Intellectual Property (IP) is a key component of an innovation economy and the Canadian government has recently recognized the importance of IP with the recent launch of an IP strategy1 . As a part of the growing internationalization of the field of IP, Canada has also acceded to a series of international conventions and agreements bringing changes to the Canadian patent law . This article provides a review of the most important changes already in force or in the makings.
First discussed in this article, the Canada-European Union Comprehensive Economic and Trade Agreement (CETA) introduced in 2017 an extension of the protection of pharmaceutical products in the form of Certificates of Supplementary Protection (CSP) and radically changed the regime for pharmaceutical patent litigation. The second section of this article covers the implementation of the Patent Law Treaty, the goals of which will lead to simplified and harmonized administrative practices with regards to patent applications. The recent Canada-United StatesMexico Agreement (CUSMA) not only affects the national treatment and market access for goods, it also features important changes relating to patents in general and patented biological, and pharmaceutical products. Finally, Canada is also contemplating a new series of changes as proposed on October 30, 2018 in the Budget Implementation Act, 2018, No. 2., to better protect intellectual property and promote of innovation in Canada.
Changes associated with the Canada-European Union Comprehensive Economic and Trade Agreement
The Canada-European Union Comprehensive Economic and Trade Agreement (CETA) is in force since September 21, 2017. This agreement offers a new patent term extension for pharmaceuticals in the form of CSP. The CSP will act as the only form of patent term extension or restoration available. A maximum extension of 2 years is instituted to account for delays in regulatory approval with respect to the making, constructing, using and selling of any drug that contains a medicinal ingredient, or combination of medicinal ingredients, by itself or in addition to any other medicinal ingredient.
The regime requires the filing of an application for marketing approval in Canada within 12 months of submission of the first marketing authorization application in the United States, Japan, Switzerland, Australia and any country of the European Union. With such a timeline, we recommend adjusting any regulatory approval plans for Canada in order to benefit from CSP.