SCC Decision on Access to NDS Information

Merck Frosst Canada Ltd v Canada (Health), 2012 SCC 3 var’g 2009 FCA 166 var’g 2006 FC 1201, 2006 FC 1200.

The litigation in this case concerned a request made under the Access to Information Act by a competitor of Merck’s [FCA 4], for access to information submitted by Merck as part of the regulatory approval process for Singulair®. While the Supreme Court dismissed Merck’s appeal in 6 - 3 split, the decision as a whole is not hostile to the interests of innovator pharmaceutical companies. It should remain possible for an innovator to protect all significant information in an NDS, though it will be more burdensome to do so than if the dissenting view had prevailed. In some important respects the Supreme Court decision is clearly more favourable to innovator pharmaceutical companies than was the decision of the FCA.