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IN RE NEXIUM (ESOMEPRAZOLE) ANTITRUST LITIGATION
CIVIL ACTION NO. 12-md-02409-WGY
UNITED STATES DISTRICT COURT FOR THE DISTRICT OF
MASSACHUSETTS
2013 U.S. Dist. LEXIS 129696
September 11, 2013, Decided
September 11, 2013, Filed
PRIOR HISTORY: In re Nexium (Esomeprazole)
and all others similarly situated, Consolidated Plaintiff: Antitrust Litig., 2013 U.S. Dist. LEXIS 10455 (D. Mass., Andrew J. Vasicek, David S. Nalven, Thomas M. Sobol, LEAD ATTORNEYS, Donna M. Evans, Hagens BermanSobol Shapiro LLP, Cambridge, MA; Kristen Johnson[*2] Parker, LEAD ATTORNEY, PRO HAC VICE, COUNSEL: [*1] For Allied Services Division Welfare
Hagens Berman Sobol Shapiro LLP, Cambridge, MA; Fund, Laborers International Union of North America Bruce E. Gerstein, Garwin Gerstein & Fisher LLP, New Local 17 Health Care Fund, Consolidated Plaintiffs: York, NY; Don Barrett, Barrett Law Office, Lexington, David B. Franco, LEAD ATTORNEY, PRO HAC VICE, MS; John D. Radice, Radice Law Firm, PC, Long Beach, The Dugan Law Firm, APLC, New Orleans, LA; Douglas R. Plymale, James R. Dugan, II, LEAD ATTORNEYS,The Dugan Law Firm, New Orleans, LA; Bruce E.
For Value Drug Company, Consolidated Plaintiff: Brian Gerstein, Garwin Gerstein & Fisher LLP, New York, D. Brooks, LEAD ATTORNEY, Smith Segura & NY; Glen DeValerio, Berman DeValerio, Boston, MA; Raphael LLP, New York, NY; Ephraim R. Gerstein, Thomas G. Shapiro, Shapiro Haber & Urmy LLP, LEAD ATTORNEY, PRO HAC VICE, Garwin Gerstein & Fisher LLP, New York, NY; Joseph Opper, LEADATTORNEY, PRO HAC VICE, Garwin, Bronzaft, For Laborers International Union of North America Local Gerstein & Fisher, New York, NY; Peter S. Pearlman, 35 Health Care Fund, Consolidated Plaintiff: Bruce E.
LEAD ATTORNEY, PRO HAC VICE, Cohn, Lifland, Gerstein, Garwin Gerstein & Fisher LLP, New York, Pearlman, Herrmann & Knopf, Saddle Brook, NJ; Russell NY; Glen DeValerio, Berman DeValerio, Boston, MA; Thomas G. Shapiro, Shapiro Haber & Urmy LLP, Heim Payne & Chorush LLP, Houston, TX; Susan C.
Segura, LEAD ATTORNEY, Smith Segura & Raphael,LLP, Alexandria, LA; Thomas M. Sobol, LEAD For A.F. of L. - A.G.C. Building Trades Welfare Plan, ATTORNEY, Donna M. Evans, Hagens Berman Sobol Shapiro LLP, Cambridge, MA; Elena Chan, PRO HAC Gerstein & Fisher LLP, New York, NY; Glen DeValerio, VICE, Garwin Gerstein & Fisher LLP, New York, NY.
For Burlington Drug Company Inc., Consolidated For American Sales Company, LLC, On behalf of itself Plaintiff: Brian D. Brooks, LEAD ATTORNEY, Smith Segura & Raphael LLP, New York, NY; Ephraim R.
Marcus, Moira E. Cain-Mannix, LEAD ATTORNEYS, Gerstein, LEAD ATTORNEY, PRO HAC VICE, Garwin Marcus & Shapira, Pittsburgh, PA; Brian C. Hill, Gerstein & Fisher [*3] LLP, New York, NY; Peter S.
Jonathan D. Marcus, LEAD ATTORNEYS, Marcus & Pearlman, LEAD ATTORNEY, PRO HAC VICE, Cohn, Lifland, Pearlman, Herrmann & Knopf, Saddle Brook,NJ; Russell A. Chorush, LEAD ATTORNEY, PRO HAC For Meijer, Inc., Meijer Distribution, Inc., Plaintiffs: VICE, Heim Payne & Chorush LLP, Houston, TX; Susan C. Segura, LEAD ATTORNEY, Smith Segura & ATTORNEYS, PRO HAC VICE, [*5] Vanek Vickers & Raphael, LLP, Alexandria, LA; Thomas M. Sobol, LEAD Masini PC, Chicago, IL; JAMES E. CECCHI, LEAD ATTORNEY, Donna M. Evans, Hagens Berman Sobol Shapiro LLP, Cambridge, MA; Elena Chan, PRO HAC BRODY & AGNELLO, P.C., ROSELAND, NJ; Linda P.
VICE, Garwin Gerstein & Fisher LLP, New York, NY.
Nussbaum, LEAD ATTORNEY, PRO HAC VICE, Grant& For Rochester Drug Co-Operative, Inc., On Behalf of itself and all others similarly situated, Consolidated OLSTEIN, BRODY & AGNELLO, ROSELAND, NJ; Plaintiff: Archana Tamoshunas, LEAD ATTORNEY, Thomas M. Sobol, LEAD ATTORNEY, Donna M.
Taus, Cebulash & Landau, LLP, New York, NY; Caitlin Evans, Hagens Berman Sobol Shapiro LLP, Cambridge, G. Coslett, Daniel C. Simons, David F. Sorensen, MA; Bruce E. Gerstein, Garwin Gerstein & Fisher LLP, New York, NY; Peter A. Barile, III, Grant & Eisenhofer, VICE, Berger & Montague, P.C., Philadelphia, PA; Eric L. Cramer, LEAD ATTORNEY, Berger & Montague PC,Philadelphia, For Fraternal Order of Police Miami Lodge 20 Insurance ATTORNEY, FARUQI & FARUQI, JENKINTOWN, Trust Fund, Plaintiff: Anne K. Fornecker, HILLIARD & PA; Peter Kohn, LEAD ATTORNEY, PRO HAC VICE, SHADOWEN LLC, AUSTIN, TX; Bruce E. Gerstein, Faruqi & Faruqi LLP, Jenkintown, PA; Thomas M.
Garwin Gerstein & Fisher LLP, New York, NY; Glen Sobol, LEAD ATTORNEY, Donna M. Evans, Hagens DeValerio, Berman DeValerio, Boston, MA; Jayne A.
Berman Sobol Shapiro LLP, Cambridge, MA; Bruce E.
Goldstein, Pomerantz Grossman Hufford Dahlstrom & Gerstein, Garwin Gerstein & Fisher LLP, New York, NY.
Gross, LLP, Weston, FL; Natalie Finkelman Bennett,Shepherd, Finkelman, Miller & Shah, LLP, Media, PA; For Laborers International [*4] Union of North America Local 345 Health Care Fund, On behalf of itself and all others similarly situated, Consolidated Plaintiff: DouglasR. Plymale, James R. Dugan, II, LEAD ATTORNEYS, For New York Hotel Trades Council and Hotel Assoc. of The Dugan Law Firm, New Orleans, LA; Frank R.
New York City, Inc. Health Benefits Fund, Plaintiff: Schirripa, LEAD ATTORNEY, PRO HAC VICE, Hach Rose Schirripa & Cheverie, LLP, New York, NY; Milstein Sellers & Toll PLLC, Washignton, DC; J.
Michael A London, LEAD ATTORNEY, Douglas & Douglas [*6] Richards, Sharon K. Robertson, LEAD London, New York, NY; Michael Aaron Rose, LEAD ATTORNEYS, PRO HAC VICE, Cohen Milstein Sellers ATTORNEY, Hach & Rose, New York, NY; Virginia E & Toll PLLC, New York, NY; Bruce E. Gerstein, Garwin Anello, LEAD ATTORNEY, Douglas & London, P.C., Gerstein & Fisher LLP, New York, NY; George Farah, New York, NY; Bruce E. Gerstein, Garwin Gerstein & PRO HAC VICE, Cohen Milstein, New York, NY; Glen DeValerio, Berman DeValerio, Boston, MA.
For Walgreen Co., The Kroger Co., Safeway Inc., For United Food Workers and Commercial Workers Supervalu, Inc., HEB GROCERY CO. LP, Consolidated Unions and Employers Midwest Health Benefits Fund, Plaintiffs: Anna T. Neill, LEAD ATTORNEY, PRO Plaintiff: Bethany R. Turke, Dawn M. Goulet, Edward A.
HAC VICE, Kenny Nachwalter, P.A., Miami, FL; Wallace, Justin N. Boley, Kenneth A. Wexler, LEAD ATTORNEYS, Kenny Nachwalter, P.A., Miami, FL.
LLP, Chicago, IL; Bruce E. Gerstein, Garwin Gerstein &Fisher LLP, New York, NY; Glen DeValerio, Berman For Giant Eagle, Inc, Consolidated Plaintiff: Bernard D.
DeValerio, Boston, MA; Jonathan Shapiro, Stern, Shapiro, Weissberg & Garin, Boston, MA; Kimberly A.
VICE, Budd Larner PC, Short Hills, NJ; Jonathan B.
Dougherty, Janet Jenner & Suggs, LLC, Boston, MA.
Berman, Kevin D. McDonald, Stephanie L. Resnik,LEAD ATTORNEYS, PRO HAC VICE, Jones Day, For Michigan Regional Council of Carpenters Employee Washington, DC; Andrew D. Lazerow, Covington & Benefits Fund, Plaintiff: Christopher M. Burke, LEAD ATTORNEY, PRO HAC VICE, Scott & Scott LLP, SanDiego, CA; Donald A. Broggi, LEAD ATTORNEY, For AstraZeneca LP, Defendant: Ashley E. Bass, Thomas PRO HAC VICE, Scott & Scott LLP, New York, NY; A. Isaacson, LEAD ATTORNEYS, PRO HAC VICE, Lisa J. Rodriguez, LEAD ATTORNEY, Rodriguez & Weingarten, John E. Schmidtlein, Paul B. Gaffney, PRO RODRIGUEZ & RICHARDS, LLP, HADDONFIELD, HAC VICE, Williams & Connolly LLP, Washington, NJ; Penelope Abdiel, [*7] LEAD ATTORNEY, PRO DC; Andrew D. Lazerow, PRO HAC VICE, Covington HAC VICE, Scott + Scott, Attorneys at Law, LLP, New & Burling LLP, Washington, DC; Dane H. Butswinkas, York, NY; Walter W. Noss, LEAD ATTORNEY, PRO PRO HAC VICE, Williams & Connolly, Washington, HAC VICE, Scott+Scott LLP, San Diego, CA; Bruce E.
DC; Michael P. Kelly, PRO HAC VICE, McCarter & Gerstein, Garwin Gerstein & Fisher LLP, New York, English LLP, Wilmington, DE; Nicholas W. Allen, NY; Glen DeValerio, Berman DeValerio, Boston, MA; William A. Zucker, McCarter & English, LLP, Boston, Joseph P. Guglielmo, Scott & Scott, LLP, New York, [*9] MA; Timothy C. Hester, Covington & Burling, For International Union of Machinists and Aerospace For RANBAXY LABORATORIES, LTD., Ranbaxy Inc., Workers District No. 15 Health Fund, Plaintiff: Brian D.
Ranbaxy Pharmaceuticals, Inc., Defendants: Lisa Jose Penny, LEAD ATTORNEY, PRO HAC VICE, Goldman Fales, Sarah Choi, LEAD ATTORNEYS, PRO HAC Scarlato Karon & Penny PC, Wayne, PA; Kevin P.
VICE, Danielle R. Foley, James Douglas Baldridge, Roddy, LEAD ATTORNEY, PRO HAC VICE, Wilentz, Venable LLP, Washington, DC; Andrew D. Lazerow, Goldman & Spitzer PA, Woodbridge, NJ; Bruce E.
Covington & Burling LLP, Washington, DC; Leslie F.
Gerstein, Garwin Gerstein & Fisher LLP, New York, NY; Glen DeValerio, Berman DeValerio, Boston, MA.
For Astrazeneca AB, Aktiebolaget Hassle, Defendants: For International Brotherhood Of Electrical Workers Local 595 Health And Welfare Fund, Plaintiff: Aaron D.
