2024 saw the introduction of proposed patent-term adjustment, the Supreme Court granting leave to appeal to consider the patentability of methods of medical treatment, and various decisions from the Canadian Courts.

Notable developments from 2024 in Canadian patent law are summarized in this article.

Patentees are entitled to equitable remedies in the absence of compelling reasons to the contrary

In 2022, the Federal Court dismissed Rovi’s action for patent infringement against Videotron (discussed here). Rovi had asserted infringement of four different patents related to interactive television program guide technology.

In 2024, the FCA dismissed Rovi’s appeals of lower court decisions (see 2024 FCA 125, and 2024 FCA 126 for a related case). Notwithstanding that issues related to remedies were not in play because there was no liability for patent infringement, the FCA commented on the availability of certain equitable remedies in response to the lower Court’s comments on remedies.

In particular, a court should start from the premise that a successful patentee is entitled to an accounting of a defendant’s profits unless there are sufficient compelling reasons to deny the remedy. In addition, a plaintiff can generally expect to receive injunctive relief where a valid patent has not expired and has been infringed. The foregoing may include situations where a patentee is in the business of licensing its invention or where a patent is close to expiry.

Methods of medical treatment coming to the Supreme Court of Canada

The patentability of methods of medical treatment in Canada has confounded the Courts and commentators for many years. In early 2024 the Federal Court of Appeal (FCA) released its decision in Pharmascience v Janssen, 2024 FCA 23, which upheld various patent claims that were alleged to be unpatentable as methods of medical treatment.

As discussed in our analysis of this decision, the FCA decision addressed the history and statutory basis of the method of medical treatment exception, its applicability to different claim types, and the specific application of the exception to claims covering dosage regimens.

Pharmascience sought leave to appeal to the Supreme Court of Canada (SCC), with its leave application asking two principal questions: (1) what (if any) is the basis for the method of medical treatment exception to patentability? and (2) what is the definition of what constitutes an unpatentable method of medical treatment? Leave was granted to Pharmascence in September, 2024, SCC case number 41209. A hearing is expected in 2025.

Coming into force of patent term extension

For any patents issued after December 1, 2025, patentees may be able to apply for patent term extension. However, the circumstances in which an extension will be granted are limited.

In order to qualify, applications must be filed within three months of patent issuance, a $2,500 application fee must be paid, and any additional term will run concurrently with any applicable Certificate of Supplementary Protection (CSP) (see here and here for further discussion on CSPs).

In addition, to be eligible patents must have been filed after December 1, 2020 and issued after the later of five years from engagement with CIPO (i.e., filing date, national entry date or presentation date for divisional applications) or three years from request for examination. Delays caused by the applicant will be deducted against any delays caused by CIPO, such that the situations in which a patent may successfully qualify for an extension may be limited. See here for further comments.

Federal Court of Appeal confirms inducement of infringement decisions

The decisions in 2024 FCA 9 and 2024 FCA 10 both affirm trial level decisions in which the generic manufacturers Apotex and Pharmascience were found to infringe a Janssen patent covering the use of paliperidone palmitate for the treatment of schizophrenia. Both infringement findings were based on the generics inducing infringement.

The primary issue in the Apotex appeal related to the second prong of the inducement analysis, whether the inducer influenced the third-party direct infringer to the point that the infringing act would not have occurred without the influence. The decision below had found that patients would receive the claimed dosage regimen as a result of referencing the Apotex product monograph, and that the Apotex product monograph included recommendations to prescribers for use of the claimed dosage regimen. Apotex argued that its monograph was essentially a copy of Janssen’s, and thus that prescribing practices of physicians would not change if Apotex were allowed to market its generic version of paliperidone palmitate.

This was dismissed by the FCA, with the following passage demonstrating its reasoning:

“The main weakness of [Apotex’s] argument is that it depends on there being a requirement that prescribing practices of physicians be altered because of Apotex’s activities. In fact, this is not necessary. What is required is that the ultimate act of direct infringement occur because of Apotex’s activities.”

