In Re Tamoxifen Citrate Antitrust Litigation

222 F. Supp. 2d 326, 2002 U.S. Dist. LEXIS 17211, 2002 WL 1962125
CourtDistrict Court, E.D. New York
DecidedAugust 26, 2002
DocketMDL 1408(ILG)
StatusPublished
Cited by7 cases

This text of 222 F. Supp. 2d 326 (In Re Tamoxifen Citrate Antitrust Litigation) is published on Counsel Stack Legal Research, covering District Court, E.D. New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
In Re Tamoxifen Citrate Antitrust Litigation, 222 F. Supp. 2d 326, 2002 U.S. Dist. LEXIS 17211, 2002 WL 1962125 (E.D.N.Y. 2002).

Opinion

MEMORANDUM AND ORDER

GLASSER, District Judge.

SUMMARY

Plaintiffs Caroline Marks (“Marks”), Maxine Blonstein (“Blonstein”), and Lois Steward (“Steward”), on behalf of themselves and those similarly situated, represent classes of consumers and indirect purchasers of tamoxifen citrate (“tamoxifen”) in California, Florida, and Kansas, respectively. Plaintiffs originally filed suits in state courts against defendants Zeneca, Inc., AstraZeneca Pharmaceuticals LP, As-traZeneca LP, AstraZeneca PLC (collectively “Zeneca”) and Barr Laboratories, Inc. (“Barr”), alleging state antitrust and consumer protection claims. Defendants subsequently removed the cases to federal court based on federal question and/or diversity jurisdiction.

Now before the Court are plaintiffs’ two motions to remand, including the Marks and Blonstein plaintiffs’ joint motion, see Marks v. Barr Labs., Inc (transferred from the Northern District of California) and Blonstein v. Barr Labs., Inc. (transferred from the Southern District of Florida), and the Steward plaintiffs’ motion, see Steward v. Barr Labs, (transferred from the District of Kansas). Because there is substantial overlap of the arguments raised in the parties’ briefs, the Court will consider the motions together.

BACKGROUND 1

These actions involve the drug tamoxifen, a critical drug for the treatment of breast cancer. In 1993, Zeneca acquired United States Patent 4,536,516 (the “ ’516 Patent”) for tamoxifen from its predecessor, Imperial Chemical Industries, PLC (“ICI”). The ’516 Patent will expire on August 20, 2002. Until that time, Zeneca owns the exclusive right in the United States to manufacture, sell, and license tamoxifen. Zeneca markets tamoxifen under the trade name Nolvadex.®

In December 1985, Barr filed an Abbreviated New Drug Application (“ANDA”) with the Food and Drug Administration (“FDA”), requesting approval to sell a generic bioequivalent version of the “pioneer” drug tamoxifen. An ANDA filing is governed by the Hatch-Waxman Act, 21 U.S.C. § 355, which provides an expedient method of obtaining FDA approval to bring generic bioequivalent drugs to the *328 market. In addition to affirming that the generic drug contains the same active in-gredientes) as the patented drug already-approved and listed by the FDA, an ANDA filer must certify, inter alia, that the patent of the pioneer drug is either invalid or would not be infringed by the generic bioequivalent version. See 21 U.S.C. § 355Cj)(2)(A)(vii). Barr’s ANDA application certified that the ’516 Patent was invalid and unenforceable. Within forty-five days of receiving notice of Barr’s ANDA application, ICI sued Barr for patent infringement in the Southern District of New York. 2 This lawsuit had the effect of staying FDA consideration and approval of Barr’s ANDA application for thirty months or until the date of a final non-appealable determination as to the validity of the patent, whichever is earlier. See 21 U.S.C. § 355(j)(5)(B)(iii). The court, in its discretion, however, may extend the stay if the litigation is not resolved within the thirty month period. Id. One of the benefits of being the first ANDA filer to obtain FDA approval is an exclusive 180-day period in which to sell the generic drug free from other generic drug competition. See 21 U.S.C. § 355(j)(5)(B)(iv). The 180-day period of market exclusivity begins when the applicant first sells its product or when a final non-appealable judicial determination is entered as to the patent’s invalidity, whichever is earlier. 3 Id.

ICI’s patent infringement suit against Barr was tried before the late Judge Vincent L. Broderick. On April 20, 1992, Judge Broderick held that the ’516 Patent was invalid and unenforceable, because ICI wrongfully withheld relevant material from the United States Patent and Trademark Office. Imperial Chem. Indus., PLC v. Barr Labs., Inc., 795 F.Supp. 619 (S.D.N.Y.1992). ICI appealed that determination to the Federal Circuit. However, in 1993, while the appeal was pending, ICI/Zeneca and Barr entered into a settlement agreement (the “Settlement Agreement”), whereby Barr agreed to drop its challenge to the validity of the ’516 Patent and to amend its ANDA application to certify that it would not seek to market its generic version of tamoxifen until the patent expired, Zeneca agreed to pay Barr $21 million and to give Barr a license to sell Zeneca’s tamoxifen under a generic label.

The Settlement Agreement was to become effective only upon entry of an order by the Federal Circuit directing the district court to vacate its finding of patent invalidity. Barr and Zeneca filed a Joint Motion to Dismiss the Appeal as Moot and to Vacate the Judgment Below. On March 19, 1993, the Federal Circuit granted the motion to dismiss and vacated the judgment below, pursuant to its practice at the time to honor settlement agreements. See *329 Imperial Chem. Indus., PLC v. Heumann Pharma GmbH & Co., 991 F.2d 811 (Fed. Cir. Mar.19, 1993) (unpublished). 4 On March 23,- 1993, Judge Broderick vacated the judgment and entered a Stipulation of Dismissal and Order. Consequently, the ’516 Patent remains valid, and Zene-ca’s Nolvadex and Barr’s generic are the only tamoxifen currently on the market.

The Settlement Agreement has spawned thirty lawsuits around the country, all of which have been transferred to this Court, pursuant to 28 U.S.C. § 1407, by the Judicial Panel on Multi-District Litigation, for coordination of pre-trial matters. The complaints allege that the Settlement Agreement has enabled Zeneca and Barr to (i) revive a patent that Barr had established was invalid and unenforceable; (ii) allocate the entire United States market for tamoxifen to one manufacturer: Zene-ca; (iii) share the monopoly profits of Zeneca’s tamoxifen; (iv) avoid price competition and maintain artificially inflated market prices for Nolvadex® and its Zene-ca-manufactured generic; and (v) exclude competition from other generic manufacturers. (See Blonstein Compl. ¶ 57; Marks Compl. ¶ 79; Steward Compl. ¶ 57.) The complaints also allege that the FDA would have been permitted to grant final approval to Barr’s generic version of tamoxifen if the appeal of the patent suit against Barr had run its course and had resulted in an affirmance of Judge Broder-ick’s finding of invalidity. (See Blonstein Compl. ¶ 60; Marks Compl. ¶ 82; Steward Compl. ¶ 58.)

As noted above, these actions were filed in state courts, and were then removed by defendants to federal courts.

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Bluebook (online)
222 F. Supp. 2d 326, 2002 U.S. Dist. LEXIS 17211, 2002 WL 1962125, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-tamoxifen-citrate-antitrust-litigation-nyed-2002.