Latest updates

PMPRB reports upward trend of high-cost drugs
Smart & Biggar
  • Healthcare & Life Sciences
  • 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
  • Healthcare & Life Sciences
  • 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).

Trademarks Office issues new limits on time extensions to respond to office actions
Smart & Biggar
  • Intellectual Property
  • Canada
  • 10 February 2020

Following a recent practice notice, the Trademarks Office will not grant time extensions for office actions issued on or after 17 January 2020 unless exceptional circumstances are demonstrated. The Trademarks Office has also expanded the list of potential exceptional circumstances.

Life sciences intellectual property: 2019 highlights
Smart & Biggar
  • Intellectual Property
  • Canada
  • 03 February 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.

Life sciences intellectual property: 2019 highlights
Smart & Biggar
  • Healthcare & Life Sciences
  • 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.

USMCA amendments: implications for Canadian IP law
Smart & Biggar
  • Intellectual Property
  • Canada
  • 27 January 2020

The United States, Mexico and Canada recently signed the Protocol of Amendment to the Agreement between the United States of America, the United Mexican States and Canada (USMCA). If ratified, the amended USMCA will replace the North American Free Trade Agreement and require a number of changes to Canada's IP laws. Many requirements of the original USMCA have already been met by recent changes in Canadian IP legislation, but more amendments will be required to implement the USMCA.

Federal Court dismisses patent infringement action for delay
Smart & Biggar
  • Intellectual Property
  • Canada
  • 20 January 2020

The Federal Court recently dismissed an action for delay following a status review under Section 382.1 of the Federal Courts Rules where the proceeding remained at the documentary discovery stage with outstanding motions pending more than six years after the action had been commenced. The plaintiff's had alleged infringement of Canadian Patent 2,595,723 in respect of water treatment processes used in Cenovus's steam-assisted gravity drainage oil production facilities.

Amendments to USMCA remove 10-year data protection requirement for biologics
Smart & Biggar
  • Healthcare & Life Sciences
  • 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.

Effectively using experts in IP litigation: theory
Smart & Biggar
  • Intellectual Property
  • Canada
  • 23 December 2019

In IP litigation, expert testimony is common and important. Experts may provide the court with a scientific primer in highly complex cases. Given this, it is important for IP litigators to appreciate the role of experts, understand the test for admissibility and be familiar with all applicable procedural rules. This article focuses on the more theoretical aspects of expert testimony.

Federal Court of Appeal confirms obviousness finding in Section 8 bortezomib action against Teva
Smart & Biggar
  • Healthcare & Life Sciences
  • 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.

Federal Court of Appeal confirms obviousness finding in Section 8 bortezomib action against Teva
Smart & Biggar
  • Intellectual Property
  • Canada
  • 16 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
  • Healthcare & Life Sciences
  • 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.

PMPRB releases draft guidelines to operationalise amended Patented Medicines Regulations
Smart & Biggar
  • Intellectual Property
  • Canada
  • 09 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
  • Intellectual Property
  • Canada
  • 02 December 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.

Federal Court issues two interlocutory decisions in Section 8 pregabalin case
Smart & Biggar
  • Healthcare & Life Sciences
  • 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.

Update on biosimilars
Smart & Biggar
  • Intellectual Property
  • Canada
  • 25 November 2019

Since June 2018 a number of biosimilar developments have taken place in Canada. For example, Amgen has sued BGP Pharma dba Mylan for patent infringement in respect of the pegfilgrastim biosimilar Fulphila, and Janssen succeeded in its patent infringement action against Hospira in respect of Hospira's biosimilar Inflectra.

Amgen not precluded from litigating same patent under amended PMNOC regulations
Smart & Biggar
  • Intellectual Property
  • Canada
  • 25 November 2019

The Federal Court of Appeal recently dismissed Pfizer's appeal of its failed motion to dismiss Amgen's action regarding an infringing patent under Section 6 of the Patented Medicines (Notice of Compliance) (PMNOC) Regulations. Pfizer had argued that Amgen's action ought to be dismissed as an abuse of process on the basis that Amgen had unsuccessfully litigated the same patent under the pre-amended PMNOC Regulations.

Amgen not precluded from litigating same patent under amended PMNOC regulations
Smart & Biggar
  • Healthcare & Life Sciences
  • Canada
  • 20 November 2019

The Federal Court of Appeal recently dismissed Pfizer's appeal of its failed motion to dismiss Amgen's action regarding an infringing patent under Section 6 of the Patented Medicines (Notice of Compliance) (PMNOC) Regulations. Pfizer argued that Amgen's action ought to be dismissed as an abuse of process on the basis that Amgen had unsuccessfully litigated the same patent under the pre-amended PMNOC Regulations.

Update on biosimilars
Smart & Biggar
  • Healthcare & Life Sciences
  • Canada
  • 20 November 2019

Since June 2018 a number of biosimilar developments – including with regard to approvals, pending submissions, regulatory matters, litigation and market access – have taken place in Canada. For example, Health Canada recently published an updated Biosimilar Biological Drugs in Canada: Fact Sheet, which provides an overview of the regulatory framework for biosimilar drugs in Canada.

New Patent Rules in force
Smart & Biggar
  • Intellectual Property
  • Canada
  • 18 November 2019

Canada has now reached the end of its journey to implement the Patent Law Treaty, with new Patent Rules and associated amendments to the Patent Act recently coming into force. To help ease the transition, this article summarises the more significant changes to Canadian patent practice and procedure that are now in effect.

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