The Federal Court dismissed an application by Eli Lilly Canada Inc., Ube Industries, Ltd., and Daiichi Sankyo Company, Limited (the Applicants) seeking a prohibition order regarding Apotex’s generic version of Lilly’s EFFIENT® (prasugrel hydrochloride). While the Court rejected
2018
Health Canada Releases Updated Guidance on Amended PM(NOC) Regulations


As we reported, Canada implemented sweeping amendments to the Patented Medicines (Notice of Compliance) Regulations on September 21, 2017. Health Canada has now issued an updated guidance document on the administration of the Regulations in light of these amendments.…
Advisory Council on the Implementation of National Pharmacare – Consultation with Canadians

Advisory Council on the Implementation of National Pharmacare – Consultation with Canadians
The Advisory Council on the Implementation of National Pharmacare (“Council”) is consulting with Canadians on the implementation of a national program to fund prescription drugs. The…
First motion for early patent dismissal fails to meet high burden under newly-amended PM(NOC) Regulations



On July 6, 2018, the Federal Court dismissed the first motion brought under section 6.08 of the newly-amended Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court’s public reasons were released July 30, 2018. The moving party, Amgen…
Getting the Deal Through – Pharmaceutical Antitrust

Norton Rose Fulbright has published a new edition of Getting the Deal Through – Pharmaceutical Antitrust. This edition is an updated, thorough overview of the application of antitrust law to the pharmaceutical sector worldwide. The pharmaceutical sector remains a…
Federal Court upholds patent validity and grants prohibition order against generic lisdexamfetamine in pre-CETA PM(NOC) application

The Federal Court dismissed Apotex’s action to invalidate the claims of Canadian Patent No. 2,527,646 (the 646 Patent), which was consolidated with Shire’s application to prohibit the Minister of Health from issuing a Notice of Compliance for Apotex’s generic…
Pan-Canadian Pharmaceutical Alliance (pCPA) releases draft brand process guidelines

On June 13, 2018, the pan-Canadian Pharmaceutical Alliance (pCPA) released its draft Brand Process Guidelines (Guidelines) for stakeholder feedback. As part of the consultation process, pCPA is planning a webinar for innovative manufacturers on June 22,…
CETA Tracker: Update on section 6 actions under the Patented Medicines (Notice of Compliance) Regulations


As we reported, Canada implemented a single-track pharmaceutical patent litigation regime through amendments to the Patented Medicines (Notice of Compliance) Regulations (the Regulations) on September 21, 2017. Below, we provide an update on new actions and decisions under…
Standing Committee on Health releases report and recommendations on National Pharmacare

On April 18, 2018 the Standing Committee on Health tabled its report on national pharmacare entitled Pharmacare Now: Prescription Medicine Coverage for All Canadians.
The Committee believes that the best way to move forward in establishing a universal single…
Apotex request to re-open validity of esomeprazole patent denied


The Federal Court dismissed Apotex’s motion to re-open the validity phase of the patent infringement action relating to esomeprazole (AstraZeneca’s NEXIUM®). Apotex had moved to re-open validity to allow the Court to adjudicate the issue of “overpromising” in…