Smart & Biggar/Fetherstonhaugh updates

Nice Classification with a trap – Canada introduces class top-up fees with no back door
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 10 June 2019

With the long-awaited changes to the Trademarks Act and Regulations imminent, brand owners should be excited about Canada's alignment with international trademark standards and the new opportunities that these changes will bring. However, brand owners should be aware that Canada has adopted a unique policy concerning the required filing fees which differs significantly from the general practice of other member countries.

Procedural decisions under PMNOC Regulations: common validity issues and naming of defendants
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 10 June 2019

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.

New oncology initiative and Health Canada study on biosimilar drugs
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 05 June 2019

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 invites submissions containing high-quality, real-world evidence
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 05 June 2019

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: amendments to Food and Drugs Act establish framework for advanced therapeutic products
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 29 May 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.

Proposed amendments to Food and Drug Regulations
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 29 May 2019

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'.

New oncology initiative and Health Canada study on biosimilar drugs
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 27 May 2019

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.

Filing fee for certificates of supplementary protection now increased
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 27 May 2019

In accordance with Section 9(1) of the Certificate of Supplementary Protection (CSP) Regulations, the fee for filing a CSP recently increased. This article sets out a number of important reminders relating to CSPs and annual maintenance fees.

Amendments to Patented Medicines Regulations expected to come into force no earlier than Spring 2020
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 22 May 2019

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.

On the (Quebec health) record: Quebec government liable for patent infringement
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 22 May 2019

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.

Amendments to Patented Medicines Regulations expected to come into force no earlier than Spring 2020
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 20 May 2019

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.

Act now: follow this to-do list to save money on Canadian trademarks before 17 June 2019
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 20 May 2019

Canada's trademark regime is changing, bringing about dramatic amendments to the law, regulations and practice. These long-awaited changes will have a significant impact on brand owners in terms of both strategy and costs. In order to prepare for the changes, brand owners should consider renewing and classifying registrations, filing multi-class applications, pushing allowed applications to registration and ensuring that all portfolios are troll-proof before the new law enters into force on 17 June 2019.

Supreme Court denies Apotex leave to appeal decision regarding India facilities
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 15 May 2019

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.

PMPRB publishes 2017 Meds Entry Watch
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 15 May 2019

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.

Competition Bureau publishes final updated IP Enforcement Guidelines
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 13 May 2019

The Competition Bureau recently published the final version of its updated IP Enforcement Guidelines (IPEGs). As noted by the bureau, the "updates are modest". Most of the changes to the IPEGs reflect the 2017 amendments to the Patented Medicines (Notice of Compliance) Regulations and, in particular, the termination of dual litigation.

On the (Quebec health) record: Quebec government liable for patent infringement
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 13 May 2019

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 launches e-learning tool for understanding pre-market regulatory requirements
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 08 May 2019

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.

Quebec Court of Appeal overturns decision to delist Remicade from Quebec's List of Medications
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 08 May 2019

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.

Supreme Court denies Apotex leave to appeal decision regarding India facilities
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 06 May 2019

In 2017 the Federal Court of Appeal dismissed Apotex's appeal of a judicial review decision of the Therapeutic Products Directorate, which required Apotex to submit additional information concerning products manufactured or tested in its facilities in India. The Supreme Court recently dismissed Apotex's application for leave to appeal.

Health Canada and CADTH launch new initiative to provide early parallel scientific advice
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 01 May 2019

Health Canada and the Canadian Agency for Drugs and Technologies in Health (CADTH) recently launch a new initiative to provide early parallel scientific advice. The initiative will enable Health Canada and the CADTH to collaborate and share perspectives while each formulating independent advice regarding a sponsor's specific drug development plan. It will also give sponsors the opportunity to hold joint meetings with Health Canada and the CADTH to discuss their advice.

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