Smart & Biggar/Fetherstonhaugh updates

Regulations will require hospitals to report adverse drug reactions and medical device incidents
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 21 August 2019

The Regulations Amending the Food and Drug Regulations (Serious Adverse Drug Reaction Reporting – Hospitals) and Regulations Amending the Medical Devices Regulations (Medical Device Incident Reporting — Hospitals) were recently published. The amendments were enacted further to Vanessa's Law and will require all hospitals to provide specific information relating to serious adverse drug reactions and medical device incidents within 30 days of first documenting the reaction or incident in the hospital.

Federal Court of Appeal dismisses first PMNOC interlocutory appeal granted leave
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 21 August 2019

Most interlocutory decisions under the Patented Medicines (Notice of Compliance) (PMNOC) Regulations are made by prothonotaries of the Federal Court. The first Federal Court of Appeal decision in an appeal of an interlocutory order under the amended PMNOC Regulations was recently issued. The court found that the prothonotary had been entitled to arrive at a view of what was best for the particular proceeding and saw no reviewable error that would justify its intervention.

Federal Court of Appeal dismisses first PMNOC interlocutory appeal granted leave
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 19 August 2019

Most interlocutory decisions under the Patented Medicines (Notice of Compliance) (PMNOC) Regulations are made by prothonotaries of the Federal Court. The first Federal Court of Appeal decision in an appeal of an interlocutory order under the amended PMNOC Regulations was recently issued. The court found that the prothonotary had been entitled to arrive at a view of what was best for the particular proceeding and saw no reviewable error that would justify its intervention.

PMPRB Steering Committee on the Modernisation of Price Review Process Guidelines releases final report
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 19 August 2019

The Patented Medicines Prices Review Board (PMPRB) Steering Committee on the Modernisation of Price Review Process Guidelines recently released its final report summarising its deliberations in providing stakeholder feedback on the PMPRB's proposed new framework for the regulation of the prices of patented medicines.

Federal Court of Appeal requires PMPRB to redetermine whether patent pertains to Galderma's Differin
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 14 August 2019

The Federal Court of Appeal recently granted the Patented Medicine Prices Review Board's (PMPRB's) appeal and returned to the board the matter of whether the invention of the patent at hand pertained to Galderma's Differin. The court addressed several issues, including whether the PMPRB had acted unreasonably in limiting its review of the patent to selected portions.

Court strikes Novo Nordisk's judicial review application
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 14 August 2019

The Federal Court recently struck Novo Nordisk's judicial review application challenging the minster of health's decision to accept for review an abbreviated new drug submission filed by Teva Canada. In striking the application, the court concluded that Novo Nordisk had neither direct nor public interest standing in the matter.

Federal Court of Appeal requires PMPRB to redetermine whether patent pertains to Galderma's Differin
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 12 August 2019

The Federal Court of Appeal recently granted the Patented Medicine Prices Review Board's (PMPRB's) appeal and returned to the board the matter of whether the invention of the patent at hand pertained to Galderma's Differin. The court addressed several issues, including whether the PMPRB had acted unreasonably in limiting its review of the patent to selected portions.

Competition Bureau updates IP Enforcement Guidelines
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 12 August 2019

The Competition Bureau recently released its updated IP Enforcement Guidelines. While the guidelines are technical and directed at IP and competition law practitioners, there are key aspects of the bureau's approach and various scenarios involving competition and intellectual property that could arise for consideration. As such, when issues relating to IP and competition law arise, including when deciding whether to pursue the licensing or enforcement of IP rights, legal advice should be sought.

Pampered Chef succeeds in trademark infringement battle
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 05 August 2019

Pampered Chef, a world leader in the sale of premium kitchenware products, recently succeeded at trial in defending trademark infringement, passing off and dilution and depreciation of goodwill claims brought by Canada's largest retailer, Loblaws, in relation to its use of a trademark that includes the letters 'P' and 'C'. After considering all of the factors, the court dismissed all of the claims against Pampered Chef, notwithstanding the fame of Loblaws' marks and the similarities between the parties' goods.

CADTH reports on integration of CDIAC functions into pCODR process
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 31 July 2019

The Canadian Agency for Drugs and Technologies in Health recently reported changes to transition Cancer Drug Implementation Advisory Committee functions to the CADTH pan-Canadian Oncology Drug Review process. Among other things, the changes aim to enhance the transparency of the pan-Canadian cancer drug review process and allow for greater stakeholder input into the development of a provisional algorithm for each new cancer drug or indication.

Life sciences intellectual property: 2019 mid-year highlights
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 31 July 2019

The first half of 2019 has seen a number of changes to life sciences IP and regulatory law, including the proposed amendments to the Food and Drugs Act. In addition, the Advisory Council on the Implementation of National Pharmacare released its final report, which recommends that Canada implement a universal, single-payer, public pharmacare programme by enacting new legislation and proceeding in a stepwise approach to implementation.

Detailed overview of deadlines and requirements under new Patent Rules
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 29 July 2019

The government recently published the final version of the new Patent Rules in Part II of the Canada Gazette. The new rules and associated amendments to the Patent Act will come into force on 30 October 2019. In order to safely and effectively prosecute Canadian patent applications under the new Patent Rules, there are a number of recommendations of which practitioners should be aware.

Life sciences intellectual property: 2019 mid-year highlights
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 29 July 2019

Although the amendments to the Patented Medicines Regulations did not come into force as expected, a number of life sciences IP and regulatory law developments took place in the first half of 2019. For example, there were two Patented Medicines (Notice of Compliance) Regulations decisions on the merits, as well as a pair of appeal decisions. In addition, the Competition Bureau released its IP Enforcement Guidelines and Bill C-100 was published to implement the United States-Mexico-Canada Agreement.

Medical devices update
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 24 July 2019

The Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Post-market Surveillance of Medical Devices) were recently pre-published. These proposed changes were made in accordance with Vanessa's Law. The proposed regulations would implement changes to the Food and Drug Regulations and Medical Devices Regulations and (among other things) establish a regulatory framework to require assessments, tests and studies of medical devices.

New PMPRB report examines most promising medicines currently in clinical trials worldwide
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 24 July 2019

The Patented Medicine Prices Review Board (PMPRB) recently published the 2018 edition of the Meds Pipeline Monitor – a horizon-scanning report which provides a snapshot of the new drug landscape. The PMPRB report considered the 733 medicines that are currently in Phase III clinical trials or pre-registration and identified 30 that have the potential to address an unmet need, offer an improvement over existing therapies and treat serious conditions.

Federal Court upholds PMPRB's pricing decision regarding Alexion's Soliris
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 17 July 2019

The Federal Court recently dismissed Alexion's application for judicial review of a Patented Medicines Price Review Board (PMPRB) panel's decision that Soliris (eculizumab) had been sold at an excessive price and its order fixing the amount of the payment to offset excess revenues (C$4.2 million). The application was dismissed on the grounds that, among other things, the PMPRB had not been unreasonable in ordering payment of excess revenues based on the highest international price comparison.

National pharmacare update: publication of advisory council's final report
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 17 July 2019

The minister of health recently published the final report from the Advisory Council on the Implementation of National Pharmacare. The council has recommended that Canada implement universal, single-payer, public pharmacare by enacting new legislation and proceeding in a stepwise approach to implementation.

Guidance document on reporting adverse reactions to marketed health products
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 10 July 2019

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.

Supreme Court of Canada denies Apotex leave to appeal in two cases
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 10 July 2019

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.

Supreme Court of Canada denies Apotex leave to appeal in two cases
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 08 July 2019

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.

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