President and Fellows of Harvard College v. Canada (Commissioner of Patents) (T.D.), [1998] 3 F.C. 510


T-275-96

President and Fellows of Harvard College (Appellant)

v.

Commissioner of Patents (Respondent)

Indexed as: President and Fellows of Harvard Collegev. Canada (Commissioner of Patents) (T.D.)

Trial Division, Nadon J."Ottawa, November 17, 1997 and April 21, 1998.

Patents Appellant seeking to patent transgenic mice containing gene artificially introduced into chromosomes of mammal at embryonic stageGene introduced predisposing mammal to developing malignant tumoursWhether higher life form, mammal, patentableCase law reviewedOrdinary tests of patentability applicable: subject-matter must beinvention, new, useful, unobviousPatent Act not requiring all characteristics be under direct control of inventor but must be element of control and everything about oncomouse except transgene independent of human interventionCreation of oncomouse marriage between nature, human interventionInvention must be reproducible to be patentableMouse not reproducible as term understood in Patent Act.

Animals Commissioner of Patents denying patent for transgenic mice containing gene introduced into chromosomes of mammal at single cell stageFertilized eggs transferred to female mouse, allowed to gestate naturallyOncomouse used to test for carcinogens, cancer-treating productsWhether oncomouseinventionunder Patent Act, s. 2Mouse complex life formNotraw materialgiven new qualities by inventorEssential feature of mouse presence of transgeneNot present without human interventionResult of gestation process variable, unknownMouse not reproducible as term understood in Patent ActLocation, presence, quality of gene uncontrollableComplex life form not within current parameters of Patent Act.

This was an appeal from a decision of the Commissioner of Patents denying appellant's patent application for transgenic mice. The application relates to a transgenic mammal containing a gene that has been artificially introduced into the chromosomes of the mammal at the embryonic stage. The fertilized eggs were then transferred to a female mouse and allowed to gestate naturally. The gene introduced, which is referred to as an oncogene or a myc gene, predisposes the mammal to developing malignant tumours. An oncomouse can be used to test for carcinogens and cancer-treating products. The Commissioner of Patents found that, since the plasmids and the transgenic unicellular material are produced under the full control of the inventor and are reproducible, they are a "manufacture" or a "composition of matter" under section 2 of the Patent Act . However, he concluded that these words do not include a non-human mammal like a mouse which, therefore, does not fall within the definition of "invention". The main issue herein was whether claims 1 through 12 of the patent application relate to patentable subject-matter following the definition of "invention" in section 2 of the Act. In reaching a conclusion on the main issue, the Court had to deal with four separate issues raised by counsel, namely: (1) the degree of the inventor's control over the creation of the claimed invention; (2) the distinction between human intervention and the laws of nature; (3) the relevance of the test of reproducibility and (4) the appropriateness of making distinctions between higher and lower life forms.

Held, the appeal should be dismissed.

Although the issue of patentability of life forms has arisen for consideration before, this is the first time the Court has been faced with the question of whether a higher life form, a mammal, is patentable. Canadian case law allows a patent to be granted for micro-organisms. The ordinary tests of patentability must be applied herein: the subject-matter must be an "invention" according to the definition found in section 2 and it must be new, useful and unobvious. There was no question that the oncomouse is new, useful and unobvious. The issue was whether it is an "invention" under the Patent Act .

(1) A mouse is a complex life form and many of its features are not under the control of the inventors. The latter have created a method to inject eggs with a myc gene, but they have not invented the mouse. It is not necessary for the inventor to directly control all aspects of the natural process leading to the creation of the end product. The ultimate product is unknown and unknowable. A court is not the forum of choice to decide where one can draw the line as to what percentage of characteristics must be controlled before it can be claimed that the entire life form is an invention. A mouse is not "raw material" which was given new qualities by the inventor. Although Patent Act does not require that all characteristics be under the direct control of the inventor, there has to be an element of control and, in the case of the oncomouse, everything except the transgene is present independently of human intervention.

(2) A mere discovery is not patentable subject-matter; there must be some inventive step involved. The essential feature of the mouse is the presence of the transgene and, while the laws of nature are involved, the transgene will not be present without human intervention. The inventor could have a patent for the creation of the plasmid and the injection process but it could not be concluded that the inventor was entitled to a patent over every descendant mouse which possesses that gene. The creation of the oncomouse is a marriage between nature and human intervention. What is involved here is the insertion of the myc gene and the subsequent breeding, cross-breeding and back-breeding of a mouse; the result of the gestation process is infinitely variable and, in its detail, unknown.

