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Ddurie@Durietangri.Com Steve@Hilliardshadowenlaw.Com MARK A Case 5:19-cv-02573-SVK Document 1 Filed 05/14/19 Page 1 of 136 1 DURIE TANGRI LLP HILLIARD & SHADOWEN LLP DARALYN J. DURIE (SBN 169825) STEVE D. SHADOWEN (pro hac vice pending) 2 [email protected] [email protected] MARK A. LEMLEY (SBN 155830) ROBERT C. HILLIARD (pro hac vice pending) 3 [email protected] [email protected] DAVID McGOWAN (SBN 154289) RICHARD BRUNELL (pro hac vice pending) 4 [email protected] [email protected] LAURA E. MILLER (SBN 271713) MATTHEW C. WEINER (pro hac vice pending) 5 [email protected] [email protected] W. HENRY HUTTINGER (SBN 312843) FRAZAR W. THOMAS (pro hac vice pending) 6 [email protected] [email protected] 217 Leidesdorff Street NICHOLAS W. SHADOWEN (pro hac vice pending) 7 San Francisco, CA 94111 [email protected] Telephone: (415) 362-6666 1135 W. 6th Street, Suite 125 8 Facsimile: (415) 236-6300 Austin, TX 78703 Telephone: (855) 344-3298 9 (see additional counsel on next page) Facsimile: (361) 882-3015 10 Attorneys for Plaintiffs Peter Staley, Steve Fuller, Gregg S. Gonsalves, PhD, Brenda Emily Goodrow, Andrew R. Spieldenner, PhD, Robert J. Vazquez, 11 Jason Walker, Michael Warner, Jacob Zydonis, Fraternal Order of Police, Fort Lauderdale Lodge 31, Insurance Trust Fund, and Service Employees 12 International Union, Local No. 1 Health Fund 13 IN THE UNITED STATES DISTRICT COURT 14 FOR THE NORTHERN DISTRICT OF CALIFORNIA 15 PETER STALEY; STEVE FULLER; GREGG S. GONSALVES, PhD; BRENDA EMILY GOODROW; 16 ANDREW R. SPIELDENNER, PhD; ROBERT J. VAZQUEZ; JASON WALKER; MICHAEL 17 WARNER; JACOB ZYDONIS; FRATERNAL ORDER OF POLICE, FORT LAUDERDALE 18 LODGE 31, INSURANCE TRUST FUND; and SERVICE EMPLOYEES INTERNATIONAL Case No. 3:19-cv-2573 19 UNION, LOCAL NO. 1 HEALTH FUND, on behalf of themselves and all others similarly situated. 20 CLASS ACTION COMPLAINT Plaintiffs, 21 v. DEMAND FOR JURY TRIAL 22 GILEAD SCIENCES, INC.; GILEAD HOLDINGS, 23 LLC; GILEAD SCIENCES, LLC; GILEAD SCIENCES IRELAND UC; BRISTOL-MYERS 24 SQUIBB COMPANY; E. R. SQUIBB & SONS, L.L.C.; JAPAN TOBACCO, INC.; JAPAN 25 TOBACCO INTERNATIONAL U.S.A., INC.; AKROS PHARMA INC.; JANSSEN R&D 26 IRELAND; and JOHNSON & JOHNSON, INC., 27 Defendants. 28 30 31 CLASS ACTION COMPLAINT / CASE NO. 3:19-CV-2573 32 Case 5:19-cv-02573-SVK Document 1 Filed 05/14/19 Page 2 of 136 1 HAGENS BERMAN SOBOL SHAPIRO LLP STEVE W. BERMAN (pro hac vice pending) 2 [email protected] THOMAS M. SOBOL (pro hac vice pending) 3 [email protected] KRISTEN A. JOHNSON (pro hac vice pending) 4 [email protected] GREGORY T. ARNOLD (pro hac vice pending) 5 [email protected] 55 Cambridge Parkway, Suite 301 6 Cambridge, MA 02142 Telephone: (617) 482-3700 7 Facsimile: (617) 482-3003 8 RADICE LAW FIRM, P.C. JOHN RADICE (pro hac vice pending) 9 [email protected] DAN RUBENSTEIN (pro hac vice pending) 10 [email protected] 475 Wall Street 11 Princeton, NJ 08540 Telephone: (646) 245-8502 12 Facsimile: (609) 385-0745 13 SHEPHERD, FINKELMAN, MILLER & SHAH, LLP JAYNE A. GOLDSTEIN (pro hac vice pending) 14 [email protected] 1625 North Commerce Parkway, Suite 320 15 Fort Lauderdale, FL 33326 Telephone: (954) 515-0123 16 Facsimile: (866) 300-7367 17 SHEPHERD, FINKELMAN, MILLER & SHAH, LLP 18 NATALIE FINKELMAN BENNETT (pro hac vice pending) [email protected] 19 MICHAEL OLS (pro hac vice pending) [email protected] 20 35 E. State Street Media, PA 19063 21 Telephone: (610) 891-9880 Facsimile: (866) 300-7367 22 23 SPERLING & SLATER, P.C. PAUL E. SLATER (pro hac vice pending) 24 [email protected] EAMON P. KELLY (pro hac vice pending) 25 [email protected] ALBERTO RODRIGUEZ (pro hac vice pending) 26 [email protected] 55 West Monroe, Suite 3200 27 Chicago, IL 60603 Telephone: (312) 641-3200 28 Facsimile: (312) 641-6492 30 31 CLASS ACTION COMPLAINT / CASE NO. 3:19-CV-2573 32 Case 5:19-cv-02573-SVK Document 1 Filed 05/14/19 Page 3 of 136 1 TABLE OF CONTENTS 2 I. INTRODUCTION ...........................................................................................................................3 3 II. JURISDICTION AND VENUE ......................................................................................................7 4 III. INTRADISTRICT ASSIGNMENT.................................................................................................8 5 IV. THE PARTIES.................................................................................................................................8 6 V. SCIENCE BACKGROUND ..........................................................................................................13 7 VI. REGULATORY BACKGROUND ...............................................................................................19 8 A. Approval of Generic Drugs and Substitution