Canada, Smart & Biggar updates

Healthcare & Life Sciences

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

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.

Amended PMNOC Regulations: second anniversary update
  • 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
  • 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.

Market access: biosimilars no longer reviewed by CADTH
  • Canada
  • 18 September 2019

The Canadian Agency for Drugs and Technologies in Health (CADTH) recently released Issue 8 of its Pharmaceutical Reviews Update announcing revisions to its Procedure and Submission Guidelines for the CADTH Common Drug Review, among other things. The update also announced that the CADTH will no longer review biosimilars through the Common Drug Review or the pan-Canadian Oncology Drug Review.


Intellectual Property

Contributed by Smart & Biggar
Foreign prosecution history evidence permitted under Section 53.1 of Patent Act
  • 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
  • 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
  • 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
  • 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
  • Canada
  • 16 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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