmark to delay its generic release and gave it a period of generic

exclusivity in exchange. (Id.)

Humana alleges this reverse payment scheme through multiple pieces of circumstantial

evidence, including: (1) Merck’s prior admissions that “marketing an [authorized generic] is in its

economic interest”; (2) Merck’s history of releasing authorized generics amidst competition from

generic manufacturers; (3) the great success of Zetia, which indicated an authorized generic would

likely have been profitable; (4) Glenmark’s press release announcing its generic drug described it

as “the first and only generic version” of Zetia in the U.S.; (5) Merck’s decision not to launch an

authorized generic during Glenmark’s 180-day period of exclusivity, even though it was not

prohibited by law and Merck had a done so in the past for other branded drugs; and (6) Glenmark’s

disclosure to its shareholders in May 2017 (before releasing its generic version), that it expected

to capture more than 58% of combined brand and generic sales, a significantly larger market share

than is typical for a generic manufacturer, and then did so within six months. (Id. ¶ 129.) This

scheme was allegedly “worth substantially more than what Glenmark could have earned if it had

prevailed in the patent litigation filed by Merck” and could not have been achieved by Glenmark

even if it had defeated the infringement claims because the scheme ensured “six months of

exclusive generic sales, free from competition from Merck’s [authorized generic] or any other

generic competitors.” (Id. ¶ 130.) Without the reverse payment scheme, generic versions of Zetia

would have entered the market “at least as early as December 6, 2011, when Merck’s regulatory

exclusivity ended[,]” by which time Humana contends Glenmark would have either won at trial or

settled on competitive terms. (Id. ¶ 132.) “By December 6, 2011, no impediments existed to the

prompt approval and launch of generic Zetia other than Merck’s assertion of infringement of the

RE ’721 patent.” (Id. ¶ 133.)

5. The Distribution Agreement Between Glenmark and Par

While Schering’s lawsuit was still ongoing and before the Zetia Settlement Agreement,

Glenmark entered into an agreement with Par on April 30, 2010 (“Distribution Agreement”), by

which Par would have the exclusive right to market, distribute, and sell Glenmark’s generic version

of Zetia in the United States in exchange for an upfront payment to Glenmark and a net profit-

sharing arrangement. (Id. ¶ 118.) Under the Distribution Agreement, Glenmark was required to

provide to Par “all documents or materials in its possession or control” relating to the ANDA patent

litigation, “keep Par reasonably informed regarding material developments made with respect to

any [l]itigation[,]” and confer with Par on “all material decisions with respect to the [l]itigation

[which would] be made jointly[.]” (Id. ¶ 119.) Glenmark also agreed not to settle its suit with

Schering/Merck without Par’s “written consent” and to share any proceeds with Par in the event

of a settlement. (Id. ¶ 120.) The Distribution Agreement also included a provision to create a joint

Steering Committee within 30 days to advise, monitor, and otherwise oversee the marketing,

distribution, and sale of the drug. (Id. ¶¶ 121–22.) Pursuant to the terms of the Agreement, Par

allegedly consented to the reverse payment scheme between Schering/Merck and Glenmark, see

supra Section I.D.4. (Id. ¶ 124.)

6. Filings with Paragraph IV Certifications for Generic Zetia Products

from Competing Manufacturers

Around April 2010, a second pharmaceutical company, Mylan Pharmaceuticals, Inc.

(“Mylan”) filed a Paragraph IV Certification for its own generic version of the branded drug. (Id.

¶ 147.) Merck filed a lawsuit against Mylan alleging infringement of the RE ’721 and ’966 patents

(the “Mylan Litigation”).6 (Id.) “Mylan raised all the same defenses that Glenmark raised in its

Zetia litigation, including the same inequitable conduct defenses[,]” which Merck allegedly

admitted were meritorious by seeking reissue of the RE ’721 patent, but it nonetheless continued

pursuing the lawsuit. (Id. ¶ 162.) Merck moved for summary judgment on the inequitable conduct

issue, which, on August 22, 2011, the District of New Jersey court denied, holding there was

“sufficient indirect and circumstantial evidence” to find Schering had knowledge the prior art it

had withheld was material, that “a deliberate decision to withhold that information” could

reasonably be inferred, and “Schering does not appear to dispute that it had knowledge of the

metabolite information during prosecution.” (Id. ¶¶ 162–63.) Later, Merck amended its complaint

and substituted the RE ’461 patent for the ’721 patent, which Humana alleges made it more

difficult for Mylan to establish its inequitable conduct and other defenses. (Id. ¶ 162.) The FDA

approved an ANDA application for Mylan’s generic on August 7, 2013, but because of the 30-

6 In fact, several Merck’s subsidiaries, Schering and Merck Sharp & Dohme, respectively, filed

parallel lawsuits alleging patent infringement in the Northern District of West Virginia and the

District of New Jersey. See Schering Corp. et al. v. Mylan Pharmaceuticals Inc. et al., No. 1:09-

cv-00167 (N.D. W. Va.); Merck Sharp & Dohme Corp. et al. v. Mylan Pharmaceuticals Inc., No.

2:09-cv-06383 (D.N.J.). The West Virginia case was filed on December 18, 2009, and voluntarily

dismissed on April 15, 2010, and the New Jersey case was filed on December 16, 2009, and was

terminated on April 27, 2012, following a bench trial and opinion in which the court found Merck’s

patent to be valid and enforceable.

month stay provided for by the Hatch-Waxman Act, Mylan was precluded from entering the

market. (Id. ¶ 147.) Mylan later “dropped nearly all of its defenses and only asserted an inequitable

conduct defense” based on the inventorship misrepresentation regarding the RE ’461 patent and

eventually lost at trial. (Id.)

On July 21, 2010, a third company, Teva Pharmaceuticals (“Teva”) filed for FDA approval

of a generic while Merck’s case against Mylan was still pending. (Id. ¶ 148.) Merck sued Teva on

September 1, 2010, in the District of New Jersey, and on July 7, 2011, the parties entered into a

settlement agreement in which Teva agreed not to launch its generic product before April 25, 2017.

(Id.) Similarly, in August 2012, a fourth company, Sandoz, notified Merck of its ANDA filing for

a generic Zetia. (Id. ¶ 149.) Merck sued Sandoz for infringement of the RE ’461 patent on

September 27, 2012; on September 5, 2013, the parties settled, and, like Teva, Sandoz agreed not

to release its generic Zetia until April 25, 2017. (Id.)

7. Reissue of the RE ’721 Patent

Schering allegedly applied to reissue the RE ’721 patent on June 9, 2010, and admitted its

“belie[f] the original patent to be wholly or partly inoperative or invalid[.]” (Id. ¶ 114.) During the

proceeding, Schering’s attorneys proposed amendments to and cancellations of several claims

based on inherent anticipation and invalidity. (Id. ¶ 115.) They also “finally disclosed” several

publications that Humana alleges were key information and wrongfully withheld from the patent

examiner during the ’115 and RE ’721 patent approval processes. (Id. ¶ 116.) The RE ’721 patent

was then reissued as the RE ’461 patent on June 14, 2011, in what Humana alleges was an attempt

by Merck “to insulate itself from other ANDA filers for Zetia using the dispositive defenses

asserted by Glenmark.” (Id. ¶ 117.)

8. Generic Versions of Zetia Enter the Market

On June 26, 2015, the FDA approved Glenmark’s ANDA 78-560, allowing Glenmark to

release its generic version of Zetia on December 12, 2016, in accordance with the Zetia Settlement

Agreement. (Id. ¶ 150.) Glenmark’s generic Zetia was the first such generic to enter the market in

the United States, as Merck did not release its own authorized generic version until on or about

June 12, 2017, when Glenmark’s 180-day exclusivity period ended. (Id. ¶¶ 151–53.) On that day,

the FDA approved ANDAs for new generic versions of Zetia by seven competitor companies. (Id.

¶¶ 154–55.) An eighth ANDA was approved in August 2017, and a ninth followed soon thereafter,

with approval in December 2017. (Id. ¶ 156.)

9. Humana’s Causes of Action

The Third Amended Complaint generally alleges that “Merck’s overarching monopolistic

scheme, Merck and Glenmark’s anticompetitive settlement agreement, and Merck, Par, and

Glenmark’s unlawful business arrangement” violate multiple federal and state antitrust and

consumer protection laws. (Id. ¶ 8.)

Specifically, Humana asserts the following causes of action: (1) Monopolization in

Violation of Various State Antitrust Laws against Merck (Count I) (id. ¶¶ 199–204); (2)

Conspiracy to Restrain Trade/Restraint of Trade in Violation of Various State Antitrust Laws

against all Defendants (Count II) (id. ¶¶ 205–097); (3) Unfair and Deceptive Trade Practices in

Violation of Various State Unfair Competition and Consumer Protection Laws against all

Defendants (Count III) (id. ¶¶ 210–307); (4) Monopolistic Scheme in Violation of Various State

7 The Court notes Humana appears to have misnumbered its paragraphs in Count II, which begins

with ¶ 205 and ends with ¶ 84, a behemoth paragraph containing 28 subsections and many more

sub-subsections. Given Count III begins with ¶ 210, and to keep the numbering consistent and

avoid undue confusion, the Court will proceed by subsuming the incorrectly labeled ¶ 84 into

¶ 209.

Antitrust Laws against Merck (Count IV) (id. ¶¶ 308–15); (5) Unjust Enrichment Under State Law

against all Defendants (Count V) (id. ¶¶ 316–28); (6) Monopolization and Monopolistic Scheme

in Violation of Section 2 of the Sherman Antitrust Act, 15 U.S.C. § 2, against all Defendants

(Count VI) (id. ¶¶ 329–41); (7) Attempted Monopolization in Violation of Section 2 of the

Sherman Antitrust Act, 15 U.S.C. § 2, against all Defendants (Count VII) (id. ¶¶ 342–49); and (8)

Conspiracy to Restrain Trade and Restraint of Trade, 15 U.S.C. § 1, against all Defendants (Count

VIII) (id. ¶¶ 350–62).

C. Procedural History

On September 22, 2021, both Humana and Centene Corp. (“Centene”), represented by the

same counsel, filed suit in two separate actions against Defendants in the District of New Jersey.

