Healthcare & Life Sciences, Canada updates

First decision under amended PMNOC Regulations: Federal Court finds Amgen's filgrastim patent obvious
Smart & Biggar
  • 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).

OCT benefits cap and private label product restrictions abolished
Smart & Biggar
  • 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
  • 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.

New reports on utilisation of biologics and biosimilars for chronic inflammatory diseases
Smart & Biggar
  • 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.

Millennium and Janssen seek leave from Supreme Court in Section 8 bortezomib case
Smart & Biggar
  • 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
  • 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
  • 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
  • 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).

Life sciences intellectual property: 2019 highlights
Smart & Biggar
  • Canada
  • 29 January 2020

There have been a number of key developments in Canadian life sciences IP and regulatory law over the past 12 months, including significant amendments to the Patented Medicines Regulations, a number of biosimilars developments relating to approvals, pending submissions and naming and the second anniversaries of the certificate of supplementary protection regime and the Patented Medicines (Notice of Compliance) Regulations.

Amendments to USMCA remove 10-year data protection requirement for biologics
Smart & Biggar
  • 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.

Federal Court of Appeal confirms obviousness finding in Section 8 bortezomib action against Teva
Smart & Biggar
  • 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.

PMPRB releases draft guidelines operationalising amended Patented Medicines Regulations
Smart & Biggar
  • 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.

Federal Court issues two interlocutory decisions in Section 8 pregabalin case
Smart & Biggar
  • 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.

Update on biosimilars
Smart & Biggar
  • 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
  • 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.

PMPRB news
Smart & Biggar
  • 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
  • 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.

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

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