Pharmascience’s appeal focused on the first branch of the inducement test, i.e. the existence of direct infringement by a third party. Some explanation of the factual matrix is necessary to understand the issue. The patent at issue claimed a dosage regimen that included 50, 75, 100 and 150 mg doses, and combinations thereof, in different situations. Pharmascience did not provide a 75 mg dose, which was an element of each patent claim.

Pharmascience argued that any 75 mg dose would be provided by Janssen, not Pharmascience, and thus there was an implied license and there could be no direct infringement. In dismissing this position, the FCA held that there was no reason to conclude that the sale of the 75 mg dose by Janssen would have been understood to constitute a license to use the entire claimed dosage regimen.

Scope of PMPRB jurisdiction clarified in Galderma v Canada

A late 2024 decision of the FCA (2024 FCA 208) overturned a decision from earlier in the year (2024 FC 46) pertaining to PMPRB jurisdiction over Galderma’s DIFFERIN product. The FCA’s decision clarifies the boundaries of the PMPRB’s jurisdiction, making clear that the Board cannot regulate the pricing of unpatented medicines.

Galderma marketed both DIFFERIN (0.1% adapalene) and DIFFERIN XP (0.3% adapalene). Galderma’s DIFFERIN patents expired in 2009, with a DIFFERIN XP patent expiring in 2016. The PMPRB sought pricing information regarding DIFFERIN from 2010 through 2016, asserting jurisdiction through the DIFFERIN XP patent. The FCA leaned on “Decades of consistent jurisprudence from multiple jurisdictions” which confirmed that “the Board can regulate the pricing of patented medicines, not unpatented medicines,” and that “the Board does not have any freestanding consumer protection or general price regulation mandate.”

In ordering that Galderma provide pricing information regarding DIFFERIN from 2010-2016, the PMPRB was said to have “crashed through the constitutional, statutory and jurisprudential guardrails.” The FCA set aside the PMPRB’s order seeking pricing information from Galderma regarding DIFFERIN.

Infringement based on “use” requires actual physical use

In Steelhead LNG (ASLNG) Ltd v Arc Resources Ltd, 2024 FCA 67, the FCA addressed the issue of what activity constituted an infringing “use” of a patented invention related to a liquefied natural gas (LNG) facility. The appellant (patentee) had argued that the respondent’s sharing of engineering drawings, specifications, and cost estimates for an LNG design, which, if ever built, would infringe the patent in suit, constituted an infringing “use.”

In dismissing the appeal, the FCA stated that the actual invention – such as a claimed physical apparatus or system—must actually be used for there to be infringement, though the appellant may have recourse under other forms of intellectual property (e.g., copyright).

In addition to having its infringement claim dismissed in the above-noted appeal, the plaintiff was also unsuccessful on the issue of patent validity. In Steelhead LNG (ASLNG) Ltd v ARC Resources Ltd, 2024 FCA 212, the FCA agreed with the trial judge’s findings of anticipation and obviousness. Of note, the FCA reaffirmed the principle that if a piece of prior art discloses a limited number of options for a thing, each of those options is disclosed for the purpose of novelty.

In addition, the FCA reaffirmed that there is no single or mandatory approach in the obviousness inquiry; a lower court has discretion as to which considerations it may consider to be relevant in a particular obviousness analysis.

Liability of US parent company for patent infringement in Canada

In Munchkin, Inc v Angelcare Canada Inc, 2024 FCA 156, the FCA upheld the lower Court’s finding that a US parent company to an infringing Canadian subsidiary was also liable for patent infringement. In particular, the FCA stated that “to infringe a Canadian patent, infringing activities must take place in Canada.

However, a person cannot avoid liability for infringement by setting itself up outside Canada, and then making arrangements from there that result in infringement of a patent in Canada. The key is whether the infringing activities took place (they did in this case), and whether the person located outside Canada (here, Munchkin, Inc.) made itself liable therefor, either by having common cause with a Canadian actor (Munchkin Canada) or otherwise being a party to the infringement.”

In addition to upholding the above finding of infringement as against the US parent company, the FCA also upheld the validity of the patents in suit when it found that an inventor’s disclosure of the subject matter of an invention to a prototype manufacturer was not an invalidating disclosure, as there is a presumption of an obligation of confidence owed by a manufacturer of articles to its client.

