407. Canada would like to thank Bolivia, Brazil, Chile, and South Africa for their communication on this issue, and to provide a brief overview of the regulatory review exception in our domestic regime.
408. Canada provides a regulatory review (or "early working") exception under section 55.2 of the Patent Act. This exception, which reads as follows, provides that "[i]t is not an infringement of a patent for any person to make, construct, use or sell the patented invention solely for uses reasonably related to the development and submission of information required under any law of Canada, a province or a country other than Canada that regulates the manufacture, construction, use or sale of any product."
409. For instance, under this exception, manufacturers of generic drugs in Canada may use a patented invention to obtain regulatory approval for marketing purposes – such as from health regulatory authorities – without the patent owner's permission before the patent expires. This allows the generic manufacturer to be in a position to enter the market as soon as possible after patent expiry.
410. It is also important to note that Canada's early working exception is drafted without prejudice to the field of technology. In other words, it is not limited to pharmaceutical patents.
411. As Members may be aware, Canada's early working exception was upheld by a WTO Dispute Settlement panel in 2000, under the dispute "DS114: Canada – Patent Protection of Pharmaceutical Products." Specifically, the Panel found that Canada's early working exception was not inconsistent with Article 27.1 of the TRIPS Agreement, and was covered by the exception in TRIPS Article 30.
