September 21, 2025, marked the eighth anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the eighth year following the amendments, including new actions and Court decisions, both on the merits and procedural. Our seventh anniversary update is available with links to prior year updates.
Status of section 6(1) actions under the Regulations
From September 21, 2024 to September 20, 2025, approximately 23 sets* of actions (24 total actions) under section 6(1) were started, which is lower than in previous years, see below:
Of the approximately 326 actions started since the amendments, the majority (264, in grey below) continue to be resolved prior to a decision on the merits of infringement and/or invalidity (in almost all such cases, prior to trial).
To date, 33 actions were pursued to decisions on the merits of infringement and/or invalidity, with the innovator successful in 17 actions. There are 20 decisions on the merits, 13 of which were in favour of the innovator (the Court issued a single decision for some actions heard together and issued two decisions—one each for infringement and invalidity—in one action).
To date, no trial decision has been overturned on appeal. There are three appeals pending in the Federal Court of Appeal. Last September, the Supreme Court of Canada (SCC) granted Pharmascience the first leave to appeal under the amended Regulations. The appeal relates to the patentability of methods of medical treatment. The hearing has been scheduled for October 9, 2025.
The following 19 drugs have at least one action ongoing:
- apalutamide (Janssen's ERLEADA)
- axitinib (Pfizer's INLYTA)
- bosutinib (Pfizer's BOSULIF)
- calcipotriol (Leo Pharma's ENSTILAR)
- diclofenac (Aralez's CAMBIA)
- empagliflozin (Boehringer's JARDIANCE)
- empagliflozin / metformin hydrochloride (Boehringer's SYNJARDY)
- esomeprazole / naproxen (Xediton's VIMOVO)
- lenvatinib (Eisai's LENVIMA)
- macitentan (Janssen's OPSUMIT)
- naloxone hydrochloride (Emergent's NARCAN Nasal Spray)
- olaparib (AstraZeneca's LYNPARZA)
- perampanel (Eisai's FYCOMPA)
- pertuzumab (Hoffmann-La Roche's PERJETA)
- rifaximin (Salix's ZAXINE)
- ruxolitinib (Novartis' JAKAVI)
- trametinib (Novartis' MEKINIST)
- trifluridine / tipiracil (Taiho's LONSURF)
- vortioxetine (Lundbeck's TRINTELLIX)
In the last year, based on the number of drugs, Sandoz, Apotex and Auro were tied for the most active challengers, each challenging patents for three drugs.
Section 8.2 actions: In the past year, eight actions were commenced under section 8.2 (for a total of 45 commenced since the amendments to the Regulations). Section 8.2 permits a first person/patentee to bring an infringement action asserting an unaddressed patent once served with a notice of allegation. Four actions are ongoing, relating to apalutamide (Janssen's ERLEADA), diclofenac (Aralez's CAMBIA), naloxone hydrochloride (Emergent's NARCAN Nasal Spray), and trametinib (Novartis' MEKINIST).
Section 8.1 actions: Section 8.1 deems a person who files a submission for a notice of compliance who has reasonable grounds to believe the drug might be alleged to infringe a patent, an 'interested person' who may bring an action for a declaration of patent invalidity.
In the last year, no actions were commenced under section 8.1. Samsung Bioepis and Amgen each have an ongoing action seeking a declaration of invalidity of a patent relating to ustekinumab (Janssen's STELARA) and a patent relating to eculizumab (Alexion's SOLIRIS), respectively.
Apart from actions under the Regulations, there were also infringement and/or impeachment actions commenced in the past 12 months in respect of sugammadex (Merck's BRIDION), COVID-19 vaccine (Moderna's SPIKEVAX) and pembrolizumab (Merck's KEYTRUDA and Sandoz's biosimilar GME751).
Decisions on the merits
In the eighth year, only one decision on the merits was released. The Federal Court granted Alexion a declaration of infringement and an injunction preventing Amgen from manufacturing, using, and selling its eculizumab product, BEKEMV (a biosimilar of Alexion's SOLIRIS) in Canada until the expiration of Alexion's 810 Patent. The trial judge concluded that Amgen did not meet its burden of establishing anticipation or obviousness. Amgen's appeal is pending.
Other Court decisions
The Federal Court dismissed Bayer's judicial review of the Minister of Health's decision to list a patent on the Patent Register against EYLEA (aflibercept) eight days after it was submitted to Health Canada, and the Federal Court of Appeal dismissed Bayer's appeal. This was the second such decision: the Federal Court also found the Minister's decision was not unreasonable to list a patent on the Register against EMD Serono's MAVENCLAD (cladribine) when it was determined to be eligible, not when it was submitted. The timing issue is important: in both cases, a biosimilar/generic manufacturer (second person) filed their regulatory submission in the intervening period and a second person is not required to address a patent added to the Patent Register on or after the filing date of its submission.
In a section 6(1) action pursuant to the Regulations, the Federal Court granted Amgen's motion, finding that a patent listed against Bayer's aflibercept (EYLEA) did not meet the product specificity requirement for listing against a supplemental new drug submission. Bayer's appeal of the decision was discontinued around the same time as the action in August 2025.
Section 8 actions
To date, there have been no amended section 8 decisions on the merits. Except for one action which remains pending, all previous section 8 actions have been discontinued in advance of trial. The one pending section 8 action was started by Pharmascience and relates to fampridine. The trial is scheduled to commence on February 2, 2026.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
The preceding is intended as a timely update on Canadian intellectual property and life sciences regulatory law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.
Reference
*Actions between the same parties regarding the same innovator reference drug are considered one "set". The counts are provided as of the eight-year anniversary, September 21, 2025.
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.
