Canada Amends IP Laws For Pharmaceuticals

by Glen Shapiro, LawAndTax-News.com, New York

23 October 2006

The Government of Canada last week published Industry Canada's Regulations Amending the Patented Medicines (Notice of Compliance) Regulations and Health Canada's Regulations Amending the Food and Drug Regulations in Part II of the Canada Gazette.

These regulations, which came into force on October 5, 2006, will strengthen the economy in the long term by restoring certainty, predictability and balance to Canada's intellectual property framework for pharmaceuticals and bio-pharmaceuticals.

Under Health Canada's Regulations Amending the Food and Drug Regulations, new and innovative drugs will receive a guaranteed minimum period of market exclusivity of eight years - up from the current five years.

This is deemed especially important to Canada's burgeoning biotechnology industry, since biologic drugs often have little patent protection left by the time they are approved for sale due to lengthy development and regulatory review times.

These regulations will also provide a further six months of market exclusivity to innovative drugs that are the subject of pediatric studies, in order to encourage companies to provide more information about the effects these products have on children.

In turn, Industry Canada's Regulations Amending the PM(NOC) Regulations will restore their original policy intent by enabling generic versions of innovative drugs to enter the market immediately following the expiry of relevant patents, while also allowing substantive improvements to innovative drugs to be duly protected.

This will provide greater certainty and predictability for the industry overall, thereby strengthening investment and innovation in Canada.

"These improvements to the intellectual property environment are the product of extensive consultations with the pharmaceutical and biotechnology industry, and respond to the major concerns expressed by each sector of that industry," explained Maxime Bernier, Minister of Industry, continuing:

"These improvements will encourage research into new and innovative drugs, and help to deliver on our government's commitment to provide the right environment for business-driven research and excellence."

"The amendments published today will benefit Canadians by making it easier for lower-cost, generic versions of these drugs to enter the market in a timely fashion," Tony Clement, Minister of Health, added.

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