Harvard College v. Canada (Commissioner of Patents) 2002: December 5

Commissioner of Patents      

Respondent

President and Fellows of Harvard College      

Appellant

Canadian Council of Churches, Evangelical Fellowship of Canada, Canadian Environmental Law Association, Greenpeace Canada, Canadian Association of Physicians for the Environment, Action Group on Erosion, Technology and Concentration, Canadian Institute for Environmental Law and Policy, Sierra Club of Canada, Animal Alliance of Canada, International Fund for Animal Welfare Inc. and Zoocheck Canada Inc.      

Interveners

Indexed as:  Harvard College v. Canada (Commissioner of Patents)

Neutral citation: 2002 SCC 76. File No.:  28155

2002: May 21; 2002: December 5

Present:  McLachlin C.J. and L'Heureux-Dubé, Gonthier, Iacobucci, Major, Bastarache, Binnie, Arbour and LeBel JJ.

ON APPEAL FROM THE FEDERAL COURT OF APPEAL

     Patents -- Patentable subject matter -- Standard of review -- Standard of review applicable to Commissioner of Patent's decision to refuse patent.

     Patents -- Patentable subject matter -- Biotechnology -- Patentability of higher life forms -- College seeking to patent genetically altered mouse for cancer research -- Whether "invention" encompasses higher life forms -- Meaning of "manufacture" and "composition of matter" -- Patent Act, R.S.C. 1985, c. P-4, s. 2 "invention".

     The respondent applied for a patent on an invention entitled "transgenic animals". According to the application, a cancer-promoting gene ("oncogene") is injected into fertilized mouse eggs as close as possible to the one-cell stage. The eggs are then implanted into a female host mouse and permitted to develop to term. After the offspring of the host mouse are delivered, they are tested for the presence of the oncogene. Those that contain the oncogene are called "founder" mice. Founder mice are mated with mice that have not been genetically altered. Fifty per cent of the offspring will have all of their cells affected by the oncogene, making them suitable for animal carcinogenic studies. In its patent application, the respondent seeks to protect both the process by which the oncomice are produced and the end product of the process, i.e. the founder mice and the offspring whose cells contain the oncogene. The process and product claims extend to all non-human mammals. The process claims were allowed by the Patent Examiner, while the product claims were rejected. The appellant Commissioner confirmed the refusal of the product claims. The Federal Court, Trial Division, dismissed the respondent's appeal from the appellant's decision. The respondent's further appeal to the Federal Court of Appeal was allowed.

     Held (McLachlin C.J. and Major, Binnie and Arbour JJ. dissenting): The appeal should be allowed. A higher life form is not patentable because it is not a "manufacture" or "composition of matter" within the meaning of "invention" in s. 2 of the Patent Act.

     Per L'Heureux-Dubé, Gonthier, Iacobucci, Bastarache and LeBel JJ.: This appeal raises the issue of the patentability of higher life forms within the context of the Patent Act.

     A. The Commissioner's power to refuse a patent under s. 40

     The standard of review applicable to the Commissioner's decision in this case is correctness. The courts are as well placed as the Commissioner to decide whether the definition of invention in s. 2 of the Patent Act encompasses higher life forms, since the Patent Act contains no privative clause, gives applicants a broad right of appeal, and the question approaches a pure determination of law that has significant precedential value. Section 40 of the Patent Act does not give the Commissioner discretion to refuse a patent on the basis of public policy considerations independent of any express provision in the Act. Since the Commissioner has no discretion independent of the Patent Act to consider the public interest when granting or denying a patent, the Commissioner's decision in this case, given its nature, is not owed deference.

     B. The Definition of Invention: whether a higher life form is a "manufacture" or a "composition of matter"

     The sole question in this appeal is whether the words "manufacture" and "composition of matter", within the context of the Patent Act, are sufficiently broad to include higher life forms. It is irrelevant whether this Court believes that higher life forms such as the oncomouse ought to be patentable. The words of the Patent Act "are to be read in their entire context and in their grammatical and ordinary sense harmoniously with the scheme of the Act, the object of the Act, and the intention of Parliament". Comparisons with the patenting schemes of other countries will therefore be of limited value. The best reading of the words of the Act supports the conclusion that higher life forms are not patentable.

     (1) The Words of the Act

     For a higher life form to fit within the definition of "invention", it must be considered to be either a "manufacture" or a "composition of matter". While the definition of "invention" in the Patent Act is broad, Parliament did not define "invention" as "anything new and useful made by man". The choice of an exhaustive definition signals a clear intention to exclude certain subject matter as being outside the confines of the Act. The word "manufacture" ("fabrication"), in the context of the Act, is commonly understood to denote a non-living mechanistic product or process, not a higher life form. The words "composition of matter" ("composition de matière") as they are used in the Act do not include a higher life form such as the oncomouse. The words occur in the phrase "art, process, machine, manufacture or composition of matter". A collective term that completes an enumeration is often restricted to the same genus as the terms which precede it, even though the collective term may ordinarily have a much broader meaning. Just as "machine" and "manufacture" do not imply a living creature, the words "composition of matter" are best read as not including higher life forms. While a fertilized egg injected with an oncogene may be a mixture of various ingredients, the body of a mouse does not consist of ingredients or substances that have been combined or mixed together by a person. Moreover, "matter" captures only one aspect of a higher life form, generally regarded as possessing qualities and characteristics that transcend the particular genetic material of which it is composed. Higher life forms cannot be conceptualized as mere "compositions of matter" within the context of the Patent Act. Just because all inventions are unanticipated and unforeseeable, it does not necessarily follow that they are all patentable. It is possible that Parliament did not intend to include higher life forms in the definition of "invention". It is also possible that Parliament did not regard cross-bred plants and animals as patentable because they are better regarded as "discoveries". Since patenting higher life forms would involve a radical departure from the traditional patent regime, and since the patentability of such life forms is a highly contentious matter that raises a number of extremely complex issues, clear and unequivocal legislation is required for higher life forms to be patentable. The current Act does not clearly indicate that higher life forms are patentable.

     (2) The Scheme of the Act

     The above interpretation of the words of the Act finds support in the fact that the patenting of higher life forms raises unique concerns which do not arise in respect of non-living inventions and which are not addressed by the scheme of the Act. The fact that the Act is ill-equipped to deal appropriately with higher life forms as patentable subject matter is an indication that Parliament never intended the definition of invention to extend to this type of subject matter. While some policy concerns, such as the environmental and animal welfare implications of biotechnology, are more appropriately dealt with outside the patent system, other concerns are more directly related to patentability and to the scheme of the Act. These concerns illustrate the fact that the Patent Act in its current form is not well suited to address the unique characteristics possessed by higher life forms. The issue of the patenting of human life forms is a complex one that cannot be readily dismissed by reference to the Charter. It is not an appropriate judicial function of the courts to create an exception from patentability for human life given that such an exception requires one to consider both what is human and which aspects of human life should be excluded. The lack of direction currently in the Act to deal with issues that might reasonably arise signals a legislative intent that higher life forms are currently not patentable. This Court does not possess the institutional competence to deal with issues of this complexity, which presumably will require Parliament to engage in public debate, a balancing of competing social interests, and intricate legislative drafting.

     (3) The Object of the Act

     Although the Patent Act is designed to advance research and development and encourage broader economic activity, it simply does not follow from the objective of promoting ingenuity that all inventions must be patentable. A product of human ingenuity must fall within the terms of the Act in order for it to be patentable; the issue of whether a proposed invention ought to be patentable does not provide an answer to the question of whether that proposed invention is patentable. In any event, the manner in which Canada has administered its patent regime reveals that the promotion of ingenuity has at times been balanced against other considerations.

