In re Relafen Antitrust Litigation

Decision Date01 October 2003
Docket NumberNo. CIV.A. 01-12239-WGY.,CIV.A. 01-12239-WGY.
Citation286 F.Supp.2d 56
PartiesIn re RELAFEN ANTITRUST LITIGATION
CourtU.S. District Court — District of Massachusetts

William Alper, Cohen, Pontani, Lieberman & Pavane, New York, NY, for Eon Labs, Inc., Consol Plaintiff.

Richard A. Arnold, Kenny Nachwalter Seymour Arnold Critchlow & Spector, PA, Miami, FL, for Walgreen Company, Consol Plaintiff.

Michael J. Boni, Kohn, Swift & Graf, Philadelphia, PA, for Meijer Distribution, Inc., Meijer, Inc., Plaintiffs.

Bernard J. Bonn, III, Abbey Gardy & Squitieri, New York, NY, for Glaxosmithkline PLC, Smithkline Beecham Corporation, Defendants.

Jacqueline E. Bryks, Cohen, Milstein, Hausfeld & Toll, New York, NY, for Meijer Distribution, Inc., Meijer, Inc., Plaintiffs.

Michael M. Buchman, Milbert, Welss, Bershad, Hynes & Lerach, LLP, New York, NY, for A.F. of L.—A.G.C. Building Trades Welfare Plan, End-Payor Plaintiffs, Hy-Vee, Inc., IBEW—NECA Local 505 Health & Welfare Plan, Sheet Metal Workers Local 441 Health & Welfare Plan, Consol Plaintiffs.

Patrick E. Cafferty, Miller, Faucher and Cafferty, LLP, Ann Arbor, MI, for A.F. of L.—A.G.C. Building Trades Welfare Plan, End-Payor Plaintiffs, Hy-Vee, Inc., IBEW—NECA Local 505 Health & Welfare Plan, Safeway, Inc., Sheet Metal Workers Local 441 Health & Welfare Plan, Consol Plaintiffs.

Neill Clark, Berger & Montague, Philadelphia, PA, for Meijer Distribution, Inc., Meijer, Inc., Plaintiffs.

Eric Cramer, Berger & Montague, Philadelphia, PA, for Meijer Distribution, Inc., Meijer, Inc., Plaintiffs.

Glen DeValerio, Berman DeValerio Pease Tabacco Burt & Pucillo, Boston, MA, for Smithfield Foods, Inc, Louise Houchins, Consol Plaintiffs.

Kathleen M. Donovan-Maher, Berman DeValerio Pease Tabacco Burt & Pucillo, Boston, MA, for Louise Houchins, Consol Plaintiff.

Ruth T. Dowling, Palmer & Dodge, LLP, Boston, MA, for Eon Labs, Inc., Consol Plaintiff.

Nancy F. Gans, Moulton & Gans, PC, Boston, MA, for Meijer Distribution, Inc., Meijer, Inc., Plaintiffs.

George G. Gordon, Dechert LLP, Philadelphia, PA, for Glaxosmithkline PLC, Smithkline Beecham Corporation, Defendants.

Daniel E. Gustafson, Heins Mills & Olson, P.L.C., Minneapolis, MN, for A.F. of L.—A.G.C. Building Trades Welfare Plan, End-Payor Plaintiffs, Hy-Vee, Inc., IBEW—NECA Local 505 Health & Welfare Plan, Sheet Metal Workers Local 441 Health & Welfare Plan, Consol Plaintiffs.

Samuel D. Heins, Heins, Mills & Olson, Minneapolis, MN, for A.F. of L.—A.G.C. Building Trades Welfare Plan, End-Payor Plaintiffs, Hy-Vee, Inc., IBEW—NECA Local 505 Health & Welfare Plan, Sheet Metal Workers Local 441 Health & Welfare Plan, Consol Plaintiffs.

Theodore M. Hess-Mahan, Shapiro Haber & Urmy LLP, Boston, MA, for Direct Purchaser, Consol Plaintiff.

Timothy C. Hester, Washington, DC, for Glaxosmithkline PLC, Smithkline Beecham Corporation, Defendants.

