On September 21, 2017, the Certificate of Supplementary Protection Regulations (CSP Regulations) came into force in Canada. The CSP Regulations established a mechanism for drug manufacturers to obtain patent term extensions to account for marketing delays arising from the regulatory review time of a drug, up to a maximum of 2 years.
The first CSPs have now been granted under the CSP Regulations. A CSP has been granted to Merck Canada Inc., in relation to its PREVYMIS (letermovir) drug and Canadian Patent No. 2,524,069 (CPS No. 900007). Pfizer Canada Inc. has been granted a CSP in relation to its TRUMENBA (neisseria meningitidis grp b recombinant lipoprotein 2086 subfamily a / neisseria meningitidis grp b recombinant lipoprotein 2086 subfamily b) drug and Canadian Patent No. 2,463,476 (CPS No. 900002).
In both incidences, the drug manufacturers were granted the maximum extension period of 2 years.
These CSPs are listed on Health Canada’s new Register of Certificates of Supplementary Protection and Applications, along with a number of pending CSP applications. The granted CSPs have also been listed on the Patent Register against Merck and Pfizer’s PREVYMIS and TRUMENBA drugs, respectively.
Summary By: Michael Migus
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