The Federal Court of Canada has dismissed the motion of Apotex Inc (Apotex) for judicial review of the Regulations Amending the Food and Drug Regulations (Data Protection) (Data Protection Regulations) (Apotex Inc v Canada
(Governor in Council), 2007 FC 232, Court File No T-2047-06). For more information regarding the application, see E-TIPS®, "Canadian Generic Pharmaceutical Association Challenges the Regulations Amending the Food and Drug Regulations (Data Protection)" Vol 5, No 12, December 6, 2006.
Justice Shore of the Federal Court found that Apotex lacked standing to bring an application for judicial review because it was not directly affected by the matter in which relief was sought: "There is no evidence that the Data Protection Regulations have been applied to impose any actual limitation on Apotex – or on any other drug manufacturer seeking a notice of compliance … [T]he possibility that Apotex
- may at some time in the future be affected by the Regulations does not give it standing now