Smart & Biggar/Fetherstonhaugh updates

Canada introduces Bill C-100: step towards ratification of NAFTA 2.0
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 24 June 2019

In a step towards ratifying the United States-Mexico-Canada Agreement (USMCA), the government recently introduced Bill C-100, entitled "An Act to implement the Agreement between Canada, the United States of America and the United Mexican States", in Parliament. If ratified, the USMCA will replace the North American Free Trade Agreement and will require several changes to Canada's IP laws.

Federal Court dismisses Servier's application for order of prohibition regarding salt patent
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 24 June 2019

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.

Court upholds issuance of NON-W letter and cancellation of reconsideration process for Apotex
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 19 June 2019

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.

Federal Court dismisses Servier's application for order of prohibition regarding salt patent
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 19 June 2019

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.

Prior user rights under recently amended Patent Act
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 17 June 2019

The Budget Implementation Act 2 has brought about several changes to the Patent Act that affect the scope of protection available under Canadian patents, including a revision of Section 56, which concerns the rights of prior users of patented technologies. However, as many of the Section 56 amendments will require judicial interpretation, the true scope of prior user rights under the revised provision may be unknown for some time.

Top 10 changes to Canada's trademark law
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 17 June 2019

After five years of anticipation, sweeping changes to Canada's trademark law have finally come into force. Among other things, Canadian applicants can now file applications in more than 80 countries around the world through a single international application and declarations of use are no longer required to secure registrations.

Procedural decisions under PMNOC Regulations: common validity issues and naming of defendants
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 12 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.

Ontario Court of Appeal overturns ban on online sales of prescription eyewear to Ontario residents
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 12 June 2019

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.

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'.

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.

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.

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
  • 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.

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.

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.

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