NurseWeek

Bristol-Myers under fire for patent control

By Noel Holton
Health24News
September 7, 2000


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Washington (H24N). The National Organization for Women has blasted Bristol-Myers Squibb for blocking the release of a generic version of one of its drugs used for treating cancer of the breast and ovaries, and for treating AIDS patients.

A patent dispute among Bristol-Myers, the Ivax Corp. and a small Santa-Monica-based biotechnology firm called American BioSciences Inc. was heard in a federal courthouse in Los Angeles today. U.S. District Judge William Matthew Byrne Jr. will review the claims of the three companies to decide whether Bristol-Myers may continue to market its cancer and AIDS drug Taxol without any generic competition for the next few years, or whether Ivax will be able to sell a generic form of the drug.

Bristol-Myers has held exclusive rights to develop and market Taxol since 1992, when it acquired the drug from the government scientists who discovered it from the bark of the Pacific yew trees found in the Washington forest. Bristol-Myers made about $1 billion from U.S. sales of Taxol last year. Experts estimate that the price of Taxol would drop about one-third in the first six months if a generic drug were introduced on the market, and by about half after that.

"In a truly reprehensible example of corporate welfare and greed, Bristol-Myers Squibb continues to charge monopoly prices for Taxol, a life-sustaining drug developed with millions of dollars of taxpayer-funded research and urgently needed by women stricken with breast and ovarian cancers and AIDS patients with Kaposi’s sarcoma," said National Organization for Women (NOW) President Patricia Ireland in a statement.

Miami-based Ivax received tentative approval from the Food and Drug Administration (FDA) to market its generic paclitaxel 6 last month. Several weeks ago, however, American BioSciences sued Bristol-Myers over a patent for its generic Taxol drug.

Bristol-Myers quickly agreed to settle with American BioScience. If the court approves the settlement, Ivax will have to prove that its generic drug does not infringe on American BioScience’s patent, which could take another 30 months. During the 30-month period, there would be no generic competition for Taxol, and Bristol-Myers could stand to make another $2 billion off of its drug. Ivax has already endured one 30-month waiting period, which ended this summer.

"By exposing Bristol-Myers’ blatant manipulation of the regulatory and judicial systems, NOW intends to pressure the company to stop its unconscionable, and so far successful campaign to block FDA approval of a generic version of Taxol," Ireland said. "We are calling on Bristol-Myers to stop this irresponsible corporate behavior. This would substantially reduce the cost of Taxol and help meet the needs of desperately ill patients, and frustrated taxpayers."