November 20 2019 Amgen not precluded from litigating same patent under amended PMNOC regulations Smart & Biggar | Healthcare & Life Sciences - Canada Healthcare & Life Sciences IntroductionPre-amended and current regulationsPfizer's motionIntroductionOn 4 October 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) (PMNOC) Regulations for a declaration that Pfizer's Nivestym, a biosimilar of Amgen's Neupogen (filgrastim), would infringe Canadian Patent 1,341,537 (the 537 patent) (for further details please see "Amgen not precluded from asserting patent under current PMNOC Regulations").(1) Pfizer had 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.Pre-amended and current regulationsThe pre-amended PMNOC Regulations permitted a 'first person' (ie, an 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 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 which party 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 (eg, Sanofi-Aventis v Novopharm, 2007 FCA 163).The new regime, which came into force on 21 September 2017 (for further details please see "Amended PMNOC Regulations: second anniversary update"), replaced summary prohibition applications with full actions to determine infringement and validity with finality, putting an end to dual litigation.Pfizer's motionThe 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, reported here), finding that Apotex's allegation of obviousness was justified.In its notice of allegation, 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 Sanofi, 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 Apotex could not "simply be grafted on the within action" given the significant changes to the PMNOC Regulations.Although Sanofi 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 (for further details please see "Federal Court of Appeal dismisses first PMNOC interlocutory appeal granted leave").For further information on this topic please contact Abigail Smith at Smart & Biggar by telephone (+1 416 593 5514) or email ([email protected]). The Smart & Biggar website can be accessed at www.smart-biggar.ca.Endnotes(1) Pfizer v Amgen, 2019 FCA 249, aff'g 2018 FC 1078.