     (4) Related Legislation: The Plant Breeders' Rights Act

     The interpretation of an ambiguous law may be informed by the substance and the form of subsequent legislation. The Plant Breeders' Rights Act is of significance to the interpretation of the Patent Act and the issue of its applicabiilty to higher life forms. Although Parliament enacted special legislation for the protection of plant breeders, it did not address other higher life forms. Moreover, the passage of the Plant Breeders' Rights Act demonstrates that mechanisms other than the Patent Act may be used to encourage inventors to undertake innovative activity in the field of biotechnology. Many of the issues that arose with respect to intellectual property protection for plant varieties also arise when considering the patentability of other higher life forms. If a special legislative scheme was needed to protect plant varieties, a subset of higher life forms, a similar scheme may also be necessary to deal with the patenting of higher life forms in general. It is beyond the competence of this Court to address in a comprehensive fashion the issues associated with the patentability of higher life forms.

     C. Drawing the line: Is it defensible to allow patents on lower life forms while denying patents on higher life forms?

     The patentability of lower life forms is not at issue before this Court, and was in fact never litigated in Canada. The distinction between lower and higher life forms, though not explicit in the Patent Act, is nonetheless defensible on the basis of the common sense differences between the two. The non-patentability of human life is not explicit in the Patent Act. If the line between lower and higher life forms is indefensible and arbitrary, so too is the line between human beings and other higher life forms. It is now accepted in Canada that lower life forms are patentable but this does not necessarily lead to the conclusion that higher life forms are patentable, at least in part for the reasons that it is easier to conceptualize a lower life form as a "composition of matter" or "manufacture" than it is to conceptualize a higher life form in these terms.

     Patentable micro-organisms are formed in such large numbers that any measurable quantity will possess uniform properties and characteristics. The same cannot be said for plants and animals. It is far easier to analogize a micro-organism to a chemical compound or another inanimate object than it is to analogize an animal to an inanimate object. Moreover, several important features possessed by animals distinguish them from both micro-organisms and plants and remove them even further from being considered a "composition of matter" or a "manufacture". Given the complexity of the issues involved, it is not the task of the Court to situate the line between higher and lower life forms. Also, the specific exception for plants and animals in trade agreements demonstrates that a distinction between higher and lower life forms is widely accepted as valid.

     Per McLachlin C.J. and Major, Binnie and Arbour JJ. (dissenting): The oncomouse is patentable subject matter. The extraordinary scientific achievement of altering every single cell in the body of an animal which does not in this altered form exist in nature, by human modification of the genetic material of which it is composed, is an inventive "composition of matter" within the meaning of s. 2 of the Patent Act.

     A.Statutory Interpretation

     Once it is acknowledged, as does the majority of this Court, that the fertilized, genetically altered oncomouse egg is an invention under the Patent Act, there is no basis in the statutory text to conclude that the resulting oncomouse, that grows from the patented egg, is not itself patentable because it is not an invention. Since the respondent has fulfilled the other statutory criteria for an invention, it is entitled to the patent.
The context and scheme of the Patent Act reinforce the expansive sense of the words "composition of matter" to render the oncomouse patentable. The proper question is not whether Parliament intended to include "oncomice" or "higher life forms" or biotechnology generally in patent legislation, but whether Parliament intended to protect "inventions" that were not anticipated at the time of enactment of the Patent Act, or indeed, at any time before the claimed invention. While Parliament did not contemplate the oncomouse in 1869 when it enacted the definition of "invention", it did not contemplate moon rockets, antibiotics, telephones, e-mail or hand-held computers either.

     The intent that can properly be attributed to Parliament, based on the language it used and the context of patent legislation generally, is that it considered it to be in the public interest to encourage new and useful inventions without knowing what such inventions would turn out to be and to that end inventors who disclosed their work should be rewarded for their ingenuity. The Commissioner of Patents was given no discretion to refuse a patent on the grounds of morality, public interest, public order, or any other ground if the statutory criteria are met.

     B.The International Context

     The mobility of capital and technology makes it desirable that comparable jurisdictions with comparable intellectual property legislation arrive at similar legal results. The expression "composition of matter" is found in the U.S. Patent Act, under which the oncomouse was patented in 1988. The oncomouse is also patented in jurisdictions that cover Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, The Netherlands, Portugal, Spain, Sweden and the United Kingdom. A similar patent has been issued in Japan. New Zealand has issued a patent for a transgenic mouse that has been genetically modified to be susceptible to HIV infection. The Commissioner's approach to this case sounds a highly discordant note. The massive private sector investment in biotechnological research is exactly the sort of research and innovation that the Patent Act was intended to promote. Healthcare is the major beneficiary of biotechnology. At the same time, vast amounts of money must be found to finance biomedical research. The Patent Act embodies the public policy that those who directly benefit from an invention should be asked, through the patent system, to pay for it, at least in part.

     C.The Line-Drawing Exercise

     The Commissioner is unable to show any statutory authority for drawing a line between those life forms that he acknowledges to be patentable and those he rejects. "Composition of matter" is an open-ended expression and is not confined to inanimate matter. While as a matter of law there can be no patent on a human being, the Patent Act does not distinguish, in its definition of invention, between "lower" and "higher" life forms. None of the proposed dividing lines between "lower" and "higher" life forms arise from the text of the Patent Act. Whether to carve out a subject-matter exception for "higher life forms", and how "higher life form" is to be defined, is a policy matter for Parliament.

     As to the contention that growth from a single fertilized cell to the complete mouse has nothing to do with the inventors and everything to do with the "laws of nature", it must be said that the "laws of nature" are an essential part of the working of many and probably most patented inventions. Pharmaceutical drugs utilize the normal bodily processes and functions of animals and humans and are not on that account regarded as less patentable. Medications, like the oncomouse, could not be brought into existence without reliance on the "laws of nature" in general and the processes of biochemistry in particular.

     D.The Plant Breeders' Rights Act

     The adoption of the Plant Breeders' Rights Act in 1990 does not mean that the subject matter of patents excludes plants and, by extension, other "higher" life forms such as seeds and animals. The rights available under the Plant Breeders' Rights Act fall well short of those conferred by patent, both in comprehensiveness and duration. In addition, the Patent Act language reaches back prior to Confederation. There was no repeal by implication in 1990 since it cannot be said that the two Acts are inconsistent.

     E.Other Objections

     As to the lack of a regulatory framework for "higher life form" inventions, there are as many areas of potential regulation as there are areas of invention. These regulatory regimes cannot and should not all be put under the inadequate umbrella of the Patent Act. It is normal that regulation follows, rather than precedes, the invention.

     The scientific accomplishment manifested in the oncomouse is profound and far-reaching. Every cell in the animal's body has been altered in a way that is highly important to scientific research. While the oncomouse is deliberately designed to grow painful malignant tumours, animals will continue to be used in laboratories for scientific research whether patented or not. With respect to the commodification of human life, the patentability of humans is precluded by law and the broadest claim here specifically excepts humans from the scope of transgenic mammals. Environmental concerns which include the diversity of the gene pool and the potential escape of genetically modified organisms into the environment are serious. They have little to do, however, with the patent system. The Patent Act has always had the modest and focussed objective of encouraging the disclosure of the fruit of human inventiveness in exchange for the statutory rewards. The balance between the other competing policy considerations is for Parliament to strike.

     F.The Court's Moratorium

     Neither the Commissioner nor the courts have the authority to declare a moratorium on "higher" life patents until Parliament chooses to act.

Cases Cited

By Bastarache J.

