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Patents - General. Pharmascience Inc. v. Janssen Inc.
In Pharmascience Inc. v. Janssen Inc. (SCC, 2026) the Supreme Court of Canada dismissed an appeal, this against a Federal CA ruling involving "whether methods of medical treatment are patentable subject matter under the Patent Act".
Here the court generally characterizes the nature and purpose of the Canadian patent regime, focussing on 'inventions' and the concept of 'patentability':A. The Purpose and Scheme of the Patent Act
[32] Patents are purely creations of statute. There is no right to a patent at common law (Commissioner of Patents v. Farbwerke Hoechst Aktiengesellschaft Vormals Meister Lucius & Bruning, 1963 CanLII 2 (SCC), [1964] S.C.R. 49, at p. 57; Teva Canada Ltd. v. Pfizer Canada Inc., 2012 SCC 60, [2012] 3 S.C.R. 625 (“Teva Canada”), at para. 45). Courts must therefore begin with the terms of the Patent Act, as interpreted in the jurisprudence.
[33] Like all legislation, the Patent Act must be interpreted in accordance with the modern principle of statutory interpretation, having regard to its text, context, and purpose (Harvard College v. Canada (Commissioner of Patents), 2002 SCC 76, [2002] 4 S.C.R. 45, at para. 154; Monsanto Canada Inc. v. Schmeiser, 2004 SCC 34, [2004] 1 S.C.R. 902, at para. 32; AstraZeneca Canada Inc. v. Canada (Minister of Health), 2006 SCC 49, [2006] 2 S.C.R. 560, at para. 26; Celgene Corp. v. Canada (Attorney General), 2011 SCC 1, [2011] 1 S.C.R. 3, at para. 21).
(1) The Purpose of the Patent Act Is to Promote Scientific and Technological Innovation Through the “Patent Bargain”
[34] The purpose of the Patent Act is to promote scientific and technological innovation for the benefit of society. It does so by creating economic incentives for research and development through the “patent bargain” between an inventor and the public, as represented by the Crown. Under that bargain, an inventor publicly discloses the knowledge underlying the invention in exchange for a patent conferring, for a limited time, “the exclusive right, privilege and liberty of making, constructing and using the invention and selling it to others to be used” (s. 42). The bargain benefits both society and the inventor. Through public disclosure, society gains new scientific and technological knowledge that may stimulate further innovation and technological progress. The inventor, in turn, gains a temporary monopoly that may provide a return on the time, effort, and risk involved in making the invention (see Nova Chemicals Corp. v. Dow Chemical Co., 2022 SCC 43, [2022] 3 S.C.R. 352, at para. 43; Teva Canada, at para. 32; S. J. Perry and T. A. Currier, Canadian Patent Law (5th ed. 2024), at §§3.02 and 3.04; M. Bourassa Forcier, W. Audet and G. Melançon, Précis de propriété intellectuelle (2020), at no 4.2).
[35] A patent is therefore “a method by which inventive solutions to practical problems are coaxed into the public domain by the promise of a limited monopoly for a limited time” (Wellcome, at para. 37; AstraZeneca Canada Inc. v. Apotex Inc., 2017 SCC 36, [2017] 1 S.C.R. 943, at para. 52). It is often described as a metaphorical “fence” surrounding the “fields” of the inventor’s monopoly, warning the public against trespassing on the inventor’s property during the term of the patent (Free World Trust v. Électro Santé Inc., 2000 SCC 66, [2000] 2 S.C.R. 1024, at para. 14, citing Minerals Separation North American Corp. v. Noranda Mines, Ltd., 1949 CanLII 55 (SCC), [1947] Ex. C.R. 306, at p. 352; Wellcome, at paras. 45 and 50; Perry and Currier, at §3.03).
