Intellectual property, genetically modified crops and bioethics

The implementation of a new technology is almost always surrounded by a debate on the moral and social implications that may arise. The debate with regard to genetically modified (GM) crops has been one of the longest and most controversial. However, one area of the debate that receives less attention is the role that intellectual property can play. The introduction of an effective and yet appropriate intellectual property system addressing society's particular needs can eliminate some of these issues. This paper looks at whether the situation in Europe is meeting our current needs and also addresses the role intellectual property can play in the debate over the introduction of GM crops in developing countries.     

Intellectual property protection for plant-related inventions in Europe

The economic and political issues that accompany the commercial growing of genetically modified crops, as well as the risk of transgene spread, are often top of the agenda for debate. But one important aspect is frequently overlooked--the intellectual property protection of plant-related inventions. What protection does European patent law afford to such inventions, how does it compare with the United States law and what are the consequences of the differences between them?     

Can you shrinkwrap a cow? Protections available for the intellectual property of the animal breeding industry

There are currently four main intellectual property protection statutory schemes available: copyright, trade secret, trademark and patent. Each of these protects a different aspect of intellectual property, which leaves gaps of protection when an innovation does not fit squarely within the boundaries of the statutes. Contracts allow the industry to tailor the protection desired. One very common approach is to license the product via contract. Licences allow intellectual property owners to retain ownership and give permission to others to use the product. Although there are several types of licences, the most common is the field of use licence, which limits the licensee's use of the product. This often leads to price discrimination where various levels of restriction are offered at corresponding prices. The more rights retained by the owner, the more restricted the buyer is and the lower the purchase price allowing customers to choose the level of restriction they are willing to accept. Therefore, the different uses and needs of various customers can be accounted for and reflected in the price. The animal breeding industry is currently struggling to protect their innovations falling into these statutory gaps. The protection for animal breeding industry innovations is most likely through contract law rather than traditional intellectual property law. By taking advantage of the unique nature of contracts, industry will be able to tailor protection and pricing to best suit the variety of customers and uses for the products sold.     

以CRISPR/Cas9专利为例的知识产权教育

随着世界经济全球化步伐的加快, 知识产权的重要性凸显。高校是知识产权意识和能力教育的主战场。我国现有知识产权教育与专业的密切程度急需提高。文章结合全球首个CRISPR/Cas9专利权的授权公布和作者授课经历, 提出了一种新的知识产权普及教育模式, 将知识产权教育分为启蒙教育和深入研修两个阶段。第一阶段将知识产权教育与专业课课程无缝整合, 后一阶段主要针对有志于发展成为知识产权专业人才的学生。我们认为这种教学模式的推广将解决现有知识产权教育中教材的欠缺以及教师的不足, 有利于知识产权意识在生物医学等理工科学生的普及。遗传学在生物医学中具有特别重要的地位, 因此, 文章以遗传学最近的热点技术之一——基于CRISPR/Cas的基因组编辑新工具为例进行阐述。CRISPR/Cas从最初的微生物遗传学发现到成为基因组编辑的重要工具, 贯穿了基础研究转化为关键技术的全过程, 可以很好体现生物医学相关的知识产权教育的精髓。     

Next issue (September 2007): Talking Biotech with the Public – including a special FREE podcast!

Edited by Dr. Kristina Sinemus, Darmstadt, Germany Highlight articles: – Public perceptions of biotechnology – Future societal issues in industrial biotechnology – The co-existence debate in Europe – The Co-Extra website – Bioethics, GM crops and intellectual property – Patent scenarios for the future – Experiences in implementation of biosafety systems – Transparent communication strategy on GMOs – Options for a rational dialogue on the acceptance of biotechnology – Attitudes that predict acceptance of genetic engineering in Australia – Biotechnology: the language of multiple views in Maori communities – Science – or not? The scientific status of biotechnology ... and much more: Read the next issue of BTJ!     

