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October 19, 2001


Canada Overrides Patent for Cipro to Treat Anthrax


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.

The Associated Press
A technician at Apotex in Toronto holds a tray of newly made ciprofloxacin tables, the generic version of Cipro, which is used to treat anthrax.

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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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