(2) Patentable Subject Matter
[36] Section 2 of the Patent Act defines an “invention” as “any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter”. This definition identifies five categories of patentable subject matter: an “art”, “process”, “machine”, “manufacture”, or “composition of matter” (see AstraZeneca (2017), at para. 40; Harvard College, at para. 156; Intellectual Property Disputes: Resolutions and Remedies (loose-leaf), by R. E. Dimock, ed., at § 1:3; D. Vaver, Intellectual Property Law: Copyright, Patents, Trade-marks (2nd ed. 2011), at pp. 290-97). By contrast, a “mere scientific principle or abstract theorem”, such as Newton’s theory of gravity or Einstein’s theory of relativity, is excluded from the scope of patentable subject matter (Patent Act, s. 27(8); Vaver, at pp. 308-9). This is the Act’s only express exclusion.
[37] The definition of “invention” in s. 2 has remained constant since 1923 and largely unchanged since 1869 (D. H. MacOdrum, A. McIntosh and M. Szweras, Fox on the Canadian Law of Patents (5th ed. (loose-leaf)), at § 3:8; The Patent Act, S.C. 1923, c. 23, s. 2(c); An Act respecting Patents of Invention, S.C. 1869, c. 11, s. 6). As Professor Vaver observes, the “taxonomy” of invention under s. 2 “traces back to the English Statute of Monopolies of 1624”, which authorized patents for “‘any manner of new manufactures,’ leaving the definition for judges to work out” (pp. 285-86 (footnote omitted); see generally MacOdrum, McIntosh and Szweras, at §§ 3:8 and 3:10-3:14; Perry and Currier, at §§6.02-6.03; D. P. Clarizio et al., Hughes & Woodley on Patents (2nd ed. (loose-leaf)), at § 5; Manual of Patent Office Practice, at ch. 17).
[38] Judicial interpretation of “invention” under s. 2 is therefore central to defining the scope of patentable subject matter. Apart from scientific principles and abstract theorems, what is and is not patentable subject matter depends on how the courts have interpreted the concept of “invention” under s. 2 (see Monsanto, at para. 133, per Arbour J., dissenting in part, but not on this point; Perry and Currier, at §6.01). Patent law has accordingly been described as “statutory but subject to multiple common law glosses” (R. H. Barrigar and A. M. Shaughnessy, Canadian Patent Act Annotated (2nd ed. (loose-leaf)), at § 1:2). Professor Vaver similarly observes that “the notion of invention is a legal term of art. It is defined by legislatures, and the legislative definitions are interpreted according to legal criteria by courts, tribunals and officials such as patent examiners and patent office appeal boards” (“Invention in Patent Law: A Review and a Modest Proposal” (2003), 11 Int. J.L. Inf. Tech. 286, at p. 288).
[39] In interpreting patentable subject matter, courts must remain attentive to the purpose of Patent Act. As the High Court of Australia explained, determining the scope of patentable subject matter “is an inquiry not into the meaning of a word so much as into the breadth of the concept which the law has developed by its consideration of the text and purpose” of the relevant patent legislation. For that reason, “any attempt to state the ambit” of the definition of an “invention” under patent legislation by “precisely defining” the words of the Act “is bound to fail” (National Research Development Corp. v. Commissioner of Patents (1959), 102 C.L.R. 252, at pp. 269-71, cited in Tennessee Eastman Co. v. Commissioner of Patents (1970), 1970 CanLII 1884 (CA EXC), 62 C.P.R. 117 (Ex. Ct.), at pp. 136-38; see also Vaver (2003), at p. 288).
[40] Patentable subject matter must also be interpreted in a manner that is “attentive to the wisdom of the case law” (Monsanto, at para. 32, per McLachlin C.J. and Fish J. (emphasis in original); see also para. 39, per McLachlin C.J. and Fish J., and para. 132, per Arbour J., dissenting in part, but not on this point). This Court has stated that the term “invention” is “broad” but not “unlimited”; it does not include as patentable “anything under the sun that is made by man” (Harvard College, at para. 158). By defining “invention” as it has, “Parliament signalled a clear intention to include certain subject matter as patentable and to exclude other subject matter as being outside the confines of the Act” (para. 158).
