Introduction

The amended Patented Medicines (Notice of Compliance) (PMNOC) Regulations came into force on 21 September 2017, heralding significant changes to the regulatory landscape for pharmaceutical companies in Canada (for further details please see "Publication of final regulations on patent linkage and term restoration relating to CETA"). The amendments stem from Canada's obligations under the Comprehensive Economic and Trade Agreement (CETA).(1) Among other changes, the amendments ended dual litigation and provided innovators a right of appeal, thus aligning the regulations more closely with the US Hatch-Waxman scheme.(2) The regulations also extend to certificates of supplementary protection (for further details please see "Certificate of supplementary protection regime: first anniversary update").

This article provides an update as of the first anniversary of the amendments.

Status of actions under amended regulations

Approximately 20 sets of actions(3) have been commenced under the amended regulations in respect of 15 innovator reference drugs.

Drug

Proceedings

Trastuzumab (Herceptin)

Genentech v Amgen (discontinued) Genentech v Celltrion Hoffmann-La Roche v Pfizer

Apixaban (Eliquis)

Bristol-Myers Squibb v Apotex Bristol-Myers Squibb v Teva

Paliperidone palmitate suspension (Invega Sustenna)

Janssen v Teva

Mesalamine (Asacol 800)

Allergan v Tillots Pharma

L-lysine-d-amphetamine (Vyvanse)

Shire v Apotex

Vardenafil hydrochloride (Staxyn)

Bayer v Jamp

Teriparatide (Forteo)

Eli Lilly v Apotex (discontinued)

Filgrastim (Neupogen)

Amgen v Pfizer Amgen v Sandoz

Rituximab (Rituxan)

Hoffmann-La Roche v Sandoz

Nanoparticle, albumin-bound paclitaxel (Abraxane)

Abraxis Bioscience v Panacea (discontinued)

Doxycycline (Apprilon)

Galderma v Apotex

Fampridine/4-aminopyridine (Fampyra)

Biogen v Taro Biogen v Apotex

Glatiramer acetate (Copaxone)

Teva v Sandoz

Lenalidomide (Revlimid)

Celgene v Natco Pharma

Daptomycin (Cubicin)

Cubist Pharmaceuticals v Teva

This number is similar to the 23 sets of applications (regarding 20 reference drugs) commenced within the same length of time (2016 to 2017) under the pre-amended regulations. Approximately one-third of the applications stem from notices of allegation served immediately before the implementation of the amended regulations.

Procedural matters

Many new procedural rules and guidelines were introduced in conjunction with the amended regulations, in part to expedite proceedings so that infringement and validity actions can be completed within the 24-month statutory stay period. Specifically, the following developments have occurred.

Guidelines and timing of actions Federal Court practice notice The Federal Court published a practice notice regarding actions brought under the amended regulations (Guidelines for Actions under Amended PMNOC Regulations – Notice to the Parties and the Profession).

Joint schedules The Federal Court issued a PMNOC timetable checklist for parties to set key deadlines at an early stage.

Trial length and timing Every trial under the amended regulations thus far has been set down for 10 days. On average, the time from the issuance of the statement of claim to the first day of trial is approximately 20.5 months, which allows for trials to be completed within the 21-month target set out in the Federal Court practice notice.

Procedural decisions First reported decision on motion for early dismissal In Genentech v Amgen (2018 FC 694), Prothonotary Aylen dismissed Amgen's motion for early dismissal pursuant to Section 6.08 of the amended regulations, which mirrors Section 6(7) of the pre-amended regulations (for further details please see "Federal Court dismisses first motion for early dismissal under amended PMNOC Regulations"). While the plaintiffs had previously sought to dismiss, adjourn and delay the hearing of that motion, as well as to extend the statutory stay as a result of it, Aylen refused the bulk of the request, ordering that the motion proceed after the completion of documentary discovery (2018 FC 303).

Motion for summary judgment or summary trial not allowed to proceed On 19 September 2018 Aylen refused to allow Pfizer to bring a motion for summary judgment or summary trial in an action involving a skinny labelling submission (Hoffmann-La Roche v Pfizer, 2018 FC 932). Pfizer had required leave from the court to bring the motion as the trial had already been set down. The court denied leave, finding that there would be a lack of significant savings of costs, time and efficiencies if the motion were permitted to proceed, especially in light of the parallel action involving the non-skinny-labelled submission.

No jurisdiction to consider confidentiality rules absent an action In Genentech v Pfizer Canada (2018 FC 233), the Federal Court found that it lacks jurisdiction to vary confidentiality rules imposed by a generic or patentee until an action is commenced under the amended regulations (for further details please see "Procedural decisions relating to Herceptin under amended PMNOC Regulations").

Leave to appeal Under Section 6.11(1) of the amended regulations, a party seeking to appeal an interlocutory order must apply for leave to the Federal Court of Appeal. Thus far, there have been two unsuccessful applications for leave to appeal (18-A-22; 18-A-23).

Other developments On 5 April 2018 Health Canada revised its Guidance Document: Patented Medicines (Notice of Compliance) Regulations (for further details please see "Health Canada issues updated guidance on PMNOC Regulations"). The guidance document addresses certain new procedures under the regulations, some of which are necessary as the minister of health is no longer a party to the proceedings under the amended regulations.

Comment

While it is still early days, many actions commenced under the amended regulations are scheduled for trial from Autumn 2019. Until then, the courts will likely provide further clarity regarding a number of procedural issues under the new scheme.

For further information on this topic please contact Katie Lee or Urszula Wojtyra at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email (khlee@smart-biggar.ca or uawojtyra@smart-biggar.ca). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.

Endnotes

(1) See also the Canada-European Union Comprehensive Economic and Trade Agreement Implementation Act.

(2) See the comparison chart, available here.

(3) Proceedings between the same parties in respect of the same innovator reference drug are considered to be one set.

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