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: