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Canada’s pharmaceutical intellectual property laws need re-vamp to encourage R&D, says analysts

08-Nov-2011

Related topics: Regulatory & Safety

Canada’s pharmaceutical intellectual property laws need a shake-up to encourage innovation in drug development, according to an article in CMAJ.

In the analysis, led by Paul Grootendorst of the Leslie Dan Faculty of Pharmacy, University of Toronto, the authors argue that drug discovery is hindered by the too-lengthy and costly process of patent validity.

They state the “broken” system is a result of overly complex rules and regulations that lead to legal ambiguity.

Current regulations also allow brand name and generic companies to contest the period of market exclusivity, which the authors say allows brand firms to delay generic production.

"We argue that the system is broken," said Grootendorst. "The adjudication of patent validity (and hence the period of market exclusivity) is determined by extraordinarily costly and time-consuming litigation between generic and brand (ie innovator) drug companies."

The authors suggest several antidotes to the problems in the framework, including replacing current regulations with a fixed period of 10 years of market exclusivity.

Grootendorst et al noted: "Other countries are facing the same challenges as Canada; none, however, have attempted fundamental reform of its laws on pharmaceutical intellectual property.

"It is time for Canada to show leadership."