Frederick B. Woyiwada

Apotex sought a Notice of Compliance (NOC) to market a generic version of AstraZeneca's drug Losec 20, comparing its product to the 1989 version of the drug.

AstraZeneca had withdrawn Losec 20 from the market in 1996 but subsequently listed two new patents against it.

The Minister of Health issued the NOC to Apotex without requiring it to address the new patents, as Apotex's product did not use the new technology.

AstraZeneca applied for judicial review.

The Supreme Court of Canada held that under the Patented Medicines (Notice of Compliance) Regulations, a generic manufacturer is only required to address patents relevant to the innovator product actually copied.

Since Apotex did not claim bioequivalence to the technology in the after-issued patents, it was not subject to the 24-month statutory freeze for those patents.

The Supreme Court of Canada considered the valuation of imported goods under the Customs Act.

Mattel Canada imported goods manufactured in Hong Kong through a three-tiered distribution system.

The Court held that the relevant 'sale for export to Canada' under s. 48(4) was the sale between Mattel U.S. and Mattel Canada, as Mattel Canada was the importer who held title when the goods entered Canada.

The Court also held that royalties paid by Mattel Canada to a third-party licensor, and periodic licence fees passed through Mattel U.S. to master licensors, were not dutiable under s. 48(5)(a)(iv) because they were not paid as a 'condition of the sale' of the goods for export.

The appeal by Mattel Canada was allowed in part, and the cross-appeal by the Deputy Minister was dismissed.