Collaborative research and intellectual property rights

Scientists find themselves working more and more with indigenous, traditional and local communities in all aspects of their collections and investigations. Indigenous knowledge has become increasingly important in research while at the same time local communities have become increasingly politicized in the use, misappropriation, and commercialisation of their knowledge and biogenetic resources. It is becoming more and more difficult for even the most well-intentioned scientists to stride into indigenous areas and collect plants, animals, folk tales, and photos without having first to convince local leaders that the scholarly efforts will somehow benefit the communities — that the benefits of research results will directly and indirectly lead to strengthening the traditional society. In many parts of the world, indigenous peoples only allow Collaborative Research in which the scientific priorities and agendas are controlled by the communities, or Community Controlled Research in which the communities actually contract scientists to carry out the group's research plan. Control over data has become one of the key battle cries for the indigenous movement, that is now demanding Intellectual Property Rights over information obtained through research and just compensation for economic benefits that eventually may accrue. This paper deals with some of the ethical and practical issues that frame this rapidly evolving debate.     

Innovation and intellectual property rights in systems biology

A framework for characterizing systems-based knowledge is needed to understand the new complexities arising from the assignment of IP rights to biological information.     

Managing genetic material to protect intellectual property rights

One of the most important policy instruments for the promotion of further biotechnology development is intellectual property right (IPR) protection. However, one cannot improve upon a biotechnological invention without physical access to the germplasm, making exchanges of genetic material necessary. A formal transfer agreement, which addresses the key issues of ownership, access, use, and equitable benefit-sharing, is a powerful legal instrument for intellectual property. Other restrictions are generally imposed as a result of national and international safety regulations. Forming strategic alliances, such as joint ventures, collaborative research agreements, joint research and development agreements, and manufacturing and distribution alliances to exploit the economic value of genetic material, provides scientists with the mechanisms they need to bring their research material and products to the marketplace. Received 06 November 1997/ Accepted in revised form 24 November 1997     

Language revitalization in Native North America--issues of intellectual property rights and intellectual sovereignty

Language revitalization, oral tradition and epistemology are expressions of Native peoples intellectual sovereignty, and thus the foundation for indigenous intellectual property rights. As the people of California move towards language and cultural revitalization the question arises: What constitutes or constructs the definitions of intellectual property and how can appropriation of indigenous knowledge be protected? Looking at the issues faced by the California's indigenous populace and by implication, other indigenous peoples in the United States, this essay examines how protection may be afforded under the United Nations definition of 'heritage'. Given that the holding safe of a 'culture' or 'heritage' is inclusive of language, and thus has been determined to be a human right.     

DNA labelling of varieties covered by patent protection: a new solution for managing intellectual property rights in the seed industry

Plant breeders’ rights are undergoing dramatic changes due to changes in patent rights in terms of plant variety rights protection. Although differences in the interpretation of »breeder’s exemption«, termed research exemption in the 1991 UPOV, did exist in the past in some countries, allowing breeders to use protected varieties as parents in the creation of new varieties of plants, current developments brought about by patenting conventionally bred varieties with the European Patent Office (such as EP2140023B1) have opened new challenges. Legal restrictions on germplasm availability are therefore imposed on breeders while, at the same time, no practical information on how to distinguish protected from non-protected varieties is given. We propose here a novel approach that would solve this problem by the insertion of short DNA stretches (labels) into protected plant varieties by genetic transformation. This information will then be available to breeders by a simple and standardized procedure. We propose that such a procedure should consist of using a pair of universal primers that will generate a sequence in a PCR reaction, which can be read and translated into ordinary text by a computer application. To demonstrate the feasibility of such approach, we conducted a case study. Using the Agrobacterium tumefaciens transformation protocol, we inserted a stretch of DNA code into Nicotiana benthamiana. We also developed an on-line application that enables coding of any text message into DNA nucleotide code and, on sequencing, decoding it back into text. In the presented case study, a short command line coding the phrase »Hello world« was transformed into a DNA sequence that was inserted in the plant genome. The encoded message was reconstructed from the resulting T1 seedlings with 100 % accuracy. The feasibility and possible other applications of this approach are discussed.     

ECVAM's approach to intellectual property rights in the validation of alternative methods

In this article, we discuss how intellectual property rights affect the validation of alternative methods at ECVAM. We point out recent cases and summarise relevant EU and OECD documents. Finally, we discuss guidelines for dealing with intellectual property rights during the validation of alternative methods at ECVAM.     

遗传资源获取和利益分享与知识产权保护

随着人类对遗传资源开发利用程度的加剧、物种资源不断减少以及国际交流合作的日益频繁,遗传资源获取和利益分享中的知识产权问题日益受到国际社会的关注。为了保护和持续利用遗传资源,本文根据《生物多样性公约》第15条的规定,以及国际社会在遗传资源获取和利益分享方面的做法,分析了我国遗传资源保护和利用以及知识产权保护的现状,提出建立和完善保护遗传资源知识产权的专利制度,遗传资源的管理制度以及遗传资源保护和利用的市场化机制等管理措施,最后,对中国和阿根廷NIDERA公司在大豆遗传资源交换,合作研究和利益分享的案例进行了分析。     

Needed: models of biotechnology intellectual property

Although never uncontroversial, intellectual property rights in biotechnological innovation are once more the focus of intense debate. The debate has yet to reach any result, largely because of several important errors in the way that various disciplines approach it. These errors include making assumptions without empirical basis and conflating various intellectual property regimes. What is needed is a transdisciplinary integrated method to correct these errors. Such a method can be implemented through the construction of alternative models of intellectual property protection designed to balance the various social, ethical and economic constraints that affect biotechnology.     

Trendspotting: a shift in intellectual property focus

An analysis of recent trends in intellectual property that impact early- to mid-stage life sciences companies and their investors.     

Review: intellectual property aspects of plant transformation

One of the recurring themes of the debates concerning the application of genetic transformation technology has been the role of Intellectual Property Rights (IPR). This term covers both the content of patents and the confidential expertise usually related to methodology and referred to as 'Trade Secrets'. This review explains the concepts behind patent protection, and discusses the wide-ranging scope of existing patents that cover all aspects of transgenic technology, from selectable markers and novel promoters to methods of gene introduction. Although few of the patents in this area have any real commercial value, there are a small number of key patents that restrict the 'freedom to operate' of new companies seeking to exploit the methods. Over the last 20 years, these restrictions have forced extensive cross-licensing between ag-biotech companies and have been one of the driving forces behind the consolidation of these companies. Although such issues are often considered of little interest to the academic scientist working in the public sector, they are of great importance in any discussion of the role of 'public-good breeding' and of the relationship between the public and private sectors.     

The rights of children: public policy statement

Children, who are vulnerable at the start of existence, are a concern shared by nations and cultures. The importance of children's conditions has led 192 out of 194 countries to ratify the UN General Assembly's Convention on the Rights of the Child. The United States has not yet ratified the convention, despite having exercised influence on the drafting of its provisions. Given the global importance of nurturing and protecting children, the Society for Medical Anthropology strongly and emphatically supports that the convention be ratified, and that the U.S. government submit the convention for approval by the U.S. Senate.