A. Statutory Interpretation

     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.]

     (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.

     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.]

     B. International Scope of Intellectual Property Law

     C. The Commercial and Scientific Context

     D.Financing Research and Development

     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.)

     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)

     [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.)

     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

     a 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]

     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.

     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.

     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.

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

     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]

     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).

     G. The Interpretation of Section 2 of the Patent Act

     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 . . . .

     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.]

     (Act respecting Patents of Invention, 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.

     (i) "Composition of Matter"

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

     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. [Emphasis added.]

     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.

     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.]

     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".

     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 . . . [Emphasis added.]

     The reference to "by law" is not limited to the Patent Act itself (as the French version "fondé en droit" makes clear). It has been established for over 200 years that people cannot, at common law, own people: Somerset v. Stewart (1772), Lofft 1, 98 E.R. 499 (K.B.). The issue of whether a human being is a "composition of matter" does not, therefore, arise under the Patent Act. If further reinforcement is required, ss. 7 and 15 of the Canadian Charter of Rights and Freedoms would clearly prohibit an individual from being reduced to a chattel of another individual.

     (iii) "Manufacture"

     H. Negative Inference from the Plant Breeders' Rights Act

     [I]t may well be that the Plant Breeders' Rights Act was passed not out of recognition that higher life forms are not a patentable subject matter under the Patent Act, but rather out of recognition that plant varieties deserve some form of intellectual property protection despite the fact that they often do not meet the technical criteria of the Patent Act.

     The rights available under the Plant Breeders' Rights Act fall well short of those conferred by patent, both in comprehensiveness and in duration.

     I. Nature of Rights Granted by a Patent

     It is crucial for rational debate on questions related to what should or should not be patentable to recognize that patents confer only prohibitive rights. The Canadian patent system is not designed to decide about what uses of technology are permissible nor is the Patent Act designed to prevent dangerous or ethically questionable inventions from being made, used, sold or imported. The responsibility and tools for dealing with such matters resides elsewhere (e.g., through regulatory approval or product safety processes). [Emphasis added.]

     I agree with this observation. This is not to say that patents are "neutral", or have no link to the ethical and social issues raised by the interveners. It is to say that those issues transcend the narrow question of patentability circumscribed by ss. 2 and 40 of the Patent Act.

     J. A Working Definition of "Life"

     K. The Ongoing Parliamentary Process in Canada

     No patent shall be granted on human bodies at any stage of development.

     This, as earlier stated, is consistent with both the common law and the Charter. Such an amendment, the CBAC reasoned, at p. 9, would

     apply only to entire human bodies from the zygote to an adult body; DNA sequences, gametes, stem and other cells, or organs will remain patentable. [Emphasis added.]

     L. Policy Arguments Against Granting a Patent for the Oncomouse

     (i) The Religious Objection

     Although some in society may hold the view that higher life forms are mere "composition[s] of matter", the phrase does not fit well with common understandings of human and animal life.

     (ii) The "Lack of Regulatory Framework" Objection

     . . . the fact that the Patent Act in its current state 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.

     With respect, I do not agree.

     . . . the intention of a legislature must be gathered from the language it has used and the task of construing that language is not to satisfy ourselves that as used it is adequate to an intention drawn from general considerations or to a purpose which might seem to be more reasonable or equitable than what the language in its ordinary or primary sense indicates. [Emphasis added.]

     This passage was quoted with approval in a patent context by Pigeon J. in Tennessee Eastman Co. v. Commissioner of Patents, [1974] S.C.R. 111, at p. 121, and again by Lamer J. in Pioneer Hi-Bred, supra, at p. 1643. What I consider to be the Commissioner's misinterpretation of s. 2 of the Patent Act proceeds, with respect, from "general considerations" of what he considers to be "reasonable or equitable" regulation of a controversial area of biotechnology. His views may or may not reflect desirable public policy but they have nothing to do with "the language" used by Parliament in s. 2 of the Patent Act.

     (iii) The "Laws of Nature" Objection

     Although the natural gestation process is required to allow the fertilized mouse egg to develop, this does not mean the organism ceases to become a "composition of matter" as it develops from the single-cell stage into an oncomouse. The founder oncomouse is therefore itself a composition of matter.

     (iv) The "De Minimis" Objection

     A person whose genetic make-up is modified by radiation does not cease to be him or herself. Likewise, the same mouse would exist absent the injection of the oncogene into the fertilized egg cell; it simply would not be predisposed to cancer.