ATTORNEYS, PRO HAC VICE, Andrew D. Lazerow, Covington & Burling LLP, Washington, DC; Adam R.
Leonard Carder LLP, Oakland, CA; Christina C. Sharp, Tarosky, James H. Weingarten, John E. Schmidtlein, Paul LEAD ATTORNEY, PRO HAC VICE, Girard Gibbs B. Gaffney, PRO HAC VICE, Williams & Connolly LLP, San Francisco, CA; Daniel C. Girard, LEAD LLP, Washington, DC; Dane H. Butswinkas, PRO HAC ATTORNEY, PRO HAC VICE, Girard Gibbs & VICE, Williams & Connolly, Washington, DC; Michael DeBartolomeo LLP, San Francisco, CA; Bruce E.
P. Kelly, PRO HAC VICE, McCarter & English LLP, Gerstein, Garwin Gerstein & Fisher LLP, New York, Wilmington, DE; Timothy C. Hester, Covington & NY; Glen DeValerio, Berman DeValerio, Boston, MA.
For A.F. of L., [*8] Plaintiff: Bruce E. Gerstein, Garwin For Ranbaxy Laboratories, LTD, Defendant: James Gerstein & Fisher LLP, New York, NY; Glen DeValerio, Douglas Baldridge, Venable LLP, Washington, DC; Andrew D. Lazerow, Covington & Burling LLP,Washington, DC.
Laboratories, Inc., Defendants: Andrew J. Miller, LEAD For TEVA USA, INC., Teva Pharmaceutical Industries, ATTORNEY, Budd Larner PC, Short Hills, NJ; Brian T.
Ltd., Defendants: Adam L. Sisitsky, Laurence A. Schoen, Moriarty, LEAD ATTORNEY, Christopher K. Albert, LEAD ATTORNEYS, Mintz, Levin, Cohn, Ferris, [*10] Hamilton Brook Smith & Reynolds, P.C., Concord, MA; Glovsky & Popeo, PC, Boston, MA; Katie Einspanier, Ellen T. Lowenthal, LEAD ATTORNEY, PRO HAC Thea Cohen, LEAD ATTORNEYS, PRO HAC VICE, Kirkland & Ellis LLP, Washington, DC; Andrew D.
"indirect purchasers." See, e.g., Defs.' Mem.
Lazerow, Covington & Burling LLP, Washington, DC; Supp. Their Mot. Dismiss Indirect Purchasers' Christopher M. Jackson, Karen N. Walker, Rebecca A.
Consol. Am. Compl. (Dkt. No. 114) Pursuant Koch, PRO HAC VICE, Kirkland & Ellis LLP, Fed. Rule Civil Procedure 12(b)(6), ECF No. 156.
Washington, DC; Jay P. Lefkowitz, PRO HAC VICE, Kirkland & Ellis LLP, New York, NY.
appellation to be more apt than the latter.
2 For Value Drug Company, Burlington Drug Company following charges against the Defendants: (1) Inc., Interested Parties: Bruce E. Gerstein, Garwin Gerstein & Fisher LLP, New York, NY; Elena Chan, Sherman Act section 2, 15 U.S.C. § 2, against PRO HAC VICE, Garwin Gerstein & Fisher LLP, New AstraZeneca [*12] and Ranbaxy; (2) conspiracy to monopolize, in violation of Sherman Actsection 2, against AstraZeneca and Teva; (3) JUDGES: WILLIAM G. YOUNG, DISTRICT JUDGE.
Sherman Act section 2, against AstraZeneca and OPINION BY: WILLIAM G. YOUNG
Dr. Reddy's; (4) agreement in restraint of trade, inviolation of Sherman Act section 1, 15 U.S.C. § 1, against AstraZeneca and Ranbaxy; (5) agreementin restraint of trade, in violation of Sherman Actsection 1, against AstraZeneca and Teva; (6) agreement in restraint of trade, in violation of I. INTRODUCTION
Sherman Act section 1, against AstraZeneca andDr. Reddy's; (7) monopolization, in violation of A group of wholesale drug distributors (the "Direct Sherman Act section 2, against AstraZeneca; (8) Purchasers") and health and welfare benefit funds (the attempt to monopolize, in violation of Sherman "End-Payors" 1) (collectively, the "Plaintiffs"), on behalf Act section 2, against AstraZeneca; (9) agreement of themselves and all others similarly situated, brings this in restraint of trade, in violation of Sherman Act multidistrict, putative class action against AstraZeneca section 1, against all of the Defendants; and (10) (collectively, "AstraZeneca"), Ranbaxy Pharmaceuticals, Sherman Act section 2, against all of the Inc., Ranbaxy Inc., and Ranbaxy Laboratories Ltd.
Defendants. See Consol. Am. Compl. & Demand Jury Trial ¶¶ 166-234, ECF No. 131.
Industries, Ltd. and Teva Pharmaceuticals USA, Inc.
(collectively, Laboratories Ltd. and Dr. Reddy's Laboratories, Inc.
consolidated complaint have set forth state-based (collectively, "Dr. Reddy's") (collectively, with Ranbaxy claims for relief that are largely analogous to the and Teva, the "Generic Defendants") (collectively, with Direct Purchasers' federal claims, as well as a AstraZeneca, the "Defendants") for alleged violations of state and federal antitrust laws. 2 Specifically, the under sections 1 and 2 of the Sherman Act and Plaintiffs contend that AstraZeneca and each of the three injunctive relief under section 16 of the Clayton Act, 15 U.S.C. § 26. See Corrected Consol. Am.
agreements to keep generic versions of AstraZeneca's Class Action Compl. & Demand Jury Trial ¶¶ heartburn medication --sold under the brand name Nexium -- out of the market, thereby facilitating the The Defendants filed five motions to dismiss the extraction of supracompetitive rents by virtue of Plaintiffs' claims under Federal Rule of Civil Procedure AstraZeneca's artificially secured monopoly market 12(b)(6) ("Rule 12(b)(6)"). The key issues in these motions can be subdivided into two groups: those relating to the Direct Purchasers and those relating to the End-Payors are alternatively referred to as End-Payors. With respect to the Direct Purchasers, the Defendants argue that (1) the exclusionary conduct at agreements. Therefore, although the Court has no reason Nexium-related patents, so no action for antitrust liability to modify its judgment with respect to the Defendants' may lie; and (2) even if antitrust liability would otherwise motion to dismiss the Direct Purchasers' claims, the attach to the Defendants' conduct, (a) the doctrine of recent arrival of Actavis compels the Court to adjust its Noerr-Pennington renders the challenged agreements rationale in light of that opinion. Finally, armed with immune from antitrust scrutiny and (b) the Direct additional briefing supplied by the parties, the Court is Purchasers' challenge to the particular agreement between now prepared to rule on the Rule 23 standing and Illinois AstraZeneca and Ranbaxy is time-barred under the law issues left unaddressed at the motion hearing.
relevant federal statute of limitations. With respect to theEnd-Payors, the Defendants argue that (1) the applicable A. Procedural Posture
The End-Payors filed a consolidated complaint on End-Payors' claims with respect to the agreement February 1, 2013, Corrected Consol. Am. Class Action between AstraZeneca and Ranbaxy; (2) the End-Payors lack standing under both Article III and Federal Rule of Compl."), ECF No. 114, after the Court was called upon Civil Procedure 23 ("Rule 23") to bring their claims; and to intercede in a dispute over which of the parties' (3) the End-Payors' claims brought under the antitrust attorneys would serve as lead class counsel, see In re laws of eight states (Arizona, Illinois, Mississippi, New York, South Dakota, Tennessee, Utah, and West 12-md-02409-WGY, 2013 U.S. Dist. LEXIS 10455, 2013 Virginia) and Puerto Rico and the consumer protection WL 326215 (D. Mass. Jan. 24, 2013). One month later, statutes of two states (Massachusetts and North Carolina) on March 1, 2013, the Defendants filed their motion to dismiss the End-Payors' consolidated complaint, Defs.' Mot. Dismiss Indirect Purchasers' Consol. Am. Compl., dismissed on the same grounds as those proffered memorandum of law, Defs.' Mem. Supp. Their Mot.
in their motion to dismiss the Direct Purchasers.
Dismiss Indirect Purchasers' Consol. Am. Compl. (Dkt.
No. 114) Pursuant Fed. Rule Civil Procedure 12(b)(6) Indirect Purchasers' Consol. Am. Compl. (Dkt.
("Defs.' Mot. Dismiss End-Payors"), ECF No. 156. The No. 114) Pursuant Fed. Rule Civil Procedure End-Payors filed their memorandum in opposition to the 12(b)(6), at 2-4, ECF No. 156. Because of their Defendants' motion to dismiss on March 22, 2013.
expressly duplicative nature, these grounds will End-Payor Class Pls' Mem. Opp'n Defs.' Mot. Dismiss ("End-Payor's Mem. Opp'n"), ECF No. 189. The memorandum dealing with the Direct Purchasers.
Defendants filed their reply to the End-Payors' opposition in further support of their motion on April 5, 2013. Defs.'Reply Mem. Further Supp. Their Mot. Dismiss Indirect At a motion hearing held on April 18, 2013, the Purchasers' Consol. Am. Compl. (Dkt. No. 114) Pursuant Court denied all of the Defendants' motions and asked for Fed. Rule Civil Procedure 12(b)(6) ("Defs.' Reply further briefing on the viability of the End-Payors' [*15] End-Payors"), [*17] ECF No. 208.
Rule 23 standing and claims under Illinois law. Uponreflection, however, the Court acknowledges that it may The Direct Purchasers, for their part, filed a have acted hastily on some of the matters presented and, consolidated complaint with this Court on February 21, therefore, takes the time here to revisit some of its earlier 2013. Consol. Am. Compl. & Demand Jury Trial ("Direct conclusions. Moreover, at the time of the motion hearing, Purchasers' Compl."), ECF No. 131. The following day, the parties -- and, quite frankly, the Court --were waiting each of the Defendants separately moved to dismiss the with bated breath for the Supreme Court's decision in Federal Trade Commission v. Actavis, 133 S. Ct. 2223, respective motions memoranda of law in support. Mot.
186 L. Ed. 2d 343, 2013 U.S. LEXIS 4545 (2013), which Dr. Reddy's Labs. Dismiss Direct Purchasers' Consol.
was anticipated to have significant implications for the Am. Compl., ECF No. 132; Mem. Supp. Mot. Dr.
instant case by resolving fundamental questions Reddy's Labs. Dismiss Direct Purchasers' Consol. Am.
AstraZeneca Defs.' Mot. Dismiss Direct Purchasers' Consol. Am. Compl., ECF No. 134; AstraZeneca Defs.' Mem. Supp. Their Mot. Dismiss Direct Purchasers' Consol. Am. Compl. (Dkt. No. 131) Pursuant Fed. RuleCivil Procedure 12(b)(6) ("AstraZeneca's Mem."), ECF At a motion hearing held on April 18, 2013, the No. 135; Teva Defs.' Mot. Dismiss, ECF No. 136; Teva Court denied all of the Defendants' motions, Elec. Clerk's Defs.' Mem. Supp. Its Mot. Dismiss Direct Purchaser Pls.' Notes, Apr. 18, 2013, ECF No. 218, and requested further Consol. Am. Compl. ("Teva's Mem."), ECF No. 137; briefing on the End-Payors' Rule 23 standing and claims Def. Ranbaxy's Mot. Dismiss Direct Purchasers' Consol.
under Illinois law, Mot. Hr'g Tr. 42:16-17, Apr. 18, 2013, Am. Compl., ECF No. 138; Def. Ranbaxy's Mem. Law ECF No. 216. Per the Court's instructions, the parties Supp. Its Mot. Dismiss Direct Purchasers' Consol. Am.
submitted briefs on these two issues on May 2, 2013.
Compl. ("Ranbaxy's Mem."), ECF No. 139. On March Defs.' Supplemental Mem. Supp. Their Mot. Dismiss [*18] 2013, the Direct Purchasers filed four Indirect Purchasers' Consol. Am. Compl. (Dkt. No. 114) memoranda in opposition to each of the Defendants' Pursuant Fed. Rule Civil Procedure 12(b)(6) motions to dismiss. 4 Direct Purchaser Class Pls.' Opp'n ("Defs.' Supplemental Mem."), ECF No. 223; End-Payor Dr. Reddy's Mot. Dismiss, ECF No. 167; Direct Class Pls.' Supplemental Mem. Opp'n Defs.' Mot.
