Damages Under Section 8 of the Patented Medicine (Notice of Compliance) Regulations: the Financial Consequences of a Statutory Injunction

Abstract:

In the past few years, the Federal Court has begun to issue decisions dealing with the quantification of the financial remedy applicable under section 8 of the Patented Medicines (Notice of Compliance) Regulations. In the first part of this article (Sections 1 to 4), we provide an overview of these decisions, outline the areas in which a consensus appears to have been reached, and highlight areas that still require clarification. We show the tension between the desire by the courts to use section 8 to provide compensation that is fair to both parties and the need for the court to adhere to the wishes of Parliament and adhere to the wording of the Regulations as a “complete code” governing this particular area of law. In the second part (Section 5), we analyze the net effect of the section 8 remedy from an economic perspective. We show how decisions dealing with section 8 damages have arrived at an understanding that on the whole successfully balances the competing economic interests of all parties within the wording Parliament has laid down.