Health Canada has issued the first Certificates of Supplementary Protection (CSPs) against the following approvals: neisseria meningitidis grp B recombinant lipoprotein 2086 subfamily A/neisseria meningitidis grp B recombinant lipoprotein 2086 subfamily B (Pfizer’s TRUMENBA), letermovir (Merck’s PREVYMIS), and guselkumab (TREMFYA)(see: Register of Certificates of Supplementary Protection). In addition, the CSP application fee as of April 1, 2018 is $9,192.
Related Publications & Articles
-
Health Canada finalizes biosimilar guidance: comparative clinical efficacy studies not typically required
In Canada, biosimilar products are approved by way of a new drug submission, following Health Canada guidance first released in 2010 and significantly revised in 2016.Read More -
2026 mid-year highlights in Canadian life sciences IP and regulatory law
In the first half of 2026, the Rx IP Update team reported on a number of developments in Canadian life sciences IP and regulatory law. Below are our top storiesRead More -
Supreme Court of Canada: methods of medical treatment unpatentable, validity of Janssen’s paliperidone dosing regimen patent upheld
Today the Supreme Court of Canada released its decision in Pharmascience Inc v Janssen Inc, 2026 SCC 26 on the patentability of methods of medical treatment, dismissing Pharmascience’s appeal.Read More