[41] This Court has applied these interpretive principles in determining what subject matter falls within, and what falls outside, the definition of “invention”. In Harvard College, this Court held that a higher life form — a genetically modified mouse predisposed to cancer — was neither a “manufacture” nor a “composition of matter” within the meaning of the Patent Act and was therefore not patentable subject matter (para. 155). In Monsanto, by contrast, the Court held that genetically modified plant cells and genes conferring herbicide resistance on canola constituted patentable subject matter (paras. 21-24). Similarly, in Wellcome, the Court held that a new use for an existing pharmaceutical compound — the treatment of HIV and AIDS with the known cancer drug AZT — constituted patentable subject matter and was not unpatentable as a method of medical treatment (paras. 48-50; see also Shell Oil, at pp. 548-56; Vaver (2011), at p. 295; MacOdrum, McIntosh and Szweras, at § 3:8).
(3) Other Requirements for Patentability Are Not at Issue in This Appeal
[42] Patentable subject matter is a necessary but not sufficient condition for a valid patent. A claimed innovation must also satisfy the Patent Act’s other requirements. It must be “new” (ss. 2 and 28.2); inventive or not “obvious” (s. 28.3; see also Apotex Inc. v. Sanofi-Synthelabo Canada Inc., 2008 SCC 61, [2008] 3 S.C.R. 265, at paras. 51-71); and “useful” (s. 2; see also AstraZeneca (2017), at paras. 26 and 52-58; Teva Canada, at paras. 37-40; Wellcome, at paras. 52-56; Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd., 1981 CanLII 15 (SCC), [1981] 1 S.C.R. 504, at pp. 525-27) (see generally Vaver (2011), at pp. 338-41; Dimock, at § 1:3; E. F. Judge and D. J. Gervais, Intellectual Property: The Law in Canada (2nd ed. 2011), at pp. 724-27). .... . Nova Chemicals Corporation v. Dow Chemicals Company
In Nova Chemicals Corporation v. Dow Chemicals Company (Fed CA, 2020) Stratas JA of the Federal Court of Appeal briefly states the 'patent bargain':[11] Broadly speaking, the Patent Act, R.S.C. 1985, c. P-4 enshrines and regulates a bargain made between inventors and the public: inventors disclose their inventions for the good of all, including the public and later inventors, and, in return, they are given a powerful monopoly for a period of time to exploit their invention. If the Patent Act did not do this, one would expect that many inventors would keep their inventions secret, depriving all of knowledge and know-how that can be built upon. Over time, one would expect fewer discoveries and, thus, fewer benefits for society. The Supreme Court and this Court have repeatedly explained this patent bargain in cases such as Free World Trust v. Électro Santé Inc., 2000 SCC 66, [2000] 2 S.C.R. 1024 at para. 13 and Apotex Inc. v. Merck & Co. Inc., 2015 FCA 171,
[2016] 2 F.C.R. 202 at para. 42 (Apotex FCA (2015)). . McCain Foods Limited v. J.R. Simplot Company
In McCain Foods Limited v. J.R. Simplot Company (Fed CA, 2021) the Federal Court of Appeal considers the nature of patent law:[72] Canada’s patent regime is wholly statutory: Apotex Inc. v. Sanofi-Synthelabo Canada Inc., 2008 SCC 61, [2008] 3 S.C.R. 265, at para. 12. While there are aspects of Canadian patent law that are not provided for explicitly in the Patent Act, or any other statute, and have been developed instead through jurisprudence (inducing patent infringement itself being a good example), all such aspects must be based on a statutory text.
[73] As indicated above, inducing patent infringement is simply a form of infringement, not a separate tort. Therefore, the statutory foundation for a claim of inducing infringement is the same as that for direct infringement: subsection 55(1), which is reproduced at paragraph 61 above. . Apotex Inc. v. Eli Lilly Canada Inc.
In Apotex Inc. v. Eli Lilly Canada Inc. (Ont CA, 2022) the Court of Appeal set out some aspects of the statutory patent regime:(i) Patent Regulatory Regime
[7] Before I set out the specific factual background, it is helpful to briefly explain the patent regulatory context in which the relevant events giving rise to these proceedings took place and which informs the issues on this appeal. I refer to only those regulatory provisions[1] that are particularly relevant to the issues on appeal.