(3) To be patentable, an invention must be reproducible. The mouse is not truly reproducible as that term is understood in the Patent Act because too much is left to luck and chance. The location and even the presence and quality of the gene are totally uncontrollable. Although the gene will be present in some mice, at some place, with some characteristics, the precise mouse, location and quality of the gene are unreproducible. The variations of the gene are created and controlled by the laws of nature and are infinite.

(4) In determining whether something is patentable subject-matter, it seems appropriate to make a distinction between higher and lower life forms on the grounds of policy. A complex life form does not fit within the current parameters of the Patent Act without stretching the meaning of the words to the breaking point.

statutes and regulations judicially considered

Patent Act, R.S.C. 1970, c. P-4, ss. 2, 4, 42.

Patent Act, R.S.C., 1985, c. P-4, ss. 2 (as am. by S.C. 1993, c. 2, s. 2), "invention", 27 (as am. by S.C. 1993, c. 15, s. 31).

Patent Act, 35 U.S.C. "101.

Plant Patent Act, 35 U.S.C. "161.

Plant Variety Protection Act, 7 U.S.C. "2321.

cases judicially considered

applied:

Pioneer Hi-Bred Ltd. v. Canada (Commissioner of Patents), [1987] 3 F.C. 8; (1987), 11 C.I.P.R. 165; 14 C.P.R. (3d) 491; 77 N.R. 137 (C.A.); Pioneer Hi-Bred Ltd. v. Canada (Commissioner of Patents), [1989] 1 S.C.R. 1623; (1989), 60 D.L.R. (4th) 223; 25 C.I.P.R. 1; 25 C.P.R. (3d) 257; 97 N.R. 185.

not followed:

Diamond, Commissioner of Patents and Trademarks v. Chakrabarty, 447 U.S. 303 (1980).

considered:

Application of Abitibi Co., Re (1982), 62 C.P.R. (2d) 81 (P.A.B.); Application for Patent of Connaught Laboratories, Re (1982), 82 C.P.R. (2d) 32 (P.A.B.).

referred to:

American Cyanamid Co. v. Charles E. Frosst & Co., [1965] 2 Ex. C.R. 355; (1965), 47 C.P.R. 215; 29 Fox Pat. C. 153; Hornblower v. Boulton (1799), 101 E.R. 1285 (K.B.); Rex v. Wheeler (1819), 106 E.R. 392 (K.B.); Merck & Co. v. Apotex Inc. (1994), 59 C.P.R. (3d) 133; 88 F.T.R. 260 (F.C.T.D.).

authors cited

Fox, H. G. The Canadian Law and Practice relating to Letters Patent for Inventions, 4th ed. Toronto: Carswell, 1969.

New Shorter Oxford English Dictionary on Historical Principles. Oxford: Clarendon Press, 1993, "manufacture".

APPEAL from a decision of the Commissioner of Patents denying the appellant's patent application for transgenic mice. Appeal dismissed.

appearances:

A. David Morrow for appellant.

Rick Woyiwada for respondent.

solicitors:

Smart & Biggar, Ottawa, for appellant.

Deputy Attorney General of Canada for respondent.

The following are the reasons for judgment rendered in English by

Nadon J.: This is an appeal from a decision rendered by the Commissioner of Patents on August 4, 1995. At issue is patent application number 484, 723 (the 723 application) whereby the appellant, the President and Fellows of Harvard College (Harvard), seeks to patent transgenic mammals, specifically mice.

The 723 application was filed on June 21, 1985 and claimed priority from a corresponding U.S. patent application (the 774 application) which was filed on June 22, 1984. The inventors, Philip Leder and Timothy Stewart, assigned the application to the appellant. Originally, the Examiner rejected 18 of the 24 claims submitted. The appellant then requested a review of the decision and amended the application, increasing the number of claims. In March of 1993 the Examiner maintained the rejection of claims 1 through 12 of the application but allowed claims 13 through 26. Claims 1 though 12 were said by the Examiner to be claims for non-statutory subject-matter. The appellant then requested an oral hearing before the Patent Appeal Board. A hearing was held in July of 1994 and the decision from which this appeal lies was signed by the Commissioner of Patents (the Commissioner) on August 4, 1995.

Claims 1 through 12 of the 723 application relate to a transgenic mammal, that is a mammal containing a gene that has been artificially introduced into the chromosomes of the mammal or its ancestor at the embryonic stage (preferably at the single cell stage). The fertilized eggs were then transferred to a female mouse ("foster" mouse) and allowed to gestate naturally. The gene introduced predisposes the mammal to developing neoplasms, i.e. malignant tumours. This gene is referred to as an oncogene or a myc gene. The mice born of this process ("founder" mice) are tested to determine if they carry the myc gene. Two males of 28 founder mice which were tested were found to have retained the artificially introduced gene. These two male mice passed along these genes "in a ratio consistent with Mendelian inheritance of single locus". The offspring of these two founder males were tested. The genes were not detected in all of the organs anticipated. The inventors were able to "backcross" and in-breed in order to obtain offspring with more widely varying sites of the new myc gene but even this generation had "qualitatively different patterns with respect to the more minor myc hybridizing fragments".