     Referred to: Commissioner of Patents v. Farbwerke Hoechst Aktiengesellschaft Vormals Meister Lucius & Bruning, [1964] S.C.R. 49; Lawson v. Commissioner of Patents (1970), 62 C.P.R. 101; Tennessee Eastman Co. v. Commissioner of Patents, [1974] S.C.R. 111; Re Application of Abitibi Co. (1982), 62 C.P.R. (2d) 81; Re Application for Patent of Pioneer Hi-Bred Ltd. (1986), 11 C.P.R. (3d) 311; Pioneer Hi-Bred Ltd. v. Canada (Commissioner of Patents), [1989] 1 S.C.R. 1623; Pioneer Hi-Bred Ltd. v. Canada (Commissioner of Patents), [1987] 3 F.C. 8; Monsanto Co. v. Commissioner of Patents, [1979] 2 S.C.R. 1108; R. v. Secretary of State for the Home Department, ex parte Al-Mehdawi, [1989] 1 All E.R. 777; Diamond v. Chakrabarty, 447 U.S. 303 (1980); Moreau-Bérubé v. New Brunswick (Judicial Council), 2002 SCC 11; Pushpanathan v. Canada (Minister of Citizenship and Immigration), [1998] 1 S.C.R. 982; Canada (Director of Investigation and Research) v. Southam Inc., [1997] 1 S.C.R. 748; Baker v. Canada (Minister of Citizenship and Immigration), [1999] 2 S.C.R. 817; Rizzo & Rizzo Shoes Ltd. (Re), [1998] 1 S.C.R. 27; Hornblower v. Boulton (1799), 8 T.R. 95, 101 E.R. 1285; Micro Chemicals Ltd. v. Smith Kline & French Inter-American Corp., [1972] S.C.R. 506; Bell ExpressVu Limited Partnership v. Rex, 2002 SCC 42; Tremblay v. Daigle, [1989] 2 S.C.R. 530; Winnipeg Child and Family Services (Northwest Area) v. G. (D.F.), [1997] 3 S.C.R. 925; Free World Trust v. Électro Santé Inc., [2000] 2 S.C.R. 1024, 2000 SCC 66; In re Bergy, Coats, and Malik, 195 U.S.P.Q. 344 (1977).

By Binnie J. (dissenting)

     Théberge v. Galerie d'Art du Petit Champlain inc., 2002 SCC 34; Continental Soya Co. v. J. R. Short Milling Co., [1942] S.C.R. 187; Laboratoire Pentagone Ltée v. Parke, Davis & Co., [1968] S.C.R. 307; Pioneer Hi-Bred Ltd. v. Canada (Commissioner of Patents), [1989] 1 S.C.R. 1623; Re Application of Abitibi Co. (1982), 62 C.P.R. (2d) 81; General Electric Co.'s Application (Patent), [1961] 2 R.P.C. 21; Re Application for Patent of Connaught Laboratories (1982), 82 C.P.R. (2d) 32; Diamond v. Chakrabarty, 447 U.S. 303 (1980); Monsanto Canada Inc. v. Schmeiser, [2002] F.C.J. No. 1209 (QL), 2002 FCA 309; Somerset v. Stewart (1772), Lofft 10, 98 E.R. 499; Bishop v. Stevens, [1990] 2 S.C.R. 467; Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd., [1981] 1 S.C.R. 505; Pioneer Hi-Bred Ltd. v. Canada (Commissioner of Patents), [1987] 3 F.C. 8; J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred International, 122 S. Ct. 593 (2001); Commissioner of Patents v. Winthrop Chemical Co., [1948] S.C.R. 46; Tennessee Eastman Co. v. Commissioner of Patents, [1974] S.C.R. 111; Apotex Inc. v. Wellcome Foundation Ltd., 2002 SCC 77; Grant of European patent No. 0 169 672 (Onco-mouse/Harvard) (1992), OJ EPO 1992, 588.

Statutes and Regulations Cited

Act to Encourage the Progress of Useful Arts within this Province, 7 Geo. 4., c. 5 (1826) (U.C.).

Act to promote the progress of useful Arts in this Province, 4 Geo. 4, c. 25 (1824) (L.C.).

Act to promote the progress of useful Arts, and to repeal the act heretofore made for that purpose, U.S. 2nd Congress, Sess. II, c. 11 (1793).

Act respecting Patents of Invention, S.C. 1869, c. 11, s. 6.

Agreement on Trade-Related Aspects of Intellectual Property Rights, being Annex 1C of the Marrakesh Agreement Establishing the World Trade Organization, 33 I.L.M. 1197 (1993), art. 27(2).

Assisted Human Reproduction Act, Bill C-56 (1st reading), 1st Session, 37th Parliament (Can.).

Berlin Convention for the Protection of Literary and Artistic Works, November 13, 1908.

Berne Convention for the Protection of Literary and Artistic Works, September 9, 1886.

Canadian Charter of Rights and Freedoms, s. 1, 7, 15.

Canadian Environmental Protection Act, R.S.C. 1985, c. 16 (4th Suppl).

Constitution Act, 1867, s. 91(22).

Convention for the Creation of an International Union for the Protection of Industrial Property (Paris Convention), March 20, 1883.

Convention on the Grant of European Patents (European Patent Convention), October 5, 1973, art. 53(a).

Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, art. 5(1), (2), 6.

North American Free Trade Agreement Between the Government of Canada, the Government of the United Mexican States and the Government of the United States of America, Can. T.S. 1994 No.2, art. 1709(2).

Patent Act, R.S.C. 1985, c. P-4, s. 2 [am. 1993, c. 2, s. 2], "invention", 27(1) [rep. & sub. c. 33 (3rd Supp.), s. 8; rep. & sub. 1993, c. 15, s. 31], 27(3) [rep. & sub. 1993, c.15, s. 31; idem, c. 44, s. 192], 40, 44 [now s. 42] [rep. & sub. c. 33 (3rd Supp.), s. 16].

Plant Breeders' Rights Act, S.C. 1990, c. 20.

Rome Convention for the Protection of Literary and Artistic Works, June 2, 1928.

Statute of Monopolies (U.K.) (1624), s. 6.

Universal Copyright Convention, September 6, 1952.

Authors Cited

Arthur, Charles. "The onco-mouse that didn't roar" (1993), 138 New Scientist 4.

Bishop, John. Transgenic Mammals. Harlow, England: Longman, 1999.

Butterworths Medical Dictionary, 2nd ed. Toronto: Butterworths, 1978, "Sachs".

Canada. Canadian Biotechnology Advisory Committee, Biotechnology and Intellectual Property: Patenting Higher Life Forms and Related Issues (Interim Report). Ottawa: Canadian Biotechnology Advisory Committee, November 2001.

Canada. Canadian Biotechnology Advisory Committee, Patenting of Higher Life Forms and Related Issues. Ottawa: Canadian Biotechnology Advisory Committee, June 2002.

Canada. Canadian Food Inspection Agency. 10-Year Review of Canada's Plant Breeders' Rights Act. Ottawa: Canadian Food Inspection Agency, 2002.

Canada. House of Commons Debates, vol. 137, 1st Sess., 37th Parl., May 9, 2002, p. 11415.

Canada. House of Commons, Minutes of Proceedings and Evidence of the Legislative Committee on Bill C-15: An Act Respecting Plant Breeders' Rights, Issue No. 1, October 11, 1989, p. 1:15.

Canada. Proceed with Care: Final Report of the Royal Commission on New Reproductive Technologies. Ottawa: Canada Communications Group, 1993.

Canada. Statistics Canada, Biotechnology Use and Development -- 1999. Ottawa: Statistics Canada, March 2001.

Canada. The 1998 Canadian Biotechnology Strategy: An Ongoing Renewal Process. Ottawa: Industry Canada, 1998.

Caulfield, Timothy A. "Underwhelmed: Hyperbole, Regulatory Policy, and the Genetic Revolution", (2000) 45 McGill L.J. 437.

Chong, Stephanie. "The Relevancy of Ethical Concerns in the Patenting of Life Forms" (1993), 10 C.I.P.R. 189.

Côté, Pierre-André. The Interpretation of Legislation in Canada, 3d ed. Scarborough, Ont.: Carswell, 2000.

Derzko, Nathalie M. "Plant Breeders' Rights in Canada and Abroad: What are These Rights and How Much Must Society Pay for Them?" (1993-1994), 39 McGill L.J. 144.

