Judge Denies Patent Claims on Cancer Drug

NEW YORK —  A federal judge struck down Bristol-Myers Squibb Co. patents on cancer drug Taxol, ruling in favor of generic drug makers who want to produce their own versions of the medication.

Taxol is the second-biggest-selling drug for Bristol-Myers Squibb with $1.5 billion in sales worldwide, but the ruling affects the estimated $1 billion in U.S. sales.

As part of the ruling filed Friday in the U.S. District Court in Newark, N.J., the parties have agreed to an expedited appeal of the judgment.

Judge William Wall, who issued the ruling, invalidated key elements of the Taxol patents last month.

“The court’s decision to allow this appeal is not likely to have any bearing on the timing of generic competition,” said Jane Kramer, a spokeswoman for Bristol Myers.

The judge’s ruling also incorporates the permanent abandonment of Bristol’s remaining patent claims relating to the use of Taxol, which is also known as paclitaxel, in the treatment of ovarian cancer.

Ivax Corp. and eight other generic drug makers plan to sell their own versions of the drug. Bristol-Myers Squibb’s patents on Taxol are due to expire this summer, except for a three-hour infusion of the drug.

Drug makers whose products are facing patent expirations typically file lawsuits against generic firms quickly after they seek regulatory permission to market generic forms of the original medicine--with the aim of preventing or delaying rival drugs from coming to market.

Competitors can be held at bay for months or years amid ensuing court battles and the appeals process, even long after the drug’s patent actually expires.

Taxol received Food and Drug Administration approval in December 1992 and the drug was launched in early 1993. It is indicated for treatment of ovarian cancer, breast cancer, a form of lung cancer and Kaposi’s sarcoma.

Kramer said none of the generic drug makers presently have approval to make generic Taxol.

Bristol-Myers Squibb, which posted $20.2 billion in 1999 revenue, hopes to reverse the decision, which could help the company retain the exclusivity of making Taxol, a report from Merrill Lynch analyst Steven Tighe said.