Purchaser Class Pls.' Opp'n AstraZeneca's Mot. Dismiss Dismiss ("End-Payors' Supplemental Mem."), ECF No.
("Direct Purchasers' Opp'n AstraZeneca's Mot. Dismiss"), ECF No. 168; Direct Purchaser Class Pls.' Opp'n Teva's B. Regulatory and Transactional Background
Mot. Dismiss ("Direct Purchasers' Opp'n Teva's Mot.
Dismiss"), ECF No. 169; Direct Purchaser Class Pls.' 1. Hatch-Waxman Regime
Opp'n Ranbaxy's Mot. Dismiss ("Direct Purchasers'Opp'n Before a drug manufacturer may market a new drug AstraZeneca filed a reply in further support of its motion to the public, it must first seek the approval of the United to dismiss on March 29, 2013, AstraZeneca Defs.' Reply States Food and Drug Administration ("FDA") by filing a Mem. Further Supp. Mot. Dismiss Direct Purchasers' New Drug Application ("NDA") with the agency.
Consol. Am. Compl. (Dkt. No. 131) Pursuant Fed. Rule Actavis, 133 S. Ct. at 2228. The road to NDA approval is Civil Procedure 12(b)(6), ECF No. 194, and on April 1, long and fraught with expense, as the process requires 2013, the Generic Defendants followed suit, Reply Mem.
applicants to submit, inter alia, a description of the proposed drug's components and composition; reports on Purchasers' Consol. Am. Compl. ("Ranbaxy's Reply"), the safety and effectiveness of the drug; and an ECF No. 199; Reply Supp. Mot. Dr. Reddy's Labs.
explanation of how the drug will be manufactured, Dismiss Direct Purchasers' Consol. Am. Compl., ECF processed, and packaged. See 21 U.S.C. § 355(b)(1).
No. 200; Teva Defs.' Reply Mem. Supp. Their Mot.
Drugs that have been approved by the FDA are then Dismiss Direct Purchaser Pls.' Consol. Am. Compl., ECF listed in a publication known colloquially as the "Orange Book." See Approved Drug Products with TherapeuticEquivalence Evaluations (Orange Book), U.S. Food & The [*19] Direct Purchasers moved to file a single, consolidated memorandum in opposition to the Defendants' motions to dismiss, Direct ugs/ucm129662.htm (last updated Aug. 23, 2013).
Purchaser Pls.' Mot. File Single Consol. Mem.
Opp'n Four Mots. Dismiss, ECF No. 162, but the The Drug Price Competition and Patent Term Court denied their request, Elec. Order, Mar. 13, Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat.
2013, ECF No. 165. As a result, in an attempt to 1585 [*21] (codified as amended at 15, 21, 28, and 35 U.S.C.) -- known more commonly by its popular title, the Purchasers' four opposition memoranda respond "Hatch-Waxman Act," derived from the surnames of the to a different set of arguments raised in the Act's principal sponsors -- was passed with the express Defendants' motions. See Direct Purchaser Class purpose of expediting the entry of noninfringing generic Pls.' Opp'n AstraZeneca's Mot. Dismiss 8 n.24, competitors into pharmaceutical drug markets in order to decrease healthcare costs for consumers. See PLIVA, Inc. the FDA is disallowed from approving ANDAs from v. Mensing, 131 S. Ct. 2567, 2574, 180 L. Ed. 2d 580 competing generic manufacturers for the same drug. The (2011). Under the Hatch-Waxman Act, generic drug manufacturers wishing to market a generic version of a Modernization Act of 2003, Pub. L. No. 108-173, 117 brand-name drug need not undertake the extensive and Stat. 2066 (codified as amended at 26 and 42 U.S.C.), expensive NDA process; instead, they may file an however, provides a number of conditions under which a Abbreviated New Drug Application ("ANDA"). Actavis, first-filer can forfeit its eligibility for 180-day exclusivity, 133 S. Ct. at 2228. An ANDA must show that the generic see 21 U.S.C. § 355(j)(5)(D)(i)(I)-(VI), the most relevant drug contains the same active ingredients, route of of which for the purposes of this case is the so-called "failure-to-market" provision, see id. § 355(j)(5)(D)(i)(I).
brand-name drug, as well as demonstrate that the generic Once the first-filer forfeits its 180-day exclusivity, and brand-name drugs are bioequivalent. See 21 U.S.C. § however, no other generic applicant may enjoy such a 355(j)(2)(A)(ii)-(iv). In addition, an ANDA must contain benefit. See id. § 355(j)(5)(D)(iii)(II).
one of four certifications: (1) that no patent for thebrand-name drug has been filed, (2) that the patent for the 2. Authorized Generics and No-Authorized Generic
brand-name drug has expired, (3) that the generic Agreements
manufacturer will not seek to market its [*22] drug An authorized generic is essentially a brand-name before the expiration of the patent for the brand-name drug produced by a brand manufacturer but marketed drug, or (4) that the patent for the brand-name drug is under a generic label. See Sanofi-Aventis v. Apotex Inc., invalid or will not be infringed by the proposed generic 659 F.3d 1171, 1174 (Fed. Cir. 2011). [*24] Because alternative. Id. § 355(j)(2)(A)(vii). Choosing the last of approval to sell their brand-name drugs, they are free to launch authorized generics during the first-filer's 180-day infringement, and often means provoking litigation." 5 exclusivity window in an effort to recoup some of the Actavis, 133 S. Ct. at 2228 (citation omitted) (quoting monopoly profits that are inherently lost by generic Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 132 S. market entry. See id. at 1175; Fed. Trade Comm'n, Ct. 1670, 1677, 182 L. Ed. 2d 678 (2012)) (internal Authorized Generic Drugs: Short-Term Effects and If a generic manufacturer files a paragraph IV cdrugreport.pdf [hereinafter FTC Report on Authorized certification and a brand manufacturer files a Generics]. A brand manufacturer may, however, opt to patent infringement suit against the generic forgo its right to market an authorized generic by entering manufacturer within forty-five days of receiving into a "no-authorized generic" agreement with the notice of the paragraph IV certification, the FDA first-filer. See Erica N. Andersen, Note, Schering the will not grant final approval to the ANDA until Market: Analyzing the Debate over Reverse-Payment either thirty months have passed or a court has Settlements in the Wake of the Medicare Modernization issued a decision deeming the patent invalid or Act of 2003 and In Re Tamoxifen Citrate Litigation, 93 not infringed, whichever is earlier. See 21 U.S.C. Iowa L. Rev. 1015, 1063 (2008). Such agreements § 355(c)(3)(C); Eli Lilly & Co. v. Medtronic, Inc., commonly take the form of an exclusive license that 496 U.S. 661, 677-78, 110 S. Ct. 2683, 110 L. Ed. allows the first-filer to market a generic version of the 180-day exclusivity period. FTC Report on Authorized To encourage generic manufacturers to bring their drugs to market and assume the potential risk ofdefending [*23] against a patent infringement action, the C. Facts Alleged6
Because [*25] the facts alleged in the Direct exclusivity to the first generic manufacturer to file an Purchasers' and End-Payors' complaints largely ANDA containing a paragraph IV certification (the mirror one another, this Court here adopts the "first-filer"), 21 U.S.C. § 355(j)(5)(B)(iv), meaning that facts alleged in the latter and largely excludes parallel citation references to similar provisions in AstraZeneca's litigation against Ranbaxy: U.S. Patent No. 4,786,505 (the "'505 patent"); U.S.
Patent No. 4,853,230
(the "'230 patent"); U.S. 1. AstraZeneca's New Drug Application Filing
Patent No. 4,738,974 (the "'974 patent"); U.S.
Patent No. 5,690,960
[*27] (the "'960 patent"); On December 3, 1999, AstraZeneca filed NDA No.
U.S. Patent No. 5,900,424 (the "'424 patent"); 21-153, by which it sought FDA approval to market U.S. Patent No. 7,411,070 (the "'070 patent"); under the brand name Nexium a proton pump inhibitor U.S. Patent No. 6,147,103 (the "'103 patent"); ("PPI") containing esomeprazole magnesium as its active U.S. Patent No. 6,191,148 (the "'148 patent"); and ingredient. 7 End-Payors' Compl. ¶¶ 64-65. AstraZeneca U.S. Patent No. 6,166,213 (the "'213 patent"). Id.
received the FDA's approval for its NDA on February 20, 2001. Id. ¶ 65. In conjunction with its NDA, AstraZenecalisted fourteen patents in the FDA Orange Book as Although AstraZeneca initiated proceedings against relating to Nexium or a way of using Nexium. Id. ¶ 66.
Ranbaxy, the End-Payors allege that AstraZeneca faced ahigh likelihood that the patents under which AstraZeneca Nexium is recommended for individuals who sued would be invalidated once challenged by generic suffer from erosive esophagitis and symptomatic manufacturers. Id. This is because, the End-Payors' gastroesophageal reflux disease. See End-Payors' Nexium's active ingredient, is "prima facie obvious inlight of the prior art," id. ¶ 67 -- that is, it was obvious in 2. The Generics' Abbreviated Drug Application
light of the information that was already in the public domain, including AstraZeneca's prior PPI, Prilosec, or a. Ranbaxy's ANDA Filing
Four years later, the generic drug manufacturer allegation by making reference to collateral AstraZeneca that it sought to market generic versions of rulings of the European Patent Office in 2006 and Nexium. Id. ¶ 73. In addition to its notice, Ranbaxy 2011 in connection with two European Nexium included [*26] a certification pursuant to paragraph IV patents, in which the challenged patents were that stated that the commercial manufacture, use, and/or determined invalid on account of their failure to sale of any generic Nexium product would not infringe any of AstraZeneca's valid patents listed in the Orange requirement, the European equivalent [*28] of Book to the extent that they expired after October 2007.
the U.S. nonobviousness requirement. Id. ¶ 71.
b. Teva's ANDA Filing
In response, AstraZeneca filed proceedings in the Several months later, on January 26, 2006, Teva District Court for the District of New Jersey (the "New notified AstraZeneca that it had filed ANDA No. 78-003 Jersey District Court") on November 21, 2005, bringing and sought to market generic versions of Nexium, id. ¶ suit under the Hatch-Waxman Act. Id. ¶ 74. AstraZeneca 77; as part of Teva's notification, it also included a claimed that Ranbaxy's generic version of Nexium would paragraph IV certification stating that its intentions regarding generic manufacture would not infringe any of "'504 patent"); U.S. Patent No. 5,877,192 (the "'192 AstraZeneca's valid patents listed in the Orange Book, id.
patent"); U.S. Patent No. 6,875,872 (the "'872 patent");U.S. Patent No. 6,428,810 (the "'810 patent"); U.S. In response, AstraZeneca filed proceedings in the Patent No. 6,369,085 (the "'085 patent"); and U.S. Patent New Jersey District Court on March 8, 2006, bringing No. 5,948,789 (the "'789 patent") -- including five which suit under the Hatch-Waxman Act. Id. ¶ 78. AstraZeneca were listed in the Orange Book. 8 Id.
claimed that Teva's generic version of Nexium wouldinfringe five patents listed in the Orange Book. 10 Id.
