The tenth meeting of the Conference of the Parties (COP 10) to the Convention on Biological Diversity (CBD) is scheduled to be held in Nagoya, Japan from October 18 to 29, 2010. With the government of Japan chairing the conference, we at Keidanren have high hopes for a successful meeting.
However, we also have reservations concerning the main item on the COP 10 agenda, the conclusion of negotiations for an international regime on access to genetic resources and benefit sharing (ABS). We are concerned that, depending on its final content, such a regime could stifle innovation and have a major impact on economic development, particularly given the lack of a clear definition of "genetic resources." In the following, we outline our basic position on ABS from the perspective of intellectual property issues, including our key concerns, policies we believe the meeting should not adopt, and recommendations for measures going forward.
The costs that businesses accrue by sharing the benefits from utilization of genetic resources with source countries will be added to the price of the goods and services consumers purchase. Among the provisions now under discussion in negotiations for an international ABS regime are changes in the intellectual property system designed to improve ABS compliance. There are grounds for concern that, depending on the content of the final agreement, the scope of mandated benefit sharing could become unreasonably broad, adding significantly to the consumer burden. Companies faced with unanticipated benefit-sharing requirements might be forced to cease the provision of goods or services. In Japan, which depends on imports for so many of its resources, we believe the economic impact could be particularly serious, both for businesses and, ultimately, for citizens.
The existing intellectual property system supports the development of industry by providing an incentive for businesses to pursue innovation. The development of industry, in turn, supports job creation and a rising living standards. There is cause for concern that the international ABS regime currently under negotiation would fundamentally alter the intellectual property system in such a way as to stifle innovation. Moreover, as the United States is not a party to the CBD, such a change could exacerbate the innovation gap between the United States and other countries, Japan in particular, with major consequences for businesses active in global markets. By causing industry to contract, such a situation could lead to a loss of jobs and have a serious impact on people's lives.
For the reasons below, we do not believe that disclosure of the origin of genetic resources should be made mandatory in patent application specifications.
(1) Government administrators would have no way of determining the accuracy of such information, as there are no criteria for assessing the origin of genetic resources.
(2) Patent applicants would be unable to meet this obligation because, while it is possible to specify the immediate source of genetic resources (e.g., a commercial supplier), it is often impossible to trace the distribution channel upstream to specify the ultimate source (the country of origin).
(3) As only a fraction of the results of research using genetic resources are patented, and as previous cases involving claims of biopiracy (unfair commercial use of biological resources) are unrelated to patented inventions, and as there is no basis for assuming that patent applications or patents can prevent biopiracy even if they disclose the origin of genetic resources, it is unlikely that mandatory disclosure would have a positive effect on CBD-ABS compliance (i.e., preventing illicit acquisition of genetic resources).
(4) If, along with mandatory disclosure of the origin of genetic resources, patent approval is also made contingent on evidence of ABS compliance through disclosure of such contract content as prior informed consent (PIC) and mutually agreed terms (MAT), then leakage of proprietary information will become rampant, jeopardizing corporations' business strategies.
For the reasons below, we do not believe that disclosure of the origin of genetic resources should be a requirement for patenting or patent validity.
(1) As there are no criteria for judging the veracity of information on the origin of genetic resources, such a requirement would engender profound uncertainty regarding the value and validity of a patent, creating an incalculable risk for business itself.
(2) Invalidation of a patent would cause economic harm to both the user of a genetic resource, i.e., the patent holder, and the provider of the resource by making it impossible for either to reap the benefits of the resource.
(3) Making disclosure of the origin of genetic resources a requirement for patenting is inconsistent with the patent systems of most countries and is, in any case, fundamentally at odds with the patent system in Japan.
For the reasons below, we do not believe the ABS's scope should be extended beyond genetic resources per se to include "biological resources" and products and derivatives of genetic resources.
(1) Extending the scope to include not only genetic resources per se but also "biological resources" and the products and derivatives of genetic resources (henceforth referred to collectively as "derivatives, etc.") would also extend the scope of disclosure requirements concerning the origin of genetic resources and thereby multiply the problems attending disclosure and its establishment as a patenting requirement.
(2) Extending the scope of application would automatically extend the scope of benefit sharing, making it necessary to share benefits from the utilization of a genetic resource irrespective of the importance of that resource's contribution to the derivatives, etc.
For the reasons below, we do not believe that access standards that do not guarantee fairness and transparency should be established.
(1) Limiting access to genetic resources on the basis of conditions without rational justification from a market economy standpoint would result in missed opportunities to put those resources to use for humankind at a global level, as well as missed opportunities for innovation.
(2) Conditions that hinder academic research would also result in missed opportunities to put genetic resources to use for humankind at a global level, as well as missed opportunities to acquire scientific knowledge necessary to maintain and preserve biodiversity.
We recommend the following measures going forward.
(1) Establish a mechanism to promote the conclusion of individual ABS contracts between providers and users of genetic resources based on mutually agreed terms (as stipulated in the Bonn Guidelines).
(2) Prevent the unauthorized export of genetic resources through border enforcement by provider countries.
(3) Assist in the creation of international access standards that promote access to genetic resources.
(4) Establish an international mechanism to assist provider countries in cracking down on illicit acquisition of genetic resources.
(5) Carry out deliberations bearing on the intellectual property system within the World Intellectual Property Organization.
(6) Rather than build a consensus on individual provisions term by term, deliberate all ABS issues in the larger context of an integrated international ABS regime under the CBD.