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 of Appeal issues decision in industry challenge to the PMPRB Patented Medicines Regulations
On December 5, 2022, the Federal Court of Appeal (FCA) upheld the validity of changes to the list of countries used for international reference pricing by the Patented Medicine Prices Review Board (PMPRB). This new schedule
ONSC dismisses Apotex’s second monopolies action
The Ontario Superior Court of Justice has released the second decision in a series of summary judgment motions relating to Apotex’s claims against innovative drug companies under various causes of action pursued above and beyond the section 8 damages regime
Federal Court of Appeal Upholds First Trial Judgment under New PM(NOC) Regulations
The Federal Court of Appeal has upheld the first trial judgment under the new Patented Medicines (Notice of Compliance) Regulations. In Amgen Inc v Pfizer Canada ULC, 2020 FCA 188, the Court dismissed Amgen’s appeal from the
First trial judgment under new PMNOC Regulations declares claims to biologic drug invalid
The Federal Court has released its first trial judgment in an action brought under the new Patented Medicines (Notice of Compliance) Regulations. In Amgen Inc v Pfizer Canada ULC, 2020 FC 522, the Court dismissed Amgen’s action