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BACKGROUND AND THE DECISION

With the December 5, 2002 release of a 5 4 majority decision in Harvard College v. Canada (Commissioner of Patents)1,  a sharply divided Supreme Court of Canada brought to an end that case's 17 year odyssey through the Canadian patent examination and judicial forums and, in effect, barred the obtaining of Canadian patent protection for genetically modified "higher" life forms such as plants and animals per se. However, it should be noted from the outset that despite Harvard Mouse, one can still obtain effective and practical patent protection in Canada for genetically modified plants and animals when properly drafted patent claims are utilized.

At stake in Harvard Mouse were the patent claims to a non human transgenic mammal whose germ cells and somatic cells contain an activated oncogene sequence introduced into the mammal, or an ancestor of the mammal, at an embryonic stage. Due to the presence of the activated oncogene within its cells, the transgenic mammal, which has become known as the Harvard Mouse or oncomouse, shows an increased propensity to develop cancer upon exposure to a suspected carcinogen.

In deciding whether Harvard's claimed oncomouse could be categorized as either a "manufacture" or "composition of matter", and thereby qualify as an "invention" under section 2 of the Patent Act2,  a majority of the Court held that the wording of section 2 should be strictly construed. In examining whether, as a matter of law, Parliament ever intended the definition of the term "invention" to be broad enough to encompass complex higher life forms, Bastarache J. understood the test to consist in determining whether a complex life form was "easily understood" to be either a "manufacture" or a "composition of matter". He went on to find that by wording the section 2 subject matter categories as it did, Parliament had signalled a clear intention to adopt "exhaustive" wording that was not sufficiently broad to encompass higher life forms. In an apparent acceptance of both the dissenting comment of Isaac J.A. at the Federal Court of Appeal and the submissions of a host of interveners at the Supreme Court of Canada, Bastarache J. further concluded that public policy was a relevant consideration in an analysis of the wording of section 2 given:

that the patenting of higher life forms is a highly contentious and complex matter that raises serious practical, ethical and environmental concerns that the Act does not contemplate ? [and that] [t]his is a policy issue that raises questions of great significance and importance and that would appear to require a dramatic expansion of the traditional patent regime3.

Relying on a public policy centred analysis of the terms "manufacture" and "composition of matter", Bastarache J. found that the common understanding of "manufacture" indicated that the term only pertained to non living mechanistic products or processes. Furthermore, while it was noted that the genetically engineered mouse egg "would appear to be cognizable as '[a] substance or preparation formed by the combination or mixture of various ingredients'" and under the control of the inventors, the same could not be said with respect to a fully developed higher life form. When applied to higher life forms, it was held that a common usage perspective of the word "matter" necessitated a consideration that, at least with respect to animals, the sentient nature of higher life forms would move them beyond the conceptual boundary of a "composition of matter". Lacking any clear and explicit directions from Parliament to construe the section 2 subject matter categories outside their enumerated common usage definitions, Bastarache J. concluded that a higher life form could not be considered to fit within the definition of an invention.

The majority also gave great weight to public policy considerations in analysing both the scheme and object of the Act in relation to higher life forms. Noting that the Act is "ill equipped to deal appropriately with higher life forms as patentable subject matter" and that Parliament was the proper forum to fully consider the potential ramifications of allowing patent protection for higher life forms, the majority was not prepared to adopt the view that the Act was designed to encompass any and all technologies. Furthermore, given that related legislation existed that was tailored to deal with a higher life form (i.e., the Plant Breeders Rights Act), the majority found that it was Parliament's prerogative to craft legislation that would deal with intellectual property rights pertaining to higher life forms, if so desired.

In a strongly worded dissenting opinion, Binnie J. concluded that there was no legal justification for a restrictive definition of an "invention", especially when based on the inclusion of public policy driven considerations in the interpretation of the wording of section 2 of the Patent Act. In the view of the dissenting justices, the majority decision essentially dictated a "reading down" of the Patent Act to exclude the patentability of higher life forms through an exercise of creative statutory interpretation. Furthermore, Parliament, in wording the Act, could not possibly have anticipated the development of future complex technologies. Without construing phrases such as "composition of matter" in anything but an expansive fashion, the purpose of the Act would effectively be thwarted. As the claimed invention satisfied the usual patentability requirements (novel, useful and unobvious), and as the Act vested no discretionary authority in the Commissioner to deny a claim to an invention due to public policy considerations, there could be no legal justification for denying the applicants their patent rights to the claimed transgenic mouse.

