Earlier today, Canada and the European Union (EU) announced an agreement in principle on a Comprehensive Economic and Trade Agreement (CETA).  While the final text of the agreement has not been made public, it appears that CETA will enhance intellectual property protection. 

The Government of Canada acknowledged that this is important for Canada’s increasing knowledge-based economy and will help foster innovation as well as stimulate job creation and attract investment.   

Of particular importance to the life sciences industry are the following:

  1. Patent Term Restoration - Patent Term Restoration will offer innovative pharmaceutical companies the potential to restore up to two years of patent protection lost due to delays arising from regulatory and government approval processes.
  2. Right of Appeal - Innovative pharmaceutical companies will finally be able to appeal decisions made under the Patented Medicines (Notice of Compliance) Regulations.  Prior to CETA, generic patent challengers were permitted to appeal decisions from the Federal Court.  In stark contrast, innovators were precluded from bringing an appeal if the generic challenger obtained marketing approval.  CETA corrects this inequity.    

Once a final text has been agreed to it will go through a “legal scrub”, be translated into 28 languages and then ratified by Canada and the EU. The ratification process could take 18-24 months.