Canadian Patent Law 2021: A Round-Up Of Interesting Developments And Court Decisions

• Published date: 27 January 2022
• Subject Matter: Intellectual Property, Litigation, Mediation & Arbitration, Patent, Trials & Appeals & Compensation
• Law Firm: Smart & Biggar
• Author: Mr David Schwartz, Nicole Boyle, Skylar Yoo, Robert Baker and Ryan Wong

2021 saw changes in Canadian patent legislation, and a variety of court decisions addressing rarely interpreted provisions of the Patent Act, early consideration of recently enacted provisions, and new takes on central tenets of patent law.

In this article, we highlight statutory changes and a selection of the most interesting patent cases reported in the 2021 calendar year.

We also recently published our review of 2021 Canadian Trademark Law developments, and in our RxIP Update we looked back on Highlights in Life Sciences IP and Regulatory Law.

College of Patent Agents and Trademark Agents Act

Most professions fall under provincial jurisdiction, and many have been self-regulated for years (e.g. lawyers and physicians). But patent and trademark law are matters of federal jurisdiction, and there is little experience with regulation of professions at the federal level. Historically, patent and trademark agents were qualified for practice pursuant to provisions of the Patent Act and Trademarks Act, under the oversight of the Canadian Intellectual Property Office (CIPO). Beyond initial qualification and annual renewal fees, there were no requirements for liability insurance, continuing education, compliance with a code of conduct, or the like.

This changed last year when the College of Patent Agents and Trademark Agents Act came into force on June 28, 2021, modernizing the patent and trademark agency professions. The Act establishes the College of Patent Agents and Trademark Agents (CPATA) to regulate the patent and trademark agent profession, including maintaining the registers of agents, administering agent qualifying examinations, collecting College fees, maintaining an agent code of conduct, establishing requirements for professional liability insurance, and establishing formal complaint, investigation, and discipline processes. For more information, visit the CPATA website.

Patentable Subject Matter - Patent Act Section 2

Apotex Inc v Janssen Inc, 2021 FCA 45

The Federal Court of Appeal dismissed Apotex's appeal of a Federal Court decision that prohibited the Minister of Health from granting a Notice of Compliance to Apotex. The patent at issue was Canadian Patent No. 2,661,422, concerning treatment of prostate cancer with the combination of abiraterone acetate and prednisone.

In addition to attacking the validity of the patent on the basis of obviousness, Apotex asserted that the claimed combination was unpatentable because it did not possess "synergy" ' i.e. the result of the whole being different than the sum of the result of the components. In the absence of synergy, there would be no patentable combination providing a "unitary result" but rather an unpatentable aggregation of elements.

If this is not a matter of novelty or obviousness, such an assertion is presumably grounded in section 2 of the Patent Act which defines the term "invention" as "any new and useful art, process, machine, manufacture or composition of matter" or improvement thereof. Something that does not fall with the definition of "invention" cannot be patented.

The Federal Court of Appeal upheld the Federal Court's findings of unobviousness and that the claimed combination achieves results in the treatment of prostate cancer that are not achieved with either drug alone. On the latter point, the Court stated that the key consideration should be whether the combination offers something that was not already available to the public. As both challenges to the patent were dismissed, the Court did not decide whether a claimed combination could be found unobvious yet nevertheless fail to constitute patentable subject matter falling within the definition of "invention." See our article about the decision in Apotex Inc v Janssen Inc.

Hoffmann-La Roche Limited v Sandoz Canada Inc, 2021 FC 384

Canada has no statutory exclusion of methods of medical treatment from subject matter eligibility (cf. Article 53(c) of the European Patent Convention). Moreover, the seminal 1974 Supreme Court of Canada decision on this issue was based on a provision of the Patent Act requiring claims to medicines to be made only in a product-by-process form that has been repealed for many years. But a prohibition on patenting methods of medical treatment lives on in Canada.

Claims directed to "uses" are nevertheless generally permitted. Such claims can still be found to constitute an unpatentable method of medical treatment, particularly when directed to a so-called "dosage regimen," the issue being whether they "encroach on the skill and judgment" of a physician. The issue arises daily in patent prosecution practice before CIPO.

There are relatively few court decisions on the issue, and each case in this area warrants study.

Here, Canadian Patent Nos. 2,667,654 and 2,709,997 were found to be invalid as impermissibly claiming a method of medical treatment among other reasons. See our article about the decision in Hoffmann-La Roche Limited v Sandoz Canada Inc.

Privileged Communications - Patent Act, Section 16.1

Janssen Inc et al v Sandoz Canada Inc, 2021 FC 1265

Section 16.1 of the Patent Act came into force on June 24, 2016, establishing privilege in communications between patent agents and their clients. Corresponding amendments were made to the Trademarks Act to establish privilege in communications between trademark agents and their clients. The privilege established in section 16.1 is limited to communications "made for the purpose of seeking or giving advice with respect to any matter relating to the protection of an invention."

The Federal Court held that section 16.1 does not apply to a patent agent's advice as to whether certain compounds were outside the scope of claims of patent rights owned by a third party. The phrase "relating to the protection of an invention" in section 16.1 of the Patent Act does not extend to an analysis as to whether a product infringes third party patent rights, and the legislature did not express an intention to attach privilege to any and all communications between patent agents and their clients.

This case appears to raise significant questions as to whether privilege attaches to validity and infringement advice provided by agents rather than only advice relating to preparation and prosecution of patent applications.

Overbreadth - Patent Act Section 27(3) and 27(4)

Seedlings Life Science Ventures, LLC v Pfizer Canada ULC, 2021 FCA 154

Can a clear and definite patent claim directed to patent-eligible subject matter that is novel, unobvious, and fully described and enabled by the specification...