NEW YORK (CNNfn) - Generic drug maker Watson Pharmaceuticals Inc. sued the U.S. Food and Drug Administration on Thursday, saying it wants a federal court to invalidate Bristol-Myers Squibb Co.'s proposed new patent on popular anti-anxiety drug BuSpar and force regulators to approve a generic version of the medication.|
Watson (WPI: Research, Estimates) had hoped to introduce its cheaper, generic product last week. But its hopes were dashed after Bristol-Myers (BMY: Research, Estimates) applied for fresh patent protection that could allow the New York-based drug giant to retain its exclusive rights to the medication for up to 30 months. Watson's lawsuit seeks to prevent the FDA from recognizing Bristol's new patent.
Corona, Calif.-based Watson filed the case in U.S. District Court in Maryland. In a statement, Watson General Counsel Robert Funsten said that Bristol's new patent application "has wrongfully delayed legitimate generic competition" to BuSpar.
"We saw no alternative other than to file this lawsuit as the fastest way to provide the public with a lower-cost generic alternative," he said.
The FDA declined comment, saying it does not comment on pending litigation. Watson officials could not be immediately reached for further comment.
Bristol-Myers says its new patent covers a metabolite, or a byproduct, produced through use of BuSpar. The company said it will now research other applications of this byproduct. Armed with the new patent, Bristol-Myers has ammunition to bring patent infringement lawsuits against generic competitors who try to introduce copycat versions of the drug. BuSpar had sales of $605 million last year.
After Bristol-Myers announced its new patent Nov. 21, Watson immediately cut its revenue and earnings forecasts through 2001. The news triggered a sharp sell-off in the company's stock the next day. Shares of other generic drug makers, including Pittsburgh-based Mylan Laboratories Inc. (MYL: Research, Estimates) and K-V Pharmaceutical Co. (KV.A: Research, Estimates), also were hit.
In early trading Thursday, Watson shares dropped $1.25 to $48.44, while Bristol-Myers stock edged up 44 cents to $72.63.