Summary
On December 3, 2020, the Federal Court of Appeal released its first decision providing guidance on the standard for obtaining leave to appeal interlocutory decisions under section 6.11(1) of the Patented Medicines (Notice of Compliance) Regulations (the Regulations): Apotex v Allergan; Pharmascience v Bayer, 2020 FCA 208. The threshold for obtaining leave requires:
- A fairly arguable case taking into account the standard of review; and
- That the issue raised is capable of having a direct impact on the overall success or failure of the case.
Analysis
Prior to 2017, litigants could appeal interlocutory decisions under the Regulations – decisions typically made by Prothonotaries – first to a Federal Court judge, and then to the Federal Court of Appeal, both as of right. However, following the coming into force of the 2017 amendments to the Regulations, new section 6.11(1) permitted interlocutory appeals to go directly to the Federal Court of Appeal, with leave of that Court.
The “fairly arguable case” standard is consistent with the well-established threshold for obtaining leave to appeal to the Federal Court of Appeal under Rule 352 of the Federal Courts Rules. The applicable standard of review colours the analysis in that issues that will be reviewed for correctness (i.e., questions of law) are more likely to be “fairly arguable” than those that will be reviewed for palpable and overriding error (i.e., questions of fact or mixed fact of law with no extricable legal principle), a very stringent standard of review.
However, the Court of Appeal ruled that in the circumstances of the Regulations, a further requirement was necessary. More specifically, given that the 2017 amendments were intended to expedite proceedings and limit appeals, “only matters of prime significance and materiality should be given leave,” such that “an applicant for leave to appeal must also persuade the Court that its decision on the interlocutory appeal will have a direct impact on the overall success or failure of the case.”
The Court of Appeal denied leave to appeal in the present cases, which related to the delivery of samples and a discovery issue. It has only granted leave to appeal under section 6.11(1) in four applications to date, out of a total 13 applications filed (with two yet unresolved). Of those four, only one was successful (reported here).
Should you have any questions, please do not hesitate to contact a member of the Pharmaceutical Litigation group.
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