An oncomouse or oncomammal can be used to test for carcinogens and for cancer-treating products. The method for producing the oncomouse is described at paragraph 11 of the appellant's memorandum which is reproduced here for clarity.

11. The patent disclosure describes the following method for producing the transgenic non-human mammal:

(i) A vehicle for transporting the oncogene into the mammal's chromosomes is constructed using a small piece of bacterial DNA referred to as a plasmid. The plasmid is cut and the oncogene is spliced into it . . . .

(ii) The plasmid, containing the oncogene, is injected into a fertilized egg at a site called the male pronucleus. The male pronucleus is the nucleus of the sperm and it exists as a separate entity in the egg for a short period of time after fertilization . . . .

(iii) After the injection step, the eggs are implanted into a host female mammal, the foster mother. The eggs then develop through a normal gestation period and the offspring are delivered by the foster mother . . . .

(iv) After delivery, the offspring are tested for the presence of the gene (the "transgene"). The offspring that contain the transgene are referred to as "founder" animals . . . .

(v) A founder animal is mated with an ordinary animal and the offspring are tested for the presence of the oncogene. As described by the Commissioner, "analysis of the DNA of the resulting transgenic offspring indicated that the injected oncogene was transmitted through the germline in a ratio consistent with Mendelian inheritance of single loci." In other words, the transgene will be passed on to the offspring in accordance with the ordinary principles of inheritance . . . .

The relevant portions of the Commissioner's decision read, at pages 6-7:

In my view the words "manufacture" and "composition of matter" as found in Section 2 apply to something that has been made under the control of the inventor . . . .

What the inventors have done in the instant application is to genetically engineer myc gene containing plasmids which are thereafter injected into the mouse eggs which in turn are injected into the female mouse and allowed to develop to term. To my mind there are two distinct phases involved, firstly the preparation of the genetically engineered plasmid and secondly the development of a genetically engineered mouse in the uterus of the host mouse. In the first phase it is human intervention that controls the production of the plasmid by choosing the necessary enzymes and processing conditions to make the plasmids. In the second phase it is the laws of nature that take over to produce the mammalian end product. In my view different considerations apply between claims to the lower life forms of the Abitibi decision and the higher life forms claimed in the instant application.

Since the plasmids and the transgenic unicellular material are produced under the full control of the inventor and are reproducible, I am satisfied that they are a "manufacture" or a "composition of matter" under Section 2 of the Act. I note that no objections, based on Section 2, were raised against such claims in the instant application.

However I cannot extend the meaning of "manufacture" or "composition of matter" to include a non-human mammal. On the plain and ordinary meaning of the words, and here I am strongly influenced by the Federal Court of Appeal decision in Pioneer Hi-Bred , I do not find that a non-human mammal like a mouse falls within the definition of "invention". The inventors do not have full control over all the characteristics of the resulting mouse since the intervention of man ensures that reproducibility extends only as far as the cancer forming gene.

Although the issue of patentability of life forms has arisen for consideration before, this is the first time the Court has been faced with the question of whether a higher life form, a mammal, is patentable. In the United States, complex life forms have been held to be patentable since 1987. In Canada, processes involving the use of micro-organisms have been patentable since the decision of the Exchequer Court in American Cyanamid Co. v. Charles E. Frosst & Co., [1965] Ex. C.R. 355. A general overview of the law is warranted before looking at the particular issues in the case at bar.

The first Canadian case of relevance is Re Application of Abitibi Co. (1982), 62 C.P.R. (2d) 81 where the Patent Appeal Board determined that a yeast culture which could be used to digest spent sulfite liquor, a waste product of pulp mills, was patentable subject-matter. The yeasts involved were naturally occurring and commonly known. It was the combination and acclimatization of the yeast to spent sulphite liquor which was novel. In reaching the conclusion that the culture was in fact patentable, the Appeal Board says, at pages 89-90:

It is of some importance, we think, to recognize how far our recommendation, if accepted, will carry us, and we believe clear guidelines should be set down for the benefit both of applicants and examiners. Certainly 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. That is, for example, the working standard of the Japanese Patent Office . . . .

