[Pharm-policy] IVAX/BMS dispute over generic Paclitaxel

[James Love]

http://www.herald.com/content/sun/business/florida/digdocs/056758.htm

Published Friday, September 8, 2000, in the Miami Herald 

IVAX CORP. 

 Drug firm cheers judge's ruling

 Miami-based Ivax (IVX), fighting to produce a generic version of
Bristol-Myers Squibb's Taxol cancer drug, won another round in the
courtroom Thursday.

 In Los Angeles, U.S. District Judge William Byrne refused to issue a
stay on his Wednesday ruling that he lacked jurisdiction in a Taxol
patent dispute.

 The dispute is between Bristol-Myers and a small California company
called American BioScience.

 Last month, Byrne had ruled that the patent dispute must be reported to
the Food and Drug Administration. Under federal regulations, that would
have automatically prevented Ivax from introducing a generic form of
Taxol for 30 months.

 After reversing himself Wednesday, Byrne was asked Thursday by
Bristol-Myers to issue a stay on his ruling until the appeals process is
completed. He declined, although he granted a limited stay of one week,
to give Bristol-Myers time to seek relief from the Ninth Circuit Court
of Apppeals. 

 Ivax has received tentative approval from the Food and Drug
Administration for its generic version of Taxol, which is the world's
best-selling cancer drug. However, all patent disputes must be settled
before its product can be marketed.

 Bristol-Myers is being investigated by the Federal Trade Commission for
its actions in the case, according to court filings, with the FTC
specifically looking at whether the company engaged in collusion to
thwart Ivax's efforts to keep a generic form of Taxol off the market.


-- 
James Love  mailto:love@cptech.org http://www.cptech.org
Consumer Project on Technology, P.O. Box 19367, Washington, DC 20036
voice 1.202.387.8030  fax  1.202.234.5176