Health Canada's haste to stockpile anthrax medication has landed it in hot water after it asked a Canadian generic drug maker to infringe on the patent of a multinational drug company by pumping out one million pills.
Yesterday, legal counsel for Bayer Inc. -- patent-holder and marketer in Canada of the antibiotic ciprofloxacin, which is sold under the name Cipro, the most potent drug available to fight anthrax infections -- said Health Canada violated the Patent Act when it ordered a generic version of the drug from Toronto-based Apotex Inc. on Monday.
Health Minister Allan Rock was unrepentant yesterday, saying the move was necessary to keep Canadians safe.
Bayer's patent lawyer, Neil Belmore, said that under the Patent Act, and even in an emergency, the government must inform Canada's patent commissioner before it overrides a brand-name company's patent -- and he has confirmed this did not happen.
"It is certainly a dangerous precedent," Mr. Belmore said.
"Health Canada appears to have approached Apotex directly.
"It didn't follow the legislative framework.
"It did not bother to circumvent Bayer by declaring a state of emergency.
"It ignored the whole section [of the Patent Act]"
He said that Health Canada and Apotex have "theoretically" exposed themselves to legal action because Bayer's patent doesn't expire until 2004.
Yesterday, Bayer's vice-president of public policy and communications, Doug Grant, said: "We cannot understand the government's decision to infringe our patent. . . . We will consider all options to defend our patent."
Earlier in the day, Mr. Rock appeared unworried about deepening the antagonism between the generic and brand-name drug manufacturers over patent protection.
"We are doing what's necessary to protect Canadians . . . I make no apologies," he said during a news conference at Health Canada's sophisticated laboratory in Winnipeg, where he unveiled nearly $12-million in "health-security" initiatives.
Among them is spending $5.6-million to create a national emergency stockpile of drugs for victims of biological or chemical warfare -- from enough antibiotics for 100,000 Canadians exposed to anthrax to the antidote for the nerve gas sarin.
Yesterday, Apotex president Jack Kay said his company will add one million ciprofloxacin tablets to Canada's stockpile by Nov. 8 -- even though it does not have Health Canada marketing approval to produce the antibiotic.
Apotex charges Ottawa $1.50 per pill, compared to "about $2" charged by Bayer for the brand-name version.
"They needed it. And I was willing to supply it. End of story," Mr. Kay said yesterday, adding that his company has had the recipe and the raw materials to make ciprofloxacin for five years. A patent dispute with Bayer has kept it off the market.
Mr. Kay said he didn't ask Health Canada for legal protection. "I'm a big boy . . . I spend $10-million year on legal bills already. We are of the strong belief that we do not infringe on their patent."
An Apotex spokesperson said yesterday that the company had complied with all safety and clinical-trial data for its generic version and that only the legal challenges from Bayer were holding up its approval.
Mr. Kay noted that there is no Canadian-based manufacturer of the brand-name version of the antibiotic -- the nearly $70-million worth of Cipro consumed here annually is imported -- and he believes that Health Canada wants to ensure the supply.
Still, there are concerns about the actions taken by Health Canada when the bioterrorist risks to Canadians are remote, as Mr. Rock has acknowledged.
Chuck Strahl, leader of the Democratic Representative Caucus, said in the House of Commons that the government has no right to overrule Canadian patent law unless it has declared an emergency. "The only legal reason to overrule the patent law is if the government has declared a domestic state of emergency."
South of the border, the U.S. government is in talks to loosen Bayer's monopoly on Cipro, to allow generic manufacturers to produce it there.
An increase in the supply in the United States could ease the fears of some Americans, who are turning to Canada for antibiotics.
Toronto-based pharmacist Dipen Kalaria said he has received calls from as far away as Florida.
"I want to get Cipro no matter what it costs. Could you please send it to me?" he recalled one caller saying.
"I live very close to ground zero, where the gentleman died of anthrax." (The man who died of anthrax lived in Florida, not New York, site of the World Trade Center, known as ground zero after it was destroyed in the Sept. 11 terrorist attacks.)
But a Canadian-licensed physician can write a prescription to be filled only in Canada, and Americans searching for antibiotics to treat anthrax don't have the disease, just the jitters.
Some Americans are asking Canadian relatives heading to Florida to pack Cipro. But most Canadian snowbirds, fed by nightly news images of masked bioterrorism crews in the United States, take only enough for themselves.
Arnold Smith, a pharmacist in west-end Montreal who caters to a large clientele of Florida-bound snowbirds, said he has filled dozens of prescriptions for Cipro this season, along with the usual drugs against heart disease, asthma and ulcers.
A woman from New York, where Cipro stocks are dwindling, this week obtained a Canadian prescription and headed to a pharmacy in Montreal. An added advantage for Americans: A Cipro tablet in Canada costs about $3, roughly half the cost in the United States.