GENERIC MAKERS CHALLENGE CANADA'S EXTENDED PATENT PROTECTION

Calling the impact of recent regulatory amendments to Canada's drug patent rules "unnecessary and costly to taxpayers," generic drug manufacturers led by the Canadian Generic Pharmaceutical Association (CGPA) are calling on a federal court to repeal modifications to federal regulations that provide brand name manufacturers with eight years of freedom from generic drug competition.

Canadian lawmakers Oct. 5 approved legislation that lengthened the period of guaranteed market exclusivity for new drugs from five to eight years.

CGPA, on behalf of its member companies, filed an application in federal court Nov. 14 seeking a judicial review of the regulations, pointing to language in the 2006 data protection amendments that it believes will harm competition. For example, the multiyear ban prevents generic drug manufacturers from filing abbreviated new drug submissions or obtaining notices of compliance, both of which are necessary to market generic drug products, according to the court document.

The association is asking the court for a ruling that would declare the amendments unlawful or suspend them. The legal challenge also called for the court to issue an order that would direct government officials to accept and review new drug submissions, supplements to new drug submissions and abbreviated new drug submissions with no regard to the new exclusivity period.

"We would like to see an injunction on the application of the rule until the case is heard in full," CGPA President Jim Keon said. Keon said he does not believe the government had the authority to extend the data exclusivity period for brand drugs.