Motion to strike a judicial review proceeding; 2008 FC 1379; Memantine; December 16, 2008
Lundbeck brought a judicial review of the Minister's decision to accept the generic companies' ANDSs for their brand of memantine. Lundbeck had received a Notice of Compliance with conditions ("NOC/c") in 2004, prior to the promulgation of the data protection amendments to the Food and Drug Regulations. However, the generic companies filed their submissions after the promulgation of these Regulations. Patents were listed on the Patent Register at the time of receipt of the NOC/c.
The Court found that, as Lundbeck was seeking relief relating to the Minister's application of the Food and Drugs Act in relation to ANDSs submitted by generic companies, there is no other purpose behind the judicial review but to block the Minister's review of those submissions. Thus, Lundbeck had no standing, including with respect to Lundbeck's challenges under the data protection provisions both old and new.
Furthermore, the decision of the Minister being reviewed was an interlocutory one. The final decision would be the Minister's determination as to whether to issue a NOC. There were no exceptional circumstances in this case to override that rule.
Full text of the decision can be found at: