On October 12 2016 the Federal Court of Appeal allowed four appeals concerning decisions by the minister of health to issue a notice of compliance to:

  • Teva for exemestane tablets (a generic version of Pfizer's Aromasin); and
  • Hospira for Inflectra, an infliximab powder for solution (a biosimilar of Janssen's Remicade).

The court found that the minister was reasonable in finding that these cross-referenced drug submissions did not trigger Section 5 of the Patented Medicines Notice of Compliance Regulations in the absence of early working, Teva Canada Limited v Pfizer Canada Inc (2016 FCA 248). Janssen's application for leave to appeal the decision was dismissed on June 22 2017 (SCC 37342).

For further information on this topic please contact Abigail Smith at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email ([email protected]). The Smart & Biggar website can be accessed at www.smart-biggar.ca.