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
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
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
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
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.
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
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
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
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)