The Comprehensive Economic and Trade Agreement (CETA) between Canada and the European Union was approved by all 28 EU member states in October 2016, and was signed promptly thereafter by Canadian Prime Minister Justin Trudeau. Under CETA, Canada has promised, inter alia, to make a number of important changes to intellectual property protection for pharmaceutical patentees in order to bring Canadian practice more in line with European practice.
On February 14, 2017, the Canadian House of Commons passed Bill C-30, “An Act to implement the Comprehensive Economic and Trade Agreement between Canada and the European Union and its Member States and to provide for certain other measures” at Third Reading. Bill C-30 has moved onto the Canadian Senate, where it will have additional readings. Once the Senate and the House of Commons have agreed on the wording of Bill C-30, it will be passed into law. While there may yet be some edits to the Bill along the way, it is unlikely that the substance of it will change significantly (the text of Bill C-30 is available online).
Bill C-30 proposes to make several changes to the Canadian Patent Act and Food and Drug Act as they pertain to protection of innovative pharmaceuticals.
Notably, Bill C-30 will amend the Canadian Patent Act to provide patent term extensions (PTEs) for pharmaceuticals, by introducing a Supplementary Protection Certificate (SPC) system similar to the European SPC system. Eligible drugs are defined broadly to include human and veterinary drugs. Eligible patents will have to pertain to a “medicinal ingredient” or a “combination of medicinal ingredients”, and only one patent can be the subject of an SPC. Where there are multiple patents, Bill C-30 provides rules for determining which patent is eligible.
Bill C-30 will also put an end to “dual litigation” in Canada. Currently, Canada has a system that allows for two legal proceedings (dual litigation) between the same parties relating the same drug and patent: (i) a summary proceeding under the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations), which link the patent regime to regulatory approval by Health Canada; and (ii) a patent infringement or impeachment action under the Patent Act. Under Bill C-30, the PM(NOC) regulations will survive but in an amended form, intended to replace the current summary proceedings with full patent infringement and validity actions that would result in a final determination on infringement and validity issues.
Assuming the Senate moves quickly, it seems likely that Bill C-30 will be passed into law sometime later in 2017. Amendments to any relevant government regulations (such as the PM(NOC) regulations) will follow.
It should be noted that CETA will not apply to the United Kingdom once it leaves the European Union. However, the changes being made to the Canadian Patent Act will affect everyone, not just members of CETA. Furthermore, it is expected that Canada will pursue a similar trade agreement with the UK after Brexit, and it will have a strong head-start, given that both parties participated in negotiations on CETA.