Open to minister to set filing date for NDS according to public policies and guidance documents

Pharmaceutical company wished to market substance pegbovigrastim as veterinary drug Imprestor to reduce incidence of clinical mastitis in first 30 days of lactation in dairy cows and replacement heifers. Company submitted incomplete veterinary new drug submission (NDS) for Imprestor, but NDS was treated as “administratively complete”. Company applied for patent for pegbovigrastim before providing information required to make NDS substantively complete. Company obtained notice of compliance (NOC) for Imprestor and patent for pegbovigrastim, but delegate of Minister of Health refused to list patent on patent register maintained pursuant to Patented Medicines (Notice of Compliance) Regulations (NOC regulations) and Food and Drug Regulations. Delegate determined NDS had been filed before patent application, contrary to timing requirements of s. 4(6) of NOC regulations. Company brought application for judicial review. Application dismissed. Standard of review was reasonableness, essentially because decision applying s. 4(6) of NOC regulations could not be dissociated with facts of case. Decision was not outside range of reasonable outcomes. Requirement that application for patent be filed before submitting NDS for drug related to patent ensured that patents for inventions discovered after existence of drug did not pre-empt generic competition with drug. Delegate reasonably determined filing date of NDS was date on which it had been found to be administratively complete and accepted for evaluation rather than date on which all substantive components of submission were provided for evaluation. In absence of legislation or regulations defining “date of filing” or prescribing rules for determining said date for filing, it was open to minister to set filing date for NDS according to her own public policies and guidance documents.

Eli Lilly Canada Inc. v. Canada (Attorney General) (2019), 2019 CarswellNat 266, 2019 CarswellNat 329, 2019 FC 5, 2019 CF 5, Roger R. Lafrenière J. (F.C.).