WHAT MESSAGE DOES THIS DECISION SEND TO THE BIOTECH INDUSTRY?

Certainly, a decision favouring Harvard would have served as a much needed catalyst in securing Canada's position as a leader in the knowledge-based biotechnology industry. As it stands, the view that has now prevailed in this case could, as suggested by Binnie J., be perceived as reluctance on Canada's part to be a contemporary player in the global intellectual property arena. Indeed, at first blush, it might appear that the decision could have a chilling effect on the burgeoning Canadian biotechnology industry given the field's critical dependence on the availability of secure patent protection for attracting investment. As well, seeing that Canada will not grant patent rights to higher life forms such as plants or mammals, the country could conceivably have difficulty attracting individuals who are willing to invest in the development of transgenic plants and mammals when such patent rights are available in practically every other industrialized nation. While it cannot be denied that these scenarios may come to pass, one should perhaps be cautious about extending the ramifications of the Harvard Mouse decision too far.

First, as noted by Binnie J., the available economic evidence indicates that even while this case has been progressing through the adjudicative process, the Canadian biotech industry has been growing. Secondly, it is worth noting that the claims to methods for producing such a transgenic mammal, the various plasmid constructs and the mammal's use in carcinogen screening and the production of cell cultures were not denied. Furthermore, there is no debate with regard to the granting of claims to a gene or recombinant gene and a cell of a higher life form that contains the gene of interest. Claims to cells have been obtainable ever since the decision of the Canadian Patent Appeal Board in Re Application of Abitibi Co.,4  a decision cited with approval by both the majority and the dissent in Harvard Mouse. In a more recent context, one need only examine the claims in the Canadian patent granted to Monsanto Company regarding its Roundup Ready® canola plants, and upon which Monsanto successfully litigated in Monsanto Canada Inc. v. Schmeiser5 . Monsanto wished to protect its Roundup Ready® plants and, arguably, did so successfully by claiming the chimeric gene and plant cells that contained the gene. Despite the absence of claims to the transgenic plant itself in Monsanto's patent, Schmeiser's reproduction and growth of the transformed plant was held to equate to reproduction of the claimed gene and plant cell, thereby infringing the patent.

Although the Harvard Mouse claims do not appear to have ever been amended to claim a mammalian cell as opposed to the mammal, there is no reason to suspect that such an amended claim would not have been granted given the reasoning pursued in Monsanto. Rothstein J.A., in the Federal Court of Appeal decision on the Harvard Mouse, notes that the inventors' apparent rationale for claiming the whole mammal was to secure practical patent protection over the product of their ingenuity6.  Arguably, as shown by Monsanto, practical patent protection for a higher life form could be achieved by claiming the gene and the gene-bearing cells of the organism. One must remember that at the time the Harvard Mouse claims were drafted, there was no technical way of monitoring for unauthorized use of the claimed process   and, by extension, of a claimed cell of the mouse   short of seeing mice that actually expressed the transformed phenotype (i.e., one mouse looking like another). With the advent of the exquisitely sensitive molecular biological technique of PCR, the presence and expression of a gene of interest can be monitored even at the level of a single cell.7  Technological advances now allow a patentee to establish that, despite having a phenotype-neutral plant or animal, a potential infringer has in fact reproduced a claimed gene or cell containing the gene.

There is no avoiding the Supreme Court of Canada's decision that higher life forms per se are not patentable. However, for the time being and until Parliament enacts specific patent legislation dealing with higher life forms in general, a solution for dealing with the consequences of the decision, while at the same time securing the best practical Canadian patent protection possible for inventions akin to the Harvard Mouse, would be to ensure that claims to cells bearing the gene or recombinant gene are included in the patent specification. Such claims have been routinely included in Canadian patent applications, where possible, all along.

1. 2002 SCC 76, Court File No.: 28155 [hereinafter Harvard Mouse ].
2. Patent Act , Section 2. Definitions
   "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.
3. Harvard Mouse at paragraph 155.
4. Re Application of Abitibi Co. , (1982) 62 C.P.R. (2d) 81 (Pat. App. Bd./Com'r Pat.).
5. Monsanto Canada Inc. v. Schmeiser , (2001) 12 C.P.R. (4th) 204 (F.C.T.D.), aff'd 2002 FCA 309, judgment released September 4, 2002 [hereinafter Monsanto].
6. 7 C.P.R. (3d) 1 at 32, 189 D.L.R. (4th) 385 at 417.
7. G. Brady & N.N. Iscove, "Construction of cDNA libraries from single cells" (1993) 225 Methods in Enzymology 611.

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