(See ECF No. 1); Centene Corp., et al. v. Merck & Co., Inc., et al., Case No. 2:23-cv-23033 (D.N.J.

Sept. 22, 2021) (ECF No. 1). On October 19, 2021, both cases were transferred from this Court to

the Eastern District of Virginia to be part of the MDL. (ECF No. 5.) By the time Humana and

Centene filed their respective suits, at least seven other actions involving common questions of

fact were transferred by the JPML pursuant to 29 U.S.C. § 1407. (Id.)

Two years later, on December 12, 2023, the JPML remanded the Humana and Centene

cases to the District of New Jersey, the original transferor court, following the completion of

pretrial proceedings. (ECF No. 7 at 1); Humana Inc., v. Merck & Co., Case No. 2:21-cv-01007

(E.D. Va. Dec. 12, 2023). In a letter submitted on February 6, 2024, Defendants sought to

consolidate the two cases, while Humana requested coordination with Centene in fact discovery.

(ECF No. 37.) On February 13, 2024, Magistrate Judge Leda D. Wettre ordered that the Humana

and Centene cases should not be consolidated and directed the parties to meet and confer and

submit a proposed briefing schedule for motions to dismiss going forward. (ECF No. 38.)

On April 29, 2024, Merck filed a Partial Motion to Dismiss all Vytorin-related claims;

Humana’s primary theories of liability for monopolization, monopolistic scheme, conspiracy to

monopolize; and all state law claims. (ECF No. 46.) Humana opposed (ECF No. 47) and Merck

replied (ECF No. 48). This Court issued an opinion on December 30, 2024, granting in part and

denying in part Merck’s partial motion to dismiss and granting Humana leave to file an amended

complaint curing the deficiencies identified in the opinion within 30 days. (ECF No. 57.)

On January 29, 2025, Humana filed its Third Amended Complaint. (ECF No. 61.) On

February 21, 2025, the Court entered a notice of voluntary dismissal as to all Glenmark

Defendants. (ECF No. 67.) On April 30, 2025, Merck filed this Partial Motion to Dismiss

Humana’s monopolization and attempted monopolization claims, all state law claims, and the per

se conspiracy claims. (ECF No. 72.)

II. LEGAL STANDARD

In deciding a motion to dismiss pursuant to Federal Rule of Civil Procedure 12(b)(6), a

district court is “required to accept as true all factual allegations in the complaint and draw all

inferences from the facts alleged in the light most favorable to [the non-moving party].” Phillips,

515 F.3d at 228 (“[A] complaint attacked by a Rule 12(b)(6) motion to dismiss does not need

detailed factual allegations.”); Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007) (citations

omitted). However, “a plaintiff’s obligation to provide the ‘grounds’ of his ‘entitle[ment] to relief’

requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of

action will not do.” Twombly, 550 U.S. at 545 (alterations in original). A court is “not bound to

accept as true a legal conclusion couched as a factual allegation.” Papasan v. Allain, 478 U.S. 265,

286 (1986). Instead, assuming factual allegations in the complaint are true, those “[f]actual

allegations must be enough to raise a right to relief above the speculative level.” Twombly, 550

U.S. at 555.

“To survive a motion to dismiss, a complaint must contain sufficient factual matter,

accepted as true, to ‘state a claim to relief that is plausible on its face.’” Ashcroft v. Iqbal, 556 U.S.

662, 678 (2009) (quoting Twombly, 550 U.S. at 570). “A claim has facial plausibility when the

plaintiff pleads factual content that allows the court to draw the reasonable inference that the

defendant is liable for the misconduct alleged.” Id. at 678 (citing Twombly, 550 U.S. at 556). This

“plausibility standard” requires the complaint allege “more than a sheer possibility that a defendant

has acted unlawfully,” but it “is not akin to a ‘probability requirement.’” Id. at 678 (citing Twombly,

550 U.S. at 556); see also In re Generic Pharms. Pricing Antitrust Litig., MDL 2724, 16-MD-2724,

Case No. 20-3539, 2023 WL 2244685, at *4 (E.D. Pa. Feb. 27, 2023) (“On a motion to dismiss,

the Court ‘consider[s] plausibility, not probability.’”). “[D]etailed factual allegations” are not

required, but “more than an unadorned, the-defendant-unlawfully-harmed-me accusation” must be

pled; it must include “factual enhancements” and not just conclusory statements or a recitation of

the elements of a cause of action. Id. (citations omitted). In assessing plausibility, the Court may

not consider any “[f]actual claims and assertions raised by a defendant.” Doe v. Princeton Univ.,

30 F.4th 335, 345 (3d Cir. 2022).

“Determining whether a complaint states a plausible claim for relief [is] . . . a

context-specific task that requires the reviewing court to draw on its judicial experience and

common sense.” Iqbal, 556 U.S. at 679. “[W]here the well-pleaded facts do not permit the court

to infer more than the mere possibility of misconduct, the complaint has alleged—but it has not

‘show[n]’—‘that the pleader is entitled to relief.’” Id. (quoting Fed. R. Civ. P. 8(a)(2)). Indeed,

after Iqbal, it is clear that conclusory or “bare-bones” allegations will no longer survive a motion

to dismiss: “[t]hreadbare recitals of the elements of a cause of action, supported by mere

conclusory statements, do not suffice.” Id. at 678. To prevent dismissal, all civil complaints must

now set out “sufficient factual matter” to show that the claim is facially plausible. Iqbal, 556 U.S.

at 677. This “allows the court to draw the reasonable inference that the defendant is liable for the

misconduct alleged.” Id. at 678. The Supreme Court’s ruling in Iqbal emphasizes that a plaintiff

must show that the allegations of his or her complaints are plausible. See id. at 670. “However,

[p]laintiffs are not required ‘to plead facts that, if true, definitively rule out all possible innocent

explanations.’” In re Generic Pharms., 2023 WL 2244685 at *4. Furthermore, “it is improper at

this stage of the proceedings to weigh alternatives and [decide] which is more plausible.” Id.

(quoting In re Broiler Chicken Antitrust Litig., 290 F. Supp. 3d 772, 788 (N.D. Ill. 2017).

While, as a general rule, the Court may not consider anything beyond the four corners of

the complaint on a motion to dismiss pursuant to Rule 12(b)(6), the Third Circuit has held that “a

court may consider certain narrowly defined types of material without converting the motion to

dismiss [to one for summary judgment under Rule 56].” In re Rockefeller Ctr. Props. Sec. Litig.,

184 F.3d 280, 287 (3d Cir. 1999). Specifically, courts may consider any “document integral to or

explicitly relied upon in the complaint.” In re Burlington Coat Factory, 114 F.3d at 1426 (emphasis

added) (quoting Shaw v. Digital Equip. Corp., 82 F.3d 1194, 1220 (1st Cir. 1996)). However,

“[w]hen the truth of facts in an ‘integral’ document are contested by the well-pleaded facts of a

complaint, the facts in the complaint must prevail.” Princeton Univ., 30 F.4th at 342.

III. DECISION

Humana’s claims against Merck are premised on allegations that Merck sought and/or

achieved an illegal monopoly through a series of actions that resulted in Humana paying artificially

high prices for Zetia and Vytorin, two cholesterol-lowering medications, and harming competition

in the U.S. markets for generic versions of those drugs. (ECF No. 61 ¶¶ 6–8.)

Merck moves to dismiss: (1) the Monopolization theories of Walker Process8 fraud, sham

litigation, and Orange Book listing from Counts I, IV, VI, and VII; (2) the Monopolistic Scheme

claims from Counts IV and VI; (3) all state law claims asserted in Counts I–V; and (4) the per se

theory underlying Humana’s Conspiracy to Restrain Trade/Restraint of Trade claims from Counts

II and VIII. (ECF No. 72 at 9–34.)

A. Monopolization in Violation of Federal Antitrust Law—Counts I, IV, VI, and VII

Humana alleges Merck took a series of actions to delay competition and monopolize the

market for generic Zetia. (ECF No. 61 ¶¶ 202–03, 309–12, 331–33, 343–46). Humana claims

Merck committed fraud, specifically Walker Process fraud, by failing to disclose certain key

information to the USPTO, initiating meritless litigation purportedly to extend its monopoly, and

wrongfully listing patents in the Orange Book for Zetia. (Id.) Each of these theories of liability is

tied to some aspect of a patent approval or prosecution process. (Id.)

A patent grant is the exclusive right to use the patented invention, effectively granting a

limited monopoly. See United States v. Line Material Co., et al., 333 U.S. 287, 300 (1948) (“[T]he

precise terms of the grant define the limits of a patentee’s monopoly and the area in which the

patentee is freed from competition.”). Under Section 2 of the Sherman Act, a plaintiff must plead

two elements to state a monopolization claim: (1) a showing that the defendant possesses

monopoly power in the relevant market; and (2) “the willful acquisition or maintenance of that

power as distinguished from growth or development as a consequence of a superior product,

business acumen, or historic accident.” Race Tires Am., Inc. v. Hoosier Racing Tire Corp., 614

F.3d 57, 75 (3d Cir. 2010). The second element in Section 2 cases can be predicated on one or

8 This theory arises out of the Supreme Court’s decision in Walker Process Equipment, Inc. v.

Food Machinery & Chemical Corp., 389 U.S. 172, 174 (1965).

more theories, including Walker Process fraud, sham litigation, wrongful Orange Book listing, a

reverse payment scheme, or an overarching scheme. See In re Lipitor Antitrust Litig., MDL No.

2332, Master Dkt. No. 3:12-cv-2389, 2013 WL 4780496, at *15 (D.N.J. Sept. 5, 2013) (reversed

on other grounds). Because patent holders enjoy considerable antitrust immunity, a plaintiff

usually must either show a defendant obtained a patent through Walker Process fraud or initiated

a sham lawsuit with the intent to interfere with a competitor’s business. See In re Indep. Serv.

Orgs. Antitrust Litig., 203 F.3d 1322, 1326 (Fed. Cir. 2000); Nobelpharma AB v. Implant

Innovations, Inc., 141 F.3d 1059, 1068 (Fed. Cir. 1998).

