Canada, Smart & Biggar updates

Healthcare & Life Sciences

Contributed by Smart & Biggar
Competition Bureau concludes investigation into alleged restrictions of off-label use of vaccines
  • Canada
  • 13 November 2019

The Competition Bureau has conducted a preliminary investigation into allegations that a vaccine manufacturer tried to contractually restrict a provincial public immunisation programme's off-label use of a vaccine product. The alleged conduct could have resulted in higher costs for the province by preventing public health authorities from using competing products in their immunisation programmes.

PMPRB news
  • Canada
  • 13 November 2019

The Patented Medicine Prices Review Board has released its CompassRx 2017/18 Annual Public Drug Plan Expenditure Report and related news release reporting various statistics regarding prescription drug expenditures by Canadian public drug plans. The report indicates that prescription drug expenditure by public plans increased by 7.4% to C$11.4 billion in 2017-18.

Health Canada updates Guidance Document: The Management of Drug Submissions and Applications
  • Canada
  • 06 November 2019

Health Canada recently released an updated version of Guidance Document: The Management of Drug Submissions and Applications. The updates follow on from an earlier consultation and reflect the updated processes and procedures relating to filing a submission or application with Health Canada.

Court dismisses judicial review application of minister of health's interchangeability designation
  • Canada
  • 06 November 2019

The Court of Queen's Bench of Alberta recently dismissed Allergan's application for judicial review of the Alberta minister of health's decision to designate Allergan's glaucoma treatment product Lumigan RC 0.01% and Sandoz's generic bimatoprost ophthalmic solution Vistitan 0.03% as interchangeable. While the criteria for interchangeability decisions and resubmissions may differ, the questions as framed by Allergan were "opposite sides of the same coin".

Certificate of supplementary protection regime: second anniversary update
  • Canada
  • 23 October 2019

The certificate of supplementary protection (CSP) regime recently celebrated its second anniversary. This article looks back on the previous year and provides an updated summary of approvals, rejections and pending applications, as well as further reminders and tips, including (among others) that it is important to consider the possibility of a CSP early in the drug development and approval lifecycle.


Intellectual Property

Contributed by Smart & Biggar
New Patent Rules in force
  • 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.

Supreme Court rules on Crown copyright
  • Canada
  • 11 November 2019

The Supreme Court recently issued a highly anticipated decision in which it found that Ontario holds the copyright in plans of survey published by the third-party operator of the province's electronic land registry system. This case was the Supreme Court's first opportunity to examine the scope and application of Crown copyright in the nearly 100 years since the enactment of the applicable provision under the Copyright Act.

Certificate of supplementary protection regime: second anniversary update
  • Canada
  • 04 November 2019

The certificate of supplementary protection (CSP) regime recently celebrated its second anniversary. This article looks back on the previous year and provides an updated summary of approvals, rejections and pending applications, as well as further reminders and tips, including (among others) that it is important to consider the possibility of a CSP early in the drug development and approval lifecycle.

Eli Lilly granted leave to add new cause of action for direct infringement absent allegation of direct infringement
  • Canada
  • 28 October 2019

Eli Lilly was recently granted leave to amend its pleadings to introduce a new cause of action for the direct infringement of claims relating to a new use without including an allegation that the product had been directly infringed. However, the court ordered that all issues relating to the new cause of action must be bifurcated and tried at the quantification phase, after all other issues have been determined.

Updated Manual of Patent Office Practice explains 'due care' standard and more
  • Canada
  • 28 October 2019

An updated Manual of Patent Office Practice (MOPOP) was recently published, explaining Patent Office administrative and examination practice effective from 30 October 2019. The updated MOPOP provides important information as to how the Patent Office will handle certain aspects of patent practice under the Patent Act and Patent Rules. Most significantly, the updated MOPOP provides details concerning (among other things) the new requirement for the submission of certified copies of priority documents.


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