College of Patent Agents and Trademark Agents Act
Patentable subject matter
This article is the first article in a series that highlights statutory changes and a selection of the most interesting patent cases reported in 2021.
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.
See also a review of the key Trademark Law developments in Canada and a look back at life sciences IP and regulatory law highlights in 2021.
College of Patent Agents and Trademark Agents Act
Most professions fall under provincial jurisdiction, and many have been self-regulated for years (eg, 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 28 June 2021, modernising the patent and trademark agency professions. The Act established 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.
Apotex Inc v Janssen Inc
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.(1) The patent at issue was Canadian Patent No. 2,661,422, concerning the 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" – that is, the result of the whole being different from 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 within the definition of "invention" cannot be patented.
The Federal Court of Appeal upheld the Federal Court's findings of unobviousness and stated that the claimed combination achieved results in the treatment of prostate cancer that were 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". For further details about this case, see "Federal Court of Appeal affirms prohibition order against Apotex regarding abiraterone".
Hoffmann-La Roche Limited v Sandoz Canada Inc
Canada has no statutory exclusion of methods of medical treatment from subject matter eligibility (see 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 the 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.(2) For further details about this case, see "Federal Court dismisses Roche's PMNOC Regulations actions against Sandoz re: pirfenidone".
Janssen Inc et al v Sandoz Canada Inc
Section 16.1 of the Patent Act came into force on 24 June 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(3) appears to raise significant questions as to whether privilege attaches to validity and infringement advice provided by agents rather than only advice relating to the preparation and prosecution of patent applications.
Seedlings Life Science Ventures, LLC v Pfizer Canada ULC
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 nevertheless fail for "overbreadth"? Stated differently, can a claim that complies with the express requirements for patentability set out in the Patent Act nevertheless be invalid if it somehow is "broader than the invention made"? The singular 1986 Amfac decision appears to answer this question in the affirmative, albeit on unusual facts, and the Seedlings decision may provide some further support.
The Federal Court of Appeal dismissed an appeal of a Federal Court decision finding that certain claims of Seedlings' LifeCard patent, Canadian Patent No. 2,486,935, were invalid and not infringed by Pfizer's next-generation EpiPen.(4) The Court maintained that all relevant claims of the patent were invalid on grounds of overbreadth and that some claims were anticipated and obvious, and further found that the Federal Court should have concluded that the relevant claims were invalid for insufficiency. Notably, the Federal Court of Appeal also maintained that overbreadth is indeed a proper and distinct ground of invalidity that must be considered separately.
The Court held that the doctrine of "overbreadth" finds statutory basis in the combined application of subsections 27(3) and 27(4) of the Patent Act. Subsection 27(3) requires the specification to, among other things, "correctly and fully describe the invention and its operation and use" and describe the invention in terms that "enable any person skilled in the art . . . to make, construct, compound, or use it". Subsection 27(4) provides that "[t]he specification must end with a claim or claims defining distinctly and in explicit terms the subject-matter of the invention for which an exclusive privilege or property is claimed". But given that the Court held that the relevant claims were invalid for insufficiency alone (ie, non-compliance with the description and enablement requirements of subsection 27(3)), this case still does not demonstrate conclusively that claims can fail exclusively for "overbreadth." For further details about this case, see "Federal Court of Appeal upholds decision finding Seedlings' LifeCard patent invalid and not infringed by Pfizer's EpiPen".
Western Oilfield Equipment Rentals Ltd v M-I LLC
Paragraph 27(3)(c) of the Patent Act provides that the specification of an invention must "in the case of a machine, explain the principle of the machine and the best mode in which the inventor has contemplated the application of that principle". This seemingly limits the requirement to disclose the inventor's best mode for practising an invention to inventions concerning machines. This can be contrasted to the corresponding US best-mode requirement in 35 US Code section 112(a), more broadly requiring disclosure of "the best mode contemplated by the inventor or joint inventor of carrying out the invention". The best-mode requirement does not arise often in Canadian patent matters.
Dismissing Western Oilfield's appeal of a Federal Court decision finding that certain claims of Canadian Patent No. 2,664,173 were valid and had been infringed, the Federal Court of Appeal noted that there is "considerable doubt" as to whether, despite the wording of paragraph 27(3)(c) of the Patent Act, the best-mode requirement is limited to machines.(5)
Apotex Inc v Shire LLC
Much has been written on the patentability of a "selection" invention, in which a particular compound or group of compounds is claimed from within a larger grouping of compounds previously disclosed in general terms and claimed in an earlier genus patent.
