News Releases

Generic Pharmaceutical Industry Pleased Government Acknowledges Need to Stop Evergreening of Drug Patents

Toronto, December 13, 2004 – Canada’s generic drug makers today welcomed proposed regulatory changes to limit the practice of “evergreening” of drug patents but cautioned that the amendments could still allow multiple patent strategies to delay access to lower-cost generic medicines.

“We’re pleased the federal government has finally recognized that brand companies are abusing Canada’s drug patent laws and that changes must be made,” said Jim Keon, President of the Canadian Generic Pharmaceutical Association (CGPA). “Our concern is that the proposed amendments may continue to allow brand-name drug companies to list and litigate several patents on the same basic medicine, forcing Canadians to pay higher drug prices for longer than they should.”

Keon noted that the regulatory package introduced by the Government of Canada on December 11, 2004 still provides brand-name drug companies with an automatic injunction against generic drug makers. The proposed changes are meant to stop evergreening but the complex nature of the government’s amendments may lead to further complicated legal strategies being developed by brand-name drug companies to block generic drug approvals. He said a better way to stop the practice of evergreening would be simply to eliminate the Patented Medicines (Notice of Compliance) Regulations.

“Brand-name drug companies should not be granted automatic extensions of their market monopolies simply because they decide to sue a generic firm,” Keon said. “Leaving the automatic injunction in place means that brand companies will still have an enormous financial incentive to initiate litigation against generic companies regardless of the strength of their cases.”

Canada’s generic drug makers do not support Health Canada’s proposed changes to the Food and Drug Regulations, which would increase data protection for brand-name drug companies.

“The Federal Court of Appeal has already ruled that Canada’s current data protection provisions are fully compliant with international trade agreements. Why would the federal government reward brand companies for abusing Canada’s drug patent laws by extending their data protection?” said Keon.

The extension of data protection from five to eight years would also put Canada’s generic drug makers at a disadvantage compared to their counterparts in the United States.

Comments on the proposed amendments must be received by February 25, 2005. Keon said generic drug makers will work with Industry Canada, Health Canada and other stakeholders over the next two months to ensure the changes minimize brand companies’ ability to unfairly block generic competition.

About the Canadian Generic Pharmaceutical Association

The Canadian Generic Pharmaceutical Association represents Canada's generic drug industry – a dynamic group of companies that specialize in the production of high quality, affordable generic drugs and fine chemicals and in conducting the clinical trials required for government approval of generic drugs. It plays an important role in helping control overall health-care costs by keeping the cost of medications down: generic drugs are priced, on average, 40-45% less than their brand-name equivalents.

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