Latest updates

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.

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.

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.

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.

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.

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.

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.

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.

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".

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.

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.

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.

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.

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.

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