On November 30, 2018, Global Affairs Canada issued a news release announcing the signing of the Canada-United States-Mexico Agreement (CUSMA or USMCA), a new agreement to modernize the North American Free Trade Agreement between Canada, the United States, and Mexico. The changes relating to intellectual property are particularly notable as they modify the landscape for pharmaceuticals, and for patent, copyright and trademark owners. The potential impact on Canada's intellectual property laws was previously reported here, including the requirement to provide a data protection term (market exclusivity) for biologics of at least ten years from the date of first marketing approval. Canada must implement this change within five years of the date the CUSMA enters into force.
Related Publications & Articles
-
Federal Court of Appeal restores Minister of Health’s decision to grant RUZURGI NOC despite FIRDAPSE data protection
The Federal Court found that subsection C.08.004.1(3) of the Food and Drug Regulations applied to prevent the Minister from issuing an NOC in view of the data protection granted to FIRDAPSE, a drug co...Read More -
Consultation open on Health Canada’s proposal on agile licensing for drugs and medical devices
On December 17, 2022, the proposed amendments to both regulations were published for consultation: Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing).Read More -
Certificate of Supplementary Protection filing fee increase effective April 1, 2023
On April 1, 2023, the fee for filing a Certificate of Supplementary Protection (CSP) will increase from $9,952 to $10,152 in accordance with subsection 9(1) of the Certificate of Supplementary Protect...Read More