Smart & Biggar updates

Amended Patented Medicines Regulations will come into force on 1 January 2021
Smart & Biggar
  • Intellectual Property
  • Canada
  • 15 June 2020

The Patented Medicine Prices Review Board recently announced that the amended Patented Medicines Regulations will now come into force on 1 January 2021. Further, a revised set of draft guidelines will be published during the week of 15 June 2020, followed by a 30-day consultation period.

Amended Patented Medicines Regulations will come into force on 1 January 2021
Smart & Biggar
  • Healthcare & Life Sciences
  • Canada
  • 03 June 2020

The Patented Medicine Prices Review Board recently announced that the amended Patented Medicines Regulations will now come into force on 1 January 2021. Further, a revised set of draft guidelines will be published during the week of 15 June 2020, followed by a 30-day consultation period.

First decision under amended PMNOC Regulations: Federal Court finds Amgen's filgrastim patent obvious
Smart & Biggar
  • Intellectual Property
  • Canada
  • 25 May 2020

The Federal Court recently issued the first decision under the amended Patented Medicines (Notice of Compliance) Regulations. In the decision, Pfizer was successful in establishing obviousness of the asserted claims of Canadian Patent 1,341,537 relating to filgrastim (Amgen's NEUPOGEN and Pfizer's biosimilar product NIVESTYM).

First decision under amended PMNOC Regulations: Federal Court finds Amgen's filgrastim patent obvious
Smart & Biggar
  • Healthcare & Life Sciences
  • Canada
  • 20 May 2020

The Federal Court recently issued the first decision under the amended Patented Medicines (Notice of Compliance) Regulations. In the decision, Pfizer was successful in establishing obviousness of the asserted claims of Canadian Patent 1,341,537 relating to filgrastim (Amgen's NEUPOGEN and Pfizer's biosimilar product NIVESTYM).

COVID-19: CIPO deadlines extended until 1 June 2020
Smart & Biggar
  • Intellectual Property
  • Canada
  • 18 May 2020

In view of the ongoing COVID-19 pandemic, the Canadian Intellectual Property Office (CIPO) has further extended patent, trademark and industrial design deadlines fixed under the relevant legislation. Deadlines up to 29 May 2020 have now been extended until 1 June 2020. The CIPO may decide to extend deadlines further, depending on how circumstances evolve.

CIPO deadlines further extended
Smart & Biggar
  • Intellectual Property
  • Canada
  • 04 May 2020

​In view of the ongoing COVID-19 pandemic, the Canadian Intellectual Property Office (CIPO) has further extended patent, trademark and industrial design deadlines fixed under the relevant legislation. Deadlines up to 15 May 2020 are now extended until 19 May 2020 (18 May 2020 being Victoria Day, when the CIPO is closed to the public).

CIPO deadlines extended
Smart & Biggar
  • Intellectual Property
  • Canada
  • 13 April 2020

Due to the ongoing COVID-19 pandemic, the Canadian Intellectual Property Office has further extended patent, trademark and industrial design deadlines fixed under the relevant legislation. Deadlines up to 30 April 2020 have now been extended until 1 May 2020.

Parliament passes legislation implementing USMCA
Smart & Biggar
  • Intellectual Property
  • Canada
  • 06 April 2020

Bill C-4, which implements the US-Mexico-Canada Agreement (USMCA), has received royal assent from the governor general. The USMCA will replace the North American Free Trade Agreement and require numerous changes to Canada's IP laws. The provisions of Bill C-4 that are relevant to intellectual property will come into force on a day to be determined by order of the governor in council.

OCT benefits cap and private label product restrictions abolished
Smart & Biggar
  • Healthcare & Life Sciences
  • Canada
  • 01 April 2020

Most of the final amendments to regulations made under the Ontario Drug Benefit Act and the Drug Interchangeability and Dispensing Fee Act came into effect on or before 1 January 2020, following public consultations. One notable change compared with the proposed amendments is the removal of the financial cap on ordinary commercial term benefits. Further, private label products will no longer be prohibited from being designated as a listed drug product or interchangeable.

Federal Court of Appeal remands Remicade new use patent decision on anticipation and obviousness
Smart & Biggar
  • Intellectual Property
  • Canada
  • 30 March 2020

In 2018 the Federal Court found that Kennedy's new use patent for infliximab (Janssen's Remicade) was valid and had been infringed by Hospira's biosimilar Inflectra. However, in January 2020 the Federal Court of Appeal released a decision remitting for reconsideration by the trial judge certain issues relating to the validity of Canadian Patent 2,261,630.

