SPRING PHARMACEUTICALS, LLC v. RETROPHIN, INC.

IN THE UNITED STATES DISTRICT COURT

FOR THE EASTERN DISTRICT OF PENNSYLVANIA

SPRING PHARMACEUTICALS, LLC, CIVIL ACTION

Plaintiff,

v.

RETROPHIN, INC., MARTIN NO. 18-4553

SHKRELI, MISSION PHARMACAL

COMPANY, and ALAMO PHARMA

SERVICES, INC.,

Defendants.

MEMORANDUM

Joyner, J. December 11, 2019

Presently before the Court are Defendants’ Motions to

Dismiss the Complaint for lack of standing under Fed. R. Civ. P.

12(b)(1), lack of personal jurisdiction under Rule 12(b)(2), and

failure to state a claim under Rule 12(b)(6). (Defs.

Mission/Alamo Motion to Dismiss, Doc. No. 40; Def. Retrophin

Motion to Dismiss, Doc. No. 42; Def. Shkreli Motion to Dismiss,

Doc. Nos. 39, 43.) For the reasons that follow, the Motions will

be granted in part and denied in part.

Factual Background

This is an antitrust action concerning the market for a

prescription drug called Thiola. Under federal and state

antitrust laws, Plaintiff Spring Pharmaceuticals, LLC (“Spring”)

seeks monetary and injunctive relief against Defendants

Retrophin, Inc. (“Retrophin”), Martin Shkreli (“Shkreli”),

Mission Pharmacal Company (“Mission”), and Alamo Pharma

Services, Inc. (“Alamo”). Plaintiff Spring is a pharmaceutical

company formed for the purpose of developing a generic version

of Thiola through the FDA’s Abbreviated New Drug Application

(“ANDA”) process. Thiola is off-patent and currently the only

FDA-approved tiopronin product for treatment of the rare genetic

disease cystinuria, which causes recurring kidney stones. In

order to develop a generic through the ANDA process, a

manufacturer must demonstrate that the generic is bioequivalent

to the brand version. In order to demonstrate bioequivalence,

the generic manufacturer must obtain samples of the brand drug.

At the crux of Plaintiff’s claims, Plaintiff alleges that

Defendants violated antitrust laws by refusing to sell to

Plaintiff samples of Thiola and that this allegedly

anticompetitive conduct has excluded Plaintiff from the

tiopronin market.

Plaintiff has asserted the following claims in its

Complaint: Count I (Mandatory Injunctive Relief pursuant to 15

U.S.C. § 26 and Fed. R. Civ. P. 65 against all Defendants);

Count II (monopolization and/or attempted monopolization under

Sherman Act Section 2 against Retrophin); Count III (conspiracy

to monopolize under Sherman Act Section 2 against all

Defendants); Count IV (contract in restraint of trade under

Sherman Act Section 1 against all Defendants); Count V (unfair

competition under Pennsylvania common law against all

Defendants); and Count VI (unjust enrichment under Pennsylvania

common law against all Defendants) (Pl. Compl., Doc. No. 1 at

37).

Analysis

Motions to Dismiss Under Fed. R. Civ. P. 12(b)(1) for Lack of

Subject Matter Jurisdiction

Defendants move to dismiss under Fed. R. Civ. P. 12(b)(1)

on grounds that Plaintiff lacks constitutional standing under

Article III of the Constitution. See Ballentine v. United

States, 486 F.3d 806, 810 (3d Cir. 2007) (“Federal Rule of Civil

Procedure 12(b)(1) provides that a party may bring a motion to

dismiss for lack of subject matter jurisdiction . . . . A motion

to dismiss for want of standing is . . . properly brought

pursuant to Rule 12(b)(1), because standing is a jurisdictional

matter.”). Defendants argue that their attack is factual, not

facial. This Court previously stayed the case to allow for

discovery on the issue of whether Plaintiff has Article III

standing. Spring Pharm., LLC v. Retrophin, Inc., 2019 WL

1558744, at *1 (E.D. Pa. Apr. 10, 2019). The stay has ended,

and, in Plaintiff’s Supplemental Brief Establishing Article III

Standing, Plaintiff requests that the Court Deny Defendants’

challenges to Plaintiff’s Article III standing and direct that

discovery should proceed. (Doc No. 81.)

I. Monetary Relief

a. Factual Challenges Versus Facial Challenges

Courts distinguish between facial attacks under Rule

12(b)(1) and factual attacks under Rule 12(b)(1). Constitution

Party of Pennsylvania v. Aichele, 757 F.3d 347, 357 (3d Cir.

2014); Mortensen v. First Fed. Sav. & Loan Ass’n, 549 F.2d 884,

891 (3d Cir. 1977).

A factual attack addresses “‘the actual failure of [a

plaintiff’s] claims to comport [factually] with the

jurisdictional prerequisites.’” CNA v. United States, 535 F.3d

132, 139 (3d Cir. 2008), as amended (Sept. 29, 2008). See also

Edmonson v. Lincoln Nat. Life Ins. Co., 777 F. Supp. 2d 869, 877

(E.D. Pa. 2011). During a factual attack, the Court may make

factual determinations to decide whether the Court has subject

matter jurisdiction. CNA, 535 F.3d at 139; Mortensen, 549 F.2d

at 891, n.16 (“That the district court is free to determine

facts relevant to its jurisdiction has long been clear.”).

Additionally, the plaintiff has the burden of proving subject

matter jurisdiction. Davis v. Wells Fargo, 824 F.3d 333, 349

(3rd Cir. 2016) (“[T]he plaintiff must prove the court has

subject matter jurisdiction.”); CNA, 535 F.3d at 139 (“[T]he

Court placed the burden of proving subject matter jurisdiction

on the plaintiff.”). Further, there is no presumption of

truthfulness for the plaintiff’s allegations. CNA, 535 F.3d at

139 (“‘[N]o presumption of truthfulness attaches to the

allegations of the plaintiff.’”); Mortensen, 549 F.2d at 891.

The Court may consider evidence outside of the pleadings. CNA,

535 F.3d at 145 (“The District Court applied Rule 12(b)(1), with

its attendant procedural consequences, properly. The Government

made a factual attack on the existence of subject matter

jurisdiction . . . . The District Court was permitted to make

factual findings, beyond the pleadings, that were decisive to

determining jurisdiction.”). For instance, Courts have

“‘discretion to allow affidavits, documents, and even limited

evidentiary hearings’ in weighing the evidence on a factual

attack.” Edmonson, 777 F. Supp. 2d at 877-78. Additionally, if

there are disputes of material facts, Courts in this

jurisdiction “must permit the case to proceed to a plenary trial

on the contested issues so that it may resolve the question of

its jurisdiction even while hearing proofs that are equally

pertinent to the merits.” Int’l Ass’n of Machinists & Aerospace

Workers v. Nw. Airlines, Inc., 673 F.2d 700, 712 (3d Cir. 1982).

Lastly, the defendant may “attack the allegations in the

complaint and submit contrary evidence in its effort to show

that the court lacks jurisdiction.” Davis, 824 F.3d 333, 349

(3rd Cir. 2016).

In contrast to a factual attack, a facial attack “concerns

‘an alleged pleading deficiency . . . . ’” CNA, 535 F.3d 132,

139 (3d Cir. 2008). See also Edmonson, 777 F. Supp. 2d at 877.

During a facial attack under Rule 12(b)(1), the Court must

determine whether the pleadings, on their face, adequately

allege subject matter jurisdiction. Constitution Party, 757 F.3d

347 at 358 (“A facial attack . . . is an argument that considers

a claim on its face and asserts that it is insufficient to

invoke the subject matter jurisdiction of the court . . . .”).

