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. RuleActavis, 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 Ciprofloxacin2d 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. atAntitrust Litig. ("Tamoxifen"), 466 F.3d 187, 212-13 (2d555. 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 CrossApp. 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 133R.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 KodakCo. 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 PoolBuilders, 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., 495Caribbean Petroleum Corp., 79 F.3d 182, 196-97 (1stU.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 (7thCir. 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., 486644 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 EstateInvestors, 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. July26, 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."
Charging Lithium Polymer (Li-Po) Cells 1. Maximum individual Cell voltage during charge cycle is 4.2 volts per cell. – DO NOT EXCEED MAXIMUM- For 6 cells: 6 cells X 4.2 volts/cell = 25.2 volts 2. Minimum cell voltage during discharge cycle is 3.0 volts per cell. – DO NOT DISCHARGE BELOW MINIMUM- For 6 cells: 6 cells X 3.0 volts/cell = 18.0 volts If a cell is discharged below 3.0 volts,
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IN RE NEXIUM (ESOMEPRAZOLE) ANTITRUST LITIGATION