Canada, Smart & Biggar updates

Healthcare & Life Sciences

Contributed by Smart & Biggar
PMPRB reports upward trend of high-cost drugs
  • 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
  • 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
  • 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
  • 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
  • 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.


Intellectual Property

Contributed by Smart & Biggar
Trademarks Office issues new limits on time extensions to respond to office actions
  • 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
  • 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.

USMCA amendments: implications for Canadian IP law
  • 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
  • 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.

Effectively using experts in IP litigation: theory
  • 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.


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