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
From the team behind the Gloucester Quays Victorian Market and Gloucester Quays Food Festival. Landmark events attracting record breaking visitor numbers to the Quays - in excess of 80,000 in the case of the Victorian Market. We don't like to blow our own trumpet, but we think we know a thing or two about organising successful events at this venue and our latest event will be no exception.This April, the alotment chic Gloucester Quays wil be in ful bloom - with our GARDEN PARTY, which includes live
POSEIDO. 2013;1(3) 165 Post-‐extraction implant: immediate vs delayed restoration Research article Immediate versus delayed restorations for implants placed in fresh extraction sockets: a 1-year comparative cohort study Antonio Barone,1,2,* Valentina Borgia,2 Fortunato Alfonsi,2 Paolo Toti,1,2 and Ugo Covani.1,2 1 Department of Surgical, Medical, Molecular and Critical Area Pathology, University of Pisa, Pisa, Italy
