Health Canada has released its statistical report for 2009 on the Patented Medicines (Notice of Compliance) Regulations and Data Protection provisions of the Food and Drug Regulations

December 17, 2010

Health Canada has released its statistical report for 2009 in respect of the administration of the Patented Medicines (Notice of Compliance) Regulations (the PM(NOC) Regulations) and data protection provisions of the Food and Drug Regulations. These statistics provide interested parties and policy makers alike with information concerning the effects of Canada’s IP regime on therapeutic medicines.

The PM(NOC) Regulations are designed to balance the competing interests of effective patent enforcement over new and innovative medicinal drugs against the timely entry of lower priced generic competitors. The Food and Drug Regulations prescribe that innovative drugs are to receive an eight year guaranteed minimum period of market exclusivity (data protection provisions). Together, these measures ensure a minimum period of protection for medicinal drugs while maintaining a reasonable ceiling on the maximum protection available.

The 2009 report shows that there were sixty-five (65) applications commenced by innovative pharmaceutical companies under the PM(NOC) Regulations seeking to prohibit the Minister of Health from issuing notices of compliance to generic pharmaceutical companies that would otherwise allow them to enter the Canadian market with lower priced drugs. Twenty-four (24) of these applications were discontinued, one (1) was granted, one (1) was dismissed, and thirty-eight (38) remain pending. While the number of applications discontinued, granted or dismissed is well down from the previous five years, the number of cases still pending is at its highest peak. This would tend to suggest that fewer lower priced generic drugs entered the market in 2009 than normal.

As for the data protection provisions of the Food and Drug Regulations, twenty-one (21) new human innovative drugs were added to the register of innovative drugs (the highest recorded other than 2007), while five (5) new veterinary innovative drugs were added to the register (the highest to date). This suggests that innovative drug companies continue to allocate significant resources on research and clinical studies to bring new drugs to market.

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