Copyright 2000 / Los Angeles Times
Los Angeles
Times
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September 7, 2000, Thursday, Home Edition
SECTION: Business; Part C; Page 1; Financial Desk
LENGTH: 709 words
HEADLINE:
FTC PROBES POSSIBLE BID TO HALT GENERIC VERSION OF DRUG;
PHARMACEUTICALS: AUTHORITIES ARE LOOKING INTO DEALINGS BETWEEN BRISTOL-MYERS
SQUIBB AND A SMALL FIRM ON TAXOL CANCER TREATMENT.
BYLINE: JERRY HIRSCH, TIMES STAFF WRITER
BODY:
The Federal Trade Commission is
investigating whether drug giant Bristol-Myers Squibb Co.
colluded with a tiny Santa Monica pharmaceuticals concern to block production of
a price-slashing generic version of the cancer-fighting drug
Taxol.
The probe was disclosed Wednesday during a U.S. District Court
hearing at which a federal judge decided that the government lacked jurisdiction
in a patent dispute over Taxol.
The ruling by Judge
William Matthew Byrne Jr. probably will pave the way for the production of a
generic version of Taxol in the coming months, slicing as much as $ 500 million
annually from the cost of treating American women with breast and ovarian
cancer.
It was also a major victory for Miami-based generic specialist
Ivax Corp., which has sought to market paclitaxel, the generic form of Taxol,
since 1997. Ivax, whose shares rose $ 5.50, or 17%, to close at $ 38 on the
American Stock Exchange on Wednesday, last week received tentative approval from
the Food and Drug Administration to begin marketing the generic
version.
Women's health and consumer advocates have pushed for a generic
version of Taxol, which can cost $ 1,000 to $ 3,000 per course of treatment and
garners Bristol-Myers an estimated $ 1 billion in domestic sales annually.
Generic competition can cut the price of a drug by half within
the first year.
"This is really good news. What has happened with Taxol
is an example that grabs people's heart strings," said Cindy Pearson, executive
director of the National Women's Health Network in Washington.
"I hope
it is a ruling that moves society to a more reasonable balance between a
company's right to make a reasonable profit and the needs of patients to pay
reasonable prices for drugs," she said.
The rights over
production of Taxol, a drug discovered through a National
Cancer Institute research program, has sparked a complicated three-way battle
between Bristol-Myers, Ivax and American BioScience Inc. of Santa Monica that
one attorney in the case likened to "a game of 3-D chess."
American
BioScience won approval of its Taxol claim from the U.S. Patent
Office on Aug. 1, seven years after it first filed an application. The
patent came just as Ivax was getting ready to issue its version
of the drug.
American BioScience then filed a lawsuit
against Bristol-Myers, which has held exclusive rights to sell the
drug since 1992, seeking to force the giant pharmaceutical
company to list American BioScience's patent in the federal
registry of Taxol patents. Official recognition of its claim
might have allowed American BioScience to collect royalties from Bristol-Myers
or other companies that wished to produce the drug.
Last month, Byrne had issued a preliminary order forcing Bristol-Myers
to list American BioScience's patent. But Wednesday, Byrne said
that federal law does not allow for court intervention in disputes over which
patents should be listed in the patent
register, called the "Orange Book."
Attorneys familiar with
pharmaceutical regulatory law say that it is generally up to the company that
holds the rights to sell a drug to decide which
patents go into the Orange Book.
If Byrne had allowed
American BioScience's patent to remain on the registry, it
probably would have triggered a 30-month extension in
Bristol-Myer's exclusive right to sell the drug. Such an
extension would be worth several billion dollars to the
company.
Joseph F. Coyne Jr., an attorney representing American
BioScience, discounted the FTC's investigation of the dealings between American
BioScience and Bristol-Myers.
"They are looking at the timing of when
our patent was issued, but the short answer is that is when the
patent office decided to issue it. There's not much more to
it," Coyne said.
Bristol-Myers representatives did not return phone
calls seeking comment. Its shares fell $ 2.06 to close at $ 50.94 on the New
York Stock Exchange.
Analysts said that Bristol-Myers could decide
unilaterally to list the American BioScience patent in the
registry. But any agreement between the companies at this point is sure to spark
vigorous FTC scrutiny for antitrust violations, said Nicolas Barzoukas, a
pharmaceutical and biotechnology patent attorney in Houston.
LOAD-DATE: September 7, 2000 