     . . . a familial disease of infancy in which there is a progressive degeneration of nerve cells throughout the whole nervous system and in the retina. It is characterized clinically by progressive muscular weakness and paralysis, mental deterioration and blindness, usually leading to death in coma or convulsions towards the end of the second year.

     (Butterworths Medical Dictionary (2nd ed. 1978), at p. 1496)

     Any suggestion that a child with or without the mutant Tay-Sachs gene is "the same person" would seriously underestimate the power of the science that we are being asked to consider.

     (v) Ordre Public or Morality

     In the case at hand three different interests are involved and require balancing: there is a basic interest of mankind to remedy widespread and dangerous diseases, on the other hand the environment has to be protected against the uncontrolled dissemination of unwanted genes and, moreover, cruelty to animals has to be avoided. The latter two aspects may well justify regarding an invention as immoral and therefore unacceptable unless the advantages, i.e. the benefit to mankind, outweigh the negative aspects.

     (Grant of European patent No. 0 169 762 (Onco-mouse/Harvard) (1992), OJ EPO 1992, 588, at pp. 591-92)

     We do not possess such a "balancing" test in our Patent Act, though some thought must have been given to it when Parliament "opened up" the Patent Act for NAFTA and TRIPS-related amendments in 1994.

     (vi) Unjust Enrichment

     Some patents for processes may be of little practical value. To discover that a competitor is carrying out the process may be difficult. If a process produces a living organism that reproduces itself, the process may have to be carried out only once: competitors who are able to get their hands on the organism need not repeat the process of producing it. What is needed is a patent for the organism . . . .

     (W. L. Hayhurst, "Exclusive Rights in Relation to Living Things" (1991), 6 I.P.J. 171, at p. 177)

     (vii) Animal Rights

     (viii) The Commodification of Human Life

     (ix) Environmental Protection

     (x) Globalization

     (xi) Contrary Considerations

     (xii) Policy Options

     M. Alleged Deficiencies in the Patent Regime

     N. Conclusion

     The judgment of L'Heureux-Dubé, Gonthier, Iacobucci, Bastarache, and LeBel JJ. was delivered by

     BASTARACHE J. --

     I. Introduction

     II. Factual Background

     III.  Relevant Statutory Provisions

     124Patent Act, R.S.C. 1985, c. P-4

     2. In this Act, except as otherwise provided,
. . .
"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;

     2. Sauf disposition contraire, les définitions qui suivent s'appliquent à la présente loi.

     . . .

     « 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.

     27. (1) The Commissioner shall grant a patent for an invention to the inventor or the inventor's legal representative if an application for the patent in Canada is filed in accordance with this Act and all other requirements for the issuance of a patent under this Act are met.

     40. Whenever the Commissioner is satisfied that an applicant is not by law entitled to be granted a patent, he shall refuse the application and, by registered letter addressed to the applicant or his registered agent, notify the applicant of the refusal and of the ground or reason therefor.

     IV. Judicial History
A. Decision of the Patent Examiner -- Final Action (March 24, 1993)

     C. Federal Court, Trial Division, [1998] 3 F.C. 510

     D. Federal Court of Appeal, [2000] 4 F.C. 528

     (1) Rothstein J.A.

     (2) Isaac J.A. (dissenting)

     In all the circumstances of this case, including the limited role that our jurisprudence has assigned to the courts in this area and the serious moral and ethical implications of this subject-matter, it seems to me that Parliament is the most appropriate forum for the resolution of the issues in dispute here.

     V. Analysis

     A. The Commissioner's Power to Refuse a Patent under Section 40

     I have underlined by law [in s. 42] to stress that this is not a matter of discretion: the Commissioner has to justify any refusal. As Duff C.J. said in Vanity Fair Silk Mills v. Commissioner of Patents (at p. 246):

     No doubt the Commissioner of Patents ought not to refuse an application for a patent unless it is clearly without substantial foundation. . . . [Emphasis in original.]

     . . . if a method of treatment consisting in the application of a new drug could be claimed as a process apart from the drug itself, then the inventor, by making such a process claim, would have an easy way out of the restriction in s. 41(1).

     B. The Definition of "Invention": Whether a Higher Life Form Is a "Manufacture" or a "Composition of Matter"

     (1) The Words of the Act

     . . . all compositions of two or more substances and . . . all composite articles, whether they be the results of chemical union, or of mechanical mixture, or whether they be gases, fluids, powders or solids.

