Latest updates

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.

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.

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.

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.

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.

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.

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.

Pharmacare advisory council delivers initial recommendations
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 01 May 2019

In March 2019 the Advisory Council on the Implementation of National Pharmacare delivered its interim report with three initial recommendations: create a national drug agency to oversee national pharmacare, develop a comprehensive, evidence-based list of prescribed drugs to harmonise coverage across Canada; and invest in data on prescription drugs and IT systems. The federal government subsequently delivered the 2019 Federal Budget, which reflects these recommendations.

Final regulations addressing public release of clinical information now in force
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 24 April 2019

The final Regulations Amending the Food and Drug Regulations and Regulations Amending the Medical Devices Regulations recently came into force. Their objective is to provide public access to clinical information submitted to Health Canada for drugs for human use and medical device applications. As a result of the regulations, Health Canada published (among other things) a guidance document to help explain aspects of the new regulations, such as the procedures to prepare information for release.

Federal Court finds invalidity allegations relating to patent for metformin formulations unjustified
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 22 April 2019

Valeant Canada's application for an order prohibiting the minister of health from issuing a notice of compliance to Generic Partners for its generic version of Valeant's Glumetza, a metformin formulation, was recently granted. With respect to anticipation and double patenting, the court found that the prior art document on which Generic Partners had relied for both allegations did not disclose all three of the size, shape and time elements of the claimed formulations.

Court of Appeal dismisses appeal of judgment awarding Apotex damages
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 17 April 2019

In December 2017 Apotex was awarded more than C$11 million in damages and pre-judgment interest for losses resulting from delays in the US Food and Drug Administration's approval of its amoxicillin-clavulanic acid and levodopa-carbidopa products, which had been caused by contractual breaches and negligence on the part of MDS Pharma Services (MDS). However, the Ontario Court of Appeal recently dismissed MDS's appeal and Apotex's cross-appeal of that judgment.

Apotex seeks leave from Supreme Court of Canada in cefaclor damages action
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 17 April 2019

The Federal Court of Appeal recently allowed in part Apotex's appeal of a decision awarding Eli Lilly more than C$100 million for Apotex's infringement of eight process patents relating to the antibiotic cefaclor. The court rejected Apotex's argument that a non-infringing alternative would have been available to Apotex during the relevant period. The case was remitted to the Federal Court for reconsideration on the issue of prejudgment interest; Apotex has applied to the Supreme Court of Canada for leave to appeal.

Save money: renew all trademark registrations now
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 15 April 2019

The new trademark law will take effect on 17 June 2019. Among the changes is a new fee-per-class structure, under which the government renewal fee will be C$400 for the first class and C$125 for each additional class. Brand owners can potentially realise huge savings if they take steps to renew all of their existing Canadian trademark registrations before the new law takes effect.

Apotex seeks leave from Supreme Court of Canada in cefaclor damages action
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 15 April 2019

The Federal Court of Appeal recently allowed in part Apotex's appeal of a decision awarding Eli Lilly more than C$100 million for Apotex's infringement of eight process patents relating to the antibiotic cefaclor. The court rejected Apotex's argument that a non-infringing alternative would have been available to Apotex during the relevant period. The case was remitted to the Federal Court for reconsideration on the issue of prejudgment interest; Apotex has applied to the Supreme Court of Canada for leave to appeal.

Costco Pharmacies receives C$7.25 million penalty for accepting drug rebates
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 10 April 2019

The Ontario Ministry of Health and Long-Term Care recently announced that CWC Pharmacies (Ontario) Ltd (Costco Pharmacies), a subsidiary of Costco, has been ordered to pay an administrative monetary penalty of C$7.25 million for accepting payments from certain generic manufacturers which had violated the prohibition on drug rebates.

Proposed changes to OHIP+ programme
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 03 April 2019

The OHIP+ programme was implemented by the Province of Ontario to provide free prescription drug coverage for all children and youths (ie, individuals aged 24 and under), regardless of family income or whether they have private insurance. However, under proposed amendments to Ontario Regulation 201/96 made under the Ontario Drug Benefit Act, only children and youths without private insurance will continue to receive coverage through the OHIP+ programme.

Health Canada publishes guidance document on post-market drug benefit-risk assessments
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 27 March 2019

Health Canada recently published its "Overview of the format and content for post-market drug benefit-risk assessment in Canada – guidance document". The objective of the guidance document is to assist market authorisation holders in developing a post-market benefit-risk assessment for a marketed drug when requested.