This article was prepared with the assistance of Mandy Yee.
2024 was an active year in Canadian patent law, with the Federal Court issuing several decisions on the merits regarding invalidity and/or infringement. The courts also considered issues of the regulation of patent agents, due care in the context of paying maintenance fees, eligibility for listing a patent on the Patent Register, and the jurisdiction of the Patented Medicines Prices Review Board, among others.
In our annual review of developments in Canadian patent law, we considered over 60 court decisions reported last year. In this article, we highlight a significant statutory change and a selection of interesting points addressed in the reported decisions.
For a comprehensive review of recent Canadian pharmaceutical decisions and developments, read our 2024 highlights in Canadian life sciences IP and regulatory law.
Table of contents
- Canada’s new patent term adjustment system
- Claim construction: let’s talk about “about”
- Claim construction: Federal Court considers what it means to “prevent” a disease or disorder
- Claim construction: can the purpose of essential claim features affect claim construction?
- Methods of medical treatment: Federal Court of Appeal confirms that claims including a dosage regimen can be product claims
- Indefiniteness: when is an inventor coined term indefinite?
- Sufficiency: requiring a minor research project is not determinant of insufficiency
- Defences: when is it appropriate to consider the Gillette defence?
- Infringement: what constitutes “use” for the purpose of proving infringement?
- Infringement: further guidance on the test for inducing infringement
- Remedies: Federal Court of Appeal considers whether prosecution delays can be relevant to refusing an accounting of profits
- Federal Court considers first application for judicial review regarding the “due care” standard
- Federal Court considers first application for judicial review of a decision by CPATA
- Patented Medicine Prices Review Board (PMPRB): Federal Court of Appeal confirms that the jurisdiction of the PMPRB does not extend to unpatented medicines
- Patent Register: Federal Court provides guidance regarding listing eligibility
- “Compound X for use in the treatment or prevention of disease Y” (EPC 2000-style)
- “Use of compound X in the manufacture of a medicament for the treatment or prevention of disease Y” (Swiss-style)
- “Use of compound X for the treatment or prevention of disease Y” (German-style).
- The acts of infringement were completed by the direct infringer;
- The completion of the acts of infringement was influenced by the acts of the alleged inducer to the point that, without the influence, direct infringement would not have taken place; and
- The influence was knowingly exercised by the inducer; in other words, the inducer knew that this influence would result in the completion of the acts of infringement.
1. Canada’s new patent term adjustment system
Canada’s patent term adjustment (PTA) system came into force on January 1, 2025, as required for compliance with Canada’s obligations under the Canada-United States-Mexico Agreement (CUSMA), which replaced the North American Free Trade Agreement (NAFTA) of 1994. PTA compensates the patentee for unreasonable delay by the Canadian Intellectual Property Office (CIPO) in the issuance of a patent.
The official application fee of CAD $2500 to obtain a PTA calculation by CIPO is substantial, and few patents ultimately will qualify for PTA. Counterintuitively, any delay by the applicant has little bearing on PTA. The one simple step applicants can take to avoid loss of potential PTA is to defer submitting the examination request and fee, and most applicants do this anyway. Therefore, the PTA system is unlikely to change Canadian patent prosecution strategy or practice materially or receive much use.
For more details on the new PTA system, please see our article, “Canada finalizes Patent Term Adjustment Rules”.
2. Claim construction: let’s talk about “about”
Patent claims often include the term “about” to provide scope around numerical values. Although CIPO often objects to this term as being unclear, such objections usually can be overcome and the Federal Court has regularly held that “about” is not indefinite, doing so again in 2024 in Medexus Pharmaceuticals Inc v Accord Healthcare Inc, 2024 FC 424. Indeed, including the term “about” may prove important.
