Right of appeal provision in CETA

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Right of appeal provision in CETA

Genéricos/Investigación | Posted 14/08/2014 0 Post your comment

The Comprehensive Economic and Trade Agreement (CETA) between the European Union (EU) and Canada has the potential to have a negative affect on the generics industry in Canada [1], with certain provisions being seen as causing the most harm.

The right of appeal provision is one such provision seen as having a detrimental effect on the generics industry.

Right of appeal
Under the terms of CETA, a new right will be established for patent holders to appeal court decisions where a patent is declared invalid, a process that has only been available to challengers in Canada to date.

This kind of patent linkage system automatically delivers the equivalent of an injunction without prior analysis of evidence that a patent is being infringed. Since the EU does not use patent linkage and CETA does not require it to do so, this right of appeal provision only applies to Canada.

In fact, the European Commission prohibits EU member countries from introducing patent linkage provisions because they delay the entry of generics. It is therefore seen as somewhat ironic that under CETA, rather than Canada eliminating its patent linkage system, it will be forced to strengthen it by providing a right of appeal that will create further delays for the entry of generics.

In practice, this means that under CETA there could be a further delay of 6–18 months before generics enter the Canadian market, as the appeal makes its way through the court system.

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Reference
1. Lexchin J1, Gagnon MA. CETA and pharmaceuticals: impact of the trade agreement between Europe and Canada on the costs of prescription drugs. Global Health. 2014;10:30.

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