Latest updates

Release of information contained in drug submissions and medical device applications
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • June 20 2018

In December 2017 Heath Canada released proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations, providing for the public release of clinical information contained in drug submissions and medical device applications. Health Canada recently published a draft guidance document addressing the implementation of the proposed amended regulations.

Bill 148: new risks for misclassifying independent contractors as employees
Fasken
  • Employment & Benefits
  • Canada
  • June 20 2018

The Ontario government is increasing the risks and penalties for employers that misclassify workers as independent contractors as part of the Fair Workplaces, Better Jobs Act. The burden is now on employers to prove that workers are not employees under the Employment Standards Act. This change of presumption will make it even more difficult for employers to defend claims filed by individuals challenging their status as an independent contractor in favour of being classified as an employee.

First CSPs issued and application fee increased
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • June 20 2018

Health Canada recently issued the first certificates of supplementary protection (CSPs) against three approvals. In addition, on 1 April 2018 the CSP application fee was increased to C$9,192.

Procedural decisions relating to Herceptin under amended PMNOC Regulations
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • June 18 2018

Two recent decisions addressed procedure under the 2017 amendments to the Patented Medicines (Notice of Compliance) Regulations. In the first case, Prothonotary Aylen ruled that the court lacked jurisdiction to consider a motion under Section 5(3.7) of the regulations to vary confidentiality rules imposed by a party that has served a notice of allegation under Section 5(3.5). In the second case, Aylen dismissed Pfizer's motion to dismiss, adjourn or delay a motion filed by Amgen under Section 6.08.

Apotex not entitled to reopen trial on esomeprazole (Nexium) patent validity
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • June 18 2018

The validity of AstraZeneca's NEXIUM patent has finally been decided by the Supreme Court of Canada, with any doubt about the court's intent resolved by its dismissal of Apotex's motion to raise new grounds of patent invalidity. The court also held that AstraZeneca was entitled to a declaration of infringement and ordered the quantification of AstraZeneca's damages or Apotex's profits.

What is the origin of a name – not as innocent a question as it seems
Fasken
  • Employment & Benefits
  • Canada
  • June 13 2018

The Human Rights Tribunal recently examined discrimination in hiring, specifically in regard to ethnic or national origin. It opined that the purpose of Section 18.1 of the Charter of Human Rights and Liberties is to eliminate discrimination in hiring at its roots by prohibiting any question relating to a personal characteristic. Accordingly, a mere question relating to one of the grounds listed in Section 10 of the charter will constitute an automatic violation of Section 18.1.

Supreme Court denies leave regarding natural health product licence
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • June 13 2018

The Supreme Court recently dismissed The Winning Combination's leave to appeal. The Federal Court of Appeal had previously set aside the order of mandamus compelling the minister of health to grant a licence to The Winning Combination for its natural health product, Resolve.

Teva seeks leave in levofloxacin damages assessment
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • June 13 2018

The Federal Court of Appeal recently dismissed Teva's appeal regarding the quantification of damages for its infringement of Janssen's patent for levofloxacin (Levaquin). The Federal Court of Appeal rejected Teva's arguments, finding that the Federal Court had not erred in constructing the hypothetical world and that its factual findings were supported by evidence. On 26 March 2018 Teva applied to the Supreme Court for leave to appeal.

Apotex fails to establish that it would have obtained non-infringing product from foreign suppliers
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • June 06 2018

Servier and its related company ADIR were recently successful in another chapter of the patent litigation concerning perindopril when the Federal Court again dismissed the non-infringing alternative defence of Apotex Inc and Apotex Pharmachem Inc (collectively, Apotex). The court found that Apotex would not have called on foreign third parties to manufacture perindopril to supply its affiliates in the United Kingdom and Australia and thus reaffirmed the quantum of profits from its original judgment.

Employer-mandated physician visit is not a privacy violation
Fasken
  • Employment & Benefits
  • Canada
  • June 06 2018

Employers are entitled to require employees to visit in-house occupational health department physicians to obtain reasonably necessary medical information if that right is provided for in their collective agreement. This was recently confirmed when an arbitrator found that an employer had not violated employee privacy rights when it required employees to visit in-house occupational health department physicians to confirm eligibility for wage loss protection benefits.