In Boehringer Ingelheim (Canada) Ltd v Jamp Pharma Corporation, 2024 FC 1198, one of the issues considered by the Federal Court was the scope of a claim defining components of a formulation in weight percentage amounts specified to two decimal places and not qualified by the term “about”. The Court rejected Boehringer Ingelheim’s argument that the claim allows for minor variability of up to 5% of the specified wt.%, noting that the inventors (1) did not use the word “about” to qualify the precise weight percentage amounts claimed and (2) elsewhere used ranges in claims that were not to be limited to a specific value.
For more details on the decision, please see our article, “Boehringer Ingelheim succeeds in nintedanib PMNOC action against JAMP”.
3. Claim construction: Federal Court considers what it means to “prevent” a disease or disorder
Claims related to a therapeutic indication often refer to the treatment and/or the prevention of that indication. Treatment and prevention are terms routinely used in everyday conversation and may be seen to have “conventional” meanings. However, adopting such “conventional” meanings may disregard important contexts provided by the patent or known to persons skilled in the art.
In Boehringer Ingelheim (Canada) Ltd v Jamp Pharma Corporation, 2024 FC 1198, one of the issues before the Federal Court was the meaning to be given to the expressions “treatment or prevention of idiopathic pulmonary fibrosis [IPF]” / “prevention or treatment of IPF”. The Court found that a skilled person would understand “prevention” to mean prevention of the progression of the disease state and the development of symptoms arising from IPF. This was based in part on the finding that a skilled person would have known that prevention can be either primary prevention—seeking to block disease from forming in the first place—or secondary prevention—aimed at preventing a disease from progressing further, and further that primary prevention of IPF was not possible.
Jamp’s appeal of the decision (Federal Court of Appeal file A-306-24) was dismissed on January 9, 2025.
4. Claim construction: can the purpose of essential claim features affect claim construction?
Claim construction precedes questions of validity and infringement and is often determinative of one or both issues. This was the case in AGI Suretrack LLC v Farmers Edge Inc, 2024 FC 934, where the Federal Court considered a number of issues in claim construction, including arguments regarding claim differentiation, the presumption of claim consistency, whether undefined terms that are used generally in fields other than the field of the patent at issue should be interpreted based on their more general use or in view of the field of the invention, and the “essentiality” of claim features.
On the last point, when considering the feature “extract content from one or more messages transmitted on the message bus and use the extracted content to determine that there is a match between the farming implement used to perform the farming operation and the known farming implement of the implement profile” (underscoring in original) the Court addressed the distinction between (1) relying on the purpose of an essential claim feature (which purpose may not be recited in the claim) to give meaning to another claim feature, and (2) reading an essential feature into a claim based on a possible purpose of a claim feature, highlighting that:
[T]here is a difference between concluding, as I have, that the POSITA would understand the phrase determine that there is a match in a way to give other essential elements within Claim 1 a purpose (i.e., the manufacturer code, device class, and version) and concluding that the POSITA would understand the phrase to incorporate a new essential element (the need to “serve the purpose of interoperability,” or the potential or intention to have multiple implement profiles) that is not found in the claim language and appears to have been deliberately left out of the claim language by the inventors.
AGI has appealed the decision (Federal Court of Appeal file A-291-24).
5. Methods of Medical Treatment: Federal Court of Appeal confirms that claims including a dosage regimen can be product claims
Methods of medical treatment are not patentable in Canada. However, claims referring to a medical “use” are. Such claims can be presented in different forms, including:
In Pharmascience Inc v Janssen Inc, 2024 FCA 23, the Federal Court of Appeal considered distinctions between the different medical use claim forms. The Court affirmed a finding of the Federal Court that claims drafted in the EPC 2000- and Swiss-styles were product claims and did not define methods of medical treatment. Notably, the Court stated, “[i]n my view, a claim may concern a vendible product even if it includes a dosing regimen as an essential element”.
Pharmascience’s application for leave to appeal to the Supreme Court of Canada was granted on September 19, 2024 (Supreme Court file 41209). For a further discussion of the Federal Court of Appeal’s decision, please see our article, “Federal Court of Appeal affirms paliperidone palmitate claims are not unpatentable methods of medical treatment”.