Federal Court of Appeal remands Remicade new use patent decision on anticipation and obviousness
Smart & Biggar
  • Healthcare & Life Sciences
  • Canada
  • 25 March 2020

In 2018 the Federal Court found that Kennedy's new use patent for infliximab (Janssen's Remicade) was valid and had been infringed by Hospira's biosimilar Inflectra. However, in January 2020 the Federal Court of Appeal released a decision remitting for reconsideration by the trial judge certain issues relating to the validity of Canadian Patent 2,261,630.

Government introduces Bill C-4 to implement USMCA's required changes
Smart & Biggar
  • Intellectual Property
  • Canada
  • 23 March 2020

Bill C-4 – which addresses some of the changes required under the US-Mexico-Canada Agreement (USMCA) – was recently introduced in the House of Commons. Amendments to the Patent Act were not introduced by Bill C-4 but are expected in the coming years, as Canada must implement the USMCA's required patent term adjustment to compensate for Patent Office delays within four-and-a-half years of the agreement coming into force.

New reports on utilisation of biologics and biosimilars for chronic inflammatory diseases
Smart & Biggar
  • Healthcare & Life Sciences
  • Canada
  • 18 March 2020

The Canadian Agency for Drugs and Technologies in Health and the Ontario Drug Policy Research Network (ODPRN) have released reports examining utilisation trends of innovator biologics and biosimilar versions of infliximab and etanercept, as well as the innovator biologic adalimumab, with regard to rheumatic conditions and inflammatory bowel disease in Ontario. This article examines the takeaway messages from the ODPRN report.

True or false: testing limits of comparative advertising
Smart & Biggar
  • Intellectual Property
  • Canada
  • 16 March 2020

Comparative advertising can be a useful tool for marketers. However, there are legal limits to comparative advertising which are set out in federal statutes such as the Competition Act and the Trademark Act. The Federal Court recently explored these limits in a case involving the registered trademark PETSECURE.

Federal Court is back on track: IP holders will continue to benefit from protective orders in IP litigation
Smart & Biggar
  • Intellectual Property
  • Canada
  • 09 March 2020

The Federal Court of Appeal recently reaffirmed the long-established practice of granting protective orders to parties involved in IP litigation before the Federal Court. In doing so, it set aside recent decisions in which the Federal Court refused to issue such an order, including instances where the order was sought with the consent of the parties.

Millennium and Janssen seek leave from Supreme Court in Section 8 bortezomib case
Smart & Biggar
  • Healthcare & Life Sciences
  • Canada
  • 04 March 2020

In 2019 the Federal Court of Appeal dismissed Millennium Pharmaceuticals' and Janssen's appeal of a decision granting Teva's claim for compensation under Section 8 of the Patented Medicines (Notice of Compliance) Regulations. Millenium Pharmaceuticals and Janssen have now applied to the Supreme Court of Canada for leave to appeal.

Consultation on draft Patented Medicines Regulations ends and selected presentations published
Smart & Biggar
  • Intellectual Property
  • Canada
  • 02 March 2020

The consultation period for the Patented Medicine Prices Review Board's (PMPRB's) draft guidelines operationalising the amended Patented Medicines Regulations recently ended, after two extensions. Further, the PMPRB has released the presentations from its January 2020 patentee webinar, December 2019 industry forum and December 2019 civil society forum.

Consultation on draft Patented Medicines Regulations ends and selected presentations published
Smart & Biggar
  • Healthcare & Life Sciences
  • Canada
  • 26 February 2020

The consultation period for the Patented Medicine Prices Review Board's (PMPRB's) draft guidelines operationalising the amended Patented Medicines Regulations recently ended, after two extensions. Further, the PMPRB has released the presentations from its January 2020 patentee webinar, December 2019 industry forum and December 2019 civil society forum.

PMPRB reports upward trend of high-cost drugs
Smart & Biggar
  • Healthcare & Life Sciences
  • Canada
  • 19 February 2020

The Patented Medicine Prices Review Board recently released the Meds Entry Watch 2018, which analyses information about medicines approved by the US Food and Drug Administration, the European Medicines Agency or Health Canada in 2017 and 2018. One of the key findings is the continued upward trend in the entry of high-cost products (eg, orphan drugs and oncology products).

Canadian Institute for Health Information publishes drug spending statistics
Smart & Biggar
  • Healthcare & Life Sciences
  • Canada
  • 12 February 2020

The Canadian Institute for Health Information recently published statistics on drug spending, finding that in 2018 approximately 40% of drug spending was spent on 2% of beneficiaries. Of this 2%, three out of five individuals used a drug therapy that cost C$10,000 or more per year (eg, antivirals or biologics for rheumatoid arthritis or Crohn's disease).

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