Healthcare & Life Sciences, Canada, Smart & Biggar updates

Health Canada issues interim order respecting drug shortages relating to COVID-19
Smart & Biggar
  • Canada
  • 11 November 2020

The minister of health recently approved the Interim Order Respecting the Prevention and Alleviation of Shortages of Drugs in Relation to COVID-19, which introduces new tools to address drug shortages, or the risk of drug shortages, that may be caused or exacerbated by the COVID-19 pandemic. This article examines some of the interim order's main features.

CADTH harmonises drug reimbursement review process
Smart & Biggar
  • Canada
  • 11 November 2020

The Canadian Agency for Drugs and Technologies in Health (CADTH) recently announced the launch of new Procedures for CADTH Drug Reimbursement Reviews, which harmonise procedures under the CADTH's drug reimbursement review pathways. This article outlines the procedure's main highlights.

New interim order for COVID-19 drugs has wide-reaching impact
Smart & Biggar
  • Canada
  • 04 November 2020

The minister of health recently approved the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. Once approved by the governor in council, the interim order will be valid for only one year from the day on which it was signed by the minister, and product authorisations issued under the interim order will be valid only while the interim order is in effect.

Final PMPRB guidelines released
Smart & Biggar
  • Canada
  • 04 November 2020

The Patented Medicine Prices Review Board (PMPRB) recently released the final guidelines operationalising the amended Patented Medicines Regulations. The guidelines describe the price review methodology that will apply to medicines from 1 January 2021, when the amended regulations come into force. The PMPRB has also released its October 2020 Newsletter, which includes an overview of final changes as well as next steps, outreach and engagement opportunities.

8 important life sciences IP issues for innovators doing business in Canada
Smart & Biggar
  • Canada
  • 30 September 2020

The US-Canada border is the longest border between any two countries and US goods and services trade with Canada totalled an estimated US$718.5 billion in 2018, possibly the largest bilateral trade volume between two individual countries. Given the extensive integration of the Canadian and US economies, US life sciences companies can expect to have Canadian business interests. This article highlights eight life sciences IP issues of importance for innovators doing business in Canada.

Federal Court strikes price calculation provision of amendments to Patented Medicines Regulations
Smart & Biggar
  • Canada
  • 12 August 2020

The Federal Court recently issued its decision on an application for judicial review of the Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements). The court ruled that Section 3(4), which would expand price calculation requirements in Section 4(4) of the Patented Medicines Regulations to encompass information beyond the first point of sale, was invalid. This article looks more closely into the court's decision and its implications.

Amended Patented Medicines Regulations will come into force on 1 January 2021
Smart & Biggar
  • Canada
  • 03 June 2020

The Patented Medicine Prices Review Board recently announced that the amended Patented Medicines Regulations will now come into force on 1 January 2021. Further, a revised set of draft guidelines will be published during the week of 15 June 2020, followed by a 30-day consultation period.

First decision under amended PMNOC Regulations: Federal Court finds Amgen's filgrastim patent obvious
Smart & Biggar
  • Canada
  • 20 May 2020

The Federal Court recently issued the first decision under the amended Patented Medicines (Notice of Compliance) Regulations. In the decision, Pfizer was successful in establishing obviousness of the asserted claims of Canadian Patent 1,341,537 relating to filgrastim (Amgen's NEUPOGEN and Pfizer's biosimilar product NIVESTYM).

OCT benefits cap and private label product restrictions abolished
Smart & Biggar
  • Canada
  • 01 April 2020

Most of the final amendments to regulations made under the Ontario Drug Benefit Act and the Drug Interchangeability and Dispensing Fee Act came into effect on or before 1 January 2020, following public consultations. One notable change compared with the proposed amendments is the removal of the financial cap on ordinary commercial term benefits. Further, private label products will no longer be prohibited from being designated as a listed drug product or interchangeable.

Federal Court of Appeal remands Remicade new use patent decision on anticipation and obviousness
Smart & Biggar
  • Canada
  • 25 March 2020

In 2018 the Federal Court found that Kennedy's new use patent for infliximab (Janssen's Remicade) was valid and had been infringed by Hospira's biosimilar Inflectra. However, in January 2020 the Federal Court of Appeal released a decision remitting for reconsideration by the trial judge certain issues relating to the validity of Canadian Patent 2,261,630.

