Industry Canada Seeks Comment On Proposed Changes To Listing Requirements Under The PM(NOC) Regulations

On May 2, 2015, the Governor in Council issued proposed amendments to sections 2, 3, and 4 of the Patented Medicines (Notice of Compliance) Regulations.¹ These amendments specifically address the eligibility of listing patent claims that may not include all medicinal ingredients referred to in the approved drug product for which listing was sought on the Patent Register.

The amendments make changes to the listing requirements for three of the four categories of patent claims that are eligible for listing in subsection 4(2) of the Regulations, namely medicinal ingredient, use, and formulation claims.² The amendments also directly address patent listing decisions made by the Minister of Health in response to the Federal Court's decision in Viiv,³ and apply to ongoing matters presently before the Courts.⁴