Whereas the USPTO, in the aftermath of Chakrabarty, displayed a full commitment to embrace its holding and narrative, by considering patent applications on GM animals, CIPO seemed more reluctant to deem that Abitibi had paved the way to the patentability of complex life forms. Its more careful approach emerged when CIPO had to examine the patent application concerning “transgenic non-human mammals” genetically modified in order to develop cancer.658 Although the patent on this invention was granted in the U.S. in 1988, in Canada patent examiners and judges considered the issue of patenting life deserving more careful consideration.
Whilst patent application ’723 was lodged in 1985, claims1-12 were rejected as directed to non-statutory subject matter by the Commissioner of Patents on 4 August 1995. President and Fellows of Harvard College (“Harvard”), the assignee, appealed against the rejection and the case triggered one of the longest and most debated patent controversies in Canadian history.
The claims all concerned a “transgenic mammal, who is a mammal containing a gene that has
657 Quigg (n 632) 328.
658 The case refers to Patent application No. 484,723 filed on 21 June 1985 and claimed priority from a corresponding U.S. patent application which was filed on 22 June 1984.
127 been artificially introduced into the chromosomes of the mammal or its ancestor at the embryonic stage”.659
The rationale for the dismissal was that the claimed invention did not fall within the words
“manufacture” or “composition of matter” under s. 2 of the Patent Act,660 which set forth the definition if invention, as the inventor did not have full control over the characteristics of the mammal.
Judge Nadon of the Federal Court, Trial Division, articulated the main questions posited by the case as follows: 1. “Is it appropriate to examine the degree of the inventor’s control over the creation of the claimed invention?”;661 2. “Is it appropriate to distinguish between human intervention and the laws of nature?”;662 3. “What is the relevance of the test of reproducibility in the present instance?”;663 4. “Is it appropriate in determining whether something is patentable subject matter to make distinctions between higher and lower life forms?”.664
He, first, remarked that processes entailing the use of microorganisms were patentable in Canada since 1965, when American Cyanamid Co. v. Charles E. Frost & Co.665 was decided by the Exchequer Court, and microorganisms were held patentable in Abitibi.666 Abitibi, however, established a threshold test of reproducibility focused on uniform reproducibility of the claimed life form, namely that “any measurable quantity would possess uniform properties”.667 In Abitibi, the Patent Appeal Board clarified that, insofar as microorganisms could be produced en masse, they were to be deemed like chemical compounds and, therefore patentable. The patentability of microorganisms resulted from drawing on the metaphor of the chemical molecule, which entailed a similarity, the reproducibility en masse.
He, then, recalled Pioneer Hi-Bred Ltd. V. Canada (Commissioner of Patents),668 a case concerning the patentability of a soybean variety obtained by cross-breading, in which the Federal Court of Appeal (“FCA”) showed awareness of how much judges largely relied on metaphors in order to define biotech products and address their patentability. The FCA
659 Federal Court of Canada, Trial Division, President and Fellows of Harvard College v. Comissioner of Patents, 79 C.P.R. (3d) 98 (1998), 100.
660 Patent Act, R.S.C. 1985, c. P-4.
661 President and Fellows of Harvard College (n 659) 109.
662 ibid 111.
663 ibid 113.
664 ibid 114.
665 American Cyanamid Co. v. Charles E. Frost & Co. (1965) 47 C.P.R. 215.
666 President and Fellows of Harvard College (n 565) 102.
667 ibid 102-103.
668 Pioneer Hi-Bred Ltd. V. Canada (Commissioner of Patents) (1987) 14 C.P.R. (3d) 491.
128 referred to the use of the terms “manufacture” and “composition of matter” applied in Chakrabarty by SCOTUS and commented:
“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”.669 Judge Nadon, therefore, pointed out that “raw material”670 and “combination of substances united by chemical or mechanical means”671 were considered to be applied “for ordinarily understood industrial tools”,672 not for plants.
Discussing the definitions of “manufacture” and “composition of matter” offered by the appellants, he remarked that:
“On even the broadest interpretation I cannot find that a mouse is a ‘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 the phrase.
A mammal is a very complex form of life and therefore it is more difficult to make analogies to chemical reactions as was done in Abitibi”.673
He, therefore, rejected the chemical metaphor674 endorsed in Abitibi, as far as higher life forms were concerned, concluding that:
“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
669 President and Fellows of Harvard College (n 659) 104.
670 ibid.