As with motions to dismiss under Rule 12(b)(6), Courts must

“only consider the allegations of the complaint and documents

referenced therein and attached thereto, in the light most

favorable to the plaintiff.” Constitution Party, 757 F.3d at

358.

b. Article III’s Requirements for Constitutional Standing

In order to satisfy constitutional standing requirements

under Article III, a plaintiff must adequately allege (1) an

injury-in-fact that is (2) “fairly traceable to the defendant’s

allegedly unlawful conduct and that is (3) likely to be

redressed by the requested relief.” Lujan v. Defs. of Wildlife,

504 U.S. 555, 590 (1992) (internal citations omitted). See also

Ballentine, 486 F.3d at 814; In re Suboxone (Buprenorphine

Hydrochloride & Naloxone) Antitrust Litig., 64 F. Supp. 3d 665,

691-92 (E.D. Pa. 2014), on reconsideration in part sub nom. In

re Suboxone (Buprenorphine Hydrochloride & Nalaxone) Antitrust

Litig., 2015 WL 12910728 (E.D. Pa. Apr. 14, 2015).

The constitutional standing assessment is separate from the

assessment of the merits. Cottrell v. Alcon Labs., 874 F.3d 154,

162 (3d Cir. 2017), cert. denied sub nom. Alcon Labs., Inc. v.

Cottrell, 138 S. Ct. 2029 (2018) (“[W]e separate our standing

inquiry from any assessment of the merits of the plaintiff’s

claim. To maintain this fundamental separation between standing

and merits at the dismissal stage, we assume for the purposes of

our standing inquiry that a plaintiff has stated valid legal

claims.”). When standing and merits are intertwined such that

material facts go to both factual issues and standing issues, a

Court adjudicating a Rule 12(b)(1) motion must “demand less in

the way of jurisdictional proof than would be appropriate at a

trial stage,” Davis, 824 F.3d at 349-350 (internal quotations

omitted), and should grant motions to dismiss “sparingly.” Id.

at 348-350 (“[W]hen a factual challenge to jurisdiction attacks

facts at the core of the merits of the underlying cause of

action, ‘the proper procedure for the district court is to find

that jurisdiction exists and to deal with the objection as a

direct attack on the merits of the plaintiff’s case’ . . . .

dismissal via a Rule 12(b)(1) factual challenge to standing

should be granted sparingly.”); CNA, 535 F.3d at 145. Thus, our

standing analysis is limited to whether Plaintiff has

constitutional standing; whether Defendants actually delayed

Plaintiff’s market entry illegally and whether Plaintiff is

actually entitled to relief are merits questions that cannot be

resolved during the constitutional standing inquiry. See id. See

also Edmonson, 777 F. Supp. 2d at 880 (“The extent of

plaintiff’s loss . . . was a question of damages (to be

calculated after the benefit of discovery), rather than injury

in fact.”).

First, an injury-in-fact is “an invasion of a legally

protected interest which is . . . concrete and particularized[,]

. . . actual or imminent, not conjectural or hypothetical . . .

.” Ballentine, 486 F.3d 806, 814 (3d Cir. 2007). See also Lujan,

504 U.S. at 560. The injury-in-fact element “is very generous to

claimants, demanding only that the claimant allege[ ] some

specific, identifiable trifle of injury.” In re Remicade

Antitrust Litig., 345 F. Supp. 3d 566, 584 (E.D. Pa. 2018)

(internal quotations omitted) (alteration in original).

Financial harm, even if minor, is a classic type of injury-in-

fact. Cottrell, 874 F.3d at 163 (“[F]inancial harm is a

‘classic’ and ‘paradigmatic form[ ]’ of injury in fact . . . .

‘Any monetary loss suffered by the plaintiff satisfies [the

injury-in-fact] element; “[e]ven a small financial loss”

suffices . . . .’”); Remicade, 345 F. Supp. 3d at 584 (“‘[T]he

Supreme Court has repeatedly recognized that financial or

economic interests are “legally protected interests” for

purposes of the standing doctrine.’”). Here, Plaintiff alleges

financial harm that includes alleged lost sales and profits from

Defendants’ allegedly anticompetitive actions of excluding

Plaintiff from the market. (Doc. No. 1 ¶¶105, at 37.) To rebut

this, Defendants argue that Plaintiff is merely a shell company

created for this litigation. (Def. Retrophin Memorandum in

Support of Retrophin’s Motion to Dismiss, Doc. No. 42-1 at 11.)

After jurisdictional discovery, the parties do not appear to

dispute that Plaintiff was founded on November 6, 2017,1 which

was over eleven months before bringing this suit on October 23,

2018, (Doc. No. 1); that Plaintiff repeatedly sought samples

from Defendants;2 and that, before Plaintiff filed this suit, a

contract development and manufacturing organization (“CDMO”)

signed and sent a proposal to Plaintiff.3 Unlike the Lujan, 504

U.S. 555 respondents, who lacked concrete plans and, thus,

injury-in-fact, Plaintiff here has suffered an actual injury.

Lujan, 504 U.S. at 564 (“Such ‘some day’ intentions - without

any description of concrete plans, or indeed even any

specification of when the some day will be - do not support a

finding of the ‘actual or imminent’ injury that our cases

require.”). And even if Plaintiff’s financial harm is only

minor, Plaintiff has still alleged an economic injury. Thus, we

1 (Doc. No. 91 at 2; Doc. No. 81, Ex. 1.)

2 (See Doc. No. 81, Ex. 25; id., Ex. 26; id., Ex. 27; id., Ex. 28; id., Ex.

29; id., Ex. 32; id., Ex. 34; id., Ex. 35; Doc. No. 91, Ex. F.)

3 (Doc. No. 81, Ex. 14.)

hold that Plaintiff has alleged an injury-in-fact under

constitutional standing requirements.

Second, to show that its injury-in fact is fairly traceable

to the Defendants’ allegedly unlawful conduct, Plaintiff must

show “a causal connection between the injury and the conduct

complained of - the injury has to be ‘fairly . . . trace[able]

to the challenged action of the defendant, and not . . . th[e]

result [of] the independent action of some third party not

before the court.’” Id. at 560. See also Cottrell, 874 F.3d at

164 (“[T]he interest asserted must be ‘related to the injury in

fact . . . .’” ). Here, the parties do not appear to dispute

that Plaintiff sought samples of Thiola.4 Additionally, as in

Cottrell, 874 F.3d 154, Plaintiff claims an economic interest in

the money that it alleges it would have received had Defendants

not allegedly delayed its market entry. Cottrell, 874 F.3d at

165. But for Defendants’ allegedly illegal conduct, Plaintiff

has demonstrated that it would have purchased the samples needed

to begin production.5 Thus, as in Cottrell, 874 F.3d 154,

Plaintiff’s alleged injury is fairly traceable to Defendants’

allegedly illegal conduct.

Third, in order to satisfy the “redressability”

requirement, Plaintiff must show that it is “‘likely,’ as

4 (See Doc. No. 81, Exs. 25-29, 32, 34-35; Doc. No. 91, Ex. F.)

5 (See Doc. No. 81, Exs. 25-29, 32, 34-35; Doc. No. 91, Ex. F. See also Doc.

No. 81, Exs. 1, 14; Doc. No. 91 at 2.)

opposed to merely ‘speculative,’ that the injury will be

‘redressed by a favorable [judicial] decision.’” Lujan, 504 U.S.

at 561. See also Cottrell, 874 F.3d at 162; Remicade, 345 F.