No Trademarks Act liability for assertion of patent ultimately found to be invalid

Under section 7(a) of the Trademarks Act, no person shall make a false or misleading statement tending to discredit the business, goods or services of a competitor. A number of cases in Canada have found that in certain circumstances a notice of infringement or cease and desist letter may create liability on the part of a patentee if ultimately the patentee’s infringement claim is unsuccessful.

In Valley Blades Ltd v Usinage Pro-24 Inc (Nordik Blades), 2023 FC 1749, the Court found the patentee’s patent claims to have been obvious, but declined to find the patentee liable under section 7(a) of the Trademarks Act in respect of letters from the patentee to the accused infringer’s customers alleging infringement and threatening legal action.

In this regard, the Court found that the evidence at trial did not demonstrate that the accused infringer’s customers had a “bad impression” of the accused infringer as a result of the letters, or that the letters tended to discredit the product or business of the accused infringer.

Federal Court finds no infringement and invalidates patent claims based on ground of overbreadth

In Proslide v Whitewater, 2024 FC 1439 the Federal Court found that none of WhiteWater’s water slide products infringed Proslide’s four patents, that three patents were invalid for overbreadth, and the asserted claims for the remaining patent were invalid for either anticipation, obviousness, or inutility.

With respect to infringement, the Court established that WhiteWater’s activities in Canada such as creating designs and mechanical specification drawings did not constitute “making” the claimed invention under the Patent Act, where the invention as claimed was for a physical object. None of the products were physically manufactured, assembled, or used in Canada.

In considering overbreadth, the Court relied on inventor and expert evidence and found that each asserted claim lacked at least one key element that had a material effect on the invention made or contemplated by the inventor.

Federal Court finds obviousness a full defense to infringement

In Medexus v Accord, 2024 FC 424 the Federal Court dismissed Medexus and medac’s patent infringement claim after finding the asserted claims to be obvious. The patent at issue concerned injectable concentrated formulations of methotrexate used for treating inflammatory autoimmune diseases. Accord conceded infringement but counterclaimed based on various invalidity grounds.

With respect to the determinative issue of obviousness, the Court accepted Accord’s evidence that every claim’s concentration element is the overall inventive concept, and found that the skilled person would not view the changing concentration in each asserted claim as a big step to differentiate between the state of the art. While it was not necessary to address the other invalidity grounds, ambiguity was addressed in more detail because, inter alia, it overlapped with claim construction.

With respect to the alleged ambiguity of certain asserted claims containing the term “about 50 mg/mL,” the Court found that the lack of an exact numerical range in this case did not render the claims ambiguous, and the word “about” did not change the nature of the claim from the skilled person’s perspective.

Federal Court decision finding selective herbicide patent valid upheld on appeal

In Agracity Crop v Upl Na Inc et al, 2024 FCA 133, the FCA dismissed Agracity’s appeal of inter alia the obviousness and anticipation finding from the underlying liability decision (2022 FC 1422) concerning a patent protecting the selective herbicide flucarbazone sodium.

The FCA reiterated the “high bar” for the disclosure requirement of anticipation and found that Agracity’s two asserted genus patent prior art publications did not meet the high bar as they did not identify flucarbazone sodium as one of the herbicides with selective properties, did not contemplate the selective properties of herbicides as a result of their chemical structures, and did not disclose the use of herbicides on the crops claimed in the patent at issue.

Regarding obviousness, the FCA rejected Agracity’s assertion that the underlying decision considered the inventive concept of the patent as a whole, instead of on a claim-by-claim basis.

FCA upholds overbreadth and insufficiency decision based on construction of “physiologically acceptable salt”

The FCA in Eli Lilly v Apotex, 2024 FCA 72 was tasked with considering a decision of the Federal Court in which claims to the use of compounds and “physiologically acceptable salts and solvates thereof” in the treatment of disease were found to be invalid for overbreadth and insufficiency.

The Federal Court had held that the claimed physiologically acceptable salts must be stable, pure, and non-toxic, and relied on evidence that pure and stable salts of the compound at issue (tadalafil) could not be made by a skilled chemist at the relevant date. To the Federal Court, this rendered the claims overly broad and insufficient.

