Recent Developments In Section 8 Jurisprudence

In very general terms, section 8 of the Patented Medicines (Notice of Compliance) Regulations ("Regulations") provides for liability by an innovator to a generic manufacturer for the generic manufacturer's damages if an application for a prohibition Order is unsuccessful. While over 40 section 8 actions have been commenced, only four have been determined on their merits to date: Apotex Inc. v. Merck & Co. Inc. et al., 2008 FC 1185 rev'd in part 2009 FCA 187, leave to appeal to S.C.C. refused [2009] S.C.C.A. No. 347 (alendronate); Apotex Inc. v. Syntex Pharmaceuticals International Ltd. et al., 2009 FC 494 aff'd 2010 FCA 155, leave to appeal to S.C.C. refused [2010] S.C.C.A. No. 312 (naproxen sustained-release); Apotex Inc. v. Merck & Co., Inc. et al., 2010 FC 1264, appeal pending (lovastatin); Apotex Inc. v. Merck & Co., Inc. et al., 2010 FC 287 aff'd 2011 FCA 329 (norfloxacin, see below). Two recent decisions, including the appeal decision in norfloxacin, are