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

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 that there is no longer an UPHN for thermometers and ventilators.

Background

As we reported, IO No. 2 (enacted … Continue Reading

Consultation on proposed amendments to Patent Rules

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 to read our team’s in-depth IP Monitor publication on the proposed amendments, which discusses topics including a number of … Continue Reading

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 changes affecting the PMPRB’s review of patented medicine prices. These include new mandatory factors to be considered by the Board, such as pharmacoeconomic value; a requirement to include “adjustments” when computing average transaction prices reported to the Board; and a revised … Continue Reading

Amendments to the Federal Courts Rules

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:

  1. The monetary relief limit for actions brought under the simplified procedure and heard before a prothonotary has been raised from $50,000 to $100,000.
  2. The deadline for delivery of a statement of defence is now 30 days from service of the statement of claim for defendants in
Continue Reading

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

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 not categorically prohibited.

Background 

The underlying Federal Court (FC) decision concerned a motion by a section 6 … Continue Reading

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

Continue Reading

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
Continue Reading
LexBlog