Supreme Court of Canada
Harvard College v. Canada (Commissioner of Patents)
Canada
2002 SCC 76
Case Details
Printible Version
Summary:
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.
Opinion of the Court:
Harvard College v. Canada (Commissioner of Patents), [2002] 4 S.C.R. 45, 2002 SCC 76
Commissioner of Patents Appellant
v.
President and Fellows of Harvard College Respondent
and
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 Section 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 matières”) 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 applicability 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 of Patents 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; Pioneer Hi‑Bred Ltd. v. Canada (Commissioner of Patents), [1989] 1 S.C.R. 1623, aff’g [1987] 3 F.C. 8, aff’g (1986), 11 C.P.R. (3d) 311 (sub nom. Re Application for Patent of Pioneer Hi‑Bred Ltd.); 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] 1 S.C.R. 249, 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] 2 S.C.R. 559, 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] 2 S.C.R. 336, 2002 SCC 34; Continental Soya Co. v. J. R. Short Milling Co. (Canada) Ltd., [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, aff’g [1987] 3 F.C. 8; 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, [2003] 2 F.C. 165, 2002 FCA 309; Somerset v. Stewart (1772), Lofft 1, 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. 504; Hinks & Son v. Safety Lighting Co. (1876), 4 Ch. D. 607; J.E.M. Ag Supply, Inc. v. Pioneer Hi‑Bred International, Inc., 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] 4 S.C.R. 153, 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 (U.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 to promote the progress of useful Arts in this Province, 4 Geo. 4, c. 25 (L.C.).
Act respecting Patents of Invention, S.C. 1869, c. 11, s. 6.
Agreement on Trade‑Related Aspects of Intellectual Property Rights, 1869 U.N.T.S. 299 (being Annex 1C of the Marrakesh Agreement Establishing the World Trade Organization, 1867 U.N.T.S. 3), art. 27(2).
Assisted Human Reproduction Act, Bill C‑56 (1st reading), 1st Sess., 37th Parl.
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, ss. 1, 7, 15.
Canadian Environmental Protection Act, R.S.C. 1985, c. 16 (4th Supp.).
Constitution Act, 1867, s. 91(22).
Convention for the Creation of an International Union for the Protection of Industrial Property, March 20, 1883.
Convention on the Grant of European Patents, 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 [rep. & sub. c. 33 (3rd Supp.), s. 16] (now s. 42).
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, 21 Ja. 1, c. 3, 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, “Tay-Sachs disease”.
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. 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. Royal Commission on New Reproductive Technologies. Proceed with Care: Final Report of the Royal Commission on New Reproductive Technologies. Ottawa: Minister of Government Service Canada, 1993.
Canada. Statistics Canada. Science, Innovation and Electronic Information Division. Biotechnology Use and Development — 1999 by Chuck McNiven. Ottawa: Statistics Canada, March 2001.
Canada. Canadian Biotechnology Strategy Secretariat. The 1998 Canadian Biotechnology Strategy: An Ongoing Renewal Process. Ottawa: Industry Canada, 1998.
Canadian Biotechnology Advisory Committee. Biotechnology and Intellectual Property: Patenting of Higher Life Forms and Related Issues. Interim Report to the Government of Canada Biotechnology Ministerial Coordinating Committee. Ottawa: Canadian Biotechnology Advisory Committee, November 2001.
Canadian Biotechnology Advisory Committee. Patenting of Higher Life Forms and Related Issues. Report to the Government of Canada Biotechnology Ministerial Coordinating Committee. Ottawa: Canadian Biotechnology Advisory Committee, June 2002.
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, 3rd 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?” (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 House, 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. Prepared for the Canadian Biotechnology Advisory Committee. Ottawa: Canadian Biotechnology Advisory Committee, March 2001.
New Shorter Oxford English Dictionary on Historical Principles, vol. 1. Oxford: Clarendon Press, 1993, “grey matter”.
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 R. 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.
The reasons of McLachlin C.J. and Major, Binnie and Arbour JJ. were delivered by
1 Binnie J. (dissenting) — 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 |
