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 summarized in this article.

Teva's section 8 claim initiated by ratiopharm summarily dismissed. On October 17, 2011, Justice Hughes of the Federal Court allowed Teva's motion for summary trial and granted summary judgment, determining that Teva cannot continue a section 8 claim against Wyeth initiated by ratiopharm: Teva Canada Limited v. Wyeth LLC, 2011 FC 1169 ("Wyeth").

The action had been commenced by ratiopharm in 2007, claiming section 8 damages against Wyeth flowing from prohibition proceedings related to the antidepressant venlafaxine (Wyeth's EFFEXOR XR) and Canadian Patent No. 2,199,778 ("the '778 patent"). In 2010, Teva (previously known as Novopharm) acquired an ownership interest in ratiopharm and the companies amalgamated under the name Teva. The amalgamated corporation (Teva) continued the action against Wyeth.

However, in 2005, Novopharm and Wyeth had entered into a licence agreement permitting Novopharm to sell a generic version of venlafaxine under the '778 patent commencing on December 1, 2006. Pursuant to the agreement, Wyeth undertook to take "commercially reasonable efforts" to address infringement of the '778 patent by third parties. In early 2006, Wyeth notified Novopharm that ratiopharm had served a notice of allegation related to venlafaxine and the '778 patent. Novopharm encouraged and expected Wyeth to commence the notice of compliance proceedings against ratiopharm.

Wyeth sought an Order declaring that Teva is not entitled to continue ratiopharm's claim or...