We can see no justifiable reason for distinguishing between these life forms when deciding the question of patentable subject-matter. Whether it reaches up to higher life forms"Plants (in the popular sense) or animals"is more debatable. Certainly the U.S. Court of Customs and Patent Appeals and the U.S. Supreme Court shied away from that extrapolation. For example in the first Bergy decision, Re Bergy et al., U.S.C. C.P.A., Oct 6, 1977 . . . .

. . .

[T]he majority opinion state (at p. 18):

. . . 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 . . . they have come to be used to produce a vast variety of chemicals and drugs such as alcohols, ketone, fatty acids, amino acids, vitamins . . . and enzymes . . . In short, microorganisms have come to be important tools in the chemical industry . . . and when a new and useful tangible industrial tool is invented which is unobvious, so that it complies with the prerequisite to patentability . . . we do not see any reason to deprive it or its creator or owner of the protection and advantage of the patent system . . . As for the board's fears that our holding will of necessity, or "logically," make all new, useful and unobvious species of plants, animals, and insects created by man patentable, we think the fear is far fetched.

We ourselves are not persuaded that the idea is so far-fetched or so illogical. If an inventor creates a new and unobvious insect 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. With still higher life forms it is of course less likely that the inventor will be able to reproduce it at will and consistently, as more complex life forms tend to vary more from individual to individual. But if it eventually becomes possible to achieve such a result, and the other requirements of patentability are met, we do not see why it should be treated differently.

Thus, in 1982, the Patent Appeal Board stated that the real criteria was that the creation be new and unobvious, uniformly reproducible and useful. The threshold of reproducibility was stated by the Appeal Board to be that any measurable quantity would possess uniform properties. Once a life form meets this threshold test, the Board saw no reason for making arbitrary distinctions on the basis of higher and lower life forms. In this vein, the Appeal Board characterized the yeast as a life form which could be produced "en masse" just like any obviously patentable chemical compound. Furthermore, the Appeal Board stressed that the inventor must be able to reproduce the organism "at will and consistently". Note that the Board expressed skepticism about the patentability of complex life forms due to individual variations found in them. This reinforces the requirement iterated by the Board that uniformity of the subject claimed is pivotal.

The Patent Appeal Board quoted the Abitibi decision at length in Re Application for Patent of Connaught Laboratories (1982), 82 C.P.R. (2d) 32 in finding that a new bovine cell line was patentable. Specifically, the Board stated that claims for new life forms are allowable and that section 42 [Patent Act, R.S.C. 1970, c. P-4] does not accord the Examiner the right to reject such claims.

The next case of note is Pioneer Hi-Bred Ltd. v. Canada (Commissioner of Patents), [1987] 3 F.C. 8 wherein the Federal Court of Appeal, per Marceau J.A. with whom Lacombe J.A. agreed (Pratte J.A. writing separate concurring reasons) stated, at page 13:

The question to be determined is basically and simply whether, on a proper construction of the terms used in that definition, the subject matter of the application, a soybean variety developed by cross-breeding, can be said to be an invention in the sense in which the word was understood by Parliament.

The Court then cited the definitions of "manufacture" and "composition of matter" used in the U.S. Supreme Court case Chakrabarty , infra and continued [at pages 13-14]:

I have not been convinced. Even if those definitions were held to be applicable to a micro-organism obtained as a result of a laboratory process, I am unable to go further and accept that they can also adapt to a plant variety produced by cross-breeding. Such a plant cannot really be said, other than on the most metaphorical level, to have been produced from raw materials or to be a combination of two or more substances united by chemical or mechanical means. It seems to me that the common ordinary meaning of the words "manufacture" and "composition of matter" would be distorted if a unique but simple variety of soybean were to be included within their scope.

Thus, the Federal Court of Appeal did not find that a complex plant form was genuinely within the definitions provided by Parliament. The expressions "raw material" and "combination of two or more substances united by chemical or mechanical means" were intended for ordinarily understood industrial tools but not the cross-breeding of plants. The Court felt clearly that to construe these terms so as to include a cross-breeding of plants would be to distort the meaning of these phrases.

The case was appealed to the Supreme Court of Canada ([1989] 1 S.C.R. 1623) which held that the description of the new soybean was insufficient to allow someone skilled in the art of cross-breeding to reproduce it. The appeal, once dismissed on the basis of insufficient disclosure, did not require that the Court consider whether a soybean came within the scope of "manufacture" or "composition of matter" per section 2 [R.S.C. 1970, c. P-4]. Lamer J., as he then was, discusses at pages 1632-1633 two modes of genetic engineering. The first he states is the crossing of different varieties by hybridization. This mode changes the frequency of genes over several generations, eventually attaining the desired genetic makeup. The second mode of genetic engineering he describes as a molecular change involving an alteration of the genetic material itself. This second mode being clearly more akin to the situation of the present application. In concluding on the issue of the question of patentable subject-matter Lamer J. states, at page 1634:

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. To do this we would have, inter alia, to consider whether there is a conclusive difference as regards patentability between the first and second types of genetic engineering, or whether distinctions should be made based on the first type of engineering, in view of the nature of the intervention. The Court would then have to rule on the patentability of such an invention for the first time. The record contains no scientific testimony dealing with the distinction resulting from use of one engineering method rather than another or the possibility of making distinctions based on one or other method.