671 ibid.
672 ibid 105.
673 ibid 110.
674 In Pioneer Hi-Bred, Judge Marceau acknowledged the metaphorical dimension linked to defining patent claims within the general concepts of invention: “I have not been convinced. Even if those definitions were held to be applicable to a microorganisms 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’ or ‘composition of matter’ would be distorted if a unique but simple variety of soybean were to be included within their scope”.
129 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”.675
He examined the following definitions of these locutions submitted by the appellant:676
He, finally, focused on the questions raised by the case and contended that the degree of control of the claimed inventor over the GM organisms was not very high as “the ultimate product which will result from the process is completely unknown and unknowable”.677 He highlighted that all the cited definitions implied an element of control and, since the Oncomouse was a complex form of life, applying the analogy with the chemical compounds, employed in Abitibi, was arduous.678
675 President and Fellows of Harvard College (n 659) 113.
676 ibid 108-109. Oxford English Dictionary on Historical Principles (Clarendon 1993) at 1691). new forms, qualities, properties or combinations whether by hand labor or by machinery”
(Diamond, Commissioner of Patents and
Trademarks v. Chakrabarty, 206 U.S.P.Q. 193 (1980) at 196-197).
“Composition of Matter”
1. “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 18).
2. “… all compositions of two or more substances and all composite articles, whether they be the
130 Moreover, he pinpointed that the claimed invention failed the test of reproducibility, which was set out in paragraph 27(3)(b) of the Patent Act. As the claims regarded all the mammals, too much was left to luck and chance: “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 irreproducible”.679
Although Judge Nadon disputed the adequacy of the metaphor of the chemical molecule to address the patent eligibility of GM organisms, the majority of the Federal Court of Appeal of Canada disagreed with his opinion and holding.
Justice Rothstein, who delivered the opinion of the majority, fully embraced the narrative of progress posited by SCOTUS in Chakrabarty.
He, first, pointed out that the purpose of the Patent Act “is to provide an incentive for the creation of processes or products which are new, useful and unobvious”.680
Justice Rothstein, dismissed the policy questions concerning the animal sufferance, human health and environment as to be addressed by Parliament, but adduced the need for harmonization to draw prescriptive policy conclusions: “The evidence is that the oncomouse has been patented in the United States and Europe. It is arguable on policy grounds that there is merit to uniformity and that Canada should follow suit”.681 He, therefore, resorted to the law lag argument. However, in this case the lag did not concern the relationship between science and the law, but the one between different patent systems and their case law.
He, then, drew on Justice Burger’s arguments in Chakrabarty, purporting that the definition of invention should be given wide scope, as inventions are “necessarily unanticipated and unforeseeable”.682 The inevitable conclusion was that the Oncomouse was a “composition of matter”:
“The process here involves injecting a plasmid containing the oncogene into a fertilized mouse egg. The oncogene is comprised of DNA. Kreuzer and Massey define DNA as: ‘the chemical molecule that is the basic genetic material found in all cells (…) DNA belongs to a class of biological molecules called nucleic acids’.
679 ibid 113.
680 Federal Court of Appeal of Canada, President and Fellows of Harvard College v. Commissioner of Patents, 3 August 2000, (2000) 7 C.P.R. (4th) 1, 12.
681 ibid 14.
682 ibid 16.
131 DNA is a physical substance and is therefore matter. The fertilized mouse egg is a form of biological matter. The combination of these two forms of matter by the process described in the specifications is thus a ‘composition of matter’”.683
After defining the Oncomouse as a “composition of matter”, he pinpointed that this locution did not imply the exclusion of living organisms.684 Nevertheless, the subsumption of a living organism under the concept of “composition of matter” rested on endorsing a reductionist scientific view of what a biological organism is, namely chemical molecules. In that respect, the definition of biotech patent eligible matter resulted from a process of co-production between science and law, in which the conflation of methodological and ontological scientific reductionism was implicitly incorporated in the patent legal discourse and supported a re-definition and re-framing of the scope of “composition of matter”.
