IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY

Transcription

1 Case 3:12-cv PGS-DEA Document 152 Filed 09/14/12 Page 1 of 4 PageID: 2166 CONNELL FOLEY LLP 85 Livingston Avenue Roseland, New Jersey (973) WHITE & CASE LLP 1155 Avenue of the Americas New York, New York (212) Attorneys for Defendants Pfizer Inc., Pfizer Ireland Pharmaceuticals, Pfizer Manufacturing Ireland, Warner- Lambert Co., and Warner-Lambert Co. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY IN RE: LIPITOR ANTITRUST LITIGATION MDL No Master Docket No. 3:12-cv-2389 (PGS/DEA) This Document Relates to: ALL ACTIONS NOTICE OF MOTION FOR STAY PENDING SUPREME COURT DECISION IN IN RE K-DUR ANTITRUST LITIGATION PLEASE TAKE NOTICE that on October 15, 2012, or as soon thereafter as counsel can be heard, the undersigned counsel for Defendants Pfizer Inc., Pfizer Ireland Pharmaceuticals, Pfizer Manufacturing Ireland, Warner-Lambert Co.,

2 Case 3:12-cv PGS-DEA Document 152 Filed 09/14/12 Page 2 of 4 PageID: 2167 Warner-Lambert Co., LLC, Ranbaxy, Inc., Ranbaxy Pharmaceuticals, Inc., Ranbaxy Laboratories Limited, Daiichi Sankyo, Inc., CVS Caremark Corporation, and California Physicians Service, Inc. d/b/a Blue Shield of California (collectively, Defendants ) shall move before the Honorable Peter G. Sheridan, U.S.D.J., at the Clarkson S. Fisher Building and U.S. Courthouse, 402 East State Street, Trenton, New Jersey for the entry of an Order staying this matter pending resolution of proceedings before the U.S. Supreme Court in In re K-Dur Antitrust Litigation. PLEASE TAKE FURTHER NOTICE that in support of this Motion, Defendants shall rely upon the Brief in Support of the Motion and Declaration of Brendan G. Woodard, with exhibits annexed thereto, filed herewith and any replies that may be submitted. PLEASE TAKE FURTHER NOTICE that a proposed form of Order is submitted herewith. Dated: September 14, 2012 CONNELL FOLEY LLP /s/ Liza M. Walsh Liza M. Walsh 85 Livingston Avenue Roseland, New Jersey Telephone: (973) Facsimile: (973)

3 Case 3:12-cv PGS-DEA Document 152 Filed 09/14/12 Page 3 of 4 PageID: 2168 WHITE & CASE LLP 1155 Avenue of the Americas New York, New York Telephone: (212) Facsimile: (212) Attorneys for Defendants Pfizer Inc., Pfizer Ireland Pharmaceuticals, Warner-Lambert Co., and Warner-Lambert Co. LLC /s/ Michael E. Patunas Michael E. Patunas LITE DEPALMA GREENBERG, LLC Two Gateway Center, Suite 1201 Newark, New Jersey (973) mpatunas@litedepalma.com Attorneys for Defendants Ranbaxy Inc., Ranbaxy Pharmaceuticals, Inc., and Ranbaxy Laboratories Limited /s/ Melissa B. Francis Melissa B. Francis MAYER BROWN LLP 1675 Broadway New York, NY (212) mfrancis@mayerbrown.com Attorneys for Defendant California Physicians Service, Inc. d/b/a Blue Shield of California Life & Health Insurance Company /s/ Stuart C. Plunkett Stuart C. Plunkett MORRISON & FOERSTER LLP 425 Market Street

4 Case 3:12-cv PGS-DEA Document 152 Filed 09/14/12 Page 4 of 4 PageID: 2169 San Francisco, California (415) splunkett@mofo.com Attorneys for Defendant CVS Caremark Corporation /s/ Noah M. Leibowitz Harrison J. Frahn IV SIMPSON THACHER & BARTLETT LLP 2550 Hanover Street Palo Alto, CA (650) nleibowitz@stblaw.com Attorneys for Defendant Daiichi Sankyo, Inc

5 Case 3:12-cv PGS-DEA Document Filed 09/14/12 Page 1 of 26 PageID: 2170 UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY IN RE: LIPITOR ANTITRUST LITIGATION MDL No Master Docket No. 3:12-cv-2389 (PGS/DEA) This Document Relates to: ALL ACTIONS BRIEF IN SUPPORT OF MOTION FOR STAY PENDING SUPREME COURT DECISION IN IN RE K-DUR ANTITRUST LITIGATION CONNELL FOLEY LLP 85 Livingston Avenue Roseland, New Jersey (973) WHITE & CASE LLP 1155 Avenue of the Americas New York, New York (212) Attorneys for Defendants Pfizer Inc., Pfizer Ireland Pharmaceuticals, Pfizer Manufacturing Ireland, Warner-Lambert Co., and Warner-Lambert Co., LLC

6 Case 3:12-cv PGS-DEA Document Filed 09/14/12 Page 2 of 26 PageID: 2171 TABLE OF CONTENTS Page INTRODUCTION...1 BACKGROUND...4 ARGUMENT...7 I. Legal Standards...7 II. A Stay Will Simplify Issues And Promote Judicial Efficiency...8 III. A Stay Will Not Harm Plaintiffs...13 IV. A Stay Will Be Of Relatively Short Duration...15 V. The RP Healthcare Action Should Also Be Stayed...16 CONCLUSION...19 i

