CASE:      Pfizer Canada Inc. et al. v. Novopharm Limited et al. (T-1868-09)  

DRUG:      LYRICA (pregabalin)  

NATURE OF CASE:      PM(NOC) Regulations, s. 6 – Confidentiality Motion  

DATE OF DECISION:      April 14, 2010

SUMMARY:

On April 14, 2010, Prothonotary Milczynski of the Federal Court dismissed a motion by Novopharm Limited (“Novopharm”) for an Order designating its notice of allegation (“NOA”) as “confidential information” under the terms of a Protective Order. This is the first time this issue has been adjudicated in Canada. Ogilvy Renault LLP represented Northwestern University in its opposition to the motion.

By letter dated October 1, 2009, Novopharm served a NOA on Pfizer Canada Inc. (“Pfizer”). Novopharm unilaterally marked the NOA as confidential and indicated that the NOA was being delivered on a confidential basis.

Pfizer commenced an application for any order prohibiting the Minister of Health from approving the Novopharm product until after the expiry of the relevant patents. Novopharm then moved under Rule 151 of the Federal Courts Rules for an order designating the NOA as confidential on the basis that:

  • it had made a substantial investment in the production of the NOA  
  • it has treated and maintained the NOA as confidential  
  • there is no public benefit to disclosing the NOA  
  • if Novopharm is successful in the proceeding and the NOA is made public to its competitors, those competitors could use the NOA to “springboard” onto the pregabalin market at considerably less expense than that incurred by Novopharm  

Novopharm conceded that the NOA did not contain trade secrets, commercially sensitive information or other confidential information. Novopharm’s argument was that the entire NOA represented a valuable work product thereby meriting protection from copying by other generic manufacturers.  

The Court dismissed Novopharm’s motion. Though the NOA required substantial time, effort, resources and money to prepare, this is not a basis to designate the NOA as confidential. The information must be of a confidential nature rather than information a litigant would prefer to keep confidential. Referring to the test enunciated by the Supreme Court regarding the designation of confidential information, the Court found that Novopharm’s market position is not an important commercial interest as required by the test. Instead, it is a narrow and personal interest to Novopharm. The Court stated that there is no public interest in ensuring Novopharm the time and/or exclusivity of its market entry over any other generic drug maker. Lastly, the Court remarked that designation of the NOA could render the entire proceeding secret thereby gravely diminishing the importance and value of open and accessible court proceedings. Novopharm has appealed the decision.  

LINK TO DECISION: http://decisions.fct-cf.gc.ca/en/2010/2010fc409/2010fc409.html