On April 26, 2023, the Office of the United States Trade Representative (USTR) released its 2023 Special 301 Report on intellectual property. The report keeps Canada on a Watch List of 29 U.S. trading partners that “merit bilateral attention to address underlying IP problems”. The report is the USTR’s annual review of the global state of IP protection and enforcement.
Highlights pharmaceutical IP issues in Canada
The USTR report identifies two specific concerns with pharmaceutical IP protection in Canada:
- The U.S. continues to monitor Canada’s outstanding commitments from the United States-Mexico-Canada Agreement (USMCA), including patent term restoration for unreasonable patent office delays. As we previously reported, Canada must implement a patent term restoration system by 2025. Draft legislation to create such a system was recently introduced in Parliament. Stay tuned for our detailed report on this to follow shortly.
- The USTR criticized Canada’s Certificate of Supplementary Protection (CSP) system, which can extend patent protection for new medicinal ingredients (or new combinations of medicinal ingredients). According to the USTR, the CSP system is “limited in duration, eligibility, and scope of protection”.
The USTR also highlights concerns about counterfeit goods, online piracy, and education-related exceptions to copyright in Canada.
- April 26, 2023 USTR report and accompanying press release