The Federal Court has ordered that two additional generic defendants (Taro Pharmaceuticals Inc., Sandoz Canada Inc.) be added to a trial of common issues currently set for Bayer Inc.’s claims against Teva Canada Limited and Apotex Inc. concerning generic versions
2019
Stockpiling generic manufacturers may be liable for direct infringement of “composition for a use” claims


The Federal Court has found that it is reasonably arguable that a claim for “a composition for use in the treatment of a disorder” may be directly infringed through the importation, manufacture and stockpiling of the composition. The Court distinguished…
Federal Court refuses to permit reply evidence on validity issues in action under the PM(NOC) Regulations
On a motion for leave to file reply expert reports, the Federal Court has reinforced the rule against case splitting and outlined the circumstances under which reply expert reports are permissible under the Federal Courts Rules. The Court…
Federal Court relies on foreign prosecution history in first application of file wrapper estoppel
In CanMar Foods Ltd. v TA Foods Ltd., 2019 FC 1233, the Federal Court interpreted and applied the new file wrapper estoppel provision, section 53.1 of the Patent Act, RSC 1985, c P-4, for the first time.…
Government releases final amendments to the PMPRB’s Patented Medicines Regulations to lower the prices of patented medicines
The Government is moving forward with changes to the PMPRB intended to lower the prices of patented medicines in Canada in order to lay the foundation for National Pharmacare. The changes are set out in final amendments to the Patented…
Competition Bureau issues statement regarding off-label use of vaccines


The Competition Bureau (Bureau) recently conducted a preliminary investigation into possible competition concerns arising from a proposal to include a clause in a procurement contract that would restrict off-label use of a vaccine. The Bureau concluded that there…
Health Canada consulting on clinical trial requirements and “new class” of advanced therapeutic products

As we reported, the Budget Implementation Act, 2019 (BIA) paved the way for changes to the regulation of clinical trials and created a new class of “advanced therapeutic products” (ATPs) regulated by Health Canada. Health…
Health Canada consulting on draft guidance distinguishing promotional and non-promotional activities for health products
Health Canada is consulting on a draft guidance document entitled The Distinction Between Promotional and Non-promotional Messages and Activities for Health Products (Draft Guidance), which is intended to replace the current 1996 policy entitled The Distinction Between …
Federal Court of Appeal agrees that the PMPRB incorrectly applied the patent-pertaining analysis
The Federal Court of Appeal has provided new guidance on the proper approach to the “patent pertaining” analysis used by the Patented Medicine Prices Review Board (PMPRB or Board), including on the identification of the medicine and the…
Patent Act Infringement Actions Cannot be Joined to PM(NOC) Infringement Actions During NOC Prohibition Period
The Federal Court recently confirmed that an infringement action under the Patent Act cannot be joined with an infringement action under the Patented Medicines (Notice of Compliance) Regulations (the Regulations) while the Regulations prohibit the Minister from granting …