Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-casd-3_11-cv-01061/USCOURTS-casd-3_11-cv-01061-0/pdf.json

Nature of Suit Code: 410
Nature of Suit: Antitrust
Cause of Action: 15:1125 Trademark Infringement (Lanham Act)

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1

 Because Amylin filed its complaint and supporting under seal, the TRO did not “issue” for

purposes of Federal Rule of Civil Procedure 65 until May 25, 2011. (Order, June 6, 2011, ECF No.

42.)

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UNITED STATES DISTRICT COURT

SOUTHERN DISTRICT OF CALIFORNIA

AMYLIN PHARMACEUTICALS, INC.,

Plaintiff,

CASE NO. 11-CV-1061 JLS (NLS)

ORDER: (1) VACATING

TEMPORARY RESTRAINING

ORDER; (2) DENYING

PLAINTIFF AMYLIN

PHARMACEUTICALS, INC.’S

MOTION FOR PRELIMINARY

INJUNCTION

(ECF Nos. 6, 14)

vs.

ELI LILLY AND COMPANY,

Defendant.

Presently before the Court is Plaintiff Amylin Pharmaceuticals, Inc.’s (Amylin) ex parte

motion for temporary restraining order (TRO) and order to show cause for preliminary injunction.

(Mot., ECF No. 6.) On May 25, 2011, the Court signed a TRO enjoining Defendant Eli Lilly and

Company (Lilly) from engaging in certain acts regarding its promotion and sale of Boehringer

Ingelheim GmbH’s (BI) linagliptin product, Tradjenta, and ordered Lilly to show cause why a

preliminary injunction should not issue.1

 (TRO, May 23, 2011, ECF No. 14.) After further briefing,

the Court held a preliminary injunction hearing on June 2, 2011. (Minute Order, June 2, 2011, ECF

No. 41.) Upon careful consideration of the written submissions and counsel’s arguments, the Court

VACATES the TRO and DENIES Amylin’s request for a preliminary injunction.

BACKGROUND AND LEGAL STANDARD

The Court’s Order granting in part Amylin’s motion for temporary restraining order set forth

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2

 To the extent that the TRO was premised on a presumption of irreparable harm (TRO 4), the

Court repudiates that premise. See Am. Trucking Ass’ns v. City of L.A., 559 F.3d 1046, 1052 (9th Cir.

2009).

3

 With respect Amylin’s claim for breach of the collaboration agreement’s confidentiality

provision (Bradbury Decl. Ex. 1, at § 6.1, ECF Nos. 6-3 to -6), Amylin concedes that primarily

misuse—as opposed to improper disclosure—is at issue at the preliminary injunction stage (TRO Hr’g

Tr. 111, ECF No. 43).

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the relevant factual background and applicable legal standard. (TRO 1–2.) In the interest of brevity,

that Order’s factual summary and legal standard are incorporated by reference here.

ANALYSIS

The governing standard requires the Court to first determine whether Amylin will suffer

irreparable harm in the absence of a preliminary injunction. Winter v. Natural Res. Def. Council, Inc.,

555 U.S. 7, 129 S. Ct. 365, 374 (2008). Under Winter, Amylin “must establish that irreparable harm

is likely, not just possible, in order to obtain a preliminary injunction.”2 Alliance for the Wild Rockies

v. Cottrell, 632 F.3d 1127, 1131 (9th Cir. 2011). “‘Irreparable harm is the single most important

prerequisite for the issuance of a preliminary injunction. . . . Accordingly, the moving party must first

demonstrate that such injury is likely before other requirements for the issuance of an injunction will

be considered.’” Freedom Holdings, Inc. v. Spitzer, 408 F.3d 112, 114 (2d Cir. 2005) (alteration in

original) (quoting Rodriguez ex rel. Rodriguez v. DeBuono, 175 F.3d 227, 233–34 (2d Cir. 1999)).

“[E]conomic injury alone does not support a finding of irreparable harm, because such injury

can be remedied by a damage award.” Rent-A-Center, Inc. v. Canyon Television & Appliance Rental,

Inc., 944 F.2d 597, 603 (9th Cir. 1991) (citing L.A. Memorial Colliseum Comm’n v. Nat’l Football

League, 634 F.2d 1197, 1202 (9th Cir. 1980)); accord Cal. Pharmacists Ass’n v. Mawell-Jolly, 563

F.3d 847, 852 (9th Cir. 2009) (“[E]conomic damages are not traditionally considered irreparable

because the injury can be later remedied by a damage award.”). However, intangible injuries, such

as damage to goodwill, Rent-A-Center, 944 F.2d at 603, or loss of prospective customers, Stuhlbarg

Int’l Sales Co. v. John D. Brush & Co., 240 F.3d 832, 841 (9th Cir. 2001), may constitute irreparable

harm. Here, Amylin contends that it will suffer two types of irreparable harm in the absence of a

preliminary injunction against Lilly’s use of a single sales force to sell Amylin’s product, Byetta, and

Tradjenta: (1) harm attributable to Lilly’s misuse of Amylin’s confidential information3

 and (2) loss

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of prospective customers and goodwill. (PI Reply 9–12, ECF No. 36.)

