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T
he Supreme Court of Canada has tentatively set April 20, 2015 as the date for the hearing of Sanofi ’s appeal against a court’s decision that the company is liable for generic drug maker Apotex’s lost sales of ramipril based on section 8 of the Patented Medicines (Notice of Compliance) Regulations (NOC Regulations). T is will be the Supreme Court’s fi rst consideration of section 8, which imposes liability on an innovator when it is unsuccessful in seeking an order of prohibition under the NOC Regulations. T e case is important for its potential impact on the strategies employed by, and dynamics between, innovators and generics jockeying for market exclusivity or share within Canada’s pharmaceutical marketplace. T e NOC Regulations link patent rights to the timing of generic market entry where approval of the generic product is sought based on a comparison or reference to the innovator’s product. When the NOC Regulations apply, the entry of a generic product is delayed until patent expiry unless the generic’s allegations, for example of patent non- infringement and invalidity, are determined to be justifi ed in a summary court proceeding. T ese regulations are vitally important to innovators. T is is because they serve to
defer generic entry pending a preliminary determination of patent rights, in circumstances where a preliminary injunction is, for all practical purposes, not available and generic companies typically are prepared to enter the market at risk of patent infringement.
Section 8 is designed to balance the respective players’ rights. If a generic’s market entry is delayed and its allegations regarding relevant patents are held to be justifi ed, the innovator is liable for the generic’s resulting losses. In this respect, Canada is unique in having a specifi c regulatory provision that exposes a pharma innovator to liability when it seeks to rely on its patent rights to prevent a generic’s approval based on a comparison to the innovator’s product.
Since 1993, the NOC Regulations have linked generic marketing approval to patents listed on the ‘patent register’. Generally, a patent is eligible for listing on the register if it includes a claim directed to a qualifying medicinal ingredient, formulation, dosage form or use. Not all patents relating to an innovator’s marketed product are
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