Federal Court of Appeal's Decision Interpreting Section 8 of the Patented Medicines (Notice of Compliance) Regulations Leads to Mixed Results
Federal Court of Appeal's Decision Interpreting Section 8 of the Patented Medicines (Notice of Compliance) Regulations Leads to Mixed Results
The Federal Court of Appeal has recently released its first decision interpreting Section 8 of the Patented Medicines (Notice of Compliance) Regulations [PM(NOC)]. The PM(NOC) Regulations essentially serve as a link between the patent system and the drug regulatory approval system. The Regulations enhance protection for pharmaceutical patents by requiring generic companies to "clear" relevant […]