The Federal Court (FC) has provided fresh guidance on applying the test for challenging patent-listing eligibility in an infringement action under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). Granting the delisting motion before it, the
Supreme Court of Canada grants leave to appeal methods of medical treatment patentability decision
On September 19, 2024, the Supreme Court of Canada granted an application for leave to appeal in a case concerning the scope of patentable subject-matter in Canadian law, focusing on an area known as “methods of medical treatment” (MMT
Federal Court addresses treatment and formulation patent claims in PMNOC case
The Federal Court (FC) has upheld the validity of a patent concerning treatment of idiopathic pulmonary fibrosis (IPF) and granted injunctive relief against the generic in an infringement action under section 6 of the Patented Medicines
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
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
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)
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
Federal Court: Transferring drug submission does not require re-serving Notice of Allegation
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
Guidance on inventor discovery and “invention story” evidence in Canadian patent actions: Federal Court rules in favour of patentee
In three recent decisions, released in July and August, the Federal Court addressed questions concerning inventors and the “invention story” during Canadian patent litigation. The Court found that: (i) a patentee has no duty to facilitate inventor discovery; (ii) patentee’s
FCA upholds selection patent protecting apixaban and rejects that a second patented invention was obvious to try
The Federal Court of Appeal (FCA) has dismissed an appeal concerning four actions related to the molecule apixaban under the Patented Medicines (Notice of Compliance) Regulations (Regulations). The Federal Court (FC) found the patents