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Amgen not precluded by invalidity decision under pre-amended PMNOC Regulations from litigating same patent under amended regulations

On October 4, 2019, the Federal Court of Appeal dismissed Pfizer’s appeal of its failed motion to dismiss Amgen’s action under section 6 of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) for a declaration that Pfizer’s NIVESTYM, a biosimilar of Amgen’s NEUPOGEN (filgrastim), would infringe Canadian Patent No. 1,341,537 (537 patent):  Pfizer v Amgen, 2019 FCA 249, aff’g 2018 FC 1078 (reported here). Pfizer argued that Amgen’s action ought to be dismissed as an abuse of process on the basis that Amgen had unsuccessfully litigated the same patent under the pre-amended PMNOC Regulations.

The pre-amended and current regulations

The pre-amended PMNOC Regulations permitted a “first person” (the innovator) to seek an order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to a “second person” in relation to the latter’s generic or biosimilar version of the innovator’s patented drug product. The invalidity and/or infringement of the relevant patent was invariably engaged by these proceedings, but disputes were resolved by way of application and resulted in no final determinations of these issues. Rather, the Court would assess whether allegations of invalidity or infringement were “justified”. Regardless of who prevailed, the validity and infringement of the relevant patent could be subsequently litigated by way of action under the Patent Act, resulting in a dual litigation process. However, if a first person failed to establish that an allegation of invalidity was justified, it was effectively prohibited from pursuing new proceedings relating to the same allegation under the pre-amended PMNOC Regulations against subsequent second persons: Sanofi-Aventis v Novopharm, 2007 FCA 163 [Sanofi].

The new regime, which came into force September 21, 2017 (see our most recent update here), replaced summary prohibition applications with full actions to determine infringement and validity with finality, putting an end to dual litigation.

Pfizer’s motion

The 537 patent was the subject of proceedings under the pre-amended PMNOC Regulations: in 2015, the Federal Court dismissed Amgen’s application against Apotex (Amgen v Apotex, 2015 FC 1261 [Apotex], reported here), finding that Apotex’s allegation of obviousness was justified.

In its Notice of Allegation (NOA), Pfizer alleged the same ground of invalidity on which Apotex had successfully relied in the prior proceeding. Amgen commenced an action under the amended PMNOC Regulations in response. Relying on the Sanofi decision, Pfizer moved to dismiss the action as an abuse of process given that Amgen had been unsuccessful in its prior application against Apotex.

The Federal Court of Appeal affirmed Prothonotary Milczynski’s conclusion that the Apotex decision could not “simply be grafted on the within action” given the significant changes to the PMNOC Regulations.

Although the Sanofi decision remains good law, the nature of a section 6 action under the amended PMNOC Regulations and the principles that underlie the doctrine of abuse of process led to the conclusion that Amgen’s action could not be considered an abuse of process. Amgen’s action posed no risk of generating inconsistent judicial decisions on the same issues in equivalent proceedings, as the prior proceedings had determined neither the validity of the patent nor whether Pfizer’s NIVESTYM infringed that patent.

This appeal was the first for which leave to appeal was granted under the amended PMNOC Regulations, and the second appeal for which a decision has been rendered (see brief regarding first decision here).

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