Health Canada Updates Its Guidance Document: Patented Medicines (Notice of Compliance) Regulations

Health Canada has updated its Guidance Document: Patented Medicines (Notice of Compliance) Regulations (Guidance Document) to exclude certain types of administrative drug submissions from the scope of section 5 of the Patented Medicines (Notice of Compliance) Regulations (Regulations). Section 5 of the Regulations specifies when a second person is required to address the patents of a first person listed on the Patent Register. The update essentially adopts the proposed amendments discussed in an earlier E-TIPS article. The changes exempt from the scope of section 5 of the Regulations administrative drug submissions filed by licensees that cross-reference a licensor’s drug submission. In such instances, the date that the patent register will be “frozen” is the date of the filing of the licensor’s submission. The update is effective as of April 16, 2012. Accordingly, licensees who filed cross-referenced administrative drug submissions prior to this date will still be subject to the provisions of Section 5 of the Regulations. The update further exempts from Section 5 administrative drug submissions for a change in the manufacturer’s name or the product name, which are filed pursuant to Health Canada’s Changes in Manufacturer’s Name and/or Product Name Policy. For the updated Guidance Document, see: http://tinyurl.com/7g9vdz8 Summary by: Michael Migus