In recent cases regarding medicinal claims, the Federal Court’s interpretation of the Patented Medicines (Notice of Compliance) regulations has been inconsistent with the original intent for these regulations. As a result, several patent applications claiming single medicinal ingredients in combination drugs became ineligible. The Canadian Gazette clarifies the intent of the regulations stating:
The policy intent of the PM(NOC) Regulations is reflective of the realities of the drug development process whereby after a medicinal ingredient is patented and a drug with that medicinal ingredient is developed, an innovator may seek to combine the patented medicinal ingredient with other known medicinal ingredients to create new, innovative, and efficacious combination drugs without forgoing the benefit of the protections afforded under the PM(NOC) Regulations. (P. 908)
Therefore, the Governor in Council has put forth a set of proposed amendments aiming to restore the original intent of the PM(NOC) regulations while providing clarity over ambiguous matters. These amendments will help restore eligibility to patents that were rendered ineligible. For more details please see Canada Gazette Part I--May 2, 2015.
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