Christopher A. Guerreiro

Subscribe to all posts by Christopher A. Guerreiro

Drug pricing: PMPRB announces next steps in Guidelines consultation

The Patented Medicine Prices Review Board (PMPRB) has announced new details regarding the progress of its consultation on new price review Guidelines. Phase 2: Discussion Guide The next phase of the PMPRB’s consultation will begin in summer 2024 with the release of a Discussion Guide. As we reported, the first phase of the consultation launched with … Continue reading

Federal Court of Appeal clarifies law on patentability of methods of medical treatment

The Federal Court of Appeal (FCA) has held that in order to determine whether a patent claims an unpatentable method of medical treatment (MMT), it is necessary to determine whether the use of the invention requires the exercise of professional skill and judgment. In the case of pharmaceutical dosing claims, the determination cannot be based … Continue reading

Drug pricing: PMPRB releases “What We Learned” Report on guidelines consultation

The Patented Medicine Prices Review Board (PMPRB or Board) has released a “What We Learned” Report (the Report), marking the next step along the path to new Guidelines. The Report was prepared by Phoenix Strategic Perspectives Inc., which was commissioned to facilitate consultation with stakeholders and report on the presentations and discussions. Overview As we … Continue reading

Federal Court finds trademark confusion between the names of two approved biologics

The Federal Court (FC) has found the brand name of a biologic drug to be confusingly similar to the brand name of a drug used to treat the same disorder, but with a different active ingredient. The application of the ordinary test for trademark confusion was not affected by the fact that the names of … Continue reading

Federal Court of Appeal clarifies scope of implied licence on sale of patented medicine

The Federal Court of Appeal (FCA) has held that the sale of a single dose of a patented multi-dose regimen does not provide an implied license to use the entire patented dosing regimen. As a result, it is possible to infringe a dosing regimen patent by combining a first dose sourced from the patentee with … Continue reading

Federal Court of Appeal Decides Case Splitting through NOAs is an Abuse of Process

The Federal Court of Appeal (FCA) held that it is abuse of process for a generic or biosimilar manufacturer to split its case across multiple notices of allegation (NOAs) under the Patented Medicines (Notice of Compliance) Regulations (Regulations). Reversing the Federal Court (FC), the FCA found that the generic or biosimilar manufacturer should raise all … Continue reading

Federal Court upholds PMPRB jurisdiction based on “clinical similarities”

The Federal Court (FC) has refused to overturn a decision of the Patented Medicine Prices Review Board (PMPRB or Board) that found that a patent can pertain to a medicine based on “clinical similarities” to the invention—even if the patent does not actually encompass the medicine. The FC concluded that the Board’s decision was reasonable. Background This case … Continue reading

Pharma in Brief’s 2023 Year in Review and Trends for 2024

As you start the new year, allow us to recap 2023’s important legal and regulatory developments for Canadian pharma. We also flag what to watch out for in 2024.  The most significant legal development in 2023 was the introduction of a system of patent term adjustment (PTA). On the regulatory front, seemingly all of Canada’s … Continue reading

Federal Court Notice on Use of Artificial Intelligence in Court Proceedings

On December 20, 2023, the Federal Court (Court) published a notice on the use of artificial intelligence (AI) in proceedings (Notice) and interim principles and guidelines on the Court’s own use of AI (Policy). Notice mandates AI Declaration from litigants Declaration requirement. The Court now expects parties to proceedings before the Court to inform it, … Continue reading

New Canadian Drug Agency formed, while National Pharmacare bill is delayed into 2024

The Government of Canada has announced the creation of the Canadian Drug Agency (CDA). According to the government, the CDA “will provide the dedicated leadership and coordination needed to make Canada’s drug system more sustainable and better prepared for the future, helping Canadians achieve better health outcomes.” As we reported, the genesis of the CDA … Continue reading

Federal Court refuses to issue injunction on infringed antibody formulation patent

On December 4, 2023, the Federal Court held that a patent claiming a formulation of adalimumab, a monoclonal antibody used to treat autoimmune diseases, is valid and is being infringed by a biosimilar product. However, the Court refused to issue an injunction removing the infringing product from the Canadian market, finding that it was not … Continue reading

Drug pricing: PMPRB releases scoping paper to consult on new Guidelines

The Patented Medicine Prices Review Board (PMPRB) has released a scoping paper on themes and questions to develop new price review Guidelines. The scoping paper also includes information on how stakeholders can participate in the consultation. The deadline for written submissions addressing the scoping paper is December 20, 2023. Background The PMPRB has not had a … Continue reading