In view of the complexity presented by the question as to the cases in which the result of genetic engineering may be patented, the limited interest shown in this area by the parties in their submissions, and since I share the view of Pratte J. that Hi-Bred does not meet the requirements of s. 36(1) of the Act, I choose to dispose of this appeal solely on the latter point.

Although he chose not to deal with the question directly, Lamer J. states that as there are no special provisions regarding "biotechnicological" inventions, specifically new life forms, the ordinary tests of patentability must be applied. Thus for the purposes of this case, I must apply the ordinary tests of patentability. The relevant criteria in this instance are: the subject-matter must be an "invention" according to the definition found in section 2; the subject-matter must be new, useful and unobvious. There is no dispute here that the oncomouse is new, useful and unobvious. The question is whether this is an "invention" to which the Patent Act [R.S.C., 1985, c. P-4] applies.

That is the state of law in Canada today. The appellant in the present action has urged the Court to follow the American jurisprudence on the issue of the patentability of life forms. In the United States, prior to the decision in Abitibi, the Supreme Court rendered a decision in Diamond, Commissioner of Patents and Trademarks v. Chakrabarty, 447 U.S. 303 (1980), which, by a 5-4 split decision, allowed a patent to issue for bacteria which could break down crude oil. The majority decision states clearly that the proper question to be addressed is not whether the subject of the patent application is animate or inanimate but rather whether it is made by a person as opposed to being something naturally occurring. The majority looked at the statutory history of the U.S. Patent Act [35 U.S.C. "101] and found that the fact that two statutes were passed subsequent to the Patent Act , dealing specifically with plants, did not alter its opinion that plant patenting was already covered under the Patent Act. The majority found that these additional acts were necessary to circumvent the difficulty in providing an appropriate written description of the method of creating new plant varieties as required by U.S. patent law and to correct a prior court decision which established the principle that "natural products" could not be the subject of a patent.

The dissenting group, however, was of the opinion that the 1930 Plant Patent Act [35 U.S.C. " 161] and the 1970 Plant Variety Protection Act [7 U.S.C. "2321] were passed in order to provide patent protection where none existed previously. At pages 319, 321-322 Brennan J. writes:

. . . 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.

. . .

 . . . the [majority'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.

I prefer the view of the minority. To say, as the majority does, that the two plant statutes were necessary to overcome a barrier established in the Patent Act and a prior decision which found that life forms were not patentable begs the question. If there is in fact a barrier within the statute, such as the subject-matter not being patentable, that ends the issue. It is then for the legislature to determine whether that barrier should be removed. Secondly, if, on the plain and simple meaning of the words used in the U.S. Patent Act, life forms or "natural products" were not included within the parameters of patentable subject-matter, then the prior court ruling referred to is correct. Congress was free to pass new legislation which provided protection for natural products as it saw fit. That this change of policy required the passage of a new statute is irrelevant. The question remains, what has the legislature already said? If it would like to say something new, that door is always open. Thus, with respect for the contrary position, I am not prepared to adopt the reasoning of the majority decision in Chakrabarty as I do not find it persuasive.

I turn now to consider the Canadian Act here at issue. The relevant portions of the Patent Act, R.S.C., 1985, c. P-4 are the following [ss. 2 (as am. by S.C. 1993, c. 2, s. 2), 27 (as am. by S.C. 1993, c. 15, s. 31)]:

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;

. . .

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.

(2) The prescribed application fee must be paid and the application must be filed in accordance with the regulations by the inventor or the inventor's legal representative and the application must contain a petition and a specification of the invention.

(3) The specification of an invention must

(a) correctly and fully describe the invention and its operation or use as contemplated by the inventor;

(b) set out clearly the various steps in a process, or the method of constructing, making, compounding or using a machine, manufacture or 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, construct, compound or use it;

. . .

(4) The specification must end with a claim or claims defining distinctly and in explicit terms the subject-matter of the invention for which an exclusive privilege or property is claimed.

(5) For greater certainty, where a claim defines the subject-matter of an invention in the alternative, each alternative is a separate claim for the purposes of sections 2, 28.1 to 28.3 and 78.3.