7 Case 3:12-cv PGS-DEA Document Filed 09/14/12 Page 3 of 26 PageID: 2172 TABLE OF AUTHORITIES CASES Andrx Pharm. Inc. v. Biovail Corp. Int l, 256 F.3d 799 (D.C. Cir. 2001)... 5 Apotex, Inc. v. Cephalon, Inc., No. 06-cv Ark. Carpenters Health & Welfare Fund v. Bayer AG, 604 F.3d 98 (2d Cir. 2010)... 4 Asahi Glass Co. v. Pentech Pharm., Inc., 289 F. Supp. 2d 986 (N.D. Ill. 2003) Bais Yaakov of Spring Valley v. Peterson s Nelnet, LLC, No , 2011 WL (D.N.J. Sept. 12, 2011)... 7, 8, 11, 16 Bechtel Corp. v. Local 215, Laborers Int l Union of N. Am., 544 F.2d 1207 (3d Cir. 1976)... 7, 8 Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007) Cent. Valley Chrysler-Jeep, Inc. v. Witherspoon, No , 2007 WL (E.D. Cal. Jan. 16, 2007) Christianson v. Colt Indus. Operating Corp., 486 U.S. 800 (1988) Cipro I & II, No. S (Cal. Feb. 15, 2012) F.T.C. v. Watson Pharm., Inc., 677 F.3d 1298 (11th Cir. 2012)... 4, 9 G.R. Homa v. Am. Express Co., No (JAP), 2010 WL (D.N.J. Oct. 18, 2010) Gong-Chun v. Aetna, Inc., No. 1:09-cv-01995, 2010 WL (E.D. Cal. May 17, 2010) In re Cardizem CD Antitrust Litig., 332 F.3d 896 (6th Cir. 2003)... 5 In re Cipro Cases I & II, No. S198616, Dkt. No. 65 (Cal. Sept. 11, 2012)... 4, 6, 17 In re Ciprofloxacin Hydrochloride Antitrust Litig., 544 F.3d 1323 (Fed. Cir. 2008) passim In re Ciprofloxacin Hydrochloride Antitrust Litigation, 363 F. Supp. 2d 514 (E.D.N.Y. 2005) ii

8 Case 3:12-cv PGS-DEA Document Filed 09/14/12 Page 4 of 26 PageID: 2173 In re Effexor XR Antitrust Litigation, No. 3:11-cv (JAP)(LHG), Dkt. No. 184 (Sept. 10, 2012)... 4 In re K-Dur Antitrust Litig., 686 F.3d 197 (3d Cir. 2012)... passim In re K-Dur Antitrust Litig. No , 2009 WL (D.N.J. Feb. 6, 2009)... 5, 6 In re Tamoxifen Citrate Antitrust Litig., 466 F.3d 187 (2d Cir. 2006)... 4, 5, 9 King Drug Co. of Florence, Inc. v. Cephalon, Inc., slip op., Dkt. No. 479 (E.D. Pa. Aug. 29, 2012)... passim Landis v. N. Am. Co., 299 U.S. 248 (1936)... 8 Marin Cnty. Bd. of Realtors, Inc. v. Palsson, 16 Cal. 3d 920 (Cal. 1976) McDonald v. Novartis Pharms., Corp., No , 2007 WL (D.N.J. Nov. 20, 2007)... 7, 11, 16 NicSand, Inc. v. 3M Co., 507 F.3d 442 (6th Cir. 2007) Resco Prods., Inc. v. Bosai Minerals Grp. Co., No , 2010 WL (W.D. Pa. June 4, 2010)... 13, 16 Richtek Tech. Corp. v. UPI Semiconductor Corp., No. C , 2011 WL (N.D. Cal. Feb. 3, 2011) Schering-Plough Corp. v. F.T.C., 402 F.3d 1056 (11th Cir. 2005)... 4, 6, 9 SmithKline Beecham Corp. v. Apotex Corp., No. 99-CV-4304, 2004 WL (E.D. Pa. July 16, 2004) Unitherm Food Sys., Inc. v. Swift-Eckrich, Inc., 375 F.3d 1341 (Fed. Cir. 2004) Valley Drug Co. v. Geneva Pharm., Inc., 344 F.3d 1294 (11th Cir. 2003)... 4 STATUTES AND RULES Fed. R. Civ. P. 12(c)... 12, 11 Sup. Ct. R. 10(a)...6 iii

9 Case 3:12-cv PGS-DEA Document Filed 09/14/12 Page 5 of 26 PageID: 2174 MISCELLANEOUS 3rd Cir. Pay-For-Delay Ruling Opens Door to High Court, Law360 (July 16, 2012), /3rd-circ-pay-fordelay-ruling-opens-door-to-high-court... 7 Case Distribution Schedule, October Term 12, available at f Dana A. Elfin, Third Circuit Says Reverse Payments In Drug Patent Cases Presumptively Illegal, Bloomberg BNA (July 17, 2012), 7 Lyle Denniston, K-Dur fight reaches Court, SCOTUSblog (Aug. 24, 2012), 7 Public Information Office of the Supreme Court of the United States, A Reporter s Guide to Applications Pending Before the Supreme Court of the United States, publicinfo.aspx iv

10 Case 3:12-cv PGS-DEA Document Filed 09/14/12 Page 6 of 26 PageID: 2175 Defendants Pfizer Inc., Pfizer Ireland Pharmaceuticals, Pfizer Manufacturing Ireland, Warner-Lambert Co., Warner-Lambert Co. LLC, Ranbaxy, Inc., Ranbaxy Pharmaceuticals, Inc., Ranbaxy Laboratories Limited, Daiichi Sankyo, Inc., CVS Caremark Corporation, and California Physicians Service, Inc. d/b/a Blue Shield of California (collectively, Defendants ) submit this memorandum in support of their motion to stay these consolidated actions pending resolution of proceedings before the U.S. Supreme Court in In re K-Dur Antitrust Litigation, 686 F.3d 197 (3d Cir. 2012) ( K-Dur ). INTRODUCTION The heart of Plaintiffs complaints is a challenge to the June 2008 agreement between Pfizer and Ranbaxy settling world-wide patent litigation regarding the blockbuster cholesterol medication Lipitor. Plaintiffs contend that this agreement is unlawful under the antitrust laws, including under Section 1 of the Sherman Act. In K-Dur, the Third Circuit adopted a standard for evaluating the legality of patent settlement agreements that involve reverse payments between innovator and generic pharmaceutical manufacturers that is at odds with all prior courts to have considered the issue. Plaintiffs have made clear that they intend to rely on K-Dur in challenging the Pfizer-Ranbaxy agreement, arguing in opposing Defendants Motion to Stay Discovery that their allegations as to that agreement clearly meet[] 1