8 The following nine other Nexium patents listedin the Orange Book did not form the basis of 10 AstraZeneca claimed Teva's generic Nexium would infringe the '504, '192, '872, '810, and '085 proceedings against Ranbaxy, and the court entered a patents. But AstraZeneca subsequently amended consent judgment (the same day that the thirty-month its complaint to withdraw its allegation that Teva stay on FDA approval of Ranbaxy's generic Nexium infringed the '810 patent and add an allegation that Teva infringed the '070 patent. Id. ¶ 78. Eightother Nexium patents listed in the Orange Book In consideration for Ranbaxy's agreeing to (1) admit (the '505, '230, '974, '960, '424, '103, '148, and that the '504, '192, '789, '872, '810, and '085 patents were enforceable and valid; (2) admit that Ranbaxy's generic AstraZeneca's litigation against Teva and would Nexium would infringe the '504, '192, '789, and '872 not [*29] have prevented Teva from entering the patents; and (3) delay the launch of its generic Nexium until May 27, 2014, AstraZeneca agreed to pay Ranbaxyover $1,000,000,000. Id. ¶¶ 91-92.
c. Dr. Reddy's ANDA Filing
After Ranbaxy allegedly entered into the reverse Later that same year, on August 17, 2006, Dr.
payment agreement with AstraZeneca, Malvinder Singh, Reddy's filed ANDA No. 78-279 and similarly notified Ranbaxy's chief executive officer, purportedly stated that AstraZeneca that it sought to market generic versions of Ranbaxy had secured as much as $1.5 billion in Nexium, id. ¶ 81; as part of Dr. Reddy's notification, it prospective [*31] revenue between the commencement also included a paragraph IV certification that its of the reverse payment agreement and the end of intentions regarding generic manufacture would not Ranbaxy's 180-day period of marketing exclusivity in infringe valid claims based on seven of AstraZeneca's 2014 envisaged by the agreement. Id. ¶ 93. AstraZeneca, patents listed in the Orange Book, id. On December 4, the Plaintiffs allege (upon information and belief), has 2007, Dr. Reddy's amended its ANDA to state that it already handed over millions of dollars to Ranbaxy under would not infringe the '504, '192, '872 patents, or that their reverse payment agreement. Id.; Direct Purchasers' Compl. ¶ 120. According to information gleaned from apress release issued two days after the alleged reverse payment agreement, however, the majority of the value proceedings in the New Jersey District Court on January accruing to Ranbaxy under the agreement will not 17, 2008, bringing suit under the Hatch-Waxman Act. Id.
become available until 2014. End-Payors' Compl. ¶ 94.
¶ 82. AstraZeneca claimed that Dr. Reddy's generic The one billion dollars of value accruing to Ranbaxy, the version of Nexium would infringe three patents listed in End-Payors contend, consisted of AstraZeneca's agreeing to refrain from producing its own authorized genericversion of Nexium during the 180-day exclusivity period, 11 AstraZeneca claimed that Dr. Reddy's generic a product which would otherwise stand in direct Nexium would infringe the '504, '872, and '085 competition with Ranbaxy's generic Nexium. Id.
patents. Id. ¶ 82. In reply to Dr. Reddy's answer,AstraZeneca also alleged that Dr. Reddy's generic Nexium would infringe its '192 patent. Id.
Ranbaxy's representation of these payments as the grantof an exclusive license, in return for Ranbaxy's rendering 3. AstraZeneca's Alleged
[*30] Reverse Payment
manufacturing and distribution services to AstraZeneca, Agreements With the Generic Defendants
however, is merely obfuscatory. Id. ¶ 95. [*32] In otherwords, they were structured to disguise the true value that a. AstraZeneca's Alleged Reverse Payment Agreement
Ranbaxy was conferring on AstraZeneca by virtue of With Ranbaxy
Ranbaxy's agreement to delay entering the market in After the parties had completed discovery, but before the New Jersey District Court could enter any rulings on End-Payors contend, would never have agreed to refrain the merits of the case, AstraZeneca allegedly entered into a reverse payment agreement with Ranbaxy on April 14, prospective market for the generic Nexium, nor would it 2008 (the "AstraZeneca/Ranbaxy Agreement"). Id. ¶ 90.
have earmarked Ranbaxy as its supplier of Nexium and Under this agreement, AstraZeneca agreed to end its authorized generic distributor of two of AstraZeneca's other PPI drugs, had Ranbaxy not agreed to delay its AstraZeneca/Ranbaxy Agreement would have succeeded competition with AstraZeneca for more than six years. Id.
in maintaining the bottleneck for six years, which wouldprevent any generic manufacturer from entering the Under the terms of AstraZeneca's alleged reverse market despite the suspected invalidity of AstraZeneca's payment agreement with Ranbaxy, Ranbaxy's 180-day market exclusivity period did not begin until May 27,2014. Id. The End-Payors allege therefore that, were it denied AstraZeneca's motion to dismiss Teva's AstraZeneca and Ranbaxy, Ranbaxy, the first-moving declaratory judgment for lack of jurisdiction, it generic manufacturer, could have entered the market granted AstraZeneca's motion to stay declaratory several years earlier (and perhaps as early as April 2008).
infringement action against Teva had beenresolved. Id. ¶ 98.
b. Teva's and Dr. Reddy's Attempt to Break the
Bottleneck

Resulting
c. AstraZeneca's Alleged Reverse Payment Agreement
AstraZeneca/Ranbaxy Reverse Payment Agreement
With Teva
After AstraZeneca and Ranbaxy allegedly entered Before the court could enter a final judgment in the into [*33] their reverse payment agreement, Teva moved principal matter concerning Teva's alleged infringement for declaratory judgment against AstraZeneca on April of AstraZeneca's patents, 14 however, AstraZeneca 30, 2008. Id. ¶ 96. Teva sought to obtain a ruling of allegedly entered into a reverse payment agreement with invalidity and noninfringement with respect to the patents Teva (the "AstraZeneca/Teva Agreement"), which ended listed in the Orange Book as to which AstraZeneca had the litigation [*35] between the parties. Id. ¶ 99. The not commenced proceedings against Teva following End-Payors allege that the parties entered into this Teva's ANDA filing for its generic version of Nexium. 12 agreement on (or about) January 7, 2010. Id. The New Id. The End-Payors argue that Teva's motivation for Jersey District Court memorialized the agreement in a filing its motion for declaratory judgment was to obtain a consent judgment. AstraZeneca's Mem., Ex. 5, Consent J.
favorable opinion with respect to all of the Nexium ("AstraZeneca/Teva Consent J.") ¶ 8, at 3-4, ECF No.
patents AstraZeneca had listed in the Orange Book. Id.
Had Teva obtained what it sought, it would havesucceeded in "uncork[ing] the FDA approval bottleneck" parties' briefing of claim construction in the AstraZeneca had settled with the first-filing generic, summer of 2009, both parties requested that the court delay its construal of their claims to drag outlitigation past January 7, 2010, by which time the parties had entered into the reverse payment motion for declaratory judgment in May 2008, by which it sought a similar judgment affirming thenoninfringement of those patents listed in the Teva, under the terms of the reverse payment Orange Book which AstraZeneca had failed to agreement, allegedly agreed to (1) admit that the patents assert previously in its infringement actions listed in the Orange Book at that time relating to Nexium against the Generic Defendants. Id. ¶ 96.
would be "enforceable and valid with respect to certainproducts"; (2) admit that its generic Nexium would When AstraZeneca sought to dismiss Teva's motion infringe the '504, '192, '789, '085, and '872 patents, as for declaratory judgment for lack [*34] of jurisdiction, well as U.S. Patent No. 7,411,070; and (3) delay the launch of its generic Nexium until May 27, 2014.
Hatch-Waxman regime by trying "to take advantage of what[, in Teva's view, was] an invalid and illegitimatepatent monopoly." Id. ¶ 97 (emphasis omitted) (internal For Teva's part, the End-Payors allege that Teva had quotation marks omitted). This is because, were Teva not "an enormous contingent liability to AstraZeneca." Id. ¶ allowed to challenge AstraZeneca's Nexium patents, the 102. This potential [*36] liability arose from Teva's decision on September 9, 2004, to begin manufacturing "at risk" a generic version of AstraZeneca's Prilosec AstraZeneca appealed the court's decision [*38] to grant through its partner, Impax. Id. Teva and Impax together Dr. Reddy's motion for summary judgment on the matter shouldered the risk associated with their generic version of its infringement of AstraZeneca's Accolate patents, Dr.
of Prilosec. Id. When, in 2008, the Federal Circuit upheld Reddy's faced the risk of significant damages in a decision from the Southern District of New York that connection with its possible patent infringement. Id. ¶ AstraZeneca's Prilosec patents were valid and thereby 106. AstraZeneca's agreement to forgive this contingent infringed by Impax's generic, In re Omeprazole Patent liability, the End-Payors allege, constituted a payment to Litig., 536 F.3d 1361, 1375, 2008 U.S. App. LEXIS 17691 (Fed. Cir. 2008), Teva was exposed to the risk ofsubstantial liability. End-Payors' Compl. ¶ 102.
Under the terms of AstraZeneca's alleged agreement with Dr. Reddy's, AstraZeneca withdrew its claim against As part of the consideration for the reverse payment Dr. Reddy's for infringement of the '085 patent, agreement, Teva and AstraZeneca allegedly agreed that following which the parties entered a consent agreement Teva need only pay an amount to AstraZeneca for its endorsed by the court which maintained that Dr. Reddy's generic Nexium did not infringe the '085 patent. Id. ¶ 83.
significant. Id. The End-Payors allege that AstraZeneca's Dr. Reddy's filed suit on May 19, 2008, seeking forgiveness of a significant portion of Teva's contingent declaratory judgment confirming that its generic Nexium liability was tantamount to a payment from AstraZeneca would not infringe the '960, '424, '103, '148, '213, and '810 patents, id. ¶ 84; AstraZeneca admitted in its answerthat Dr. Reddy's generic Nexium would not infringe the Whatever the pretextual reasons given for these '148 or '810 patents, id.
agreement with Teva, the End-Payors allege, was to delay The End-Payors allege that the AstraZeneca/Dr.
generic entry [*37] into the market for Nexium until Reddy's Agreement was designed to foreclose generic May 27, 2014. Id. ¶ 103. Without Teva's alleged entry into the market until AstraZeneca's patents expired agreement to delay competition resulting from its on May 27, 2014. Id. ¶ 107. Had Dr. Reddy's not agreed launching a generic version of Nexium, the End-Payors to [*39] this delay, the End-Payors' submit, AstraZeneca contend, AstraZeneca would not have forgiven (so would never have agreed to drop its case against Dr.
significant a portion of) Teva's contingent liability. Id.
AstraZeneca's
The End-Payors allege that the effect of the Agreement With Dr. Reddy's
Agreements, between AstraZeneca and the second and AstraZeneca allegedly entered into a similar reverse third ANDA filers, was to ensure that the bottleneck resulting from the AstraZeneca/Ranbaxy Agreement "AstraZeneca/Dr. Reddy's Agreement") on January 28, remained securely in place. Id. ¶ 108.
2011, before the court could enter a final judgmentconcerning 4. Anticompetitive Effects of AstraZeneca's Alleged
AstraZeneca's Nexium patents. Id. ¶ 104. This brought Reverse Payment Agreements With the Generic
any Nexium-related litigation between AstraZeneca and Defendants
The End-Payors allege that AstraZeneca's reverse In consideration for Dr. Reddy's agreement to refrain payment agreements were anticompetitive. Id. ¶ 109.
from challenging AstraZeneca's Nexium patents and to This is because the agreements were designed to deprive defer its launching a generic version of Nexium until the putative class members of a market in which generic May 27, 2014, AstraZeneca allegedly agreed to forgive drug manufacturers made commercial decisions based Dr. Reddy's contingent liability to AstraZeneca arising upon the strength of drug patents, balanced against the from Dr. Reddy's production of a generic version of countervailing risks of litigation, free from the distortive AstraZeneca's Accolate "at risk" in November 2010. Id.
influence of brand manufacturers' payments. Id. ¶ 110.
Such reverse payment agreements, the End-Payors are set to expire on May 27, 2014, and the remainder of further allege, are inconsistent with the purpose of the the active Nexium patents will expire on dates ranging Hatch-Waxman Act, as they enabled AstraZeneca to (1) from November 25, 2014, to November 3, 2019. 15 See delay the entry of less expensive generic versions of Direct Purchasers' Compl. ¶ 73. The Defendants argue Nexium, (2) fix the price of Nexium, (3) maintain a that the May 27, 2014, generic market entry date set out monopoly [*40] in the United States for Nexium, and (4) in the New Jersey District Court's consent judgments is allocate the entirety of the market for delayed-release the earliest date that any of the patents at issue would esomeprazole magnesium in the United States to have expired and that any alleged anticompetitive effects flowing from the settlement agreements underlying theconsent judgments would fall squarely within the term of Were it not for these reverse payment agreements, the End-Payors allege, a generic ANDA filer would have monopoly patent power. [*42] See AstraZeneca's Mem.
obtained FDA approval to begin marketing on (or about) 9-10; Teva's Mem. 13-14; Ranbaxy's Mem. 8.
