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Breast cancer is one of the leading causes of death in women. During the 1990s, more than 1.5 million women in the United States were newly diagnosed with breast cancer, and over 25 percent of these women will die of the disease. In 1999 alone, approximately 175,000 women developed breast cancer in the United States.
The development of Tamoxifen (tamoxifen citrate) in the 1970s dramatically improved treatment options for women with breast cancer. Studies showed this synthetic hormone counteracts the cancer-promoting effects of estrogen in the breast by binding itself to the estrogen receptor in the cancerous cell, thus impeding tumor growth.
Since the 1970s, Tamoxifen has been used in conjunction with or instead of more drastic and invasive forms of breast cancer therapy. Tamoxifen regimens treat both early and advanced-stage breast cancer, and help to prevent recurrence. It is the most widely prescribed treatment for breast cancer. In fact, tamoxifen is the single most-prescribed drug in the world for the treatment of any sort of cancer.
In the United States, AstraZeneca, Inc. (Zeneca) manufactures the only FDA-approved form of tamoxifen. Zeneca sells tamoxifen under the brand name Nolvadex®. Zeneca's tamoxifen also is sold in the United States as a "generic” by Barr Laboratories, Inc. (Barr), pursuant to an agreement between Zeneca and Barr that precludes the marketing of other versions of generic tamoxifen.
When Barr initially developed a generic form of tamoxifen, patent litigation ensued. On April 20, 1992, the court found the patent for tamoxifen to be unenforceable, yet while an appeal was pending, the parties reached an agreement. Barr both abandoned its challenge to Zeneca’s tamoxifen patent, and agreed not to manufacture and market its own generic tamoxifen until Zeneca’s patent expires in 2002. In exchange, Zeneca and its former parent (Imperial Chemistry Industries, PLC) agreed to pay Barr $21 million and to supply Barr with Zeneca-manufactured tamoxifen for resale in the United States as a "generic." This agreement was conditioned upon the United States Court of Appeal for the Federal Circuit ordering the trial court to vacate the finding of patent invalidity, which the trial court subsequently did. The agreement, nonetheless, was privately negotiated without meaningful review or approval by any court.
The Zeneca and Barr Settlement Agreement enabled those two companies 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 (Zeneca); (iii) share the monopoly profits of Zeneca's brand name tamoxifen; (iv) avoid price competition and/or maintain an artificially-inflated market price for Nolvadex ® and its Zeneca-manufactured "generic;" and (v) exclude other generic tamoxifen competition.
As a result of the collusive agreement between Zeneca and Barr, there has not been, and is not now, competition in the market for tamoxifen. While generic drugs are usually priced 30% to 80% below the brand-name product, the "generic" tamoxifen sold by Barr is priced only five percent (5%) less than Nolvadex®. Women in need of tamoxifen have had no choice but to pay supra-competitive prices. But for Zeneca’s and Barr’s illegal agreement, lower-priced generic tamoxifen would be available in the United States.
In May 2001, PAL filed eight lawsuits in state and federal courts against Zeneca and Barr. The lawsuits allege that Zeneca and Barr illegally colluded to keep the price of tamoxifen high. The result of their collusive agreement was that women with breast cancer were forced to pay very high prices for a drug crucial to their treatment. Lawsuits were filed in the U.S. District Court for the Eastern District of New York and in state courts in Massachusetts, New York, California, Florida, New Mexico, Maine, and West Virginia.
Both the state court and the federal court Tamoxifen cases were consolidated in the United States District Court for the Eastern District of New York.
Update: In May 2003, the Court granted Defendants' Motion to Dismiss the case. PAL attorneys filed an appeal. On November 3, 2005, the appeals court affirmed the May 2003 dismissal. The plaintiffs requested a rehearing. On September 14, 2006, the appeals court denied the petition for rehearing. Plaintiffs submitted a petition for a writ of certiorari to the U.S. Supreme Court in early December 2006. On June 25, 2007, the Supreme Court announced it would not review the case, bringing it to a final close.
Court: Second Circuit Court of Appeals, on appeal from the U.S. District Court, Eastern District of New York (Judge Glasser)