Rules that extend drug patents face challenge
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* Barbara Sibbald

The Competition Bureau of Canada is investigating whether a method of prolonging drug patents contravenes Canadian law. The investigation began after a coalition of union and consumer groups alleged anticompetitive practices in the drug industry. “The runaway cost of drugs is threatening the financial sustainability of public medical care,” says Mike Luff, spokesperson for the 325 000-member National Union of Public and General Employees.

The coalition, which also includes the Consumers' Association of Canada, accuses companies that underwrite the development of new drugs of aggressively pursuing strategies to extend their market monopolies. “We're skeptical whether the MPs and Parliament will act against the pharmaceutical lobby,” says Luff. “So we decided to sidestep Parliament.”

The coalition's complaint relates to companies that file sequential patents after making minor improvements in a drug — such as a new pill shape — and then alleging infringement on each patent. The process, known as “evergreening,” extends a drug's patent protection long after the initial 20-year patent expires. For instance, the original patent on AstraZeneca's omeprazole (Losec) expired in 1999, but in Canada competitors that want to market a generic version are still tied up in court because of 10 additional patents. “We're frustrated by government inaction,” says Luff.

Canada's Research-based Pharmaceutical Companies would not comment on the issue, but the industry has repeatedly said the patent regime is necessary to foster innovation. Jim Keon, president of the Canadian Generic Pharmaceutical Association, says its members are “happy [the Competition Bureau] is looking into it,” but they are not affiliated with the coalition.

Canada is the only nation that now allows “evergreening.” On Aug. 18, the US implemented a new policy that limits companies to 1 patent extension of 30 months, clarifies what constitutes a patent change and cuts about 3 months off the 20-month approval process for generic products. The US Food and Drug Administration estimates that the changes will save consumers $35 billion over the next decade.

However, there is considerable Canadian opposition to changing the law here. It was introduced during the last days of Brian Mulroney's Conservative government, and opposition to change is particularly strong in Quebec, where the production of brand-name drugs is a major industry. — *Barbara Sibbald*, CMAJ