Generics in Canada: The race for market exclusivity


Gunars Gaikis

Generics in Canada: The race for market exclusivity


Section 8 of Canada’s Patented Medicines (Notice of Compliance) Regulations is a unique provision under which an innovator can be liable for a generic’s losses that result from a delay in coming to market, as Gunars Gaikis explains

The 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).

This will be the Supreme Court’s first consideration of section 8, which imposes liability on an innovator when it is unsuccessful in seeking an order of prohibition under the NOC Regulations. The 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.

The 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 justified in a summary court proceeding.

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