21 September 2019 was the second anniversary of the coming into force of the amended Patented Medicines (Notice of Compliance) (PMNOC) Regulations, heralding significant changes to the landscape for pharmaceutical companies in Canada. Among other changes, the amendments ended dual litigation and provided innovators with a right of appeal, thus bringing the regulations much closer to the Hatch-Waxman scheme in the United States (for further details please see "New pharmaceutical patent linkage litigation scheme"). The regulations also extend to certificates of supplementary protection (CSPs) (for further details please see "Certificate of supplementary protection regime: first anniversary update").

A significantly greater number of actions were commenced in the second year compared with the first year (approximately 35 versus 20 sets), which was also greater than the number of applications commenced in the last year under the pre-amended regulations (approximately 35 versus 23).(1) This article provides an update as of the second anniversary of the amendments (for further details please see "Amended PMNOC Regulations: first anniversary update").

Status of actions under amended regulations

Of the approximately 55 sets of actions commenced under the amended regulations, 20 have been discontinued or dismissed before trial.

The chart below lists actions for drugs in respect of which at least one action is ongoing.




Abiraterone acetate (Zytiga)


Apotex Sandoz (discontinued) Pharmascience Dr Reddy's

Apixaban (Eliquis)

Bristol-Myers Squibb

Apotex Teva (discontinued) Pharmascience Natco (discontinued) Sandoz

Bortezomib (Velcade)


Taro Pfizer

Daptomycin (Cubicin)

Cubist Pharmaceuticals

Teva (discontinued) Accord (discontinued) Sandoz Dr Reddy's

Dasatinib (Sprycel)

Bristol-Myers Squibb

Teva (discontinued) Taro Pharmascience

Fampridine or 4-Aaminopyridine (Fampyra)


Taro Apotex Pharmascience

Filgrastim (Neupogen or Neulasta)


Pfizer Sandoz

Glatiramer acetate (Copaxone)


Sandoz (discontinued) Pharmascience

Lenalidomide (Revlimid)


Natco Pharma Apotex

Liraglutide 6 mg/mL prefilled pens (Victoza)

Novo Nordisk


L-lysine-d-amphetamine (Vyvanse)


Apotex (stayed)

Paliperidone palmitate suspension (Invega sustenna)



Pirfenidone (Esbriet)

Hoffmann-La Roche


Rivaroxaban (Xarelto)


Teva Apotex Taro Sandoz Dr Reddy's Accord

Silodosin (Rapaflo)



Sodium risedronate (Actonel dr)



Ulipristal acetate (Fibristal)



On the eve of the two-year anniversary, the first patent infringement action permitted by Section 8.2 of the regulations was started by Novo Nordisk against Teva in respect of its abbreviated new drug submission for liraglutide (Novo Nordisk's Victoza). Section 8.2 permits a first person or patentee to bring an infringement action regarding a patent not listed on the Patent Register once served with an allegation notice. It remains to be seen what timeline will be instituted for this action and whether it will coincide with the existing action pursuant to the amended regulations.

Procedural matters

There have not yet been any decisions on the merits. However, there have been several interlocutory decisions, including one from the Federal Court of Appeal. The section below provides an overview of key decisions, as well as an overview of trial scheduling.

Procedural decisions Proceedings under old regulations not determinative In Amgen v Pfizer (2018 FC 1078) (for further details please see "Amgen not precluded from asserting patent under current PMNOC Regulations") the court dismissed Pfizer's motion to dismiss Amgen's action on the basis that Amgen had been unsuccessful against Apotex under the old regulations, finding that the previous application had not conclusively determined validity. Pfizer was granted leave to appeal, which was heard in April 2019; a decision is pending.

Only second persons may be defendants In Genentech v Celltrion (2019 FC 293) the court refused to allow the plaintiffs to name Teva parties and an additional Celltrion party as further defendants, as only second persons may be named as defendants in such actions.

Joinder of infringement action not allowed In Teva v Pharmascience (2019 FC 595) the court struck a claim for infringement of a strength previously approved that was not the subject of a notice of allowance, finding that joinder of a regular infringement action with a PMNOC action had been precluded (for further details please see "Infringement based on making and selling under existing NOC struck from action").

Common issues heard together The court has been willing to schedule the concurrent trial of common issues across multiple actions. For example, in Biogen v Taro; Biogen v Apotex (2018 FC 1034) the court ordered common invalidity issues relating to Biogen's fampridine (Fampyra) against Taro and Apotex to be heard concurrently even though the actions were commenced two months apart.

In actions relating to Bayer's Xarelto (rivaroxaban), the court similarly ruled that common validity issues in actions against Apotex and Teva will be heard concurrently (Bayer v Apotex; Bayer v Teva (2019 FC 191)) (for further details please see "Procedural decisions under PMNOC Regulations: common validity issues and naming of defendants"). While the actions of Taro and Sandoz were commenced four and six months later, respectively, they too were added to the Teva/Apotex trial (Bayer v Teva (2019 FC 1039)).


Leave to appeal A party seeking to appeal an interlocutory order must apply for leave to the Federal Court of Appeal. Thus far, there have been nine applications for leave to appeal, of which the majority (five) have been dismissed and two remain pending. Only two leaves to appeal have been granted.

The first leave to appeal was Pfizer's appeal from the decision in Amgen v Pfizer (2018 FC 1078) (discussed above).

The second leave to appeal was Apotex's appeal of a prothonotary's decision refusing to compel certain discovery questions answered. The Federal Court of Appeal dismissed the appeal from the bench (2019 FCA 194) (for further details please see "Federal Court of Appeal dismisses first PMNOC interlocutory appeal granted leave").

Timing and length of trials

Trial length The majority of trials have been set down for 10 days. There are a few trials scheduled for fewer than 10 days. The few trials scheduled for more than 10 days involve many patents or trials of common issues from more than one action involving more than one generic challenger.

Timing On average, the time from issuance of the statement of claim until the first day of trial is approximately 19.9 months, which allows for completion of the trial within the 21-month target noted in the Federal Court's practice notice.

The first trial was scheduled to start on 30 September 2019, between Janssen and Teva in respect of paliperidone palmitate suspension (Janssen's Invega Sustenna); however, it has been adjourned. The next scheduled trial is between Bristol-Myers Squibb and Apotex in respect of apixaban (Eliquis), which is scheduled to start on 4 November 2019.

Health Canada publications

Health Canada has issued the Statistical Report 2018/2019 for the Patented Medicines (Notice of Compliance) Regulations, Data Protection and Certificates of Supplementary Protection. The statistical report has statistics as of 31 March 2019 regarding patents listed on the Patent Register and litigation pursuant to the regulations (as well as CSPs, Register of Innovative Drugs and submissions remaining on IP hold).


The past year has seen many further decisions on procedure under the amended regulations and more actions have been commenced.


(1) Actions between the same parties in respect of the same innovator reference drug are considered one 'set'. The statistics are provided as of the two-year anniversary (ie, on 21 September 2019).

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