Canada’s federal 2024 budget has set aside $1.5 billion over five years to launch pharmacare, which will introduce national universal drug coverage to Canada. Background As we reported, on February 29, 2024, the federal government tabled Bill C-64, An Act respecting pharmacare (the Pharmacare Act). The Pharmacare Act outlines 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, single-payer system, contingent on provincial and territorial agr ..read more

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 a Scoping Paper in November 2023, followed by the release of a “What We Learned” Report in February 2024. Building on this first phase, the Board’s announcement states that the Discussion Guide “will indicate a direction on cert ..read more

The pan-Canadian Pharmaceutical Alliance (pCPA) has launched its Temporary Access Process (pTAP) to facilitate early market access to new drugs that were assessed under the time-limited reimbursement recommendation (TLR) pathway at the Canada Drug and Health Technology Agency (CADTH). The pCPA has published principles and conditions for the pTAP as well as information on its negotiation process and pricing.  Background on CADTH time-limited recommendations CADTH conducts health technology assessments (HTAs) for provincial (except Québec), territorial, and federal publicly-funded drug plan ..read more

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, single-payer system, contingent on provincial and territorial agreement. Bill C-64 was introduced and had its first reading on February 29, 2024 in the House of Commons. Background on Pharmacare Following an announcem ..read more

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 solely on whether the claimed dosing and schedule is fixed or not. Background Janssen markets INVEGA SUSTENNA® (paliperidone palmitate) for the treatment of schizophrenia and related disorders. Janssen’s Canadian Patent No. 2,655,335 (335 Patent) teac ..read more

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 (ii) the company sponsoring the generic drug. Background on the GSUR List Since 2018, Heath Canada has disclosed abbreviated new drug submissions (ANDSs) that it is currently reviewing on the Generic Submissions Under Review List (GSUR List).&nb ..read more

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 reported, the PMPRB launched its consultation on new Guidelines with a Scoping Paper in November 2023. The Scoping Paper identified six themes for consultation: The PMPRB mandate Excessive pricing Considerations for PMPRB Guidelines T ..read more

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 alternate CRP, which could include another generic drug, when filing an Abbreviated New Drug Submission (ANDS). Background Generic approvals: In Canada, generic drugs are typically approved through the ANDS pathway, which requires that a gen ..read more

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 other doses sourced from an unlicensed third party. Likewise, a third party may induce infringement by selling an unlicensed dose to be used in a combination with other doses obtained from the patentee. Background Janssen markets INVEGA SUSTENNA® (paliperidone palmitate) for the treatment of ..read more

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 of its allegations in its NOA, and it should not keep some in reserve in the event that it is not initially successful. Background Janssen markets INVEGA SUSTENNA® (paliperidone palmitate). Apotex sought a Notice of Compliance (NOC) to marke ..read more