April 14, 2008, and it would have been in a position tobegin selling its generic version not long thereafter. Id. ¶ Three of the formerly active Nexium patents 111. After the end of the 180-day exclusivity period listed in the FDA Orange Book in connection granted to this generic ANDA filer, other generics would with AstraZeneca's NDA expired in 2007. See be permitted to enter the market, resulting in further Until recently, there was deep disagreement among The End-Payors therefore allege that the Defendants' the courts of appeals as to how reverse payment action in concert unlawfully allowed AstraZeneca to sell agreements ought be viewed under the law. To wit, one Nexium at supracompetitive prices. Id. ¶ 112.
set of circuits followed the "scope-of-the-patent" test(upon which the Defendants' argument is predicated), II. ANALYSIS
which held that "absent sham litigation or fraud inobtaining the patent, a reverse payment settlement is A. Standard of Review
anticompetitive effects fall within the scope of the To survive a motion to dismiss under Rule 12(b)(6), exclusionary potential of the patent." Federal Trade a complaint must allege facts sufficient "to state a claim Comm'n v. Watson Pharms., Inc., 677 F.3d 1298, 1312 to relief that is plausible on its face." Bell Atl. Corp. v. (11th Cir. 2012), rev'd sub nom., Actavis, 133 S. Ct. Twombly, 550 U.S. 544, 570, 127 S. Ct. 1955, 167 L. Ed. 2223, 186 L. Ed. 2d 343; accord In re Ciprofloxacin 2d 929 (2007). The grounds of entitlement to relief set Hydrochloride Antitrust Litig. ("Cipro"), 544 F.3d 1323, forth in the complaint must constitute "more than labels 1336 (Fed Cir. 2008), abrogated by Actavis, 133 S. Ct. and conclusions, and a formulaic recitation of the 2223, 186 L. Ed. 2d 343; In re Tamoxifen Citrate elements of a cause of action will not [*41] do." Id. at Antitrust Litig. ("Tamoxifen"), 466 F.3d 187, 212-13 (2d 555. Nevertheless, a defendant's burden "is a heavy one Cir. 2006), abrogated by Actavis, 133 S. Ct. 2223, 186 L. when a motion to dismiss is filed." Stein v. Smith, 270 F. Ed. 2d 343. The Third Circuit in [*43] In re K-Dur Supp. 2d 157, 164 (D. Mass. 2003) (Lindsay, J.). In its Antitrust Litigation ("K-Dur"), 686 F.3d 197 (3d Cir. consideration of a motion to dismiss, the Court is 2012), vacated, Merck & Co. v. La. Wholesale Drug Co., instructed to "accept as true all well-pleaded facts in the 133 S. Ct. 2849 (mem.), Upsher-Smith Labs., Inc. v. La. complaint and draw all reasonable inferences in favor of Wholesale Drug Co., 133 S. Ct. 2849 (mem.), adopted an the plaintiffs." Gargano v. Liberty Int'l Underwriters, alternative, "quick-look" rule-of-reason test that instructs Inc., 572 F.3d 45, 48 (1st Cir. 2009).
juries to regard reverse payments as "prima facie B. Direct Purchasers' Claims
evidence of an unreasonable restraint of trade, whichcould be rebutted by showing that the payment[s] (1) 1. Legality of Reverse Payment Agreements after
[were] for a purpose other than delayed entry or (2) offer[] some pro-competitive benefit." 16 Id. at 218.
Two of the remaining eleven active Nexium patents Although the Third Circuit formally stood alone in opposition to its sister circuits, earlier restrictive practice imposes an unreasonable restraint on jurisprudence in the Sixth and District of competition." Arizona v. Maricopa Cnty. Med. Soc'y, 457 Columbia Circuits provides additional foundation U.S. 332, 343, 102 S. Ct. 2466, 73 L. Ed. 2d 48 (1982).
for the Third Circuit's reasoning. See In re Judges engaging in rule-of-reason analysis are directed to Cardizem CD Antitrust Litig., 332 F.3d 896, 908 consider three primary factors: (1) whether "the alleged (6th Cir. 2003) (ruling that an agreement effecting agreement involved the exercise of power in a relevant economic market," (2) whether "this exercise had manufacturers is "a classic example of a per se anti-competitive consequences," and (3) whether "those illegal restraint of trade"); Andrx Pharms., Inc. v. detriments outweighed efficiencies or other economic Biovail Corp. Int'l, 256 F.3d 799, 811, 347 U.S. benefits." 18 Stop & Shop Supermarket Co. v. Blue Cross App. D.C. 178 (D.C. Cir. 2001) (holding that a & Blue Shield of R.I., 373 F.3d 57, 61 (1st Cir. 2004).
reverse payment agreement "could reasonably be The Court now weighs each of these factors.
viewed as an attempt to allocate market share andpreserve monopolistic conditions").
Although this three-factor inquiry is set forth in a First Circuit case in which only section 1 of the Sherman Act was at issue, see Stop & Shop address this circuit split, and in Actavis, it formally Supermarket Co. v. Blue Cross & Blue Shield of pronounced on the legality of reverse payments. See 133 R.I., 373 F.3d 57, 61 (1st Cir. 2004), various S. Ct. 2223, 186 L. Ed. 2d 343. In so doing, the Supreme other courts, [*46] including the Supreme Court, Court rejected the widely followed scope-of-the-patent have held that the rule of reason applies with test. 17 Id. at 2230-34. The Supreme Court did not go so equal force to claims brought under section 2, see, far as to endorse K-Dur's strict, presumptively-unlawful e.g., Standard Oil Co. of N.J. v. United States, test, however. Id. at 2237-38. Instead, it adopted a 221 U.S. 1, 61-62, 31 S. Ct. 502, 55 L. Ed. 619 (1911); cf., e.g., United States v. Microsoft Corp., compromise, the contours of which have been left to the 253 F.3d 34, 59, 346 U.S. App. D.C. 330 (D.C. 2. Rule-of-Reason Analysis
fivefold: (1) reverse payments raise a "potentialfor genuine adverse effects on competition," a. Market Power in the Relevant Market
Actavis, 133 S. Ct. at 2234 (quoting Federal The first rule-of-reason criterion to address is Trade Comm'n v. Ind. Fed'n of Dentists, 476 U.S. whether the Defendants exercised market power in the 447, 460, 106 S. Ct. 2009, 90 L. Ed. 2d 445 relevant market. The Defendants argue that the Direct (1986)) (internal quotation marks omitted); (2) Purchasers have failed to allege a plausible relevant "these anticompetitive consequences will at least market, see Dr. Reddy's Mem. 15-17; AstraZeneca's sometimes prove unjustified," id. at 2235-36; (3) Mem. 10-17, suggesting that the Court need not even "where a reverse payment threatens to work reach the question of whether the Defendants conceivably unjustified anticompetitive harm, the patentee possess the market power necessary for the Direct likely possesses the power to bring that harm Purchasers to state claims against them under the about in practice," id. at 2236; (4) "[a]n Sherman Act, 15 U.S.C. §§ 1-2. Specifically, the unexplained large reverse payment itself would Defendants contend that the Direct Purchasers' proposed normally suggest that the patentee has serious market -- namely, brand Nexium and generic equivalents doubts about [*45] the patent's survival," id.; and that also share its active ingredient, esomeprazole (5) "the fact that a large, unjustified reverse magnesium -- is far too narrow because it excludes other payment risks antitrust liability does not prevent products that are either similar in chemical composition litigating parties from settling their lawsuit," id. at or used to treat comparable medical conditions. Dr. [*47] 2237. See generally id. at 2234-37.
Reddy's Mem. 15-17 (noting that the Direct Purchasers' Rule-of-reason analysis demands a determination as complaint "spends several paragraphs . . . describing the to "whether under all the circumstances of the case the similarities in structure between Prilosec (omeprazole)and Nexium (esomeprazole)," id. at 16 (citing Direct Purchasers' Compl. ¶¶ 75-78)); AstraZeneca's Mem.
United States v. Archer-Daniels-Midland Co., 866 F.2d 13-17 (noting that the Direct Purchasers' complaint 242, 248 & n.1 (8th Cir. 1988) (concluding that, although alleges that other PPIs, as well as H2 blockers and high fructose corn syrup and sugar serve near-identical non-prescription antacids, "are used to treat the same or functional purposes, the absence of strong cross-price similar conditions" as Nexium, id. at 14 (quoting Direct elasticity between the two products suggested that they Purchasers' Compl. ¶ 71) (internal quotation marks were not in fact within the same market). The Supreme omitted), and that "observed differences in healing rates Court has held that a properly constituted market may and symptom relief for Nexium and Prilosec may reflect indeed be comprised of a single product, Eastman Kodak Co. v. Image Technical Servs., Inc., 504 U.S. 451, pharmacologic differences," id. at 17 (quoting Direct 481-82, 112 S. Ct. 2072, 119 L. Ed. 2d 265 (1992), and Purchasers' Compl. ¶ 89) (internal quotation marks lower courts across the country have on numerous occasions ruled that both a brand-name drug and itsgeneric analogs can fall within the bounds of a relevant The Defendants' arguments ring hollow upon review market, see, e.g., In re Terazosin Hydrochloride Antitrust of the case law. In order to state a claim under section 1 Litig., 352 F. Supp. 2d 1279, 1319 n.40 (S.D. Fla. 2005) of the Sherman Act, a plaintiff must demonstrate that "the (deeming a relevant market to be composed of branded defendant had market power in the relevant market, and and generic terazosin hydrochloride); In re Cardizem CD the specific intent to restrain competition." CVD, Inc. v. Antitrust Litig. ("Cardizem"), 105 F. Supp. 2d 618, Raytheon Co., 769 F.2d 842, 851 (1st Cir. 1985).
680-81 (E.D. Mich. 2000) [*50] (accepting plaintiffs' Relatedly, under section 2 of the Sherman Act, a plaintiff contention that branded and generic versions of a heart [*48] must show that "the defendant had the specific medication with the chemical compound diltiazem intent to monopolize the relevant market, and a hydrochloride constitute a single market), aff'd, 332 F.3d dangerous probability of success." Id. The Supreme Court 896 (6th Cir. 2003). Although it may be beyond this has declared that, for antitrust purposes, a "relevant Court's competence to confirm the accuracy of the Direct interchangeable by consumers for the same purposes." interchangeability of brand Nexium with other drugs, United States v. E.I. du Pont de Nemours & Co., 351 U.S. such a factually intensive determination is better left for 377, 395, 76 S. Ct. 994, 100 L. Ed. 1264 (1956). The resolution by a jury, see Eastman Kodak, 504 U.S. at 482 reasonable interchangeability of a set of products is not (observing that "[t]he proper market definition . . . can be dependent on the similarity of their forms or functions; determined only after a factual inquiry into the instead, "[s]uch limits are drawn according to the 'commercial realities' faced by consumers," id. (quoting cross-elasticity of demand for the product in question -- United States v. Grinnell Corp., 384 U.S. 563, 572, 86 S. the extent to which purchasers will accept substitute Ct. 1698, 16 L. Ed. 2d 778 (1966))); Todd v. Exxon products in instances of price fluctuation and other Corp., 275 F.3d 191, 199-200 (2d Cir. 2001) (explaining changes." George R. Whitten, Jr., Inc. v. Paddock Pool Builders, Inc., 508 F.2d 547, 552 (1st Cir. 1974); see also fact-intensive inquiry, courts hesitate to grant motions to Brown Shoe Co. v. United States, 370 U.S. 294, 325, 82 dismiss for failure to plead a relevant product market"), S. Ct. 1502, 8 L. Ed. 2d 510 (1962) ("The outer so, by definition, the Defendants' motions to dismiss boundaries of a product market are determined by the reasonable interchangeability of use or the cross-elasticityof demand between the product itself and substitutes for What is more, in this particular case, the Direct Purchasers may not even need to allege arelevant market in order to state their Sherman The Direct Purchasers' complaint expressly alleges [*51] Act claims. The relevant market serves that "Nexium does not exhibit significant, positive merely as a proxy for market power when direct cross-elasticity of demand [*49] with respect to price evidence of market power is unavailable. IIB with any product other than AB-rated generic versions of Nexium." Direct Purchasers' Compl. ¶ 145. The fact that Antitrust Law ¶ 531a, at 232 (3d ed. 2007) other drugs may be used to treat heartburn and related ("Finding the relevant market and its structure is conditions is immaterial to the present inquiry. See, e.g., typically not a goal in itself but a mechanism for considering the plausibility of antitrust claims that alleged that AstraZeneca, in its position as a monopolist, the defendants' business conduct will create, has been able to charge supracompetitive prices for brand enlarge, or prolong market power."). But see id. ¶ Nexium. See Direct Purchasers' Compl. ¶¶ 143-145, 531a, at 233 ("Even when direct measures of 147-151 (alleging, inter alia, that "Nexium does not power are feasible, courts would still find market exhibit significant, positive cross-elasticity of demand definition useful . . . . Thus, while market with respect to price with any product other than definition and computation of market share is AB-rated generic versions of Nexium," id. ¶ 145, and that often said to be a surrogate for more 'direct' "AstraZeneca . . . sold Nexium at prices well in excess of measures of market power, it is often more than a marginal costs, and substantially in excess of the surrogate."). Where direct evidence of market competitive price, and enjoyed high profit margins," id. ¶ power is available, however, a plaintiff need not attempt to define the relevant market. Id. ¶ 531f,at 241. Such appears to be the case here, see b. Anticompetitive Consequences
Direct Purchasers' Compl. ¶¶ 143-145, 147-151 The second rule-of-reason criterion to address is (alleging that "[AstraZeneca] had the power to whether the Defendants' exercise of market power maintain the price of the drug it sold as Nexium at generated anticompetitive consequences. The Generic supracompetitive levels without losing substantial Defendants argue that the Direct Purchasers have failed sales to other products prescribed and/or used for to allege how the settlement agreements between the same purposes [*52] as Nexium, with the AstraZeneca and each of the Generic Defendants [*54] Nexium," id. ¶ 143, and that "AstraZeneca . . .
