Richard Naiberg

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 appellants challenged the validity of the respondents' patent for the use of AZT in the treatment and prophylaxis of HIV/AIDS.

The appellants argued that the patent lacked utility at the time of application, claimed more than was invented, and failed to name NIH scientists as co-inventors.

The Supreme Court of Canada dismissed the appeal, holding that the utility of AZT was established through the doctrine of sound prediction at the time of the patent application.

The Court also found that the prophylactic claims were soundly predicted and that the NIH scientists were not co-inventors because they merely verified the respondents' inventive concept.