6. Indefiniteness: when is a term coined by an inventor indefinite?
The claims of a patent alert the public to what can be done without infringing the patent. To effectively perform this notice function, the claims must define the subject matter claimed distinctly and in explicit terms. This is reflected in subsection 27(4) of the Patent Act, which states that the specification must end with one or more claims “defining distinctly and in explicit terms the subject-matter of the invention for which an exclusive privilege or property is claimed”. While allegations of invalidity based on ambiguity or indefiniteness are often raised, there are few cases where a court has found a claim invalid solely for ambiguity or indefiniteness. Tekna Plasma Systems Inc v AP&C Advanced Powders & Coatings Inc, 2024 FC 871 is one such example.
The patents at issue related to inter alia processes for manufacturing metal powders through gas atomization and a spheroidization manufacturing process. One of the issues before the Federal Court was whether a skilled reader would understand the meaning of the term “depletion layer” (a term that was not generally used in the field) and determine whether particular particles had a depletion layer. The Court found:
[W]ith the exception of a few claims [of the relevant patent], it is impossible for the skilled reader to know or determine whether or not a powder particle has a depletion layer within the meaning of the patents’ claims. Neither the claims nor the disclosure of the patents provide the reader with the ability to understand and assess whether a particle has a depletion layer, and thus whether a given process or system reads on the claims or not.
In contrast, the few claims of one patent that were found not to be ambiguous specify how to determine the existence of a depletion layer by setting out how to identify the boundaries of the depletion layer and defining its depth. These claims, however, were not asserted to be infringed.
AP&C Advanced Powders & Coatings Inc has appealed the decision (Federal Court of Appeal file A-274-24).
7. Sufficiency: requiring a minor research project is not determinant of insufficiency
Subsection 27(3) of the Patent Act requires that the specification “correctly and fully describe the invention and its operation or use as contemplated by the inventor”. The leading case on subsection 27(3) of the Patent Act is Teva Canada Ltd v Pfizer Canada Inc, 2012 SCC 60 (Teva), where the Supreme Court of Canada found a patent invalid for insufficiency because it would have taken “a minor research project” for a skilled person to determine which compound disclosed in the patent was effective for the use contemplated by the patent.
Since Teva, the Federal Court of Appeal has on numerous occasions clarified that a patent specification may be sufficient even if some non-inventive trial and error is required, provided that it would not require undue experimentation to put the claimed invention into operation. This was reaffirmed in Eli Lilly Canada Inc v Apotex Inc, 2024 FCA 72, where the Federal Court of Appeal noted that merely requiring a minor research project is not sufficient to establish insufficiency; as long as inventive or undue experimentation is not required, the requirements of subsection 27(3) of the Patent Act may be met.
For a further discussion of the Federal Court of Appeal’s decision, please see our article, “Federal Court of Appeal upholds invalidity of Lilly’s CIALIS patent, extending to 'physiologically acceptable salt'”.
8. Defences: when is it appropriate to consider the Gillette defence?
The Gillette defence is a defence to patent infringement where the alleged infringer argues that the product at issue is the same as, or not patentably distinct from, a product in the prior art. If this is the case, then the alleged infringer cannot be infringing a valid patent—either the patent does not cover the product at issue or, if it does, the patent is invalid for covering the prior art (i.e. the patent lacks novelty). The Gillette defence can therefore provide an avenue to avoid the need to construe the claims and then consider validity and/or infringement. However, it is not always clear when a court should separately consider the Gillette defence.
In Molo Design Ltd v Chanel Canada ULC, 2024 FC 1260, the Federal Court declined to consider the Gillette defence, as doing so would have been “superfluous and unnecessary”. The alleged infringers (Chanel and Procédés Chénel) had brought counterclaims seeking declarations that the claims of the patent asserted by Molo were invalid, and these counterclaims were not dependent or conditional on the outcome of Molo’s infringement claim. Because the Court still had to construe the claims and consider validity to assess the counterclaims, considering the Gillette defence would not have provided the “shortcut” around these steps intended by the defence.
