The applicant brought a judicial review of Health Canada’s decision that its new drug submission triggered the PM(NOC) Regulations, and moved for a confidentiality order. The Federal Court has now upheld a decision requiring notice of the motion to another innovator company, confirming that the second innovator has a legal interest in the determination of the issue under review and must be notified.
Case: Innovator Company v Canada (Attorney General), 2017 FC 864 (Court File No. T-485-17), affirming 2017 FC 548.
Nature of case: Appeal of a prothonotary’s decision denying a 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: September 26, 2017
Background
The applicant’s new drug submission contains information that Health Canada determined makes a direct or indirect comparison to a product for which another innovator has patents listed on the Patent Register. Health Canada therefore required the applicant to give notice to the other innovator pursuant to section 5 of the Regulations. The applicant disputed the necessity of giving such notice and filed for judicial review.
The applicant (identified only as “Innovator Company” in the decisions) moved for a confidentiality order in respect of its identity, the identity of the drug product, the contents of the submission to Health Canada, and any other information provided in support of the submission. Innovator Company did not serve notice of the motion on the other innovator.
The Government of Canada responded that the other innovator was a necessary respondent to the application and the confidentiality order could not be granted without notice to the other innovator. As we reported, Prothonotary Tabib agreed, and adjourned the motion until Innovator Company had served notice on the other innovator.
Innovator Company appealed her decision.
Other innovator directly affected
The court rejected Innovator Company’s submission that the other innovator is not a person directly affected by its application for judicial review, unless and until the application failed. The court held instead that Health Canada’s decision that the Regulations are engaged conferred rights on the other innovator, making it a person affected and that there is no compelling reason why a patentee with listed patents should be required to await the issuance of market approval to a competitor before being able to address the issue in dispute in this judicial review.
The court also rejected the argument that alerting the other innovator, a known competitor, of the possible timing of market entry was business information that ought to be protected to prevent unfair commercial use.
The court therefore found that the prothonotary did not err and Innovator Company must serve notice on the other innovator before a confidentiality motion could be considered.
Link:
