0001193125-11-150904.txt : 201105260001193125-11-150904.hdr.sgml : 2011052620110526061306ACCESSION NUMBER:0001193125-11-150904CONFORMED SUBMISSION TYPE:8-KPUBLIC DOCUMENT COUNT:8CONFORMED PERIOD OF REPORT:20110526ITEM INFORMATION:Other EventsITEM INFORMATION:Financial Statements and ExhibitsFILED AS OF DATE:20110526DATE AS OF CHANGE:20110526

FILER:

COMPANY DATA:COMPANY CONFORMED NAME:AMYLIN PHARMACEUTICALS INCCENTRAL INDEX KEY:0000881464STANDARD INDUSTRIAL CLASSIFICATION:PHARMACEUTICAL PREPARATIONS [2834]IRS NUMBER:330266089STATE OF INCORPORATION:DEFISCAL YEAR END:1231

FILING VALUES:FORM TYPE:8-KSEC ACT:1934 ActSEC FILE NUMBER:000-19700FILM NUMBER:11872533

BUSINESS ADDRESS:STREET 1:9360 TOWNE CENTRE DRSTREET 2:SUITE 110CITY:SAN DIEGOSTATE:CAZIP:92121BUSINESS PHONE:6195522200

MAIL ADDRESS:STREET 1:9360 TOWNE CENTRE DRSTREET 2:SUITE 110CITY:SAN DIEGOSTATE:CAZIP:92121

8-K1d8k.htmFORM 8-K

Form 8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

Current Report

Pursuant to Section13 or 15(d) of

the Securities Exchange Act of1934

Date of Report (Date of earliest event reported): May26, 2011

AMYLIN PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

Delaware0-1970033-0266089

(State or Other Jurisdiction

of Incorporation)

(Commission

File Number)

(I.R.S. Employer

Identification No.)

9360 Towne Centre Drive

San Diego, California 92121

(Address of principal executive offices and zip code)

Registrantstelephone number, including area code: (858)552-2200

Check the appropriate box belowif the Form 8K is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a12 under the Exchange Act (17 CFR 240.14a12)

Precommencement communications pursuant to Rule 14d2(b) under the Exchange Act (17 CFR 240.14d2(b))

Precommencement communications pursuant to Rule 13e4(c) under the Exchange Act (17 CRF 240.13e4(c))

Item8.01.Other Events.

OnMay26, 2011, Amylin Pharmaceuticals, Inc., or Amylin, announced that the United States District Court for the Southern District of California issued a temporary restraining order against Eli Lilly and Company, or Lilly, relating toAmylins litigation with respect to the collaboration agreement between Amylin and Lilly. The U.S. District Court restrained Lilly from proceeding with its plans to use the same sales force to sell exenatide and Boehringer Ingelheim GmbHslinagliptin. The court also enjoined Lilly from disclosing any confidential information about exenatide to any of its sales representatives or employees participating in the marketing, promotion or sale of linagliptin.

A complete copy of the courts order is attached as Exhibit 99.1 and is incorporated herein by reference. The briefing schedule setforth in the attached order is in the process of being modified based upon the courts availability.

Item9.01.Financial Statements and Exhibits.

(d)Exhibits.

Number

Description

99.1Order of the United States District Court for the Southern District of California, dated May 23, 2011.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

AMYLIN PHARMACEUTICALS, INC.

Dated: May 26, 2011

By:

/s/ HARRY J. LEONHARDT

Harry J. Leonhardt

Vice President, Legal and Governance, and Corporate Secretary

EXHIBIT INDEX

Number

Description

99.1Order of the United States District Court for the Southern District of California, dated May 23, 2011.

EX-99.12dex991.htmORDER OF THE U.S. DISTRICT COURT DATED MAY 23, 2011

Order of the U.S. District Court Dated May 23, 2011

Exhibit 99.1

Case 3:11-cv-01061-JLS-NLS *SEALED* Document 14 Filed 05/23/11 Page 1 of 6

UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF CALIFORNIA

AMYLIN PHARMACEUTICALS, INC.,

Plaintiff,

vs.

ELI LILLY AND COMPANY, Defendant.

CASE NO. 11CV1061 JLS (NLS)

ORDER 1) GRANTING INPART PLAINTIFFS MOTION FOR TEMPORARY RESTRAINING ORDER AND 2) SETTING DATE AND BRIEFING SCHEDULE FOR HEARING ON PRELIMINARY INJUNCTION

(Doc. No.6.)

Presently before the Court isPlaintiff Amylin Pharmaceuticals motion for temporary restraining order. (TRO Motion, ECF No.6.) Also before the Court is Defendant Eli Lilly and Companys opposition, (Oppn, ECF No.11), and Amylins reply. (Reply,ECF No. #.) After consideration, the Court GRANTS IN PART Plaintiffs motion for temporary restraining order.

BACKGROUND

Love triangles exist in the corporate world too. Playing the role of jilted lover is Plaintiff Amylin Pharmaceuticals, Inc. Defendant Eli Lilly and Company occupies the middle. Androunding out the trio is Boehringer Ingelheim GmbH. Framing the triangle is hundreds of millions of dollars and the world of diabetes Pharmaceuticals.

Amylin produces exenatide, a drug used to treat type 2 diabetes. The drug is currently marketed as Byetta, a twice-daily injectable anti-diabetic medication. Pending FDA approval,

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exenatide will also be marketed as Bydureon, a once-weekly injectable. In 2002 Amylin entered an alliance with Lillyto maximize the commercialization of pharmaceutical products containing or incorporating exenatide, whether in development or approved by any regulatory authority. (Co-Promotion Agreement 2.1, Bradbury Decl. Exhibit 2, ECF No.6-4.)

At the beginning of 2011, Lilly announced that it had entered an alliance with Boehringer to jointly developand commercialize a portfolio of diabetes compounds, including Boehringers linagliptin, a DPP-IV inhibitor used to treat type 2 diabetes. (Compl. U 63, ECF No.1.) This agreement may not have disturbed Amylin but for the fact thatlinagliptin is allegedly a direct competitor with Amylins exenatide.

For several months Amylin and Lillydiscussed the implications of the Boehringer-Lilly alliance. But as Boehringers product barreled closer to launch, the two were no closer to resolution. Amylin resorted to litigation. With its complaint, Amylin filed the present motion fortemporary restraining order. Amylin requests the Court temporarily restrain and enjoin Lilly and all those acting in concert with Lilly from: 1) disclosing any of Amylins confidential information to Boehringer; 2) utilizing the same salesforce to commercialize Amylins drug alongside Boehringers; and 3) falsely describing Amylins products to segment the market in type 2 diabetes drugs. (TRO Motion 1.)

LEGAL STANDARD

Temporary restraining orders are governed by the standard applicable to preliminary injunctions. A plaintiff seeking a preliminary injunction must establish that he is likely to succeed onthe merits, that he is likely to suffer irreparable harm in the absence of preliminary relief, that the balance of equities tips in his favor, and that an injunction is in the public interest. Winter v. Natural Res. Def. Council, Inc., 555 U.S. 7,129 S. Ct. 365, 374 (2008). Although all four factors must be met, they operate on a sliding scale. Under this approach, the elements of the preliminary injunction test are balanced, so that a stronger showing of one element may offset aweaker showing of another. Alliance for the Wild Rockies v. Cottrell, 632 F.3d 1127, 1131 (9th Cir. 2011). For example, a stronger showing of irreparable harm to plaintiff might offset a lesser showing of likelihood of success on themerits. Id. at 1135.

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Case3:11-cv-01061-JLS-NLS *SEALED* Document 14 Filed 05/23/11 Page 3 of 6

DISCUSSION

A. Likelihood of Success on the Merits

Plaintiffasserts multiple causes of action. But the Court discusses only the breach of contract claim, specifically breach of the confidentiality provision, here.

As part of the Amylin-Lilly alliance, Amylin and Lilly agreed to maintain each others confidences. This required both parties to maintain in confidence, and not disclose to anyperson or entity . the other Partys Confidential Information. (Collaboration Agreement 6.1 (a).) Confidential Information consists of all information, scientific, clinical, regulatory, marketing, financial, commercial, orotherwise. (Id. 1.7.)

Amylin argues that the Boehringer-Lilly alliance, as it is to beimplemented, would violate Amylin and Lillys confidentiality agreement. The Court agrees. Amylin has demonstrated a likelihood of success on the merits of this claim.

The core of this claim involves the sales representatives. Lilly organizes its diabetes sales force into sleeves. (Mihalik Decl. 11.) There are two such sleeves: thePrimary Care Physician sleeve and the Focus sleeve. (Id. 11-12.) The Primary Care sleeve contains 679 sales representatives and promotes Byetta in the second detail position.1 (Id.) The Focus sleeve has 95 salesrepresentatives and also details Byetta in the second position. (Id.)

The Amylin-Lilly alliance salesrepresentatives are provided with copious amounts of confidential Amylin information. This includes promotional strategy, direction and themes, along with specific promotional tools, e.g., studies and marketing materials, used to support theByetta marketing platform. (Mahmood Decl. 46, ECF No.6-10.) The sales representatives are also aware of strategies concerning sample distribution; consumer strategy, messaging and tools used to support patient initiation; andmessaging and tools utilized to handle objections to initiation and the maintenance of patients. (Id.)

