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

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 … Continue reading

Amendments to the Federal Courts Rules

By Colin Hyslop, David Yi and Kristin Wall on July 7, 2021 Posted in Uncategorized

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 … Continue reading

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

By Morgan Westgate and Brian R. Daley on July 5, 2021 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

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 … Continue reading

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 and Kristin Wall on June 22, 2021 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

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 … Continue reading

Federal Court of Appeal Gradually Phases Out Suspension Period

By Jordana Sanft, Allyson Whyte Nowak, Kristin Wall and Brian R. Daley on June 22, 2021 Posted in Intellectual property

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 … Continue reading

Federal Court quashes NOC in dispute over Data Protection Provisions

By William Chalmers, Christopher A. Guerreiro and Kristin Wall on June 9, 2021 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court has quashed a notice of compliance (NOC) issued to Médunik Canada (Médunik) for its amifampridine product, RUZURGI, over an issue concerning data protection for another amifampridine product. The Minister provided no reasons for its issuance of the NOC, and the Court found that the Certified Tribunal Record (CTR) outlining the decision-making process … Continue reading

Overview of IP Law In Canada – The Intellectual Property Review, 10th Edition

By Caroline Henrie, Adam Haller and Kristin Wall on June 8, 2021 Posted in Uncategorized

The recently published Tenth Edition of the Intellectual Property Review (the Review) includes a Canadian chapter. Readers are invited to learn more on the various forms of IP protection available in Canada, and highlights of important changes in Canadian IP law over the past year. The chapter was authored by members of the Pharma in Brief team. The … Continue reading

Federal Court Issues Consolidated IP Guidelines

By Caroline Henrie, Jordana Sanft and Kristin Wall on May 26, 2021 Posted in Intellectual property

On May 18, 2021, the Federal Court (FC) issued amended Case and Trial Management Guidelines for Complex Proceedings (the Updated FC Guidelines). As we previously reported, the FC first issued the FC Guidelines to consolidate and address topics in earlier FC Notices to the Profession. Notable amendments: The Updated FC Guidelines include the following notable … Continue reading

Quebec Prohibits Financial Assistance by Drug Manufacturer for Patients’ Drug Costs

By Gregory Bordan and Kimberly Jeffers on April 29, 2021 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

At the end of 2016, the previous Quebec government prohibited a number of common commercial practices by drug manufacturers and pharmacists with the aim of fostering greater price competition between drug manufacturers and reducing the cost of the public drug insurance scheme.[1] Among the new prohibitions was one that would prohibit a manufacturer from offering … Continue reading

Federal Court of Appeal Restores Suspension Period

By Jordana Sanft, Allyson Whyte Nowak, Kristin Wall and Brian R. Daley on April 26, 2021 Posted in Uncategorized

On April 21, 2021, the Federal Court of Appeal (FCA) announced that it will restore the Suspension Period by default for all new matters and begin reinstating the Suspension Period on existing matters by removing them from its Selected Files List. Selected Files As previously reported in June 2020 (June 2020 Update), the FCA began … Continue reading