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ARTICLE · 06 MAY 2015

Proposed Amendments To The PM(NOC) Regulations

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The Canadian Government has proposed amendments to the PM(NOC) Regulations ("Regulations").

CanadaIntellectual Property
Adrian J. Howard
Adrian J. Howard
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The Canadian Government has proposed amendments to the PM(NOC) Regulations ("Regulations"). These changes come in light of recent decisions of the Federal Court that would not allow the listing of certain patents on the Patent Register, contrary to the intent of the Regulations. The preamble to the amendments states that the "purpose of these amendments is to provide rules for the interpretation of the eligibility requirements for listing patents on the patent register in respect of combination drugs in a manner that is consistent with the purpose of the PM(NOC) Regulations and the authority under which they are made".

Patents that are listed on the Patent Register must be addressed by a company seeking to obtain approval for a generic version of a medicine, before Health Canada will give them marketing approval. Contrary to recent decisions of the Federal Court (e.g. Gilead Sciences Canada Inc. v. Canada (Health), 2012 FCA 254 and Viiv Healthcare Ulc v. Canada

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