This is a reminder to patentees of their filing requirements respecting revenues and development expenditures. These filing requirements are contained in section 5 of the Patented Medicines Regulations.

The Annual Form 3 filing to the PMPRB is due on March 1, 2022. As part of the filing, patentees must report:

• The details of licensee’s identifying all persons in Canada with a license (including a compulsory license) or other agreement with the reporting patentee that entitles that person to any right related to a patent.
• The following information for all human and veterinary use medicine (for patented and non-patented products)
  • The total gross revenues from all sales in Canada during the year by the patentee
  • The total gross revenues from all sales in Canada during the year by the licensees
• A summary of all expenditures made during the year by the patentee towards R&D costs (for patented and non-patented medicines) carried out in Canada

 For any inquiries on how PDCI can help with the filing, please contact Mevin Mathew at Mevin.Mathew@pdci.ca