Supp. 3d at 584. It is well-established that money damages

redress injuries-in-fact and, thus, satisfy the redressability

requirement. Montanez v. HSBC Mortg. Corp. (USA), 876 F. Supp.

2d 504, 512 (E.D. Pa. 2012) (“[M]oney damages . . . [are] a

‘very conventional remedy’ that ‘would do much to redress their

injuries.’”). Here, as a matter of law, the money damages that

Plaintiff seeks would redress its alleged injury-in-fact.

Similarly, as in Edmonson, 777 F. Supp. 2d 869, Plaintiff’s

claim for disgorgement is redressable. Edmonson, 777 F. Supp. 2d

at 881. The amount of monetary relief that Plaintiff is entitled

to is not relevant to constitutional standing. Id. at 880.

Thus, after reviewing the record after jurisdictional

discovery, we find that there are no disputes of material fact

as to the issue of constitutional standing, and we hold that

Plaintiff has standing under Article III of the Constitution for

its claims for monetary relief. Our holding “that Plaintiff has

standing is consistent with the liberal approach of the Third

Circuit to challenges to subject matter jurisdiction.” Id. at

883.

II. Mootness Doctrine

“A case becomes moot - and therefore no longer a “Case” or

“Controversy” for purposes of Article III - “when the issues

presented are no longer ‘live’ or the parties lack a legally

cognizable interest in the outcome.’” Already, LLC v. Nike,

Inc., 568 U.S. 85, 91 (2013).

However, under the voluntary cessation doctrine, a case

does not become moot simply because the defendant stops its

allegedly illegal conduct. Id. at 91 (“[A] defendant cannot

automatically moot a case simply by ending its unlawful conduct

once sued . . . . Otherwise, a defendant could engage in

unlawful conduct, stop when sued to have the case declared moot,

then pick up where he left off, repeating this cycle until he

achieves all his unlawful ends.”). Additionally, “‘a defendant

claiming that its voluntary compliance moots a case bears the

formidable burden of showing that it is absolutely clear the

allegedly wrongful behavior could not reasonably be expected to

recur.’” Id. (internal citation omitted).

In arguing that Plaintiff’s request for injunctive relief

is not moot, Plaintiff asserts that Defendant Retrophin is

refusing to sell samples of Thiola EC – a newer formulation of

Thiola. (Pl. Reply Brief in Support of its Supplemental Brief,

Doc. No. 95 at 8.) However, the original Complaint sought an

injunction requiring Defendants to sell only Thiola, not Thiola

EC. (Doc. No. 1 at 37 (“Plaintiff . . . requests . . . the

following relief: (a) Compelling Defendants to sell Plaintiff

sufficient quantities of Thiola at market prices so that

Plaintiff may conduct bioequivalence testing . . . .”).) Thus,

we only consider Plaintiff’s request for injunctive relief as to

Thiola, not as to Defendants’ other formulations.

The parties do not contest that Defendant Retrophin

eventually agreed to sell samples of Thiola to Plaintiff. (Def.

Retrophin’s Opposition to Spring Pharmaceutical’s Supplemental

Brief, Doc. No. 91, at 9; Doc. No. 81, Ex. 36; Doc. No. 91, Ex.

V.) Defendant does not contest that Plaintiff has accepted and

remitted payment to Retrophin. (See Doc. No. 95, at 5; id., Exs.

1, 2.) Thus, the question for the Court is whether, under the

voluntary cessation doctrine, Defendants have met their burden

of demonstrating that the case is moot. Here, because Defendant

has agreed to sell samples to Plaintiff and Plaintiff has

already purchased the Thiola samples from Defendant Retrophin,

we find that Plaintiff’s request for an injunction compelling

Defendant Retrophin to sell samples of Thiola to Plaintiff is

moot.

Accordingly, we grant Defendants Retrophin’s, Mission’s,

and Alamo’s Motions to Dismiss under Rule 12(b)(1) as to the

claim for injunctive relief, and we grant Plaintiff leave to

amend. We deny Defendants Retrophin’s, Mission’s, and Alamo’s

Motions to Dismiss under Rule 12(b)(1) regarding monetary

relief.

Motions to Dismiss Under Fed. R. Civ. P. 12(b)(2) for Lack of

Personal Jurisdiction

Under Rule 4, a federal District Court may have personal

jurisdiction over a defendant according to the law of the state

where the Court sits. Radio Music License Comm., Inc. v. Glob.

Music Rights, LLC, 2019 WL 1437981, at *20-21 (E.D. Pa. Mar. 29,

2019). Here, Pennsylvania’s long-arm statute authorizes

jurisdiction to the extent permitted by the Due Process Clause.

Id. at *20–21 (“Pennsylvania’s long-arm statute is coextensive

with the Due Process Clause . . . and permits the exercise of

personal jurisdiction over a non-resident to the extent allowed

by the United States Constitution.”).

In the absence of an evidentiary hearing, the Court “‘must

accept all of the plaintiff’s allegations as true and construe

disputed facts in favor of the plaintiff.’” Commonwealth of

Pennsylvania by Kane v. Think Fin., Inc., 2016 WL 183289, at *27

(E.D. Pa. Jan. 14, 2016). See also Radio, 2019 WL 1437981, at

*2, *13 (Plaintiff, “as the non-moving party to a 12(b)(2)

motion without an evidentiary hearing, is entitled deference to

all well-pled factual allegations and the resolution of any

factual disputes in its favor . . . . Where a jurisdictional

challenge is raised and the Court does not hold an evidentiary

hearing, plaintiff need only establish a prima facie case of

personal jurisdiction . . . . In this circumstance, a court must

accept as true all uncontroverted allegations in the pleadings

and all reasonable inferences therefrom.”).

Nonetheless, when the defendant challenges personal

jurisdiction, the plaintiff has the burden of proving that the

Court has personal jurisdiction over the defendant. Patterson v.

FBI, 893 F.2d 595, 603-04 (3d Cir. 1990); Radio, 2019 WL

1437981, at *13. In rebutting a Rule 12(b)(2) motion, the

plaintiff must present facts through evidence, such as

affidavits, and may not merely rely on allegations in the

complaint. Patterson, 893 F.2d at 603-04; Radio, 2019 WL

1437981, at *13 (“‘[O]nce the defense has been raised, then the

plaintiff must sustain its burden of proof by establishing

jurisdictional facts through sworn affidavits or other competent

evidence’ . . . . The proffered evidence must show ‘with

reasonable particularity the existence of sufficient contacts

between the defendant and the forum state to support

jurisdiction.’ . . . . Where ‘allegations are contradicted by an

opposing affidavit . . . plaintiff[ ] must present similar

evidence in support.’”).

Accordingly, Courts may consider extrinsic evidence when

adjudicating a contest to personal jurisdiction. Patterson, 893

F.2d at 603-04 (“A Rule 12(b)(2) motion . . . is inherently a

matter which requires resolution of factual issues outside the

pleadings, i.e. whether in personam jurisdiction actually

lies.”); Radio, 2019 WL 1437981, at *13.

Though a Rule 12(b)(2) motion is distinct from a motion for

summary judgment, there are occasions where the jurisdictional

and merits questions are intertwined and, thus, “it may be

necessary for the district court ‘to proceed to a decision which

impacts on the merits.’” Patterson, 893 F.2d at 604 (“A Rule

12(b)(2) motion cannot be treated as one for summary judgment.

There are situations, however, where ‘the question of the

district court’s jurisdiction [is] entwined with the ultimate

question on the merits’”).

I. Defendant Mission

Both Plaintiff and Mission contend that Mission “is a

corporation organized under the laws of the State of Texas, with

its principal place of business in San Antonio, Texas.” (Doc.

No. 1 ¶21; Mission/Alamo Memorandum in Support of Their Motion

to Dismiss, Doc. No. 41, at 10.)

a. Personal Jurisdiction Under the Clayton Act

Plaintiff contends that this Court has personal

jurisdiction over Defendant Mission under Section 12 of the

Clayton Act. Section 12 of the Clayton Act states that:

Any suit, action, or proceeding under the antitrust laws

against a corporation may be brought not only in the

judicial district whereof it is an inhabitant, but also in

any district wherein it may be found or transacts business;

and all process in such cases may be served in the district

of which it is an inhabitant, or wherever it may be found.

Clayton Act, 15 U.S.C. § 22. However, this provision does not

confer personal jurisdiction onto U.S. corporations. Radio, 2019

WL 1437981, at *21 (“[T]he Third Circuit Court of Appeals has

interpreted this section as only applying to foreign, non-U.S.,

corporations . . . . This provision has never been applied to

establish personal jurisdiction over a domestic antitrust

defendant . . . .”).

Here, because Defendant Mission is a U.S. company, (Doc.

No. 1 ¶21; Doc. No. 41 at 10), Section 12 of the Clayton Act

does not confer on this Court personal jurisdiction over

Mission. See Radio, 2019 WL 1437981, at *21.

b. Alter Ego

When the parent has sufficient control over its

subsidiary’s daily operations, the subsidiary is an alter ego of

the parent for purposes of personal jurisdiction. Simeone ex

rel. Estate of Albert Francis Simeone, Jr. v. Bombardier-Rotax

GmbH, 360 F. Supp. 2d 665, 675 (E.D. Pa. 2005) (“‘A subsidiary

will be considered the alter-ego of its parent only if the

parent exercises control over the activities of the subsidiary’

. . . . More precisely, a plaintiff must prove that the parent

controls the day-to-day operations of the subsidiary such that

the subsidiary can be said to be a mere department of the

parent.”). In this situation, a Court may have personal

jurisdiction over the parent by virtue of the subsidiary’s

connection with the forum. Id.

In Simeone, 360 F. Supp. 2d 665, the Court focused on

multiple factors in finding an alter ego relationship between

the parent and subsidiary for purposes of personal jurisdiction:

(1) the parent owned all of the subsidiary’s stock; (2) the

subsidiary had its own management team, but the parent had power

to hire the subsidiary’s CEO, who reported to a board that

consisted partially of the parent’s executives; (3) the

subsidiary was akin to a department of the parent because annual

reports often treated the parent and subsidiary as

interchangeable; (4) and the parent and subsidiary shared a

common marketing image, again because annual reports treated the

parent and subsidiary as interchangeable; (5) the subsidiary

received instructions from the parent because the parent “made

major business decisions” for the subsidiary, such as whether to

spin-off a part of the subsidiary; (6) the parent conducted

performance reviews of the subsidiary and reviewed the

subsidiary’s budget; (7) a detailed policy manual dictated how

the subsidiary should operate; and (8) the subsidiary sold 45%

of its engines product to the parent. Id. at 676–78.

First, “Alamo is Mission’s wholly-owned subsidiary.” (Pl.

Opposition to the Motions to Dismiss, Doc. No. 50 at 58. See

also Doc. No. 1 ¶22; Doc. No. 41 at 8.) Second, “Mission and

Alamo share at least some officers and directors,” including

Mission’s Chief Financial Officer. (Doc. No. 50 at 55, 58; id.,

Exs. 12 at 1; 22; 23; 24 at 1; 25 at 1; Doc. No. 41 at 11.)

Third, Mission and Alamo use at least some common employees.

(Doc. No. 50 at 55, 58; id., Exs. 12 at 1; 22; 23; 24 at 1; 25

at 1; 26; 27; Doc. No. 41 at 11.)

However, unlike in Simeone, 360 F. Supp. 2d 665, Plaintiff

does not prove that Alamo is akin to a department of Mission.

Though Plaintiff argues that Alamo’s sales representatives

replaced an analogous team that Mission once had, (Doc. No. 50

at 58), this falls short of the standard in Simeone, 360 F.

Supp. 2d 665, where annual reports treated the parent and

subsidiary interchangeably. Simeone, 360 F. Supp. 2d 665 at 678.

Additionally, though Plaintiff argues that “Alamo markets and

sells Mission’s products on behalf of Mission,” (Doc. No. 50 at

58), Plaintiff does not allege, or present any evidence showing,

that Alamo received instructions from Mission or that Mission

controlled the daily operations of Alamo. Thus, we find that, on

the current record, Alamo is not an alter ego of Mission.

c. General Jurisdiction

Courts may exercise general jurisdiction over defendants

whose contacts with the forum are “continuous and substantial,”

thus rendering the defendant “at home” in the forum state. Barth

v. Walt Disney Parks & Resorts U.S., Inc., 697 F. App’x 119 (3d

Cir. 2017), cert. denied, 138 S. Ct. 987, 119 (2018); Radio,

2019 WL 1437981, at *20. A defendant corporation is at home in

its state of incorporation and principal place of business.

Barth, 697 F. App’x at 119. In addition, a corporation may be at

home in a state where its activities are so substantial as to

render it at home in that state. Id. (“Also, in ‘exceptional

case[s], ... a corporation’s operations in a [different] forum .

. . may be so substantial and of such a nature as to render the

corporation at home in that State.’”). Crucially, general

jurisdiction does not turn on whether the defendant’s activities

that give rise to the suit are connected to the forum. Radio,

2019 WL 1437981, at *20 (“General jurisdiction exists where a

nonresident’s contacts with the forum are ‘continuous and

substantial,’ thus permitting the court to exercise jurisdiction

‘regardless of whether the subject matter of the cause of action

has any connection to the forum.’”).

In determining whether the corporation’s operations render

it at home in the forum state, Courts consider several factors,

including: whether the defendant is qualified or licensed to do

business in the forum state; whether it has ever conducted

business in the forum state; whether it has offices or places of

business in the forum state; and whether it owns assets in the

forum state. Barth v. Walt Disney Parks & Resorts U.S., Inc.,

206 F. Supp. 3d 1026, 1030 (E.D. Pa. 2016), aff’d, 697 F. App’x

119 (3d Cir. 2017). See also Simeone, 360 F. Supp. 2d at 671.

Notably, even conducting substantial business in the forum state

is inadequate to render the corporation at home in that state.

Barth, 206 F. Supp. 3d at 1031 (“‘The allegation that an entity

transacts business, even substantial business, in Pennsylvania

is insufficient to establish that it is essentially “at home” in

Pennsylvania.’”).

Here, both Plaintiff and Mission contend that Mission “is a

corporation organized under the laws of the State of Texas, with

its principal place of business in San Antonio, Texas.” (Doc.

No. 1 ¶21; Doc. No. 41 at 10.) Thus, the question here is

whether “this is an exceptional case,” Barth, 206 F. Supp. 3d at

1030, where Mission’s activities in Pennsylvania are “‘so

substantial and of such a nature as to render the corporation at

home in that State.’” Barth, Inc., 697 F. App’x at 120.