The question is what is meant by "manufacture" and "composition of matter". Counsel for the appellant has provided the Court with many alternative definitions of "manufacture" which are reproduced here:

. . . an article made by hand; a person's physical handiwork . . . an article or material produced by labour or machinery, now spec. one produced on a large scale. [The New Shorter Oxford English Dictionary on Historical Principles. (Oxford: Clarendon, 1993, at p. 1691.]

. . . something made by the hands of man. [Hornblower v. Boulton (1799), 101 E.R. 1285 (K.B.), at p. 1288, per Lord Kenyon C.J.]

Something of a corporeal and substantial nature, something that can be made by man from the matters subjected to his art and skill, . . . is requisite to satisfy this word. [Rex v. Wheeler (1819), 106 E.R. 392 (K.B.), at p. 395, per Abbott C.J.]

. . . 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. [Diamond, Commissioner of Patents and Trademarks v. Chakrabarty 447 U.S. 303 (1980), at p. 308.]

Counsel for the appellant submits to the Court the following definitions of "composition of matter":

A "composition of matter" may be taken broadly to mean chemical compounds, compositions and substances. In Electric Fireproofing Co. of Canada v. Electric Fireproofing Co. Archibald J. defined the term "composition of matter" as including all composite matter whether it was the result of chemical reaction or of mechanical mixture [H. G. Fox, The Canadian Law and Practice relating to Letters Patent for Inventions , 4th ed. (Toronto: Carswell, 1969), at p. 18.]

. . . 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. [Diamond, Commissioner of Patents and Trademarks v. Chakrabarty, 447 U.S. 303 (1980), at p. 308.]

The issue which I have to decide is whether claims 1 through 12 relate to patentable subject-matter according to the definition of "invention" found in section 2 of the Patent Act . The remaining four "issues" dealt with by counsel are indicia of how section 2 should be construed. For the sake of convenience, each of the separate issues raised will be dealt with in reaching a conclusion on the main issue.

Is it appropriate to examine the degree of the

    inventor's control over the creation of

    the claimed invention?

It is the appellant's position that the Commissioner added the requirement that "all the characteristics" of an invention be under the control of the inventor, even those characteristics which are not relevant to the invention claimed. The appellant submits that the end product is within the parameters of the invention if it carries the transgene, irrespective of any other characteristic of the mammal. Finally, the appellant's position is that, because the presence of the gene can be verified with certainty, this means that the inventor has "complete control over [the mammal's] relevant characteristic".

For its part the respondent submits that the very claims drafted by the appellant and at issue here cover the entire animal and not just the oncogene and therefore encompass all of the properties and characteristics of that mammal including (as stated in paragraph 20 of its memorandum):

. . . distinctive anatomical traits (ranging from the common ability to bear live young to differentiations in size, colour, etc.), intelligence, mobility, survival instincts, behavioural patterns, etc. Only one characteristic on this virtually endless list is directly attributable to the acts of the Appellant:

Furthermore, claim 1 is for any mammal, even a whale, which has the oncogene. The respondent then argues that where the claimed invention itself is one with a myriad of attributes and characteristics, in order to have a valid claim for the entire thing, the control factor which is inherent in the above-cited definitions must cover more than one attribute of the animal.

Verifying the presence of the gene is not an indicia of control. It is mere ex post facto testing to determine what already exists. By the time the inventor has reached this testing stage, control is no longer an issue.

At paragraph 20 of its memorandum the appellant writes:

A mammalian end product which carries the transgene falls within the parameters of the invention regardless of any other features of the mammal, such as its eye colour or birth weight. It is not necessary for the inventors to be able to control these other features in order for the end product to be an invention. The patent application describes a method whereby researchers are able to insert a specific gene into a founder animal's first cell.

Nothing could be more true. However, note that what the application describes is the insertion of the gene into the first cell, that is the oocyte. The process of insertion is already patented by the appellant. A mouse is a complex life form and thus there are many features of the mice which are not under the control of the inventors. They have created a method to inject eggs with a myc gene but they have not invented the mouse. It is not necessary for the inventor to directly control all aspects of the natural process leading to the creation of the end product. One need only think of the chemical or bio-chemical reactions which produce many different patented end products to know the truth of this statement. However, the ultimate product which will result from the process is completely unknown and unknowable. Furthermore, it may be that there is a logical place at which one can draw a line and say definitively that a certain percentage of characteristics must be controlled before one can claim the entire life form as an invention. However, that line was not shown to me in the present case and the complexities of the issue make it unlikely that the Court is the forum in which to decide where the line should be drawn. On even the broadest interpretation I cannot find that a mouse is "raw material" which was given new qualities from the inventor. Certainly the presence of the myc gene is new, but the mouse is not new nor is it a "raw material" in the ordinary sense of that phrase.

