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).
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Publication Date: 2007-06-29 03:00