Canada’s Intellectual Property Law Firm

The Federal Court has dismissed Elanco’s application for judicial review of the Minister of Health’s refusal to list Canadian Patent No. 2,812,704 on the Patent Register in respect of IMPRESTOR (pegbovigrastim): Elanco v Canada (Attorney General), 2019 FC 5. The Minister assigned a filing date for Elanco’s New Drug Submission (NDS) as the date the Veterinary Drugs Directorate determined the submission to be administratively complete, rather than the date on which all substantive components of the submission were provided for evaluation. All substantive components had not initially been submitted as Health Canada had agreed that Elanco could participate in a phased submission process, aligned with the timeline for submission of data to the United States Food and Drug Administration to enable simultaneous reviews. The Judge found that the Minister’s determination of the filing date was reasonable. Since Elanco filed its patent application after the NDS filing date, the patent did not meet the timing requirements for listing eligibility under subsection 4(6) of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations). Elanco did not appeal.