The Federal Court of Appeal dismissed an appeal by Apotex from a Federal Court decision holding that the claims of Canadian Patent No. 2,527,646 were valid and prohibiting a notice of compliance from being issued by the Minister of Health to Apotex until the expiry of the patent.(6)
The Court affirmed that the validity analysis does not change depending on whether a patent is classified as a selection patent. While characterising a patent as a "selection" invention may assist the court in understanding "the nature of the beast", the focus of the anticipation and obviousness analysis remains on what the patent actually claims in comparison to what is disclosed in the prior art. For further details about this case, see "Supreme Court of Canada denies leave regarding lisdexamfetamine patent decision" and "Federal Court of Appeal upholds Federal Court decision finding Shire's VYVANSE patent valid".
Apotex Inc v Shire LLC
As discussed above, the Federal Court of Appeal dismissed an appeal by Apotex from a Federal Court decision holding that the claims of Canadian Patent No. 2,527,646 were valid, and prohibiting a notice of compliance from being issued by the Minister of Health to Apotex until the expiry of the patent.(7)
Although the requirement for "inventiveness" or "unobviousness" has long been part of Canadian patent law, it was only on 1 October 1996 that the Patent Act was amended to set forth a statutory requirement of unobviousness. The newly added section 28.3 provided that "[t]he subject-matter defined by a claim in an application for a patent in Canada must be subject-matter that would not have been obvious on the claim date to a person skilled in the art or science to which it pertains".
In 2008, in a case concerning a patent pre-dating section 28.3, the Supreme Court of Canada in Apotex Inc v Sanofi-Synthelabo Canada Inc (Sanofi)(8) adopted an obviousness analysis requiring assessment of the "inventive concept" of a claim in question.
How does the requirement in section 28.3 of the Patent Act to assess obviousness based on the "subject-matter defined by a claim" fit with the Supreme Court's requirement in Sanofi to identify the "inventive concept of the claim"?
Here, the Court confirmed that assessment of the "inventive concept" of a claim is a discrete exercise from claim construction. This was of particular importance in this case concerning claims to bare chemical compounds per se. Construction of the claims to determine what would constitute infringement would not take into account advantageous or surprising properties of the compounds not recited in the claims. The Federal Court of Appeal held that the Federal Court had not erred in taking into account advantageous properties of the claimed compounds in determining the inventive concept of the claims. More specifically, section 28.3 of the Patent Act does not narrow the "inventive concept" to the essential elements of the claim itself.
Further, the Court reaffirmed that, while the three non-exhaustive "obvious to try" factors enumerated by the Supreme Court of Canada in Sanofi must all be explicitly considered in order to answer the overall question of whether it is "more or less self-evident to try to obtain the invention", they need not all be met. For further details about this case, see "Supreme Court of Canada denies leave regarding lisdexamfetamine patent decision" and "Federal Court of Appeal upholds Federal Court decision finding Shire's VYVANSE patent valid".
Western Oilfield Equipment Rentals Ltd v M-I LLC
Section 38.2 of the Patent Act provides (inclusive of minor amendments effective from 30 October 2019) that a patent application "may not be amended to add matter that cannot reasonably be inferred from the specification or drawings contained in the application on its filing date". The question of added matter arises regularly during prosecution before the CIPO but is rarely an issue before the courts.
As noted above, the Federal Court of Appeal dismissed Western Oilfield's appeal of a Federal Court decision finding that certain claims of Canadian Patent No. 2,664,173 (the 173 patent) were valid and had been infringed.(9) The appellants argued that the 173 patent was invalid on various grounds, including that some of the claims included added subject matter not reasonably inferable from the patent application as filed. Cautioning against the appellants' submission that the strict UK approach to the admissibility of new subject matter should apply, the Federal Court of Appeal held that subsection 38.2(2) of the Patent Act allows for reasonable inference. The Federal Court did not err in finding that the claims in question were at least reasonably inferable from the original patent application.
For further information on this topic please contact David Schwartz, Nicole Boyle, Robert Baker or Skylar Yoo at Smart & Biggar by telephone (+1 613 232 2486) or email ([email protected], [email protected], [email protected] or [email protected]). The Smart & Biggar website can be accessed at www.smartbiggar.ca.
Ryan Wong, articling student, assisted in the preparation of this article.
(1) 2021 FCA 45.
(2) 2021 FC 384.
(3) 2021 FC 1265.
(4) 2021 FCA 154.
(5) 2021 FCA 24.
(6) 2021 FCA 52.
(7) 2021 FCA 52.
(8) 2008 SCC 61
(9) 2021 FCA 24.