As we reported, Canada implemented sweeping amendments to the Patented Medicines (Notice of Compliance) Regulations on September 21, 2017. Health Canada has now issued an updated guidance document on the administration of the Regulations in light of these amendments. The update also reflects administrative practices. The guidance document is effective as of May 11, 2018 and is applicable to all drugs that receive a notice of compliance (NOC).

The guidance document elaborates on a number of elements of the new regime, including:

  • The scope and application of section 5 of Regulations, including providing clarification for the types of submissions that will be captured by the provision when a second person applies for an NOC.
  • Information on the TPD's process for assessing submissions (including supplements) under the new regime. This includes details on the process for submitting Form Vs and addressing additions to the Patent Register, as well as certification letter issuance and service.
  • Situations in which a second person must retract a notice of allegation, including screening rejections, notices of non-compliance-withdrawal, and notices of deficiencies-withdrawal.
  • How parties are to disclose litigation information to the TPD given that the Minister of Health is no longer a party to actions commenced under the amended Regulations. Health Canada has emphasized the importance of complying with this procedure in order to avoid the issuance of an NOC while a proceeding under the Regulations is still ongoing.
  • The TPD's process for assessing CSPs under the Regulations, and in particular the manner and circumstances in which CSPs will be added to the Patent Register.
  • The process for placing submissions on Intellectual Property Hold.
  • The process for requesting that the TPD verify portions of a submission or supplement under the Regulations
  • The process for a first person to renounce the twenty-four month stay .
  • The TPD's procedure for maintaining the Patent Register, including the removal of patents and CSPs that are found to be ineligible for listing. Notably, the guidance document states that patents and CSPs declared invalid or void will be deleted after an initial finding and will be added back to the Patent Register if the decision is subsequently reversed. Second persons who file submissions while the patent or CSP is not on the Patent Register will not need to address that patent or CSP.

Link to Guidance Document:

Guidance Document: Patented Medicines (Notice of Compliance) Regulations

About Norton Rose Fulbright Canada LLP

Norton Rose Fulbright is a global law firm. We provide the world's preeminent corporations and financial institutions with a full business law service. We have 3800 lawyers and other legal staff based in more than 50 cities across Europe, the United States, Canada, Latin America, Asia, Australia, Africa, the Middle East and Central Asia.

Recognized for our industry focus, we are strong across all the key industry sectors: financial institutions; energy; infrastructure, mining and commodities; transport; technology and innovation; and life sciences and healthcare.

Wherever we are, we operate in accordance with our global business principles of quality, unity and integrity. We aim to provide the highest possible standard of legal service in each of our offices and to maintain that level of quality at every point of contact.

For more information about Norton Rose Fulbright, see nortonrosefulbright.com/legal-notices.

Law around the world
nortonrosefulbright.com

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.