Hospira Healthcare Corporation v Canada (Health), 2014 FC 179

The present motion raises the issue of an innovator’s standing and right to be made a party to a judicial review of the Minister of Health’s administration of the data protection regime. [1]

Minister of Health advised Hospira that it would not issue Hospira’s NOC for its drug until the expiration of the data protection period for Sanofi’s oxaliplatin, even though Hospira’s ANDS was otherwise approvable. [5] Hospira sought a judicial review of the Minister’s decision, but the Notice of Application did not name and was not served on Sanofi. [6]

The Court granted the motion and referenced rule 303 of the Federal Courts Rules, stating “[t]he question before the Court is therefore simply whether Sanofi would be directly affected by such an order.” [8]

The Court stated that “…an order reversing the Minister’s determination that the data protection regime was engaged and ordering the issuance of an NOC to Hospira would prejudicially affect Sanofi in a direct way, and not merely because it would suffer economic or competitive prejudice.” [16]

The Court noted that “Hospira’s application seeks to reverse…[the Minister’s] decision and withdraw the protection and benefits to which the Minister has determined Sanofi was entitled. It is beyond question that the order sought will directly prejudice Sanofi, as it will remove the protection and its right to the exclusion of Hospira’s product from the market, both of which were intended for Sanofi’s direct benefit.” [19]

Finally, the Court held that “the test for standing does not require that legal rights or obligations flow to a person from the order sought; it is sufficient that it be prejudicially affected in a direct way.” [20]