On September 9, 2014, Justice Gauthier of the Federal Court of Appeal, released the Reasons for Judgment in Hospira Healthcare Corporation v. Canada (Health) stemming from Hospira’s judicial review Application challenging the Minister’s refusal to issue a NOC to Hospira until the expiration of the the data protection period for Sanofi’s ELOXATIN product.
On October 27, 2006, before ELOXATIN was listed on the Register of Innovative Drugs, Hospira filed an NDS seeking an NOC for a drug containing “Chemical Entity A” as its active ingredient. In its correspondence with the Minister, Hospira made reference to the product monograph for ELOXATIN, and on this basis, the Minister concluded that Hospira had made a “direct or indirect comparison” between its drug and ELOXATIN, thereby triggering the data exclusivity provisions of the Food and Drug Regulations.
Hospira then brought an application to review the Minister’s decision on a number of grounds, but did not name Sanofi as a party. Sanofi brought a motion for standing before Prothonotary Tabib, claiming that it was a person directly affected by the order sought by Hospira in its judicial review application, and therefore, pursuant to Rule 303 of the Federal Courts Rules, ought to have been named as a respondent.
In her reasons, Prothonotary Tabib provided a concise summary of the opposing lines of jurisprudence on the issue of standing in respect of the regulations made under the Food and Drugs Act, while distinguishing the case before her from Lundbeck Canada. In the end, Prothonotary Tabib stated the test for standing thusly:
…“In the end, it always comes down to whether the order sought affects the legal rights of the innovator, imposes obligations on it, or prejudicially affects it in some direct way”.
Applying this test, Prothonotary Tabib held that Sanofi was directly affected by the Judicial Review Application, as the order sought would directly prejudice Sanofi and remove its right to market exclusivity. On this basis, Hospira was ordered to add Sanofi as a respondent to its judicial review application
Hospira appealed on the basis that the Prothonotary erred in finding that Sanofi was “directly affected” by Hospira’s Judicial Review Application. Before Justice Mactavish, Hopsira did not dispute that “Chemical Entity A” was oxaliplatin. Justice Mactavish dismissed Hospira’s appeal holding (i) the Prothonotary did not exercise her discretion based upon a wrong principle and (ii) the Prothonotary provided detailed reasons for concluding why Sanofi was indeed “directly affected” by Hospira’s Application.
Hospira then further appealed essentially reiterating arguments advanced below. In short reasons delivered from the bench. Justice Gauthier dismissed Hospira’a appeal holding that that that Justice Mactavish did not err and that the Prothonotary Tabib was not clearly wrong,
A copy of the Federal Court of Appeal’s Reasons for Judgment can be found here.