[e-farmacos] Canada, pasa por alto la patente de Cipro?

[e-farmacos@usa.healthnet.org]

E-farmacos: Canada, pasa por alto la patente de Cipro?
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[El mensaje de la lista de discusion e-drug al que se refiere mabel
Valsecia en su ultimo mensaje, lo remitio Ellen 't Hoen
<ethoen@hotmail.com> (gracias). Lo reproducimos por si alguien esta
interesado en leer el texto completo, AF]

Canada overrides patent for cipro to treat anthrax
[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.


[NOTA: Mensaje sin acentos ni caracteres especiales.]
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