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
Brian R. Daley
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)…
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…
Thirty years of the Patented Medicines (Notice of Compliance) Regulations
This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations (Regulations), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators. …
Federal Court finds salt patent valid in a PM(NOC) action regarding sitagliptin
The Federal Court has allowed an infringement action concerning sitagliptin phosphate monohydrate products under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court dismissed allegations of obviousness and insufficiency, and it found the asserted claims to be…
Federal Court rejects motion for summary judgment in Canadian patent infringement case following voluntary dismissal of parallel US litigation
In a recently released decision, the Federal Court (FC) considered what happens when a patent infringement plaintiff agrees to resolve a dispute in a foreign jurisdiction, but continues to press parallel litigation against the …
Federal Court finds inducement of infringement at summary trial under the PM(NOC) Regulations
The Federal Court has confirmed that issues of infringement, including by inducement, may be decided by summary trial in an infringement action under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court rejected the Defendant’s attempt to…
FCA upholds patent validity, rejects argument that a soundly predicted invention must be obvious
The Federal Court of Appeal (FCA) has affirmed a decision of the Federal Court (FC) finding that a patent concerning glatiramer acetate (GA) is valid and would be infringed under the Patented Medicines (Notice…
PMPRB Update: further-delayed implementation of Patented Medicines Regulations amendments and new Guidelines
Changes to the Patented Medicine Prices Review Board (PMPRB) regime, contained in pending amendments to the Patented Medicines Regulations, have been delayed until July 1, 2022.
These amendments form the basis for new PMPRB Guidelines. The…