As previously reported, the amended Patented Medicines (Notice of Compliance) Regulations (“Regulations”) came into force on September 21, 2017, heralding significant changes to the landscape for pharmaceutical companies in Canada. The amendments flowed from Canada’s obligations under CETA (the Comprehensive Economic and Trade Agreement; see also the Canada-European Union Comprehensive Economic and Trade Agreement Implementation Act). Among other changes, the amendments ended dual litigation and provided the innovator a right of appeal, thus bringing the Regulations much closer to the Hatch-Waxman scheme in the US (see our chart here for a comparison). As noted in our companion article, the Regulations also extend to certificates of supplementary protection.
The below provides an update as of the one year anniversary of the amendments.
Status of actions under the amended Regulations
Approximately 20 sets of actions* have been commenced under the amended Regulations in respect of 15 innovator reference drugs:
Genentech v Amgen (discontinued)
Bristol-Myers Squibb v Apotex
paliperidone palmitate suspension
Janssen v Teva
mesalamine (ASACOL 800)
Allergan v Tillots Pharma
Shire v Apotex
vardenafil hydrochloride (STAXYN)
Bayer v Jamp
Eli Lilly v Apotex (discontinued)
Amgen v Pfizer
Hoffmann-La Roche v Sandoz
nanoparticle, albumin-bound paclitaxel
Abraxis Bioscience v Panacea (discontinued)
Galderma v Apotex
fampridine / 4-aminopyridine (FAMPYRA)
Biogen v Taro
glatiramer acetate (COPAXONE)
Teva v Sandoz
Celgene v Natco Pharma
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 (2016-2017) under the pre-amended Regulations. Around one third of the applications stem from notices of allegation served immediately before the implementation of the amended Regulations.
Many new procedural rules and guidelines were introduced in conjunction with the amended Regulations, in part to expedite proceedings such that an infringement and validity action could be completed within the 24-month statutory stay period. Since enactment, there have been various developments:
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, guidelines for actions under the Amended PMNOC Regulations.
- 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 a period of 10 days. On average, the time from issuance of the statement of claim until the first day of trial is approximately 20.5 months, which allows for completion of the trial within the 21 month target noted in the Federal Court practice notice.
- First reported decision on motion for early dismissal: As previously reported, in Genentech, Inc. and Hoffmann-La Roche Limited v Amgen Canada Inc., 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. While the plaintiffs had previously sought to dismiss, adjourn and delay the hearing of that motion, as well as extend the statutory stay as a result of the motion, Prothonotary Aylen refused the bulk of the request, ordering that the motion proceed after completion of documentary discovery (2018 FC 303).
- Motion for summary judgment or summary trial not allowed to proceed: Most recently, on September 19, 2018, Prothonotary Aylen refused to allow Pfizer to bring a motion for summary judgement or summary trial in an action involving a ‘skinny labeling’ submission: Hoffmann-La Roche v Pfizer Canada Inc, 2018 FC 932. Pfizer required leave from the Court to bring the motion as trial has already been set down. The Court denied leave finding a lack of significant savings of costs, time and efficiencies if the motion was permitted to proceed, especially in light of the parallel action involving the non-skinny labeled submission.
- No jurisdiction to consider confidentiality rules absent an action: As previously reported, in Genentech, Inc. v Pfizer Canada, 2018 FC 233, the Federal Court found that it lacked jurisdiction to vary confidentiality rules imposed by the generic or patentee until an action is commenced under the amended 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).
On April 5, 2018, Health Canada revised its Guidance Document: Patented Medicines (Notice of Compliance) Regulations (as previously reported). 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.
While it is still early days, many actions commenced under the amended Regulations are scheduled for trial starting in the fall of 2019. Until then, we can look forward to the Courts providing further clarity regarding a number of procedural issues under the new scheme.
*Proceedings between the same parties in respect of the same innovator reference drug are considered one “set”.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.