Canada Rejects Patents on Higher Life Forms
From DrugPedia: A Wikipedia for Drug discovery
Canada’s ruling on 5 December 2002 makes her the only industrialized country to prohibit patents on higher life forms. The test case was Harvard University’s 17-year quest for ownership of its genetically engineered "oncomouse". Researchers inserted a cancer-promoting gene (oncogene) into fertilised mouse eggs, producing transgenic mice more susceptible to tumours, thus facilitating clinical work and faster experimental results for cancer research.
The oncomouse was patented in the US in 1988, and has patent protection in Australia, Japan and several European countries. The patents give Harvard exclusive rights to create the mice and charge licensing fees for their use. The "invention" is licensed to Du Pont, which sells the mice to research labs.
In its application, Harvard sought to protect both the process by which the oncomice are produced and the end product of the process, i.e. mouse and offspring whose cells contain the oncogene. The process and product claims extend to all similarly altered non-human mammals.
Canada allows single-celled organisms, such as yeasts and bacteria, and GM crops to be patented. It also allows patents for modified human genes and cell lines. The Supreme Court, Canada’s highest court, however conceded that ownership of more complicated life forms is a radically different concept, thus ending the legal battles over the oncomouse.
Harvard had obtained a patent on the oncogene and related process claims from the Canadian Intellectual Property Office in 1993 - but not on the mouse itself or its offspring with the oncogene. The Commissioner of Patents upheld the decision in 1995, and the Trial Division of the Federal Court in 1998 dismissed Harvard’s appeal against this.
In 2000 however, the Federal Court of Appeal overturned the trial judge and concluded that both the process and the mouse could be patented. Ruling 2-1 in favour of the full patent, it said that nothing in Canada’s 1869 Patent Act outlawed patenting animals, although asserted that it shouldn’t be extended to allow patenting of human beings.
The Supreme Court ruling now puts the ball firmly in Parliament’s court. It ruled by 5-4 that a living mouse cannot be patented, even if its genes are genetically modified. It said the mouse fails to meet the definition of an invention.
The Canadian Patent Act defines "invention" as "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". The Supreme Court confined itself to debating whether the words "manufacture" and "composition of matter", within the context of the Patent Act, are sufficiently broad to include higher life forms.
The Court ruled that the mouse is not a "manufacture", as that denotes a non-living, mechanistic product or process. And it isn’t a "composition of matter" either, because the phrase must be considered in the context of the other words. Justice Michel Bastarache, writing for the majority, said, "Just as ‘machine’ and ‘manufacture’ do not imply a living creature, the words ‘composition of matter’ are best read as not including higher life forms".
"Composition of matter", and hence patenting, can apply to lesser life forms, the Supreme Court concluded, but not to higher life forms, as animals’ capacity to display emotion and to behave unpredictably separates them from lower life forms and shows they are more than a composition of matter. "Higher life forms are generally regarded as possessing qualities and characteristics that transcend the particular genetic material of which they are composed", wrote Justice Bastarache.
The judges conceded that the 133-year-old Patent Act is simply inadequate to address the complex ethical and legal questions. Rather than extending patent laws to higher life forms, as has been done by other nations’ courts, they urged that the issue be clearly addressed in Parliament. The judges decided that the unique ethical issues posed by genetic engineering of complex animals and plants are such that no higher life forms should be patented in Canada until Parliament debates the issues and passes laws specifically designed to address this rapidly developing realm of science.
One of the dissenting justices, Ian Binnie, dismissed the prospect that allowing the patent on the Harvard mouse would open the door to patenting humans, saying that the Canadian Charter of Rights would prohibit ownership of human beings for commercial purposes. He claimed it ludicrous that Canada should stand alone in refusing to grant patent protection to Harvard.
But Justice Bastarache warned that the issue of human patenting is complex and cannot be readily dismissed by reference to the Charter. He said that it would be inappropriate for the courts to create an exception from patentability for human life, given that this requires consideration of what is human and which aspects of human life should be excluded. Accordingly, he recommended that Parliament deal with the "increasingly blurred line between human beings and other higher life forms".
