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 thePM(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 (Minister of Health), 2014 FC 328 and 2014 FC 893), the Government is seeking to restore the original intent of the Regulations by permitting claims to the use of a medicinal ingredient to be listed on the Patent Register against products that “may include additional medicinal ingredients, or additional uses of the medicinal ingredient.”
Drug manufacturers who have been affected by these Federal Court decisions will have a 30 day window to resubmit their patents if a previous request to add a patent to the register has been denied on the basis of the Federal Court’s interpretation of the Regulations in Viiv, or if its patent was removed from the register on the same basis. However, the frozen register rule will apply. This means a second person filing a submission for an NOC will not be required to address a patent added to the register after the filing date of the second person’s submission for an NOC.
Note that interested persons may make representations concerning the proposed Regulations within 30 days after the date of publication of the notice (May 2, 2015).