Here, Plaintiff alleges that Mission has registered with

Pennsylvania’s Department of Health under The Controlled

Substance, Drug, Device and Cosmetic Act, (Doc. No. 50 at 53;

id., Ex. 10); that Mission “employs sales representatives or

agents within Pennsylvania,” (id. at 53); that the outdoor

signage on Alamo’s location in Doylestown, Pennsylvania also

says “Mission Pharmacal,” (id. at 55); that Mission’s website

calls the Doylestown location “Mission’s commercial office,”

(id.); and that some Mission employees physically work in

various offices in Pennsylvania, (id. at 56.). Plaintiff alleges

that Mission describes itself on its website as a

“pharmaceutical company based in Pennsylvania and Texas.” (Id.,

Ex. 17.)

However, establishing general jurisdiction in a forum where

the defendant is neither incorporated nor has its principal

place of business is an uphill battle. For instance, in BNSF Ry.

Co. v. Tyrrell, 137 S. Ct. 1549 (2017), the Supreme Court held

that Montana courts did not have general jurisdiction over a

defendant that had “over 2,000 miles of railroad track and more

than 2,000 employees in Montana.” BNSF, 137 S. Ct. at 1559.

Accordingly, we find that Plaintiff has not sufficiently

demonstrated that Mission is at home in Pennsylvania for

purposes of general jurisdiction.

d. Specific Jurisdiction

When general jurisdiction is lacking, the Court may have

specific jurisdiction over a defendant whose contacts with the

jurisdiction give rise to the suit. Radio, 2019 WL 1437981, at

*21 (“In the absence of general jurisdiction, a court may

exercise specific jurisdiction where a three-part test is met .

. . .”). There are three requirements for a Court to have

specific jurisdiction over a defendant: “(1) ‘the defendant must

have “purposefully directed [its] activities” at the forum’; (2)

‘the litigation must “arise out of or relate to” at least one of

those activities’; and (3) ‘. . . the exercise of jurisdiction

otherwise “comport[s] with fair play and substantial justice.”

Id.

i. Purposefully Direct Activities at Forum

A defendant’s “single purposeful act,” UHS of Delaware,

Inc. v. United Health Servs., Inc., 2013 WL 12086321, at *6

(M.D. Pa. Mar. 26, 2013), can create specific jurisdiction. Id.

(“The Supreme Court and the Third Circuit Court of Appeals have

found that a single purposeful act may be sufficient to support

specific jurisdiction when it creates a ‘substantial connection’

that satisfies the requirements of due process . . . .”).

According to nonbinding but persuasive authority from the

Middle District of Pennsylvania, getting a license from the

Pennsylvania Department of Health and Safety, and “then doing

business under that license,” id., is sufficient to establish “a

substantial connection,” id., to Pennsylvania. Id.

(“Pennsylvania law forbids any entity from supplying home care

services without first obtaining a license from the Pennsylvania

Department of Health and Safety. 28 Pa. Code § 611.2. Clearly,

[Defendant] PHCI formed a substantial connection through the act

of obtaining a license to provide home care and later doing

business under that license. PHCI’s procurement of the license

constitutes an explicit availment of the benefits and privileges

of doing business in the Commonwealth. PHCI would therefore have

had every expectation that it was forging a connection with the

state, precluding any suggestion that the contact is ‘random,

fortuitous, or attenuated.’”).

The Court in UHS, 2013 WL 12086321 was further convinced of

the defendant’s substantial contacts with Pennsylvania because

the defendant “then . . . [did] business under that license,”

id. at *6, and earned “some, albeit limited, revenues in

Pennsylvania under this license.” Id. (“That [Defendant] PHCI

has actually transacted business, generating some, albeit

limited, revenues in Pennsylvania under this license further

substantiates the connection . . . . These contacts are

emblematic of the Burger King axiom that specific jurisdiction

attaches where ‘the defendant purposefully avails itself of the

privilege of conducting activities with the forum state, thus

invoking the benefits and protections of its law.’”).

Similar to the defendant in UHS, 2013 WL 12086321, Mission

is licensed with the Pennsylvania Department of Health. (Doc.

No. 50 at 53; id., Ex. 10.) The parties do not dispute that

Mission has actually employed agents or representatives in

Pennsylvania. (Id. at 53; Doc. No. 41 at 11.) Thus, Mission has

purposefully directed its activities at Pennsylvania.

ii. The Litigation Must Arise from Those Activities

Additionally, the litigation must arise out of those

activities directed at the forum. See Radio, 2019 WL 1437981, at

*21. Here, Plaintiff contends that litigation arose out of

Mission’s actions of employing a Mission Pennsylvania employee –

the Vice President of Corporate Business Development - who: (1)

served as the “point of contact” for the allegedly

anticompetitive contract between Mission and Retrophin; (2)

“confirmed receipt of the signed contract;” and (3) “coordinated

substantial portions of the agreement.” (Doc. No. 50 at 62.)

Additionally, Mission concedes that “details [were] worked out

by a Mission employee who operates out of the Doylestown[,

Pennsylvania] office . . . .” (Doc. No. 41 at 14.) On the other

hand, Plaintiff concedes that at least some “in-person

negotiations” occurred outside of Pennsylvania. (Doc. No. 50 at

62.) Mission contends that: (1) the contract was negotiated

outside of Pennsylvania, (Doc. No. 41 at 14); (2) “no meetings

[about the contract] were ever held in Pennsylvania,” (id.); and

(3) the contract “was signed by Mission” outside of

Pennsylvania, (id.) It appears that, at minimum, key aspects of

the allegedly anticompetitive contract were coordinated by a

relatively high-ranking Mission employee in Pennsylvania. We

find that Plaintiff has carried its burden of proving that this

suit arises out of Defendant’s conduct of employing a

Pennsylvania employee who coordinated in creating the allegedly

anticompetitive contract. See Radio, 2019 WL 1437981, at *21.

iii. Due Process Clause

When the defendant has sufficient minimum contacts with the

forum, subjecting the defendant to suit in the forum usually

comports with the Due Process Clause. Burger King Corp. v.

Rudzewicz, 471 U.S. 462, 477 (1985) (“[W]here a defendant who

purposefully has directed his activities at forum residents

seeks to defeat jurisdiction, he must present a compelling case

that the presence of some other considerations would render

jurisdiction unreasonable.”). Courts focus on several factors in

determining where the Due Process Clause allows personal

jurisdiction. Id. at 476-77. The factors include: (1) “‘the

burden on the defendant,’ [2] ‘the forum State’s interest in

adjudicating the dispute,’ [3] ‘the plaintiff’s interest in

obtaining convenient and effective relief,’ [4] ‘the interstate

judicial system’s interest in obtaining the most efficient

resolution of controversies,’ and [5] the ‘shared interest of

the several States in furthering fundamental substantive social

policies.’” Id. at 477.

Though Mission is at home in Texas, it has multiple

employees in Pennsylvania, so the burden of litigating in

Pennsylvania would not violate the Due Process Clause.

Pennsylvania has an interest in the anticompetitive conduct of

Pennsylvania employees. While the Plaintiff is allegedly a

Virginia entity, Virginia is not so far as to render litigating

in Pennsylvania – Plaintiff’s chosen forum – inconvenient and

ineffective for Plaintiff for purposes of the Due Process

Clause. Interstate judicial interests in efficiency point

towards a finding of specific jurisdiction because the claims

against two of Mission’s co-Defendants will proceed in this

forum. Accordingly, we find that exercising specific

jurisdiction over Mission comports with the Due Process Clause.

See id.

Thus, we find that this Court has specific jurisdiction

over Mission. Accordingly, we deny Defendant Mission’s Motion to

Dismiss for lack of personal jurisdiction under Rule 12(b)(2).

See Burger King, 471 U.S. at 477.