The ruling was devastating for numerous Canadian companies awaiting patents on plants and animals. They claim that it threatens to stifle biotechnological research in Canada, by depriving researchers of legal protection for their inventions. As many as 1,500 applications for plant and animal patents have been on hold pending the Supreme Court’s verdict.
Harvard denounced the decision, saying, "Canadian scientists are at risk of being left behind their colleagues around the world". It urged Parliament to change Canadian law to enable patenting of the mouse (and in general non-human higher life forms, except where society makes such research illegal).
Canada’s national association of biotechnology research companies echoed Harvard’s warning. "This decision stops dead in its tracks our pursuit of knowledge and innovation", said Janet Lambert, president of BIOTECanada. The inability to receive life form patents "could create a chilling effect on scientists doing research here".
But evidence shows that patents sometimes actually deter innovation. Inventions that involve many patented components (as biotech usually does) divert time and money from innovation into negotiating - and often litigating - licences and royalties. Patent holders may use patents strategically to prevent competitors from developing new products. Patents also don’t necessarily encourage public disclosure - one study showed that 20% of life-scientists delay disseminating research findings in order to file patents. Ironically, leading US cancer researchers charge that the meddlesome licensing policies of DuPont (which holds exclusive rights to the oncomouse) are deterring scientists from researching with the oncomouse.
Patents on life forms could foreclose opportunities for research and product development to non-patent holders. While this potential is inherent in patent systems, the impact may be more significant for biotechnology products. Access to basics such as DNA sequences, cell lines, plants and animals at reasonable cost, is crucial. High research costs can drive up the price of the end product, many of which are important for public health needs.
Those who would broaden what patents can cover say this is essential for the viability of Canada’s biotechnology industry. In fact, their case is unclear; a 1995 survey indicated that Canada’s weak intellectual property regimes were not regarded by its biotechnology sector as important obstacles. Mechanisms other than the patents can still encourage real innovation.
The ramifications of this judgement on the patenting of GM crops and other life forms remain to be seen. It is however expected to shape Canada’s policies on cloning and genetic engineering.
University of Saskatchewan patent law specialist Martin Phillipson expects the ruling to derail as yet unapproved patent applications, but that it won’t roll back patents already awarded for products such as Monsanto’s Roundup Ready canola. (Canadian farmer Percy Schmeiser has asked the Supreme Court to hear his case, hoping it will overturn lower court rulings that found him guilty of infringing Monsanto’s patent, despite contamination of his crops by the transgene.)
Phillipson argues that patents on life forms until now have covered events within cells, while the resulting life form has not itself been patented. Monsanto’s and other crop patents apply to the process of splicing genes and inserting them into cells, but have not been extended to living plants, although the end result is still de facto protection of the whole plant.
Industry Minister Allan Rock accepts the court’s invitation to embark on the thorny debate on how the government should address patenting higher life forms, including humans. The government plans to consult its citizens and the Canadian Biotechnology Advisory Committee (CBAC), an expert panel that advises on biotech issues, before deciding what to do.
The CBAC recommended last June that Canada open its doors to animal and plant patents. It has now renewed calls for Rock to revamp the Patent Act so that it permits patents for all higher life forms except humans and foetuses.
As the issue is hotly debated in Canada, implications on developing countries should also be considered. The Canadian Catholic Organization for Development and Peace asserts that banning life form patenting in Canada will stop Canadian patents on seeds of staple food crops. Some 1.4 billion farmers depend on free access to seeds for their food security. It said, "The Supreme Court decision should be a signal to the government that Canada must use its influence within the World Trade Organization to support developing countries in their efforts to resist pressure to allow patents on seeds and other life forms".
The Africa Group in the WTO has already recognised the serious implications patents on life forms would have on the rights of local communities to food security. It proposed in 1999, and again in 2001, that the mandated review of Article 27.3(b) of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) (relating to patents on living organisms and processes) should make clear that plants, animals and micro-organisms and their parts, and all living processes, cannot be patented.
The complete document with references, is available in the ISIS members site.