New reports on utilisation of biologics and biosimilars for chronic inflammatory diseases
Smart & Biggar
  • Canada
  • 18 March 2020

The Canadian Agency for Drugs and Technologies in Health and the Ontario Drug Policy Research Network (ODPRN) have released reports examining utilisation trends of innovator biologics and biosimilar versions of infliximab and etanercept, as well as the innovator biologic adalimumab, with regard to rheumatic conditions and inflammatory bowel disease in Ontario. This article examines the takeaway messages from the ODPRN report.

Millennium and Janssen seek leave from Supreme Court in Section 8 bortezomib case
Smart & Biggar
  • Canada
  • 04 March 2020

In 2019 the Federal Court of Appeal dismissed Millennium Pharmaceuticals' and Janssen's appeal of a decision granting Teva's claim for compensation under Section 8 of the Patented Medicines (Notice of Compliance) Regulations. Millenium Pharmaceuticals and Janssen have now applied to the Supreme Court of Canada for leave to appeal.

Consultation on draft Patented Medicines Regulations ends and selected presentations published
Smart & Biggar
  • Canada
  • 26 February 2020

The consultation period for the Patented Medicine Prices Review Board's (PMPRB's) draft guidelines operationalising the amended Patented Medicines Regulations recently ended, after two extensions. Further, the PMPRB has released the presentations from its January 2020 patentee webinar, December 2019 industry forum and December 2019 civil society forum.

PMPRB reports upward trend of high-cost drugs
Smart & Biggar
  • Canada
  • 19 February 2020

The Patented Medicine Prices Review Board recently released the Meds Entry Watch 2018, which analyses information about medicines approved by the US Food and Drug Administration, the European Medicines Agency or Health Canada in 2017 and 2018. One of the key findings is the continued upward trend in the entry of high-cost products (eg, orphan drugs and oncology products).

Canadian Institute for Health Information publishes drug spending statistics
Smart & Biggar
  • Canada
  • 12 February 2020

The Canadian Institute for Health Information recently published statistics on drug spending, finding that in 2018 approximately 40% of drug spending was spent on 2% of beneficiaries. Of this 2%, three out of five individuals used a drug therapy that cost C$10,000 or more per year (eg, antivirals or biologics for rheumatoid arthritis or Crohn's disease).

Life sciences intellectual property: 2019 highlights
Smart & Biggar
  • Canada
  • 29 January 2020

There have been a number of key developments in Canadian life sciences IP and regulatory law over the past 12 months, including significant amendments to the Patented Medicines Regulations, a number of biosimilars developments relating to approvals, pending submissions and naming and the second anniversaries of the certificate of supplementary protection regime and the Patented Medicines (Notice of Compliance) Regulations.

Amendments to USMCA remove 10-year data protection requirement for biologics
Smart & Biggar
  • Canada
  • 15 January 2020

The United States, Mexico and Canada recently signed amendments to the US-Mexico-Canada Agreement (USMCA). The original USMCA was signed on 30 November 2018. The recent amendments have removed a provision, such that Canada can maintain its current data protection laws which provide an eight-year data protection term, with a possible six-month paediatric extension, for all pharmaceutical products, including biologics.

Federal Court of Appeal confirms obviousness finding in Section 8 bortezomib action against Teva
Smart & Biggar
  • Canada
  • 18 December 2019

In 2018 the Federal Court granted Teva's claim for compensation under Section 8 of the Patented Medicines (Notice of Compliance) Regulations relating to Teva's bortezomib product. According to Justice Locke, Teva would not have infringed Patents 2,203,936 and 2,435,146 because their relevant claims were invalid for obviousness. The Federal Court of Appeal has now upheld the finding of obviousness, dismissing Millennium Pharmaceuticals' and Janssen's appeal.

PMPRB releases draft guidelines operationalising amended Patented Medicines Regulations
Smart & Biggar
  • Canada
  • 11 December 2019

The Patented Medicines Prices Review Board recently released new draft guidelines for consultation and a backgrounder. The new guidelines aim to operationalise the amended Patented Medicines Regulations, which come into force on 1 July 2020, and provide a number of circumstances in which categories or price ceilings may be reassessed.

Federal Court issues two interlocutory decisions in Section 8 pregabalin case
Smart & Biggar
  • Canada
  • 27 November 2019

The Federal Court recently issued two decisions relating to Pharmascience's claim for Section 8 damages under the pre-amended Patented Medicines (Notice of Compliance) Regulations for its pregabalin product (Pfizer's Lyrica). In the first, the court granted motion for summary trial on the relevance of Pfizer's ex turpi causa defence; in the second, it overturned the prothonotary's order, which had denied Pfizer leave to amend a pleading.

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