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05-2851-cv(l)

UNITED STATES COURT OF APPEALS FOR THE SECOND CIRCUIT ARKANSAS CARPENTERS HEALTH AND WELFARE FUND, MARIA LOCURTO, PAPER, ALLIED-INDUS, UNITED FOOD AND COMMERCIAL WORKERS UNION-EMPLOYER, LOUISIANA WHOLESALE DRUG CO., INC., CVS PHARMACY, INC., RITE AID CORPORATION, ARTHUR'S DRUG STORE, INC. SOL LUBIN, ANN STUART, LINDA K. MCINTYRE, PLAINTIFFS, -AGAINST- BAYER AG, BAYER CORP., FORMERLY DOING BUSINESS AS MILES INC. HOECHST MARION ROUSSEL, INC., THE RUGBY GROUP, INC., WATSON PHARMACEUTICALS, INC., BARR LABORATORIES INC., On Appeal from the United States District Court for the Eastern District of New York Brief Of 34 State Attorneys General As Amici Curiae In Support Of Petition For
Rehearing En Banc Filed By Appellants Louisiana Wholesale Drug Co., Inc.,
CVS Pharmacy, Inc., Rite Aid Corporation, and Arthur's Drug Store, Inc.
EDMUND G. BROWN JR. WILLIAM H. SORRELL ATTORNEY GENERAL OF CALIFORNIA ATTORNEY GENERAL OF VERMONT Cheryl Lee Johnson Sarah E.B. London Counsel of Record 109 State Street ATTORNEY GENERAL OF FLORIDA Montpelier, Vermont 05609-1001 Elizabeth G. Arthur Counsel for Amici Curiae *05-2863-cv has been transferred to the Federal Circuit Court of Appeals. See order filed 11/7/09. TABLE OF CONTENTS
TABLE OF AUTHORITIES . ii
STATEMENT OF INTEREST OF AMICI CURIAE . 1
BACKGROUND . 3
ARGUMENT . 3
CONCLUSION . 8
CERTIFICATE OF SERVICE . 10
TABLE OF AUTHORITIES
Alabama v. Bristol-Myers Squibb Co., No. 01-cv-11401 (S.D.N.Y. 2002) (In re Buspirone Antitrust Litig., 185 F. Supp. 2d 340 (S.D.N.Y. 2002)) . 2 Ark. Carpenters Health & Welfare Fund v. Bayer AG os. 05-2851-cv(L), 05-2852-cv(CON), 2010 WL 1710683 (2d Cir. Apr. 29, 2010) . passim Cafeteria & Rest. Workers Union, Local 473 v. McElroy, 284 F.2d 173 (D.C. Cir. Eisen v. Carlisle & Jacquelin, 479 F.2d 1005 (2d Cir. 1973) . 7 Florida v. Abbott Labs(In re Terazosin Hydrochloride Antitrust Litig., 352 F. Supp. 2d 1279 (S.D. Fla. 2005)).…….2, 7 In re Cardizem CD Antitrust Litigation, 332 F.3d 896 (6th Cir. 2003) . 2, 6, 7 Joblove v. Barr Labs., Inc., 466 F.3d 187 (2d Cir. 2006) . passim King Drug Co. v. Cephalon, No. 6-cv-1797, 2010 WL 1221793 (E.D. Pa. Mar. 29, Lanza v. Drexel & Co., 479 F.2d 1277 (2d Cir. 1973) . 7 New York v. Aventis S.A., No. 01-cv-71835 (E.D. Mich. 2001) (In re Cardizem CD Antitrust Litigation, 332 F.3d 896 (6th Cir. 2003)) . 2 Ohio v. Bristol-Myers Squibb Co., No. 02-cv-01080, 2003 WL 21105104 (D.D.C. State Oil Co. v. Khan, 522 U.S. 3 (1997) . 4 Valley Drug Co. v. Geneva Pharms., Inc., 344 F.3d 1294 (11th Cir. 2003) . 7 Statutes and Rules
Drug Price Competition and Patent Term Restoration Act of 1984 (the "Hatch- Waxman Act") 35 U.S.C. § 271(e)(1) (2000) . 3, 4, 5, 8 FED. R. APP. P. 35(a) . 3
Other Authorities

Brief Amici Curiae of 28 Professors of Law, Business, and Economics in Support of Appellants, In re Ciprofloxacin Hydrochloride Antitrust Litigation, 544 F.3d 1323 (Fed. Cir. 2008) (No. 08-1097), 2008 WL 644392. 4
Brief of States as Amici Curiae in Support of FTC in FTC v. Schering-Plough
Corp., 548 U.S 919 (2006) (No. 05-273), 2005 WL 2454839 . 4 David Reiffen & Michael R. Ward, Generic Drug Industry Dynamics, 87 Rev. Econ. & Stat. 37 (2005)………………………………………………………….2 Federal Trade Commission, Generic Drug Entry: Prior to Patent Expiration (July 2002), available at .5 Food and Drug Administration, Center for Drug Evaluation and Research, Generic Competition and Drug Prices (2010), available at 2 Kaiser Family Foundation, Prescription Drug Trends (2008), available at Scott Hemphill, An Aggregate Approach to Antitrust: Using New Data and Rulemaking to Preserve Drug Competition, 109 Colum. L. Rev. 629 (2009) . 5 INTEREST OF AMICI
The Attorneys General of Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Hawaii, Idaho, Illinois, Iowa, Kentucky, Maine, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, Montana, Nevada, New Hampshire, New Mexico, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, West Virginia, and Wyoming are the chief law enforcement or legal officials of their respective states. The Attorneys General have a long history of enforcing state and federal antitrust laws, and protecting consumers and state entities from actions that unlawfully thwart competition. The Attorneys General have a strong interest in this case because the agreement entered into by Bayer AG and its