Section 8 at the SCC

On Monday, April 20th, the Supreme Court will hear oral arguments in Sanofi-Aventis’ appeal in Apotex’s Ramipril proceeding pursuant to Section 8 of the Patented Medicine (Notice of Compliance Regulations). The appeal is from the March 2014 split decision of the Federal Court of Appeal in 2014 FCA 68 relating to among other things the ‘hypothetical world’, the ramp-up period and non-indicated uses.

The decision under appeal, Apotex Inc v Sanofi-Aventis, 2014 FCA 68 is in turn an appeal from a decision of Justice Snider (2012 FC 553). The Federal Court of Appeal decision was released at the same time as Teva’s appeal (Teva Canada Limited v Sanofi-Aventis Canada Inc, 2014 FCA 67) and Sanofi’s challenge to the validity of Section 8 (Sanofi-Aventis Canada Inc. v. Teva Canada Limited, 2014 FCA 69).

In addition to Sanofi-Aventis and Apotex, two industry groups have intervened: Canada’s Research-Based Pharmaceutical Companies and Canadian Generic Pharmaceutical Association.

Due to confidentiality orders, the factums are not available online and the hearing will not be webcast.

More information on other intellectual property proceedings at the Supreme Court are available on my Supreme Court litigation page.