- Legal Review of Ceta Completed by Canada and European Union; Likely in Force In 2017
- March 21, 2016
- Law Firm: Smart Biggar/Fetherstonhaugh - Ottawa Office
On February 29, 2016, Canada’s Minister of International Trade (Chrystia Freeland) and the European Commissioner for Trade (Cecilia Malmström) announced that the legal review of the Canada-European Union Comprehensive Economic and Trade Agreement (CETA) has been completed. As part of the review, modifications were made to the investment chapter of CETA relating to provisions on governments’ right to regulate and the structure and process relating to the dispute-settlement tribunal.
As previously reported, CETA will have an impact on pharmaceutical product protection in Canada. In particular, the key provisions include:
- Innovator right of appeal - CETA will provide innovators with “equivalent and effective rights of appeal” as generic entrants under the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations), which will effectively reverse Canadian jurisprudence holding that once a prohibition application is dismissed and a generic manufacturer receives marketing approval for a drug, any appeal by the innovator is rendered moot.
- Changes to “dual litigation” - the right of appeal under CETA also “gives scope for Canada to end the practice of dual litigation”, meaning that the current system of parties litigating a patent for the same product under both the PM(NOC) Regulations and the Patent Act as an infringement or impeachment action may come to an end.
- Patent term restoration - an additional “sui generis” term of protection will be provided for pharmaceutical products covered by eligible patents in Canada. Where there are delays in obtaining regulatory approval for a pharmaceutical product, a patentee may be able to apply for an extension of patent protection for up to two years. For more details, see our previous article on patent term restoration under CETA.