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Federal Court Ruling Upholds Data Protection Period for Research-Based, Innovative Drug Companies

Federal Court Ruling Upholds Data Protection Period for Research-Based, Innovative Drug Companies

The period of data protection allocated to research-based, innovative drug companies is a┬áhotly debated topic in the pharmaceutical industry and beyond. This period of protection allows research-based, brand name drug companies to maintain a monopoly on the market for any particular drug for a specified duration. During the period of data protection, competing generic drug […]

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 […]