Innovator Company v Canada (Attorney General), 2017 FC 548

A third party whose patent interests may be affected by an application is entitled to notice of the application.

In this Federal Court (“FC”) decision, an entity under the pseudonym [1] Innovator Company brought an application for judicial review [3] over Section 5 of the Patented Medicines (Notice of Compliance) Regulations (“PM(NOC) Regulations”). [2] Innovator Company asserted that the Minister of Health (“the Minister”) erred in its application of Section 5, which deemed Innovator Company to be a Second Person, as defined in the PM(NOC) Regulations. [2] The FC found for the Attorney General (“AG”) [8] who argued that as another innovator (“the Other Innovator”) also had patents listed on the Patent Register pertaining to products to which Innovator Company made comparisons, [2] the Other Innovator was a necessary respondent to the application. [7]

Background

Innovator Company had filed a New Drug Submission (“NDS”) with Health Canada in order to obtain approval to market a certain drug in Canada. [2] Along with its name, Innovator Company wanted to keep the identity of this drug confidential as well. [2]

Innovator Company alleged that its submission referenced certain clinical studies in which itself and the Other Innovator had propriety rights to use the resulting data relating to the product at issue. [3] It also submitted that the Minister erred in applying the PM(NOC) Regulations mechanically and failing to consider that Innovator Company was an innovator in its own right with a proprietary interest in the data generated by the studies and the right to use it, as opposed to merely a generic seeking to use an innovator’s confidential data. [3]

The Notice of Application sought an order declaring that Innovator Company’s NDS did not trigger the application of Section 5 of the PM(NOC) Regulations, an order quashing the Minister’s decision finding that the NDS triggers the application of Section 5 of the PM(NOC) Regulations, and an order directing the Minister to process the NDS without requiring the filing of the relevant forms. [4] Innovator Company brought the current motion seeking 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. [5] While it was not specifically stated in the proposed order, the confidentiality order would protect the identity of the Other Innovator as well. [5]

Analysis

The FC found the circumstances of this case to be indistinguishable from Apotex Inc v Canada (Minister of Health), 2006 FC 846 [Apotex]. [9] In that decision, Apotex Inc. had submitted an application for judicial review to compel the Minister to process its Abbreviated New Drug Submission without regard for the PM(NOC) Regulations. [9] The FC had determined that it was “apparent that the proprietary interest of a third party may be directly affected by the application.” [9] The FC was not persuaded [11] by Innovator Company’s argument that another case, Novopharm v Canada (Health), 2010 FC 566, distinguished Apotex. [10] The decision in Forest Ethics Advocacy Association v Canada (National Energy Board), 2013 FCA 236 had also held that a party has a direct interest and standing to be named as a respondent in a judicial review proceeding when “it is prejudicially affected in some direct way.” [15]

Conclusion

The FC was satisfied that the Other Innovator was a person directly affected by the order being sought, that it should have been named as a respondent and that the motion for a confidentiality order could not be considered without giving the Other Innovator a chance to be heard. [16]

The motion was adjourned without the merits or the confidential affidavit being considered. [18]

Commentary

Section 5 of the PM(NOC) Regulations is an element stemming from basic administrative law principles, in that it allows for interested parties to receive notice of matters that may concern them. Rights related to notice are fundamental in ensuring procedural fairness. As administrative principles umbrella over all areas of the law, it would be a violation of them to allow a party to bring an application without the knowledge of another party that has a legitimate interest in the outcome of the decision. Innovator Company unsuccessfully attempted to persuade the FC to do exactly this – circumvent having to name the Other Innovator as a respondent. Without checks and balances like Section 5 in place, the practical implications would involve more diligence for patent owners and their agents in ensuring they follow developments related to their interests. The risk of missing or overlooking relevant applications would also be greater and may even result in more parties pursuing litigation to resolve matters that took place behind their backs.