II. Defendant Shkreli

a. General Jurisdiction

Plaintiff does not argue that this Court has general

jurisdiction over Shkreli. (Doc. No. 50 at 50.) Thus, we will

not address general jurisdiction as to Shkreli.

b. Specific Jurisdiction

In determining jurisdiction over an individual employee,

Courts should evaluate the employee’s contacts, not their

employer’s contacts. Calder v. Jones, 465 U.S. 783, 790 (1984).

Additionally, Plaintiff does not allege that Retrophin’s acts

should be imputed to Shkreli. (Doc. No. 50 at 51.) Thus, we

evaluate whether Shkreli’s contacts are sufficient to establish

personal jurisdiction.

Plaintiff alleges that Shkreli signed the allegedly

anticompetitive agreement on behalf of Retrophin, (Doc. No. 1

¶20); “pushed through the negotiations,” (Doc. No. 50 at 51);

and was personally “involved in negotiating the Agreement . . .

.”, (id. at 5. See also Doc. No. 1 ¶27.) Under Element Fin.

Corp. v. ComQi, Inc., 52 F. Supp. 3d 739, 746-47 (E.D. Pa.

2014), the record is insufficient to determine whether Shkreli’s

conduct regarding the contract could establish specific

jurisdiction over Shkreli.

c. Jurisdictional Discovery

Plaintiff requests jurisdictional discovery in the event

that we find that Plaintiff has not shown personal jurisdiction

as to Defendant Shkreli. (Doc. No. 50 at 62, n.50.) Courts allow

jurisdictional discovery, rather than dismissal under 12(b)(2),

when: (1) plaintiff alleges “with reasonable particularity”

facts that support jurisdiction and (2) plaintiff’s claim is not

“clearly frivolous.” Toys “R” Us, Inc. v. Step Two, S.A., 318

F.3d 446, 456 (3d Cir. 2003) (“[C]ourts are to . . . allow[]

jurisdictional discovery unless the plaintiff’s claim is

‘clearly frivolous.’ . . . . If a plaintiff presents factual

allegations that suggest ‘with reasonable particularity’ the

possible existence of the requisite ‘contacts’ . . . the

plaintiff’s right to conduct jurisdictional discovery should be

sustained. Where the plaintiff has made this required threshold

showing, courts within this Circuit have sustained the right to

conduct discovery before the district court dismisses for lack

of personal jurisdiction.”).

As to Defendant Shkreli, Plaintiff’s claim does not appear

frivolous. Thus, instead of dismissing Plaintiff’s claims

against Defendant Shkreli for lack of personal jurisdiction, we

stay Defendant Shkreli’s Motion to Dismiss under Rules 12(b)(2)

and 12(b)(6) for a period of ninety days to allow for limited

jurisdictional discovery on the question of whether this Court

may exercise specific jurisdiction over Shkreli.

III. Defendant Alamo

If a defendant litigates the merits of a complaint before

contesting personal jurisdiction, that defendant has consented

to personal jurisdiction in that forum. Richard v. U.S. Airways,

Inc., 2011 WL 248446, at *1 (E.D. Pa. Jan. 26, 2011) (“Personal

jurisdiction is a right that may be waived . . . . a party may

consent to personal jurisdiction if he or she ‘actually

litigates the underlying merits . . . .’”).

Though Defendants Mission and Alamo filed a joint Motion to

Dismiss, (Doc. No. 41), in which Mission contends that this

Court lacks personal jurisdiction over Mission under Rule

12(b)(2), (Doc. No. 41 at 8, 17), Mission and Alamo contest only

the personal jurisdiction of Mission and do not contest the

personal jurisdiction of Alamo, (id.). Thus, Alamo has not moved

to dismiss Plaintiff’s Complaint under Rule 12(b)(1) on grounds

that this Court lacks personal jurisdiction over Alamo, (id.),

and Alamo has litigated the merits of Plaintiff’s claims (see

Doc. No. 41). Accordingly, Alamo has consented to personal

jurisdiction in this forum.

IV. Defendant Retrophin

Like Alamo, Defendant Retrophin has not moved to dismiss

Plaintiff’s Complaint under Rule 12(b)(2) for lack of personal

jurisdiction (Retrophin’s Motion to Dismiss, Doc. No. 42; Doc.

No. 42-1) and has briefed the merits, (Doc. No. 42-1). Thus,

Retrophin has consented to personal jurisdiction in this forum.

Motions to Dismiss Under Fed. R. Civ. P. 12(b)(6) for Failure

to State a Claim

Under 12(b)(6), “[t]he Court may grant a motion to dismiss

for failure to state a claim upon which relief can be granted

under Rule 12(b)(6) if, ‘accepting all well-pleaded allegations

in the complaint as true, and viewing them in the light most

favorable to the plaintiff, plaintiff is not entitled to

relief.’” Ballentine, 486 F.3d at 810.

Unlike factual attacks under Rule 12(b)(1), in determining

motions to dismiss for failure to state a claim, Courts should

consider only “the complaint, exhibits attached to the

complaint, matters of public record, as well as undisputedly

authentic documents if the complainant’s claims are based upon

these documents.” Mayer v. Belichick, 605 F.3d 223, 230 (3d Cir.

2010). See also Witasick v. Minnesota Mut. Life Ins. Co., 803

F.3d 184, 192 (3d Cir. 2015).

To survive a motion to dismiss under 12(b)(6), the

complaint must contain sufficient factual matter accepted as

true “to state a claim that is plausible on its face.” Ashcroft

v. Iqbal, 556 U.S. 662, 697 (2009) (quoting Bell Atlantic Corp.

v. Twombly, 550 U.S. 544, 570 (2007)). Courts are to take as

true all of the factual allegations in the complaint and the

reasonable inferences that can be drawn from those facts.

Witasick, 803 F.3d at 192; Ethypharm S.A. Fr. v. Abbott

Laboratories, 707 F.3d 223, 225, n.1 (3d Cir. 2013).

Lastly, though defendants face a more difficult standard on

12(b)(6) motions to dismiss antitrust cases, “[t]he facts

underlying the elements of an antitrust claim must be pled with

specificity.” Brotech Corp. v. White Eagle Int’l Techs. Grp.,

Inc., 2004 WL 1427136, at *3 (E.D. Pa. June 21, 2004). Courts

should disregard “legal conclusions and ‘[t]hreadbare recitals

of the elements of a cause of action, supported by mere

conclusory statements . . . .” Ethypharm, 707 F.3d at 231, n.14.

Count I - Mandatory Injunctive Relief Pursuant to 15 U.S.C. § 26

and Fed. R. Civ. P. 65 Against All Defendants

For the reasons described above in the section addressing

the mootness of Plaintiff’s claims for injunctive relief, we

grant Defendants’ Motions to Dismiss as to Count I with leave to

amend.

Count II - Monopolization and/or Attempted Monopolization Under

Sherman Act Section 2 Against Defendant Retrophin; Count III -

Conspiracy to Monopolize Under Sherman Act Section 2 Against All

Defendants; and Count IV - Contract in Restraint of Trade Under

Sherman Act Section 1 Against All Defendants

I. Antitrust Standing

Defendants Retrophin, Mission, and Alamo argue that

Plaintiff lacks prudential standing to bring suit under

antitrust laws. Separate from Article III’s constitutional

standing, antitrust standing is a judge-made doctrine that

focuses on “whether the plaintiff is a proper party to bring

[the] private antitrust action.” In re Wellbutrin XL Antitrust

Litig. Indirect Purchaser Class, 868 F.3d 132, 163-64 (3d Cir.

2017), judgment entered sub nom. In re Wellbutrin XL Antitrust

Litig., 2017 WL 3529114 (3d Cir. Aug. 9, 2017); Suboxone, 64 F.

