Motion by Plaintiffs: EMD Serono and Merck Serono SA filed a motion seeking a declaration that certain information in a redacted document related to Apotex’s generic cladribine submission is not confidential. Specifically, they contested the confidentiality of the “Date Completed” information.
Protective Order: The information was previously designated as confidential under a Protective Order issued on August 23, 2023. This order allows parties to classify information as “Confidential Information” or “Solicitor’s Eyes Only Information” if the information meets certain criteria.
Confidentiality Challenge Mechanism: Paragraph 28 of the Protective Order allows for challenges to the confidentiality designation. The burden of proof lies on the party asserting confidentiality to show, on a balance of probabilities, that the information is indeed confidential and that its disclosure could cause harm.
Court’s Interpretation: The court interpreted that the term “in fact” in paragraph 28 requires the party asserting confidentiality to provide factual evidence, not just a good faith belief, that the information falls into the designated confidential categories and that its disclosure could cause harm.
Court's Findings:
Evidence Review: The court found general evidence about Apotex’s practices but concluded that Apotex did not establish specific harm that could result from the public disclosure of the “Date Completed” information in the Redacted Acknowledgement.
Conclusion: The court declared that the information in the Redacted Acknowledgement is not confidential.
Order:
The redacted information related to Apotex’s generic cladribine submission is no longer confidential and should not be treated as such.
Apotex is ordered to pay costs of $1,500 to the plaintiffs.
