As we reported, on September 21, 2017 the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act and accompanying regulations came into force. The legislation provided key reforms to the Patent Act affecting the pharmaceutical industry, including up to two years of patent term restoration for patented pharmaceuticals under the Certificate of Supplementary Protection Regulations (CSP).
The protection given under a CSP is intended to "partly compensate for time spent in research and obtaining marketing authorization." A CSP provides "patent-like rights" that take effect after patent expiry, and is subject to the "same limitations and exceptions" as the patent. Like a patent, a CSP is subject to the jurisdiction of the Patented Medicine Prices Review Board and can be listed on the Patent Register, as well as on the CSP Register.
CSPs are now available for patents relating to drugs with a notice of compliance issued on or after September 21, 2017, provided all other eligibility requirements are met.
The fee for filing a CSP application has increased to $9192 on April 1, 2018.
Health Canada's online Register of Certificates of Supplementary Protection and Applications indicates that the first CSP has issued in relation to TrumenbaTM, a meningococcal group B vaccine. The CSP is also now listed on the Patent Register.
About Norton Rose Fulbright Canada LLP
Norton Rose Fulbright is a global law firm. We provide the world's preeminent corporations and financial institutions with a full business law service. We have 3800 lawyers and other legal staff based in more than 50 cities across Europe, the United States, Canada, Latin America, Asia, Australia, Africa, the Middle East and Central Asia.
Recognized for our industry focus, we are strong across all the key industry sectors: financial institutions; energy; infrastructure, mining and commodities; transport; technology and innovation; and life sciences and healthcare.
Wherever we are, we operate in accordance with our global business principles of quality, unity and integrity. We aim to provide the highest possible standard of legal service in each of our offices and to maintain that level of quality at every point of contact.
For more information about Norton Rose Fulbright, see nortonrosefulbright.com/legal-notices.
Law around the world
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.