Ranbaxy's Mem. 12-13; Dr. Reddy's Mem. 11-15; Teva's enjoyed high barriers to entry with respect to Mem. 17-19. Specifically, the Generic Defendants claim competition . . . due to patent and other regulatory that the Direct Purchasers' assertion that the Generic Defendants would have entered the market prior to the expansion," id. ¶ 150), which would tend to expiration of the Nexium patents but for the settlement eliminate the need formally to define a relevant agreements is far too speculative to state an actionable market, see Coastal Fuels of P.R., Inc. v. claim. The theories upon which this argument is founded Caribbean Petroleum Corp., 79 F.3d 182, 196-97 differ slightly among the Generic Defendants: Ranbaxy and Teva contend that there is no indication that they Taking the relevant market to be comprised of brand would have prevailed in their patent litigations against and generic Nexium alone for the purposes of this AstraZeneca or that they would have launched "at-risk" memorandum, this Court reaches the conclusion that the generic versions of Nexium, Ranbaxy's Mem. 12-14; Direct Purchasers' complaint alleges more than enough Teva's Mem. 17-19, whereas Dr. Reddy's raises identical facts to enable a reasonable jury to find that the arguments with respect to its own patent litigation with Defendants exercise market power. Market power can be proven in one of two ways: either by (1) "direct evidence first-filing status would nevertheless have precluded it from entering the market at any time before the closing of supracompetitive prices and restricted output)" or by (2) Ranbaxy's 180-day exclusivity window (unless Dr.
"circumstantial evidence of market power . . . [which] Reddy's received a favorable court decision and had show[s] that the defendant has a dominant share in a tentative approval from the FDA). Dr. Reddy's Mem.
well-defined relevant market and that there are significant barriers to entry in that market and that existing To state a claim under the federal antitrust laws, a competitors lack the capacity to increase their output in [*55] must sufficiently allege an "antitrust [*53] the short run." Coastal Fuels of P.R., Inc. v. injury." Atlantic Richfield Co. v. USA Petroleum Co., 495 Caribbean Petroleum Corp., 79 F.3d 182, 196-97 (1st U.S. 328, 334, 110 S. Ct. 1884, 109 L. Ed. 2d 333 (1990) Cir. 1996) (citation omitted). This Court need not engage (emphasis omitted) (quoting Brunswick Corp. v. Pueblo in an extensive analysis of circumstantial evidence of Bowl-O-Mat, Inc., 429 U.S. 477, 489, 97 S. Ct. 690, 50 L. market power because direct evidence of such power is Ed. 2d 701 (1977)) (internal quotation mark omitted). An available -- the Direct Purchasers have thoroughly antitrust injury is described as an "injury of the type the an ANDA is permitted to delay marketing as long as it antitrust laws were intended to prevent and that flows likes, the statutory scheme does not envision the first from that which makes defendants' acts unlawful." Id. applicant's agreeing with the patent holder of the pioneer (quoting Brunswick, 429 U.S. at 489) (internal quotation drug to delay the start of the 180-day exclusivity mark omitted). "[An] injury, although causally related to an antitrust violation, nevertheless will not qualify as'antitrust Part III of the Supreme Court's opinion in Actavis anti-competitive aspect of the practice under scrutiny." added an additional gloss to standard antitrust-injury analysis, however. There, the Supreme Court explainedthat a rule-of-reason approach to reverse payment There is support in the case law for the proposition agreements is preferable to quick-look treatment because that allegations waxing poetic on the probability of "the likelihood of a reverse payment bringing about successful patent invalidity or unenforceability claims anticompetitive effects depends upon its size, its scale in and of a proposed would-have-been date of generic relation to the payor's anticipated future litigation costs, market entry that rest upon but-for theories of causation its independence from other services for which [*58] it will not suffice to raise a triable antitrust issue. See, e.g., might represent payment, and the lack of any other Watson Pharms., 677 F.3d at 1312-13 ("[I]t is simply not convincing justification." 133 S. Ct. at 2237. In other true that an infringement claim that is 'likely' to fail words, only those reverse payment agreements whose actually will fail. . . . Rational parties settle [*56] to cap anticompetitive consequences are sufficiently great and the cost of litigation and to avoid the chance of losing."); sufficiently unrelated to the settlement of a particular In re Ciprofloxacin Hydrochloride Antitrust Litig. patent dispute will be censured by the courts.
("Cipro"), 261 F. Supp. 2d 188, 199-202 (E.D.N.Y. 2003)(holding that plaintiffs' allegations that brand defendant's In the instant case, the Plaintiffs allege that patent was invalid or unenforceable and that brand AstraZeneca agreed to pay over $1,000,000,000 to defendant "paid enormous sums of money to avoid a judicial determination of the patent infringement case," agreement with it, see End-Payors' Compl. ¶¶ 92, 94, id. at 200, were not enough to state a triable claim).
which seems like outsize accommodation from a Certain authority cuts the other way, however. See, e.g., company to whom Ranbaxy was purportedly liable for Andrx Pharms., Inc. v. Biovail Corp. Int'l, 256 F.3d 799, patent infringement. It is also alleged that Teva and Dr.
804, 808-09, 347 U.S. App. D.C. 178 (D.C. Cir. 2001) Reddy's were forgiven by AstraZeneca of contingent ("One can fairly infer from [the agreement providing for liabilities tied to their infringement of AstraZeneca's the payment of $10 million per quarter to a generic patents in Prilosec and Accolate, respectively, see id. ¶¶ manufacturer] . . . that but for the Agreement, [the generic manufacturer] would have entered the market." AstraZeneca's earlier Nexium-related suits against these Id. at 809). Moreover, the fact that each of the Generic parties. Moreover, as section II.B.1.c explains, there Defendants have launched at-risk products in the past, see exists no persuasive procompetitive justification for the Direct Purchasers' Opp'n Teva's Mot. Dismiss 11 & alleged agreements at issue. Taking all intendments in the nn.44-47, would seem to undermine the notion that they light most favorable to the Direct Purchasers, then, the would not have done so in this case. Finally, in response to Dr. Reddy's separate allegation regarding first-filers, AstraZeneca and Ranbaxy and AstraZeneca's forgiveness courts have looked with particular skepticism upon of Teva's and Dr. Reddy's contingent liabilities related to agreements [*57] that allow first-filers to exploit their 180-day exclusivity period by prohibiting other generic consequences to allow the Direct Purchasers' claims to demonstrated intention to market their generic drug. See, e.g., Watson Pharms., 677 F.3d at 1311 (noting that a Yet even if it can be said that the Defendants' reverse settlement whose purpose is to facilitate a bottleneck in payment agreements were sufficiently anticompetitive, it generic market entry would "create[] anticompetitive is not readily apparent that the Direct Purchasers have effects beyond the scope of the patent"); Andrx Pharms., recourse under the antitrust laws, so the Generic 256 F.3d at 809 ("Although it is true that the first to file Defendants claim, because the Generic Defendants did not receive any kind of monetary payment from AstraZeneca in exchange for their alleged commitment to Admittedly, the Supreme Court spoke only to the merits stay out of the market. 20 See Dr. Reddy's Mem. 10-11; of cash payouts as a quid pro quo for promises of delayed Teva's Mem. 14-17; Ranbaxy's Mem. 8-12. Instead, generic market entry. See, e.g., 133 S. Ct. at 2229 AstraZeneca and Ranbaxy allegedly entered into a (describing a brand manufacturer's agreement with three "no-authorized generic agreement" granting Ranbaxy "an generic manufacturers to "pay millions of dollars to each exclusive license . . . to market generic delayed-release generic"); id. at 2233 (noting that "[i]n reverse payment esomeprazole magnesium during Ranbaxy's first-filer settlements, . . . a party with no claim for damages 180-day period of generic market exclusivity," Direct (something that is usually true of a paragraph IV Purchasers' Compl. ¶ 121, while Teva and Dr. Reddy's litigation defendant) walks away with money simply so it were allegedly forgiven by AstraZeneca of contingent will stay away from the patentee's market"). Yet Actavis liabilities for past patent infringement, id. ¶¶ 129-130, only involved a brand manufacturer's bargain with three generic manufacturers "to pay [*62] millions of dollarsto each generic," see id. at 2229, so the Supreme Court's 20 The [*60] Generic Defendants, however, pay confined analysis hardly seems surprising. This Court no heed to the Direct Purchasers' allegation that does not see fit to read into the opinion a strict limitation "AstraZeneca has already paid Ranbaxy millions of its principles to monetary-based arrangements alone.
Adopting a broader interpretation of the word Purchasers' Compl. ¶ 120. That said, because this "payment," on the other hand, serves the purpose of allegation was made simply upon information and aligning the law with modern-day realities. 22 belief -- and, more importantly, because theinclusion AstraZeneca/Ranbaxy agreement ultimately does authored the dissenting opinion in the case, not affect this Court's analysis -- this Court has no qualms crediting the Generic Defendants' account.
consideration carry worth in the antitrust context.
See id. at 2239 (Roberts, C.J., dissenting) It is true that some courts have opted for a narrow (commenting that the brand defendant "gave its construal of the term "payment." See, e.g., In re Lamictal competitors something of value (money) and, in Direct Purchaser Antitrust Litig., No. 12-995 (WHW), exchange, its competitors gave it something of 2012 U.S. Dist. LEXIS 183627, 2012 WL 6725580, at *6 value (dropping their legal claims)").
(D.N.J. Dec. 6, 2012) (holding that "the term 'reverse payment' is not sufficiently broad to encompass any two federal agencies responsible for enforcing benefit that may fall to [a generic manufacturer] in a federal antitrust laws, has published numerous negotiated settlement" and that "[t]he Third Circuit's K-Dur opinion is directed towards settlements when a pay-for-delay agreements in which a brand drug generic manufacturer is paid off with money"); Asahi manufacturer declines to sell an authorized Glass Co. v. Pentech Pharms., Inc., 289 F. Supp. 2d 986, generic during a first-filer's 180-day exclusivity 994 (N.D. Ill. 2003) (reasoning that "[i]f any settlement period constitute reverse payments. See, e.g., FTC agreement is thus to be classified as involving a Report on Authorized Generics, supra, [*63] at forbidden 'reverse payment,' [*61] we shall have no 152 (concluding that "[a] review of recent more patent settlements"). This Court need not take the brand-generic settlements reveals that agreements same tack, however. Cf. In re Lipitor Antitrust Litig., No. not to compete with ANDA-generics through an 3:12-cv-2389 (PGS), 2013 U.S. Dist. LEXIS 126468, [authorized generic] have become a recognized 2013 WL 4780496, at *26 (D.N.J. Sept. 5, 2013) mode for a brand to provide compensation to (allowing plaintiffs challenging an alleged reverse generics and, therefore, can be used as exclusion payment agreement to amend their complaint to include payments in patent settlement agreements"); Fed.
allegations beyond those of a purely monetary nature).
