The Supreme Court of Canada has denied Apotex leave to appeal in two recent cases. In the first case, Apotex sought leave to appeal a decision of the Ontario Court of Appeal permitting Sanofi and Schering to amend their defences to claims relating to ramipril. In the second case, Apotex sought leave to appeal a decision of the Federal Court of Appeal relating to damages awarded to Eli Lilly in respect of Apotex's infringement of process patents relating to cefaclor.
Health Canada has published its Overview of the Reporting Adverse Reactions to Marketed Health Products – Guidance Document for Industry. The guidance document provides market authorisation holders with assistance on how to report adverse reactions to pharmaceutical drugs, biologics, radiopharmaceutical drugs and natural health products.
Two sets of proposed amendments to the Food and Drug Regulations were recently published and contain provisions which would streamline the process for providing access to unauthorised drugs for medical emergencies. Access to the drugs will continue to be facilitated through the Special Access Programme for human drugs and the Emergency Drug Release Programme for veterinary products.
Health Canada recently released the new Guidance Document: Regulatory Requirements for Drug Identification Numbers. The document assists in interpreting the regulatory requirements associated with drug identification numbers and offers guidance to manufacturers on their obligation to accurately report notifications for a change of drug status to Health Canada.
The Federal Court has granted in part Pharmascience's motion to strike out portions of Teva's statement of claim under Subsection 6(1) of the Patented Medicines (Notice of Compliance) (PMNOC) Regulations relating to glatiramer acetate (Teva's Copaxone and Pharmascience's Glatect). The court found that it is plain and obvious that Section 6.02 of the PMNOC Regulations prohibits the joinder of a regular infringement action under the Patent Act with an action pursuant to Subsection 6(1).
The Patented Medicine Prices Review Board (PMPRB) previously announced that the steering committee on guidelines modernisation would hold its final meeting on 13 May 2019 to discuss both a draft report of its deliberations and the working group's final report. Once the steering committee's report has been finalised and the regulatory amendments have been published in Part II of the Canada Gazette, the PMPRB will release its draft guidelines for public consultation.
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.
Health Canada recently released a notice inviting drug submissions containing high-quality, real-world evidence along with a document providing principles for the collection and evaluation of real-world evidence. A further joint document regarding the use of real-world evidence is expected to be published later in 2019.
Bill C-97, which was recently introduced in the House of Commons, includes proposed amendments to the Food and Drugs Act to introduce a new framework for advanced therapeutic products, including a new licensing framework. It is expected that advanced therapeutic products may include the regulation of newer technologies, such as cell and gene therapies, 3D printing and novel drug delivery methods.
Health Canada recently released its proposed Regulations Amending the Food and Drug Regulations (Improving Access to Generics). The proposed regulations clarify and codify Health Canada's expectations and policies regarding differences in the form of medicinal ingredients in generic drug products that are eligible for submission under the abbreviated new drug submission pathway by introducing a regulatory definition for 'therapeutically active component'.
In a digital-age David versus Goliath case, the Federal Court recently held that the Quebec government had infringed two patents owned by Dr Luc Bessette relating to a shared medical records system that he had invented 20 years ago. This is the first time that the Quebec government has been held liable for patent infringement and the decision provides important guidance to institutions, enterprises and inventors alike.
Health Canada recently released its Forward Regulatory Plan 2019-2021: Regulations Amending the Patented Medicines Regulations. This brief document provides a high-level overview of the anticipated amendments released in draft form on 2 December 2017, the expected impact of these amendments and the consultation process.
The Patented Medicine Prices Review Board recently announced the publication of the 2017 edition of Meds Entry Watch. According to the notice, this publication provides information on new medicines entering Canadian and international markets and examines the availability, sales, uptake, pricing and treatment costs of new medicines that were approved by the US Food and Drug Administration, the European Medicines Agency and Health Canada in 2016 and 2017.
In 2018 the Federal Court of Appeal dismissed Apotex's appeal of a judicial review decision of the Therapeutic Products Directorate (TPD), finding that the Federal Court made no reviewable error in its conclusion that the TPD's decision was not improperly motivated. The Supreme Court recently dismissed Apotex's application for leave to appeal.
The Quebec Court of Appeal recently found the minister of health and social services's decision to delist Janssen's Remicade from Quebec's List of Medications to be invalid and ordered the minister to reinstate the drug on the list. The court concluded that the minister had violated procedural fairness and should have given Janssen formal notice and an opportunity to respond before making the change.
Health Canada recently launched its e-learning tool for understanding pre-market regulatory requirements for medical devices. Among other things, the tool will provide targeted guidance to enable greater consistency in the understanding, interpretation and application of the Food and Drugs Act, the Medical Devices Regulations and their related policies and guidelines.