The Federal Court recently dismissed Servier's application for a prohibition order under the pre-amended Patented Medicines (Notice of Compliance) Regulations for Canadian Patent 2,423,825 regarding a perindopril arginine/amlodipine product (Servier's Viacoram). Apotex had alleged that the patent was invalid for obviousness, overbreadth, inutility and insufficiency.
The Federal Court of Appeal recently affirmed the Federal Court's dismissal of Apotex's application for judicial review of a minister of health decision relating to its Apo-Omeprazole (omeprazole magnesium) delayed-release tablets. The minister had issued a Notice of Non-Compliance – Withdrawal letter in respect of Apotex's abbreviated new drug submission on the basis that the tablets were not bioequivalent to the relevant Canadian reference product.
The Ontario Court of Appeal has overturned the Ontario Superior Court of Justice's finding that online sales of prescription eyewear by Essilor Group Canada Inc to Ontario residents violated the Regulated Health Professions Act. The court found that the mere act of delivery did not, in itself, establish a sufficient connection to Ontario so as to bring Essilor's online transactions within the ambit of the act.
In two recent cases, the Federal Court considered procedural decisions in actions under the Patented Medicines (Notice of Compliance) Regulations. In one case, the court ordered that common validity issues in actions relating to Bayer's Xarelto against Apotex and Teva will be heard concurrently. In another case, the court refused to allow the plaintiffs to name additional Teva parties as further defendants in three actions relating to Celltrion's Herzuma, a trastuzumab biosimilar of Roche's Herceptin.
The new pan-Canadian Oncology Biosimilars Initiative aims to ensure appropriate implementation and cost-effective use of therapeutic oncology biosimilars. Separately, Health Canada recently announced that it is collaborating with the Drug Safety and Effectiveness Network on a project to study patients with certain diseases who are taking biologic drugs. The study aims to compare the safety and effectiveness of biosimilar drugs to the reference biologic drug.