Nowhere in Actavis did the Supreme Court explicitly Company Pay-Offs Cost Consumer Billions 5 require some sort of monetary transaction to take place 670, 89 S. Ct. 1902, 23 L. Ed. 2d 610 (1969) (acknowledging that "the Patent Office is often obliged to pay-for-delay agreements involve cash payments).
reach its decision in an ex parte proceeding, without the In addition, case law confirms that although aid of the arguments which could be advanced by parties contingent liabilities technically "depend[] on a interested in proving patent invalidity"); Fed. Trade future event that may not even occur[] to fix Comm'n, Generic Drug Entry Prior to Patent Expiration: Freeland v. Enodis Corp., 540 F.3d 721, 730 (7th Cir. 2008) (second alteration in original) (quoting (finding in a study of the success rate of paragraph IV In re Knight, 55 F.3d 231, 236 (7th Cir. 1995)) (internal quotation marks omitted), courts have applicants prevailed 73 percent of the time"), and although patent holders enjoy broad exclusionary rights, liabilities are without any value whatsoever, see, see, e.g., U.S. Const. art. I, § 8, cl. 8 (granting to patent e.g., id. ("[A] contingent liability is not valued at holders "the exclusive Right to their respective Writings its full amount . . . . Rather, a contingent liability and Discoveries" for limited [*66] periods of time); is valued at its face amount multiplied by the Dawson Chem. Co. v. Rohm & Haas Co., 448 U.S. 176, probability [*64] that it will become due.").
215, 100 S. Ct. 2601, 65 L. Ed. 2d 696 (1980) (echoing"the long-settled view that the essence of a patent grant is c. Weighing Economic Detriments Against Economic
the right to exclude others from profiting by the patented Benefits
invention"), these rights are not limitless, see, e.g.,Standard Oil Co. (Ind.) v. United States, 283 U.S. 163, The final rule-of-reason criterion requires the Court 169, 51 S. Ct. 421, 75 L. Ed. 926 (1931) ("The limited to balance the economic detriments of the agreements at monopolies granted to patent owners do not exempt them Defendants have not put forward a shred of affirmative evidence tending to show that the agreements into whichthey allegedly entered produced any countervailing Accordingly, this Court holds that the Direct procompetitive benefits whatsoever. See AstraZeneca's Mem.; Dr. Reddy's Mem.; Teva's Mem.; Ranbaxy's Mem.
motion-to-dismiss stage to establish violations of sections The lone conceivable benefit of reverse payment 1 and 2 of the Sherman Act under the rule of reason.
agreements -- namely, the settlement of patent disputes --cannot 3. Exceptions to Antitrust Liability
discussed earlier in section II.B.1.b. See Actavis, 133 S.
Ct. at 2234-37
(entertaining a number of arguments The Defendants contend that even if their actions are against the brand and generic respondents' position in that deemed anticompetitive, (1) all of the agreements case and ultimately holding that "these considerations, between AstraZeneca and the Generic Defendants ought taken together, outweigh the single strong consideration enjoy Noerr-Pennington immunity, see AstraZeneca's -- the desirability of settlements -- that led the Eleventh Mem. 4-8; and (2) the relevant statute of limitations bars Circuit to provide near-automatic antitrust immunity to reverse payment settlements," id. at 2237). "Where a AstraZeneca/Ranbaxy agreement, 23 Ranbaxy's Mem.
5-6; see also AstraZeneca's Mem. 17-20. The Court considerations, such as avoided litigation [*65] costs or addresses each of these contentions in turn.
fair value for services, there is not the same concern that The Court need not address the Defendants' a patentee is using its monopoly profits to avoid the risk [*67] contention that Federal Circuit law governs of patent invalidation or a finding of noninfringement." this dispute, see AstraZeneca's Mem. 8-9; Teva's Id. at 2236. Such traditional settlement considerations do Mem. 7-9, as the Supreme Court has already not appear to be present here, however. Moreover, the weighed in on this issue, see Actavis, 133 S. Ct. at presumptive validity accorded to patents upon issuance 2231 ("[I]t would be incongruous to determine has been cast in significant doubt by judges and empiricists alike, cf. Lear, Inc. v. Adkins, 395 U.S. 653, payment] settlement's anticompetitive effects solely against patent law policy, rather than by Writing on behalf of all of the Defendants, measuring them against procompetitive antitrust AstraZeneca argues that because the New Jersey District policies as well. . . . [T]his Court has indicated Court entered consent judgments sanctioning settlement that patent and antitrust policies are both relevant agreements struck between AstraZeneca and each of the in determining the 'scope of the patent monopoly' three Generic Defendants, any anticompetitive harms that -- and consequently antitrust law immunity --that flow from such agreements are properly attributable to is conferred by a patent."); id. at 2236 ("[I]t is governmental -- not private -- action. See AstraZeneca's normally not necessary to litigate patent validity Mem. 5-6. For support, AstraZeneca contends that the to answer the antitrust question . . . ."). But see id. settlement agreements (1) imposed upon the Defendants at 2240 (Roberts, C.J., dissenting) (asserting that only the obligation "to file an executed consent judgment questions of patent invalidity and infringement, in in the [New Jersey District Court] within five business the context of reverse payments, are "plainly a days of signing the agreement," (2) "would become effective only when the consent judgment was entered asan order by the [New Jersey District Court]," and (3) a. Noerr-Pennington Immunity
would have been rendered null and void in the event thatthe Defendants had failed to obtain the New Jersey District Court's blessing within forty-five days of the date immunity to persons and organizations who, with the of the consent judgment filings. AstraZeneca's Mem. 5; intent to restrain trade and diminish competition, act in concert to petition the government to adopt laws and implement [*68] policies that are anticompetitive in nature. 24 See Allied Tube & Conduit Corp. v. Indian AstraZeneca's Mem., Ex. 2, Settlement Agreement Head, Inc., 486 U.S. 492, 499, 108 S. Ct. 1931, 100 L. ("AstraZeneca/Teva Settlement Agreement") §§ 2.1-2.3, Ed. 2d 497 (1988). Although it originally arose in the at 6-7, ECF No. 157-1; AstraZeneca's Mem., Ex. 3, context of an individual's right to entreat the legislature and the executive, see United Mine Workers of Am. v. Settlement Agreement") §§ 2.1-2.3, at 6-7, ECF No.
Pennington, 381 U.S. 657, 669-70, 85 S. Ct. 1585, 14 L. 157-2. 25 Moreover, AstraZeneca stresses that it was the Ed. 2d 626 (1965); Eastern R.R. Presidents Conference v. New Jersey District Court that formally enjoined the Noerr Motor Freight, Inc., 365 U.S. 127, 136, 81 S. Ct. Generic Defendants from offering generic versions of 523, 5 L. Ed. 2d 464 (1961), the doctrine has since been Nexium in the marketplace before May 27, 2014.
deemed to cover advocacy before all organs of AstraZeneca's Mem. 6; see also AstraZeneca's Mem., Ex.
government, including, most relevantly for the present 4, Consent Order & Final J. ¶ 7, ECF No. 135-6; inquiry, courts, see, e.g., California Motor Transp. Co. v. AstraZeneca/Teva Consent J. ¶ 8, at 3-4; AstraZeneca's Trucking Unlimited, 404 U.S. 508, 510, 92 S. Ct. 609, 30 Mem., Ex. 6, Consent J. ¶ 3, at 32, ECF No. 135-8.
L. Ed. 2d 642 (1972). Moreover, the Supreme Court hasheld that the Noerr-Pennington doctrine extends not only to "direct" petitioning but also to activities that are support of its motion to dismiss and the three "'incidental' to a valid effort to influence governmental action." Allied Tube, 486 U.S. at 499 (quoting Noerr, 365 referenced therein were filed eleven days apart.
U.S. at 143). Ultimately, though, "[t]he scope of The disparity in the filing dates is explained, [Noerr-Pennington's] protection depends . . . on the however, by the fact that the Court denied source, context, and nature of the anticompetitive AstraZeneca's motion to impound the settlement agreements, see Elec. Order, Feb. 28, 2013, ECFNo. 153; see also AstraZeneca Defs.' Mot.
Impoundment Confidential Materials, ECF No.
Noerr-Pennington doctrine is ostensibly rooted in 140, which led AstraZeneca [*71] to furnish the First Amendment's Petition Clause, [*69] these documents to the Court at a later date.
which provides that "Congress shall make no law Accordingly, for the purposes of citation, this . . . abridging the right of the people . . . to Court effectively treats the redacted versions of petition the Government." U.S. Const. amend. I.
the settlement agreements as though they were appended to AstraZeneca's support memorandumin the first instance.
Raymond Ku, Antitrust Immunity, the First Amendmentand Settlements: Defining the Boundaries of the Right to Courts are largely uniform in their view that private Petition, 33 Ind. L. Rev. 385, 404 (2000). Ku asserts that settlement agreements entered into during the pendency this self-described, two-pronged "means/source test" of litigation that are neither presented to nor approved by ultimately can be reduced to a single question: "Is the the judge presiding over the dispute fall outside the ambit private conduct a valid effort to influence government?" of Noerr-Pennington immunity. See, e.g., Andrx Pharms., 256 F.3d at 818-19; Cardizem, 105 F. Supp. 2d at634-36. There is little guidance, however, on the question Applying Ku's framework to the instant case, it of whether a judge's entry of a consent judgment falls becomes clear that the consent judgments entered by the squarely within the scope of Noerr-Pennington.
New Jersey District Court are not eligible candidates for Noerr-Pennington coverage. Courts have A thirteen-year-old law review article published in acknowledged that the distinction between private the Indiana Law Review proposes a sensible analytical settlements and consent judgments is far from obvious approach whose adoption proves useful in determining and modest at best. See, e.g., Lorain NAACP v. Lorain whether the consent judgments at issue ought be covered Bd. of Educ., 979 F.2d 1141, 1148 (6th Cir. 1992) under Noerr-Pennington. In the article, Raymond Ku (observing that a consent decree is best described as a draws upon language in the Supreme Court's decision in "strange hybrid in the law," id. (quoting Brown v. Neeb, Allied Tube & Conduit Corp. v. Indian Head, Inc., 486 644 F.2d 551, 557 (6th Cir. 1981)) (internal quotation marks omitted), that "is at once a voluntary settlement [Noerr-Pennington's] protection [*72] depends . . . on the agreement which could be fully effective without judicial source, context, and nature of the anticompetitive intervention and a final judicial order . . . plac[ing] the restraint at issue," id. at 499 -- to create a bidimensional power and prestige of the court behind the compromise struck by the parties," id. (alteration in original) (quotingWilliams v. Vukovich, 720 F.2d 909, 920 (6th Cir. 1983)) [T]he history of the right to petition and (internal quotation marks omitted)); cf., e.g., Local No. 93, Int'l Ass'n of Firefighters, AFL-CIO C.L.C. v. City of that immunity is justified based upon the Cleveland, 478 U.S. 501, 519, 106 S. Ct. 3063, 92 L. Ed. nature of the activity in question and the 2d 405 (1986) ("[C]onsent decrees bear some of the source of the injury to competition. This earmarks of judgments entered after litigation. At the same time, because their terms are arrived at through mutual agreement of the parties, consent decrees alsoclosely resemble contracts."). Unlike an opinion, which is aided by an [*74] adversarial system that grants a judge the occasion formally to review the merits of the claims asserted, "the means employed in reaching [a consent judgment] are still the same as those used to enter into private settlement or any private commercial contract," Ku, supra, at 427, in that "the parties can be treated as orchestrating the decision-making process by privately negotiating the terms of the settlement and then presenting them to the court as a fait accompli which anycourt would be hard-pressed to reject," id. at 428. The ways in which parties maneuver to transform a settlement agreement into a judicially approved consent judgment, then, cannot be fairly characterized as direct "petitioning" -- at least not as that word is commonly understood in thecontext of the political process. 26 Cf. Sosa v. DIRECTV,Inc., 437 F.3d 923, 933 (9th Cir. 2006) (observing that common end: the persuasion of a judicial officer to obtain 'communication[s] to the court' may be fairly described as a redress of grievances. Consent judgments effected at 'petitions'" and that "[s]uch communications include [a] the behest of private parties, on the other hand, do not complaint, an answer, a counterclaim and other assorted share the same purpose. 27 Although certain resolutions to litigation require judicial approval, see, e.g., Antitrust defendants make representations and present arguments Procedures and Penalties Act, Pub. L. No. 93-528, 88 [*75] to support their request that the court do or not do Stat. 1706 [*77] (codified at scattered sections of 15 something," id. (first and third alteration in original) U.S.C.) (mandating, in the resolution of antitrust actions, (quoting Freeman v. Lasky, Haas & Cohler, 410 F.3d that "the court . . . determine that the entry of [a consent] 1180, 1184 (9th Cir. 2005)) (internal quotation marks judgment is in the public interest," 15 U.S.C. § 16(e)(1), by affirmatively considering the impact of such judgmenton competition, id. § 16(e)(1)(A)-(B)); Fed. R. Civ. P. 23(e) (allowing settlement of a class action only if a court motion to dismiss the End-Payors' complaint, the "approve[s] [the proposed settlement agreement] . . . after Defendants present an alternate interpretation of a hearing and on finding that it is fair, reasonable, and the relevant petitioning conduct, arguing that they adequate," Fed. R. Civ. P. 23(e)(2)), most settlements can "petition[ed] the [New Jersey District Court] to be made final without the stamp of a judge, see Fed. R. enter consent judgments as orders of the court Civ. P. 41(a)(1)(A) (allowing the dismissal of an action enjoining Ranbaxy, Teva, and [Dr. Reddy's] from by a plaintiff without a court order, so long as the marketing a generic version of Nexium until May plaintiff gains the signatures of all parties to the litigation 2014." Defs.' Mot. Dismiss End-Payors 3. Even on a stipulation of dismissal and files it, along with a were this Court to adopt the Defendants' broader notice of dismissal, with the court); cf. also United States definition of "petitioning," the conclusion reached v. Cannons Eng'g Corp., 720 F. Supp. 1027, 1035 (D. in this memorandum ultimately would be the Mass. 1989) (Wolf, J.) ("Approval of a proposed consent same, as it is not the Defendants' mere efforts to decree is committed to the discretion of the district court.
