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

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 to the Patent Act are also set to come into force on this date.

Certificates of Supplementary Protection

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Federal Court of Appeal Gradually Phases Out Suspension Period

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 result, many appeals were deselected from the list.

On June 17, 2021, the FCA announced that the Deselected Files would begin to reappear … Continue Reading

Federal Court quashes NOC in dispute over Data Protection Provisions

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 did not allow the Court to determine how the Minister interpreted section C.08.004.1 of the Food and Drug Regulations (the Data Protection Provisions).  The Court found that the decision was therefore unreasonable and remanded the matter back to … Continue Reading

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

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 chapter also provides an overview of patent law, protection of IP in respect of pharmaceuticals including under the PM(NOC) Regulations, data protection, and patent term restoration. Canada is one of 18 jurisdictions featured in the Review, with chapters also … Continue Reading

Federal Court Issues Consolidated IP Guidelines

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 changes:

  1. Examinations for discovery are to be conducted by way of a single comprehensive examination.[1]  Second round discovery will need leave of the FC;
  2. Parties are required to prepare and deliver claim charts two weeks before trial;
  3. Parties are encouraged
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Quebec Prohibits Financial Assistance by Drug Manufacturer for Patients’ Drug Costs

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 any financial assistance to patients to help cover the cost of a drug on the provincial List of Medications (Quebec’s formulary). The aim was to end the practice of brand name drug manufacturers covering the patients’ portion of the cost of brand name drugs … Continue Reading

Federal Court of Appeal Restores Suspension Period

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 to gradually lift the indefinite Suspension Period, [1] by adding ongoing files to its Selected Files List. The Suspension Period was lifted for these files which were to proceed according to the time limits under the Federal Courts Rules or set out … Continue Reading

Proposed amendments to the PM(NOC) Regulations: Patents claiming different salt forms of medicinal ingredients eligible for inclusion on the Patent Register

On April 23, 2021, Proposed PM(NOC) Amendments [1] were published in the Canada Gazette, Part I. These amendments permit patents claiming different forms of a medicinal ingredient (e.g., salt forms) to be listed on the patent register and are intended to balance Proposed FDR Amendments [2] published on March 30, 2019 which allow generic manufacturers to file an ANDS for an alternative form of a medicinal ingredient in comparison to the CRP.

Proposed FDR Amendments Create Imbalance in Linkage Regime

As previously reported, the Proposed FDR Amendments were intended to clarify the regulatory requirements under the Abbreviated New Drug … Continue Reading

New Proposed Amendments to the Federal Courts Rules: Proportionality, Abuse of Process, and Motions Before the Federal Court of Appeal

On April 10, 2021, the Rules Committee of the Federal Court of Appeal and the Federal Court (the Rules Committee) launched a consultation on amendments to the Federal Courts Rules (the Rules) on proportionality, abuse of process, and Federal Court of Appeal motions.

In the Regulatory Impact Analysis Statement (RIAS), the Committee has stated these amendments are necessary to “allow the Courts to strike a balance between the importance and the complexity of the case and the amounts involved”, “provide the Courts with the necessary tools to deal directly with dysfunctional or destructive conduct in … Continue Reading

PMPRB Update: New periods for compliance with the new Guidelines

The PMPRB has confirmed that patentees of “Grandfathered” and “Gap” medicines will have two reporting periods to comply with new price ceilings to be set under its new Guidelines, replacing previous guidance that only one reporting period would be permitted.

Updates to the Guidelines

As we reported, the Guidelines were released by the PMPRB on October 23, 2020 and are intended to implement amendments to the Patented Medicines Regulations that were passed in August 2019.

At the time they were released, the Guidelines were scheduled to take effect together with the amendments to the Regulations on January 1, … Continue Reading

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