On September 7, 2022, the Federal Court of Canada (the Court) in Janssen Pharmaceutica N.V. v Apotex Inc., 2022 FC 1262, granted a protective order in the form presented by Apotex Inc. (Apotex) with respect to the exchange of documents and information with Janssen Pharmaceutica (Janssen) during the discovery process.

The plaintiff, Janssen, brought a motion pursuant to the Patented Medicines (Notice of Compliance) Regulations (the Regulations) regarding the terms of a protective order with the defendant, Apotex. Both parties agreed that a protective order should be issued, but disagreed on two terms.

The parties agreed that the confidential information (as defined in the draft protective order) may be disclosed to up to three in-house legal counsel. However, Apotex asserted that the parties should also be able to disclose the confidential information to two employees or corporate officers of the receiving party, which Janssen objected to.

Further, the parties agreed that independent consultants or outside experts may receive confidential information, subject to the terms of the order, but did not agree on the number of such independent consultants or outside experts. Apotex asserted that there should be no limitation, whereas Janssen wanted to cap the number at five.

The Court reviewed the recent jurisprudence around protective orders and the general principles for the issuance of such orders in actions under the Regulations. The Court concluded that since Janssen sought to impose limitations for the exchange of information, it bears the burden of proving the following in accordance with the test for protective orders set out in Paid Search Engine Tools, LLC v Google Canada Corporation, 2019 FC 559:

  • the information at issue has been treated at the relevant times as confidential;
  • the information is confidential in nature; and
  • that there is a reasonable probability that disclosure of the information could cause harm to proprietary, commercial and scientific interests.

Upon reviewing the evidence presented by Janssen, the Court held that Janssen has not provided sufficient evidence to demonstrate that there is a reasonable probability that disclosure of the information on the terms proposed by Apotex could cause harm to its proprietary, commercial, and scientific interests.

As a result, the Court issued a protective order in the form presented by Apotex, dismissed Janssen’s motion, and awarded $2,000 in costs payable to Apotex.

Summary By: Victoria Di Felice


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