Health Canada reports on consultation on proposed approach to cannabis regulation
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • June 06 2018

Bill C-45 – An Act respecting Cannabis and to amend the Controlled Drugs and Substances Act, the Criminal Code and Other Acts – is currently before the Senate. Rather than pre-publishing draft regulations, the government released regulatory proposals by way of a consultation paper. Health Canada recently announced the release of a report which provides a summary of the comments received on the consultation paper.

Franchisors rejoice! Ontario Court of Appeal raises bar for franchise rescission
Lapointe Rosenstein Marchand Melançon LLP
  • Franchising
  • Canada
  • June 05 2018

The Ontario courts have recently endeavoured to clarify the outer limits of the parameters within which a franchisee may exercise its right to rescind a franchise agreement. A long-awaited Ontario Court of Appeal decision sends a clear message to the lower courts that a franchisee's right to rescission is an exceptional measure that should not be granted lightly, and that the terms and conditions negotiated between a franchisor and its franchisee cannot be ignored.

Judicial review and private entities: court confirms limits of remedy
Dentons
  • Litigation
  • Canada
  • June 05 2018

Judicial review is a public law remedy – but does this preclude its availability for decisions made by private entities (eg, voluntary associations and political parties)? Divergent lines of judicial authority have led to inconsistent answers to this question in Ontario. However, a recent Ontario Divisional Court decision has confirmed that the answer to this question is yes.

Teva seeks leave in levofloxacin damages assessment
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • June 04 2018

The Federal Court of Appeal recently dismissed Teva's appeal regarding the quantification of damages for its infringement of Janssen's patent for levofloxacin (Levaquin). The Federal Court of Appeal rejected Teva's arguments, finding that the Federal Court had not erred in constructing the hypothetical world and that its factual findings were supported by evidence. On 26 March 2018 Teva applied to the Supreme Court for leave to appeal.

First CSPs issued and application fee increased
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • June 04 2018

Health Canada recently issued the first certificates of supplementary protection (CSPs) against three approvals. In addition, on 1 April 2018 the CSP application fee was increased to C$9,192.

Proposed national pharmacare programme and prescription and generic drug pricing modifications
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • May 30 2018

Unlike many Organisation for Economic Cooperation and Development member countries, Canada has no national pharmacare programme (ie, a single system of public insurance coverage for prescription drugs). However, the Standing Committee on Health recently released a report advocating the establishment of such a programme as an insured service under the Health Act. The report also made a number of recommendations, including with respect to drug pricing.

CADTH releases 2018-2021 strategic plan
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • May 30 2018

The Canadian Agency for Drugs and Technologies in Health (CADTH) recently announced the release and published a brief overview of its strategic plan for 2018 to 2021. According to the plan, the CADTH – a health technology assessment agency – plans to transition to a health technology management agency.

Bill 6 – amendments to British Columbia Employment Standards Act
Fasken
  • Employment & Benefits
  • Canada
  • May 30 2018

British Columbia's minority New Democratic Party government recently introduced Bill 6 into the British Columbia legislature. The bill contains many amendments dealing with the British Columbia Employment Standards Act. Among other things, the proposed amendments align provincial leave benefits with the changes made to federal employment insurance benefits. Bill 6 would also provide new and extended maternity, parental and compassionate care leave.

Apotex fails to establish that it would have obtained non-infringing product from foreign suppliers
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • May 28 2018

Servier and its related company ADIR were recently successful in another chapter of the patent litigation concerning perindopril when the Federal Court again dismissed the non-infringing alternative defence of Apotex Inc and Apotex Pharmachem Inc (collectively, Apotex). The court found that Apotex would not have called on foreign third parties to manufacture perindopril to supply its affiliates in the United Kingdom and Australia and thus reaffirmed the quantum of profits from its original judgment.

New patent term extension framework
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • May 28 2018

The amendments to the Patent Act and the enactment of the Certificate of Supplementary Protection (CSP) Regulations flowing from the Canada-EU Comprehensive Economic and Trade Agreement introduced a new framework in Canada for the issuance of CSPs. CSPs provide an additional patent-like protection term and are intended to partly compensate innovators for the time required to research and obtain regulatory approval in Canada.