Janssen Inc. v. Minister of Health — Appeal Dismissed with Costs
Janssen Inc. sought to add its patent CA3113837C — covering a method of treating ulcerative colitis with an anti-IL12/IL23 antibody — to a Canadian patent list against SNDS 224739. The Federal Court of Appeal found no reviewable error in the Office of Submissions and Intellectual Property's refusal, dismissing the appeal with costs after approximately 118 days of proceedings.
Janssen's patent list strategy rejected at Canada's Federal Court of Appeal
Janssen Inc. filed appeal A-192-23 at the Canada Federal Court of Appeal on 26 July 2023, challenging a Federal Court ruling that had upheld a refusal by the Office of Submissions and Intellectual Property (OSIP) to add Canadian patent CA3113837C to a patent list against Supplemental New Drug Submission (SNDS) 224739. The patent at issue relates to a safe and effective method of treating ulcerative colitis using an anti-IL12/IL23 antibody — the therapeutic mechanism underpinning Janssen's biologic franchise in that disease area.
The Federal Court of Appeal dismissed the appeal with costs on 21 November 2023. The court was not convinced that OSIP's analysis was unreasonable, and it rejected Janssen's argument that subsection 4(7) of the Patented Medicines (Notice of Compliance) Regulations permitted it to update the patent list by adding a reference to an additional SNDS. The court held that subsection 4(7) — which requires a first person to keep information on the list up to date — does not authorise adding a new patent to the list, and that the information on Janssen's existing patent list was already up to date.
The appeal was resolved in approximately 118 days, a relatively swift timeline for appellate proceedings, consistent with the court treating the regulatory interpretation question as well-settled. The ruling signals that the scope of subsection 4(7) of the PM(NOC) Regulations is narrowly construed: the maintenance obligation does not serve as a mechanism to expand patent list coverage to additional SNDSs. The specific commercial or licensing implications, if any, are not disclosed in the available record.
See Complete Case & Patent Analysis →Filing to Appeal Dismissed in 118 days
Days from filing to dismissal (July–November 2023)
CA3113837C — Anti-IL12/IL23 antibody method for ulcerative colitis
Any company developing a biosimilar or follow-on therapy targeting the IL-12/IL-23 pathway — including anti-p40 antibody products indicated for ulcerative colitis — should assess freedom to operate against CA3113837C. While this appeal concerned patent list procedural rights, the patent itself remains in force. Its claims covering methods of treatment for ulcerative colitis with anti-IL12/IL23 antibodies are independently enforceable outside the PM(NOC) linkage framework.
Official order — verbatim text
The court's verdict expressly found no reviewable error in OSIP's conclusion, confirming that the reasonableness standard of review was applied throughout. The court rejected both of Janssen's principal arguments: that OSIP's analysis was unreasonable, and that subsection 4(7) of the PM(NOC) Regulations permits patent list expansion to additional SNDSs. By dismissing with costs, the court signalled that Janssen's regulatory interpretation lacked sufficient merit to avoid a cost award.
Appeal dismissed: what the ruling means for both parties
What 'appeal dismissed' means in this regulatory context
A dismissal of the appeal leaves the Federal Court's underlying decision intact. The court found no reviewable error in OSIP's refusal to add CA3113837C to the patent list against SNDS 224739. Costs were awarded against Janssen, making this a full adverse outcome at the appellate level. The regulatory interpretation of subsection 4(7) of the PM(NOC) Regulations, as articulated by the court, now stands as the operative guidance.
No reviewable error foundJanssen's patent list strategy fails at appellate level
Janssen cannot add CA3113837C to the patent list against SNDS 224739 via the subsection 4(7) maintenance mechanism. The dismissal with costs means Janssen bears the respondent's legal costs in addition to its own. The patent itself remains in force, but its ability to trigger PM(NOC) protections in relation to that specific SNDS is not established by this ruling. The specific downstream regulatory or commercial consequences are not disclosed in the available record.
Patent list addition deniedOSIP's refusal upheld; regulatory position confirmed
The Minister of Health and OSIP's position is fully vindicated. The court confirmed that OSIP's interpretation — that subsection 4(7) does not permit adding a patent to a list but only keeping existing information current — was reasonable. This outcome reinforces the regulator's discretion to refuse patent list amendments that go beyond the maintenance obligation, reducing the risk of strategic patent list expansion by brand-name manufacturers.
Regulatory refusal upheldNarrow reading of PM(NOC) Regulations limits patent list tactics
This ruling clarifies that the subsection 4(7) 'keep information up to date' obligation in Canada's PM(NOC) Regulations cannot be used to add new SNDSs to an existing patent list. Brand-name pharmaceutical companies seeking PM(NOC) protection for line-extension submissions must ensure patent list filings are made through the correct procedural pathway from the outset. Generic and biosimilar manufacturers may find SNDS-linked patent list gaps more difficult for innovators to close retroactively.