First, Amylin has failed to establish that it will suffer any irreparable injury from any misuse

of its confidential information. Although Amylin asserts that Lilly’s sales representatives will misuse

Amylin’s confidential information (see Mihalik Decl. ¶ 27, ECF No. 6-2; Bradbury Decl. ¶ 81), this

assertion is entirely the product of speculation on Amylin’s part. “Speculative injury does not

constitute irreparable injury sufficient to warrant granting a preliminary injunction.” Carribean

Marine Servs. Co. v. Baldrige, 844 F.2d 668, 674 (9th Cir. 1988). Further, as explained below, that

federal law prohibits Lilly’s sales representatives from falsely describing Byetta undercuts Amylin’s

assertion that they would misuse Amylin’s confidential information to do so. And in any event, any

losses attributable to Lilly’s misuse of Amylin’s confidential information—as distinguished from

actual disclosure—are fully compensable in damages. See Faiveley Transport Malmo AB v. Wabtec

Corp., 559 F.3d 110, 118–19 (2d Cir. 2009) (“Where a [trade secret] misappropriator seeks only to

use those secrets—without further dissemination or irreparable impairment of value—in pursuit of

profit . . . an award of damages will often provide a complete remedy for such an injury.”).

Second, Amylin has failed to show that a loss of prospective customers and goodwill is likely

to occur absent a preliminary injunction. This is because pertinent Food and Drug Administration

regulations prohibit Lilly’s sales representatives from making any statement regarding Byetta without

adequate supporting data, including comparative statements between Byetta and Tradjenta. (See

Drezin Decl. ¶¶ 13–20, ECF No. 11-1; Conterno Decl. ¶ 12, ECF No. 11-6.) Contrary to Amylin’s

assertion, Lilly’s sales representatives cannot “tell[] customers not to use Byetta until exhausting oral

treatments” or disparage Byetta without violating federal law. (TRO Reply 9, ECF No. 34; see also

Mihalik Decl. ¶ 31 (“Lilly will . . . irreparably harm sales of exenatide by falsely asserting that

exenatide is situated toward the end of the continuum of care . . . .”); Bradbury Decl. ¶ 78 (“By

invoking a so-called ‘injection barrier’ . . . Lilly is falsely describing the nature, characteristics and

attributes of exenatide. These false descriptions will irreparably harm Amylin’s reputation, sales and

goodwill.”); Mahmood Decl. ¶ 38, ECF Nos. 6-10 to -12 (“Lilly now proposes to market Byetta as

a ‘third line’ treatment to be used only after oral treatments, such as Tradjenta, have been

exhaused.”).) Amylin has offered no concrete evidence that Lilly’s sales representatives would risk

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 That treble damages are available for Amylin’s antitrust claim bolsters the conclusion that

money damages would remedy any potential harm to Amylin. See 15 U.S.C. § 15.

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FDA sanctions to maximize sales of Tradjenta. Thus, the Court cannot conclude that Amylin is likely

to lose prospective customers and goodwill simply because Lilly’s sales representatives will sell

Byetta and Tradjenta from the “same bag.”

Finally, Amylin has failed to show that money damages would not suffice to remedy any

potential harm. As Lilly’s economic expert explains:

To the extent that Amylin would suffer from the alleged actions, the resulting loss

would take the form of profits on lost exenatide sales. Losses of this nature are

generally calculable through the use of standard economic analyses undertaken in the

calculation of economic harm generally and, specifically, in antitrust actions. This is

true both for any Byetta sales and profits as well as any Bydureon-related losses.4

(Addanki Decl. ¶ 34, ECF No. 11-3.) Although Plaintiff cites several cases holding that “‘intangible

injuries, such as damage to goodwill, can constitute irreparable harm’” (PI Reply 11 (emphasis added)

(citing Ticketmaster LLC v. RMG Techs, Inc., 507 F. Supp. 2d 1096, 1115 (C.D. Cal. 2007)), neither

Plaintiff nor Plaintiff’s economic expert points to any evidence that seriously refutes Dr. Addanki’s

conclusion that, in this case, any potential harm is quantifiable. (See generally Dick Decl., ECF No.

6-7.) The Court has no reason to doubt the veracity of this conclusion.

Amylin has failed to make the requisite “clear showing” that it is entitled to preliminary

injunctive relief. Winter, 129 S. Ct. at 376. Because Amylin has failed to show that it is likely to

suffer irreparable harm in the absence of preliminary relief, the Court need not address the remaining

elements of the preliminary injunction standard. Ctr. for Food Safety v. Vilsack, 636 F.3d 1166, 1174

(9th Cir. 2011); Oakland Tribune, Inc. v. Chronicle Publ’g Co., 762 F.2d 1374, 1376 (9th Cir. 1985).

CONCLUSION

For the reasons stated, Amylin’s motion for a preliminary injunction is DENIED. The TRO

issued on May 25, 2011 is HEREBY VACATED.

IT IS SO ORDERED.

DATED: June 8, 2011

Honorable Janis L. Sammartino

United States District Judge

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