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The significance of ‘pipefill’ in two generic drug damages awards

Wednesday, October 18, 2017 @ 9:03 AM | By Greg McEvoy

In early 2017 the Federal Court issued decisions involving two significant damages awards under s. 8 of the Patented Medicines (Notice of Compliance) Regulations. An important component of these damages awards related to the concept of “pipefill.”

Section 8 damages awards compensate generic manufacturers for being kept off the market through a regulatory stay petitioned by the innovator companies while the courts decide: (i) whether the generic drug is entitled to a Notice of Compliance (NOC); (ii) whether the patent is valid, and; (iii) whether the...