11 Case 3:12-cv PGS-DEA Document Filed 09/14/12 Page 7 of 26 PageID: 2176 what the Third Circuit states is a prima facie case under K-Dur. 1 Defendants position is that K-Dur is inapplicable to the settlement at issue here (and even if it were, the Pfizer-Ranbaxy settlement is still lawful). Defendants also believe that K-Dur was wrongly decided and that the test applied by the majority of courts which focuses on whether the agreement at issue exceeds the scope of the patent is the correct one. The Pfizer-Ranbaxy settlement is clearly lawful under that standard. Staying these proceedings would allow this Court to decide the case once the legal uncertainty regarding the applicable standard has been resolved. Otherwise, that uncertainty may require the Court to revisit the issue and could complicate appellate review. Defendants also contend that the K-Dur standard does not apply because this matter is subject to the appellate jurisdiction of the Federal Circuit, not the Third Circuit. The question of appellate jurisdiction becomes especially important where the legal standards of the Third and Federal Circuits differ significantly as they do now in light of K-Dur. Compare In re K-Dur Antitrust Litig., 686 F.3d 197 (3d Cir. 2012), with In re Ciprofloxacin Hydrochloride Antitrust Litig., 544 F.3d 1323 (Fed. Cir. 2008) ( Cipro ). 1 Memorandum in Opposition to Defendants Motion to Stay, Dkt. No. 143, at 8 (Sept. 7, 2012); see also End-Payor Plaintiffs Memorandum in Opposition to Defendants Motion to Stay Discovery, Dkt. No. 145, at 6 (Sept. 7, 2012); End- Payor Plaintiffs Consolidated Class Action Complaint and Jury Demand, No , Dkt. No. 150 ( End-Payor Plts Compl. ) 302 (Sept. 10, 2012). 2

12 Case 3:12-cv PGS-DEA Document Filed 09/14/12 Page 8 of 26 PageID: 2177 The defendants in K-Dur have petitioned the Supreme Court for a writ of certiorari. Those petitions likely will be granted, and thus the Supreme Court may well provide guidance in the coming months on the proper standard for evaluating patent settlements. While Defendants are confident in prevailing even if K-Dur is applied here, it makes little sense for the parties to debate and for this Court to resolve the application of K-Dur, let alone the choice-of-law issues, before the Supreme Court speaks in K-Dur. Needless to say, proceeding with motions to dismiss if the Supreme Court rejects the legal standard sought to be applied by Plaintiffs would be a substantial waste of the parties and the Court s resources. Accordingly, in the interests of judicial economy, Defendants move to stay this matter pending resolution of Supreme Court proceedings in K-Dur. This Court has the discretion to order such a stay to prevent the needless duplication of proceedings and/or to maximize judicial efficiency. Faced with a similar prospect in a series of cases that, like here, challenge patent settlements and include claims of fraudulent patent procurement and sham patent enforcement, Judge Goldberg in the Eastern District of Pennsylvania just two weeks ago stayed and placed those cases on administrative suspension until proceedings before the Supreme Court in K-Dur are concluded. See King Drug Co. of Florence, Inc. v. Cephalon, Inc., slip op., 2:06-cv MSG, Dkt. No. 479 (E.D. Pa. Aug. 29, 2012), Declaration of 3

13 Case 3:12-cv PGS-DEA Document Filed 09/14/12 Page 9 of 26 PageID: 2178 Brendan G. Woodard ( Woodard Decl. ), Exhibit A. 2 In addition, the California Supreme Court on Wednesday, September 12, 2012, stayed a similar case challenging patent settlements pending Supreme Court action in K-Dur. See In re Cipro Cases I & II, No. S (Cal. Sept. 12, 2012) ( Cipro I & II ), Woodard Decl., Exhibit B. Defendants respectfully request that this Court do the same. 3 BACKGROUND Over the past decade, the unanimous rule in the federal courts of appeals has been that patent settlements consistent with the scope of the settled patent were lawful, barring fraud in the procurement of the patents or sham enforcement. See, e.g., F.T.C. v. Watson Pharm., Inc., 677 F.3d 1298 (11th Cir. 2012); Ark. Carpenters Health & Welfare Fund v. Bayer AG, 604 F.3d 98 (2d Cir. 2010); Cipro, 544 F.3d 1323; In re Tamoxifen Citrate Antitrust Litig., 466 F.3d 187 (2d Cir. 2006); Schering-Plough Corp. v. F.T.C., 402 F.3d 1056 (11th Cir. 2005); Valley Drug Co. v. Geneva Pharm., Inc., 344 F.3d 1294 (11th Cir. 2003); see also 2 Wyeth (Pfizer) and Teva have also moved before Judge Pisano in this District for a stay in In re Effexor XR Antitrust Litigation on this basis. See Mot. for Stay Pending Supreme Court Decision in In Re K-Dur Antitrust Litigation, In re Effexor XR Antitrust Litigation, No. 3:11-cv (JAP)(LHG), Dkt. No. 184 (Sept. 10, 2012). 3 Defendants separately moved to stay discovery pending this Court s resolution of Defendants forthcoming motions to dismiss, and believe that discovery should be stayed for the reasons set forth in that motion. The high likelihood of the Supreme Court granting the petitions for certiorari in K-Dur warrants staying this case in its entirety, including the briefing and resolution of motions to dismiss, pending the Supreme Court s review of K-Dur. 4

14 Case 3:12-cv PGS-DEA Document Filed 09/14/12 Page 10 of 26 PageID: 2179 In re K-Dur Antitrust Litig., No , 2009 WL (D.N.J. Feb. 6, 2009). Two early circuit court decisions addressed agreements falling outside the scope of the patents and are reconcilable with later courts scope of the patent test. In re Cardizem CD Antitrust Litig., 332 F.3d 896 (6th Cir. 2003); Andrx Pharm. Inc. v. Biovail Corp. Int l, 256 F.3d 799 (D.C. Cir. 2001); see Tamoxifen, 466 F.3d at (distinguishing Cardizem); K-Dur, 686 F.3d at (noting that Andrx defendants created bottleneck in generic entry by delaying 180-day exclusivity). The Third Circuit, however, rejected the majority rule with its decision in K-Dur, instead adopting a test under which any settlement involving a reverse payment even if within the scope of the patent is deemed presumptively unlawful. See K-Dur, 686 F.3d at 214 ( [W]e cannot agree with those courts that apply the scope of the patent test. ). In light of the clear circuit split this decision created, the defendants in K- Dur have filed petitions for certiorari, currently pending before the Supreme Court. Petition for Writ of Certiorari, Merck & Co. v. La. Wholesale Drug Co., No (Aug. 24, 2012); Petition for Writ of Certiorari, Upsher-Smith Labs., Inc. v. La. Wholesale Drug Co., No (Aug. 29, 2012). Certiorari is most likely to be granted when a United States court of appeals has entered a decision in conflict with the decision of another United States court of appeals on the same important matter... or has so far departed from the accepted and usual course of 5