Supp. 3d at 696.

First, in order to have antitrust standing, the private

plaintiff must demonstrate that it has suffered an antitrust

injury, which is “an injury of the type the antitrust laws were

intended to prevent and that flows from that which makes [the]

defendants’ acts unlawful.” Wellbutrin, 868 F.3d at 163–64

(internal quotations omitted). See also Roxane Labs., Inc. v.

SmithKline Beecham Corp., 2010 WL 331704, at *2 (E.D. Pa. Jan.

26, 2010) (“Plaintiff must show proof of some damage resulting

from the unlawful behavior; a plaintiff ‘need not exhaust all

possible alternative sources of injury.’”).

Additionally, in light of the procompetitive purpose of

antitrust laws, Courts must also consider the injury from the

consumer’s perspective, such as the impact on pricing, quantity,

and quality of the goods in the product market. Brotech, 2004 WL

1427136, at *4.

Second, the Court must consider the defendant’s allegedly

anticompetitive conduct. Roxane, 2010 WL 331704, at *2.

Third, there must be a material causal connection between

the defendant’s allegedly unlawful conduct and the plaintiff’s

harm. Id. (“Whether a defendant may be held liable for a

plaintiff’s injury requires courts to evaluate the plaintiff’s

harm, the alleged wrongdoing by the defendants, and the

relationship between them . . . . This inquiry is a component of

antitrust standing . . . . As part of showing antitrust

standing, a private plaintiff must demonstrate . . . that the

defendant’s alleged unlawful conduct was a material cause of

injury to its business or property.”) (internal quotations

omitted).

Additionally, when the defendant argues that plaintiff’s

injury results from a reason other than defendant’s allegedly

illegal conduct, Courts must determine that the allegedly

unlawful conduct, rather than the alternative reason, has caused

plaintiff’s harm. In re Wellbutrin SR/Zyban Antitrust Litig.,

281 F. Supp. 2d 751, 756 (E.D. Pa. 2003) (“When a defendant

relies upon the existence of an independent cause, however, such

cause ‘must be examined closely to make sure that it is the

independent cause, rather than the illegal antitrust action,

that gives rise to the plaintiff’s injury.’”).

Further, potential competitors must show “intention and

preparedness to enter the market.” Roxane, 2010 WL 331704, at *3

(“A plaintiff who was a “potential” competitor during the time

of the alleged unlawful behavior - in other words, a competitor

who had not yet entered the market - must demonstrate intention

and preparedness to enter the market in order to show injury . .

. . If a plaintiff cannot show it was ready to enter the market,

‘there is unlikely to be any plausible evidence to show that

defendants impeded this effort . . . .’ If a plaintiff was

unprepared to enter the market, then the defendant’s behavior

was not a but-for cause of plaintiff’s inability to enter the

market.”); Brotech, 2004 WL 1427136, at *5-6 (On a motion to

dismiss, “[a] competitor . . . that has not yet entered the

market may also suffer injury[,] but courts require a potential

competitor to demonstrate both its intention to enter the market

and its preparedness to do so . . . .”) (internal quotations

omitted).

In order to show “intention and preparedness,” the

plaintiff must prove: (1) that plaintiff had the background and

experience to enter the market; (2) that plaintiff had the

financial ability to enter the market; and, (3) most

importantly, that plaintiff took affirmative actions to enter

the market. Roxane, 2010 WL 331704, at *3; Brotech, 2004 WL

1427136, at *5-6 (On a motion to dismiss, “[t]he following

factors are considered to be sufficient indicia of preparedness

to enter the market: adequate background and experience in the

new field, sufficient financial capability to enter it, and the

taking of actual and substantial affirmative steps toward entry,

such as the consummation of relevant contracts and procurement

of necessary facilities and equipment.”) (internal quotations

omitted). Additionally, when the market entrant seeks FDA

approval, whether the market entrant alleges either that the FDA

is likely to approve its product or that it believes that the

FDA is likely to approve its product is a “significant factor.”

Roxane, 2010 WL 331704, at *4 (stating that “the probability of

FDA approval [is] . . . one significant factor to recognize

within the intent and preparedness standard.”); id. at *4, n.3

(“[T]here is little substantive difference between a plaintiff

generic manufacturer alleging in a complaint that FDA approval

was probable versus alleging that it anticipated that FDA

approval was probable. Further, a claimant can sufficiently show

intention and preparedness to enter a market with an allegation

that is framed subjectively, assuming such a belief is

accompanied by other factual allegations which in fact show

intent and preparedness.”); Brotech, 2004 WL 1427136, at *6 (“As

the Amended Complaint does not allege facts establishing . . .

that FDA approval of said products is probable, the Court finds

that . . . the Amended Counterclaim is insufficient to state an

antitrust injury.”). See also Andrx Pharm., Inc. v. Biovail

Corp. Int’l, 256 F.3d 799, 807 (D.C. Cir. 2001) (“Biovail did

not explicitly allege that it was prepared to bring a generic

version . . . to market or that it anticipated FDA approval . .

. . Based on Biovail’s failure to plead sufficient intent and

preparedness to enter the market, the district court dismissed

Biovail’s antitrust counterclaim.”).

In Roxane, 2010 WL 331704, the Court held that the

plaintiff, a potential competitor who alleged that defendant’s

anticompetitive behavior delayed plaintiff’s entry into the

market of Flonase brand name and generic nasal sprays, had

satisfied the “intent and preparedness” requirement during the

motion to dismiss stage. Id. at *4. Specifically, the Court

focused on the fact that: plaintiff “is a longstanding generic

drug manufacturer with over 20 years of experience marketing

generic drugs in the United States . . . and possessed a

familiarity with the FDA approval process,” id.; plaintiff had

taken affirmative actions to enter the market, such as

submitting an ANDA, manufacturing the generic at issue in

anticipation of approval, and possessing “manufacturing and

distribution networks in place at the relevant time,” id.; and

plaintiff had “alleged that it reasonably believed that FDA

approval was probable . . . , and that it intended to enter the

market at this time.” Id.

In Brotech, 2004 WL 1427136, the Court dismissed

counterclaim-plaintiff’s complaint because counterclaim-

plaintiff – a potential competitor – had not sufficiently

alleged “intent and preparedness.” Id. at *5-6. Specifically,

the Court pointed out that counterclaim-plaintiff did not allege

how the FDA would categorize the devices using its product - a

key factor that would impact the regulatory requirements of FDA

approval; how much FDA review of such devices was necessary

prior to marketing; how much plaintiff had done to get FDA

approval of products incorporating its compound; when plaintiff

anticipated FDA approval; whether FDA approval was likely; and

whether plaintiff would be prepared to enter the relevant market

once the FDA had granted approval. Id. at *6. Counterclaim-

plaintiff’s allegations that it was seeking FDA approval and

that FDA approval was required were, alone, insufficient to

allege antitrust standing. Id. See also Roxane, 2010 WL 331704,

at *4.

Plaintiff’s claim rises or falls on whether Plaintiff

sufficiently pleads “intent and preparedness” in the Complaint,

Complaint’s exhibits, matters of public record, and undisputedly

authentic documents. See Mayer, 605 F.3d at 230. See also

Witasick, 803 F.3d at 192.

Here, Plaintiff has failed to allege explicitly that the

FDA is likely to approve its product or, alternatively, that

Plaintiff believes that the FDA is likely to approve its

product. Plaintiff’s Exhibit A describes average FDA approval

times, (Doc. No. 50, Ex. A Part 1 at 24-25), and the Complaint

both describes the process of securing FDA approval under the

ANDA process and states that FDA approval is required. (Doc. No.

