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PMPRB excessive price decision quashed by Federal Court of Appeal

By Christopher A. Guerreiro & Kristin Wall

August 3, 2021

The Federal Court of Appeal has quashed an excessive-price decision of the Patented Medicine Prices Review Board (PMPRB) in a proceeding concerning the drug SOLIRIS. The matter has been remitted to the PMPRB for redetermination. Procedural background The PMPRB issued a decision in 2017 finding that Alexion Pharmaceuticals Inc. sold SOLIRIS (eculizumab) at an excessive price in Canada and ordering Alexion to remit excess revenues earned between 2009 and 2017. Alexion’s application was dismissed by…

Pharma in Brief

CADTH convenes Advisory Panel on a pan-Canadian prescription drug list

By Kassandra Shortt & Kristin Wall

July 28, 2021

CADTH has convened a pan-Canadian Advisory Panel on a Framework for a Prescription Drug List (the Panel). The Panel will provide recommendations on developing a potential pan-Canadian prescription drug list (or formulary). Stakeholder consultations are scheduled to take place in the fall and winter of 2021, leading to a final public report setting out the Panel’s non-binding recommendations in April 2022. Mandate and membership of the Panel According to CADTH, the Panel’s recommendations are intended…

Pharma in Brief

PMPRB Guidelines update: consultation on changes re delayed implementation

By Christopher A. Guerreiro, Brian R. Daley & Kristin Wall

July 25, 2021

The Patented Medicine Prices Review Board (PMPRB) has launched a consultation on proposed changes to its new Guidelines (the New Guidelines). These changes include revisions to the price tests for some medicines marketed prior to the anticipated coming-into-force date of the New Guidelines. The PMPRB has indicated that these changes are intended to account for delays in the coming-into-force date of amendments of the Patented Medicines Regulations (the Regulations). As we reported, the New…

Pharma in Brief

Certain COVID-19 medical devices no longer hold urgent public health need status under Interim Order No. 2

By Sarah Pennington, John Greiss & Kristin Wall

July 22, 2021

Health Canada has issued a notice explaining a policy change to the review of applications for COVID-19 medical devices. As of July 16, 2021, Health Canada is no longer accepting applications for certain categories of medical devices under Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (IO No. 2) if there is no longer an urgent public health need (UPHN) for those devices. The notice states…

Pharma in Brief

Consultation on proposed amendments to Patent Rules

By Anna Wilkinson, Christian Cawthorn & Tom Sutherland

July 18, 2021

The Government of Canada has proposed a series of amendments to the Patent Rules intended to keep Canada compliant with its obligations under the Canada-United States-Mexico Agreement (CUSMA) and the Patent Cooperation Treaty (PCT). As part of the proposal, the Canada Gazette published a Regulatory Impact Analysis Statement on July 3, 2021, summarizing the changes and their anticipated impact. Interested persons have a short window in which to make representations concerning the proposed amendments. We invite you…

Pharma in Brief

PMPRB Update: delayed implementation of Patented Medicines Regulations amendments and new Guidelines

By Christopher A. Guerreiro, Brian R. Daley & Kristin Wall

July 7, 2021

Changes to the Patented Medicine Prices Review Board (PMPRB) regime, contained in pending amendments to the Patented Medicines Regulations, have been delayed until January 1, 2022. These amendments form the basis for new PMPRB Guidelines, which are scheduled to come into force at the same time as the amendments. The amendments contain a number of changes affecting the PMPRB’s review of patented medicine prices. These include new mandatory factors to be considered by the…

Pharma in Brief

Amendments to the Federal Courts Rules

By Colin Hyslop, David Yi & Kristin Wall

July 7, 2021

On June 17, 2021, a series of amendments to the Federal Courts Rules (the Amended Rules), were registered and came into force. On July 7, 2021, the Amended Rules were officially published in the Canada Gazette Part II. Key Changes and Additions: The Amended Rules include the following key changes and additions: The monetary relief limit for actions brought under the simplified procedure and heard before a prothonotary has been raised from $50,000 to…

Pharma in Brief

Generic allowed to plead new grounds of invalidity not raised in the Notice of Allegation

By Morgan Westgate & Brian R. Daley

July 5, 2021

The Federal Court of Appeal (FCA) has confirmed that in an infringement action under the Patented Medicines (Notice of Compliance) Regulations, the “second person” (i.e., generic/biosimilar) is not precluded from pleading invalidity allegations in its Statement of Defence beyond those that were raised in its notice of allegation (NOA). While new allegations may not be appropriate in every case, nor without consequence for the second person in a subsequent section 8 claim, they are…

Pharma in Brief

CSP Amendments to the PMPRB Regime: Jurisdiction of Patented Medicine Prices Review Board to Include Medicines Protected by Certificates of Supplementary Protection

By Corey McClary, Christopher A. Guerreiro & Kristin Wall

June 22, 2021

A suite of amendments to the Patent Act and the Patented Medicines Regulations (the Regulations) will soon require holders of Certificates of Supplementary Protection (CSPs) to report information to the Patented Medicine Prices Review Board (PMPRB) on substantially the same terms and conditions as would be reported by patentees. Regulations amending the Regulations, which will come into force on June 30, 2021, were recently published in the Canada Gazette, Part II. The corresponding amendments…

Pharma in Brief

Federal Court of Appeal Gradually Phases Out Suspension Period

By Jordana Sanft (CA), Allyson Whyte Nowak, Kristin Wall & Brian R. Daley

June 22, 2021

The Federal Court of Appeal (FCA) has begun to gradually restore filing deadlines in appeals before the Court that were subject to the Court’s Suspension Period. Under the Suspension Period system, the progress of individual appeals has been managed by “selecting” and “deselecting” them from a Selected Files list. As we previously reported, the FCA began to gradually lift the Suspension Period in June 2020 before reinstating it on April 21, 2021. As a…

Pharma in Brief

Blog Authors

PMPRB excessive price decision quashed by Federal Court of Appeal

CADTH convenes Advisory Panel on a pan-Canadian prescription drug list

PMPRB Guidelines update: consultation on changes re delayed implementation

Certain COVID-19 medical devices no longer hold urgent public health need status under Interim Order No. 2

Consultation on proposed amendments to Patent Rules

PMPRB Update: delayed implementation of Patented Medicines Regulations amendments and new Guidelines

Amendments to the Federal Courts Rules

Generic allowed to plead new grounds of invalidity not raised in the Notice of Allegation

CSP Amendments to the PMPRB Regime: Jurisdiction of Patented Medicine Prices Review Board to Include Medicines Protected by Certificates of Supplementary Protection

Federal Court of Appeal Gradually Phases Out Suspension Period

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