9. Infringement: what constitutes “use” for the purpose of proving infringement?
A patent grants to a patentee and the patentee’s legal representatives “the exclusive right, privilege and liberty of making, constructing and using the invention and selling it to others to be used” for the term of the patent (see, Section 42 of the Patent Act). In Monsanto v Schmeiser, 2004 SCC 34, the Supreme Court of Canada held that “[t]he question in determining whether a defendant has ‘used’ a patented invention is whether the defendant’s activity deprived the inventor in whole or in part, directly or indirectly, of full enjoyment of the monopoly conferred by law”, thus providing an expansive interpretation of what may constitute “use” of a claimed invention.
In Steelhead LNG (ASLNG) Ltd v Arc Resources Ltd, 2024 FCA 67, the Federal Court of Appeal considered the meaning of the term “use” in section 42 of the Patent Act. The Court affirmed the Federal Court’s decision that disclosing a proof of concept consisting of drawings, specifications and cost estimates to prospective business partners and stakeholders of a design which, if ever built, would comprise the essential elements of the patent at issue did not constitute “use” of the claimed apparatus. “Use” of the claimed apparatus was not made out, as the apparatus was never actually built in Canada.
Steelhead has filed an application for leave to appeal to the Supreme Court of Canada (Supreme Court file 41323).
10. Infringement: further guidance on the test for inducing infringement
In addition to, or instead of, pursuing a party who directly infringes a claim, a patentee or the patentee’s legal representatives can also pursue a party who induces another to infringe. To successfully make out an allegation of inducing infringement, it is necessary to establish that:
The Federal Court of Appeal provided guidance regarding both the first and second prongs of the test in 2024.
In Pharmascience Inc v Janssen Inc, 2024 FCA 10, Pharmascience argued that the first prong of the test for inducing infringement was not met because of an implied license. The patent at issue was directed to dosing regimens for treating schizophrenia that included two loading doses followed by monthly maintenance doses. Pharmascience did not provide maintenance doses, only Janssen did. Pharmascience argued that the purchase of the maintenance doses from Janssen provided an implied license covering any activity using Pharmascience’s product for the two loading doses that would fall within the scope of the patent. The Federal Court of Appeal rejected Pharmascience’s argument and held that the sale of a component of a patented invention did not grant an implied license to use the entire invention.
In Apotex Inc v Janssen Inc, 2024 FCA 9, the Federal Court of Appeal confirmed that the second prong of the test for inducing infringement can be characterized as a “but for” test, or a “would not have occurred without” test. This appears to contrast with a decision of a different panel of the Federal Court of Appeal last year (Teva Canada Limited v Janssen Inc, 2023 FCA 68) that held that “but for” causation is not required in the second prong of the test. It remains to be seen how courts will reconcile these two seemingly contrasting decisions.
Pharmascience and Apotex’s applications for leave to appeal to the Supreme Court of Canada were dismissed on June 27, 2024 (Supreme Court files 41162 and 41164). For a further discussion of the Federal Court of Appeal’s decisions, please see our article, “FCA upholds inducement of infringement findings relating to paliperidone palmitate”.
11. Remedies: Federal Court of Appeal considers whether prosecution delays can be relevant to refusing an accounting of profits
In 2022, the Federal Court considered, in obiter, whether delays in prosecution can be a relevant consideration in determining whether a patentee is entitled to elect an accounting of profits, an equitable remedy (see, Rovi Guides, Inc v Videotron Ltd, 2022 FC 874 and Rovi Guides, Inc v Bell Canada, 2022 FC 1388).