The FCA characterized the issue as one of mixed fact and law, characterizing the “real question” on appeal being the trial court’s decision to give weight to one of Apotex’s expert witness, and thus subject to the palpable and overriding error standard. With no allegation by the appellants of any palpable and overriding error, the appeal was dismissed.

Dismissal of infringement action based on lack of ownership evidence

A majority of the FCA in Mud Engineering Inc v Secure Energy Services Inc, 2024 FCA 131 dismissed an appeal from a summary trial decision of the Federal Court (2022 FC 943) where each side was claiming ownership of the patents in suit.

The lower Court had found that there was insufficient evidence to find either party was the owner, and so dismissed the pending action and counterclaim. In upholding this outcome, the FCA noted that it was not absurd for there to be no declaration of ownership in favour of either party, as courts do not declare that someone owns property unless they are satisfied they have the factual and legal bases to make that declaration.

In this case, both of the parties fell short of the mark.

Rare invalidation of patent claims based on ambiguity

In Tekna Plasma Systems Inc v AP&C Advanced Powders & Coatings Inc, 2024 FC 871, which was an impeachment action with an accompanying counterclaim for infringement, the Court found that all claims of one patent and most of the claims of another patent were invalid for ambiguity. As the Court noted, there is a “general disinclination to find a patent claim ambiguous.”

However, in this case, the Court found that it was:

“[I]mpossible 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.”

Federal Court decision finding infringement of Crocs industrial design upheld on appeal

In 2022, the Federal Court found in favour of the Plaintiff Crocs in an action for infringement of an industrial design (similar to a design patent in the United States) pertaining to its MAMMOTH products. In particular, the Court upheld the validity of the design, found that the Defendant, Double Diamond Distribution, infringed the design, and ordered an accounting of Double Diamond’s profits.

The underlying decision clarified various matters of industrial design law in Canada. An appeal of this decision was heard and dismissed in 2024 (2024 FCA 204), discussed here.

Interlocutory decisions—non-PM(NOC) Regulations.

This year saw numerous interlocutory decisions that relate to matters being litigated outside of the PM(NOC) Regulations.

There were notable decisions concerning discovery obligations. Following Justice Zinn’s dismissal of both parties’ requests for summary judgement (2023 FC 20, discussed here) Meridian Manufacturing v Concept Industries, 2024 FC 604 concerned Meridian’s motion for various discovery-related relief. As a result of Concept’s breach of its documentary discovery obligations by its late production of relevant documents, the Court ordered Concept to pay costs “thrown away as a result of the late production of documents” and costs associated with the necessary continued discovery of Concept’s corporate representative.

Concept was also ordered to particularize the parts of each piece of prior art it relied on for each of its invalidity defences. Meridian’s request for a substitute corporate representative was denied, without prejudice to its ability to seek substitution if it turned out that Concept’s corporate representative is an inappropriate witness.

In Adeia Guides v BCE, 2024 FC 927, the Court did not grant Adeia’s request for a further and better affidavit of documents. Adeia’s inferences were “predicated largely on search terms and answers on examination for discovery of the Defendants” was not persuasive enough evidence that further relevant documents likely existed. The Associate Judge’s Order was upheld in the 2024 FC 1471 Rule 51 appeal.

There were also three decisions involving Adeia Guides and BCE related to pleading amendments.

  1. In 2024 FC 942, Adeia was partially successful in amending its pleading with respect to naming additional vendors as contributors to infringement. It was unsuccessful in adding additional components of alleged infringing systems to its claim because there were “no particulars provided beyond the pleading” and no material facts.
  2. This decision was upheld on appeal in 2024 FC 1470, where the Court reiterated that the Defendants are “entitled to know the case they have to meet” but recognized that the Plaintiffs were not “precluded from trying again with reformulated amendments.”
  3. The Court subsequently granted the Defendants’ motion to add additional prior art to their pleading in 2024 FC 1842 after finding that the proposed amendment goes to the invalidity issues already pled and finding no evidence of prejudice.