of Generics for Branded Drugs ..................19 9 B. The Hatch-Waxman Amendments .....................................................................................20 10 C. Paragraph IV Certifications ...............................................................................................21 11 D. Approvals Under 21 U.S.C. § 355(b)(2) ............................................................................22 12 E. New Chemical Entity Exclusivity ......................................................................................23 13 F. Effects of AB-Rated Generic Competition ........................................................................24 14 VII. DEFENDANTS’ ANTICOMPETITIVE CONDUCT ..................................................................25 15 A. Unlawful No-Generics Restraints: Gilead and Japan Tobacco ..........................................26 16 B. Unlawful No-Generics Restraints: Gilead and BMS .........................................................29 17 C. Unlawful No-Generics Restraints: Gilead and Janssen .....................................................34 18 D. Increased Prices and Reduced Innovation .........................................................................40 19 1. The No-Generics Restraints increased prices. .......................................................40 20 2. The No-Generics Restraints reduced innovation. ..................................................44 21 E. Gilead’s Unlawful Degrading of Stribild ...........................................................................54 22 F. Gilead’s Unlawful Degrading of Standalone TAF ............................................................55 23 1. Gilead anticompetitively withheld standalone TAF in 2015-2016. .......................56 24 2. Gilead anticompetitively withheld standalone TAF 10mg. ...................................57 25 3. Gilead anticompetitively withheld an HIV indication for standalone TAF. ..........59 26 4. Gilead degraded standalone TAF with anticompetitive purpose and effect. .........60 27 G. Gilead’s Unlawful Regulatory Gaming .............................................................................63 28 1. TAF is vulnerable to generic competition in May 2023. .......................................64 30 1 CLASS ACTION COMPLAINT / CASE NO. 3:19-CV-2573 31 32 Case 5:19-cv-02573-SVK Document 1 Filed 05/14/19 Page 4 of 136 1 2. Gilead withheld an HIV indication in order to impair competition. ......................66 2 H. Gilead’s Anticompetitive Conduct to Delay Entry of Generic Viread, Truvada, and Atripla ................................................................................................................................68 3 1. Most-Favored-Entry and Most-Favored-Entry-Plus clauses delay generic 4 entry. ......................................................................................................................69 5 2. Gilead used MFEs and MFEPs to delay generic entry. .........................................71 6 VIII. MARKET POWER ........................................................................................................................78 7 IX. MARKET EFFECTS .....................................................................................................................87 8 X. ANTITRUST IMPACT AND EFFECT ON INTERSTATE AND INTRASTATE COMMERCE .................................................................................................................................89 9 XI. CLASS ACTION ALLEGATIONS ..............................................................................................90 10 XII. ONGOING AND FUTURE HARM ..............................................................................................93 11 XIII. CLAIMS FOR RELIEF .................................................................................................................96 12 XIV. DEMAND FOR JUDGMENT .....................................................................................................131 13 XV. JURY DEMAND .........................................................................................................................133 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 30 2 CLASS ACTION COMPLAINT / CASE NO. 3:19-CV-2573 31 32 Case 5:19-cv-02573-SVK Document 1 Filed 05/14/19 Page 5 of 136 1 Plaintiffs, on behalf of themselves and all others similarly situated (the “Class,” as defined 2 below), on personal knowledge with respect to facts pertaining to them and upon information and belief 3 as to other matters, bring this class action complaint against Defendants Gilead Sciences, Inc., Gilead 4 Holdings, LLC, Gilead Sciences, LLC, Gilead Sciences Ireland
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