ARTICLE
2 July 2018

Health Canada Issues Updated Guidance On PMNOC Regulations

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Smart & Biggar

Contributor

Smart & Biggar uncovers and maximizes intellectual property and technology assets for our clients. Today’s fast-paced innovation economy demands a higher level of expertise and attention to detail when it comes to IP strategy and protection. With over 125 lawyers, patent agents and trademark agents collaborating across five Canadian offices, Smart & Biggar is trusted by the world’s leading innovators to find value in their IP rights. As market leaders in IP, Smart & Biggar’s team is on the pulse when it comes to the latest developments and the wider industry changes that impact our clients. To stay informed, visit smartbiggar.ca/insights, including access to our RxIP Update (smartbiggar.ca/insights/rx-ip-updates), a monthly digest of the latest decisions and law surrounding the life sciences and pharmaceutical industries.
Health Canada has issued updated guidance reflecting the September 21, 2017 amendments: Guidance Document: Patented Medicines (Notice of Compliance) Regulations (see our summary of the amendments here).
Canada Food, Drugs, Healthcare, Life Sciences

Health Canada has issued updated guidance reflecting the September 21, 2017 amendments: Guidance Document: Patented Medicines (Notice of Compliance) Regulations (see our summary of the amendments here). The guidance, which became effective on May 11, 2018, also reflects current administrative practices, for example, by replacing references to "patent hold" with its currently preferred term, "intellectual property hold". Further revisions include:

  • Directions on how to provide litigation information to Health Canada so that it is aware of barriers to the issuance of a second person's NOC, given that the Minister is no longer a party to proceedings commenced under the amended PMNOC Regulations;
  • Example scenarios outlining when Certificates of Supplementary Protection will and will not be eligible for inclusion on the Patent Register and the process for eligibility assessments; and
  • Directions on how to renounce the application of the 24-month stay imposed on second persons when an action is commenced under subsection 6(1) of the amended PMNOC 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.

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