Driedger, Elmer A. Construction of Statutes, 2nd ed. Toronto: Butterworths, 1983.

Ernst & Young's Seventh Annual European Life Sciences Report 2000. London: Becket, 2000.

Florencio, Patrik S. "Genetics, Parenting, and Children's Rights in the Twenty-First Century" (2000), 45 McGill L.J. 527.

Godson, Richard. A Practical Treatise on the Law of Patents for Inventions, and of Copyright in Literature, the Drama, Music, Engraving and Sculpture, and also in Ornamental and Useful Designs for the Purposes of Sale and Exhibition, 2nd ed. London: William Benning, 1851.

Gold, E. Richard. "Biomedical Patents and Ethics: A Canadian Solution" (2000), 45 McGill L.J. 413.

Gold, E. Richard. Body Parts: Property Rights and the Ownership of Human Biological Materials. Washington: Georgetown University Press, 1996.

Gold, E. Richard. "Making Room: Reintegrating Basic Research, Health Policy, and Ethics Into Patent Law". In Timothy A. Caulfield and Bryn Williams-Jones, eds., The Commercialization of Genetic Research: Ethical, Legal, and Policy Issues. New York: Klumer Academic, 1999, 63.

Grand Robert de la langue française, 2e éd. Paris : Dictionnaires Le Robert, 2001, "composition", "fabrication", "matière".

Hayhurst, William L. "Exclusive Rights in Relation to Living Things" (1991), 6 I.P.J. 171.

Heller, Michael A., and Rebecca S. Eisenberg. "Can Patents Deter Innovation? The Anticommons in Biomedical Research" (1998), 280 Science 698.

Knoppers, Bartha Maria. "Reflections: The Challenge of Biotechnology and Public Policy" (2000), 45 McGill L.J. 559.

Mooney, Pat Roy. The Impetus for and Potential of Alternative Mechanisms for the Protection of Biotechnological Innovations. Ottawa: Canadian Biotechnology Advisory Committee, March 2001.

Oxford English Dictionary, 2nd ed. Oxford: Clarendon Press, 1989, "composition", "manufacture", "matter".

Rudolph, John R. A Study of Issues Relating to the Patentability of Biotechnological Subject Matter. Ottawa: Industry Canada, 1996.

Schrecker, Ted, et al. Ethical Issues Associated with the Patenting of Higher Life Forms. Ottawa: Industry Canada, 1997.

Vaver, David. Intellectual Property Law: Copyright, Patents, Trade-marks. Concord, Ont: Irwin Law, 1997.

     APPEAL from a judgment of the Federal Court of Appeal, [2000] 4 F.C. 528, 189 D.L.R. (4th) 385, 7 C.P.R. (4th) 1, [2000] F.C.J. No. 1213 (QL), reversing a decision of the Trial Division, [1998] 3 F.C. 510, 146 F.T.R. 279, 79 C.P.R. (3d) 98, [1998] F.C.J. No. 500 (QL). Appeal allowed, McLachlin C.J. and Major, Binnie and Arbour JJ. dissenting.

     Graham Garton, Q.C., and Frederick B. Woyiwada, for the appellant.

     A. David Morrow, Steven B. Garland, and Colin B. Ingram, for the respondent.

     William J. Sammon, for the interveners Canadian Council of Churches and Evangelical Fellowship of Canada.

     Michelle Swenarchuk, Theresa McClenaghan, and Paul Muldoon, for the interveners Canadian Environmental Law Association, Greenpeace Canada, Canadian Association of Physicians for the Environment, Action Group on Erosion, Technology and Concentration, and Canadian Institute for Environmental Law and Policy.

     Written submissions only by Jerry V. DeMarco for the intervener Sierra Club of Canada.

     Written submissions only by Clayton C. Ruby and Lesli Bisgould for the interveners Animal Alliance of Canada, International Fund for Animal Welfare Inc. and Zoocheck Canada Inc.

     PARAGRAPH NUMBERING
The reasons are published in the SCR by order of precedence and the paragraph numbering included in those reasons has been prepared accordingly. For this case, the reasons will be published in the following order:
Binnie J. (and McLachlin C.J. and Major and Arbour JJ.) [paras. 1 to 117]
Bastarache J. (and L'Heureux-Dubé, Gonthier, Iacobucci and LeBel JJ.) [paras. 118 to 207]
CITATION
Before publication in the S.C.R., this judgment should be cited using the neutral citation: President and Fellows of Harvard College v. Canada (Commissioner of Patents), 2002 SCC 76. Once the judgment is published in the S.C.R., the neutral citation should be used as a parallel citation: President and Fellows of Harvard College v. Canada (Commissioner of Patents), [2002] x S.C.R. xxx, 2002 SCC 76.
BINNIE J. __

1     The biotechnology revolution in the 50 years since discovery of the structure of DNA has been fuelled by extraordinary human ingenuity and financed in significant part by private investment. Like most revolutions, it has wide ramifications, and presents potential and serious dangers as well as past and future benefits. In this appeal, however, we are only dealing with a small corner of the biotechnology controversy. We are asked to determine whether the oncomouse, a genetically modified rodent with heightened genetic susceptibility to cancer, is an invention. The legal issue is a narrow one and does not provide a proper platform on which to engage in a debate over animal rights, or religion, or the arrogance of the human race.

2     The oncomouse has been held patentable, and is now patented in jurisdictions that cover Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, The Netherlands, Portugal, Spain, Sweden, the United Kingdom and the United States. A similar patent has been issued in Japan. New Zealand has issued a patent for a transgenic mouse that has been genetically modified to be susceptible to HIV infection. Indeed, we were not told of any country with a patent system comparable to Canada's (or otherwise) in which a patent on the oncomouse had been applied for and been refused.

3     If Canada is to stand apart from jurisdictions with which we usually invite comparison on an issue so fundamental to intellectual property law as what constitutes "an invention", the respondent, successful everywhere but in Canada, might expect to see something unique in our legislation. However, one looks in vain for a difference in definition to fuel the Commissioner's contention that, as a matter of statutory interpretation, the oncomouse is not an invention. The truth is that our legislation is not unique. The Canadian definition of what constitutes an invention, initially adopted in pre-Confederation statutes, was essentially taken from the United States Patent Act of 1793, a definition generally attributed to Thomas Jefferson. The United States patent on the oncomouse was issued 14 years ago. My colleague, Bastarache J., acknowledges that the fertilized, genetically altered oncomouse egg is an invention under our Patent Act, R.S.C. 1985, c. P-4 (para. 162). Thereafter, we part company, because my colleague goes on to conclude that the resulting oncomouse, that grows from the patented egg, is not itself patentable because it is not an invention. Subject matter patentability, on this view, is lost between two successive stages of a transgenic mouse's genetically pre-programmed growth. In my opinion, with respect, such a "disappearing subject-matter" exception finds no support in the statutory language.

4     A patent, of course, does not give its holder a licence to practise the invention free of regulatory control (any more than an unpatented invention enjoys such immunity). On the contrary, the grant of a patent simply reflects the public interest in promoting the disclosure of advancements in learning by rewarding human ingenuity. Innovation is said to be the lifeblood of a modern economy. We neglect rewarding it at our peril. Having disclosed to the public the secrets of how to make or use the invention, the inventor can prevent unauthorized people for a limited time from taking a "free ride" in exploiting the information thus disclosed. At the same time, persons skilled in the art of the patent are helped to further advance the frontiers of knowledge by standing on the shoulders of those who have gone before.

5     The issues being thus identified, I think the majority decision of the Federal Court of Appeal was correct. The appeal should be dismissed.

     A. Statutory Interpretation

6     The issue, in the words of s. 2 of the Patent Act, is whether the oncomouse that has been produced by a combination of genetic engineering and natural gestation is a "composition of matter" that is new, unobvious and useful. If it is, then the President and Fellows of Harvard University, who funded the research, are entitled to a patent. My colleague, Bastarache J., writes of the oncomouse as follows (at para. 163):

     The fact that it has this predisposition to cancer that makes it valuable to humans does not mean that the mouse, along with other animal life forms, can be defined solely with reference to the genetic matter of which it is composed. [Emphasis added.]

