Social and Ethical Concerns Raised by Biotechnology, Other Issues Related to Biotechnology and Intellectual Property, Improving the Administration of the Patent System, Alignment: Limited Role for Patent System. The results of these efforts may provide guidance to courts or legislatures in Canada in addressing claims for damage caused by products of biotechnology, whether or not they have been patented. This matches the principle of justice, which we define in part as "a commitment to ensure a fair distribution of benefits and burdens." other matters such as the lack of benefit-sharing and animal welfare. Medical researchers are interested in identifying genetic causes of certain diseases. 83 OF 1990. 2. We recognize that, in proposing the inclusion of a farmers’ privilege provision in the Patent Act, more work needs to be done to identify the extent of the privilege in relation to plants and for animals. Under the treaty, members are to establish a multilateral system to facilitate access to genetic resources and to share the resulting benefits. EU Directive and the Legal Protection of Biotechnological Inventions, by Dr. Richard Gold, Assistant Professor, Faculty of Law, University of Western Ontario, London, Ontario; Assistant Professor, Senior Fellow, Einstein Institute for Science, Health & the Courts; Research Associate, Health Law Institute, University of Alberta; and Alain Gallochat, Advisor, French Ministry of Research, France. Recommendation: International Harmonization. The detailed provisions contained in the Directive also led to confusing results. Another issue raised by some participants at our industry sector meeting is the possibility of Canada adopting a patent restoration policy similar to those that exist in the United States, Europe and Japan. In Canada, the Patent Office describes higher life forms as "multi-cellular differentiated organisms (plants, seeds and animals)" and does not consider them to be patentable.7 This interpretation of Canadian patent law is currently being challenged in the courts in the "Harvard mouse" case. It is therefore imperative that, in extending the coverage of patent rights to higher life forms, Parliament not extend those rights too far. The patent claim may be cancelled or confirmed; in addition, amended or new claims may be incorporated into the patent. It will take several years for the treaty to come into force. The concerns that CBAC identified through its consultations and its commissioned reports are as follows: The commodification of life (including genetic material) is an ethical concern that most clearly arises directly from the application of patent law to higher life forms. Research into genes is thought to be the next great medical frontier, but to achieve greatness within this field, there must be profitability. Recommendation: Guidelines for Patents on Biological Material. One element of the concept of human dignity is that humans are not commodities. Fifth, provincial governments have called for a clarification of the experimental use exception in Canada.23. Even if Canada decides not to grant patents over plants and non-human animals, many of its trading partners do. People were invited to send comments, from March to May 14, 2001, via the committee’s toll-free telephone number or web site, or by fax or regular mail. 19 | The Canadian Oxford Dictionary defines "adventitious" as accidental, not planned, or extrinsic. Parties to the Convention agree to facilitate access to the genetic resources in their territory to other parties, obtain prior informed consent (PIC) when accessing those resources, and take measures to achieve a fair and equitable sharing of the results of research and development and the benefits arising from the commercial and other utilization of genetic resources with the member country that provided the resources. A lawyer would probably respond that a patent doesn't confer ownership. This option is premised on the belief that the patent system is not an effective tool with which to regulate social and ethical concerns linked to the commercialization of biotechnology. (b) report regularly on its performance with respect to those standards and the steps being taken (such as increasing capacity and/or expertise) to meet them. CIPO should carefully consider the view expressed in a recent report from the Government of Ontario on gene patenting that there should be a distinction made between the chemical structure and the information contained in a DNA sequence in order to remedy some of the problems related to gene patents.29 In addition, CIPO should play a role in the proposed joint federal-provincial-territorial study on the effects of gene patents on health care. Even if the courts could technically develop answers to what can and cannot be patented and could formulate the necessary rules to implement that decision, the principles of accountability and autonomy call for a parliamentary solution. It is generally believed unlikely that a holder of a patent over a human DNA sequence or cells (including stem cells) would be able to exercise control over a human body containing that sequence or cell. If it is found that the delays are due to a shortage of qualified examiners, this needs to be addressed quickly. The patent system attains this goal by providing inventors with a sufficient incentive -- but not more than sufficient -- to disclose their inventions and to make their inventions available to the public. Public interest embraces, for instance, people’s health and quality of life, the health of the environment, a strong national economy and a peaceful global community. They described patents as protecting developed economies but perhaps disadvantaging indigenous populations worldwide and local cultures in less developed countries. This position raises several issues, including standards that ought to be used to determine whether an unacceptable degree of market power has been developed; if it has developed, whether this power is being abused; the agency within the government most capable of rendering these decisions; and appropriate remedies to be applied to reduce or end the abuse. In balancing the interests of patent holder and "innocent-but-technical" infringer, we believe the latter ought to receive protection within the body of the Patent Act. A schedule will need to be established, with completion dates for steps such as notification of the patentee, publication of the opposition, filing of interventions by interested parties, hearings on temporarily suspending the effect of the patent, filing of the positions of the various parties, holding the hearing and issuing a decision. In formulating our recommendations (reduced to 13 from 16), we took into account a Statement of Principles and Values we adopted to guide our activities. In effect, by simply extending patent coverage to higher life forms, Canada would be discriminating in favour of some patent holders in the biotechnology field and against those in other fields.16. By providing economic incentives to conduct certain biotechnology research, the patent system encourages activities that have both significant potential for positive and negative ethical, environmental, health and/or social consequences.


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