15 Case 3:12-cv PGS-DEA Document Filed 09/14/12 Page 11 of 26 PageID: 2180 judicial proceedings, or sanctioned such a departure by a lower court, as to call for an exercise of [the Supreme] Court s supervisory power. Sup. Ct. R. 10(a). Here, there is a clear conflict between the Third Circuit s rule and those applied in the Second, Eleventh, and Federal Circuits. See K-Dur, 686 F.3d at (rejecting the majority rule). Indeed, the Third Circuit decided to apply a different standard to assess exactly the same agreements already found lawful by the Eleventh Circuit under the scope of the patent test. No clearer example of conflict between circuits is imaginable. 4 See Schering-Plough, 402 F.3d at 1076; K-Dur, 686 F.3d at 207, , 214. At least two courts a federal court in this Circuit and a state supreme court have already recognized the likelihood that the Supreme Court will grant certiorari and stayed proceedings similar to this one pending the Supreme Court s decision. See King Drug, Woodard Decl., Exhibit A, at 6; 5 Cipro I & II, Exhibit B, 4 The Eleventh Circuit s decision involved a challenge by the Federal Trade Commission ( FTC ) to agreements between Schering-Plough and generic manufacturers, whereas the Third Circuit case involves a challenge by private plaintiffs to the same agreements. See Schering-Plough, 402 F.3d at ; In re K-Dur, 2009 WL , at *10-12 (detailing the history of the FTC challenge). 5 The King Drug court s stay decision was motivated in part by a concern that, due to patent claims in one of the plaintiffs cases, the court might have to apply different legal standards to each plaintiff depending on whether or not the claim qualified for Federal Circuit jurisdiction. See King Drug, Woodard Decl., Exhibit A, at 4 ( [T]his Court could conceivably preside over two antitrust trials applying different legal standards to the same issue the Federal Circuit s scope of the 6

16 Case 3:12-cv PGS-DEA Document Filed 09/14/12 Page 12 of 26 PageID: 2181 at 1. Commentators widely expect certiorari to be granted. See, e.g., Dana A. Elfin, Third Circuit Says Reverse Payments In Drug Patent Cases Presumptively Illegal, Bloomberg BNA (July 17, 2012), 6 The odds of the Supreme Court granting the K-Dur petition doubtlessly are high. ARGUMENT I. Legal Standards The Court has broad power to stay proceedings. Bais Yaakov of Spring Valley v. Peterson s Nelnet, LLC, No , 2011 WL , at *2 (D.N.J. Sept. 12, 2011) (quoting Bechtel Corp. v. Local 215, Laborers Int l Union of N. Am., 544 F.2d 1207, 1215 (3d Cir. 1976)). It is well-settled that [i]n the exercise of its sound discretion, a court may hold one lawsuit in abeyance to abide the outcome of another which may substantially affect it or be dispositive of the issues. McDonald v. Novartis Pharm. Corp., No (JBS), 2007 WL , at *1 (D.N.J. Nov. 20, 2007) (quoting Bechtel, 544 F.2d at 1215) (alteration in original). There is no requirement that the parties in the case to be patent test could apply to Apotex s claims, and the Third Circuit s quick look rule of reason analysis would govern the other claims. ). 6 See also, e.g., Melissa Lipman, 3rd Cir. Pay-For-Delay Ruling Opens Door to High Court, Law360 (July 16, 2012), /3rd-circ-pay-for-delay-ruling-opens-door-to-high-court; Lyle Denniston, K-Dur fight reaches Court, SCOTUSblog (Aug. 24, 2012), 7

17 Case 3:12-cv PGS-DEA Document Filed 09/14/12 Page 13 of 26 PageID: 2182 stayed be the same as those in the continuing, controlling matter. See Landis v. N. Am. Co., 299 U.S. 248, (1936) (courts may stay proceedings pending outcome of controversy to which petitioning party is a stranger). Three factors typically are considered in determining whether to grant such a stay: [1] whether a stay will simplify issues and promote judicial economy, [2] the balance of harm to the parties, and [3] the length of the [] stay. Bais, 2011 WL , at *2 (quoting McDonald, 2007 WL , at *1) (alteration in original). Here, a stay is appropriate under each factor. II. A Stay Will Simplify Issues And Promote Judicial Efficiency Granting a stay pending the Supreme Court s review of K-Dur will simplify the issues in this case and promote judicial efficiency by avoiding repeat litigation and complicated appellate proceedings. Where another court s decision might eliminate a party s claims, it is appropriate to await that decision rather than potentially waste judicial resources. Bechtel, 544 F.2d at 1215 ( possibility that arbitration would eliminate legal claims sufficient justification to warrant the stay ); Bais, 2011 WL , at *2 ( [P]roceeding with the case despite the possibility of dismissal would be a waste of judicial resources. ). The Supreme Court s decision in K-Dur may eliminate Plaintiffs Section 1 claims in their entirety in at least two ways. 8

18 Case 3:12-cv PGS-DEA Document Filed 09/14/12 Page 14 of 26 PageID: 2183 First, the Supreme Court may adopt the majority scope of the patent test or something similar. Under that test, adopted by the Second, Eleventh, and Federal Circuits, patent settlements are lawful so long as the generic drug manufacturer does not agree to restrictions beyond the exclusionary scope of the underlying patents. See Watson, 677 F.3d at 1309; Cipro, 544 F.3d at ; Tamoxifen, 466 F.3d at ; Schering-Plough, 402 F.3d at Here, the Pfizer- Ranbaxy settlement agreement permitted Ranbaxy to begin marketing a generic Lipitor product in the United States on November 30, 2011, more than six years before the expiry of the last patent covering Lipitor. 7 There is no credible claim that the Pfizer-Ranbaxy settlement exceeds the scope of the Lipitor patents, and thus there is no doubt that Plaintiffs have no claim as to the Pfizer-Ranbaxy settlement. The standard in the Third Circuit, on which Plaintiffs appear to rely, does not follow the scope of the patent test, where the settlement includes a reverse payment. K-Dur holds that any reverse payment settlement is prima facie 7 Pfizer owns the following patents covering Lipitor whose expiration dates are after November 30, 2011: U.S. Patent No. 5,686,104 (expiring May 11, 2015), U.S. Patent No. 6,126,971 (expiring July 19, 2013), and U.S. Patent No. 5,969,156 (expiring January 8, 2017). See Woodard Decl., Exhibit C; see also Consolidated Amended Class Action Complaint and Jury Demand, Dkt. No. 149 ( Dir. Purch. Plts Compl. ) , 322. As Plaintiffs acknowledge, Pfizer also owns process patents relating to Lipitor that expire after November 30, See, e.g., Dir. Purch. Plts Compl. 195, 322; End-Payor Plts Compl. 244, 295 n.18. 9

