Information in the redacted acknowledgment is not confidential

In a motion related to Apotex’s generic cladribine submission, EMD Serono seeks a declaration that a redacted version of the Acknowledgement and Certification of Information Received which was marked confidential in this proceeding is in fact not confidential. Serono seeks to use information in the Acknowledgement in another proceeding with Apotex (Court File No. T-1369-23).  

Apotex designated the information in the Acknowledgement as confidential pursuant to the protective order. In order to mark a document as confidential, the protective order requires that the disclosing party maintains the information as confidential and that they could be harmed if the information were made available to the public. The parties agreed that a challenge to a designation of confidentiality requires the party asserting confidentiality (i.e., the disclosing party) to prove these requirements on a balance of probabilities.

Apotex argued that their burden was met if they believe in good faith that the information meets the requirements for confidentiality. However, the court concluded that this interpretation ignores the disclosing party’s burden to prove “in fact” that the information is confidential. The requirement to establish that the information is, as a fact, information that could harm Apotex if available to the public is consistent with the Sierra Club test.

The Court commented that on the record before the court, “there is evidence of a general nature as to Apotex’s practices regarding information of the type contained in an Acknowledgment and Certification.” However, with respect to the specific information disclosed in the Acknowledgment, Apotex had not established on a balance of probabilities that their interests could be harmed if the information were made public.

A copy of Associate Judge Crinson’s Reasons may be found here.