Smart & Biggar updates
Federal Court dismisses patent infringement action for delay
Smart & Biggar- Intellectual Property
- 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.
Amendments to USMCA remove 10-year data protection requirement for biologics
Smart & Biggar- Healthcare & Life Sciences
- 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.
Effectively using experts in IP litigation: theory
Smart & Biggar- Intellectual Property
- 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.
Federal Court of Appeal confirms obviousness finding in Section 8 bortezomib action against Teva
Smart & Biggar- Healthcare & Life Sciences
- 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.
Federal Court of Appeal confirms obviousness finding in Section 8 bortezomib action against Teva
Smart & Biggar- Intellectual Property
- Canada
- 16 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.
PMPRB releases draft guidelines operationalising amended Patented Medicines Regulations
Smart & Biggar- Healthcare & Life Sciences
- Canada
- 11 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.
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.
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.