7     While acknowledging, therefore, that the oncomouse is a "composition of [genetic] matter", my colleague's contention is that the oncomouse is a "composition of [genetic] matter" plus something else, undefined. The respondent, however, does not claim to have invented the "plus". Its sole claim is to have modified what my colleague describes as the "genetic matter of which [the oncomouse] is composed", as described in the disclosure portion of the patent application:

     (i)the desired oncogene is obtained from the genetic code of a non-mammal source, such as a virus;

     (ii)a vehicle for transporting the oncogene into the mammal's chromosomes is constructed using a small piece of circular bacterial DNA referred to as a plasmid; the plasmid is chemically cut and the oncogene is chemically "spliced" into the plasmid;

     (iii) the plasmid containing the oncogene is then mechanically injected into
fertilized eggs at a site called the male pronucleus;

     (iv)the eggs are then implanted in a host mammal or "foster mother";

     (v)the eggs are permitted to develop and the offspring are delivered by the foster mother;

     (vi)after delivery, the offspring are tested for the presence of the oncogene; the offspring that contain the oncogene are called "founder" animals;

     (vii) founder animals are subsequently mated with ordinary animals and
the offspring are again tested for the presence of the oncogene before the offspring are used in research.

8     As will be explained more fully below, I believe that the extraordinary scientific achievement of altering every single cell in the body of an animal which does not in this altered form exist in nature, by human modification of "the genetic material of which it is composed", is an inventive "composition of matter" within the meaning of s. 2 of the Patent Act.

9     The position taken by the Commissioner of Patents is, I think, curious. While expressly acknowledging that the oncomouse is new, useful and non-obvious, and therefore meets the usual statutory criteria, the Commissioner of Patents denies that "higher life forms" fall within the subject matter contemplated by Parliament as patentable. He says, at para. 51 of his factum:

     In 1869, when Parliament first made provision for the patenting of "any new and useful ... manufacture, or composition of matter", genetic engineering was unheard of. Thus, Parliament could not at the time of enactment have intended that higher life forms would come within the meaning of those words. [Emphasis added.]

10     It is true, of course, that in 1869, when the post-Confederation patent act was passed, Parliament did not contemplate genetically engineered "higher life forms" (Act respecting Patents of Invention, S.C. 1869, c. 11). Parliament in 1869 did not contemplate genetically engineered "lower life forms" either, although in recent years Canadian patents have regularly been issued for such inventions. (My colleague, Bastarache J., at para. 201, affirms that "lower life" forms will continue to be patentable.) Nor did Parliament in 1869 contemplate moon rockets, antibiotics, telephones, e-mail or hand-held computers. The proper question is not whether Parliament intended to include "oncomice" or "higher life forms" or biotechnology generally in patent legislation, but whether Parliament intended to protect "inventions" that were not anticipated at the time of enactment of the Patent Act, or indeed, at any time before the claimed invention.

11     I accept, as does my colleague, that the proper approach to interpretation of this statute is to read the words "in their entire context and in their grammatical and ordinary sense harmoniously with the scheme of the Act, the object of the Act, and the intention of Parliament": Driedger, Construction of Statutes (2nd ed. 1983), at p. 87. In my opinion, with respect, the context and scheme of the Patent Act reinforce the expansive sense of the words "composition of matter" to render the oncomouse patentable. The intent that can properly be attributed to Parliament, based on the language it used and the context of patent legislation generally, is that it considered it to be in the public interest to encourage new and useful inventions without knowing what such inventions would turn out to be and to that end inventors who disclosed their work should be rewarded for their ingenuity. A further indication of Parliament's intent is that the Commissioner of Patents was given no discretion to refuse a patent on the grounds of morality, public interest, public order, or any other ground if the statutory criteria are met: Patent Act, s. 40. In my view, the respondent has fulfilled the statutory criteria and "by law" is entitled to the patent.

     B. International Scope of Intellectual Property Law

12     Intellectual property has global mobility, and states have worked diligently to harmonize their patent, copyright and trademark regimes. In this context, the Commissioner's approach to this case sounds a highly discordant note. Intellectual property was the subject matter of such influential agreements as the International Convention for the Protection of Industrial Property (Paris Convention) as early as 1883. International rules governing patents were strengthened by the European Patent Convention in 1973, and, more recently, the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) in 1994. Copyright was the subject of the Berne Convention for the Protection of Literary and Artistic Works in 1886, revised by the Berlin Convention of 1908 and the Rome Convention of 1928. The Universal Copyright Convention was concluded in 1952. Legislation varies of course, from state to state, but broadly speaking Canada has sought to harmonize its concepts of intellectual property with other like-minded jurisdictions.

13     The mobility of capital and technology makes it desirable that comparable jurisdictions with comparable intellectual property legislation arrive (to the extent permitted by the specifics of their own laws) at similar legal results: Théberge v. Galerie d'Art du Petit Champlain inc., 2002 SCC 34, at para. 6.

14     The appellant Commissioner's definition of unpatentable "higher life forms" includes not only animals but also plants and seeds. Genetically modified foods are controversial, but these are not controversies that should be dealt with by judicial exclusion of "higher life forms" from the definition of "an invention". Parliament itself has clearly signalled its limited view of the role and function of the Patent Act. In 1993, it repealed the prohibition in the former s. 27(3) of the Patent Act against patenting "an invention that has an illicit object in view". It thereby made it clear that granting a patent is not an expression of approval or disapproval. At that time, Parliament did not add a provision, present in the European Patent Convention and in many civil law systems and international agreements, that patents will not be granted for inventions whose use or exploitation would be inconsistent with ordre public, public morality, or environmental or health protection. That type of provision would open the door to value judgments in assessing patentability. Parliament did not endorse such an approach, even though the 1993 amendments were introduced to bring Canadian patent law into compliance with various international agreements. Parliament thereby signalled, however passively, that these important aspects of public policy would continue to be dealt with by regulatory regimes outside the Patent Act.

15     A more recent indication of the government's approach is the Assisted Human Reproduction Act. A discussion paper was placed before the Canadian public in 2000 and a bill placed before Parliament by the Minister of Health as Bill C-56 on May 9, 2002 (re-introduced in the same form as Bill C-13 on October 9, 2002). The bill would prohibit the cloning of human beings, modifying the germ line identity of human beings and the use of human embryos for industrial or commercial purposes. At the same time, Bill C-13 would not prevent inventions in that regard from being patented in Canada. This illustrates, again, the fundamental distinction made by Parliament between patentability of an invention and regulation of activity associated with an invention.

     C. The Commercial and Scientific Context

16     Biotechnology is global in scope. Worldwide demand is expected to more than double from $20 billion in 1995 to $50 billion by 2005. Canada is a significant player. Statistics Canada reports that Canada's biotechnology sector in 1999 generated almost $2 billion in revenues, including $718 million in exports. These revenues are expected to exceed $5 billion in 2002. The Canadian Biotechnology Advisory Committee (CBAC), formed in 1999 to advise the federal government on these matters, recently reported that Canada has more biotechnology companies per capita than any other country: Patenting of Higher Life Forms and Related Issues: Report to the Government of Canada Biotechnology Ministerial Coordinating Committee, June 2002, p. 2. It was calculated by Ernst & Young in its Seventh Annual European Life Sciences Report 2000, that Canada is second behind the U.S. in terms of number of companies, third behind the U.S. and U.K. in revenues, and first in R&D per employee.

