Status of actions under Regulations
Trial decisions on the merits
Federal Court of Appeal decisions on the merits
Procedural matters

The fifth anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (the Regulations) was marked on 21 September 2022. This article provides an update on activities in the fifth year following the amendments, including new actions and a wave of court decisions, both on the merits and procedural.(1)

Status of actions under Regulations

In the period from 21 September 2021 to 21 September 2022, approximately 29 sets(2) (40 total) of actions were started. A comparison to previous years is provided in Figure 1.(3)

Figure 1: sets of actions started since 2017

Of the approximately 221 actions started since the amendments, the majority continue to be resolved prior to completion of the trial (155, in grey in Figure 2). 26 actions were pursued to a decision on the merits; the innovator was successful in 12. Since some of the actions were tried and decided in a single set of reasons, there are 15 decisions on the merits, nine of which were in favour of the innovator. Appeals are pending from eight decisions on the merits; four trial decisions were affirmed on appeal.

Figure 2: outcome of actions started since 2017

The following 19 drugs have at least one action ongoing:

  • adalimumab (AbbVie's Humira);
  • aflibercept (Bayer's Eylea);
  • bimatoprost (Allergan's Lumigan RC);
  • carfilzomib (Amgen's Kyprolis);
  • dexlansoprazole (Takeda's Dexilant);
  • efinaconazole (Bausch's Jublia);
  • empagliflozin (Boehringer's Jardiance);
  • emtricitabine, rilpivirine, tenofovir alafenamide (Gilead's Odefsey);
  • ibrutinib (Janssen's Imbruvica);
  • linagliptin (Boehringer's Trajenta);
  • nintedanib (Boehringer's Ofev);
  • paliperidone palmitate (Janssen's Invega Sustenna);
  • riociguat (Bayer's Adempas);
  • sacubitril/valsartan (Novartis's Entresto);
  • selexipag (Janssen's Uptravi);
  • sitagliptin and metformin hydrochloride (Merck's Janumet);
  • tenofovir alafenamide (Gilead's Vemlidy);
  • tenofovir alafenamide/emtricitabine (Gilead's Descovy); and
  • vortioxetine (Lundbeck's Trintellix).

In the past year, Apotex was the most active patent challenger (a defendant in 17 actions relating to seven drugs), followed by a tie for second between JAMP Pharma and Sandoz, each with five actions relating to five drugs.

In addition, in the past year, four actions were commenced further to section 8.2 (for a total of 17 commenced since the amendments to the Regulations). Section 8.2 permits a first person/patentee to bring an infringement action asserting a patent not listed on the Patent Register once served with a notice of allegation (NOA). Only the four actions started in the past year are ongoing, relating to:

  • efinaconazole (Bausch's Jublia)
  • sitagliptin and metformin hydrochloride (Merck's Janumet)
  • aflibercept (Bayer's Eylea)

In general, trials of section 8.2 proceedings have been scheduled approximately three to four months after the trial of the section 6 proceedings. None have yet proceeded to trial.

Three actions pursuant to section 8 of the Regulations were commenced in the past year (for a total of eight started under the amended Regulations, though only five are pending) seeking damages following unsuccessful patent infringement actions:

  • fampridine (commenced by Pharmascience and separately Taro Pharmaceuticals); and
  • abiraterone (commenced by Pharmascience)

To date, there have been no decisions on the merits of a section 8 action under the amended Regulations. The first trials are scheduled for June 2023 (Apotex and Dr Reddy's Laboratories' actions against Janssen regarding abiraterone).

Trial decisions on the merits

A number of further decisions on the merits were released in the fifth year (for further details, see "2022 mid-year highlights in Canadian life sciences IP and regulatory law"):

Federal Court of Appeal decisions on the merits

Federal Court of Appeal decisions on the merits include the following:

  • Pharmascience v Teva (glatiramer acetate, Copaxone, Glatect) – for further details, see "Federal Court of Appeal upholds validity of glatiramer acetate patent". The Federal Court of Appeal upheld the finding that claims to use of 40 milligrams of glatiramer acetate administered by subcutaneous injection three times weekly for treatment of relapsing-remitting multiple sclerosis (the 802 patent) were valid (utility soundly predicted, not obvious). The infringement finding was not challenged on appeal. Pharmascience has sought leave to appeal.
  • Pharmascience Inc v Bristol-Myers Squibb Canada Co (apixaban, Eliquis) – for further details, see "Federal Court of Appeal upholds validity of two patents relating to Eliquis". The Federal Court of Appeal upheld the finding that the two patents were valid:
    • the 202 patent, which claims apixaban, an anticoagulant, and the use of apixaban in the treatment of thromboembolic disorders (novel, not obvious, no double patenting and sufficient); and
    • the 171 patent, which claims tablet formulations of apixaban (not obvious, not ambiguous/overbroad); and
  • Biogen Canada Inc v Pharmascience Inc, Taro (fampridine, Fampyra) – for further details, see "Federal Court of Appeal upholds invalidity of fampridine patent". The Federal Court of Appeal upheld the finding that the patent relating to uses of fampridine sustained release compositions to treat multiple sclerosis was invalid (obvious).

Procedural matters

In addition, a number of procedural decisions were released, including to provide interpretation on aspects of the Regulations:

For further information on this topic please contact Urszula Wojtyra or Katie Lee at Smart & Biggar by telephone (+1 416 593 5514) or email ([email protected] or [email protected]). The Smart & Biggar website can be accessed at


(1) See prior updates marking the first, second, third and fourth anniversary of the amendments.

(2) Actions between the same parties in respect of the same innovator reference drug are considered one "set". The counts are provided as of the fifth-year anniversary, 21 September 2022.

(3) The number for 2020-2021 is lower than reported in the article published to mark the fourth anniversary of the amendments, which included five section 8.2 actions.