Recently, in Genentech, Inc. et al v Pfizer Canada Inc, 2018 FC 233, the Federal Court held that it does not have jurisdiction to decide a motion to vary confidentiality terms imposed by a "second person" under the PM(NOC) Regulations, in the absence of an underlying action.
Pfizer served eight Notices of Allegation on Roche relating to its trazimera (trastuzumab biosimilar) product, and imposed certain confidentiality restrictions relating to portions of its abbreviated new drug submission on Genentech and Roche, pursuant to section 5(3.5) of the Regulations. Before commencing an action under section 6 of the Regulations, Genentech and Roche brought a motion to vary the terms of the confidentiality restrictions under section 5(3.7) of the Regulations. Pfizer opposed the motion on the basis that the Court did not have jurisdiction to vary the confidentiality terms in the absence of an underlying action under section 6.
Under significant, recent amendments to the Regulations, PM(NOC) proceedings are now brought by way of action rather than application. The amended Regulations also require early disclosure. A second person must serve with its Notice of Allegation a searchable copy of the portions of its drug submission that are under its control and relevant to determine if any patent or supplementary protection certificate referred to in the Notice of Allegation would be infringed. Given the commercial sensitivity of the drug submission, the amendments allow the second person to impose reasonable terms to maintain confidentiality. If the first person or patent owner believes that the terms are unreasonable, they may bring a motion under section 5(3.7) for an order setting aside or varying the terms.
The motion turned on the parties' conflicting interpretations of the Regulations. Pfizer argued that the Federal Courts Rules require proceedings to be commenced by a statement of claim or a notice of application, or by another document if specified by an Act of Parliament. Section 5(3.7) did not authorize the commencement of proceedings by way of a motion, but rather simply confirms that relief may be sought by motion in an ongoing proceeding. Genentech's and Roche's position was that Parliament intended a motion under section 5(3.7) to be an originating motion that could be brought prior to a section 6 action. Section 6.03(4), which permits a second person to challenge confidentiality obligations imposed by the first person, refers to "the action", while section 5(3.7) does not, and thus Parliament intended a section 5(3.7) motion to be brought in the absence of an underlying action.
The Court sided with Pfizer holding that a motion under section 5(3.7) of the Regulations cannot be brought as a separate proceeding by way of motion or application. It must be brought as an interlocutory motion within an existing action under section 6. The Court reasoned that section 5(3.7) does not refer to the commencement of a proceeding, and if "motion" meant an originating proceeding then the first person or patent owner would have no ability to challenge confidentiality rules in the context of a section 6 action. The Court concluded that this cannot have been Parliament's intention. Rather, section 5(3.7) uses the word "motion" in the same way as it appears elsewhere in the Regulations, where it clearly means a motion within the context of an action. The word "motion" must be interpreted consistently throughout the Regulations. The Court also noted that section 5(3.7) permits the Court, on its own initiative, to set aside or vary the second person's confidentiality rules. As the Court cannot institute its own proceedings, it can only exercise this power within the context of an existing action.
Accordingly, the Court does not have jurisdiction to determine a motion under section 5(3.7) of the Regulations, except in the context of an existing action under section 6.
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