In Re Relafen Antitrust Litigation

286 F. Supp. 2d 56, 69 U.S.P.Q. 2d (BNA) 1898, 2003 U.S. Dist. LEXIS 18416, 2003 WL 22357954
CourtDistrict Court, D. Massachusetts
DecidedOctober 1, 2003
DocketCIV.A. 01-12239-WGY
StatusPublished
Cited by18 cases

This text of 286 F. Supp. 2d 56 (In Re Relafen Antitrust Litigation) is published on Counsel Stack Legal Research, covering District Court, D. Massachusetts primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
In Re Relafen Antitrust Litigation, 286 F. Supp. 2d 56, 69 U.S.P.Q. 2d (BNA) 1898, 2003 U.S. Dist. LEXIS 18416, 2003 WL 22357954 (D. Mass. 2003).

Opinion

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 nabume-tone, 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 es-toppel, move to preclude Smithkline from “re-litigating” issues they claim were previously decided by the district court.

*60 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 Smith-kline. On November 2, 1982, after Smith-Mine 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 SmithMine filed a response to the final rejection, including declarations and affidavits, the Patent Office reversed its position and issued SmithMine a patent for na-bumetone (the “ ’639 Patent”) on December 13,1983. SmithMine commenced sales of its nabumetone product known as “Re-laten” in February, 1992.

Subsequently, SmithMine 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 seeMng 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 Smith-Mine 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.). SmithMine 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 SmithMine has marketed under the brand name Relafen. Smith-Mine’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 SmithMine of their contention that their generic products did not infringe the ’639 Patent. Id. Smith-Mine 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 SmithMine’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 Pis.’ Mem. Opp’n [Docket No. 80] at 4. That stay period terminated in May, 2000. All of the cases embodied in the instant consolidated action were filed over four years after SmithMine filed its several patent suits.

Essentially, the plaintiffs claim that, but for SmithMine’s wrongful filing of a patent lawsuit, purchasers could have begun purchasing nabumetone in a competitive mar *61 ket — comprising both Relaten and the generic alternatives — as early as August, 1998. Because of the thirty-month stay, however, the generic alternatives did not become available until May, 2000. The plaintiffs allege that Smithkline’s filing of a lawsuit was anti-competitive behavior that caused injury, in violation of federal antitrust laws.

C. Procedural Background

Meijer, Inc. and Meijer Distribution, Inc. (“Meijer”) are the lead plaintiffs in this consolidated action, which comprises many plaintiffs and several defendants. On December 18, 2001, Meijer filed suit against Smithkline 1 for, inter alia, violations of the federal antitrust laws. The case was originally drawn by Judge Lindsay, but he transferred the consolidated action to this Court on April 12, 2002.

The complaints of the other plaintiffs in the consolidated action present similar, though slightly varied, counts. 2 A consolidated class action complaint was filed on December 26, 2002. Eon and Teva, which are competitors and producers of generic nabumetone, also filed suit against Smith-Mine. Teva, however, settled its case with SmithMine on May 1, 2008.

II. STATUTE OF LIMITATIONS

Save for the claims of Eon Labs, Smith-Mine has moved to dismiss the consolidated complaint as untimely filed. SmithMine has not moved to dismiss Eon’s claims in this set of motions. The first legal question presented is thus discrete: when does the instant action accrue for purposes of analyzing the relevant statute of limitations? SmithMine contends that the action began to accrue when it filed the alleged sham lawsuit(s), but the plaintiffs maintain that the relevant date is much later.

A. Four-Year Statute of Limitations

Federal law requires that “[a]ny action to enforce any cause of action under [the Sherman or Clayton Antitrust Acts] shall be forever barred unless commenced within four years after the cause of action has accrued.” 15 U.S.C. § 15b (2000) (emphasis added). Under this section, “a cause of action accrues and the statute begins to run when a defendant commits an act that injures a plaintiffs business.” Zenith Radio Corp. v. Hazeltine Research, Inc., 401 U.S. 321, 338, 91 S.Ct. 795, 28 L.Ed.2d 77 (1971). The “act” complained of in this case is the alleged sham patent lawsuit filed by SmithMine in 1997.

Free access — add to your briefcase to read the full text and ask questions with AI

Related

Padmanabhan, MD PhD v. Hulka
D. Massachusetts, 2018
Padmanabhan v. Hulka
308 F. Supp. 3d 484 (District of Columbia, 2018)
In re Niaspan Antitrust Litigation
42 F. Supp. 3d 735 (E.D. Pennsylvania, 2014)
Ahmed v. Hosting.Com
28 F. Supp. 3d 82 (D. Massachusetts, 2014)
In re Nexium
968 F. Supp. 2d 367 (D. Massachusetts, 2013)
Peterson v. U.S. Bank National Ass'n
918 F. Supp. 2d 89 (D. Massachusetts, 2013)
Molecular Diagnostics Laboratories v. Hoffmann-La Roche Inc.
402 F. Supp. 2d 276 (District of Columbia, 2005)
Chemi SpA v. GlaxoSmithKline
356 F. Supp. 2d 495 (E.D. Pennsylvania, 2005)
In Re Relafen Antitrust Litigation
346 F. Supp. 2d 349 (D. Massachusetts, 2004)
Andrea Doreen Ltd. v. Building Material Local Union 282
299 F. Supp. 2d 129 (E.D. New York, 2004)
Eon Laboratories, Inc. v. SmithKline Beecham Corp.
298 F. Supp. 2d 175 (D. Massachusetts, 2003)

Cite This Page — Counsel Stack

Bluebook (online)
286 F. Supp. 2d 56, 69 U.S.P.Q. 2d (BNA) 1898, 2003 U.S. Dist. LEXIS 18416, 2003 WL 22357954, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-relafen-antitrust-litigation-mad-2003.