[Pharm-policy] Reuters on IVAX/BMS and generic Paclitaxel

[James Love]

http://biz.yahoo.com/rf/000915/n15159461_3.html

Friday September 15, 8:02 pm Eastern Time

FDA OKs IVAX' generic form of cancer drug Taxol
By Ransdell Pierson and Edward Tobin

NEW YORK, Sept 15 (Reuters) - IVAX Corp. (AMEX:IVX - news) said on
Friday it received approval from
U.S. regulators to sell a generic form of Taxol, marking a victory in
the company's heated battle to sell a copycat version of Bristol-Myers
Squibb Co.'s blockbuster treatment for ovarian and breast cancer.

IVAX has been fighting New York drug giant Bristol-Myers (NYSE:BMY -
news) for two years to sell its
version of Taxol, whose chemical name is paclitaxel. It will be the
first generic form of Taxol on the U.S. market, which means no other
generic drugmaker can sell generic paclitaxel for 180 days.


  [snip]

Taxol's U.S. sales would have risen 10 percent to $1.1 billion in 2001,
according to some analysts, but could now decline as much as $300
million with competition from the IVAX treatment. 

   [snip]

``Anyone who has followed IVAX' efforts to bring its generic version of
Taxol to market in the United States knows IVAX has had to overcome a
succession of disruptive and delaying tactics,'' said Neil Flanzraich,
vice chairman and president of IVAX.


  [snip]  


A Newark federal judge in March invalidated key provisions of patents
protecting Taxol, but Bristol-Myers lawyers continued to challenge the
IVAX product.

IVAX last month received tentative approval from the U.S. Food and Drug
Administration to begin marketing its generic, but the FDA go-ahead was
contingent on IVAX resolving its patent disputes.

The fight between Bristol-Myers and IVAX took a decisive turn last week,
when Los Angeles U.S. District Court William Byrne ruled against a tiny
privately held California company called American BioScience Inc. (ABI)
that had a business arrangement with Bristol-Myers.

Bristol-Myers had signed an option for a non-exclusive license to an ABI
patent that related to dosing of Taxol. Despite their relationship, ABI
then sued Bristol-Myers and demanded it list the ABI patent in the FDA's
so-called Orange Book, which lists patents related to marketed drugs.

Once a patent is listed in the book, the FDA is forbidden for 30 months
to approve any generic drug which might interfere with that patent, a
policy meant to give competing parties time to complete their court
proceedings.

Byrne initially ordered Bristol-Myers to have the ABI patent listed in
the Orange Book, a ruling Wall Street deemed a victory for both ABI and
Bristol-Myers because it implied IVAX could be stymied for years from
introducing its generic.

But Byrne reversed gears on Sept. 6 -- saying he had no jurisdiction in
the case and that Bristol-Myers must de-list the ABI patent. The U.S.
Ninth Circuit Court of Appeals on Wednesday refused to stay Byrne's
decision and ordered Bristol- Myers to remove ABI's patent from the
Orange Book.

``We were notified of a change in the status of a patent for Taxol (by
the California court), and after being notified that's when we took the
action'' to approve Taxol, said Gary Buehler, acting director of the
FDA's Office of Generic Drugs.

The FDA acted despite another wrinkle in the dispute, a petition that
Bristol-Myers filed earlier this week with the U.S. District Court for
the Southern District, in Manhattan.

In the petition, Bristol-Myers asked the court whether the company
indeed should remove the ABI patent from the Orange Book. With IVAX'
drug now approved, analysts said it remains to be seen what action -- if
any -- the New York court will take.

   [snip]

http://biz.yahoo.com/rf/000914/n1346187.html


Thursday September 14, 12:44 am Eastern Time
Bristol-Myers rakes it in as Taxol dispute drags on
By Ransdell Pierson

NEW YORK, Sept 13 (Reuters) - Although the patent battle over cancer
drug Taxol is baffling and could take months to resolve, Bristol-Myers
Squibb Co (NYSE:BMY - news) stands to gain almost $1 million each
additional day the dispute remains tangled in the courts, Wall Street
analysts said on Wednesday.