The Experimental Use Exception Under The Recently Amended Canadian Patent Act

Canada recently introduced new legislation (The Budget Implementation Act, 2018, No. 2) which brought about several changes to the Patent Act affecting the scope of protection available under Canadian patents. Included in the changes was the addition of a new provision providing an exception from infringement for experimental use of patented technologies.

New section 55.3 of the Patent Act, which came into force on December 13, 2018, provides:

55.3 (1) An act committed for the purpose of experimentation relating to the subject-matter of a patent is not an infringement of the patent.

(2) The Governor in Council may make regulations respecting

(a) factors that the court may consider, must consider or is not permitted to consider in determining whether an act is, or is not, committed for the purpose set out in subsection (1); and

(b) circumstances in which an act is, or is not, committed for the purpose set out in subsection (1).

The experimental use exception from infringement also extends to infringement of a Certificate of Supplementary Protection (CSP) issued for a patent.

The new provisions apply in respect of any action or proceeding that has not been finally disposed of as of December 13, 2018.

Prior Reference to Experimental Use in the Patent Act

Although there was no codified experimental use exception prior to these new provisions of the Act, a "Bolar" exception from infringement for activities occurring during the regulatory approval process is found in subsection 55.2(1), providing:

55.2(1) 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.

Notably, previous subsection 55.2(6) of the Act stated that the Bolar exception does not affect any exception from infringement for certain non-commercial or experimental use that might exist "at law":

55.2(6) For greater certainty, subsection (1) does not affect any exception to the exclusive property or privilege granted by a patent that exists at law in respect of acts done privately and on a non-commercial scale or for a non-commercial purpose or in respect of any use, manufacture, construction or sale of the patented invention solely for the purpose of experiments that relate to the subject-matter of the patent. (emphasis added)

With the enactment of section 55.3, subsection 55.2(6) has been amended to remove reference to experimental use, but the reference to non-commercial activity remains:

55.2(6) For greater certainty, subsection (1) does not affect any...