On February 29, 2024, the federal government tabled Bill C-64, An Act respecting pharmacare (the Pharmacare Act). The Pharmacare Act outlines the “foundational principles” for the first phase of a national universal drug coverage plan in Canada. The legislation includes a commitment to first launch diabetes medication and contraceptives coverage for Canadians through a universal, … Continue reading
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
On February 23, 2024, Health Canada published a Notice advising that it was making its review process for generic drug submissions more transparent. Specifically, for generic drug submissions accepted into review on or after April 1, 2024, Health Canada will start disclosing: (i) the year and month that the submission was accepted for review; and … Continue reading
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
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
On January 26, 2024, Health Canada published a Notice concerning its application of the definition of Canadian Reference Product (CRP) in the Food and Drug Regulations (Regulations). The Notice advises that if an innovative drug is categorized as “Dormant” in Health Canada’s Drug Product Database, then a generic manufacturer can compare its drug against an … Continue reading
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
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
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
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
On January 5, 2024, the US Food and Drug Administration (FDA) approved Florida’s proposal to import prescription drugs from Canada. This is the first approval of a Section 804 Importation Program (SIP) by the FDA. Whether Florida is able to import drugs from Canada, including in light of Canadian regulations controlling drug exports, remains to … Continue reading
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
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
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
On October 19, 2023, the Ontario government proposed regulatory amendments that may eliminate the need to submit certain clinical studies and evidence when requesting that a “well-established drug” be (i) listed or (ii) designated as interchangeable on Ontario’s publicly-funded formulary. The government is seeking feedback on the proposed amendments. Background A manufacturer can apply to … Continue reading
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
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
The Federal Court has upheld a decision of the Minister of Health (Minister) that the new owner of a biosimilar new drug submission (NDS) could adopt the notice of allegation (NOA) served by its predecessor. Consequently, the new owner was properly added as a defendant to an on-going action under subsection 6(1) of the Patented … Continue reading
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
On July 31, 2023, Health Canada published its updated Guidance on distinction between advertising and other activities for health products (the Distinction Guidance). The Distinction Guidance outlines the factors that contribute to rendering a message or activity promotional in nature. Promotional messages and activities are subject to the advertising provisions of the Food and Drugs … Continue reading
The pan-Canadian Pharmaceutical Alliance (pCPA) has recently published a set of principles and conditions for a pCPA Temporary Access Process (pTAP) which will inform the negotiation process and potential product listing agreements (PLAs) for drug products following the Canada Drug and Health Technology Agency (CADTH) time-limited recommendation pathway. CADTH Time-Limited Reimbursement Recommendations Starting in the … Continue reading
On June 22, 2023, Canada’s federal government passed legislation (Bill C-47) introducing a system of general patent term adjustment (PTA). The provisions amending the Patent Act to introduce PTA passed without substantive amendment and are scheduled to come into force no later than January 1, 2025. Canada’s new PTA system is intended to compensate patentees … Continue reading
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
On May 12, 2023, Health Canada announced the release of an updated version of the Guidance Document: Certificates of Supplementary Protection (CSP Guidance). The CSP Guidance was revised to reflect amendments to the definition of “authorization for sale” in the Certificate of Supplementary Protection Regulations (CSP Regulations) and to reflect changes to Health Canada’s administrative … Continue reading