In Rovi Guides Inc v Videotron Ltd, 2024 FCA 125, the Federal Court of Appeal took the opportunity to address some of the Federal Court’s observations on remedies, finding that the Federal Court erred in finding certain aspects of Rovi’s conduct, including (1) a failure to specifically identify for Videotron which claims in the patents in suit were being infringed; (2) Rovi’s practice of licencing and firmly defending its patents; (3) Rovi declining to send a cease and desist letter, provided a basis for denying the requested accounting of profits. Notably, on the issue of “patent hold-up”, the Court did not completely reject the possibility that delays could be relevant, stating:
As for the length of time that it took Rovi to prosecute the Patents before the Patent Office, I would not completely foreclose the possibility that this sort of delay could be relevant to refusing an accounting of profits. If there were ever a basis to determine that a plaintiff had unclean hands in seeking to extend the prosecution time to allow a defendant to accumulate profits that the plaintiff would then obtain, such conduct could well be found to be so inequitable as to disentitle the plaintiff to an accounting of profits. The problem though, in the present case, is that the Federal Court had no evidence about normal practice and delays typically seen before the Patent Office, nor about Rovi’s motives in prosecuting the Patents the way it did.
See, also, Rovi Guides Inc v Telus Corporation, 2024 FCA 126.
12. Federal Court considers first application for judicial review regarding the “due care” standard
On October 30, 2019, the Patent Act and Patent Rules were amended to bring the Patent Law Treaty (PLT) into force in Canada. The most consequential changes have proven to be the handling of missed maintenance fee payments, requiring in some instances a showing of “due care” by the applicant or patentee to excuse a missed maintenance fee payment. We wrote about the due care standard and analyzed several decisions of the Patent Office in our article, “Canadian patents: Establishing “due care” after failure to pay a maintenance fee”. Taillefer v Canada (Attorney General), 2024 FC 259 is the first decision by the Federal Court on an application for judicial review of a decision by the Commissioner of Patents to refuse to reverse the deemed expiry of a patent.
The Patentee and their Canadian agent had successfully communicated by email for close to 10 years. However, unbeknownst to either party, all correspondence related to the 2020 maintenance fee deadline was caught by the Patentee’s spam filter. The maintenance fee was therefore not timely paid.
The Federal Court dismissed the application for judicial review, finding that it was reasonable for the Commissioner to have looked at steps that could have avoided the communication failure; to expect the Patentee to ensure that their email was working effectively; to expect that the agent would have had back-up mechanisms in place to ensure that they could contact the Patentee; and to expect that the agent would have implemented these back-ups in the circumstance, where the lack of a response to their numerous emails was inconsistent with prior experience.
Taillefer has appealed the decision (Federal Court of Appeal file A-103-24).
13. Federal Court considers first application for judicial review of a decision by CPATA
The College of Patent Agents and Trademark Agents (CPATA) was established by statute enacted in 2018 to regulate patent and trademark agents, with responsibilities for licensure officially transferred to CPATA on June 28, 2021. Olkowski v College of Patent Agents and Trademark Agents, 2024 FC 1331 is the first decision by the Federal Court concerning a complaint against a patent agent.
A patent application was filed naming a corporate assignee as the applicant in the usual course. An inventor who had executed an assignment in favour of the corporate applicant subsequently contested inventorship and ownership, complained to the patent agent acting on behalf of the corporate applicant, sought a remedy from CIPO, and brought an action in an Alberta court, which was later discontinued. A complaint by the inventor to the Law Society of Alberta was dismissed, the Law Society finding no solicitor-client relationship between the lawyer/agent and the inventor. The inventor’s complaint to CIPO was transferred to CPATA after it was established. CPATA dismissed the complaint, finding that the evidence did not support the complainant being a client of the patent agent, or that the patent agent owed the complainant duties as if he were a client.
The Federal Court dismissed the inventor’s application for judicial review of CPATA’s decision, finding CPATA’s conclusion that the inventor was not the client of the patent agent was reasonable.