subsidiary, Bayer Corporation (collectively "Bayer") and Barr Laboratories, Inc. ("Barr") allegedly delayed the entry of generic ciprofloxacin for six and a half years, reducing both consumers' and state entities' access to lower cost antibiotics. The Attorneys General are uniquely situated to provide the Court with guidance regarding the analytical framework for evaluating reverse payment agreements. As parens patriae representatives of consumers and as representatives of the states' proprietary interests, the Attorneys General have prosecuted several antitrust cases against pharmaceutical companies involving reverse payment settlements of patent infringement suits.1 As a result, the Attorneys General have insight into the policy concerns implicated by such agreements, including the detrimental effect these agreements have on consumers and state entities. Access to affordable prescription medication is particularly important to the states and their consumers during these difficult economic times. Government entities pay approximately 33% of the $234 billion spent on drugs in the United States per year.2 Competition from generic drug manufacturers is critical to the affordability of drugs – competition decreases the price of prescription drugs by 20% to 80% or more.3 However, reverse payment agreements are expressly designed to delay and prevent competition in pharmaceutical markets. The interest of the Attorneys General in this case is that antitrust law be interpreted consistent 1See, e.g., Florida v. Abbott Labs., No. 01-4006 (S.D. Fla. 2005) (In re Terazosin Hydrochloride Antitrust Litig., 352 F. Supp. 2d 1279 (S.D. Fla. 2005)) ("Hytrin"); Ohio v. Bristol-Myers Squibb Co., No. 02-cv-01080, 2003 WL 21105104 (D.D.C. 2003); New York v. Aventis S.A., No. 01-cv-71835 (E.D. Mich. 2001) (In re Cardizem CD Antitrust Litig., 332 F.3d 896 (6th Cir. 2003)); Alabama v. Bristol-Myers Squibb Co., No. 01-cv-11401 (S.D.N.Y. 2002) (In re Buspirone Antitrust Litig., 185 F. Supp. 2d 340 (S.D.N.Y. 2002)). 2Kaiser Family Foundation, Prescription Drug Trends 1 (2008), available at 3Food and Drug Administration, Center for Drug Evaluation and Research, Generic Competition and Drug Prices (2010), available at David Reiffen & Michael R. Ward, Generic Drug Industry Dynamics, 87 Rev. Econ. & Stat. 37, 38 (2005). with the spirit of the Hatch-Waxman Act,4 and in a manner that serves the public interest and promotes competition. Background
On April 29, 2010, a panel of this Court entered an order affirming summary judgment for the defendants in Arkansas Carpenters Health & Welfare Fund v. stating that it was bound by its earlier decision in Joblove v. Barr Laboratories, Inc. (In re Tamoxifen Citrate Antitrust Litigation) ("Tamoxifen"),6 and therefore the plaintiffs' claims in Cipro could not survive. The Cipro Court recognized, however, that there are compelling reasons to revisit Tamoxifen and invited Appellants to petition for rehearing en banc.7 Argument
Federal Rule of Appellate Procedure 35(a) allows a rehearing en banc when the proceeding involves a question of exceptional importance.8 This is such a case. The Cipro Court itself recognized that exclusionary reverse payment agreements involve difficult and important antitrust issues and that the number of these 4Drug Price Competition and Patent Term Restoration Act of 1984 (the "Hatch-Waxman Act"), 35 U.S.C. § 271(e)(1) (2000). 5Nos. 05-2851-cv(L), 05-2852-cv(CON), 2010 WL 1710683 (2d Cir. Apr. 6466 F.3d 187 (2d Cir. 2006). 7Cipro, 2010 WL 1710683, at *7-8. 8FED. R. APP. P. 35(a). agreements is increasing.9 The frequency and divergent treatment of these agreements make the issues in this case of exceptional importance. The Tamoxifen decision has been the subject of widespread criticism. As the Cipro Court acknowledged, the principal drafter of the Hatch-Waxman Act, Senator Hatch, denounced reverse payment agreements as "appalling."10 The Federal Trade Commission and the U.S. Department of Justice, as well as a large contingent of state Attorneys General11, legal scholars, and economic scholars have strongly criticized the Tamoxifen decision.12 Additionally, Congress has recognized that reverse payment agreements are problematic, although a recent attempt to pass legislation banning reverse payment agreements failed. Regardless of Congress' failed legislation, this Court should shape the antitrust rules in a manner that protects consumers. See ("Congress expected the courts to give shape to the [Sherman Act's] broad mandate by drawing on common-law tradition" (quotation omitted)). There is good reason for the criticism of Tamoxifen. As reported by the Federal Trade Commission, the Tamoxifen decision has demonstrably escalated the 9Cipro, 2010 WL 1710683, at *8. 