1. Walker Process Fraud Theory

In Counts I, IV, VI, and VII of the Third Amended Complaint, Humana alleges Merck

“knowingly” and “willfully” preserved their monopoly power by failing to disclose key

information to the USPTO. (ECF No. 61 ¶¶ 204, 315, 333, 346.)

Merck moves to dismiss Humana’s theory of monopolization and monopolistic scheme for

several reasons. Generally, it contends Humana fails “to overcome the ‘considerable antitrust

immunity’ afforded patent holders like Merck.” (ECF No. 72 at 9.) Merck asserts Humana’s

recycled argument that Merck “fail[ed] to disclose prior art . . . and misrepresent[ed] the true

inventors” of the ’115 and RE ’721 patents is still insufficient and should be dismissed with

prejudice because Humana does not “explain [the individuals’] ‘roles or degree of involvement’

in any metabolization study” (id. at 14 (quoting ECF No. 57 at 33)); show the individuals had the

requisite specific intent such as “knowledge of [the study’s purported] materiality,” or that they

“intentionally withheld it” from the USPTO (id.); or allege “that the June 1997 study or any other

purportedly omitted study was ‘material to patentability’” (id. at 15 (quoting In re Lipitor Antitrust

Litigation, 868 F.3d 231, 266 (3d Cir. 2017))). Additionally, Merck argues Humana’s improper

inventorship theory likewise fails because it does not plausibly allege Afonso was an inventor, a

theory previously rejected in the Mylan Litigation “more than a decade ago” (id. at 18–20);

materiality (id. at 20–21); or specific intent (id. at 21–22).

In its Opposition, Humana disputes Merck’s characterizations of its positions, arguing the

Third Amended Complaint provides “the who, what, when, where and how” of the alleged fraud.

(ECF No. 73 at 4–7 (quoting In re Lipitor, 868 F.3d at 249, 267 (3d Cir. 2017)).) By alleging

Burnett and Clader were both inventors on the ’115 and RE ’721 patents and inventors listed on

relevant studies, Humana contends “it is reasonable to infer that as co-authors of the paper

documenting the study, Burnett and Clader were involved in the study and knew what they co-

wrote” (id. at 5), pointing to case law from the Federal Circuit in which the court held intent can

be inferred “‘from indirect and circumstantial evidence’ because ‘direct evidence of deceptive

intent is rare’” (id. at 7 (quoting TransWeb, LLC v. 3M Innovative Props. Co., 812 F.3d 1295, 1304

(Fed. Cir. 2016))). Humana claims it provides sufficient details to show “Burnett and Clader knew,

based at least on their involvement with WO ’048 and the 1997 [] article, that WO ’048 inherently

anticipated the metabolites of SCH48461, yet they intentionally withheld that information to

secure a patent, with Magatti going so far as to characterize WO ’048 as merely providing

‘background.’” (Id. at 6–7.) Humana also suggests Merck misstates the standard for pleading

Walker Process fraud claims, arguing “a strong showing of both materiality and intent to deceive”

are not always required. (Id. at 9.) Regardless, Humana asserts it has met its burden on materiality

because it explained “how and why ‘the patent[s] would not have issued but for’ the omission.”

(Id. at 10.) Humana further argues Merck’s reliance on the decisions in the Mylan Litigation for

its improper inventorship argument is “an improper application of collateral estoppel.” (Id. at 11.)

Humana contends its allegations Rosenblum and Nelson allegedly had knowledge “Afonso should

have been an inventor and intentionally omitted him from the patent” are sufficient to show intent

and materiality. (Id. at 11–14.)

Merck replies that Humana still does not “fill the gaps the Court identified” in its prior

opinion concerning its failure to disclose theory because: (1) the Third Amended Complaint only

alleges “at least two of the inventors named on the ’115 patent family” identified SCH48461 but

does not identify them, thereby failing to identify the “who” under In re Lipitor (ECF No. 74 at 2–

3 (citing 868 F.3d at 249)); (2) neither Burnett nor Clader were authors of the June 1997

manuscript/study and Humana does not allege either “had any involvement with or awareness of

the manuscript” (id. at 3); and (3) Humana does not “allege that Magatti had any ‘role[],’

‘involvement in,’ or even awareness of any metabolization study,” let alone the June 1997

manuscript, and therefore “do[es] not specifically allege ‘what’ [Magatti] knew or ‘how’ or ‘when’

[Magatti] knew it” (id. at 4). Merck continues that, as a result of these enduring gaps, “there are

no facts from which the Court could infer [Burnett, Clader, or Magatti] ‘both knew of invalidating

information’ and ‘withheld that information with a specific intent to deceive.’” (Id. at 4.)

Moreover, Merck insists Walker Process fraud claims require but-for causation, as opposed to

inequitable conduct claims which only requires a showing “the PTO would not have allowed a

claim had it been aware of the undisclosed prior art[,]” (quoting Therasense, Inc. v. Becton,

Dickinson & Co., 649 F.3d 1276, 1291 (Fed. Cir. 2011)), and, separately, that Humana never

alleged any study was material to the patentability of any claim, or even define a claim or any of

its limitations. (ECF No. 74 at 5–6.)

Additionally, Merck contends Humana’s improper inventorship theory fails in part because

Humana does not allege Afonso “conceived of any compounds claimed in the ’115 or RE ’721

Patents” as “being the first to reduce a compound to practice is not sufficient to show

inventorship,” and does not allege “facts ‘corroborating’ his self-serving letter.” (Id. at 6.) Merck

also notes Humana mischaracterizes Merck’s argument about the Mylan decision as precluding

Humana’s claim, whereas Merck merely suggests “the decision is persuasive[.]” (Id. at 7.) Merck

also claims Humana does not show the patentability of the ’115 and RE ’721 patents would have

been affected had Afonso been disclosed as an inventor. (Id. at 7.) Finally, Merck argues Humana

does not show any specific individual had the intent to deceive by not including Afonso as an

inventor, claiming Rosenberg “averred under oath that Dr. Afonso was not an inventor,” and

Nelson had no duty to disclose as he was neither involved in the patent prosecution nor had

knowledge of Afonso’s inventorship claims at the time the patents were issued. (Id. at 8.)

“[E]ach individual associated with the filing and prosecution of a patent application has a

duty of candor and good faith in dealing with the office, which includes a duty to disclose to the

[USPTO] all information known to that individual to be material to patentability.” 37 C.F.R. § 1.5.

In Walker Process, a pivotal patent infringement case, the Supreme Court held that an action

brought to enforce a fraudulently obtained patent violated Section 2 of the Sherman Act so long

as all other Section 2 elements are met. 389 U.S. at 174. Subsequent decisions have expounded on

so-called Walker Process fraud claims to explain they are based in common law fraud, require a

showing of actual fraud on the USPTO, and are governed by Federal Circuit law. See Daiichi

Sankyo, Inc. v. Apotex, Inc., Civ. A. No. 030937, 2009 WL 1437815, at *5 (D.N.J. May 19, 2009);

see also In re Lipitor Antitrust Litig., 855 F.3d 126, 145 (3d Cir. 2017) (plaintiffs asserting Walker

Process fraud claims must show “the patentee committed fraud before the PTO, that the fraud

caused the patent to issue, and that the patentee enforced the fraudulently procured patent”);

TransWeb, 812 F.3d at 1306 (explaining antitrust plaintiffs must establish each element of

Sherman Act monopolization claim as well as show patent was fraudulently obtained). The higher

pleading threshold for both intent and materiality in Walker Process fraud claims requires:

independent and clear evidence of deceptive intent together with a

clear showing of reliance, i.e., that the patent would not have been

issued but for the misrepresentation or omission. Therefore, for an

omission such as a failure to cite a piece of prior art to support a

finding of Walker Process fraud, the withholding of the reference

must show evidence of fraudulent intent. A mere failure to cite a

reference to the PTO will not suffice.

Nobelpharma, 141 F.3d at 1070–71 (emphasis added); see TransWeb, 812 F.3d at 1303–04 (“A

judgment of inequitable conduct requires clear and convincing evidence of materiality, knowledge

of materiality, and a deliberate decision to deceive.”). A plaintiff must show but-for materiality,

“meaning that ‘the PTO would not have allowed a claim had it been aware of the undisclosed prior

art.’” TransWeb, 812 F.3d at 1304. Furthermore, intent requires “a reasonable inference” of

deceptive intent, defined as “one that is plausible and that flows logically from the facts alleged,

including any objective indications of candor and good faith.” Exergen Corp. v. Wal-Mart Stores,

Inc., 575 F.3d 1312, 1329 n.5 (Fed. Cir. 2009).

The Court finds Humana’s allegations concerning Merck’s purported failure to disclosure

information about relevant scientific studies and inventorship during prosecution of the ’115 and

RE ’721 patents are still insufficient to support its Walker Process fraud theory. Although the

Third Amended Complaint includes additional information relevant to the inquiry—specifically,

details surrounding the metabolization studies allegedly withheld and the name of an individual

whose inventorship was purportedly omitted from the patent application—critical information is

lacking to reasonably establish that some relevant individual had material information and

specifically intended to withhold that information to deceive the USPTO in addition to, and

contemporaneous with, having knowledge of the materiality of that information. For example,

Humana alleges “Schering scientists, including at least two of the inventors named on the ’115

patent family, identified SCH48461” (ECF No. 61 ¶ 69), and “at least one other Schering inventor

named on the ’115 and RE ’721 patents committed inequitable conduct by allowing each of the

patent applications to be submitted to the USPTO with incorrect inventorship” (id. ¶ 72). Humana

also alleges Burnett and Clader are named inventors on the ’115 and RE ’721 patents. (Id. ¶ 74.)

However, Humana does not actually allege that Burnett and Clader are the two inventors who

identified SCH48461. (ECF No. 61 ¶¶ 69–76.) Moreover, Humana fails to substantiate its

suggestion that Burnett’s and Clader’s purported ‘awareness’ of relevant information, such as the

June 1997 manuscript, somehow metamorphosed into the specific intent to deceive the USPTO by

withholding critical known information. (Id. ¶ 76.) Absent this degree of specificity, mere

awareness (assuming, arguendo, such awareness did exist) does not meet the pleading

requirements. See Nobelpharma, 141 F.3d at 1070 (“[A] misrepresentation or omission must

evidence a clear intent to deceive the examiner and thereby cause the [US]PTO to grant an invalid

patent.”).