19 Case 3:12-cv PGS-DEA Document Filed 09/14/12 Page 15 of 26 PageID: 2184 evidence of an unreasonable restraint of trade even if it creates no restraint on competition beyond the scope of the underlying patents. K-Dur, 686 F.3d at 218. The Third Circuit test does not apply here because the Pfizer-Ranbaxy settlement does not include a reverse payment, and because this matter is subject to the jurisdiction of the Federal Circuit. 8 Plaintiffs continued reliance on K-Dur, however, and therefore this Court s need to address it in response, creates legal uncertainty in light of the pending petitions before the Supreme Court. Were the Court to deny a motion to dismiss based on the Third Circuit s K-Dur decision, and the Supreme Court then to reverse the Third Circuit, this Court and the parties would be forced to repeat the process, most likely under Rule 12(c). 8 The Federal Circuit has jurisdiction here because Plaintiffs claims necessarily require resolution of a substantial question of federal patent law. Christianson v. Colt Indus. Operating Corp., 486 U.S. 800, 809 (1988). Plaintiffs claim that Pfizer fraudulently procured patents, enforced them through sham litigation, then wrongfully settled the litigation. These claims undeniably raise patent issues at the heart of the Federal Circuit s jurisdiction. See, e.g., Unitherm Food Sys., Inc. v. Swift-Eckrich, Inc., 375 F.3d 1341, (Fed. Cir. 2004). This case is thus substantively identical to the indirect purchaser claims in In re Ciprofloxacin Hydrochloride Antitrust Litigation, where, as here, plaintiffs asserted antitrust claims based on patents allegedly procured by fraud on the PTO, then enforced by sham litigation, then settled. 363 F. Supp. 2d 514, , 519 (E.D.N.Y. 2005). The Walker Process claims caused the Second Circuit to transfer the antitrust case to the Federal Circuit, which validated the settlements as within the scope of the patent and held that settlements otherwise within the scope of the patent themselves implicate patent issues (due to the need to show that the settled patent was fraudulent or sham). Cipro, 544 F.3d at 1330,

20 Case 3:12-cv PGS-DEA Document Filed 09/14/12 Page 16 of 26 PageID: 2185 Second, even if the Supreme Court articulated an analysis similar to the K- Dur rule, its decision may clarify how that rule is to be applied, particularly in cases like this one where there was no reverse payment such as the cash payment at issue in K-Dur. The Court may explicitly instruct that such a rule is limited to cases involving reverse payments of the type at issue in K-Dur. If so, that would likewise conclude this matter as Plaintiffs do not, and cannot, allege any such cash payments from Pfizer to Ranbaxy. Given that consideration of Plaintiffs Section 1 claims will certainly be simplified and may well be eliminated by the Supreme Court s decision in K-Dur, proceeding before the Supreme Court has spoken would waste judicial resources. Bais, 2011 WL , at *2 (staying case because of waste of judicial resources where outcome of pending case may be dispositive); McDonald, 2007 WL , at *3 (same); Bounds, 2010 WL , at *2 (same). Furthermore, allowing this case to proceed would risk an inefficient expenditure of the parties efforts in briefing, and the Court s efforts in deciding, motions to dismiss. For example, the Supreme Court may rule on K-Dur after this Court has expended significant effort reviewing extensive briefing and exhibits, and the ruling may require re-briefing or re-argument. Similarly, although this Court should grant the motions to dismiss, if it does so while K-Dur is pending before the Supreme Court, the Court of Appeals could remand in light of the new 11

21 Case 3:12-cv PGS-DEA Document Filed 09/14/12 Page 17 of 26 PageID: 2186 standard. Indeed, even should this Court deny the motions to dismiss, a decision in K-Dur inevitably would necessitate another round of motions under Fed. R. Civ. P. 12(c). Continuing with motions to dismiss while K-Dur is before the Supreme Court would create a substantial risk of inefficiently using the Court s and parties efforts and resources. To the extent that Plaintiffs argue that some aspects of the case should proceed while the challenge to the patent settlement is stayed, such a piecemeal approach would be inefficient and a waste of resources. See Gong-Chun v. Aetna, Inc., No. 1:09-cv-01995, 2010 WL , at *4 (E.D. Cal. May 17, 2010) (refusing to proceed piecemeal ); see also Richtek Tech. Corp. v. UPI Semiconductor Corp., No. C , 2011 WL , at *6 (N.D. Cal. Feb. 3, 2011) (same). Indeed, although King Drug involved the very same types of overall scheme claims at issue here, including not only patent settlement, but also Walker Process and sham litigation claims, Judge Goldberg stayed the entire matter pending the Supreme Court s decision in K-Dur. See King Drug, Woodard Decl., Exhibit A, at 6; Apotex s Second Amended Complaint at 19, 30-31, 59-60, 67-68, Apotex, Inc. v. Cephalon, Inc., No. 06-cv-2768 (E.D. Pa. Jan. 6, 2010), Dkt. No And although the plaintiffs there argued that certain patent and class certification issues would not depend on K-Dur, the court rejected this argument 12

22 Case 3:12-cv PGS-DEA Document Filed 09/14/12 Page 18 of 26 PageID: 2187 noting that until the Supreme Court spoke it would be impossible to determine the reach of its opinion. King Drug, Woodard Decl., Exhibit A, at 5. Granting a stay of this case, including the filing of motions to dismiss due October 25, would simplify the issues to be decided and promote judicial efficiency. III. A Stay Will Not Harm Plaintiffs The balance of harms also favors a stay because the burdens of proceeding far outweigh any concerns that Plaintiffs might have regarding a slight postponement. Courts do not hesitate to grant stays where there is a significant risk, as there is here, that the Court s and the parties efforts will be wasted. See G.R. Homa v. Am. Express Co., No (JAP), 2010 WL , at *9 (D.N.J. Oct. 18, 2010); Resco Prods., Inc. v. Bosai Minerals Grp. Co., No , 2010 WL , at *7 (W.D. Pa. June 4, 2010); Bounds, 2010 WL , at *3. As discussed, commencing briefing and consideration of motions to dismiss in this case would risk imposing substantial burdens on the Court and the parties. Further, in the event that the Court denies the motions to dismiss, any discovery conducted would be shaped by the then-existing legal standard one that may change once the Supreme Court has ruled in K-Dur. Courts, including the Supreme Court, have stressed that antitrust litigation, including discovery, is 13

