September 21, 2019 was the second anniversary of the coming into force of the amended Patented Medicines (Notice of Compliance) Regulations (Regulations) heralding significant changes to the landscape for pharmaceutical companies in Canada. 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 (CSPs).

A significantly greater number of actions were commenced in the second year over the first year (approximately 35 vs 20 sets1), which was also greater than the number of applications commenced in the last year under the pre-amended Regulations (approximately 35 vs 231). This article provides an update as of the second anniversary of the amendments (see our first anniversary update here).

Status of actions under the amended Regulations:

Of the approximately 55 sets of actions commenced under the amended Regulations, 20 have been discontinued/dismissed before a trial.

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

Drug

Plaintiff

Defendant

abiraterone acetate (ZYTIGA)

Janssen

ApotexSandoz (discontinued)PharmascienceDr. Reddy’s

apixaban (ELIQUIS)

Bristol-Myers Squibb

ApotexTeva (discontinued)PharmascienceNatco (discontinued)Sandoz

bortezomib (VELCADE)

Millennium

TaroPfizer

daptomycin (CUBICIN)

Cubist Pharmaceuticals

Teva (discontinued)Accord (discontinued)SandozDr. Reddy’s

dasatinib (SPRYCEL)

Bristol-Myers Squibb

Teva (discontinued)TaroPharmascience

fampridine / 4-aminopyridine (FAMPYRA)

Biogen

TaroApotexPharmascience

filgrastim (NEUPOGEN / NEULASTA)

Amgen

PfizerSandoz

glatiramer acetate (COPAXONE)

Teva

Sandoz (discontinued)Pharmascience

lenalidomide (REVLIMID)

Celgene

Natco PharmaApotex

liraglutide 6 mg/mL prefilled pens (VICTOZA)

Novo Nordisk

Teva

L-lysine-d-amphetamine (VYVANSE)

Shire

Apotex (stayed)

paliperidone palmitate suspension (INVEGA SUSTENNA)

Janssen

Teva

rivaroxaban (XARELTO)

Bayer

TevaApotexTaroSandozDr. Reddy’sAccord

silodosin (RAPAFLO)

Allergan

Sandoz

sodium risedronate (ACTONEL DR)

Allergan

Apotex

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/patentee to bring an infringement action regarding a patent not listed on the Patent Register once served with a notice of allegation. 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. There have, however, 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 the old Regulations not determinative: In Amgen v Pfizer, 2018 FC 1078 (see brief here), 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 (see brief here), 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 (see brief here), the Court struck a claim for infringement of a strength previously approved that was not the subject of an NOA, finding that joinder of a regular infringement action with a PMNOC action was precluded.
  • 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, see brief here), 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; see brief here). While the actions of Taro and Sandoz were commenced four and six months later, respectively, they too were ordered added to the Teva/Apotex trial ( Bayer v Teva, 2019 FC 1039).

Appeals:

  • 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 was Pfizer’s appeal from the decision in Amgen v Pfizer, 2018 FC 1078, discussed above.
    • The second 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, see brief here).

Timing of trials, and length:

  • Trial length: The majority of trials have been set down for ten days. There are a few trials scheduled for fewer than ten days. The few trials scheduled for greater than ten 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 practice notice.
  • The first trial was scheduled to start on September 30, 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), scheduled to start November 4, 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 March 31, 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 intellectual property hold).

Conclusion:

The past year has seen many further decisions on procedure under the amended Regulations and more actions commenced. We look forward to the first substantive trial this fall.