Elizabeth J. Holland, Kenyon & Kenyon, New York, NY, for Teva Pharmaceutical Industries LTD, Teva Pharmaceuticals USA, Inc., Consol Plaintiffs.

Mayme A. Holt-Brown, Percy, Smith, Foote, & Gadel, LLP, Alexandria, LA, for Teamsters Local No. 35 Heath Plans, Elliot Franklin, Patrick J. Lynch, Consol Plaintiffs.

Michael J. Kane, Mager White & Goldstein LLP, Jenkintown, PA, for Barbara Brown, Consol Plaintiff.

Robert N. Kaplan, Kaplan, Fox & Kilsheimer LLP, New York, NY, for Meijer Distribution, Inc., Meijer, Inc., Plaintiffs.

Kevin T. Kerns, Dechert LLP, Philadelphia, PA, for Glaxosmithkline PLC, Smithkline Beecham Corporation, Defendants.

Richard J. Kilsheimer, Kaplan Fox & Kilsheimer LLP, New York, NY, for Meijer Distribution, Inc., Meijer, Inc., Plaintiffs.

Peter Kohn, Berger & Montague, Philadelphia, PA, for Meijer Distribution, Inc., Meijer, Inc., Plaintiffs.

Steven J. Lee, Kenyon & Kenyon, New York, NY, for Teva Pharmaceutical Industries LTD, Teva Pharmaceuticals USA, Inc., Consol Plaintiffs.

Theodore M. Leiverman, Spector, Roseman & Kodroff, Philadelphia, PA, for A.F. of L.—A.G.C. Building Trades Welfare Plan, End-Payor Plaintiffs, IBEW— NECA Local 505 Health & Welfare Plan, Sheet Metal Workers Local 441 Health & Welfare Plan, Consol Plaintiffs.

Lester L. Levy, Wolf, Popper, Ross, Wolf & Jones, New York, NY, for Barbara Brown, Consol Plaintiff.

Richard D Margiano, Palmer & Dodge LLP, Boston, MA, for Eon Labs, Inc., Consol Plaintiff.

James W. Matthews, Sherin and Lodgen LLP, Boston, MA, for Teva Pharmaceutical Industries LTD, Teva Pharmaceuticals USA, Inc., Consol Plaintiffs.

Robert J. Muldoon, Jr., Boston, MA, for Teva Pharmaceutical Industries LTD, Teva Pharmaceuticals USA, Inc., Consol Plaintiffs.

Edward Notargiacomo, Hagens Berman, Boston, MA, for A.F. of L.—A.G.C. Building Trades Welfare Plan, End-Payor Plaintiffs, Hy-Vee, Inc., IBEW—NECA Local 505 Health & Welfare Plan, Safeway, Inc., Sheet Metal Workers Local 441 Health & Welfare Plan, Barbara Brown, Jennifer Kravitz, Consol Plaintiffs.

Linda P. Nussbaum, Cohen, Milstein, Hausfeld & Toll, New York, NY, for Meijer Distribution, Inc., Meijer, Inc., Plaintiffs.

Joseph Opper, Garwin, Bronzaft, Gerstein & Fisher, New York, NY, for Teva Pharmaceutical Industries LTD, Teva Pharmaceuticals USA, Inc., Consol Plaintiffs.

Margaret H. Paget, Sherin & Lodgen, Boston, MA, for Teva Pharmaceutical Industries LTD, Teva Pharmaceuticals USA, Inc., Consol Plaintiffs.

David K. Park, Willkie Farr & Gallagher, New York, NY, for Teva Pharmaceutical Industries LTD, Teva Pharmaceuticals USA, Inc., Consol Plaintiffs.

David Pastor, Gilman and Pastor, LLP, Saugus, for Tyler Fox, Consol Plaintiff.

Douglas H. Patton, Dewsnup, King & Olsen, Salt Lake City, UT, for Teamsters Local No. 35 Heath Plans, Walgreen Company, Elliot Franklin, Patrick J. Lynch, Consol Plaintiffs.

Bemard Persky, Goodkind, Labaton, Rudoff & Sucharow, LLP, New York, NY, for Meijer Distribution, Inc., Plaintiff.

