The applicant brought a judicial review application regarding the Minister of Health’s determination that it compared its product to a product with listed patents and was therefore required to address the listed patents. The Federal Court determined that the third-party innovator of the product with listed patents is a person “directly affected” by the application and ought to have been named as a respondent.
Case: Innovator Company v Canada (Attorney General), 2017 FC 548 (Court File No. T-485-17)
Nature of case: Motion for a confidentiality order in the context of an application for judicial review of a decision from the Minister of Health pursuant to the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (the Regulations).
Successful party: Attorney General of Canada
Date of decision: June 5, 2017
The applicant, an innovative pharmaceutical company, filed a new drug submission (NDS) with Health Canada. Both the applicant’s and drug’s identities were undisclosed in the decision.
The Minister of Health determined that the applicant’s NDS makes a direct or an indirect comparison to a product for which another innovator has one or more patents listed on the patent register. The other innovator’s identity is also undisclosed. Section 5 of the Regulations is therefore triggered and the applicant is required to address the patents listed against the other innovator’s product.
The applicant sought judicial review of the minister’s decision and also brought a motion for a confidentiality order in respect of its own identity, the identity of its drug product, the entire content of its NDS and any information it provided to the minister in support of its NDS.
The other innovator is not named as a respondent to the judicial review and was therefore not served with or notified of either the notice of application for judicial review or the motion for a confidentiality order.
Regulations confer a “direct benefit” to the innovator
Following prior decisions of the Federal Court, the court concluded that once the minister decides the Regulations are engaged in favour of an innovator, “a direct commercial benefit is conferred on that innovator,” sufficient to provide standing.
The court noted the circumstances of this case are indistinguishable from those in Apotex Inc v Canada (Minister of Health), 2006 FC 846.
The court also considered the decisions in Forest Ethics Advocacy Association v Canada (National Energy Board), 2013 FCA 236 and Hospira Healthcare Corporation v Canada (Health), 2014 FC 179, upheld 2014 FC 235 and 2014 FCA 194 , which held that a proceeding seeking to set aside a decision by the minister that a patent listed on the register must be addressed directly affects the innovator who listed the patent against the referenced product. In Forest, the Court of Appeal clarified that a party has a direct interest not only when its legal rights are affected or legal obligations are imposed on it, but also when “it is prejudicially affected in some direct way.”
As the motion for a confidentiality order “cannot be isolated from the question of whether all of the necessary parties have been properly served notice of the underlying application,” the court adjourned the motion, holding that the motion could not go forward without giving the other innovator an opportunity to be heard. The court ordered that the motion materials be served on the other innovator.