[8] Patent law is “wholly statutory” with “no inherent common law right to a patent”, with the result being that “[a]n inventor gets his patent according to the terms of the Patent Act, no more and no less”: Apotex v. Sanofi-Sythelabo Canada Inc., 2008 SCC 61, [2008] 3 S.C.R. 265, at para. 12; Commissioner of Patents v. Farbwerke Hoechst Aktiengesellschaft Vormals Meister Lucius & Bruning, 1963 CanLII 2 (SCC), [1964] S.C.R. 49, at p. 57.
[9] Patents are granted under s. 27 of the Patent Act as an approved new invention for a specific term. In the case of Eli Lilly’s patent, the term was for 20 years from the filing date in accordance with s. 44. Section 43(2) provides that “[a]fter the patent is issued, it shall, in the absence of any evidence to the contrary, be valid and avail the patentee and the legal representatives of the patentee for the term mentioned [in this case] in section 44”. An “early working” exception under s. 55.2(1) of the Patent Act allows a generic drug company to develop copycat drugs before the expiry of a patent. See: AstraZeneca Canada Inc. v. Canada (Minister of Health), 2006 SCC 49, at para. 15.
[10] The PM(NOC) Regulations were enacted pursuant to s. 55.2(4) of the Patent Act to prevent patent infringements by persons who take advantage of the “early working” exception set out in s. 52.2(2). The regulatory scheme under the PM(NOC) Regulations creates a Patent Registry within the Ministry of Health (“MOH”) in which an innovator drug company may list its patents. See: AstraZeneca, at paras. 15-17.
[11] Once a competitor’s patent is listed on the Patent Registry, a company may only bring a generic version of the drug to market before the expiration of the patent if that patent is declared invalid. A patent or any claim in a patent may be declared invalid or void by the Federal Court at the request of the Attorney General of Canada or any “interested person”, including a generic drug company: Patent Act, s. 60(1). Under s. 5 of the PM(NOC) Regulations, a generic drug company may also allege that a patent is invalid by filing a submission for a notice of compliance (“NOC”) containing the allegation and serving a notice of allegation (“NOA”) on the patent holder.
[12] The NOA generally triggers the commencement of a proceeding by the patent holder to the Federal Court under the provisions of s. 6 of the PM(NOC) Regulations to prohibit the issuance of an NOC to the generic drug company (the “prohibition proceeding”). The mere initiation by the patent holder of its prohibition proceeding freezes ministerial action for 24 months under s. 7 of the PM(NOC) Regulations, unless the prohibition proceeding instigated by the patent holder is earlier disposed of, which apparently is rare. See: AstraZeneca, at para. 17.
[13] If the allegations of patent invalidity are found to be unjustified and the patent holder is successful in the prohibition proceeding, the issuance of the generic drug company’s NOC is prohibited until the occurrence of the latest of the events listed under s. 7(1) of the PM(NOC) Regulations, including the expiration of the patent.
[14] If a patent, or part of a patent, is declared invalid or void, s. 62 of the Patent Act provides that it shall be held “to have been void and of no effect, unless the judgment is reversed on appeal”. Section 8 of the PM(NOC) Regulations allows a generic drug company to apply for compensation from the patent holder for loss caused by the statutory stay in the event that a patent holder fails in the prohibition proceeding.
[15] The Food and Drugs Act, R.S.C., 1985, c. F-27 governs the safety, efficacy, and approval of drugs for marketing in Canada. A drug cannot be marketed unless and until the MOH issues an NOC under s. C.08.004 of the Food and Drug Regulations, C.R.C., c. 870. Innovator drug companies must submit a New Drug Submission in support of their request for an NOC. Generic drug companies may submit an Abbreviated New Drug Submission (“ANDS”) to the MOH where they seek an NOC for a drug that is the pharmaceutical equivalent of a previously approved drug. . ViiV Healthcare Company v. Gilead Sciences Canada, Inc.
In ViiV Healthcare Company v. Gilead Sciences Canada, Inc. (Fed CA, 2021) the Federal Court of Appeal considers interpretation and standard of review issues in a patent dispute [paras 54-69].
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