10Id. 11Brief of States as Amici Curiae in Support of FTC, FTC v. Schering- Plough Corp., 548 U.S 919 (2006) (No. 05-273), 2005 WL 2454839. 12Brief Amici Curiae of 28 Professors of Law, Business, and Economics in Support of Appellants at 2, In re Ciprofloxacin Hydrochloride Antitrust Litigation, 544 F.3d 1323 (Fed. Cir. 2008) (No. 08-1097), 2008 WL 644392. use of reverse payment settlement agreements between brand and generic pharmaceutical companies.13 One recent study quantified the cost of reverse payment agreements to be some $12 billion per year in excessive drug costs paid by consumers and state governments.14 The resulting inflated and monopolistic pharmaceutical prices only aggravate the financial distress of our citizens and state budgets. The Tamoxifen Court's endorsement of reverse payment agreements to thwart generic competition requires further review to avoid continued undue financial hardship on both consumers and the states. En banc review is appropriate when a court has doubts as to whether the issues have been resolved correctly in another case. See errors does not make for sound judicial administration). Here, the Cipro Court has expressed concern that the Tamoxifen Court relied on a clear misunderstanding of the terms of the Hatch-Waxman Act.15 13Federal Trade Commission, Generic Drug Entry: Prior to Patent Expiration (July 2002) 31-32, available at 14Scott Hemphill, An Aggregate Approach to Antitrust: Using New Data and Rulemaking to Preserve Drug Competition, 109 Colum. L. Rev. 629, 651-53 (2009). 15Cipro, 2010 WL 1710683 at *8. The Tamoxifen Court also relied on an unfounded assumption that a patentee could not realistically pay off all potential generic competitors,16 although this occurred with the pharmaceutical product Provigil. Provigil's manufacturer, Cephalon, settled with each of the four potential generic entrants. In exchange for payments, each generic manufacturer allegedly agreed not to compete. King Drug Co. v. Cephalon, No. 6-cv-1797, 2010 WL 1221793, at *4 (E.D. Pa. Mar. 29, 2010). To date, a generic version of Provigil is still not available on the market. The Cipro Court also expressed concern that it could not address important policy arguments because it was bound by the Tamoxifen decision.17 The Tamoxifen Court dismissed the plaintiffs' complaint before any discovery occurred; it therefore lacked a full evidentiary record on which to evaluate the important implications of exclusionary reverse payment agreements. The Cipro case is also of exceptional importance because the United States Supreme Court has refused to review the split between the Sixth and the Eleventh Circuits. In 2001, the Attorneys General of twenty-nine states brought an antitrust action against a brand pharmaceutical manufacturer, Hoechst Marion Roussel, for its reverse payment agreement with a generic pharmaceutical company, Andrx Pharmaceutical.18 In Cardizem, the Sixth Circuit found that the agreement was a 16Tamoxifen, 466 F.3d at 212. 17Cipro, 2010 WL 1710683 at *8. 18In re Cardizem CD Antitrust Litig., 332 F.3d 896 (6th Cir. 2004). "naked horizontal restraint of trade that is per se illegal because it is presumed to have the effect of reducing competition . . to the detriment of consumers." 19 The State of Florida and others also challenged a reverse payment agreement ("Hytrin"). In Hytrin, the district court found that the reverse payment agreement was per se illegal.20 On appeal, however, the Eleventh Circuit reversed and found that reverse payment agreements are not per se illegal if they do not extend beyond the protection of the patent. Valley Drug Co. v. Geneva Pharms., Inc., 344 F. 3d 1294, 1312 (11th Cir. 2003). Given the uncertainty within this area of the law, granting a rehearing en banc in Cipro will yield more effective judicial administration. See Eisen v. Carlisle & Jacquelin, 479 F.2d 1005, 1020-21 (2d Cir. 1973), vacated on other grounds, 417 U.S. 156 (1974). Finally, a rehearing en banc in this case is appropriate because the principal question is important to the development of the law. See Lanza v Drexel & Co., 479 F.2d 1277, 1279 (2d Cir. 1973). Both the Hytrin and Cardizem cases were decided after extensive litigation, unlike the Tamoxifen case. Because the Attorneys General have developed a thorough understanding of the antitrust issues involved in reverse payment agreements, they are in a unique position to provide guidance regarding the standard that should apply to these agreements. 19Id. at 911. 20Hytrin, 352 F. Supp. 2d at 1286. Conclusion