     In Chakrabarty, the majority attributed the widest meaning possible to the phrases "composition of matter" and "manufacture" for the reason that inventions are, necessarily, unanticipated and unforeseeable. Burger C.J., at p. 308, also referred to the fact that the categories of invention are prefaced by the word "any" ("any new and useful process, machine, manufacture, or composition of matter"). Finally, the Court referred to extrinsic evidence of Congressional intent to adopt a broad concept of patentability, noting at p. 309 that: "The Committee Reports accompanying the 1952 Act inform us that Congress intended statutory subject matter to `include anything under the sun that is made by man'".

     The action or process of making by hand . . . . The action or process of making articles or material (in modern use, on a large scale) by the application of physical labour or mechanical power.

     The Grand Robert de la langue française (2nd ed. 2001), vol. 3, at p. 517, defines thus the word "fabrication":

     [TRANSLATION] Art or action or manufacturing. . . . The manufacture of a technical object (by someone). Manufacturing by artisans, by hand, by machine, industrially, by mass production . . . .

     In Chakrabarty, supra, at p. 308, "manufacture" was defined as

     the production of articles for use from raw or prepared materials by giving to these materials new forms, qualities, properties, or combinations, whether by hand-labor or by machinery.

     These definitions use the terminology of "article", "material", and "objet technique". Is a mouse an "article", "material", or an "objet technique"? In my view, while a mouse may be analogized to a "manufacture" when it is produced in an industrial setting, the word in its vernacular sense does not include a higher life form. The definition in Hornblower v. Boulton (1799), 8 T.R. 95, 101 E.R. 1285 (K.B.), cited by the respondent, is equally problematic when applied to higher life forms. In that case, the English courts defined "manufacture" as "something made by the hands of man" (p. 1288). In my opinion, a complex life form such as a mouse or a chimpanzee cannot easily be characterized as "something made by the hands of man".

     It is argued that the very nature of the patent system and the benefits that were expected therefrom should lead to the conclusion that Parliament intended the most open and favourable approach to its statute. Maybe so, but I do not think that such an approach would permit the interpreter to dispense with the necessity to respect the results suggested by a careful analysis of the terms used in the statute. Besides, speaking of the intention of Parliament, given that plant breeding was well established when the Act was passed, it seems to me that the inclusion of plants within the purview of the legislation would have led first to a definition of invention in which words such as "strain", "variety" or "hybrid" would have appeared . . . .

     While the first method 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.

     It is thus possible that Parliament did not regard crossbred plants and animals as patentable, not because they are higher life forms, but because they are better regarded as "discoveries". Unable to anticipate genetic alteration, Parliament would not have foreseen that higher life forms could be created in a manner reasonably understood as an invention. If this is the case, we should be wary of applying too broad or literal an interpretation of the phrase "composition of matter". Even if higher life forms were more easily cognizable as "composition[s] of matter", I still would find it difficult to conclude that the definition of "invention" was intended to be sufficiently broad to include higher life forms.

     (2) The Scheme of the Act

     . . . it seems to me that the inclusion of plants within the purview of the legislation would have led . . . to the enactment of special provisions capable of better adapting the whole scheme to a subject matter, the essential characteristic of which is that it reproduces itself as a necessary result of its growth and maturity. I do not dispute the appellant's contention that those who develop new types of plants by cross-breeding should receive in this country, as they do elsewhere, some kind of protection and reward for their efforts but it seems to me that, to assure such result, the legislator will have to adopt special legislation, as was done a long time ago in the United States and in many other industrialized countries.

     Marceau J.A.'s observation in this regard is compelling. The patenting of higher life forms raises special concerns that do not arise in respect of non-living inventions. Unlike other inventions, biologically based inventions are living and self-replicating. In addition, the products of biotechnology are incredibly complex, incapable of full description, and can contain important characteristics that have nothing to do with the invention (see Canadian Biotechnology Advisory Committee, Patenting of Higher Life Forms and Related Issues: Report to the Government of Canada Biotechnology Ministerial Coordinating Committee, June 2002, at p. 11; see also Rudolph, supra, at p. 5). In my view, the fact that the Patent Act in its current state 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.

