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Smart & Biggar | Canada | 8 Sep 2021

Federal Court of Appeal remits pricing decision on Alexion's Soliris to Patented Medicine Prices Review Board

In 2017 the Patented Medicine Prices Review Board (the board) decided that Alexion's Soliris (eculizumab) was sold at an excessive price. However, the Federal Court of Appeal recently set aside the Federal Court's decision to dismiss Alexion's application for judicial review and remitted the matter to the board for redetermination, directing it "to examine the evidence, interpret the......
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Smart & Biggar | 1 Sep 2021

Health Canada TPD, BRDD and NNHPD annual performance reports released

The Therapeutic Products Directorate, the Biologic and Radiopharmaceutical Drugs Directorate and the Natural and Non-Prescription Health Products Directorate have released their drug submission performance annual reports for the fiscal year 2020-2021. The reports contain information regarding pharmaceutical, biologic and radiopharmaceutical drug submission review activity, including average......
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Smart & Biggar | 30 Mar 2020

Federal Court of Appeal remands Remicade new use patent decision on anticipation and obviousness

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.
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Smart & Biggar | Canada | 25 Mar 2020

Federal Court of Appeal remands Remicade new use patent decision on anticipation and obviousness

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.
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Smart & Biggar | Canada | 19 Feb 2020

PMPRB reports upward trend of high-cost drugs

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).
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Smart & Biggar | Canada | 12 Feb 2020

Canadian Institute for Health Information publishes drug spending statistics

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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Smart & Biggar | 2 Dec 2019

Federal Court issues two interlocutory decisions in Section 8 pregabalin case

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,......
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Smart & Biggar | Canada | 27 Nov 2019

Federal Court issues two interlocutory decisions in Section 8 pregabalin case

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,......
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Smart & Biggar | Canada | 6 Nov 2019

Health Canada updates Guidance Document: The Management of Drug Submissions and Applications

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.
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Smart & Biggar | Canada | 16 Oct 2019

Amended PMNOC Regulations: second anniversary update

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.
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