PM(NOC) list strategy constrainedFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | JANSSEN INC. | Company | /Search in Eureka ↗ |
| Defendant | THE MINISTER OF HEALTH | Individual | /Search in Eureka ↗ |
| Plaintiff counsel | Jordana Sanft | Attorney | Counsel for JANSSEN INC.Search in Eureka ↗ |
| Plaintiff counsel | Sana Halwani | Attorney | Counsel for JANSSEN INC.Search in Eureka ↗ |
| Plaintiff law firm | Lenczner Slaght LLP | Law Firm | Representing JANSSEN INC.Search in Eureka ↗ |
| Defendant counsel | Elizabeth Koudys | Attorney | Counsel for THE MINISTER OF HEALTHSearch in Eureka ↗ |
| Defendant counsel | James Schneider | Attorney | Counsel for THE MINISTER OF HEALTHSearch in Eureka ↗ |
| Defendant counsel | Leah Bowes | Attorney | Counsel for THE MINISTER OF HEALTHSearch in Eureka ↗ |
| Presiding judge | Judge N/A | Judge | Canada Federal Court of AppealSearch in Eureka ↗ |
R&D signals in the anti-IL12/IL23 biologics space
Forward-looking patent and R&D intelligence signals derived from Janssen's CA3113837C litigation and the anti-IL12/IL23 antibody landscape in Canada and globally.
Janssen's anti-IL biologic filings beyond CA3113837C
Janssen Inc. holds a broader portfolio of anti-IL12/IL23 antibody patents covering dosing regimens, patient subpopulations, and combination therapies. Mapping this portfolio reveals which additional claims may be listed — or potentially listable — against other SNDSs, and where lifecycle management filings are clustered. This signals Janssen's long-term protection strategy for its anti-IL franchise in Canada.
Janssen IL-12/23 portfolio depthFiling trends in anti-IL12/IL23 antibody therapies for IBD
The anti-IL12/IL23 antibody space — covering both pan-p40 and selective IL-23 inhibitors — is seeing increased filing activity as next-generation selective agents emerge. Understanding where global filing density is growing, particularly around ulcerative colitis and Crohn's disease indications, helps identify which competitors are positioning for NOC linkage gaps created by rulings like this one.
IL-12/23 IBD filing activityBiosimilar developers targeting the anti-p40 mechanism
With Janssen's patent list addition denied for SNDS 224739, biosimilar developers holding or developing anti-p40 antibody candidates should assess the resulting PM(NOC) exposure landscape. Monitoring competitor patent filings around manufacturing processes, formulations, and administration methods for anti-IL12/IL23 antibodies reveals where freedom-to-operate gaps may be widening.
Biosimilar FTO opportunityAdjacent claim space near CA3113837C — method-of-treatment gaps
CA3113837C claims a method of treating ulcerative colitis with an anti-IL12/IL23 antibody. Adjacent white space may exist in optimised dosing schedules, biomarker-stratified patient selection, combination regimens with JAK inhibitors or S1P modulators, and paediatric formulations — areas where independent claim positions could be developed without overlapping the existing Janssen filing.
Method-of-treatment white spaceSimilar Canadian PM(NOC) patent list appeal cases
Explore Federal Court of Appeal decisions involving PM(NOC) patent list disputes, anti-IL biologic therapies, and OSIP regulatory refusals in Canada.
What this case signals for the Canadian pharma IP landscape
The ruling tightens the PM(NOC) patent list framework, with direct implications for biologic and small-molecule lifecycle management strategies in Canada.
Subsection 4(7) is a maintenance obligation, not a filing pathway
Innovator companies must not rely on the 'keep information up to date' obligation in subsection 4(7) of the PM(NOC) Regulations to add patents or new SNDSs to an existing patent list. This case confirms that OSIP and the courts will apply a narrow, literal reading of that provision. Any patent intended to trigger NOC linkage must be listed through the correct procedural route at the appropriate submission stage.
Biologic patent list strategy requires early, submission-specific filing
For anti-IL biologic portfolios and other complex biologics, patent list decisions are effectively locked in at the time of the relevant NDS or SNDS filing. Companies managing multi-indication or multi-formulation biologics should audit their patent list coverage across all submissions before regulatory milestones, as retroactive additions via the maintenance pathway are now clearly foreclosed by this ruling.
JANSSEN v MINISTER — key questions answered
The Federal Court of Appeal dismissed Janssen's appeal with costs on 21 November 2023, finding no reviewable error in OSIP's refusal to add patent CA3113837C to a patent list against SNDS 224739. The court held that subsection 4(7) of the PM(NOC) Regulations does not permit adding a patent to a list under the guise of keeping information up to date.
Subsection 4(7) requires a first person to keep the information on a patent list up to date. The Federal Court of Appeal held that this obligation is narrow: it does not permit a first person to add a new patent or link a patent to an additional SNDS. The provision covers maintenance of existing listed information only — not expansion of the list's coverage.
CA3113837C is a Canadian patent held by Janssen Inc. covering a safe and effective method of treating ulcerative colitis with an anti-IL12/IL23 antibody. The patent relates to the use of an antibody targeting the shared p40 subunit of IL-12 and IL-23 — a mechanism central to Janssen's biologic therapy in inflammatory bowel disease.
OSIP is the Office of Submissions and Intellectual Property within Health Canada, responsible for administering the patent list provisions of the Patented Medicines (Notice of Compliance) Regulations. In this case, OSIP refused Janssen's request to add CA3113837C to a patent list against SNDS 224739. Both the Federal Court and the Federal Court of Appeal upheld that refusal as reasonable.
The ruling confirms that an innovator cannot retroactively expand PM(NOC) patent list coverage to additional SNDSs using the subsection 4(7) maintenance mechanism. Biosimilar developers may find that patent list gaps resulting from failed addition attempts are not easily closed by innovators, potentially narrowing the set of patents that can trigger a 24-month NOC stay in relation to a given SNDS.
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