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patenting of genes and related issues

It is generally understood that an entire human body could not be patented. Traditional Knowledge: Industry often uses the traditional knowledge of indigenous peoples and some developing nations to help identify plants and non-human animals that could lead to valuable products, but the companies are not required to share the benefits of these products. 6 | Even though human beings are animals, most lawyers maintain that a whole human being is not patentable, or else that patents over whole humans would not be enforceable. To support these national access laws, the aforementioned Bonn Guidelines encourage governments to adopt measures to ensure disclosure of the sources of traditional knowledge in applications for patent rights. It has been proposed that Canada address this concern by amending the Patent Act to include an explicit experimental use exemption. Others suggested that Canada accept the patent decisions made in the United States or Europe. While some proposals have been made to modify the Patent Act (see Annex D), the existing range of mechanisms available to restrict or prevent activities determined to be socially or morally undesirable is quite extensive. (b) ratifying, as soon as possible, the Patent Law Treaty, which addresses the formal requirements for filing patent applications and maintaining patents. As noted in the report, CBAC is of the view that social and ethical considerations are essential underpinnings of effective public policy, and that the full range of legal, regulatory and institutional means needs to be considered when developing policy related to fundamental values. As noted in the Interim Report, while these issues are very important, they are not central to our particular project on biotechnological intellectual property. Rather, it means that they must be particularly vigilant when a new transformative body of knowledge and technology develops. We referred to these principles and values in resolving the central issues underlying the debate about whether to permit the patenting of higher life forms in Canada. Whether invented plants or animals were patented would not change this requirement or the criteria which must be met to permit release into the environment. Comments were requested from interested Canadians by March 2002 and a summary of responses can be found on the CBAC web site. In fact, the patent system appears to have no way to address this issue satisfactorily. Patentees could still license, rather than sell, the patented animal or plant, which would allow them to impose any contractual obligations they wish, including an obligation on the farmer not to reuse the seeds or breed the non-human animals. There are, however, some concerns that are clearly closely connected with the patent system, even if indirectly. This regime which would need to be established through new federal legislation, would describe a process to apply for biological product protection, the scope and duration of that protection and its enforcement. The document must clearly define this principle. That individual (the "innocent bystander") may face a patent infringement suit -- one of the most difficult and expensive legal actions against which to defend -- and damages for infringement without a countervailing remedy against the patent holder. 10. If patent rights are extended to plants and animals, what ought to be the scope of those rights, taking into account their particular nature? Medical researchers are interested in identifying genetic causes of certain diseases. This option does not require any change to either the Patent Act or its administration and thus has the advantages of continuity, stability and predictability, which are highly valued in the business community. The second exception is designed to ensure that future generations of researchers have access to the fundamental knowledge on which to build more knowledge and construct new and better inventions. We note, moreover, that in its May 2002 opinion on the ethical aspects of patenting inventions involving human stem cells, the body charged by the European Directive to prepare these reports -- the European Group on Ethics in Science and New Technologies -- recommended that an ethical review by an independent body should be incorporated into the patent examination process. The Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilization were adopted at the April 2002 Conference of the Parties to the CBD.

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