Carol Hitchman

Seven generic drug manufacturers sought judicial review of a decision by the Executive Officer of the Ontario Public Drug Programs to designate Apotex's product, Apo-Lisinopril, as a benefit under the Ontario Drug Benefit Formulary.

The applicants argued that Apotex could not meet the supply pre-condition at the time of its application due to a patent injunction.

The Divisional Court dismissed the application, finding that the Executive Officer correctly interpreted the regulations to require a prospective assessment of the manufacturer's capability to supply the product to meet anticipated demand, rather than requiring sufficient inventory on hand at the moment of application.

The applicants sought leave to bring an application for judicial review before a single judge of the Superior Court pursuant to s. 6(2) of the Judicial Review Procedure Act, arguing urgency.

The matter concerned the proposed designation of Apotex Inc.'s version of Lisinopril as a benefit under the Ontario Drug Benefit Act.

The respondent Minister opposed the application, arguing the urgency was self-created and economic loss was insufficient.

The court granted leave, finding the potential economic loss significant and the applicants' prior inaction not fatal.

The Minister of Health and Genpharm appealed a decision granting judicial review that quashed the extension of a cut-off date for generic drug submissions to the Ontario Drug Benefit Formulary.

The application judge had found the process procedurally unfair and ordered a new cut-off date, resulting in all five competing generic drug companies having their products listed.

The Court of Appeal dismissed both appeals as moot, finding that the new Formulary had already been published, the legal landscape had changed, and Genpharm's proposed future action for damages did not justify hearing the appeal on the merits.

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.