Scott E. Perwin, Kenny, Nachwalter, Seymour, Arnold, Critchlow & Spector, Miami, FL, for Albertson's, Inc., Eckerd Corporation, Hy-Vee, Inc., Kroger Co., The, Walgreen Company, Consol Plaintiffs.

MEMORANDUM AND ORDER

YOUNG, Chief Judge.

I. INTRODUCTION

This case presents a consolidated action against Smithkline Beecham Corporation and Glaxosmithkline P.L.C. (collectively "Smithkline") for various violations of the antitrust laws with respect to its patent for the chemical compound known as nabumetone, which it sells commercially as "Relafen." Smithkline moves to dismiss all claims against it as barred by the applicable statute of limitations, and the plaintiffs, pursuant to the doctrine of collateral estoppel, move to preclude Smithkline from "re-litigating" issues they claim were previously decided by the district court.

A. Factual Background

On August 29, 1974, Smithkline filed with the Patent and Trademark Office (the "Patent Office") the first in a series of six related patent applications concerning the compound nabumetone. The first five patent applications were either rejected by the Patent Office or abandoned by Smithkline. On November 2, 1982, after Smithkline filed its sixth application (the "'190 Application"), the Patent Office issued its final rejection, specifically citing a 1973 article (the "Chatterjea & Prasad Publication") as the basis of the rejection. After Smithkline filed a response to the final rejection, including declarations and affidavits, the Patent Office reversed its position and issued Smithkline a patent for nabumetone (the "'639 Patent") on December 13, 1983. Smithkline commenced sales of its nabumetone product known as "Relafen" in February, 1992.

Subsequently, Smithkline filed suit against Teva Pharmaceutical Industries, Ltd. and Teva Pharmaceuticals USA ("Teva"), Eon Labs, Inc. ("Eon"), and others for infringement of its '639 Patent. Teva filed a counterclaim seeking an order declaring claims 2 and 4 of the '639 Patent invalid because nabumetone was anticipated by prior art. Teva also claimed that the '639 Patent was unenforceable because of alleged inequitable conduct of Smithkline before the Patent Office. The case was tried before Judge Lindsay of this district and the bench trial, commencing January 8, 2001, lasted sixteen days. On August 14, 2001, the district court issued a sixty-seven-page opinion in which it found, inter alia, that (1) claims 2 and 4 of the '639 Patent were invalid as anticipated by prior art; and (2) the '639 Patent was unenforceable because of Smithkline's inequitable conduct. In re '639 Patent Litig., 154 F.Supp.2d 157, 194-95 (D.Mass. 2001) (Lindsay, J.). Smithkline appealed Judge Lindsay's decision. On August 15, 2002, the Federal Circuit affirmed the District Court's decision as to the validity of the '639 Patent. Smithkline Beecham Corp. v. Copley Pharm., Inc., 45 Fed. Appx. 915, 917 (Fed.Cir.2002) (unpublished opinion). That court, however, did not reach the issue of inequitable conduct. Id.

B. Timing of Smithkline's Suit and the FDA's Stay

The '639 Patent claims the compound nabumetone, a non-steroidal anti-inflammatory drug that Smithkline has marketed under the brand name Relafen. Smithkline's Mem. [Docket No. 24] at 1. In the Fall of 1997, Copley Pharmaceutical, Inc. ("Copley") and Teva sought approval from the Food and Drug Administration (the "FDA") to market generic nabumetone products and notified Smithkline of their contention that their generic products did not infringe the '639 Patent. Id. Smithkline filed the alleged sham patent suits in question on October 27, 1997 (against Copley), November 13, 1997 (against Teva), and February 17, 1998 (against Eon). Id. Upon commencement of Smithkline's lawsuit, the FDA, following its procedures, stayed approval of the generic drugs for thirty months. Id. at 4. On August 8, and December 24, 1998, the FDA issued tentative approval to Eon's and Teva's generic nabumetone products, but the FDA withheld final approval until the conclusion of the thirty-month stay period. Id.; End-Payor Pls.' Mem. Opp'n [Docket No. 80] at 4. That stay period terminated...

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