Drug pricing: PMPRB announces framework for new guidelines consultation

The Patented Medicine Prices Review Board (PMPRB) has announced a framework for the launch of its consultation on new guidelines, beginning with a scoping paper to be published in advance of Policy Roundtable sessions to be held December 5 (English) and December 6 (French), 2023. The PMPRB has not had a full set of guidelines … Continue reading

Drug reimbursement: CADTH publishes procedures on time-limited reimbursement

Canada’s Drug and Health Technology Agency (CADTH) has published its procedures for a new time-limited reimbursement recommendation category. This recommendation category is intended to help provide earlier access to new therapies for severe, rare, or debilitating conditions where there is an unmet medical need. The pathway includes mechanisms to revisit the clinical and economic evidence … Continue reading

Drug pricing: PMPRB finalizes Interim Guidance amendments

The Patented Medicine Prices Review Board (PMPRB) has amended its Interim Guidance to address prices of “New Medicines”, implementing a review threshold based on “below the median” of the PMPRB11 countries (Median International Price, MIP). “New Medicines” are defined as patented medicines that did not receive a PMPRB ceiling price as of July 1, 2022. … Continue reading

Patent term adjustment: Canada consults on proposed regulatory framework

On August 7, 2023, the Canadian Intellectual Property Office (CIPO) launched a consultation on proposed features of regulations on patent term adjustment (PTA) in Canada (the Consultation). The PTA system is intended to compensate patentees for “unreasonable delays” by CIPO in issuing a patent. The Consultation seeks feedback on proposals that would impact the length of … Continue reading

PMPRB Update: Consultation on Amendment to the Interim Guidance re New Medicines

The Patented Medicine Prices Review Board (PMPRB) has launched a 60-day consultation on proposed changes to the price-review process set out in its Interim Guidance of August 18, 2022 (Interim Guidance). The proposed changes would affect products classified as “New Medicines” with list prices that are below the median of prices in the basket of … Continue reading

Supreme Court denies leave to appeal in generic Statute of Monopolies case

On April 27, 2023, the Supreme Court of Canada dismissed an application by Apotex Inc. and Apotex Pharmachem Inc. (Apotex) for leave to appeal from a decision of the Ontario Court of Appeal (ONCA), dismissing its claim for damages in the Ontario courts under the Statutes of Monopolies and other novel causes of action. In the Courts below, Apotex … Continue reading

PMPRB Update: Federal Standing Committee on Health begins review of the Board

The Standing Committee on Health (HESA) has begun a study on the Patented Medicine Prices Review Board (PMPRB). HESA is made up of 12 Members of Parliament representing the four main parties in the House of Commons. In connection with this study, HESA has conducted two meetings to ask questions of witnesses regarding the PMPRB: The events … Continue reading

Federal Court of Appeal rejects elevated standard of proof for induced infringement in paliperidone case

The Federal Court of Appeal (FCA) has allowed an appeal concerning induced infringement in an action under the Patented Medicines (Notice of Compliance) Regulations (Regulations). The FCA found that the Federal Court (FC) had erred by applying an elevated causation requirement. The FCA also rejected an appeal by the generic from the finding that the patent was … Continue reading

Federal Court launches IP Chamber pilot project

The Federal Court has created a new, specialized Chamber of judges to be used for assigning intellectual property and competition law hearings. The Chamber formalizes the Court’s existing practice of endeavouring to assign judges with relevant IP expertise to preside over IP matters. It is intended to increase transparency and provide greater certainty regarding the … Continue reading

PMPRB Update: New Chairperson Appointed

The Governor in Council has appointed Thomas J. Digby as the new Chairperson of the Patented Medicine Prices Review Board (PMPRB). According to the Government’s news release, “Mr. Digby is a lawyer with expertise in intellectual property and has an extensive educational background in the Biological Sciences” and has been appointed for a term of five … Continue reading

Pharma in Brief: The 2022 Year in Review

Does 2022 already seem like a blur? The Pharma in Brief team is here for you with a summary of some of 2022’s most significant legal and regulatory developments in the Canadian pharmaceutical space. We also flag what to watch out for in 2023.    The most significant legislative changes concerned the Patent Act and … Continue reading

Federal Court of Appeal overturns judicial review decision in data protection dispute

The Federal Court of Appeal (FCA) has overturned a decision of the Federal Court (FC) that found the Minister of Health’s (Minister) analysis of the data protection provisions of the Food and Drug Regulations unreasonable. The FCA restored the Minister’s decision granting an NOC to Médunik Canada (Médunik) for its amifampridine product, RUZURGI. Background Catalyst … Continue reading
LexBlog