In summary, the test is not that all characteristics be under the direct control of the inventor. This is clearly not a requirement of the Patent Act. However, an element of control is included in each of the definitions cited by counsel for both parties in this case. Because we are dealing with a mammal, a very complex form of life, it is more difficult to make analogies to chemical reactions as was done in Abitibi. The inherent genetic makeup of the mouse itself controls a myriad of characteristics. I understand that these other characteristics are completely irrelevant from the appellant's point of view. For its purpose, only the presence of the transgene is important. However, there is no way to separate the transgene from the rest of the mouse once it is introduced and everything else about the mouse is present completely independently of human intervention.

Is it appropriate to distinguish between

    human intervention and the laws of nature?

With respect to the contrary position, there is no doubt that this is a valid consideration when examining the scope and validity of a patent. In fact, Lamer J. discussed this very distinction in the passage from Hi-Bred quoted above. Anything which is merely a discovery is not patentable subject-matter. There must be some inventive step involved. The remaining question is the scope of the patent. The scope is determined by asking which steps were sufficiently the result of human intervention that the new product is within the realm of patentable subject-matter.

The complexity of the life form at issue makes the distinction between human intervention and the laws of nature more difficult to maintain. The main problem is that the myc gene, which is introduced by human intervention, is embedded in a mammal. Is it sufficient that the inventor has introduced one new plasmid into this mammal, or one of its ancestors, when the appellant seeks to patent the entire mammal? At paragraph 23 of its memorandum the appellant writes:

The essential feature of the invention, the presence of the transgene in the mammalian end product, is achieved by human intervention, specifically by artificially injecting a transgene into a fertilized egg.

I agree with the appellant that, as far as it is concerned, the essential feature of the mouse is the presence of the transgene. This is what makes these mice useful for the testing of carcinogens, etc. I also agree that, while the laws of nature are involved, the transgene will not be present without human intervention. This clearly gives the inventor a patent for the creation of the plasmid and the process of injection thereof. I cannot however pass the final hurdle and conclude that ipso facto the appellant can then claim a patent over every descendant mouse which possesses that gene. The creation of the oncomouse is a marriage between nature and human intervention. But that is exactly the point. The question of which aspects can be attributed to human intervention and for which aspects one is forced to merely sit back and allow nature to run its course is the exact issue.

At paragraph 24 of the memorandum the appellant writes:

It is arbitrary to distinguish between the immediate effects of man's intervention in the production of the plasmids and the transgenic fertilized egg and the subsequent effects in the production of a transgenic mammal from such an egg that man has introduced into the uterus of a female mammal. Both phases are equally governed by the laws of nature and equally caused by the intervention of man. By analogy, it would be equally arbitrary to say that, for example, the product of a process involving a catalyst is not patentable because once man has introduced the catalyst, the laws of nature take over to complete the reaction, or that the product of a fermentation process using novel yeast cells is not patentable because, once the yeast cells have been placed in the vat, the laws of nature take over to cause the necessary reactions to take place that produce the wine or beer. Where man has, by his deliberate intervention, initiated a physical and/or chemical process, it is arbitrary to say that the result of that process is not patentable simply because no further intervention is necessary in order to complete the process. [Emphasis in original.]

This is true but no such distinction has been made in this case. The appellant has received a patent for the plasmid and the injection into the oocyte but not for any subsequent effects of this process. There has been no distinction between mediate and immediate effects. This point is therefore irrelevant.

Not all of the offspring of the founder mice have the gene. Even at the initial stage, not all of the eggs incorporate the transgene. Paragraph 11(v) of the appellant's memorandum, reproduced above, describes how a founder mammal is mated with an ordinary mammal and the offspring are then tested for the oncogene. The occurrence of positive test results is in line with a "Mendelian" ratio. This is the natural rate of inheritance. The appellant puts forward a claim to all of the founder's descendants which carry the oncogene, irrespective of how that descendant acquires the gene, i.e. through chance breeding, through breeding with an ordinary mouse or through breeding between two founder mice. To my mind, this process of breeding a mouse which contains a desired trait with an ordinary mouse is completely analogous with the process described in the Hi-Bred decision. I adopt the language of the Federal Court of Appeal [at page 13] in that case in finding that such a mouse "cannot really be said, other than on the most metaphorical level, to have been produced from raw materials or to be a combination of two or more substances united by chemical or mechanical means". It is true that, when the gene appears, it does so as a result of prior human intervention. Oncomice do not occur naturally.