Notably, an issue discussed at length in the Federal Court decision is unlikely to arise in the future. At the relevant time, US patent law required the inventor to be named as the applicant in a US patent application, even if the inventor did not own the invention. Consequently, the inventor had executed a PCT Power of Attorney form in favour of the patent agent’s law firm, in contemplation that the inventor would be named as an applicant in any subsequent US national phase application, as required by law. The inventor cited the PCT Power of Attorney as evidence of a client relationship with the agent. However, pursuant to the America Invents Act, as of 2012, a corporate assignee may be named as the patent applicant in a US patent application instead of the inventor, and a Power of Attorney executed by the inventor is not required.
14. Patented Medicine Prices Review Board (PMPRB): Federal Court of Appeal confirms that the jurisdiction of the PMPRB does not extend to unpatented medicines
The PMPRB is a quasi-judicial body established by the Patent Act,tasked with regulating excessive pricing of patented medicines. The PMPRB has jurisdiction where an invention pertains to a medicine. What it means for an invention to pertain to a medicine is defined in subsection 79(2) of the Patent Act. Long standing jurisprudence has established that the nexus between the patent and the medicine could be “one of the merest slender thread” (ICN Pharmaceuticals Inc v Canada (1996), 119 FTR 70, 138 DLR (4th) 71 (FCA)). However, more recently, the Federal Court of Appeal has cautioned that the language “one of the merest slender thread” cannot replace the statutory definition of “pertains to” in subsection 79(2) of the Patent Act (Canada v Galderma Canada Inc, 2019 FCA 196).
In Galderma Canada Inc v Canada (Attorney General), 2024 FC 46, the Federal Court found that the Board did not err in requiring Galderma to provide information on an unpatented medicine, as there was a patent directed to a different medicine that had clinical similarities with the unpatented medicine. The decision was overturned in Galderma Canada Inc v Canada (Attorney General), 2024 FCA 208, with the Federal Court of Appeal holding that the PMPRB can only regulate the pricing of patented medicines.
For a further discussion of the Federal Court of Appeal’s decision, please see our article, “FCA sets aside PMPRB’s order that Galderma’s patent claiming 0.3% adapalene “pertained to” 0.1% adapalene DIFFERIN”.
15. Patent Register: Federal Court provides guidance regarding listing eligibility
Subsection 3(2) of the Patented Medicines (Notice of Compliance) Regulations requires the Minister of Health to “maintain a register of patents that have been submitted for addition to the register and certificates of supplementary protection in which any of those patents are set out”. There are benefits for a patentee in having a patent listed on the Patent Register, such as potential entitlement to a 24-month statutory stay preventing Health Canada from granting regulatory approval to a generic or biosimilar product during litigation of the patent. However, there are a number of requirements that must be met before a patent can be added to the Patent Register, including eligibility requirements related to the claims of the patent.
In Bayer Inc v Amgen Canada Inc, 2024 FC 1849, the Court granted a motion brought by Amgen for a declaration that Canadian Patent No. 3,007,276 was ineligible for inclusion on the Patent Register. Eligibility was assessed based on a single claim which, when considered together with the claims from which it depends, claimed:
Aflibercept for treatment of wet macular degeneration in a subject, wherein the aflibercept is formulated for intravitreal administration to the subject in an amount of about 2 mg quarterly, and wherein the subject has at least one of the following single nucleotide polymorphisms (“SNP”): rs2056688, rs5962084, rs5962087, rs5915722, rs5962095, and rs1405303, and the subject was previously treated with a 2 mg dose of aflibercept every 4 weeks for about one year.
In finding that the 276 patent was ineligible for listing, the Court accepted Amgen’s argument that because the claim requires knowledge and consideration of the patient’s SNP status in making treatment decisions while the change in use approved by the NOC in response to the relevant SNDS is divorced from any consideration of the patient’s genetics, the claim does not claim the change in use approved by the NOC issued in response to the SNDS.
Further details regarding the Federal Court’s decision can be found in our article, “Federal Court finds patent ineligible for listing against SNDS”.
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