Anthony G. Creber

Apotex appealed a prohibition order preventing the Minister of Health from issuing a notice of compliance for its generic version of Plavix.

Apotex alleged that Sanofi's selection patent for clopidogrel bisulfate was invalid on the grounds of anticipation, obviousness, and double patenting.

The Supreme Court of Canada dismissed the appeal, clarifying the tests for anticipation and obviousness in Canadian patent law.

The Court adopted a two-step approach for anticipation (prior disclosure and enablement) and a four-step approach for obviousness, including a flexible 'obvious to try' consideration.

The Court found the selection patent was not anticipated, not obvious, and did not constitute double patenting.

The appellant developed a cancer-fighting drug containing paclitaxel, a medicine in the public domain.

The respondent held patents for specific formulations and uses of paclitaxel.

The appellant applied for a Notice of Compliance (NOC) as a new drug, not relying on the respondent's data.

The Minister issued the NOC.

The respondent sought to quash the NOC, arguing that under s. 5(1.1) of the Patented Medicines (Notice of Compliance) Regulations, the mere presence of paclitaxel triggered a statutory freeze.

The Supreme Court of Canada held that s. 5(1.1) does not apply to innovative drugs but is confined to generic copies.

The Minister was entitled to issue the NOC without subjecting the appellant to the statutory freeze.