Yoon Jong Kang

The Court allowed AstraZeneca’s appeal and held the patent ‘promise doctrine’ is not the correct approach to utility under s. 2 of the Patent Act.

It found the doctrine improperly imports disclosure obligations into the utility requirement and wrongly invalidates patents when one of multiple promised uses is unproven.

The correct test asks whether the claimed subject-matter has at least one practical use related to that subject-matter, demonstrated or soundly predicted at filing.

Applying that test, the ‘653 patent had sufficient utility and was not invalid.

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AstraZeneca had withdrawn Losec 20 from the market in 1996 but subsequently listed two new patents against it.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