[e-drug] Canada overrides patent for cipro to treat anthrax

["Ellen 't Hoen" <ethoen@hotmail.com>]

E-drug: Canada overrides patent for cipro to treat anthrax
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[Copied as fair use. HH]

http://www.nytimes.com/2001/10/19/business/19cana.html

Canada Overrides Patent for Cipro to Treat Anthrax
by Amy Harmon and Robert Pear, October 19, 2001

Canada, taking an unusual step that the United States has resisted,
said yesterday that it had overridden Bayer's patent for Cipro, an
antibiotic to treat anthrax, and ordered a million tablets of a generic
version from a Canadian company.

"These are extraordinary and unusual times," said Paige Raymond
Kovach, a spokeswoman for Health Canada. "Canadians expect and
demand that their government will take all steps necessary to
protect their health and safety."

But Cipro's manufacturer, Bayer A.G. (news/quote), condemned the
move and said it could meet the demand for Cipro on its own.

The White House said it was unmoved by Canada's action and was
not considering breaking Bayer's patent. "We don't feel there's a
need to lift the patent at this time," said Anthony T. Jewell, a
spokesman at the Department of Health and Human Services.
"Multiple drugs can be used to treat anthrax, and Bayer has assured
us that it can meet our demand for Cipro."

But Senator Charles E. Schumer, Democrat of New York, who has
been negotiating with the administration on a plan to buy generic
versions of Cipro, said he had called Tommy G. Thompson, the
secretary of health and human services, to renew his plea that the
United States follow Canada's lead. 

"I know there's concern about what the pharmaceutical industry
thinks but we're in an emergency situation and everybody has to
give," Senator Schumer said.

Even as the debate grew over how best to supply anthrax
treatments in a hurry, the government took several steps to address
the problem.

The Senate moved to develop legislation that would provide as
much as $10 billion to deal with the threat of bioterrorism. The
legislation would allocate much more money than the Bush
administration has sought to buy drugs and vaccines and to
increase the capacity of hospitals, laboratories and state and local
government agencies to respond to bioterrorist attacks. The money
could be used to buy medical supplies and to train health care
workers to treat the victims of an attack.

On Wednesday, the Bush administration requested $1.5 billion to
help the Department of Health and Human Services combat
bioterrorism. The Defense Department is also seeking hundreds of
millions of dollars, though the precise amount is not clear.

The Canadian police have responded to numerous reports of
suspicious white powder, but, so far, none of the substances have
tested positive for anthrax. Nonetheless, Canadian officials want to
build a stockpile of drugs adequate to treat 100,000 people. So, the
government has ordered a million tablets of a generic version of
Cipro from Apotex Inc., which is based in Toronto, and has also
placed orders with Bayer for undisclosed amounts of Cipro.

Jack Kay, president of Apotex, said that his company made the
drugs through a process that did not infringe on Bayer's patent and
that Apotex could deliver the drugs faster and for about 63 cents
less than the approximately $1.25 that Bayer charges the Canadian
government for a 500-milligram tablet. He added that he did not
think Bayer would immediately file a patent-infringement lawsuit,
because that would be "a public relations nightmare" for the
company.

Bayer disagreed, saying that its manufacturing operations were
capable of meeting the increased demand for the drug, and that
breaking patents - even under these circumstances - undermines the
crucial incentive that motivates pharmaceutical companies to invest
in developing drugs.

"Bayer has been fully cooperating with the Canadian government to
meet their requests," said Doug Grant, vice president for public
policy and communications for Bayer in Canada. "But we take
patent infringement very seriously, and we are prepared to consider
all options in order to defend our patents."

Nevertheless, Bayer has faced some skepticism. "There's no way
you can tell me getting it from six companies is going to be slower
than getting it from one company," said James P. Love, director of
the Consumer Project on Technology, part of Ralph Nader's
organization pushing for lower drug prices.

John W. Dienhart, a business ethics professor at Seattle University,
said the company should act as a good corporate citizen.

"This is not breaking a patent but adjusting a patent to meet a
particular need," he said.

In the Senate, the new legislation is being developed by Edward M.
Kennedy, Democrat of Massachusetts, and Bill Frist, Republican of
Tennessee. The Senate Republican leader, Trent Lott of Mississippi,
said yesterday that the measure could be on the Senate floor as
early as next week. 

Senate aides said the legislation envisioned a high degree of
collaboration between government and industry in setting priorities
and in deciding who should produce how much of which medicines
and vaccines. Such cooperation is reminiscent of techniques used
by the Pentagon to buy military equipment.

In meetings this week, drug company executives told Congress
they were eager to help, but wanted guidance from Washington.
They said they needed some relief from antitrust laws, to make
clear that they could work together on certain projects. Lawmakers
have initially been receptive to that idea.

"We face an extraordinary threat, and an extraordinary response is
needed," Mr. Kennedy said. "This legislation provides a
comprehensive program to meet the challenge of bioterroism." In a
separate action yesterday, prompted in part by the public alarm
over anthrax, the Senate Judiciary Committee unanimously
approved a bill to help generic drug companies produce low-cost
versions of brand-name medicines.

The bill would require drug makers to notify the government
whenever they signed an agreement to delay production of generic
drugs.

Brand-name drug companies have made payments to potential
competitors to delay the production and marketing of generic drugs.
The Federal Trade Commission has challenged several such
agreements as illegal restraints of trade.

Senator Patrick J. Leahy, the Vermont Democrat who is chairman
of the Judiciary Committee, said the bill would give the F.T.C. and
the Justice Department access to information on "secret deals"
between drug companies. "If we had passed this legislation last
year," Mr. Leahy said, "generic alternatives to Cipro might have
been on the market today."

The trade commission is investigating reports that Bayer paid
another drug company to delay the introduction of generic versions.

Under the bill approved by the Judiciary Committee, a federal judge
could void agreements that limit the production of generic drugs.


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