However, the majority recalled that, like in Chakrabarty, this conclusion did not entail that there were no limits to patentability. Natural phenomena, scientific principles and abstract theorems were excluded from the scope of invention, as in Canada subsection 27(8) of the Patent Act 685 formally ruled out scientific principles and abstract theorems from patentability.686
Judge Rothstein argued that, although the laws of nature were involved in the gestation process, the insertion of the oncogene into the mammal substantially marked the resulting transgenic mammals as a product of inventive ingenuity.687
Inasmuch the majority consistently relied on the majority’s judgement in Chakrabarty, it needed to justify the peculiar reliance on a piece of case law of another jurisdiction, even though influential in the U.S. for its impact on the patentability of biotech products. The majority acknowledged that the origins of Canadian patent law rested in the common law of England and the royal prerogative of granting monopolies. Therefore, the law of the U.K. was referred to as authoritative in interpreting Canadian patent law.688
Nonetheless, it justified the reliance on the high similarity of the definition of invention in the two jurisdictions: as the first Canadian Patent Act, enacted in 1869, was shaped according to U.S. patent statutes of 1836, the likeness of provisions legitimized the similarity in their
683 ibid 17.
684 ibid 18.
685 Subsection 27(8) Patent Act R.S.C. 1985 c. P-4, 35, states: “No patent shell be granted for any mere scientific principle or abstract theorem”.
686 President and Fellows of Harvard College (n 680) 18.
687 ibid 19-20.
688 ibid 22.
132 interpretation by courts in different jurisdictions.689 The majority noted that, although U.S decisions do not operate as stare decisis or constitute an estoppel in Canada, Fox pointed out that they ought to be considered with respect.690
Since the U.S. opinion was persuasive, Justice Rothstein believed its rationale ought to be employed in defining the boundaries of the scope of invention in Canada. In explaining why he preferred the majority’s opinion in Chakrabarty rather than the minority’s arguments, he pointed out that he could not share that there was a “common understanding” that the patent legislation did not cover living organisms.691 Consequently, he relied on Justice Burger’s interpretation of what was common understanding in the U.S. and considered it applicable in Canada, notwithstanding a constant opposite patent examination practice. However, the majority championed an approach that will be embraced by courts in several jurisdictions deciding on biotech patent cases, namely to use the arguments’ rationale of landmark patent adjudications in other jurisdictions, even though they could not be considered as precedents.
The majority, finally, addressed the issues of control over the claimed invention and its degree of reproducibility. It noted that a reference to a control test was made in the CIPO’s Manual of Patent Office Practice, which set forth that: “In assessing whether subject matter falls within the meaning of the definition of patentable subject matter under Section 2 of the Patent Act, the prerequisites established by Canadian jurisprudence and legislation that must be satisfied are inter alia: (b) whether the subject matter is operable, controllable and reproducible by the means described by the inventor so that the desired result inevitably follows whenever it is worked”.692
Justice Rothstein clarified that the wording of this guideline was modelled on the Patent Appeal Board’s decision in Organon, in which the Board deemed the test implicit in the requirement of usefulness.693 As the claimed invention has been judged useful, it was deemed to pass the control test.694
Moreover, as he pinpointed that the invention was sufficiently disclosed by the applicant, reproducibility did not constitute a major problem affecting the patentability of the challenged claims.695
689 ibid 23.
690 ibid.
691 ibid 25.
692 ibid 26.
693 ibid 26-27.
694 ibid 27.
695 ibid 30.
133 Judge Isaac, who dissented, mainly based his opinion on the reasonableness of the Commissioner’s conclusion and the deference that courts ought to pay to the technical expertise of patent examiners in assessing and deciding on the patentability of inventions. He cited salient case law pinpointing that examiners “are persons with technical expertise” and concluded that the Commissioner was “an expert tribunal”.696
Examining the second question, the Judge noted that the complexity of life forms made the distinction between the laws of nature and human intervention difficult to draw.
He addressed a basic problem in applying the chemical metaphor and the analogies it implies to complex life forms. His argument was centered on the complexity of organic processes, which could hardly be curtailed under the aegis of forms of reductionism.
He, consequently, concluded that the issues of the patentability of “higher life forms” should be addressed by the legislature, since the Oncomouse did not meet the standard of reproducibility en masse established in Abitibi.
As this section has illustrated, the majority of the FCA has endorsed the metaphor of the chemical molecule to define both the oncogene, as DNA sequences, and the transgenic mammal and subsumed them under the locution “composition of matter”, concluding they were patentable. Moreover, it relied on the narrative of progress set out in Chakrabarty in order to justify a broad interpretation of the concept of “invention” in Canada.