Accordingly, Merck’s motion to dismiss the Walker Process fraud theory is GRANTED.

Given this was Humana’s third time amending its complaint, the dismissal is with prejudice as

further amendment would be futile. See Fed. R. Civ. P. 15(a)(2).

2. Sham Litigation Theory

Humana alleges the lawsuit by Schering and MSP Singapore, as patent assignee and

exclusive licensee, respectively, against Glenmark asserting infringement of the RE ’721 patent

was meritless and was initiated “for the specific purpose of unlawfully delaying generic

competition.” (ECF No. 61 ¶¶ 312, 333.)

In its Motion, Merck argues Humana’s sham litigation theory “relies entirely on the[]

Walker Process fraud theory,” and should be denied on the same basis. (ECF No. 72 at 22.) It also

contends the sham litigation theory should be denied “to the extent it is predicated on the Mylan

Litigation” because “Merck won at trial in that case” and a winning suit is, by definition, not a

sham. (Id. at 23 (citing Pro. Real Est. Invs., Inc. v. Columbia Pictures Indus., Inc., 508 U.S. 49, 60

n.5 (1993)).) Humana claims the Third Amended Complaint cured deficiencies in the Walker

Process fraud allegations, which should allow its sham litigation claims to proceed “at least to

summary judgment.” (ECF No. 73 at 14.)

Because the Court reads Humana’s sham litigation theory as predicated on its Walker

Process fraud argument, and in light of the Court’s determination the Walker Process fraud theory,

as alleged, is insufficiently pled, supra Section III.A.1., the sham litigation theory likewise fails.

Accordingly, Merck’s motion to dismiss the sham litigation theory is GRANTED with prejudice.

3. Wrongfully Listing Patents in the Orange Book

In addition to the Walker Process fraud and sham litigation theories of monopolization,

Humana alleges Merck wrongfully listed patents in the Orange Book for Zetia knowing that they

either did not cover Zetia or were invalid. (ECF No. 61 ¶¶ 196, 202, 312, 333, 346.) Merck argues

this theory suffers “from the same deficient allegations of Walker Process fraud” and must be

dismissed. (ECF No. 72 at 24.) Humana disagrees, instead claiming the Orange Book theory is

based on the wrongful listing of: (1) the ’966 patent in the Orange Book for Zetia “despite knowing

the patent does not cover that product”; (2) the RE ’721 patent in the Orange Book for both Zetia

and Vytorin with the knowledge “the patent was invalid and unenforceable”; and (3) the ’106

patent for Zetia “knowing it was invalid.” (ECF No. 73 at 15.) Merck responds Humana does not

allege either the ’966 or ’106 patents “were procured through fraud,” so the Orange Book theory

cannot proceed. (ECF No. 74 at 8.)

An Orange Book listing can only be deemed wrongful if the relevant patent was obtained

through fraud or objectively had no merit. See Daiichi Sankyo, 2009 WL 1437815 at *9. Without

such a showing, an Orange Book listing claim cannot proceed. See id. Given the insufficiency of

the Walker Process fraud theory, and the absence of sufficient allegations of fraud in the

procurement of the ’966 or ’106 patents, the Court finds Humana’s Orange Book listing theory is

still insufficiently pled. Accordingly, Merck’s motion to dismiss the Orange Book theory claim is

GRANTED with prejudice.

B. Monopolistic Scheme with Schering—Counts IV and VI

Humana argues Merck “knowingly” and “willfully” engaged in a scheme with Schering to

monopolize the market for Zetia and/or Vytorin through Walker Process fraud, pursuing sham

litigation, wrongfully listing patents in the drugs’ Orange Books, and by entering into the Zetia

Settlement Agreement which allegedly included an illegal reverse payment to delay generic entry

and extend Merck’s monopoly. (ECF No. 61 ¶¶ 312, 333.)

Merck contends the monopolistic scheme claim should be dismissed to the extent it relies

on the insufficiently pled Walker Process fraud, sham litigation, and Orange Book listing theories.

(ECF No. 72 at 25.) Merck quotes language from this Court’s prior opinion granting in part and

denying in part Defendants’ partial motion to dismiss, in which this Court granted dismissal of

Humana’s monopolistic scheme claim because “[w]hen specific allegations of conduct are

determined to be insufficient to support a claim for relief, a separate claim that is nothing more

than a combination of those specific allegations must also be deemed meritless.” (Id. (quoting ECF

No. 57 at 38.) In its opposition, Humana repeats its argument that Merck “merely cross-reference[s

its] earlier arguments regarding the individual grounds” of Walker Process fraud, sham litigation,

and Orange Book listing. (ECF No. 73 at 16.) Merck insists the “monopolistic scheme theor[y]

also fail[s].” (ECF No. 74 at 8.)

Once again, the Court finds the monopolistic scheme is “nothing more than a combination”

(ECF No. 57 at 38) of “the individual grounds” of Walker Process fraud, sham litigation, and

Orange Book listing (ECF No. 73 at 16) and still cannot be accepted, even on Humana’s third

attempt. Accordingly, Merck’s motion to dismiss Humana’s monopolistic scheme claim is

GRANTED, and Counts IV and VI are dismissed with prejudice.

C. All State Law Claims—Counts I-V

In general, Merck argues in favor of dismissing state law claims to the extent the claims

rely on “deficiently pleaded theories of monopolization[.]” (ECF No. 72 at 26.) Merck tailors its

arguments for each state law claim for which it seeks dismissal, and each is discussed in turn.

1. State Law Antitrust Claims

a. Vermont

Merck points to the parties’ joint stipulation that, among other things, Humana fails to state

a plausible claim under the Vermont consumer protection and/or unfair and deceptive trade

practice statute (ECF No. 46-12, Ex. I, ¶ 1) and should be dismissed on that basis (ECF No. 72 at

26–27.) Humana concedes and does not oppose dismissal. (ECF No. 73 at 1 n.3.) Therefore,

Merck’s motion to dismiss Humana’s Vermont state antitrust claim is GRANTED.

b. Montana

Merck contends indirect purchasers are barred from seeking redress under Montana

antitrust law pursuant to Illinois Brick.9 (ECF No. 72 at 27.) Humana argues “[a] Montana court

expressly rejected this same argument.” (ECF No. 73 at 20 (citing Olson v. Microsoft Corp., No.

2000-219, 2001 WL 36083237 (Mont. Dist. Ct. Feb. 15, 2001).) Merck replies “the Montana

Supreme Court has held that ‘due weight’ should be given to ‘federal courts’ interpretation’ of the

9 See Illinois Brick Co. v. Illinois, 431 U.S. 720 (1977).

antitrust laws[,]” and because Montana’s statute was modeled after federal law, it “should be

interpreted consistent with federal law.” (ECF No. 74 at 9 (quoting Smith v. Video Lottery

Consultants, Inc., 858 P.2d 11, 13 (Mont. 1993).) Merck points to a decision from the Northern

District of California dismissing an indirect purchaser claim brought under Montana law. (Id.

(citing In re TFT-LCD (Flat Panel) Antitrust Litig., 599 F. Supp. 2d 1179, 1186–1187 (N.D. Cal.

2009)).)

The Court finds indirect purchasers like Humana are barred from bringing claims under the

Montana Unfair Trade Practices Act. See Mont. Code. §§ 30-14-101 et seq. The recent decision in

Miami Products & Chemical Co. v. Olin Corp., 546 F. Supp. 3d 223 (W.D.N.Y. 2021), is instructive.

In that case, the court observed the Montana statute defined consumers as individuals purchasing

or using goods “for personal, family, or household purposes,” and noted the Montana Supreme

Court “held that the purchase of goods ‘entirely for business purposes’ does not ‘come within the

statutory definition’” of a consumer. Id. at 234–35. Just as in Miami Products, in which the court

ultimately dismissed plaintiffs’ indirect purchaser claims under Montana law, here, Humana is

undeniably an indirect purchaser given it buys Zetia and/or Vytorin for resale to consumers. Id. at

235. In re TFT-LCD gives further support for dismissal based on its comparative analysis of the

standing requirements under the Sherman Act and Montana antitrust law, concluding “[i]n the

absence of any Montana authority holding that indirect purchaser plaintiffs have standing under

Montana antitrust law, the Court declines to find so.” 599 F. Supp. 2d at 1187.

Accordingly, Merck’s motion to dismiss Humana’s Montana state antitrust claim is

GRANTED.

c. Puerto Rico

Merck asserts Puerto Rico law, like Montana law, precludes indirect purchasers from

recovering for antitrust injuries under Illinois Brick. (ECF No. 72 at 27–28.) Humana disputes this

characterization, contending the Puerto Rico Supreme Court has expressly declined to limit

recovery to direct purchasers. (ECF No. 73 at 18–19.) Humana cites to a string of cases from

multiple jurisdictions suggesting interpretations of Puerto Rico law by Puerto Rican judges are

given considerable deference, specifically with respect to whether indirect purchasers should be

able to assert antitrust claims under Puerto Rican law. (Id. at 19 (citing, e.g., Rivera-Muñiz v.

Horizon Lines Inc., 737 F. Supp. 2d 57, 61 (D.P.R. 2010)).) Merck replies that, “[c]ourts

consistently reject [Humana’s] view” of Puerto Rico law (ECF No. 74 at 9), pointing to a recent

decision from the District of Connecticut in which the court dismissed damages claims on behalf

of indirect purchasers on the ground that Puerto Rico law has not expressly rejected the Illinois

Brick antitrust standing limitation and is therefore still subject to it. (Id. (citing Connecticut v.

Sandoz, Inc., No. 3:20-cv-00802, 2024 WL 4753308, at *24 (D. Conn. Nov. 12, 2024)).)

Courts have long grappled with the antitrust standing implications of Pressure Vessels P.R.,

v. Empire Gas P.R., a seminal decision from the Supreme Court of Puerto Rico. See 137 D.P.R.