With Boehringer entering the fray, Lilly will restructure its sales force. Lilly proposes four sleeves: PC-1, PC-2, PC-3, and Focus. (Mihalik Decl.17.) PC-1 will have 679 sales

1 The detail positions indicate the order in which products are discussed. A product in the second detail position isdiscussed second.

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representatives and will detail linagliptin and Byetta in the first and third positions, respectively. (Id. 18.) PC-2 willhave 45 representatives and will utilize the same product positions as PC-1. (Id. 19.) PC-3 will have 325 representatives and will detail Byetta and linagliptin in the second and third positions, respectively. And finally, Focus will include 95representatives. It will also promote Byetta and linagliptin, but the product positioning is not known. (Id. 21.)

Herein lies the problem. Sales representatives that were part of the Amylin-Lilly alliance, and privy to confidential Amylin information, will now play a part in the Boehringer-Lillyalliance and sell Boehringer-Lilly product. Under the circumstances, it seems impossible for Lilly to maintain in confidence Amylins confidential information.

Every piece of information that was used to promote and sell exenatide is now in the mind of a sales representative charged with promoting and selling linagliptin. Two salesrepresentatives can be walled off, but the mind of one cannot. In charging Amylin-Lilly sales representatives with duties under the Boehringer-Lilly banner, Lilly has essentially disclosed Amylins confidential information to a member of theBoehringer-Lilly alliance. The Court cannot expect a Boehringer-Lilly representative to ignore Amylin information when promoting Boehringer product. And Amylin certainly has an interest in controlling the release and use of confidential informationto a sales force promoting what it views as a competitive product. On this basis, the Court finds that Amylin has shown a likelihood of success on the merits of its breach of contract claim. B. Irreparable Harm

Amylins breach of confidentiality claim informs the irreparable harm it will suffer. If Lilly proceeds withits intended plan to sell linagliptin and exenatide using the same sales force, Amylin will immediately suffer the loss of invaluable confidential marketing and selling strategy information that has been developed with the express purpose ofcapturing market share from oral products such as [Boehringers] linagliptin. (Mahmood Decl. 45.) Such loss constitutes irreparable harm. See TMX Funding, Inc. v. Impero Technologies, Inc., 2010 WL 1028254, at *8 (N.D. Cal. March18,2010) (indicating that in the context of trade secrets, California courts have

presumed irreparable harmwhen proprietary information is misappropriated).

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C. Balance of Equities and Public Interest

The balance of equities and public interest also militates in favor of a temporary restraining order. Maintaining the status quo requires that sales representatives with Amylinsconfidential information not sell Boehringer product. But breaking the status quo is far more troublesome. It means releasing Amylins confidential information, without its permission, to sales representatives tasked with selling a competingproduct. The scales weigh in favor of maintaining the moment. As for the public interest, it is servedamong other thingsby ensuring the protection of confidential information and by ensuring the enforcement of contractual obligations.See Merrill Lynch, Pierce, Fenner& Smith Inc. v. Chung, 2001 WL 283083, at *6 (C.D. Cal. Feb. 2, 2001).

CONCLUSION

For the reasons stated, PlaintiffAmylin Pharmaceuticals, Inc.s application for a temporary restraining order is GRANTED.

IT IS HEREBYORDERED:

(1) The Court temporarily restrains and enjoins Defendant Eli Lilly and Company and all those actingin concert with Lilly and receiving notice of this Order, pending adjudication of Amylins preliminary injunction motion, from:

(a) Utilizing any sales representatives, or any other Lilly employees, who have received proprietary or confidential information about exenatide from participating in the marketing,promotion, and/or sale of Boehringer Ingelheim GmBHs linagliptin;

(b) Disclosing any of Amylinsconfidential information to Boehringer and/or to any sales representatives, or any other Lilly employees who will be participating in the marketing, promotion, and/or sale of Boehringers linagliptin.

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(2) A hearing to show cause why a preliminary injunction should not issue in this case is set for hearing on Tuesday,May31, 2011 at 9:30 a.m. in Courtroom 6 of the Edward J. Schwartz United States Courthouse, 940 Front Street, San Diego, California 92101. Defendants SHALL FILE an opposition to the imposition of a preliminary injunction not later thanWednesday, May25, 2011 at 4:30 p.m. Plaintiff may file a reply memorandum not later than Friday, May27, 2011 at 10:00 a.m. All briefing IS LIMITED to 15 pages.

(3) No bond is set at this time. The issue will be discussed at the preliminary injunction hearing.

IT IS SO ORDERED.

DATED: May23, 2011

/s/ Janis L. Sammartino

Honorable Janis L. Sammartino United States District Judge

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GRAPHIC3g194133g14l12.jpgGRAPHIC

begin 644 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