17     Genetic tests and "engineered" products hold out the possibility of modifying genetic mutations that either cause a disorder (e.g., Tay-Sachs disease, cystic fibrosis, Huntington's disease) or are responsible for increasing an individual's risk to develop, at some point during his or her lifetime, a particular disease (e.g., breast cancer). In addition, some research indicates a genetic element in some "behavioural illnesses" such as schizophrenia, Alzheimer's, autism, attention-deficit hyperactivity disorder, and Tourette's syndrome: P. S. Florencio, "Genetics, Parenting, and Children's Rights in the Twenty-First Century" (2000), 45 McGill L.J. 527, at p. 535.

18     This is not to suggest that because something is beneficial it is necessarily patentable. As stated, such value judgments have been excluded from the administration of the Patent Act. It is to say, however, that the massive investment of the private sector in biotechnical research is exactly the sort of research and innovation that the Patent Act was intended to promote.

     D. Financing Research and Development

19     As this case demonstrates, even university research has to be paid for, and intellectual property rights are an important contributor.

20     We are told that in the United States (comparable statistics do not seem to be available in Canada), a health-related biotechnology product on average costs between 200 and 350 million dollars (U.S.) to develop, and takes 7 to 10 years from the research and development stage to bring it to market (Biotechnology Use and Development __ 1999, Statistics Canada (March 2001), at p. 25). One would think it in the public interest to shorten the time and reduce the cost of research designed to minimize human suffering, and to reward those who develop research tools (such as the oncomouse) that might make this possible, provided the inventors disclose their work for others to build on.

21     Transgenic mice, including the oncomouse, have a role of potential importance. The evidence is that use of transgenic mice improves the effectiveness of the research that can be done, and shortens the time required to produce results. As Dr. Philip Leder, the co-inventor of the oncomouse, told a Congressional hearing in 1989:

     In the past few weeks, the gene for cystic fibrosis has been identified and the ability to replace this gene, for example, in a mouse, with the defective human cystic fibrosis gene would constitute an extremely powerful model system for the development of an effective treatment.

     For individuals and families at risk for this and other diseases, this would represent a priceless asset.

     (Quoted in T. Schrecker, et al., Ethical Issues Associated With the Patenting of Higher Life Forms (1997), at pp. 25-26.)

22     Dr. Leder's view is widely shared:

     Transgenic mice produced by DNA injection have been employed in a vast range of studies. For instance the method allows evaluation of the effects of gene mutations thought to be implicated in the inception of cancer. It has also contributed greatly to our understanding of the immune defence system. Indeed there are few areas of biology which have not been illuminated by the study of transgenic mice.

     (Extract from J. Bishop, Transgenic Mammals (1999), at p. 7)

23     The CBAC report of June 2002 observed that healthcare is the major beneficiary of biotechnology. "More than 90 percent of the advanced biotechnology products on the world market are related to health. It is expected that about three-quarters of global biotechnology demand will continue to be in this area" (supra, p. 2). Medical research inevitably relates to life, and its products will often impinge, directly or indirectly, on "higher life forms".

24     The practical application of biotechnology is in large measure the preoccupation of enterprises that need to profit from their successes to finance continued research on a broader front. These successes are few and far between (Biotechnology Use and Development __ 1999, supra, at pp. 13-14). It seems Du Pont spent about US $15 million to fund the oncomouse research: C. Arthur, "The onco-mouse that didn't roar" (1993), 138 New Scientist 4. Leder, the afore-mentioned co-inventor of the Harvard mouse, made the point to Congress as follows:

     [T]he great and costly engine for invention can only be effectively driven with the support from the private sector, motivated to serve a public need.

     The patent system offers the only protection available for the intellectual product of this research, and thus, the only hope of a fair return against the great financial risks that investment in biotechnology entails.

     (Quoted in Schrecker, supra, at p. 25)

25     There are those who question the level of incentive required to induce sufficient research in the biomedical field. Professor Richard Gold of McGill University argues:

     The argument for greater patent protection should be understood for what it is: an attempt to maximize profit, not to maximize levels of innovation. Clearly, a company would prefer to have as large a monopoly as possible.... But patent law is not about individual profit maximization; it is about maximizing the overall level of innovation in society. The two do not necessarily go together.

     (E. R. Gold, "Biomedical Patents and Ethics: A Canadian Solution" (2000), 45 McGill L.J. 413, at p. 423)

     Nevertheless it is indisputable that vast amounts of money must be found to finance biomedical research. It is necessary to feed the goose if it is to continue to lay the golden eggs. The Patent Act embodies the public policy that those who directly benefit from an invention should be asked, through the patent system, to pay for it, at least in part.

     E. Patenting Life Forms in Canada

26     My colleague, Bastarache J., comments that "[t]he patentability of lower life forms is not at issue before this Court, and was in fact never litigated in Canada" (para. 198). However, certain enzyme products (which are living matter) were held to be patentable by this Court 60 years ago in Continental Soya Co. v. J. R. Short Milling Co., [1942] S.C.R. 187, as were engineered micro-organisms used as an antibiotic in Laboratoire Pentagone Ltée v. Parke Davis & Co., [1968] S.C.R. 307.

27     The attempt to patent life forms last came before this Court in Pioneer Hi-Bred Ltd. v. Canada (Commissioner of Patents), [1989] 1 S.C.R. 1623. In that case, a patent was sought for a new soybean variety developed from artificial crossbreeding and selection, but cultivated naturally. The applicant's "disclosure" consisted of depositing seed samples with the Patent Office. This Court upheld the rejection of the patent application on the basis that filing a seed sample did not meet the disclosure requirements of s. 36(1) of the Patent Act, R.S.C. 1970, c. P-4, which then (as now (s. 27(3)) required the inventor to set forth clearly the various steps required to make the "composition of matter, in such full, clear, concise and exact terms as to enable any person skilled in the art or science to which it pertains, or with which it is most closely connected, to make ... it". In light of the deficient disclosure, the Court expressly declined to go on to consider whether the new soybean variety could be regarded as an invention within the meaning of s. 2.

28     In the course of his reasons for the Court, however, Lamer J. (as he then was) pointed out an important distinction between two approaches to "genetic engineering". The first method (employed by Pioneer Hi-Bred) was hybridization and selection. In this method, "[t]here is thus human intervention ... which does not alter the actual rules of reproduction, which continues to obey the laws of nature" (pp. 1632-33).

29     The second method (which was used here to develop the oncomouse) requires

     change in the genetic material __ an alteration of the genetic code affecting all the hereditary material __ since in the latter case the intervention occurs inside the gene itself. The change made is thus a molecular one and the "new" gene is thus ultimately the result of a chemical reaction, which will in due course lead to a change in the trait controlled by the gene. While the first method [crossbreeding] implies an evolution based strictly on heredity and Mendelian principles, the second also employs a sharp and permanent alteration of hereditary traits by a change in the quality of the genes. [p. 1633]

30     I do not think Lamer J. expressed any doubt that an "alteration of the genetic code affecting all the hereditary material" produced "an invention" (although he did not decide the point). His doubts seemed rather to be related to whether crossbreeding without altering the genetic code using modern variants of techniques that are almost as old as agriculture itself was inventive within the scope of the Act:

     The courts have regarded creations following the laws of nature as being mere discoveries the existence of which man has simply uncovered without thereby being able to claim he has invented them. Hi-Bred is asking this Court to reverse a position long defended in the case law. [p. 1634]

     The Harvard researchers did not merely "uncover" a naturally occurring oncomouse. The complexity of the genetic splicing did not "follow" the laws of nature, but was a human intervention of a high order. They engineered that part of its genetic code that appears to be responsible for its commercial value.