1 ¶69 (“[B]efore Spring can market any generic version of

Thiola, it must receive approval from the FDA that its proposed

generic product is indeed ‘bioequivalent’ to Thiola. Such

approval is conditioned on bioequivalence testing that requires

that Spring obtain samples of Thiola.”); id. ¶35 (“Then, once

the generic manufacturer demonstrates bioequivalence and secures

regulatory approval, including an ‘AB’ rating from the FDA - a

designation conveying that the generic alternative has satisfied

bioequivalence standards - the generic version becomes subject

to ‘automatic substitution’ laws in effect in most states,

including Pennsylvania. These substitution laws require or allow

pharmacists to substitute the AB-rated generic version of a

product for the brand product, unless the prescribing physician

specifically requests otherwise.”).) However, as in Brotech,

2004 WL 1427136 - where the Court held that alleging FDA

approval was both required and requested was insufficient to

allege antitrust standing - Plaintiff’s allegations that FDA

approval is required, along with a description of the ANDA

approval process, are likewise insufficient to establish “intent

and preparedness.” (See Doc. No. 1, Ex. A Part 1 at 24-25; id.

¶35); Brotech, 2004 WL 1427136, at *6. See also Andrx, 256 F.3d

at 807; Roxane, 2010 WL 331704, at *4.

Additionally, Plaintiff has not adequately plead that it

has taken sufficient affirmative steps to enter the market.

Here, Plaintiff alleges in the Complaint that Plaintiff, or its

founders, have (1) attempted to obtain Thiola samples, (Doc. No.

1 ¶¶70-76), had “discussions with pharmaceutical manufacturers,

laboratories, and consultants regarding the development of a

generic version of Thiola,” (id. ¶78), “been in negotiations

with multiple, experienced . . . CDMOs . . . regarding product

development and manufacturing,” (id.), “reached an agreement

with one CDMO to perform the necessary development work once

Spring is able to acquire the Thiola samples required to advance

the work,” (id.), and had “discussions with expert consultants

who will assist with the necessary regulatory processes that

will be required to obtain approval of its generic version of

Thiola,” (id. ¶79).

While the definition of sufficient affirmative steps is not

precise, Plaintiff is clearly unlike the Roxane, 2010 WL 331704

plaintiff, who had submitted an ANDA and manufactured the

generic at issue in anticipation of approval. Id. at *4.

Additionally, unlike the Roxane, 2010 WL 331704 plaintiff, it is

unclear from the Complaint and exhibits whether Plaintiff here

has established sufficient manufacturing and distribution

networks because Plaintiff, in its Complaint, seems to allege

only one agreement and states without much detail that Plaintiff

had “discussions” without explaining how these discussions and

agreement constitute sufficient manufacturing and distribution

networks. (Doc. No. 1 ¶¶78-79.) See also Roxane, 2010 WL 331704,

at *4. Further, Brotech, 2004 WL 1427136 suggests that “relevant

contracts” must be consummated in order to establish “intent and

preparedness,” id. at *5. Here, while Plaintiff alleges that it

has an agreement with a CDMO to complete the necessary

development work once Plaintiff obtains the needed samples,

(Doc. No. 1 ¶78), and has sought samples of Thiola for

bioequivalency testing, (id. ¶¶ 70-76), it is not clear whether

any other relevant contracts would be needed to reach FDA

approval and whether Plaintiff has started the process of

securing those contracts.

Because Plaintiff has not adequately plead affirmative

steps to enter the market or that FDA approval is probable,

Plaintiff here has not established its “intent and preparedness”

to enter the market. See Roxane, 2010 WL 331704, at *4; Brotech,

2004 WL 1427136, at *6. See also Andrx, 256 F.3d at 807.

Accordingly, we grant Defendant Retrophin’s Motion to

Dismiss Count II (monopolization and attempted monopolization

under Sherman Act Section 2 against Defendant Retrophin) and

Defendant Retrophin’s, Mission’s, and Alamo’s Motions to Dismiss

Count III (conspiracy to monopolize under Sherman Act Section 2

against all Defendants) and Count IV (contract in restraint of

trade under Sherman Act Section 1 against all Defendants). We

grant leave to amend.

Count V - Unfair Competition Under Pennsylvania Common Law

Against All Defendants

Plaintiff and Defendants Retrophin, Mission, and Alamo

contend that Count V (unfair competition under Pennsylvania

common law) is analogous to the federal antitrust claims. (Doc.

No. 42-1 at 41; Doc. No. 45; Doc. No. 50 at 33.) Thus, because

Plaintiff has failed to establish antitrust standing, we

likewise dismiss Count V with leave to amend.

Count VI - Unjust Enrichment Under Pennsylvania Common Law

Against All Defendants

Unjust enrichment under Pennsylvania common law is

available when: “(1) one party confers a benefit on the

recipient, (2) the recipient appreciates that benefit, and (3)

the recipient accepts and retains the benefit under such

circumstances that it would be inequitable or unjust for the

recipient to retain the benefit without payment.” Southeastern.

Pennsylvania Transp. Auth. v. Gilead Scis., Inc., 102 F. Supp.

3d 688, 704–05 (E.D. Pa. 2015). See also Stutzle v. Rhone-

Poulenc S.A., 2003 WL 22250424, at *1 (Pa. Com. Pl. Sept. 26,

2003).

Courts do not permit antitrust plaintiffs to end run

Pennsylvania’s antitrust common law with claims under

Pennsylvania’s unjust enrichment common law. See Stutzle, 2003

WL 22250424, at *2 (“Moreover, to allow plaintiffs to use a

claim for unjust enrichment as a means for collecting damages

which are not allowable by Pennsylvania’s antitrust law, is not

a proper use of the claim and can only lead to mischief.”). See

also Steamfitters Local Union No. 420 Welfare Fund v. Philip

Morris, Inc., 171 F.3d 912, 937 (3d Cir. 1999) (“We can find no

justification for permitting plaintiffs to proceed on their

unjust enrichment claim once we have determined that the

District Court properly dismissed the traditional tort claims

because of the remoteness of plaintiffs’ injuries from

defendants’ wrongdoing.”). See also Suboxone, 64 F. Supp. 3d at

703-04, 710 (“In any event, because I have previously found that

the End Payors have stated a claim for a violation of

Pennsylvania’s consumer protection law, I do not find that

allowing an unjust enrichment claim would provide an end-run

around the Pennsylvania legislature’s determination.”).

As described above in our analysis on Plaintiff’s federal

antitrust claims, Plaintiff here has failed to allege a claim

for unjust enrichment, especially in the absence of successful

antitrust claims.

Thus, we likewise dismiss Count VI with leave to amend.

Conclusion

We deny Defendants Retrophin’s, Mission’s, and Alamo’s Rule

12(b)(1) Motions to Dismiss for lack of subject matter

jurisdiction as to monetary relief and grant said Motions as to

injunctive relief with leave to amend. We grant without

prejudice Defendants Retrophin’s, Alamo’s, and Mission’s Motions

to Dismiss under 12(b)(6) for failure to state a claim as to all

Counts, and we grant leave to amend. See Andrx, 256 F.3d at 808.

We deny Defendant Mission’s Motion to Dismiss for lack of

personal jurisdiction under Rule 12(b)(2). We stay Defendant

Shkreli’s Motion to Dismiss for a period of ninety days to allow

for limited jurisdiction discovery on the question of whether

this Court has specific jurisdiction over Shkreli. An

appropriate Order follows.