Interim Report on Patenting of Higher Life Forms
March 1, 2002
The Canadian Biotechnology Advisory Committee (the CBAC) is a group of independent members, established to provide advice to the government on crucial policy issues associated with the ethical, social regulatory, economic, scientific, environmental and health aspects of biotechnology. In November 2001, the CBAC released its Interim Report and recommendations on the patenting of higher life forms.
The CBAC is inviting comments on its draft recommendations from interested parties, providing stakeholders in the industry with a ground-floor opportunity to influence the ways in which Canada will regulate biotechnology. Comments are to be received by CBAC before March 15, 2002, in order to be taken into account in the formulation of the final report to the Government of Canada.
The Interim Report is a synthesis of the input received in response to the Consultation Paper, released earlier, and takes the form of a series of draft recommendations to government.
The key issues addressed in this interim report concern:
The CBAC will formulate its final recommendations after considering the responses to this Interim Report and further discussion among its members. The CBAC report contains 16 Draft Recommendations. A brief discussion of some of the recommendations that we believe are of particular interest to the biotech community are set out below.
Patentability of Higher Life Forms (Plants, Seeds and Animals), including Humans
The CBAC has recommended that the Canadian Patent Act be amended to include a statement that human beings, at all stages of development, are not patentable.
In Canada, patents have been granted on biotechnological processes, on products made with those processes, on plant, animal and human DNA sequences, genes and cells and on micro-organisms. To date, the Canadian Intellectual Property Office (CIPO), the organization responsible for issuing patents, has not considered higher life forms to be patentable. However, this has been challenged through two levels of court and is now set to be decided by the Supreme Court of Canada.
The patentability of higher life forms has already been established in the United States and Europe through judicial interpretation of existing laws. Europe has incorporated these changes into the laws governing patenting of biological material. In some countries, such as Australia, the principle that human beings cannot be owned or enslaved, and therefore cannot be patented, has been explicitly stated in patent legislation. Canada may choose to amend the Patent Act in a similar manner.
The wording of the proposed amendment is of concern. For example, if the prohibition is against patenting human beings, does this leave the door open to the patenting of human parts, such as tissues or organs? If the term human body is used instead, issues about the point after conception at which a body can be said to exist are raised. Even the phrase at all stages of development is not straightforward, as it has been defined in European legislation to include sperm and unfertilized eggs.
This proposed amendment also raises issues about the application of biotechnological processes to humans. Government and industry will have to decide whether inventions that involve cloning of human beings, modifying the germ line identity of human beings and the use of human embryos for industrial or commercial purposes should or should not be patentable. Europe has already addressed many of these considerations, and has recently adopted provisions that specify that such inventions are not patentable because they offend against ordre public or morality. In Canada, the draft Assisted Human Reproduction Act, as currently written, would prohibit these activities, but would not prevent them from being patented in Canada.
Patentability of Higher Life Forms (Plants, Seeds and Non-human Animals)
The CBAC has recommended that higher life forms (i.e., plants, seeds and non-human animals) that meet the criteria of novelty, non-obviousness and utility be recognized as patentable, subject to placing limits on patent holders rights, such as (a) a Farmers Privilege; (b) Protection for Innocent Bystanders; and (c) Liability for Damages.
The first limit involves farmers privilege and refers to the traditional farming practice of saving seed from crops for planting the following year. This practice could potentially infringe a patent holders rights. The CBAC has recommended that the Patent Act include a farmers privilege provision that would permit this practice, provided that the next generation of plant or animal was sold as produce and not sold for further replanting or breeding. The negative impact that such a provision could have on new developments in agricultural biotechnology does not appear to have been canvassed by the CBAC.
Further, since patented plants and animals may be capable of reproducing outside the control of the patent holder or licensee, the CBAC has recommended a second limit on a patent holders rights an amendment to the Patent Act that would protect innocent bystanders from claims of patent infringement with respect to natural / accidental spreading of patented seed, patented genetic material, or the insemination of an animal by a patented animal. However, no analysis exists in the CBAC report of the current state of the law respecting innocent bystanders in such circumstances.
The third limit proposed on a patent holders rights concerns liability for damage. The CBAC is recommending that Canada actively participate in international negotiations to address issues of liability (such as those currently in progress under the Biosafety Protocol) for undesired natural / accidental spreading of patented seed, patented genetic material, or the insemination of an animal by a patented animal. However, it is not clear how these negotiations would impact upon a patent holders rights, nor is it clear why biosafety issues should be restricted only to patented technologies.
In addition, the CBAC report has recommended that patent holder rights be restricted by much broader experimental use exceptions than presently provided in the Patent Act and at common law. The proposal is to expand the experimental use exception to provide that it is not an infringement of a patent to use a patented process or product for either:
These limits have the potential to have significant consequences on the rights held by patent owners, making such rights unenforceable in certain situations.
CBAC recommends that the federal research granting councils, the National Committee on Ethics in Human Research and other relevant bodies explore options for sharing the benefits of research (including its commercial exploitation) with the communities or populations involved in the research.
Without the participation of various populations and communities, the research and development of new drugs, medical processes or research into various health conditions and treatments would often be impossible. The CBAC has suggested that the involvement and contribution of these persons be compensated in some manner. The CBAC has recommended a general concept of benefit sharing, but has not specified further what is meant by that term. Discussions on this issue will no doubt include debates about forms of royalty payments, investment options, and other means by which communities and populations may claim entitlement to the profits of the commercialization of their contribution.
Research on Impact of Biotechnology on Health Care
CBAC recommends that a systematic program of research be undertaken on the impact of biotechnology patents on health services.
The CBAC has suggested that researchers examine the effect that biotechnology patents have on the ability and willingness of patent holders or companies to commercialize their inventions, thus making them available to the health care system. This would also include taking into account the effect of patenting of biological inventions on accessibility to important preventive, diagnostic and therapeutic innovations.
The CBAC has suggested that there be research to examine the impact biotechnology patents would have on the net cost of health care. This research will also explore methods to address the impact of the cost of new inventions for the health care system be examining such arrangements as licences, mandatory access, large buyer groups, assessments of medical / health value to support provincial formularies or analogous systems used for other kinds of medical technology.
With the release of this report, CBAC enters Phase 3 of its work on intellectual property and the patenting of higher life forms. Phase 3 entails collecting additional input from stakeholders and other interested Canadians on the recommendations presented here. CBAC will then analyze the additional input and take it into account when preparing its final report to the Government of Canada.
We would be pleased to discuss any of these issues with you and to assist in the preparation of any submissions you would like to make.
Anyone wishing to comment directly on this report should do so by March 15, 2002. Comments may be submitted either through the website at www.cbac-cccb.ca, by fax at 613 946 2847, or by mail to CBAC, 240 Sparks Street, Room 570E, Ottawa, Ontario K1A 0H5.
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