     First, the values content of the issues calls for a Parliamentary rather than a judicial approach. Second, the responses we received from the research community suggest that researchers do not feel that the current research exception is sufficiently clear. Third, studies have illustrated that the failure to have a clear research exception has curtailed important health research. Fourth, the member states of the European Union have included experimental use exceptions in their patent legislation without any apparent negative effect . . . . Fifth, provincial governments have called for a clarification of the experimental use exception in Canada.

     The pig receives human genes. The human receives pig organs. Where does the pig end and the human begin? How much DNA does it take before one becomes the other? The answer to these questions, once ridiculous and offensive, may now just be a matter of degree.

     The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions.

     The second paragraph allows for a patent on "[a]n element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene . . . even if the structure of that element is identical to that of a natural element". Paragraph 1 of article 6 sets out a general exception to patentability for inventions where their commercial exploitation would be contrary "to ordre public or morality". Paragraph 2 further specifies that processes for cloning human beings, processes for modifying the germ line genetic identity of human beings and uses of human embryos for industrial or commercial purposes are all considered unpatentable as being contrary to "ordre public or morality".

     (3) The Object of the Act

     The patent laws attempt to reconcile this Nation's deep-seated antipathy to monopolies with the need to encourage progress. Deepsouth Packing Co. v. Laitram Corp., 406 U.S. 518, 530-531 (1972); Graham v. John Deere Co., 383 U.S.1, 7-10 (1966). Given the complexity and legislative nature of this delicate task, we must be careful to extend patent protection no further than Congress has provided. In particular, were there an absence of legislative direction, the courts should leave to Congress the decisions whether and how far to extend the patent privilege into areas where the common understanding has been that patents are not available.

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

     If newly developed living organisms not naturally occurring had been patentable under § 101 [the equivalent to the definition of "invention" in s. 2 of the Canadian Patent Act], the plants included in the scope of the 1930 and 1970 Acts could have been patented without new legislation. Those plants, like the bacteria involved in this case, were new varieties not naturally occurring.

     The minority went on to note, at pp. 321-22:

     . . . the Court's decision does not follow the unavoidable implications of the statute. Rather, it extends the patent system to cover living material even though Congress plainly has legislated in the belief that § 101 does not encompass living organisms. It is the role of Congress, not this Court, to broaden or narrow the reach of the patent laws. This is especially true where, as here, the composition sought to be patented uniquely implicates matters of public concern.

     . . . Bill C-15 is designed to allow Canadian producers access to the best possible plant varieties, whatever country they originate in. It provides for certain rights for plant breeders and outlines their application, and further details restrictions that will apply to these rights to better protect the public interest. The legislation is designed to deal with the complexities of the issue and that is why we have chosen this route rather than to amend the Patent Act.

     (See 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 at p. 1:15.)

     C. Drawing the Line: Is it Defensible to Allow Patents on Lower Life Forms While Denying Patents on Higher Life Forms?

     . . . this decision will extend to all micro-organisms, yeasts, moulds, fungi, bacteria, actinomycetes, unicellular algae, cell lines, viruses or protozoa; in fact 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.

     The nature and commercial uses of biologically pure cultures of microorganisms . . . are much more akin to inanimate chemical compositions such as reactants, reagents, and catalysts than they are to horses and honeybees or raspberries and roses.

     The difference in the end product was noted by Derzko, supra, at p. 161, in reference to the Plant Breeders' Rights Act:

     The rights do not extend to the actual plant. This is done because, unlike inert objects that are patentable, and unlike unicellular organisms that replicate into exact copies of each other, higher organisms such as plants start off from a cell and then grow and differentiate into a complete plant. The difficulty lies in having to decide what should and should not be protected.

     VI. Conclusion

     Appeal allowed, MCLACHLIN C.J. and MAJOR, BINNIE and ARBOUR JJ. dissenting.

     Solicitor for the appellant:  The Attorney General of Canada, Ottawa.

     Solicitors for the respondent:  Smart & Biggar, Ottawa.

     Solicitors for the interveners Canadian Council of Churches and Evangelical Fellowship of Canada: Barnes, Sammon, Ottawa.

     Solicitors 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: The Canadian Environmental Law Association, Toronto.

     Solicitors for the intervener Sierra Club of Canada: The Sierra Legal Defence Fund, Toronto.

     Solicitors for the interveners Animal Alliance of Canada, International Fund for Animal Welfare Inc., and Zoocheck Canada Inc.: Ruby & Edwardh, Toronto.