497 (1994). Pressure Vessels discussed the requirements for pleading an antitrust injury under U.S.

Supreme Court precedent and held:

it is not necessary, in order to satisfy the “by reason of” requirement,

for the complaining party to prove anything more than a factual

causal link between the harm suffered and the violation of the statute;

that is, it is sufficient that, as a result of the violation of the law, the

plaintiff has suffered damage.

Id. at 520. Since that decision, some courts in Puerto Rico and other jurisdictions have determined

that the Puerto Rico Antitrust Act (“PRAA”) sanctions claims from both direct and indirect

purchaser-plaintiffs. See, e.g., Rivera-Muñiz, 737 F. Supp. 2d at 61; Gov’t of Puerto Rico v.

Carpenter Co., 442 F. Supp. 3d 464, 478 (“[U]nder the current state of Commonwealth law, there

exists a liberal construction of who and whom possess standing to bring to court an antitrust case.”);

In re Zetia (Ezetimibe) Antitrust Litig., 400 F. Supp. 3d 418, 433 (adopting “the Magistrate Judge’s

finding that indirect purchasers have standing under Puerto Rico law”); In re Crop Prot. Prods.

Loyalty Program Antitrust Litig., 779 F. Supp. 3d 624, 651 (“[T]his court concludes the Illinois

Brick rule does not bar Plaintiffs from proceeding under the PRAA.”) On the other hand, many

courts have found the PRAA allows only direct purchasers to assert claims for antitrust injuries.

See In re Crop Prot. Prods. Loyalty Program, 779 F. Supp. 3d at 650 (collecting cases) (“[A]

majority of federal district courts have concluded indirect purchasers are barred from seeking

damages under the PRAA.”); Connecticut v. Sandoz, Inc., 2024 WL 4753308, at *25 (collecting

cases) (“I agree with the many district courts that have found that the analysis in Pressure Vessels

is not an express rejection of the Illinois Brick rule.”)

The Court is persuaded that the PRAA precludes suits by indirect purchasers. As the court

in Connecticut v. Sandoz, Inc., 2024 WL 4753308 at *25, explained very clearly, the language in

Pressure Vessels construing the PRAA as requiring nothing “more than a factual causal link

between the harm suffered and the violation of the statute[,]” concerns the requirements for

pleading an antitrust injury, not antitrust standing. Pressure Vessels, 137 D.P.R. at 520. Although

the court in Pressure Vessels mentions antitrust standing, the relevant text is situated within the

context of an in-depth discussion of the requirements for antitrust injury. See id. at 518–21. Indeed,

the holding itself refers to the “by reason of” requirement for pleading an antitrust injury. Id. at

520. As such, and in the absence of a statute explicitly repealing it (i.e., a “repealer statute”), the

Illinois Brick rule remains unchanged and applicable to claims brought under the PRAA.

Accordingly, Merck’s motion to dismiss Humana’s antitrust claim under Puerto Rico law is

GRANTED.

d. Rhode Island

Merck argues Humana’s Rhode Island antitrust claim “must be dismissed because Rhode

Island followed Illinois Brick until it passed a ‘repealer statute’ in 2013 permitting indirect claims.”

(ECF No. 72 at 28.) Humana does not dispute that claims tied to injuries occurring before Rhode

Island repealed Illinois Brick are barred, but asserts it is seeking recovery for injuries incurred after

the repealer statute and therefore should be allowed to proceed on that basis. (ECF No. 73 at 16–

18.) Merck replies that Humana’s claim under the Rhode Island law “must be limited to

overcharges incurred after its enactment.” (ECF No. 74 at 9.) Accordingly, Merck’s motion to

dismiss Humana’s antitrust claim under Rhode Island law is GRANTED with respect to any pre-

enactment injuries and DENIED with respect to any post-enactment injuries.

e. Allegations Regarding Pre-Suit Notice—Arizona, Hawaii,

Nevada, Rhode Island, and Utah

Merck contends the “failure to allege compliance with [] states’ pre-suit notice

requirements” dooms Humana’s claims brought under the state antitrust laws of Arizona, Hawaii,

Nevada, Rhode Island, and Utah. (ECF No. 72 at 28.) Humana disputes that this is a proper basis

for dismissal, arguing courts have declined to dismiss claims on this basis because, whether

substantive or procedural, the notice provisions “do not alter the substantive elements of Plaintiff[’s]

claims and are not a pleading requirement for the Complaints.” (ECF No. 73 at 21 (quoting In re

Generic Pharms. Pricing Antitrust Litig., 368 F. Supp. 3d 814, 835 (E.D. Pa. 2019)).) Humana

further requests leave to amend in the event the Court grants dismissal for failure to include

allegations of compliance with notice requirements. (Id. at 22.) In response, Merck notes Humana

does not dispute its failure in this regard and claims some cases Humana cites “recognize that

many courts have held that ‘a plaintiff’s failure to comply with these state notice requirements

warrants dismissal.’” (ECF No. 74 at 11 (quoting Edgar v. Teva Pharm. Indus., Ltd., No. 22-2501,

2024 WL 1282436, at *33 (D. Kan. Mar. 26, 2024)).)

The Court finds that, “[r]egardless of whether the relevant notice provisions are substantive

or procedural,” dismissal for failure to allege compliance with these notice requirements10 is

unwarranted. In re Generic, 368 F. Supp. 3d at 835. Merck does not argue, and the Court does not

believe, any substantive rights were affected by any such failure. Moreover, Humana claims it

complied with these requirements by “sen[ding] notice letters with attached complaints to the State

Attorneys General’s offices of Arizona, Nevada, and Rhode Island before [it] initially filed” (ECF

No. 73 at 21 n.8), thereby eliminating the risk of “forum shopping and the inequitable

administration of laws” raised by Merck (ECF No. 74 at 11 (quoting In re Effexor Antitrust Litig.,

357 F. Supp. 3d 363, 388–89 (D.N.J. 2018))).11

Accordingly, Merck’s motion to dismiss Humana’s antitrust claims under Arizona, Hawaii,

Nevada, Rhode Island, and Utah laws for failure to allege compliance with pre-suit notice

requirements is DENIED.

10 The text of the statutory notice requirements in Arizona, Hawaii, Nevada, Rhode Island, and

Utah are substantially similar, generally requiring a copy of a complaint or responsive pleading to

be filed with the state attorney general. See Ariz. Rev. Stat. Ann. § 44-1415(A); Haw. Rev. Stat.

§ 480-13.3(a)(1); Nev. Rev. Stat. Ann. § 598A.210(3); R.I. Stat. § 6-36-21; Utah Code Ann. § 76-

10-3109(9).

11 Humana correctly notes the statutory requirements of Hawaii and Utah apply only to class

actions on behalf of indirect purchasers and are therefore inapplicable here. (See ECF No. 73 at 21

n.8.)

2. State Law Consumer Protection Claims

a. Allegations Alleging Deception or Fraud was Directed at

Consumers—Arizona, Colorado, North Dakota, Pennsylvania,

and Virginia

Generally, Merck argues state consumer protection laws “require that the challenged

conduct relate to a consumer transaction or target consumers[,]” and because Humana purportedly

does not make any such allegations, these claims must be dismissed. (ECF No. 72 at 29.) Humana

puts forth two core arguments. First, Humana argues its allegation that Merck inflated prices for

“drugs dispensed to [its] members” is an allegation of fraud or deception directed at consumers

because its members “are indisputably consumers.” (ECF No. 73 at 23.) Second, it contends its

Third Amended Complaint includes many express allegations “that, among other forms of

deceptive and unlawful conduct, Merck entered into an anticompetitive settlement agreement that

was hatched in secret, maintained through deception, and caused Merck’s drugs to be dispensed to

consumers at inflated prices[,]” and claims the statutes “do not require more.” (Id.) Merck replies

that Humana’s arguments lack merit because its purchases of Zetia and/or Vytorin were for its own

purposes, “rather than for a personal or household use, as is required under these statutes[,]” and

its arguments resting on Merck’s purported anticompetitive settlement agreement are

“[in]sufficient to allege deception.” (ECF No. 74 at 11–12.)

The Arizona Consumer Fraud Act declares unlawful any “act, use or employment by any

person of any deception, deceptive or unfair act or practice, fraud, . . . with intent that others rely

on [it] . . . in connection with the sale or advertisement of any merchandise,” regardless of whether

anyone is in fact deceived or mislead. Ariz. Rev. Stat. § 44-1522(A). Colorado’s equivalent statute

prohibits “[e]ither knowingly or recklessly engag[ing] in any unfair, unconscionable, deceptive,

deliberately misleading, false, or fraudulent act or practice[.]” Colo. Rev. Stat. § 6-1-105(rrr).

North Dakota’s consumer protection statute likewise prohibits “any deceptive act or practice, . . .

with the intent that others rely thereon in connection with the sale or advertisement of any

merchandise[.]” N.D. Cent. Code. § 51-15-02. The Pennsylvania Unfair Trade Practices and

Consumer Protection Law prohibits “[u]nfair methods of competition and unfair or deceptive acts

or practices in the conduct of any trade or commerce[,]” 73 Pa. Stat. Ann. § 201-3(a), and the

Virginia Consumer Protection Act likewise targets numerous enumerated “fraudulent acts or

practices committed by a supplier in connection with a consumer transaction[,] Va. Code Ann.

§ 59.1-200.

Here, the Court finds Humana’s allegations are insufficient to establish a claim under

Virginia law for a prohibited act “in connection with a consumer transaction” because the

allegations focus solely on actions or inactions taking place between and among Merck and other

manufacturers, the USPTO, and the FDA. Va. Code Ann. § 59.1-200; (see generally ECF No. 61).

