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.
All patentees must submit their Form 3 information for 2017 by March 1, 2018. Form 3, the template created by the PMPRB to help patentees file this information, is available on the PMPRB website under Regulatory Filings, and can be accessed via the following link:
http://www.pmprb-cepmb.gc.ca/view.asp?ccid=489
As part of their Form 3 filing, patentees must report:
- The name and address of all licensees in Canada. Patentees are required to identify all persons in Canada with whom the reporting patentee has a license (including a compulsory license) or other agreement that entitles that person to exercise any rights in relation to a patent.
- The total gross revenues from all sales in Canada during the year by the patentee of medicine (whether patented or not) for human and veterinary use and the total revenues received from all licensees from the sale in Canada of medicine (whether patented or not) for human and veterinary use.
- A summary of all expenditures made during the year by the patentee towards the cost of R&D relating to medicine for human and veterinary use carried out in Canada by or on behalf of the patentee. Note that the expenditures to be reported are not limited to R&D related to patented medicines under the PMPRB’s jurisdiction, but rather encompass R&D related to any medicine, whether patented or not.
The failure by any patentee to report any of the above-noted information may result in Board Staff seeking an order from the Board requiring the patentee to disclose such information. In addition, Board Staff emphasizes that, pursuant to section 76 of the Patent Act, any person who makes false representation to the PMPRB, or submits any false information, or produces any document containing false information, is guilty of an indictable offence.
For questions, please contact Lokanadha Cheruvu at (613) 288-9601 or lokanadha.cheruvu@pmprb-cepmb.gc.ca.