The allure of art and intellectual property: artisans and industrial replicas in Mexican cultural economies

This article considers the establishment of a collective trademark by Mexican artisans which occurred in response to the discovery of industrial replicas of Oaxacan woodcarvings, and it suggests that artisans’ appeals to intellectual property cannot be readily understood as resulting from the economic or cultural threat that the replicas ostensibly pose. By bringing an analysis of aesthetics and the desirability of art into anthropological discussions of intellectual property, I argue that intellectual property is appealing to cultural producers in such contexts because it seems to offer an opportunity to stabilize the ambiguities concerning the relationship between authorship and the allure of artworks within competitive cultural markets. I conclude that in this case, claims to intellectual property reveal concerns that are more about local practices than about foreign production.     

Measuring the performance of international genomics research projects in fostering genomic capacity in the developing world

Therapeutic applications of genomic medicine are slowly finding their way into the healthcare framework of developing countries. The establishment of equitable innovation policies is a determining factor in how genomic-based therapeutic applications will evolve in these countries. In the biomedical field, the commercialization of research results has established itself as the dominant paradigm in the innovation system. However, many recent studies have demonstrated that this emphasis on commercialization and the protection of intellectual property has led to disappointing results. A growing number of stakeholders in this debate argue that it is now necessary to go beyond the commercialization of research and implement policies based on the research valorization paradigm, which supports the achievement of social as well as economic objectives. We thus propose a new set of more inclusive research performance indicators to help policymakers measure the impact of international genomics projects on developing countries.     

Intellectual property strategy in bioinformatics and biochips

Intellectual property rights are essential in today's technology-driven age. A strong intellectual property protection strategy is crucial in the bioinformatics and biochips technology spaces as monetary and temporal resources are tremendous in finding a blockbuster drug or gene therapy, as well as in deploying advanced biosensor and other medical systems. Current problems and intellectual property practice in the genomic space are presented and analyzed. Various strategy and solutions are proposed to guide bioinformatic and biochip companies in forming an aggressive strategy to protect one's intellectual property and competitive positioning.     

Biotechnology: developing countries and globalization

Biotechnology in a globalizing economy involves the participation of all countries–industrialized, developing and least developed, in the interconnected web of trade liberalization in closed and open-market economies. The various geopolitical or geocultural regions show striking approaches to the application of biotechnologies for development and the safeguarding of intellectual property rights. The generally held view that developing countries are doomed to being marginalized in a globalizing economy is, seemingly, in need of revision.     

跨国公司生物技术知识产权保护策略分析——以棉花转化体MON531为例

近年来,转基因棉花种植面积在多个国家得到了快速增长。为深入研究转基因抗虫棉花的技术体系和知识产权保护状况,现以棉花转化体MON531为例研究跨国生物公司的知识产权保护策略。结果显示,目前MON531转化体涉及3件处于有效保护期限内的专利,并在多个国家受到保护,实现了从功能基因及调控元件到最终商业化品种的全方位有效保护。申请人还通过申请植物品种权对下游的品种进行保护,美国有19件品种获得授权,在中国仅有1件相关申请处于审查中。对棉花转化体MON531技术体系的知识产权保护策略的研究,可以为我国研发转基因作物并采取知识产权保护提供有利的借鉴。     

跨国种企作物育种专利布局及对我国的启示*

当前全球种业基本形成“两超、四强、差异化发展”新格局,种业巨头主导着全球作物育种技术研发和产业发展。通过深入分析和挖掘跨国种企作物育种专利,洞察其技术研发布局,为我国合理部署作物育种技术研发、改善知识产权布局与保护具有借鉴意义。基于Derwent Innovation(DI)专利数据库,以“两超四强”跨国种企2015~2019年申请的作物生物育种专利为研究对象,通过文本聚类法全面分析了“两超四强”跨国种企的生物育种研发布局,通过计量指标结合专家咨询遴选出其重点专利,厘清其技术研发重点。据此提出我国应当瞄准生物育种核心领域加强新兴前沿技术原始创新与集成开发,加强新型抗虫基因挖掘与抗虫新机制研发,强化生物育种核心技术链、产业链知识产权协同保护与布局,提升知识产权保护水平及全球化结合重点布局的知识产权战略意识的建议。     

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.     