The same reasoning applies to Humana’s claims under Arizona law, which various courts have

explained requires some showing of consumer reliance on the alleged fraud or deception. See Sheet

Metal Workers Local 441 Health & Welfare Plan v. GlaxoSmithKline, PLC, 737 F. Supp. 2d 380,

403–04 (E.D. Pa. 2010) (citing Persky v. Turkey, Nos. 88-1820, 88-2089, 1991 WL 327434, at *9

(D. Ariz. Dec. 19, 1991)) (explaining plaintiffs must allege not only fraudulent misrepresentations

but “that those misrepresentations were relied upon by consumers”); In re DDAVP Indirect

Purchaser Antitrust Litig., 903 F. Supp. 2d 198, 222–23 (S.D.N.Y. 2012) (holding plaintiff stated

a claim under Arizona law because “[i]n paying supra-competitive prices for DDAVP, consumers

arguably relied” upon misrepresentations). Similarly, the Court finds Humana’s allegations are

insufficient to state a claim under Colorado’s consumer protection statute because they do not

reasonably establish any prohibited conduct “intended to induce consumer reliance[.]” Sheet Metal

Workers, 737 F. Supp. 2d at 408.

By contrast, the Court finds Humana sufficiently states a claim under the Pennsylvania

statute because Humana’s allegations concern purported deception and/or fraud in the patent

procurement process, whereas In re Niaspan Antitrust Litig., on which Merck relies, concerns

solely anticompetitive allegations. (ECF No. 72 at 29 (citing 42 F. Supp. 3d 735, 760 (E.D. Pa.

2014)).) Similarly, Humana’s allegations are sufficient to state a claim under North Dakota’s

consumer protection law because they arise out of allegedly fraudulent or deceptive conduct, and

the statute does not require allegations of reliance. See In re New Motor Vehicles Canadian Export

Antitrust Litig., 350 F. Supp. 2d 160, 197–98 (D. Maine 2004) (citing N.D. Cent. Code § 51-15-

02); see also In re Generic, 368 F. Supp. 3d at 846.

Accordingly, Merck’s motion to dismiss Humana’s consumer protection claims under

Arizona, Colorado, and Virginia law is GRANTED, and Merck’s motion to dismiss Humana’s

consumer protection claims under Pennsylvania and North Dakota law is DENIED.

b. Recasting of antitrust claims as consumer protection claims to

circumvent Illinois Brick—Indiana, Louisiana, and Missouri

Merck contends Humana’s claims under Indiana and Louisiana consumer protection laws

must be dismissed because “‘to permit an indirect purchaser . . . to recast his antitrust claim as a

consumer fraud violation would . . . essentially permit an end run around the policies allowing

only direct purchasers to recover under the’ state’s antitrust laws.” (ECF No. 72 at 29–30 (quoting

In re K-Dur Antitrust Litig., Civ. A. No. 01-1652, 2008 WL 2660778, at *3 (D.N.J. Feb. 25, 2008)

(internal citation omitted)).) Humana responds courts have rejected such repackaging arguments

because “states remain free to permit recovery by indirect purchasers.” (ECF No. 73 at 26 (quoting

In re Generic, 368 F. Supp. 3d at 840 (internal citation omitted)).) Humana further notes “Merck

even raised the same argument in the Zetia MDL with respect to the end-payor plaintiff class’s

claims under Missouri law, and the MDL court correctly rejected the argument.” (Id.) Merck does

not offer an argument in response.

The Indiana Deceptive Consumer Sales Act prohibits “unfair, abusive, or deceptive act[s],

omission[s], or practice[s] in connection with a consumer transaction.” Ind. Stat. § 24-5-0.5-3(a).

It “is a remedial statute and ‘shall be liberally construed and applied to promote its purposes and

policies.’” Kesling v. Hubler Nissan, Inc., 997 N.E. 2d 327, 332 (Ind. 2013) (quoting Ind. Stat.

§ 24-5-0.5-1). The Louisiana Unfair Trade Practices and Consumer Protection Act, see 51 La. Rev.

Stat. §§ 1400 et seq., prohibits similar acts and requires plaintiffs to be either “direct consumer[s]

or business competitor[s]” to have standing to sue under the statute. Washington Mut. Bank v.

Monticello, 976 So. 2d. 251, 258 (La. Ct. App. 2008). Similarly, a majority of courts addressing

the issue have concluded “Illinois Brick does not bar indirect-purchaser claims under the [Missouri

Merchandising Practices Act].” In re Packaged Seafood Prods. Antitrust Litig., 242 F. Supp. 3d

1033, 1079 (S.D. Cal. 2017).

The Court finds Humana’s claims under Indiana, Louisiana, and Missouri consumer

protection laws are viable claims independent of any other claims brought under the states’ antitrust

laws. As explained in In re Generic, plaintiffs “are not barred from pursuing such a recovery under

the various state consumer protection laws so long as their allegations are enough to plead the

relevant consumer protection violation.” 368 F. Supp. 3d at 840. Provided Humana can state a

claim for relief under the consumer protection laws of Indiana, Louisiana, and Missouri, the Court

sees no reason why Illinois Brick’s limitation on indirect purchaser recovery for antitrust violations

should be applied to these state law claims.

Accordingly, Merck’s motion to dismiss Humana’s Indiana, Louisiana, and Missouri

consumer protection claims is DENIED.

c. Allegations Zetia and/or Vytorin purchases were for personal,

familial, or household use—Mississippi and Missouri

Because Humana is a health plan provider, Merck contends it cannot allege its Zetia and/or

Vytorin purchases were for personal, familial, or household use, as the Mississippi and Missouri

consumer protection laws require. (See ECF No. 72 at 30.) Humana argues its purchases of the

drugs are sufficient to confer standing to sue because the drugs were dispensed “to [its] members

for personal use” (ECF No. 73 at 28), and that courts in Mississippi and Missouri allow “third-

party payors” like Humana to bring claims under their respective consumer protection statutes (id.

at 29–30). Merck reiterates Humana’s claims are not allowed under the statutes as the purchases

were not made for an allowable use. (ECF No. 74 at 12.)

Courts have found the Mississippi statute defines “person” as including businesses, and

explained “an insurer, standing in as a proxy for the end-user, not as an independent buyer in the

business of reselling the product as a retailer or distributor” has standing to sue. Staley v. Gilead

Sciences, Inc., 589 F. Supp. 3d 1132, 1141 (N.D. Cal. 2022) (citing Miss. Code Ann. § 75-24-15).

Similarly, another court in this Circuit recently held the Missouri Merchandising Practices Act

defines “person[s]” who may bring claims as “includ[ing] entities.” Mayor and City Council of

Baltimore v. Merck Sharp & Dohme Corp., Civ. A. No. 23-828, 2023 WL 8018980, at *16 (E.D.

Pa. Nov. 20, 2023) (citing Mo. Ann. Stat. § 407.010(5)).12

Here, the Court is persuaded that the Mississippi Consumer Protection Act and the Missouri

Merchandising Practices Act contain broad language allowing claims by indirect purchasers like

12 Indeed, Merck was the defendant in Mayor and City Council of Baltimore and pursued this

argument unsuccessfully. 2023 WL 8018980, at *15.

Humana. Both statutes expressly define the category of persons who may bring suit to include not

only natural persons but also business entities like Humana. See Miss. Code Ann. § 75-24-3; Mo.

Ann. Stat. § 407.010(5). Moreover, taking Humana’s allegations as true, as it must at this stage,

the Court finds Humana’s Zetia and/or Vytorin purchases were made for and on behalf of its

members, who are natural persons making personal, familial, and household use of them. (ECF

No. 61 ¶¶ 251, 255.)

Accordingly, Merck’s motion to dismiss Humana’s consumer protection claims under

Mississippi and Missouri law is DENIED.

d. “Natural persons”—Nevada and West Virginia

Merck asserts “only natural persons may bring suit under these states’ consumer protection

laws[,]” and therefore Humana’s claims under Nevada and West Virginia consumer protection laws

cannot go forward. (ECF No. 72 at 30–31.) Humana disputes this, arguing first that the Supreme

Court of Nevada as well as “multiple federal courts” have recently changed course, holding that

“non-natural persons may bring consumer protection claims[.]” (ECF No. 73 at 30–31.) Humana

also claims Merck’s argument relies on a defunct version of the West Virginia statute, which now

allows organizations like Humana to state claims. (Id. at 31–32.) Merck replies that Humana’s

position “ignore[s] other decisions rejecting” claims by non-persons under Nevada law, and that

Humana’s claims are not governed by West Virginia’s statutory amendment broadening the class

of plaintiffs because the claims accrued before the amendment was enacted. (ECF No. 74 at 13.)

The Nevada Deceptive Trade Practices Act prohibits, among other things, knowingly

making false representations in a transaction, Nev. Rev. Stat §§ 598.0915–.0925, and expressly

delegates enforcement authority to various state actors, including the Attorney General, id.

§ 598.096, with the exception of civil actions by elderly persons or persons with disabilities, id.

§ 598.0977. See In re Wellbutrin XL Antitrust Litig., 260 F.R.D. 143, 163 (E.D. Pa. 2009) (finding

that “[t]he defendants are correct” the Nevada statute grants causes of action to elderly or disabled

people only); In re Cast Iron Soil Pipe and Fittings Antitrust Litig., No. 1:14-md-508, 2015 WL

5166014, at *31 (E.D. Tenn. June 24, 2015) (same); but see In re Fragrance Direct Purchaser

Antitrust Litig., Nos. 2:23-02174, 2:23-03249, 2:23-16127, 2025 WL 579639, at *22 (D.N.J. Feb.

21, 2025) (holding that the Nevada consumer protection act provides “enhanced relief for some

classes of individuals, including elderly, disabled, or minor persons, but does not bar recovery by

other persons”); Del Webb Cmties., Inc. v. Partington, 652 F.3d 1145, 1152–53 (9th Cir. 2011)

(noting the Nevada statute provides “[a]n action may be brought by any person who is a victim of

consumer fraud” including business competitors); In re DDAVP, 903 F. Supp. 2d at 226–27

(determining “any victim of consumer fraud may bring a civil action” under the Nevada statute).

The West Virginia consumer protection statute, known as the Consumer Credit and

Protection Statute, W. Va. Code §§ 46A-6-101 et seq., protects consumers against “[u]nfair

methods of competition and unfair or deceptive acts or practices in the conduct of any trade or

commerce[,]” id. § 46A-6-104. As of June 12, 2015, it defines “consumer[s]” as “natural person[s].”

Id. § 46A-6-102. An earlier version of the West Virginia statute also required plaintiffs to be

“natural persons who purchased goods for household, personal, or family purposes[.]” In re

Dynamic Random Access Memory (Dram) Antitrust Litig., 516 F. Supp. 2d 1072, 1118–19 (N.D.