23 Case 3:12-cv PGS-DEA Document Filed 09/14/12 Page 19 of 26 PageID: 2188 extraordinarily difficult and burdensome and should not be undertaken lightly. See, e.g., Bell Atl. Corp. v. Twombly, 550 U.S. 544, (2007) (antitrust cases have potentially enormous expense of discovery ); NicSand, Inc. v. 3M Co., 507 F.3d 442, 450 (6th Cir. 2007); Asahi Glass Co. v. Pentech Pharm., Inc., 289 F. Supp. 2d 986, 995 (N.D. Ill. 2003) (Posner, J.) ( patent antitrust case will have inevitably costly and protracted discovery phase ). For example, K-Dur calls for an inquiry into possible procompetitive justifications for the terms of the agreement. See K-Dur, 686 F.3d at 218. The discovery and factual development of such claims alone would be burdensome, involving significant factual and expert development, none of which would be necessary under the scope of patent test. Defendants would be substantially harmed by such expensive and wasteful discovery proceedings. Plaintiffs face no comparable injury from any temporary stay of this case. Their alleged damages were sustained in a finite window that is now closed. Generic Lipitor entered the market almost one year ago, and the only remaining question is whether direct purchaser plaintiffs may recover for an alleged delay in that entry. See King Drug, Woodard Decl., Exhibit A, at 4-5. Indeed, Plaintiffs delayed the filing of their lawsuits for more than three years after the Pfizer- Ranbaxy settlement. There is no argument that Plaintiffs need an immediate resolution to preserve or protect their businesses from any alleged injury, and no 14

24 Case 3:12-cv PGS-DEA Document Filed 09/14/12 Page 20 of 26 PageID: 2189 Plaintiff here alleges that it is in danger of going out of business as a result of the alleged misconduct. See SmithKline Beecham Corp. v. Apotex Corp., No. 99-CV- 4304, 2004 WL , at *8-9 (E.D. Pa. July 16, 2004) (stay would not harm party that continued to sell materials to generic producers despite pending litigation); Cent. Valley Chrysler-Jeep, Inc. v. Witherspoon, No , 2007 WL , at *15 (E.D. Cal. Jan. 16, 2007) (granting stay pending Supreme Court decision where as a practical matter, Plaintiffs are unlikely to suffer any inequity or hardship from a six-month stay of proceedings ). The balance of harm accordingly favors a stay pending the Supreme Court s decision in K-Dur. IV. A Stay Will Be Of Relatively Short Duration Finally, a stay will likely be short in duration, particularly when considering the significant benefit to judicial efficiency discussed above. Petitions for certiorari already have been filed in the K-Dur matter, well in advance of the deadline for doing so. With respondents opposition briefs due soon, the Supreme Court should decide whether to grant the petitions in November or December. The petitions should be scheduled for consideration at the Court s November 20, 2012, conference, meaning that the disposition of the petitions ordinarily would be announced on November 26. Public Information Office of the Supreme Court of the United States, A Reporter s Guide to Applications Pending Before the 15

25 Case 3:12-cv PGS-DEA Document Filed 09/14/12 Page 21 of 26 PageID: 2190 Supreme Court of the United States, at 16, available at (noting that petitions are typically considered within six weeks); Case Distribution Schedule, October Term 12, available at (last visited Sept. 12, 2012); see also McDonald, 2007 WL , at *3; Bais, 2011 WL , at *2 (staying a case pending Supreme Court s decision within the year); Resco, 2010 WL , at *6 ( [T]he court does not agree with plaintiff s position that staying the proceedings for six to twelve months would be substantially prejudicial. ). Thus, even if the Court denied certiorari, the stay would be very short and any cost would be minimal. Even if certiorari is granted, however, the stay likely would not last beyond June of next year: argument likely would be calendared for the spring of 2013, with a decision following by the end of the term in June At the same time, a grant of certiorari makes a stay even more compelling. A reasonable stay of the motions to dismiss while awaiting such resolution would be appropriate under the circumstances. V. The RP Healthcare Action Should Also Be Stayed Plaintiffs in the RP Healthcare action, which currently is consolidated as part of this MDL, moved for remand to California state court. See RP Healthcare 16

26 Case 3:12-cv PGS-DEA Document Filed 09/14/12 Page 22 of 26 PageID: 2191 Plaintiffs Motion to Remand, Dkt. No. 111 (Aug. 13, 2012). As set forth in Defendants September 7, 2012, Opposition to the RP Healthcare Plaintiffs Motion to Remand, see Dkt. No. 146, the RP Healthcare action should remain in federal court as part of MDL No Any attempt by the RP Healthcare Plaintiffs to argue that their case should not be stayed because their claims arise only under California state law and are not governed by the Third Circuit s decision in K-Dur should be rejected. The standard for evaluating the legality of patent settlement agreements under California law is presently under review by the California Supreme Court in the Cipro case noted above. See Cipro I & II, No. S (Cal. Feb. 15, 2012) (granting petition to review). On September 12, 2012, however, the California Supreme Court, on its own motion, stayed the case pending action by the Supreme Court in K-Dur. See Cipro I & II, Woodard Decl., Exhibit B. Therefore, the California Supreme Court may take into consideration the U.S. Supreme Court s treatment of the overall issues in K-Dur. See Marin Cnty. Bd. of Realtors, Inc. v. Palsson, 16 Cal. 3d 920, 925 (Cal. 1976) ( A long line of California cases has concluded that the Cartwright Act is patterned after the Sherman Act and both statutes have their roots in the common law. Consequently, federal cases interpreting the Sherman Act are applicable to problems arising under the Cartwright Act. ). A stay of these consolidated actions, including the RP 17

27 Case 3:12-cv PGS-DEA Document Filed 09/14/12 Page 23 of 26 PageID: 2192 Healthcare case, is appropriate for the additional reason of allowing the California Supreme Court to render a decision in Cipro I & II. That decision will be material to this Court s determination of Defendants forthcoming motions to dismiss the California claims asserted by the RP Healthcare Plaintiffs and also alleged in 17 other actions that are part of the MDL before this Court. Judicial economy also counsels strongly against permitting the RP Healthcare case to proceed, while the other actions consolidated in this MDL might be stayed, given the overlap between the claims and underlying conduct in that case with the others. See Defendants Opposition to RP Healthcare Plaintiffs Motion to Remand, Dkt. No

