Robert Shapiro

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.