Latest updates

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.

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.

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.

Competition Bureau concludes investigation into alleged restrictions of off-label use of vaccines
Smart & Biggar
  • Healthcare & Life Sciences
  • 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
Smart & Biggar
  • Healthcare & Life Sciences
  • 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.

Supreme Court rules on Crown copyright
Smart & Biggar
  • Intellectual Property
  • 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.

Court dismisses judicial review application of minister of health's interchangeability designation
Smart & Biggar
  • Healthcare & Life Sciences
  • 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".

Health Canada updates Guidance Document: The Management of Drug Submissions and Applications
Smart & Biggar
  • Healthcare & Life Sciences
  • 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.

Certificate of supplementary protection regime: second anniversary update
Smart & Biggar
  • Intellectual Property
  • 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.

Updated Manual of Patent Office Practice explains 'due care' standard and more
Smart & Biggar
  • Intellectual Property
  • 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.

Eli Lilly granted leave to add new cause of action for direct infringement absent allegation of direct infringement
Smart & Biggar
  • Intellectual Property
  • 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.

Certificate of supplementary protection regime: second anniversary update
Smart & Biggar
  • Healthcare & Life Sciences
  • 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.

Eli Lilly granted leave to add new cause of action for direct infringement absent allegation of direct infringement
Smart & Biggar
  • Healthcare & Life Sciences
  • Canada
  • 23 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.

Foreign prosecution history evidence permitted under Section 53.1 of Patent Act
Smart & Biggar
  • Intellectual Property
  • Canada
  • 21 October 2019

The Federal Court recently released the first decision in which the scope of Section 53.1 of the Patent Act – the so-called 'file wrapper estoppel' provision – was considered. The court's decision suggests that, notwithstanding the clear language of the provision, foreign prosecution histories may be admissible for the purposes of claim construction in certain extraordinary circumstances.

Get ready now: new Patent Rules in force 30 October 2019
Smart & Biggar
  • Intellectual Property
  • Canada
  • 21 October 2019

Two requirements under the new Patent Rules warrant particular attention for new Canadian patent applications and national phase entries: the Patent Cooperation Treaty national phase entry deadline and the requirement for certified copies of priority documents. Applicants should plan now to ensure that applications under the new rules enter the Canadian national phase within 30 months of the earliest priority date.

Innovators commence court challenges regarding recent amendments to Patented Medicines Regulations
Smart & Biggar
  • Healthcare & Life Sciences
  • Canada
  • 16 October 2019

The recent amendments to the Patented Medicines Regulations have been the subject of two court challenges launched by groups of innovative pharmaceutical companies – one in the Quebec Superior Court and the other in the Federal Court. The applicants before the Quebec court brought a constitutional challenge to the Patented Medicine Prices Review Board provisions of the Patent Act and the regulations, while the applicants before the Federal Court challenged the validity of the amending regulations.

Amended PMNOC Regulations: second anniversary update
Smart & Biggar
  • Healthcare & Life Sciences
  • Canada
  • 16 October 2019

The amended Patented Medicines (Notice of Compliance) Regulations, which came into force in 2017, heralded significant changes to the landscape for pharmaceutical companies in Canada. Among other changes, the amendments ended dual litigation and provided innovators with a right of appeal. This article provides an update as of the second anniversary of the amendments.

Innovators commence court challenges regarding recent amendments to Patented Medicines Regulations
Smart & Biggar
  • Intellectual Property
  • Canada
  • 14 October 2019

The recent amendments to the Patented Medicines Regulations have been the subject of two court challenges launched by groups of innovative pharmaceutical companies – one in the Quebec Superior Court and the other in the Federal Court. The applicants before the Quebec court brought a constitutional challenge to the Patented Medicine Prices Review Board provisions of the Patent Act and the regulations, while the applicants before the Federal Court challenged the validity of the amending regulations.

Amended PMNOC Regulations: second anniversary update
Smart & Biggar
  • Intellectual Property
  • Canada
  • 14 October 2019

The amended Patented Medicines (Notice of Compliance) Regulations, which came into force two years ago, heralded significant changes to the IP landscape for pharmaceutical companies in Canada. Among other changes, the amendments ended dual litigation and provided innovators with a right of appeal. This article provides an update as of the second anniversary of the amendments.

Countdown begins: getting ready for new patented medicines pricing regime
Smart & Biggar
  • Healthcare & Life Sciences
  • Canada
  • 18 September 2019

The long-awaited amendments to the Patented Medicines Regulations were recently published in Part II of the Canada Gazette. Major changes include the introduction of three new price regulatory factors and a revised schedule of reference countries. Although the new law will not be in force until 1 July 2020, there are immediate implications.

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