28 Case 3:12-cv PGS-DEA Document Filed 09/14/12 Page 24 of 26 PageID: 2193 CONCLUSION For the foregoing reasons, Defendants respectfully request that the Court stay these consolidated actions pending the Supreme Court s resolution of the K- Dur matter. Dated: September 14, 2012 Respectfully submitted, CONNELL FOLEY LLP /s/ Liza M. Walsh Liza M. Walsh CONNELL FOLEY LLP 85 Livingston Avenue Roseland, NJ (973) lwalsh@connellfoley.com WHITE & CASE LLP 1155 Avenue of the Americas New York, NY Attorneys for Defendants Pfizer Inc., Pfizer Ireland Pharmaceuticals, Warner-Lambert Co., and Warner- Lambert Co. LLC /s/ Michael E. Patunas Michael E. Patunas LITE DEPALMA GREENBERG, LLC Two Gateway Center, Suite 1201 Newark, New Jersey

29 Case 3:12-cv PGS-DEA Document Filed 09/14/12 Page 25 of 26 PageID: 2194 (973) Attorneys for Defendants Ranbaxy Inc., Ranbaxy Pharmaceuticals, Inc., and Ranbaxy Laboratories Limited /s/ Melissa B. Francis Melissa B. Francis MAYER BROWN LLP 1675 Broadway New York, NY (212) Attorneys for Defendant California Physicians Service, Inc. d/b/a Blue Shield of California Life & Health Insurance Company /s/ Stuart C. Plunkett Stuart C. Plunkett MORRISON & FOERSTER LLP 425 Market Street San Francisco, California (415) Attorneys for Defendant CVS Caremark Corporation /s/ Noah M. Leibowitz Harrison J. Frahn IV SIMPSON THACHER & BARTLETT LLP 2550 Hanover Street Palo Alto, CA (650)

30 Case 3:12-cv PGS-DEA Document Filed 09/14/12 Page 26 of 26 PageID: 2195 Attorneys for Defendant Daiichi Sankyo, Inc. 21

31 Case 3:12-cv PGS-DEA Document Filed 09/14/12 Page 1 of 29 PageID: 2196 Liza M. Walsh CONNELL FOLEY LLP 85 Livingston Avenue Roseland, New Jersey WHITE & CASE LLP 1155 Avenue of the Americas New York, NY Attorneys for Defendants Pfizer Inc., Pfizer Manufacturing Ireland, Pfizer Ireland Pharmaceuticals, Warner-Lambert Co., and Warner-Lambert Co. LLC UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY IN RE: LIPITOR ANTITRUST LITIGATION This Document Relates to: ALL ACTIONS ) ) ) ) ) ) ) ) ) ) ) ) ) MDL No Master Docket No. 3:12-cv-2389 (PGS/DEA) DECLARATION OF BRENDAN G. WOODARD IN SUPPORT OF DEFENDANTS MOTION FOR STAY PENDING SUPREME COURT DECISION IN IN RE K- DUR ANTITRUST LITIGATION I, Brendan G. Woodard, declare as follows: 1. I am an attorney at law and am duly licensed to practice law in the State of New York and am admitted pro hac vice before this Court in the above-captioned matter. I am a partner in the law firm of White & Case LLP, counsel of record for Defendants Pfizer Inc., Pfizer Manufacturing Ireland, Pfizer Ireland Pharmaceuticals, Warner Lambert Co., and Warner

32 Case 3:12-cv PGS-DEA Document Filed 09/14/12 Page 2 of 29 PageID: 2197 Lambert Company LLC ( Pfizer ). I submit this declaration in support of Defendants Motion for Stay Pending Supreme Court Decision in In Re K-Dur Antitrust Litigation. 2. Attached hereto as Exhibit A is a true and correct copy of an Order in King Drug Co. of Florence, Inc. v. Cephalon, Inc., slip op., 2:06-cv MSG, Dkt. No. 479 (E.D. Pa. Aug. 29, 2012). 3. Attached hereto as Exhibit B is a true and correct copy of an Order in In re Cipro Cases I & II, No. S (Cal. Sept. 12, 2012). 4. Attached hereto as Exhibit C is a true and correct copy of U.S. Food and Drug Administration, Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations, Lipitor, available at (last visited Sept. 13, 2012). I declare under penalty of perjury that the foregoing is true and correct. Dated: September 14, 2012 Brendan G. Woodard 2

33 Case 3:12-cv PGS-DEA Document Filed 09/14/12 Page 3 of 29 PageID: 2198 EXHIBIT A

34 Case 3:12-cv PGS-DEA Case 2:06-cv MSG Document Document Filed Filed 09/14/12 08/29/12 Page Page 4 of 129 of PageID: IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA : KING DRUG COMPANY OF FLORENCE, INC., : CIVIL ACTION et al., : Plaintiffs, : : v. : No. 2:06-cv-1797 : CEPHALON, INC., et al., : Defendants. : : VISTA HEALTHPLAN, INC., et al., : CIVIL ACTION Plaintiffs, : : v. : No. 2:06-cv-1833 : CEPHALON, INC., et al., : Defendants. : : : APOTEX, INC., : CIVIL ACTION Plaintiff, : : v. : No. 2:06-cv-2768 : CEPHALON, INC., et al., : Defendants. : : : FEDERAL TRADE COMMISSION, : CIVIL ACTION Plaintiff, : : v. : No. 2:08-cv-2141 : CEPHALON, INC., : Defendant. : :

35 Case 3:12-cv PGS-DEA Case 2:06-cv MSG Document Document Filed Filed 09/14/12 08/29/12 Page Page 5 of 29 of PageID: ORDER th AND NOW, this 29 day of August, 2012, after review of the Third Circuit Opinion in In re K-Dur Antitrust Litigation, 686 F.3d 197 (3d Cir. Jul. 16, 2012), we find as follows: 1. After ruling on the patent claims asserted in Apotex v. Cephalon, Dkt. No. 2:06-cv- 2768, the Court issued a briefing schedule for motions concerning the effect of the patent rulings on the antitrust claims that are still pending in this litigation. Plaintiffs filed motions on this issue on January 20, 2012, and briefing was complete at the end of March On April 12, 2012, the Court dismissed these motions without prejudice, pending the decision of the United States Court of Appeals for the Third Circuit in In re K-Dur. 2. On July 16, 2012, the Third Circuit issued its opinion in In re K-Dur, finding that reverse payment settlements are subject to a quick look rule of reason analysis. 618 F.3d at 218. Under this test, any payment from a patent holder to a generic patent challenger who agrees to delay entry into the market [is] prima facie evidence of an unreasonable restraint of trade, which [may] be rebutted by showing that the payment (1) was for a purpose other than delayed entry or (2) offers some procompetitive benefit. Id. 3. In applying a quick look rule of reason analysis, the Third Circuit rejected the scope of the patent test adopted by the United States Courts of Appeals for the Second, Eleventh and Federal Circuits. See In re Tamoxifen Citrate Antitrust Litig., 466 F.3d 187 (2d Cir. 2006); In re Ciprofloxacin Hydrochloride Antitrust Litig., 544 F.3d 1323 (Fed. Cir. 2008); FTC v. Watson Pharms, Inc., 2012 WL (11th 2