31     Reference should also be made to Re Application of Abitibi Co. (1982), 62 C.P.R. (2d) 81 (Patent Appeal Board), in which the applicant sought to patent a living organism, namely a "mixed fungal yeast culture system" (p. 83) useful in digesting effluent from wood pulp mills. In holding the subject matter to be patentable, the Patent Appeal Board rejected the Patent Office's somewhat narrow view "derived from a time when the many gradations of living forms were not as fully apprehended as is now possible" (General Electric Co.'s Application (Patent), [1961] R.P.C. 21, at p. 25, cited in Abitibi at p. 85). Somewhat in advance of its time, the Patent Appeal Board in Abitibi then commented at p. 90 that "[i]f an inventor creates a new and unobvious insect [i.e., a "higher life form"] which did not exist before (and thus is not a product of nature), and can recreate it uniformly and at will, and it is useful (for example to destroy the spruce bud worm), then it is every bit as much a new tool of man as a micro-organism" and thus, subject to certain conditions as to reproducibility, patentable. In relation to the Abitibi micro-organism at hand, the Patent Appeal Board ruled (at p. 91):

     The organism, to be claimed, should not of course have existed previously in nature, for in that event the "inventor" did not create it, and his "invention" is old. It must also be useful, in the sense that it carries out some useful known objective, such as separating oil from sand, producing antibiotics or the like. It cannot be a mere laboratory curiosity whose only possible claim to utility is as a starting material for further research. And it must be sufficiently different from known species that it can be said that its creation involved the necessary element of inventive ingenuity. In the present case we believe the product claims meets these tests, and the [Patent Office] objection should be withdrawn.

32     In Re Application for Patent of Connaught Laboratories (1982), 82 C.P.R. (2d) 32, the Patent Appeal Board allowed that cell lines derived from "higher life forms" were patentable, thus removing another possible dividing line. Not all aspects of "higher life forms" were unpatentable. The Patent Office (now the Canadian Intellectual Property Office) regularly allows patents on human genes, proteins, cells and DNA sequences. Under Canadian law, it is not "life" per se which is unpatentable. The issues are, rather, the view taken by the Commissioner to narrow the range of living matter to be considered patentable, and where in the Patent Act is there statutory authority for the line the Commissioner wants to draw?

     F. Patenting of "Higher Life Forms" in Comparable Jurisdictions

33     In 1873, Louis Pasteur was granted a patent in the United States on a certain yeast, which is a living organism.

34     A patent for the Harvard oncomouse was issued by the United States Patent Office on April 12, 1988 and by the European Patent Office on May 13, 1992, despite the explicit power under the European Patent Convention to refuse a patent based on "morality" or "ordre public". As mentioned earlier, a similar patent has been issued in Japan, and New Zealand has issued a patent for a transgenic mouse.

35     The appellant Commissioner's principal argument is that to allow the oncomouse patent would be to "expand" the scope of the Patent Act (i.e., his factum, paras. 2, 3, 35, 73), but the opposite conclusion reached in so many countries with comparable legislation suggests the contrary. In those jurisdictions, patents for the oncomouse have been issued without any need for legislative amendment, including the United States where the language of our definition of "invention" originated. The Commissioner seeks to restrict the legislative definition of invention, and he does so (in my view) for policy reasons unrelated to the Patent Act or to its legitimate role and function.

36     The majority of the Federal Court of Appeal in this case found persuasive the interpretative principles applied by the United States Supreme Court in Diamond v. Chakrabarty, 447 U.S. 303 (1980). In that case the inventor, Al Chakrabarty, had genetically engineered bacteria capable of breaking down crude oil spills. The invention was environmentally useful but the bacteria, necessarily, were alive. One of the arguments made by the U.S. Commissioner of Patents and Trademarks, echoed in this appeal before us 22 years later, was that

     micro-organisms cannot qualify as patentable subject matter until Congress expressly authorizes such protection. [The Commissioner's] position rests on the fact that genetic technology was unforeseen when Congress enacted § 101. From this it is argued that resolution of the patentability of inventions such as respondent's should be left to Congress. The legislative process, the [Commissioner] argues, is best equipped to weigh the competing economic, social, and scientific considerations involved, and to determine whether living organisms produced by genetic engineering should receive patent protection. [p. 314]

37     Burger C.J.'s answer (at p. 315), also applicable here, was that "[i]t is, of course, correct that Congress, not the courts, must define the limits of patentability; but it is equally true that once Congress has spoken it is `the province and duty of the judicial department to say what the law is'". The 5-4 majority held at pp. 309-10 that the inventor's micro-organism

     plainly qualifies as patentable subject matter. His claim is not to a hitherto unknown natural phenomenon, but to a nonnaturally occurring manufacture or composition of matter __ a product of human ingenuity "having a distinctive name, character [and] use". [Emphasis added.]

     The proper distinction was not living versus inanimate but between the discovery of a product of nature (whether living or not) versus a human-made invention. Burger C.J. did not subscribe to the notion that patents could be obtained for "anything under the sun that is made by man", quoted as part of his narrative in footnote 6. In fact, at p. 309, he specifically states that "[T]his is not to suggest that [the Act] has no limits or that it embraces every discovery". On the contrary, the patent issued because its subject matter was held to be a "manufacture" or "composition of matter" within the statutory test laid down by Congress. "A rule that unanticipated inventions are without protection would conflict with the core concept of the patent law that anticipation undermines patentability" (Chakrabarty, at p. 316).

38     The appellant Commissioner argues that Chakrabarty should be rejected because of differences he perceives in the legislative history in Canada and the United States, an allegedly different common understanding of what "composition of matter" meant when the Patent Act was passed in 1869, and subsequent legislative action in Canada in 1990 with respect to plant breeders (factum, at paras. 60 and 61). In my view, for reasons given below, these distinctions are not well founded but, in any event, the only interest we have in Chakrabarty is the extent to which its reasoning adds persuasive force to the respondent's argument and confirms harmony, broadly speaking, in intellectual property matters among like-minded jurisdictions.

     G. The Interpretation of Section 2 of the Patent Act

39     The appellant Commissioner denies that a patent can be obtained in Canada for "anything under the sun that is made by man" and I agree. He says that this expression, used in Congressional hearings in 1952, distinguishes the U.S. legislative history from ours, but this is not so, strictly speaking. A 1952 expression of opinion by a Congressional Committee almost 150 years after the definition was inserted into the U.S. Patent Act of 1793 is scarcely contemporanea expositio.

40     The check on the indiscriminate grant of patents lies in the established criteria of utility, novelty and non-obviousness. Those are the criteria judged by Parliament to be relevant to its statutory purpose, which is to encourage ingenuity by rewarding its disclosure. The expression "composition of matter" was included in our patent laws prior to Confederation. It appears in 1824 in the Lower Canada statute entitled An Act to promote the progress of useful Arts in this Province, 4 Geo. 4, c. 25, and in Upper Canada two years later in An Act to Encourage the Progress of Useful Arts within this Province, 7 Geo. 4, c. 5. The 1826 Act included the terms "manufacture" and "composition of matter" in the preamble setting out its object:

     Whereas it is expedient for the encouragement of Genius and of Arts in this Province to secure an exclusive right to the Inventor of any New and Useful Art, Machine, Manufacture, or Composition of Matter ...

41     Section 91(22) of the Constitution Act, 1867, assigned legislative competence in respect of "Patents of Invention and Discovery" to Parliament which two years later defined patentable subject matter as follows:

     Any person ... having invented or discovered any new and useful art, machine, manufacture, or composition of matter, or any new and useful improvement on any art, machine, manufacture or composition of matter, not known or used by others before his invention or discovery thereof, or not being at the time of his application for a patent in public use or on sale in any of the Provinces of the Dominion with the consent or allowance of the inventor or discoverer thereof ... [Emphasis added.]

     (Patent Act, S.C. 1869, c. 11, s. 6)

     The wording has not changed much in the intervening years, apart from dropping the reference to "discovery". Section 2 of the present Patent Act now provides as follows:

     "invention" means 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.

     « invention » Toute réalisation, tout procédé, toute machine, fabrication ou composition de matières, ainsi que tout perfectionnement de l'un d'eux, présentant le caractère de la nouveauté et de l'utilité.

42     It is common ground that to meet the subject matter criteria of the Patent Act the oncomouse must qualify as a "composition of matter" or a "manufacture".

