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In the 21st century, biotechnology is expected to become a major driver of economic growth. It has the potential to improve the quality of life and to enhance job creation and promote economic growth in a variety of industrial sectors. If Canada is to participate to its full potential in the "biotechnology revolution", it must have a sound and effective infrastructure of policies in the area of
intellectual property rights. The ultimate goal is to devise policies that reflect the social and ethical values of Canadians, support the growth of biotechnology in an ethical and sustainable manner, and maximize the benefits of biotechnology for Canadians.
However, policies on granting or extending intellectual property rights in the field of biotechnology, including exemptions and exceptions, must be framed within the general context of the balance of their potential benefits and disadvantages. This context must include the public's concern about access to new developments, and Canada's international treaty obligations.
In early 2000, The Canadian Biotechnology Advisory Committee (CBAC) initiated a research and consultation program on the patenting of higher life forms and related issues. They chose this topic for study because the Harvard onco-mouse case was before the courts in Canada and because both government officials and CBAC members had identified intellectual property issues relating to biotechnology
generally and to the patenting of higher life forms in particular as areas of growing concern.
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The report released in June of 2002 represents the views of CBAC on the patenting of higher life forms and related issues after having taken into account the results of policy research studies, sector roundtables, public opinion research, multi-stakeholder consultations and responses to the Interim Report of November 2001.
The observations and recommendations in the report are organized under four main themes:
Theme #1:
Social and Ethical Concerns Raised by Biotechnology:
This section of the report describes a number of social and ethical concerns arising from or linked with the development of biotechnology. It summarizes three possible approaches to addressing these considerations.
Recommendations:
"Higher life forms" are all living organisms with more than one cell, including all members of the plant and animal kingdoms, as well as human beings. Although humans are also animals, no country, including Canada, allows patents on the human body. It is generally understood that an entire human body could not be patented. Thus, CBAC recommended that the Patent Act include a statement "no patent
shall be granted on human bodies at any stage of development."
Theme #2:
Patentability of Higher Life Forms:
After addressing the issue of the patentability of human beings, this section of the report describes the main arguments supporting or opposing the patenting of plants, seeds and animals.
Recommendations:
Four of the five recommendations in this section are linked and should be considered as a group. CBAC (with the exception of one member) recommends that other higher life forms (plants, seeds, non-human animals) which meet the criteria in the Patent Act be patentable, subject to certain limits to be spelled out in the Act.
Those limits are:
- allowing farmers to save and sow seeds from patented plants, or to reproduce patented animals, so long as the progeny are not sold as commercial propagating material, and as long as it does not undermine the value of the genetically engineered progeny to its creator (farmers' privilege);
- protection from claims of patent infringement in the case of adventitious spread of patented seed or insemination of an animal by a patented animal (innocent bystander); and
- a research and experimental use exemption covering private and non-commercial purposes or for the purpose of studying the invention to investigate its properties, improve upon it, or create a new product or process as a result.
Theme #3:
Other Issues Related to Biotechnology and Intellectual Property:
This section deals with issues of a social or ethical nature that are clearly linked to the patent regime. The section also draws attention to recent developments concerning the impact of biotechnology patents on the health care system.
Recommendations:
The report contains three recommendations which address certain social and ethical considerations concerning traditional knowledge and benefit-sharing. In summary, they are that:
- policies be developed to encourage the sharing of the benefits of research involving genetic material with the communities or populations which allowed access to the plant, animal or human genetic resources used in the research
- Canada support international efforts to determine a form of intellectual property could be developed to protect traditional knowledge; and
- the Canadian Intellectual Property Office (CIPO) describe how traditional knowledge that has been made public through oral as well as written transmission is to be considered when assessed what is "prior art" with respect to a patent application.
Theme #4:
Improving the Administration of the Patent System:
This section contains a series of comments and recommendations concerning both the operation and the policy orientation of the Canadian patent system. The focus of this section is to identify a series of measures to strengthen the patent system.
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