obtain a consent judgment that the Plaintiffs are This discretion is to be exercised in light of the strong challenging. Rather, the Plaintiffs have taken policy in favor of voluntary settlement of litigation." particular issue with the settlement agreements [*78] (citation omitted)), aff'd, 899 F.2d 79 (1st Cir. undergirding the consent judgments and the purported use of the New Jersey District Court asan instrument to legitimate the Defendants' 27 The same argument can be made with respect allegedly anticompetitive arrangement.
to settlements alone. See Ku, supra, at 421-26.
Admittedly, courts have deemed settlements The entry of a consent judgment [*76] cannot be between private parties and the state to be construed as conduct that is "incidental" to litigation, incidental to the petitioning that takes place via either. A wide variety of activities -- including the litigation. See, e.g., A.D. Bedell Wholesale Co. v. Philip Morris Inc., 263 F.3d 239, 252-54 (3d Cir. communications, decisions to accept or reject settlement 2001). These types of settlements are quite offers, and threats to litigate -- have been held exempt distinguishable from those assented to between from antitrust liability under Noerr-Pennington. See, e.g., two or more private parties, however, because, in Sosa, 437 F.3d at 936-38 (presuit demand letters); the former case, the state is operating as an actor Freeman, 410 F.3d at 1184 (discovery communications); that is directly engaged in the decisionmaking Columbia Pictures Indus., Inc. v. Prof'l Real Estate Investors, Inc., 944 F.2d 1525, 1528 (9th Cir. 1991)(decisions to accept or reject settlement offers), aff'd on other grounds, 508 U.S. 49, 113 S. Ct. 1920, 123 L. Ed. AstraZeneca and the Generic Defendants from simply 2d 611 (1993); Coastal States Mktg., Inc. v. Hunt, 694 stipulating to a dismissal of the patent infringement F.2d 1358, 1367-68 (5th Cir. 1983) (threats to litigate).
actions. A decision of a court that serves merely to Despite the breadth of their diversity, however, all of memorialize a bargained-for agreement that could have these activities share a common purpose and anticipate a otherwise been resolved without judicial intervention ought not benefit from the exemption allowed by cursory inspection by public officials, or public officials Noerr-Pennington. Cf. MedImmune, Inc. v. Genentech, may approve conduct without consideration or awareness Inc., No. CV 03-2567 MRP, 2003 U.S. Dist. LEXIS of its anti-competitive aspects. [*81] The issue in such 23443, 2003 WL 25550611, at *7 (C.D. Cal. Dec. 23, 2003) (holding that an order and judgment executed by a 'governmental', but whether the real decision makers judge was eligible for Noerr-Pennington [*79] immunity were public officials or private businessmen." (citations because the result achieved by the order and judgment -- namely, the reversal of a priority decision by the U.S.
Patent and Trademark Office's Board of Patent Appeals Having reviewed the record made available by the and Interferences -- "could not have been accomplished parties, it is not apparent that the New Jersey District through private agreement"). Adopting the alternative Court actually played an independent role in drafting the view would provide litigants with an avenue wholly terms in the consent judgments. Although AstraZeneca impervious to antitrust scrutiny simply by seeking out a asserts that the New Jersey District Court exercised its discretion in enjoining the Generic Defendants fromentering the market, AstraZenca's Mem. 6-8, the underlying settlement agreements are heavily redacted, Noerr-Pennington remains that "[i]f anticompetitive harm is caused by the decision of a court, even though granted at the request of a private party, no private restraint of AstraZeneca/Dr. Reddy's Settlement Agreement, so it is trade occurs because the intervening government action unclear how much of the content found within the breaks the causal chain." Andrx Pharms., 256 F.3d 799 at consent judgments is properly attributable to the New 818, 347 U.S. App. D.C. 178; see also I Phillip E. Areeda Jersey District Court judge's deliberation. Moreover, the & Herbert Hovenkamp, Antitrust Law ¶ 202c, at 166-67 entering of a consent decree does not, by itself, reflect a (3d ed. 2006). Some courts have suggested, however, that court's assent to the substantive terms found therein, see, where a judge plays nothing more than a perfunctory role e.g., Liu v. Amerco, 677 F.3d 489, 497 (1st Cir. 2012) in branding a privately ordered settlement with the (noting that "[a] consent decree is neither an adjudication imprimatur of law, the protections of Noerr-Pennington nor an admission by [the defendant]"); Ku, supra, at 429 are not implicated. See, e.g., MedImmune, 2003 U.S. [*82] ("[W]hen asked to approve a settlement agreement, Dist. LEXIS 23443, 2003 WL 25550611, at *6 (noting, a court is not being asked to determine liability or with approval, the parties' understanding that "a court's approve the substance of the agreement."), so it is unclear stamp of approval [*80] will not immunize private whether the judge could be fairly said to have endorsed the terms of the settlement agreements. 28 Therefore, this necessary for Noerr-Pennington immunity to apply"); Court cannot in good conscience accord the consent Cipro, 261 F. Supp. 2d at 212-13 (ruling that a consent judgment entered by the New Jersey District Court the judgment certifying agreements between a brand-name aegis of antitrust immunity under Noerr-Pennington. 29 drug manufacturer and manufacturers of generic drugs todelay market competition and extinguish all patent Despite the Defendants' protestations to the litigation claims was not subject to Noerr-Pennington contrary, the fact that the settlement agreements protection because the judge in the case "played no role other than signing the Consent Judgment," id. at 212, and approval of the New Jersey District Court has no "was . . . [not] even apprised of the terms before he 'so ordered' the Consent Judgment," id. at 213, and because Indeed, the very fact that the Defendants can "[t]he Consent Judgment did not include the terms of the agreements," id. at 212-13). The First Circuit has itself Noerr-Pennington argument based on consent suggested that it is aware of the meaningful difference between action that is truly governmental in substance exceptionally wary of exercising their equitable and action that is simply governmental in form. See powers at the joint behest of the parties. Cf., e.g., George R. Whitten, Jr., Inc. v. Paddock Pool Builders, Inc., 424 F.2d 25, 33 n.8 (1st Cir. 1970) ("An 12-10169-WGY, 12-10374-WGY, 2013 U.S. Dist. anti-competitive practice may receive only the most LEXIS 104948, 2013 WL 3853233 (D. Mass. July 26, 2013); SEC v. Citigroup Global Mkts., Inc., acts separate and apart from the initial act giving rise to 827 F. Supp. 2d 328 (S.D.N.Y. 2011) (Rakoff, J.).
the original injury. See, e.g., Midwestern Mach., 392 F.3d Far better to let the parties simply agree among at 271 ("Only where the monopolist actively reinitiates the anti-competitive policy and enjoys benefits from thataction can the continuing [*85] violation theory apply."); b. Federal Statute of [*83] Limitations
Berkson v. Del Monte Corp., 743 F.2d 53, 55 (1st Cir.
1984)
(suggesting that the plaintiff's antitrust claims Federal antitrust enforcement actions are subject to a based upon the defendants' allegedly wrongful agreement four-year statute of limitations. 15 U.S.C. § 15b. Any regarding the sale of banana-growing properties in such action that is not brought "within four years after the Guatemala were barred by the four-year statute of cause of action accrued" is deemed "forever barred." Id.
Generally, a cause of action accrues under the Sherman furtherance of the alleged conspiracy [was] described or Act when the plaintiff suffers an injury that is traceable to even hinted at" in the plaintiff's complaint, id., so "any the defendant's conduct. See In re Relafen Antitrust Litig., subsequent harm must be seen as the unabated inertial 286 F. Supp. 2d 56, 61 (D. Mass. 2003). An exception to consequence[ ] of the earlier events," id. (alteration in this default rule exists, however, where the defendant's conduct "constitute[s] a continuing violation of the Pollution, 591 F.2d 68, 72 (9th Cir. 1979) (internal Sherman Act . . . [that] inflict[s] continuing and quotation marks omitted)). That said, the Supreme Court accumulating harm." Id. at 62 (first alteration in original) in Klehr v. A.O. Smith Corp., 521 U.S. 179, 117 S. Ct. (quoting Hanover Shoe, Inc. v. United Shoe Mach. Corp., 1984, 138 L. Ed. 2d 373 (1997), observed the following: 392 U.S. 481, 502 n.15, 88 S. Ct. 2224, 20 L. Ed. 2d 1231(1968)) (internal quotation mark omitted).
The Defendants argue that the Direct Purchasers' price-fixing conspiracy that brings about a Sherman Act claims relating to the AstraZeneca/Ranbaxy series of unlawfully high priced sales over Agreement ought be dismissed because the consent a period of years, each overt act that is part judgment memorializing said agreement was entered by the New Jersey District Court on April 14, 2008, more plaintiff, e.g., each sale to the plaintiff, than four years before the first direct purchaser complaint starts the statutory period running again, was filed (on August 27, 2012). Ranbaxy's Mem. 5-6; see regardless of the plaintiff's knowledge of also AstraZeneca's [*84] Mem. 18. The Defendants are the alleged illegality [*86] at much earlier correct. Therefore, to the extent that the Direct Purchasers seek to challenge the AstraZeneca/Ranbaxy reversepayment agreement itself, this Court holds that the Direct Id. at 189 (quoting 2 P. Areeda & H. Hovenkamp, Purchasers' claims are barred by the four-year statute of Antitrust Law ¶ 338b, at 145 (rev. ed. 1995)) (internal quotation marks omitted). In this way, "[a]lthough the business of a monopolist's rival may be injured at the continuing-violation exception is not applicable in the time the anticompetitive conduct occurs, a purchaser, by contrast, is not harmed until the monopolist actually agreement harms -- that is to say, the harms flowing from exercises its illicit power to extract an excessive price."

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_______________________________________________________________________________________________________________________________________________SCHERING CORPORATION, SCHERING-PLOUGH CORPORATION, VICTORIA L. McGILLS, R.N. ________________________________________________________________________On appeal from the Circuit Court of Cook County, Illinois,County Department, Law Division, No. 04 L 902

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MORGAN HILL UNIFIED SCHOOL DISTRICT SCIENCE STANDARDS FOR GRADE TWO (Board Adopted March 2001) [Bold print are the essential standards. ] STUDENTS WHO MEET THIS STANDARD WILL: *Italics indicate district standards exceed state standards Physical Sciences 1. The motion of objects can be observed and measured. As a basis for understanding this concept, students know: a.

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