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    U.S. Supreme Court Refuses Case Alleging AstraZeneca, Barr Conspired To Monopolize Market For Breast Cancer Drug Tamoxifen

The U.S. Supreme Court on Monday refused to consider a case alleging that AstraZeneca and Barr Laboratories conspired to delay marketing of tamoxifen so as to maintain a monopoly for Nolvadex, AstraZeneca's brand name version of the drug, Dow Jones reports (Anderson, Dow Jones, 6/25). Tamoxifen, which blocks the production of estrogen, is the only FDA-approved drug for reducing breast cancer risk, but it increases risk for uterine cancer and blood clots (Kaiser Daily Women's Health Policy Report, 6/20).

According to Dow Jones, the case challenged "reverse payments" made between the two companies, which occur when pharmaceutical companies pay a drug maker to hold off on marketing a generic version of a brand-name drug that is nearing the end of its exclusive patent protections. Under the agreement, AstraZeneca and its former parent company Imperial Chemical Industries paid Barr and its supplier $56.9 million and provided Barr with Nolvadex for resale in the U.S. to delay marketing its generic tamoxifen (Dow Jones, 6/25).

Attorneys representing the consumers said the arrangement resulted in tamoxifen remaining a "single-source, monopoly product," with Barr distributing generic tamoxifen for 5% less than Nolvadex. They added that generic drugs usually are priced 30% to 80% below the brand-name products (Rugaber, AP/Philadelphia Inquirer, 6/26).

The 2nd U.S. Circuit Court of Appeals in New York City dismissed the case in 2005, Dow Jones reports. U.S. Solicitor General Paul Clement, in a legal brief issued to the Supreme Court, said the "court of appeals applied an insufficiently stringent standard in scrutinizing" the reverse-payment" but added that the "case does not appear to present an appropriate opportunity" for the Supreme Court to "establish the correct standard for distinguishing legitimate patent claims" (Dow Jones, 6/25).

"Reprinted with permission from You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at The Kaiser Daily Health Policy Report is published for, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Publication Date: 2007-06-29 03:00

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