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Proposed amendments to the Patented Medicines (Notice of Compliance) Regulations to address strict matching test for listing a patent for a single compound against a fixed-dose combination product

Industry Canada’s Forward Regulatory Plan for 2014-2016 provides information on regulatory proposals that Industry Canada expects to bring forward over the next two years. One such initiative proposes amendments to the PM(NOC) Regulations regarding the requirements for listing patents naming a single compound against fixed-dose combination products.

The objective of the amendments is described as:

The Patent Medicines (Notice of Compliance) Regulations will be amended to address the exclusion of certain pharmaceutical patents from Health Canada’s Patent Register following recent Federal Court and Federal Court of Appeal decisions relating to patents claiming single medicinal ingredients found in combination drugs. A strict interpretation of these decisions could mean that Health Canada must change its practice in respect of listing of certain patents onto the register.

The proposed amendments would confirm established Health Canada practices in relation to the policy intent of the NOC Regulations and clarify the listing requirements as they relate to single medicinal ingredients found in combination drugs.

The notice is referring to two decisions: Viiv Healthcare ULC v Canada (Minister of Health), 2014 FC 893 (reported in the October 2014 edition of Rx IP Update, appeal pending), finding a patent with claims to only one of the active ingredients in two fixed-dose combinations was ineligible for listing against those combination products and Gilead Sciences Canada v Minister of Health, 2012 FCA 254 (reported in the December 2012 issue of Rx IP Update).

While the notice does not provide a timeline for release of the proposed amendments, it indicates that interested stakeholders will have the opportunity to comment when the proposed amendments are pre-published in the Canada Gazette, Part 1.

Regulatory Initiative: Amendments to the Patented Medicines (Notice of Compliance) Regulations

The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.