Confidentiality Order Appropriate to Conceal Subject-Matter of Novopharm's Abbreviated New Drug Submission

June 11, 2010

Novopharm Limited v. The Minister of Health, 2010 FC 566

Novopharm filed an abbreviated new drug submission (ANDS) for a generic version of a drug, and represented to the Minister of Health that the ANDS did not attract the application of the Patented Medicines (Notice of Compliance) Regulations (and therefore the requirement to address patents listed on the patent register thereunder), since the patents were added after Novopharm had purchased the Canadian Reference Products and completed its clinical studies.  The Minister disagreed however, and required Novopharm to address a specific patent listed on the patent register before it would issue a notice of compliance (NOC) allowing Novopharm to commence marketing its drug.  Novopharm took issue with this decision, and accordingly commenced an application for judicial review of the Minister’s decision.  The application identifies the patents and drugs at issue by letter (i.e. Drugs A and B and Patents X and Y) in order to maintain confidentiality over the drug submission.

In the context of this application, Novopharm brought a motion for a confidentiality order pursuant to Rule 151 of the Federal Courts Rules in order to ensure that all of its dealings with the Minister relating to the review of its ANDS would be maintained in the strictest confidence.   Novopharm argued that disclosure of any details relating to its ANDS would entail disclosure of Novopharm’s legal and business strategy which would result in serious prejudice to its commercial interest.  The Minister opposed this motion, arguing that the innovator of drugs A and B had a right to participate as a party to the proceeding, and that it should be named as a respondent. 

Prothonotary Aalto agreed with Novopharm and granted a confidentiality order.  Novopharm’s commercial interests were clearly at stake.  It was only the Minister’s decision that was at issue, and that decision only affected Novopharm.  The patentee currently had no direct interest at stake giving it the right to be added as a party.  The Minister was, in part, seeking to abdicate the responsibility of substantiating its decision by inviting the innovator to assist in supporting its decision on grounds that would be directed primarily to protecting the interests of the innovator and not the integrity of the Minister’s own internal decision-making process and record.  In order to do so, the Minister would be revealing the record upon which the Minister’s decision was made, thereby revealing confidential information of Novopharm in the context of the ANDS procedure.  This would have been improper.

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