The Attorneys General have had substantial experience analyzing and enforcing the antitrust laws regarding reverse payment agreements. The use of reverse payment agreements subverts the purpose and spirit of the Hatch-Waxman Act to the detriment of consumers and state entities. This Court should grant the Petition for Rehearing En Banc of Appellants Louisiana Wholesale Drug Co., Inc., Arthur's Drug Store, Inc., CVS Pharmacy, Inc., and Rite Aid Corporation because en banc review will provide more effective judicial administration and resolve uncertainty on an issue of exceptional importance. Dated: May 20, 2010 Respectfully Submitted, Sarah E.B. London Assistant Attorney General 109 State Street Montpelier, Vermont 05609-1001 Counsel for Amici Curiae Daniel S. Sullivan Attorney General of Alaska Attorney General of Arizona Edmund G. Brown Jr. Attorney General of Arkansas Attorney General of California Richard Blumenthal Attorney General of Colorado Attorney General of Connecticut Joseph R. Biden, III Attorney General of Delaware Attorney General of Florida Lawrence G. Wasden Attorney General of Hawaii Attorney General of Idaho Attorney General of Illinois Attorney General of Iowa Attorney General of Kentucky Attorney General of Maine Douglas F. Gansler Attorney General of Maryland Attorney General of Massachusetts Attorney General of Minnesota Attorney General of Mississippi Attorney General of Missouri Attorney General of Montana Catherine Cortez Masto Attorney General of Nevada Attorney General of New Hampshire Attorney General of New Mexico Attorney General of Ohio W. A. Drew Edmondson Attorney General of Oklahoma Attorney General of Pennsylvania Marty J. Jackley Attorney General of South Carolina Attorney General of South Dakota Robert E. Cooper Attorney General of Tennessee Attorney General of Texas Darrell V. McGraw, Jr. Attorney General of Utah Attorney General of West Virginia Bruce A. Salzburg Attorney General of Wyoming CERTIFICATE OF SERVICE
I, Sarah E.B. London, certify that on May 20, 2010, I caused copies of Brief Of 34 State Attorneys General As Amici Curiae In Support Of Petition For Rehearing En Banc Filed By Appellants Louisiana Wholesale Drug Co., Inc., CVS Pharmacy, Inc., Rite Aid Corporation, and Arthur's Drug Store, Inc. to be served on the persons listed below by electronic and U.S. mail at the addresses indicated. Dated: May 20, 2010 Sarah E.B. London Assistant Attorney General 109 State Street Montpelier, Vermont 05609-1001 Counsel for Amici Curiae Bruce E. Gerstein Steve D. Shadowen Monica L. Rebuck Hangley Aronchick Segal & Pudlin Garwin Gerstein & Fisher LLP 30 N. Third Street, Suite 700 1501 Broadway, Suite 1416 Harrisburg, PA 17101 New York, NY 10036 Sperling & Slater, P.C. David F. Sorensen 55 West Monroe St. Berger & Montague, P.C. Chicago, IL 60603 Philadelphia, PA 19103 Fred H. Bartlit, Jr. Peter B. Bensinger, Jr. Michael J. Valaik Gregory L. Skidmore Paul J. Skiermont Kirkland & Ellis LLP Bartlit Beck Herman Palenchar & 655 15th St., N.W., Suite 1200 Washington, D.C. 20005 54 West Hubbard St., Suite 300 Chicago, IL 60654 National Assoc. of Chain Drug Stores 413 North Lee St. David E. Everson P.O. Box 1417-D49 Victoria L. Smith Alexandria, VA 22313 Stinson Morrison Hecker LLP 1201 Walnut St., Suite 2900 Kansas City, MO 64106-2150 Catherine G. O'Sullivan U.S. Department of Justice 950 Pennsylvania Ave., N.W. Heather S. Woodson Stinson Morrison Hecker LLP Washington, D.C. 20530 10975 Benson, Suite 550 12 Corporate Woods Overland Park, KS 66210 Bruce B. Vignery Phillip A. Proger Kevin D. McDonald Lawrence D. Rosenberg Washington, D.C. 20049 51 Louisiana Ave., N.W. Washington, D.C. 20001 Federal Trade Commission 600 Pennsylvania Avenue, N.W., Washington, DC 20580

Source: http://www.atg.state.vt.us/assets/files/Sts%20Amicus%20Br%20Cipro.pdf

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