In Impulse v Challenger, 2024 FC 1600, the Court adjudicated the parties’ disagreements on Protective Order terms. Impulse met its burden to designate its technical and financial documents as “SEO” because it treated that information as confidential at all relevant times and demonstrated that there is a serious threat to its interests since the parties were competitors in a small market, and the dispute involved intellectual property.

The Court found it unreasonable to permit an alleged inventor to be able to see Impulse’s technical documents from the action, as he was a “prolific inventor and operates in a small, specialized area in direct competition with Impulse” and not a party to the action. The Court also found that Impulse failed to lead evidence to support a limit to the number of individuals that may view the confidential information, and granted Challenger’s request for four delegates.

In Seismotech IP v Ecobee, 2024 FCA 144, the FCA upheld the underlying decision (2023 FC 1335, discussed here) for the manufacturer of the alleged infringing products, Ecobee, to be added as a defendant on its own motion. The Court held that the Motion Judge was correct in law and made no palpable and overriding error in applying Rule 104(1)(b).

In Pfizer v uniQure, 2024 FC 1089, the Court dismissed Pfizer’s motion for an elevated lump sum award calculated at 50% of actual fees plus disbursements as the discontinuing party of the patent impeachment action involving uniQure’s patent. The Court rejected Pfizer’s position that uniQure’s dedication of its patent to the public deemed Pfizer the successful party in the action, as there was no adjudication on the merits of the case.

Regarding quantum, the Court found that Pfizer’s request for elevated costs of 50% of $753,846.04 incurred prior to examinations for discovery was unjustified and was “troubled” by the lack of sufficient detailed evidence of fees actually incurred, the quantum claimed under each phase, and the phases themselves. The Court found if costs were appropriate, they were to be calculated under the Tariff.

Interlocutory PM(NOC) decisions and other decisions related to the PM(NOC) Regulations

Various decisions were released that pertain to practice specifically under the PM(NOC) Regulations. Some of these are discussed below.

Two decisions involving Pharmascience and Janssen related to production obligations in section 8 proceedings. In Pharmascience v Janssen, 2024 FC 335 the generic manufacturer sought production of settlement agreements that it believed Janssen to have entered into with other generic manufacturers in settling their respective section 8 cases. This motion was denied, with the settlement agreements being protected by settlement privilege. The second motion, Pharmascience v Janssen (2024 FC 440), was an appeal of an interlocutory order requiring the plaintiff in a section 8 proceeding to produce its financial statements. The appeal was unsuccessful, and the financial statements were required to be produced.

EMD Serono v Apotex, 2024 FC 820 pertained to whether Apotex could maintain the “date completed” information in Apotex’s Acknowledgement and Certification of Information Received related to its generic drug submission as confidential. The Court ruled that this information was not confidential.

In the same underlying action, EMD Serono sought a judicial review (2024 FC 1848) of the Minister’s decision to list EMD Serono’s patent on the register on the date it was found to be eligible for listing (one week after submission), and sought for the patent to be added to the register date at the date of submission, or alternatively, the date of the Minister’s preliminary eligibility analysis conducted five days after submission.

In the interim period between the Minister’s preliminary analysis and listing of EMD Serono’s patent on the Register, Apotex submitted its Form Vs without addressing EMD Serono’s patent that was listed one day later. The Federal Court found that the Minister’s interpretation of the Regulations was not unreasonable, and that Apotex was not obliged to address EMD Serono’s patent. This decision is currently under appeal in A-398-24.

In Samsung v Janssen, 2024 FC 1715, the Defendant unsuccessfully sought to add a counterclaim. The action sought the impeachment of a patent covering the biologic medicine STELARA. Months after the action was commenced, the biosimilar was granted its Notice of Compliance by Health Canada, and the at-issue motion to add an infringement allegation via counterclaim was brought. The motion was denied for being insufficiently particularized and not disclosing a reasonable cause of action.

Bayer v Amgen, 2024 FC 1849 is the first decision under the “new” (i.e. post-2017) PM(NOC) Regulations pertaining to a challenge to the listing of a patent in ongoing subsection 6(1) proceedings. The Court de-listed Bayer’s patent, finding a “mismatch” between the patent claim being considered and the approved use of the medicine. The decision is under appeal.