Ethical and regulatory issues surrounding African traditional medicine in the context of HIV/AIDS

It has been estimated that more than 80% of people in Africa use traditional medicine (TM). With the HIV/AIDS epidemic claiming many lives in Africa, the majority of people affected rely on TM mainly because it is relatively affordable and available to the poor populations who cannot afford orthodox medicine. Whereas orthodox medicine is practiced under stringent regulations and ethical guidelines emanating from The Nuremburg Code, African TM seems to be exempt from such scrutiny. Although recently there have been calls for TM to be incorporated into the health care system, less emphasis has been placed on ethical and regulatory issues. In this paper, an overview of the use of African TM in general, and for HIV/AIDS in particular, is given, followed by a look at: (i) the relative laxity in the application of ethical standards and regulatory requirements with regards to TM; (ii) the importance of research on TM in order to improve and demystify its therapeutic qualities; (iii) the need to tailor-make intellectual property laws to protect traditional knowledge and biodiversity. A framework of partnerships involving traditional healers' associations, scientists, policy makers, patients, community leaders, members of the communities, and funding organizations is suggested as a possible method to tackle these issues. It is hoped that this paper will stimulate objective and constructive debate that could enhance the protection of patients' welfare.     

基于全流程的医院科研项目知识产权管理模式研究

高等医学院校附属医院在实施国家创新战略中具有举足轻重的作用。以科研项目生命周期为切入点,运用概念性决策模型,构建基于全流程的医院科研项目知识产权管理模式,提升医院知识产权管理能力,推动医学科研成果转化。     

Access to essential medicines: a Hobbesian social contract approach

Medicines that are vital for the saving and preserving of life in conditions of public health emergency or endemic serious disease are known as essential medicines. In many developing world settings such medicines may be unavailable, or unaffordably expensive for the majority of those in need of them. Furthermore, for many serious diseases (such as HIV/AIDS and tuberculosis) these essential medicines are protected by patents that permit the patent-holder to operate a monopoly on their manufacture and supply, and to price these medicines well above marginal cost. Recent international legal doctrine has placed great stress on the need to globalise intellectual property rights protections, and on the rights of intellectual property rights holders to have their property rights enforced. Although international intellectual property rights law does permit compulsory licensing of protected inventions in the interests of public health, the use of this right by sovereign states has proved highly controversial. In this paper I give an argument in support of states' sovereign right to expropriate private intellectual property in conditions of public health emergency. This argument turns on a social contract argument for the legitimacy of states. The argument shows, further, that under some circumstances states are not merely permitted compulsory to license inventions, but are actually obliged to do so, on pain of failure of their legitimacy as sovereign states. The argument draws freely on a loose interpretation of Thomas Hobbes's arguments in his Leviathan, and on an analogy between his state of War and the situation of public health disasters.     

The superior fault tolerance of artificial neural network training with a fault/noise injectionbased genetic algorithm

Artificial neural networks (ANNs) are powerful computational tools that are designed to replicate the human brain and adopted to solve a variety of problems in many different fields. Fault tolerance (FT), an important property of ANNs, ensures their reliability when significant portions of a network are lost. In this paper, a fault/noise injection-based (FIB) genetic algorithm (GA) is proposed to construct fault-tolerant ANNs. The FT performance of an FIB-GA was compared with that of a common genetic algorithm, the back-propagation algorithm, and the modification of weights algorithm. The FIB-GA showed a slower fitting speed when solving the exclusive OR (XOR) problem and the overlapping classification problem, but it significantly reduced the errors in cases of single or multiple faults in ANN weights or nodes. Further analysis revealed that the fit weights showed no correlation with the fitting errors in the ANNs constructed with the FIB-GA, suggesting a relatively even distribution of the various fitting parameters. In contrast, the output weights in the training of ANNs implemented with the use the other three algorithms demonstrated a positive correlation with the errors. Our findings therefore indicate that a combination of the fault/noise injection-based method and a GA is capable of introducing FT to ANNs and imply that the distributed ANNs demonstrate superior FT performance.     