Cal. 2007).

Here, the Court finds the Nevada consumer protection statute does not limit standing to

natural persons, but the West Virginia law does. The subsections providing definitions of key terms

in the Nevada law do not define “person” but do define “elderly person[,]” Nev. Rev. Stat

§ 598.0933, and “person with a disability[,]” id. § 598.0936. This strongly suggests, as the court

found in In re Fragrance Direct Purchaser Antitrust Litig., that the Nevada law intended

“enhanced relief” for those classes of individuals, but not to exclude all other claimants. Moreover,

the Court is persuaded by the case law that any victim of consumer fraud, including business

entities, may file suit under the Nevada statute. See Del Webb, 652 F.3d at 1152–53; In re DDAVP,

903 F. Supp. 2d at 226–27. With respect to the West Virginia law, the parties appear to agree the

statute required plaintiffs to be natural persons throughout the period during which Humana’s

claims accrued, and the Court concurs. (See ECF Nos. 73 at 31; 74 at 13.)

Accordingly, Merck’s motion to dismiss Humana’s consumer protection claims is

GRANTED with respect to Humana’s claim under West Virginia law and DENIED with respect

to Humana’s claim under the Nevada law.

e. State consumer protection laws extending to pure antitrust

violations—Illinois and Wyoming

Merck’s position is that Humana’s consumer protection claims under Illinois and Wyoming

statutes, given they “are predicated entirely on alleged anticompetitive conduct,” must be

dismissed because the statutes are not meant to provide duplicative causes of action for a single

set of alleged antitrust violations. (ECF No. 72 at 31.) In its Opposition, Humana argues the Illinois

consumer protection law covers “conduct that may also be covered by antitrust law” (ECF No. 73

at 32), and that Merck’s argument “disregards the plain language of the [Wyoming] statute[,]”

which “is broad enough to encompass Merck’s alleged misconduct here” (id. at 33). With respect

to the Illinois statute, Merck claims “the law is not ‘an additional enforcement mechanism for all

antitrust violations’” (ECF No. 74 at 13 (quoting Batson v. Live Nation Ent., Inc., 746 F.3d 827,

831 (7th Cir. 2014))), where the “allegations of consumer fraud overlap entirely with the

allegations of anticompetitive conduct” (id. (quoting In re Effexor, 357 F. Supp. 3d at 395–96)).

Merck also argues Humana offered no cases to show similar claims going forward under the

Wyoming law, whereas “courts regularly dismiss antitrust claims like [Humana’s].” (Id. at 14.)

The Illinois Consumer Fraud and Deceptive Business Practices Act, see 815 Ill. Comp. Stat

§§ 505/1–12, targets a broad range of “unfair methods of competition and unfair or deceptive acts

or practices,” id. § 505/2. The Supreme Court of Illinois has held “the language of the Act shows

that its reach was to be limited to conduct that defrauds or deceives consumers or others” and

“[t]here is no indication that the legislature intended that the Consumer Fraud Act be an additional

antitrust enforcement mechanism.” Laughlin v. Evanston Hosp., 550 N.E.2d 986, 993 (Ill. 1990);

see In re Interior Molded Doors Antitrust Litig., Civ. A. Nos. 3:18-cv-00718, 3:18-cv-00850, 2019

WL 4478734, at *21 (E.D. Va. Sept. 18, 2019) (relying on Laughlin in dismissing plaintiffs’

consumer protection claim under Illinois law where the claim was based on the same set of conduct

as their asserted antitrust claims).

The Wyoming Consumer Protection Act, see Wyo. Stat. Ann. §§ 40-12-101 et seq., “is

targeted at ‘unscrupulous and fraudulent marketing practices’ that are distinguishable from

allegations of antitrust violations, and moreover, the Wyoming legislature has seen fit to provide a

scheme to redress antitrust violations through enactment of a separate antitrust statute.” In re

Dynamic Random Access Memory (Dram), 516 F. Supp. 2d at 1120 (internal citation omitted). The

Supreme Court of Wyoming dismisses claims brought under the statute which pertain to conduct

more directly covered by a separate statutory scheme. See Herrig v. Herrig, 844 P.2d 487, 495

(Wyo. 1992).

Here, the Court is not persuaded the Illinois or Wyoming consumer protection statutes

provide additional causes of action for a set of conduct covered entirely by the respective state’s

antitrust laws. Although distinct claims arising out of a common set of facts are regularly pursued

in the judicial system, this practice can be limited by the legislature or judiciary, as both states have

done. See Laughlin, 550 N.E.2d at 993; Herrig, 844 P.2d at 495. Accordingly, Merck’s motion to

dismiss Humana’s consumer protection claims under Illinois and Wyoming law is GRANTED.

3. Unjust Enrichment Claims

a. Recasting of antitrust claims as unjust enrichment claims to

circumvent Illinois Brick— Delaware, Georgia, Kentucky,

Louisiana, New Jersey, Oklahoma, Pennsylvania, Texas,

Virginia, Washington, and Wyoming

Merck contends Illinois Brick’s prohibition on indirect purchasers from recovering for

antitrust violations bars unjust enrichment claims brought on behalf of an indirect purchaser like

Humana. (ECF No. 72 at 31–32.) In its Opposition, Humana considers Merck’s position untenable,

arguing “courts have declined to dismiss unjust enrichment claims simply because a particular

state has not repealed Illinois Brick[,]” and insisting the Court should do the same. (ECF No. 73 at

34 (citing In re Generic, 368 F. Supp. 3d at 849–50).)

Unjust enrichment is an equitable theory centered on the principle that “a person shall not

be allowed to enrich himself unjustly at the expense of another.” Assocs. Com. Corp. v. Wallia, 511

A.2d 709, 716 (N.J. Super. Ct. App. Div. 1986). It can be pled in the alternative even where there

appears to be an adequate remedy at law. In re G-Fees Antitrust Litig., 584 F. Supp. 2d 26, 46

(D.D.C. 2008) (citing Fed. R. Civ. P. 8(d)(2)–(3)).

Here, the Court finds Illinois Brick has no effect on Humana’s unjust enrichment claims.

The antitrust concerns surrounding the effect of Illinois Brick in barring indirect purchasers “are

not implicated in the context of unjust enrichment claims because ‘the very nature of such claims

requires a focus on the gains of the defendants, not the losses of the plaintiffs.’” In re Generic, 368

F. Supp. 3d at 850 (citing Martin v. Ford Motor Co., 292 F.R.D. 252, 280 (E.D. Pa. 2013)). Indeed,

the Court is convinced “[n]o reason or logic supports a conclusion that a state’s adherence to the

rule of Illinois Brick dispossesses a person not only of a statutory legal remedy for an antitrust

violation, but also dispossesses the same person of his right to pursue a common law equitable

remedy.” In re G-Fees, 584 F. Supp. 2d at 46.

Accordingly, Merck’s motion to dismiss Humana’s unjust enrichment claims under

Delaware, Georgia, Kentucky, Louisiana, New Jersey, Oklahoma, Pennsylvania, Texas, Virginia,

Washington, and Wyoming law is DENIED.

b. Allegations Humana conferred a direct benefit on, or had a

direct relationship with, Merck—Alabama, Georgia, Kentucky,

Maine, New Jersey, New York, North Carolina, North Dakota,

Pennsylvania, Rhode Island, Utah, and Wyoming

Merck claims Humana’s allegations “make clear that [its] indirect purchaser claims do not

stem from any direct dealings [it] allegedly had with (or any direct benefit they allegedly conferred

on) Merck[,]” whereas these states’ laws restrict unjust enrichment claims to precisely those types

of direct interactions. (ECF No. 72 at 32–33.) Humana suggests Merck’s narrow interpretation of

the legal requirements masks the central question, which is “whether the plaintiff’s detriment and

the defendant’s benefit are related to, and flow from, the challenged conduct[,]” which Humana

argues emphatically they are. (ECF No. 73 at 35–36 (quoting In re K-Dur, 338 F. Supp. 2d 517,

544 (D.N.J. 2004)).) Humana asserts the cases on which Merck relies are unavailing because they:

(1) rely on incorrect and unsubstantiated assumptions (id. at 36); (2) provide shallow explanations

for how and why “allegations that overpayments indirect purchasers made, and benefitted the

defendant, fail to satisfy” direct benefit requirements (id. at 37); and (3) are grounded in reasoning

refuted by other cases cited by Merck (id. at 37–38). In its Reply, Merck argues the cases Humana

cites “paint[] with a broad brush” rather than engaging with each state’s unjust enrichment laws.

(ECF No. 74 at 14.) Merck insists courts have consistently found indirect purchasers “‘do not plead

a direct benefit’ and thus cannot bring claims under states that ‘require that a plaintiff confer a

direct benefit on the defendant.’” (Id. at 15 (quoting In re Novartis & Par Antitrust Litig., 18 Civ.

4361, 5536, 5603, 5708, 5886, 6776, 9861, 11835, 12293, 2019 WL 3841711, at *6 (S.D.N.Y. Aug.

15, 2019)).)

The requirements for unjust enrichment in the various states differ in important ways. One

set of states—Alabama, Georgia, New Jersey, North Carolina, North Dakota, Pennsylvania, Utah,

and Wyoming—requires a direct benefit be plead for unjust enrichment claims. See Danny Lynn

Elec. & Plumbing, LLC v. Veolia ES Solid Waste Southeast, Inc., Civ. A. No. 2:09-192, 2011 WL

2893629, at *6 (M.D. Ala. July 29, 2011) (“Since the individual defendants enjoyed no direct

benefit, the unjust enrichment claim against them is due to be dismissed”); Archer v. Holmes, Civ.

A. No. 1:17-2051, 2018 WL 534475, at *5 (N.D. Ga. Jan. 23, 2018) (“[I]n Georgia, unjust

enrichment claims lie only in those situations where a defendant has received a direct benefit from

a plaintiff.”); Snyder v. Farnam Companies, Inc., 792 F. Supp. 2d 712, 723–24 (D.N.J. 2011)

(finding plaintiffs fail to state a claim for unjust enrichment “since they never directly conferred a

benefit on Defendants”); Norman Owen Trucking, Inc. v. Morkoski, 506 S.E.2d 267, 273–74 (N.C.

