Apotex Not Entitled To Damages For Delayed Generic Drug Launch

The Ontario Court of Appeal's recent decision in Apotex Inc. v. Eli Lilly and Company offers important clarity for pharmaceutical companies engaged in patent litigation under the Patented Medicines (Notice of Compliance) Regulations ("NOC Regulations"). The case centres on Apotex's attempt to recover damages under section 8 of the NOC Regulations after a prohibition application filed by Eli Lilly delayed its product's entry into the market.

Regulatory Framework for Generic Drug Marketing

Under Canadian law, brand-name pharmaceutical companies hold a 20-year patent monopoly on their products. However, the Patent Act and accompanying NOC Regulations allow for early preparations by generic manufacturers to enter the market upon patent expiry.