Understanding Bolar And Bolar-Like Exceptions In The U.S. And Abroad – Part 2 - Canada

This is part 2 in our multiple part series examining Bolar and Bolar-like exemptions in U.S. as well as in a number of foreign jurisdictions. Part 1, the Bolar Exemption in the U.S., can be found here.

Exemptions to Patent Infringement for Research under Canadian law

Canada provides both a statutory and common law exemption to patent infringement.

Statutory exemption

The statutory exemption to patent infringement is found in Section 55.2(1) of the Canadian Patent Act which states that:

It 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.

Generally, Section 55.2(1) pertains to activities "reasonably" related to the development and submission of information required by a regulatory body (such as Health Canada, which is similar to the US FDA). As in the US, the information does not necessarily have to be actually submitted to the regulator. While this provision relates to regulatory approval for inventions in any area of technology (not just pharmaceuticals), much of the case law has evolved in the pharmaceutical area involving generic drugs. However, a recent Federal Circuit decision in Eurocopter v. Bell Helicopter Textron Canada Ltee, 2012 FC 112, aff'd 2013 FCA 219 (Eurocopter), involving Canadian Patent 2,207,787 for a skid-type helicopter landing gear, considered Section 55.2(1) to be potentially applicable in a mechanical device case involving two competitors developing helicopter landing gear. However, the defendant's (Bell's) argument failed because the evidence showed that its landing gear was used for commercial purposes in addition to regulatory testing. Finally, it is also important to note that Section 55.2(1) relates to information that may be required by a regulatory body not only in Canada, but anywhere in the world.

Common law exemption

Under the common law exemption, an experimental user who does not have a license to a patent but is conducting bona fide experiments with the patented invention is not considered to be an infringer. Examples of bona fide experiments that have been held not to constitute an infringement include making a patented substance, not for profit, but to establish that quality product could be manufactured according...