Ct. App. 1998) (same); Midland Diesel Serv. v. MDU Res. Grp., Inc., 307 N.W.2d 555, 557 (N.D.

1981) (explaining a claimant sufficiently states a claim for unjust enrichment where a defendant

“obtained a benefit at the direct expense” at his or her expense); Schmidt v. Ford Motor Co., 972

F. Supp. 2d 712, 721 (E.D. Pa. 2013) (“The ‘benefit’ must be conferred by the plaintiff directly[.]”);

Jones v. Mackey Price Thompson & Ostler, 355 P.3d 1000, 1018 (Utah 2015) (“A defendant is

liable under the unjust enrichment prong of quantum meruit only if he or she received a direct

benefit from the plaintiff.”); Boyce v. Freeman, 39 P.3d 1062 (Wyo. 2002) (finding defendant

“received no direct benefit from this action” and affirming the lower court’s denial of plaintiff’s

unjust enrichment claim following a bench trial).

The second set of states do not require such directness. Kentucky law only requires “the

plaintiff must allege that it conferred a benefit on the defendant[,]” allowing both direct and

indirect benefits to state a claim for unjust enrichment. Dixie Fuel Co., LLC v. Straight Creek, LLC,

Civ. No. 08-326, 2011 WL 845828, at *4–5 (E.D. Ky. Mar. 8, 2011). Similarly, in Maine, a plaintiff

must confer a benefit on a defendant to plead an unjust enrichment claim, but the Supreme Judicial

Court has explained that benefit can be received from the plaintiff or “anyone else,” and therefore

need not be direct. Platz Associates v. Finley, 973 A.2d 743, 751 (Me. 2009). Rhode Island law

defines the concept of “benefit” broadly, explaining it “denotes any form of advantage.” State v.

Lead Indus. Ass’n, Inc., No. 99-5226, 2001 WL 345830, at *15 (R.I. Super. Apr. 2, 2001) (citing

Restatement of Restitution § 1, cmt. b (1937)). Finally, in Sperry v. Crompton Corp., the New York

Court of Appeals concluded the connection pleaded by the plaintiff was “simply too attenuated”

to support an unjust enrichment claim. 863 N.E. 3d 1012, 1018 (N.Y. Ct. App. 2007). After Sperry,

courts have been split with respect to whether the phrase “too attenuated” automatically

disqualifies all indirect purchasers, or those plaintiffs who can make “an adequate factual showing

as to traceability” can proceed. See In re Hard Disk Drive Suspension Assemblies Antitrust Litig.,

No. 19-md-02918, 2021 WL 4306018, at *27–28 (N.D. Cal. Sept. 22, 2021).

The Court concludes Humana cannot state a claim for unjust enrichment under Alabama,

Georgia, New Jersey, North Carolina, North Dakota, Pennsylvania, Utah, and Wyoming law

because it cannot allege the requisite degree of directness in benefit conferred. Humana’s

allegations involve at least one “intermediary in the chain of distribution from which it purchased

Zetia, Vytorin, and generic Zetia,” and therefore it cannot claim it directly conferred a benefit to

Merck. (ECF No. 61 ¶ 321.) Conversely, the Court finds the laws for unjust enrichment in

Kentucky, Maine, New York, and Rhode Island do not require such directness, and Humana’s

allegations are sufficient at this stage to show it conferred a benefit on Merck through its payment

of allegedly inflated prices. (Id. ¶ 328.)

Accordingly, Merck’s motion to dismiss Humana’s claims under Alabama, Georgia, New

Jersey, North Carolina, North Dakota, Pennsylvania, Utah, and Wyoming law is GRANTED, and

its motion to dismiss Humana’s claims under Kentucky, Maine, New York, and Rhode Island law

is DENIED.

c. Affirmatively alleging an adequate remedy at law exists under

antitrust and consumer protection laws— California, Hawaii,

and New York

Merck claims plaintiffs proceeding under California, Hawaii, or New York law “cannot

bring a claim for unjust enrichment where an adequate remedy at law exists.” (ECF No. 72 at 33.)

Humana asserts Federal Rule of Civil Procedure 8 “permits alternative pleading of claims” and

insists the cases Merck cites do not address this controlling rule. (ECF No. 73 at 38–39.) Merck

reiterates the laws of the respective states preclude equitable claims where a plaintiff fails to allege

it lacks an adequate remedy at law and expresses concern these claims are duplicative of other

claims. (ECF No. 74 at 15 (citing Bolos v. Waldorf Astoria Mgmt. LLC, 762 F. Supp. 3d 975, 1016–

17 (D. Haw. 2025)).)

“A party may set out 2 or more statements of a claim or defense alternatively or

hypothetically, either in a single count or defense or in separate ones.” Fed. R. Civ. P. 8(d)(2).

Plaintiffs may not, however, “obtain ‘double recovery’ by an award in equity for damages also

obtained at law.” Bolos, 762 F. Supp. 3d at 1017.

At this stage of the litigation, given Federal Rule of Civil Procedure 8’s allowance for

alternative pleading, and the Court’s duty to draw all inferences in Humana’s favor, the Court finds

Humana has pleaded sufficient facts to plausibly state claims for unjust enrichment under

California13, Hawaii, and New York law. See Fed. R. Civ. P. 8(d)(2); Iqbal, 556 U.S. at 678; see

also In re Generic, 368 F. Supp. 3d at 851 (declining to “dismiss . . . unjust enrichment claims

based on Defendant’s argument regarding an adequate legal remedy”). Merck’s concern for

duplicative claims, though generally well-founded, is not so pressing in a case involving dozens

of claims the Court has already allowed to proceed.

Accordingly, Merck’s motion to dismiss Humana’s unjust enrichment claims under

California, Hawaii, and New York law for failure to allege an inadequate remedy at law is

DENIED.

d. Unjust enrichment as standalone cause of action—Mississippi

Merck argues Humana’s unjust enrichment claims under Mississippi must be dismissed as

Mississippi does not recognize unjust enrichment as an independent cause of action. (ECF No. 72

at 33–34.) Humana counters that courts applying Mississippi law have allowed unjust enrichment

claims to proceed. (ECF No. 73 at 39–40.)

While it is not a standalone cause of action in Mississippi, unjust enrichment is readily

recognized as a remedy “where there is no legal contract and ‘the person sought to be charged is

in possession of money or property which in good conscience and justice he should not retain but

should deliver to another.’” Mississippi ex rel. Fitch v. Eli Lilly & Co., 620 F. Supp. 3d 532, 544

(S.D. Miss. 2022) (quoting Powell v. Campbell, 912 So. 2d 978, 982 (Miss. 2005)). Given that

13 Although unjust enrichment is not a standalone cause of action in California, it “can be construed

as a claim that the plaintiff is entitled to restitution under a theory that ‘the defendant obtained a

benefit from the plaintiff by fraud’ and the plaintiff ‘choose[s] not to sue in tort, but instead to seek

restitution on a quasi-contract theory (an election referred to at common law as waiving the tort

and suing in assumpsit).’” In re Hard Disk Drive, 2021 WL 4306018, at *24 (quoting McBride v.

Boughton, 123 Cal. App. 4th 379, 387 (2004)).

courts in Mississippi appear to regularly allow unjust enrichment claims to proceed under a quasi-

contract theory of restitution, the Court sees no reason to dismiss Humana’s claim.

Accordingly, Merck’s motion to dismiss Humana’s unjust enrichment claims under

Mississippi law is DENIED.

D. Per Se Conspiracy to Restrain Trade/Restraint of Trade – Counts II and VIII

Merck argues Humana “improper[ly] attempt[s] to reassert” the per se conspiracy to

restrain trade theory, which was previously rejected by the Court in its prior order. (ECF No. 72 at

34.) Humana concedes without “conced[ing] the correctness” of the ruling. (ECF No. 73 at 1 n.3.)

Accordingly, Merck’s motion to dismiss Humana’s per se conspiracy to restrain trade claim is

GRANTED, and Counts II and VIII are dismissed with prejudice.

IV. CONCLUSION

For the reasons set forth above, and for good cause having been shown, Merck’s Partial

Motion to Dismiss (ECF No. 72) is GRANTED in part and DENIED in part. Specifically, the

Motion is GRANTED WITH PREJUDICE as to Humana’s: (1) Walker Process fraud, sham

litigation, and Orange Book theories of Monopolization from Counts I, IV, VI, and VII; (2)

Monopolistic Scheme claims (Counts IV and VI); and (3) Per Se Conspiracy to Restrain

Trade/Restraint of Trade (Counts II and VIII). The Motion is GRANTED WITHOUT

PREJUDICE as to the following state law claims:

1) State Law Antitrust Claims

a. Vermont

b. Montana

c. Puerto Rico

d. Rhode Island (to the extent of pre-enactment injuries)

2) State Law Consumer Protection Claims

a. Arizona

b. Colorado

c. Virginia

d. West Virginia

e. Illinois

f. Wyoming

3) Unjust Enrichment Claims

a. Alabama

b. Georgia

c. New Jersey

d. North Dakota

e. Pennsylvania

f. Utah

g. Wyoming

The Motion is DENIED as to following state law claims:

1) State Law Antitrust Claims

a. Rhode Island (to the extent of post-enactment injuries)

b. Arizona

c. Hawaii

d. Nevada

e. Rhode Island

f. Utah

2) State Law Consumer Protection Claims

a. Pennsylvania

b. North Dakota

c. Indiana

d. Louisiana

e. Missouri

f. Mississippi

g. Nevada

3) Unjust Enrichment Claims

a. Delaware

b. Georgia

c. Kentucky

d. Louisiana

e. Oklahoma

f. Texas

g. Virginia

h. Washington

i. Wyoming

j. Maine

k. New York

l. Rhode Island

m. California

n. Hawaii

o. Mississippi

An appropriate Order follows.

Date: September 4, 2025 /s/ Brian R. Martinotti

HON. BRIAN R. MARTINOTTI

UNITED STATES DISTRICT JUDGE