36 Case 3:12-cv PGS-DEA Case 2:06-cv MSG Document Document Filed Filed 09/14/12 08/29/12 Page Page 6 of 329 of PageID: Cir. Apr. 25, 2012). The Third Circuit s analysis also differed somewhat from the approach taken by the United States Courts of Appeals for the Sixth and D.C. Circuits in In re Cardizem CD Antitrust Litig., 332 F.3d 896 (6th Cir. 2003) and Andrx Pharms., Inc. v. Biovail Corp., Int l, 256 F.3d 799 (D.C. Cir. 2001). 4. On August 7, 2012, this Court held a telephone conference to discuss how to best proceed in light of the Third Circuit s ruling in In re K-Dur. Plaintiffs urged that because their claims have been pending for as long as six years, the antitrust litigation should proceed. Plaintiffs requested that the Court set a briefing schedule for the re- 1 filing of motions regarding the collateral effect of the Court s patent rulings, as well as summary judgment and class certification motions. In Plaintiffs view, the ruling in In re K-Dur removed any uncertainty regarding the legal standard applicable to their antitrust claims. 5. Defendants, on the other hand, argued that the antitrust litigation should be stayed given the continuing uncertainty regarding the applicable antitrust legal standard. Defendants stressed the potential for the United States Supreme Court to clarify the applicable standard should it review the Third Circuit s decision in In re K-Dur. In Defendants view, there is a strong likelihood that a petition will be filed, and, given the present disagreement among the federal circuits, that the Supreme Court will grant the writ. Defendants urged that clarification of the legal standard would impact class certification, summary judgment and the collateral effect of the patent rulings 1 The FTC, although urging the Court to proceed with its claims, stated that it no longer intends to ask the Court to give its patent rulings collateral effect. 3

37 Case 3:12-cv PGS-DEA Case 2:06-cv MSG Document Document Filed Filed 09/14/12 08/29/12 Page Page 7 of 429 of PageID: in the present case, and that the Court should refrain from setting a briefing schedule on any motions until clarity is obtained regarding litigation in the Supreme Court. 6. We are sympathetic to Plaintiffs position. Given how long their claims have been pending, Plaintiffs desire to proceed toward resolution of this case is certainly understandable. However, to a large extent, the value of such resolution depends upon its finality. It makes little sense to rule upon important motions and proceed to a protracted antitrust trial, while the applicable legal standards governing those motions and trial are subject to review by the Supreme Court. 7. Cephalon also points out that, because the Apotex antitrust case was brought alongside the patent claims, both claims could be subject to review by the Federal Circuit, which, as noted above, applies the scope of the patent test to antitrust matters. Thus, if Cephalon s supposition is correct, this Court could conceivably preside over two antitrust trials applying different legal standards to the same issue the Federal Circuit s scope of the patent test could apply to Apotex s claims, and the Third Circuit s quick look rule of reason analysis would govern the other claims. While we cannot predict whether the Supreme Court will resolve the disagreement among the circuit courts, it seems imprudent to proceed while clarification by the Supreme Court remains a possibility. 8. Under these circumstances, we conclude that the interests of judicial administration outweigh Plaintiffs interest in speedy resolution of their claims. This is particularly so in light of Cephalon s undisputed representation that generic drug companies have entered the modafinil market. Accordingly, there is no concern that delay could 4

38 Case 3:12-cv PGS-DEA Case 2:06-cv MSG Document Document Filed Filed 09/14/12 08/29/12 Page Page 8 of 529 of PageID: cause Plaintiffs additional alleged injury. Rather, it appears that Plaintiffs (other than the FTC), if they establish liability, will be limited to monetary damages for the period when Cephalon precluded generic competition through the reverse payment agreements at issue a period which may now be closed by virtue of the entry of generic competition into the market. 9. Finally, we disagree with Plaintiffs argument that neither the collateral effect of the Court s patent rulings nor class certification will be affected by the legal standard applicable to the merits of their antitrust claims. Collateral estoppel applies to bar relitigation of identical issues. Parklane Hosiery Co., Inc. v. Shore, 439 U.S. 322, 330 (1979). The issues relevant to Plaintiffs antitrust claims plainly depend upon the legal standard applicable to those claims. Similarly, the legal standard significantly impacts the question of class certification, which is only appropriate in antitrust cases where plaintiffs can show, by a preponderance of the evidence, that proof of the essential elements of the cause of action... do not require individual treatment. In re K-Dur, 686 F.3d at (citing In re Hydrogen Peroxide, 522 F.3d 305, 307, 311 (3d Cir. 2008)). The class certification question therefore requires an assessment of Plaintiffs evidence in relation to the elements they must prove at trial. Id. 10. Counsel are directed to submit a joint report to the Court on or before October 31, 2012, regarding the status of litigation in the Supreme Court in the In re K-Dur case, or any other Supreme Court litigation pertaining to the antitrust legal standards applied to reverse payment settlement agreements (e.g., FTC v. Watson Pharms, Inc., 5

39 Case 3:12-cv PGS-DEA Case 2:06-cv MSG Document Document Filed Filed 09/14/12 08/29/12 Page Page 9 of 629 of PageID: WL (11th Cir. Apr. 25, 2012)). WHEREFORE, for the reasons set forth above, the antitrust matters pending before this Court will be stayed until it is known whether the United States Supreme Court will resolve the disagreement among the Circuit Courts of Appeal as to the legal standard applicable to Plaintiffs antitrust claims. It is thus hereby ORDERED that the above matters shall be placed in SUSPENSE. The Clerk of Court is directed to mark these matters CLOSED for statistical purposes. BY THE COURT: /s/ Mitchell S. Goldberg Mitchell S. Goldberg, J. 6