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Innovators in Canada can now enjoy patent term extension for the first time as the Comprehensive Economic and Trade Agreement (CETA) between the EU and Canada entered into force provisionally today.
Patentees can apply for a two-year certificate of supplementary protection (CSP) for drugs containing a new medicinal ingredient, or a new combination of medicinal ingredients, and protected by an eligible patent (formulation patents are ineligible).
The term of a CSP, at two years, is shorter than the five-year supplementary protection certificate in the EU and is the minimum requirement under CETA.
CETA, which was signed last year but will enter into force permanently only when all EU member states have ratified the deal, cuts duties on 98% of products traded between the territories.
According to a European Commission fact sheet, IP is one of seven key parts of the agreement, along with trade and other areas including sustainable development.
The new CSP regime falls under the Certificate of Supplementary Protection Regulations, which are required for Canada to comply with CETA.
To be eligible for a CSP, patentees must have filed a New Drug Submission in Canada within 12 months of the first equivalent international filing in any of the following territories: Australia, EU, Japan, Switzerland and the US.
For the first year of the regulations being in force, this period is 24 months.
Under the new framework, there is an exemption allowing generic products to be made or sold for the purpose of export.
One change since the last draft regulations were released is that patentees will no longer be required to have two years or more remaining on their patent in order to apply for a CSP.
Declan Hamill, vice president, legal and regulatory affairs and policy at Innovative Medicines Canada, an industry association, said that patentees must apply for a CSP before either: (a) where the patent is granted before product approval by Health Canada, 120 days from Health Canada approval; or (b) where the patent is granted after Health Canada product approval, within 120 days after the patent has been granted
The new system is a positive move for Canada, which until the signing of CETA, was the only G7 country not to legislate for patent term extension.
Daphne Lainson, partner at Smart & Biggar/Fetherstonhaugh, said that for most pharma products, the real value in the patent is at the end of the term.
“Having an additional term of supplementary protection is of tremendous value to innovators and that value will drive future innovations.”
SPCs, patent term extension, certificate of supplementary protection, CETA, patent, pharmaceuticals, Innovative Medicines Canada, Smart & Biggar/Fetherston