     (i) "Composition of Matter"

43     "Composition of matter" (composition de matières) is an open-ended expression. Statutory subject matter must be framed broadly because by definition the Patent Act must contemplate the unforeseeable. The definition is not expressly confined to inanimate matter, and the appellant Commissioner agrees that composition of organic and certain living matter can be patented. In the case of the oncomouse, the modified genetic material is a physical substance and therefore "matter". The fertilized mouse egg is a form of biological "matter". The combination of these two forms of matter by the process described in the disclosure is thus, as pointed out by Rothstein J.A. ([2000] 4 F.C. 528, at para. 120), a "composition of matter".

44     What, then, is the justification under the Patent Act for drawing a line between certain compositions of living matter (lower life forms) and other compositions of living matter (higher life forms)?

45     My colleague, Bastarache J., quotes from the Oxford English Dictionary (2nd ed. 1989) vol. IX, at p. 480, the entry that "matter" is a "[p]hysical or corporeal substance in general ..., contradistinguished from immaterial or incorporeal substance (spirit, soul, mind), and qualities, actions, or conditions", but this, of course, depends on context. "Matter" is a most chameleon-like word. The expression "grey matter" refers in everyday use to "intelligence" __ which is about as incorporeal as "spirit" or "mind". Indeed, the same Oxford editors define "grey matter" as "intelligence, brains" (New Shorter Oxford English Dictionary (1993), vol. 1, p. 1142). The primary definition of matter, according to the Oxford English Dictionary, is "[t]he substance, or the substances collectively, out of which a physical object is made or of which it consists; constituent material" (at p. 479). The definition of "matière" in Le Grand Robert, quoted by my colleague, is to the same effect. The question, then, is what, in the Commissioner's view, is the "constituent material" of the oncomouse as a physical entity? If the oncomouse is not composed of matter, what, one might ask, are such things as oncomouse "minds" composed of? The Court's mandate is to approach this issue as a matter (that slippery word in yet another context!) of law, not murine metaphysics. In the absence of any evidence or expert assistance, the Commissioner now asks the Court to take judicial notice of the oncomouse, if I may use Arthur Koestler's phrase, as a "ghost in a machine" but this pushes the scope of judicial notice too far. With respect, this sort of literary metaphor (or its dictionary equivalent) is an inadequate basis on which to narrow the scope of the Patent Act, and thus to narrow the patentability of scientific invention at the dawn of the third Millennium.

     (ii) Defining the Exception for "Higher Life Forms"

46     The appellant Commissioner says the Federal Court of Appeal erred by allowing a patent on a "higher intelligent life form", but he himself offers no definition of an "intelligent" life form, much less does he identify a dividing line between a "higher" intelligent life form and a "lower" intelligent life form.

47     The Patent Act does not distinguish, in its definition of invention, between subject matter that is less complex ("lower life forms") and subject matter that is more complex ("higher life forms"). The degree of complexity is not a criterion found in the Act or in the jurisprudence in determining patentability. The distinction between "lower life forms" and "higher life forms" in its application to s. 2 is the invention of the Patent Office.

48     While refusing to issue a patent for a higher animal life form in this case, the Commissioner has issued patents under the Patent Act for higher plant life forms: see, e.g., Canadian Patent 1,313,830 issued February 23, 1993 for "Round-up Ready Canola", a genetically modified plant, recently before the courts in Monsanto Canada Inc. v. Schmeiser, [2002] F.C.J. No. 1209 (QL) (C.A.).

49     The CBAC report says, at p. 6:

     The term "higher life form" is not defined in law. In common usage, it includes plants and non-human animals other than single-celled organisms.

     The line, on this view, is not drawn between sentient beings and non-sentient beings or intelligent beings and unintelligent beings, but between simple one-cell organisms (such as bacteria) and their more complicated cousins, perhaps as rudimentary as moulds or other fungi.

50     Other approaches abound. In a paper prepared for the Intellectual Property Policy Directorate of Industry Canada, A Study of Issues Relating to the Patentability of Biotechnological Subject Matter (1996), J. R. Rudolph offered the following explanation, at pp. 11-12:

     Microorganisms are a large and diverse group of organisms consisting of only one cell or cell clusters of prokaryotic or eucaryotic cells. Examples of eukaryotic organisms are algae, fungi, molds and yeasts. An example of prokaryotes is bacteria. An important distinction between single cells or cell clusters which are microorganisms, and single cells or cell clusters which are not microorganisms, is that microbial cells are able to live alone in nature: single animal or plant cells or cell clusters are unable to exist by themselves in nature and can only be successful in either a specialized environment such as a culture system (typically created by man in the laboratory) or as part of a multicellular organism such as a plant or animal. The so-called "higher life forms" are complex multicellular organisms such as simple plants or oysters, for example, which contain thousands or hundreds of thousands of cells. The human, which is a complex multicellular organism, has been estimated to contain at least 1014 cells. [Emphasis added.]

51     My colleague, Bastarache J., takes the view that a key factor is "the unique ability of higher life forms to self-replicate" (para. 170), but in fact self-reproduction is also a fundamental characteristic of "lower life forms". Indeed, one of the most widely held objections to the genetically engineered bacteria in the Chakrabarty case was the potential for such unnatural bacteria to escape and reproduce in the wild with unknown consequences for the environment.

52     The various distinctions attempted to be made between "patentable" lower life composition of matter and "unpatentable" higher life composition of matter, shows, I think, the arbitrariness of the Commissioner's approach. My colleague writes at para. 199:

     The distinction between lower and higher life forms, though not explicit in the Act, is nonetheless defensible on the basis of common sense differences between the two.

     With respect, there seems to be as many versions of "common sense" as there are commentators:

     (1)Some would say all living organisms are excluded (e.g., Brennan J. for the dissenters in Chakrabarty);

     (2)Some would allow micro-organisms but only those that can be produced en masse with identical features, like bacteria. In Re Abitibi, supra, the Patent Appeal Board recommended that patents extend "to all new life forms which are produced en masse as chemical compounds are prepared, and are formed in such large numbers that any measurable quantity will possess uniform properties and characteristics" (p. 89). "Mass" live organisms have a long history of patentability, including food products such as beer and yogurt.

     (3) Then there are the proponents of "higher life" organisms versus "lower life" organisms, the latter being defined by the CBAC as having only a single cell.

     (4)Others divide the universe between prokaryotic cells (e.g., bacteria and certain forms of algae) and eukaryotic cells (more complex life forms) and consider "higher" life forms to start only with more "complex" multicellular organisms.

     (5)The Patent Appeal Board allowed multi-celled organisms such as moulds and fungi in Connaught Laboratories, supra.

     (6)Some argue that "complex life forms" are unpatentable. Nadon J. took this position at trial in this case, [1998] 3 F.C. 510, at para. 35.

     (7)The Commissioner issues patents for genetically modified complex plants (Monsanto, supra) but refuses to issue a patent for a genetically modified complex mouse.

     (8)Others draw the line at sentient beings.

     (9)Still others draw the line at "intelligent" beings.

     (10)The Commissioner opened his argument in this case by asking whether "a complex intelligent living being could be considered an invention".

53     In my view, none of these proposed dividing lines arise out of the present text of the Patent Act. All of them are policy driven and, if they are to be introduced at all, should be introduced by Parliament.

54     The Federal Court of Appeal and CBAC drew the line at human bodies in their entirety at any stage of development, as discussed below. The true basis for the exclusion is not extraneous to the Patent Act but lies in an explicit limitation in s. 40 which provides that:

     40. Whenever the Commissioner is satisfied that an applicant is not by law entitled to be granted a patent, he shall refuse the application ... [Emphasis added.] 40. Chaque fois que le commissaire s'est assuré que le demandeur n'est pas fondé en droit à obtenir la concession d'un brevet, il rejette la demande ... [Je souligne.] The reference to "by law" is not limited to the Pat