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...
