While the general objective of IP laws can be stated rather simply, in the fast-paced world of high technology applying these laws can present significant challenges. In the 1980s, a debate raged as to whether software should be protected by copyright. Later the question arose whether the topographies used to create integrated circuits should be protected under the patent or copyright regime (or both). In short, it is not unusual for a new technological development to raise the question of whether and how it should be protected under IP laws.
The Oncomouse
The latest case to wrestle with this recurring conundrum was prompted by the so-called Harvard oncomouse. Essentially, researchers had developed a mouse susceptible to cancer, which would make it very valuable for testing drugs that fight cancer, and for other cancer-related research purposes. The oncomouse was created by transforming its genetic make-up, by adding to it a gene that turns normal cells into cancerous tumours.
The question that confronted the Supreme Court of Canada was whether the developers of the oncomouse should be afforded patent protection for their creation. In a decision released on December 5, 2002, in a five to four decision, Justice Bastarache, speaking for the majority, said no, while Justice Binnie, expressing the views of the minority, concluded yes. Their respective approaches provide a fascinating study in contrasts, and illustrate yet again the challenges posed to the law by the rapid pace of technological change.
Divining Parliamentary Intent
The majority approached the central question of whether the oncomouse could be patented largely on the narrow basis of statutory interpretation. Under the Patent Act, an "invention" is defined as any new and useful "art, process, machine, manufacture or composition of matter." Accordingly, the majority distilled the case down to whether the transgenic mouse could be said to be a "composition of matter".
While acknowledging that lower life forms (such as bacteria, fungi, yeasts or moulds) could come within the phrase "composition of matter", the majority concluded that higher life forms (such as plants and animals) could not. The majority arrived at this conclusion by pointing out that the patenting of higher life forms raises a host of practical, ethical and environmental issues, and that the Act's statutory and administrative regime simply does not address them. Thus, in the view of the majority, Parliament could not have intended higher life forms to be included under the patent system.
The majority invited Parliament to act on this issue if they chose to address the protection of higher life forms. The majority pointed to a similar process a dozen years ago when Parliament enacted the Plant Breeders' Rights Act as a result of the S.C.C. disallowing a patent for a crossbred soybean variety. Indeed, the enactment of this separate statute to address crossbred plants offered further evidence for the majority that the Patent Act was not intended to cover higher life forms.
One concern that animated the majority was that if the Patent Act were interpreted to include higher life forms, it would then have to include the patenting of human life as well. Clearly this was a result the majority could not countenance. Again, if Parliament wished to enact IP protection for higher life forms, they could do so in a manner that also addressed human life issues.
Just a Patent
The minority's decision in the Harvard mouse case stands in fairly sharp contrast to that of the majority. On the question of statutory interpretation, the minority found it difficult to try to assess what Parliament, in 1869 (when the modern Patent Act was first enacted), intended to cover by way of inventions because, by definition, patentable inventions are not obviously foreseeable. On this point the minority noted that in 1869 Parliament equally could not have foreseen "moon rockets, antibiotics, telephones, e-mail or hand-held computers".
Put another way, the minority did not draw a distinction, for Patent Act purposes, between lower and higher life forms; rather, all would be patentable provided they met the usual criteria of patentability, namely utility, novelty and inventiveness. At the same time, however, the minority was quick to add that patents would not be allowed on human life as it is contrary to the common law and to the Canadian Charter of Rights and Freedoms for someone to own someone else.
The minority was not unmindful of the various policy issues raised by the genetic manipulation of higher life forms. Various religious, environmental, agricultural and non-profit research groups intervened in the case, and the minority heard their views. Their concerns, however, argued the minority, should be addressed in a separate regulatory regime, as determined by Parliament, and not through the Act.
The minority pointed out that this is what has occurred with any number of other inventions that society considers unsafe or otherwise in need of some degree of regulatory oversight. Nuclear technology is patented under the Act, but cannot be marketed unless compliant with the relevant nuclear regulatory regime. Equally with prescription drugs: they are patented under the Act, but unable to be sold to the public until approved under our health regulatory regime that ensures the drug's safety and efficacy. And so on with a long list of other products, including firearms, for example, in each case the Act allows them (or components of them) to be patented, but another statute deals with their manufacture, marketing, licensing, etc.
In effect, the minority did not suggest we ignore the broader implications of transgenic animals, but rather that these issues be dealt with in a legislative/regulatory setting outside of the patent regime. Indeed, ironically, by denying patent protection for higher life forms these broader issues are not dealt with at all, and in fact are perhaps exacerbated inasmuch as there is then less control on the distribution of these items in Canada.
It's a Small World
An important theme articulated by the minority decision is the international ramifications of the decision of the majority. The minority pointed out that biotechnology is a global business, and that intellectual property is particularly mobile on a worldwide basis. It is therefore noteworthy that the Harvard oncomouse has been granted patent protection in Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, The Netherlands, Portugal, Spain, Sweden, the United Kingdom and the United States, and with similar patents granted in Japan (and a transgenic mouse susceptible to HIV has been patented in New Zealand).
As for the U.S., our most important trading partner, the U.S. Supreme Court some 20 years ago confronted a very similar issue and concluded, albeit in a close five to four decision, that life forms (in that case, genetically engineered bacteria that could break down oil in spills, such as from ocean going tankers that broke up) are patentable. Thus, with the decision from the majority, Canada is clearly out of step with our peer countries, which matters a great deal when it comes to competing for the talent and financial resources required for biotechnology research.
Over to Ottawa
While the majority and minority decisions in the Harvard mouse case differ dramatically in their interpretation of the current Patent Act as it relates to the protection of higher life forms, the respective authors are probably unanimous that Parliament should respond quickly to the challenges posed by the case. And indeed Ottawa should.
Press reports indicate that some five hundred patent applications now sit in abeyance waiting for direction as to where the dividing line is between higher and lower life forms, and whether higher life forms will be provided any protection under an amendment to the Act. Clearly what is required is certainty on these issues, together with a regulatory regime that addresses at least some of the concerns with genetic engineering expressed by the majority.
Fortunately, we have some fairly recent experience on the regulatory front, in the form of Bill C-13, which, when enacted, will create a regulatory regime for dealing with genetic cloning, assisted reproduction procedures generally, and related questions. Difficult questions surrounding controversial issues such as surrogate mothering are addressed by this proposed law. Presumably there would be numerous parallels between Bill C-13 and an appropriate regulatory regime for the creation of higher life forms.
In the Harvard mouse case we have seen, yet again, the rapid pace of technological change outstrip the current capacity of our legal system. It is now up to Parliament to ensure that our intellectual property law remains up-to-date and relevant to the biotechnology community and to society at large.
George S. Takach is head of the technology, communications and intellectual property group at McCarthy Tétrault LLP, the author of Computer Law, and an adjunct professor in computer law at Osgoode Hall Law School. This column is intended to convey brief, timely but only general information and does not constitute legal advice; readers are encouraged to speak with legal counsel to understand how the general issues noted above apply to their particular circumstances.