Patenting nonassociated polymeric structures (NAPS): implications for structural genomic data release

The intellectual property laws that govern patent rights should provide a reasonable balance between the competing concerns of open access and exclusivity. Open access can facilitate knowledge dissemination and collaboration in furthering science. On the other hand, exclusivity can ensure interest and financial investment in scientific research and development.In recent days, the appropriate balance between open access and exclusivity has been a focus of public debate, particularly with regard to genomic inventions and their applications. In seeking to reconcile the timing of structural genomic data release with certain efforts to secure intellectual property rights, the International Structural Genomics Organisation joins others confronting this controversy.This paper seeks to inform the discussion with an overview of the U.S. standards for patenting nonassociated polymeric structures (NAPS), which include polynucleotides or polypeptides of unknown biological significance, and their corresponding structural data. In the United States, the present ability to obtain patent rights to these discoveries appears problematic given the requirement of specific, substantial and credible utility, among other things. Without demonstrable utility, NAPS and NAPS-related data likely will not be entitled to patent protection, whether the U.S. Patent & Trademark Office rejects NAPS claims as unpatentable in the first instance, or the U.S. federal courts invalidate NAPS claims in later patent litigation. As such, the improbability of obtaining enforceable patent rights to NAPS might undermine the rationale for delaying structural genomic data release to allow for the filing of patent applications in this regard.Abbreviations: ESTs, expressed sequence tags; ISGO, International Structural Genomics Organisation; NAPS, nonassociated polymeric structures; SNPs, single nucleotide polymorphisms; USPTO, U.S. Patent & Trademark Office     

智力水平还是文化表现?——尼安德特人与现代人文化精致程度差异研究述评

尼安德特人和解剖学意义上的现代人在文化精致程度上的区别已经争论了很长时间,考古学者希望能得出一个确定的答案,两个假设应运而生:智力水平(尼人不能发展出精致的文化)与文化表现(尼人不需要发展出精致程度较高的文化)。古人类与考古材料显示智力水平假设有缺陷:尼人的基因进入了现代人的基因库中,而且他们有能力学习现代人的技术,在"过渡工业"的材料中可以找到相关证据;与此同时,至今还未找到关系到智力水平的大脑结构证据证明尼人智力水平不如现代人。检验文化表现假设的前提是尼人与早期现代人在智力水平上没有差异,却呈现出不同的社会网络和社会组织。本文在讨论尼人与现代人人口与社会交流的基础上,认为现代人复杂的社会组织切割了尼人的生活环境,同时火山爆发引起了资源短缺,最终导致了尼人在欧洲灭绝。     

生物信息数据库知识产权保护初探

生物信息技术是当今生命科学乃至整个自然科学的重大前沿领域之一,生物信息数据库是生物信息技术中非常重要的部分,对生命科学的发展起着重要的推动作用。本文叙述了生物信息数据库的特点及国内外知识产权保护现状,初步讨论了生物信息数据库知识产权保护中存在的问题,提出了保护我国生物信息数据库的建议。     

Intellectual developmental disorders: towards a new name, definition and framework for "mental retardation/intellectual disability" in ICD-11

Although "intellectual disability" has widely replaced the term "mental retardation", the debate as to whether this entity should be conceptualized as a health condition or as a disability has intensified as the revision of the World Health Organization (WHO)'s International Classification of Diseases (ICD) advances. Defining intellectual disability as a health condition is central to retaining it in ICD, with significant implications for health policy and access to health services. This paper presents the consensus reached to date by the WHO ICD Working Group on the Classification of Intellectual Disabilities. Literature reviews were conducted and a mixed qualitative approach was followed in a series of meetings to produce consensus-based recommendations combining prior expert knowledge and available evidence. The Working Group proposes replacing mental retardation with intellectual developmental disorders, defined as "a group of developmental conditions characterized by significant impairment of cognitive functions, which are associated with limitations of learning, adaptive behaviour and skills". The Working Group further advises that intellectual developmental disorders be incorporated in the larger grouping (parent category) of neurodevelopmental disorders, that current subcategories based on clinical severity (i.e., mild, moderate, severe, profound) be continued, and that problem behaviours be removed from the core classification structure of intellectual developmental disorders and instead described as associated features.