I agree with the appellant's argument with respect to chemical processes. In a chemical process A + B = C is always true. However, in the creation of mammals A + B = C, D, E, F. . . N. The chemical reaction and its products are known (once discovered) and constant, whereas the parameters of the resulting mammal are largely unknown and change every time. Thus, what is involved here, i.e. the insertion of the myc gene and the subsequent breeding, cross-breeding and back-breeding is more analogous to the process involved in the Hi-Bred case than it is to the process seen in Abitibi. What will result from the gestation process is infinitely variable and, in its detail, unknown.

What is the relevance of the test of

    reproducibility in the present instance?

In his decision, the Commissioner clearly stated that the presence of the oncogene is reproducible. The problem is that everything else about a mouse is intentionally uncontrolled. There is no question that, in order for an invention to be patentable, it must be reproducible (see paragraph 27(3)(b) of the Patent Act). This then leads one back to the same question, i.e. what is the scope of the appellant's invention. Is it sufficient to receive a patent over the entire mouse which happens to have that particular gene to say that the oncogene is reproduced in a Mendelian ratio? Because the appellant is not merely claiming the transgene but the entire mammal, and the appellant has not made any claims to even minor control over any aspect of the mammal except the presence of the transgene, the appellant can make no claim to being able to reproduce the mammal at will by doing anything other than ordinary breeding. In my view this is insufficient.

In my view, the mouse is not truly reproducible as that term is understood in the Patent Act because too much is left to luck and chance as was the case in Pioneer Hi-Bred. If someone skilled in the art wanted to produce an oncomouse with the gene in a particular organ, he or she would only be able to do so if lucky. The location and even the presence and quality of the gene are totally uncontrollable. Thus, although the gene will be present in some mice, at some place, with some characteristics, the precise mouse, the precise location and the precise quality of the gene are unreproducible. The variations of the gene are created and controlled completely by the laws of nature and are infinite. (See generally, Merck & Co. v. Apotex Inc. (1994), 59 C.P.R. (3d) 133 (F.C.T.D.), at page 178.)

Is it appropriate in determining whether

    something is patentable subject-matter to make

    distinctions between higher and lower life forms?

In Abitibi the Appeal Board felt that there was no statutory basis upon which to distinguish between higher and lower life forms provided that the invention was "reproducible en masse". Even if I were to agree with this statement the oncomouse does not meet this standard. In Hi-Bred Marceau J.A. stated, at pages 13-14:

It seems to me that the common ordinary meaning of the words "manufacture" and "composition of matter" would be distorted if a unique but simple variety of soybean were to be included within their scope.

If the cross-breeding of soybeans is outside the scope of the definitions, certainly cross-breeding of mice is. In the end, once the original plasmid has been injected into the fertilized egg, the inventor is only engaged in cross-breeding.

Finally, in the Hi-Bred case at the Supreme Court Lamer J. refused to address the issue stating that it was more appropriately to be decided by the legislature. On this basis, although I need not decide the issue, it would seem to me to be appropriate to make such a distinction on the grounds of policy.

Having concluded that the process is not within the scope of the Abitibi decision, there is no Canadian jurisprudential authority to support the appellant's position. Additionally, as discussed above, not only am I not persuaded by the majority decision in Chakrabarty, I am in complete agreement with the minority. In addressing the negative social issues put forth by counsel for the Commissioner relating to the policy of allowing life forms to be patented, the majority in Chakrabarty states, at page 317:

What is more important is that we are without competence to entertain these arguments"either to brush them aside as fantasies generated by fear of the unknown, or to act on them. The choice we are urged to make is a matter of high policy for resolution within the legislative process after the kind of investigation, examination, and study that legislative bodies can provide and courts cannot. That process involves the balancing of competing values and interests, which in our democratic system is the business of elected representatives. Whatever their validity, the contentions now pressed on us should be addressed to the political branches of the government, the Congress and the Executive, and not to the courts.

A complex life form does not fit within the current parameters of the Patent Act without stretching the meaning of the words to the breaking point, which I am not prepared to do. However, if Parliament so wishes, it clearly can alter the legislation so that mammals can be patented.

In the result, although not a consideration in this decision, even if a mouse were found to be within the realm of patentable subject-matter it would give the inventor no additional protection in this instance. The inventor has already received a patent for the creation of the plasmid and the injection thereof into the mouse oocyte. The appellant can exclude all others from participating in any activity which infringes that which is already patented. Even to stretch the definition of invention would not enhance the protection already accorded the appellant.

For these reasons this appeal shall be dismissed. With respect to costs, I will be prepared to hear the parties on this issue upon application.

v.475