Patent extension in Canada: Making up for lost time
It cuts duties on 98% of products traded, saves EU businesses €590 million ($701 million) a year, and has received much scrutiny and criticism. It is the Comprehensive Economic and Trade Agreement (CETA), signed between the EU and Canada in October 2016 after five years of negotiations.
Most major trade deals are inextricably linked to IP, and CETA is no exception—the agreement covers seven main areas, one of them IP, others including trade in goods and services (unsurprisingly), investment and sustainable development. It entered into force provisionally on September 21 but must be ratified by all EU member states before it becomes permanent.
Depending on where you sit on the Brexit debate, CETA demonstrates either the EU’s ability to negotiate complex and wide-ranging deals with major trading partners, or the slow progress of meeting so many countries’ interests.
To comply with CETA, Canada had to introduce a system of patent term extension (PTE) for the first time; until CETA was signed, Canada was the only G7 country not to legislate for PTE. The new system, allowing pharmaceutical patentees to recover time lost during clinical trials and regulatory review, is a landmark moment for the country’s IP framework.
Patent owners can now apply for a two-year certificate of supplementary protection (CSP), an extension that is considerably shorter than the five-year supplementary protection certificate (SPC) over in the EU. It is to the dismay of innovators that Canada decided to meet only the minimum period of two years required under CETA.
These applications, which will be filed with Health Canada, must cover drugs containing a new medicinal ingredient, or a new combination of medicinal ingredients, and which are protected by an eligible patent, ie, product, product-by-process and use claims, but not formulation patents.
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, the EU, Japan, Switzerland and the US—but for the first year of the regulations being in force, this period is 24 months.
