Marine Biodiversity and Gene Patents (original) (raw)

Biological Diversity in the Patent System

Biological diversity in the patent system is an enduring focus of controversy but empirical analysis of the presence of biodiversity in the patent system has been limited. To address this problem we text mined 11 million patent documents for 6 million Latin species names from the Global Names Index (GNI) established by the Global Biodiversity Information Facility (GBIF) and Encyclopedia of Life (EOL). We identified 76,274 full Latin species names from 23,882 genera in 767,955 patent documents. 25,595 species appeared in the claims section of 136,880 patent documents. This reveals that human innovative activity involving biodiversity in the patent system focuses on approximately 4% of taxonomically described species and between 0.8-1% of predicted global species. In this article we identify the major features of the patent landscape for biological diversity by focusing on key areas including pharmaceuticals, neglected diseases, traditional medicines, genetic engineering, foods, biocides, marine genetic resources and Antarctica. We conclude that the narrow focus of human innovative activity and ownership of genetic resources is unlikely to be in the long term interest of humanity. We argue that a broader spectrum of biodiversity needs to be opened up to research and development based on the principles of equitable benefit-sharing, respect for the objectives of the Convention on Biological Diversity, human rights and ethics. Finally, we argue that alternative models of innovation, such as open source and commons models, are required to open up biodiversity for research that addresses actual and neglected areas of human need. The research aims to inform the implementation of the 2010 Nagoya Protocol on Access to Genetic Resources and the Equitable Sharing of Benefits Arising from their Utilization and international debates directed to the governance of genetic resources.

Biodiversity and Gene Patents: a study guide

2014

During the last decades, there has been a significant change in biodiversity governance: from the "common heritage of mankind", biodiversity is becoming a resource subject to national sovereignty and Intellectual Property Rights. Bioprospecting is increasingly supported by laws and measures, at both national and international levels, involving ethics, patenting and benefit-sharing. This change, let not only by scientific development but also by policy and judicial changes, isn't occurring without controversy, and the main question is who should benefit from it: government, community, patent holders, or just nature itself. Among all causes of disagreement, the first question is over the nature of biodiversity patents, whether genes or organisms are appropriately classified as patents, both being natural in themselves, and therefore challenging the basic criteria of novelty, inventiveness, and utility. The second issue is how to distribute properly the benefits of bioprospecting. Ideally, patents can promote effective benefit sharing by supporting the development of new products and processes to society. Finally, at the national level, there is the issue of traditional knowledge, coming from local and indigenous communities who conserve and utilize biodiversity in a sustainable way. This study guide aims to address all those questions, first assessing the historical background of the issue and the international institutions and actions regarding the problem. It also looks into the differences amongst countries and regions of the world. At last, it proposes a series of questions to further discussion.

Genomics knowledge and equity: a global public goods perspective of the patent system

Bulletin of the World Health Organization, 2004

Genomics, the comprehensive examination of an organism's entire set of genes and their interactions, will have a major impact on the way disease is diagnosed, prevented and treated in the new millennium. Despite the tremendous potential it holds for improving global health, genomics challenges policy-makers to ensure that its benefits are harnessed equitably across populations and nations. The classification of genomics as a global public good and the inequity encountered in the development and application of genomics knowledge are outlined in this paper, We examine the effect of the current patent system on the distribution of costs and benefits relating to genomics knowledge between countries of different economic strength. The global public goods concept provides a normative economic rationale for the modification of certain aspects of the current patent system and for the creation of complementary mechanisms to respond to the health needs of low-income and middle-income coun...

Reviewing International Patent Policy on Biotechnological Inventions and the Adequacy of Equitable Benefit Sharing Principle

UUM journal of legal studies, 2020

The purpose of this study is to review the international patent policy related to biotechnological inventions, particularly from the Venetian Patent Law to the TRIPs Agreement. It closely examines whether such inventions fulfill the patentability thresholds and analyses the reason why such patents are regarded as having the potential to cause facility misappropriation of biodiversity, which is considered unfair. The most important part of this study is the adequacy analysis of the principles of equitable benefit sharing of the Convention on Biodiversity (CBD), including disclosure requirements and prior informed consent (PIC), to prevent misappropriation of biological resources in this era of the fourth industrial revolution. This study is based on the normative legal research method and uses primary and secondary legal resources. The analysis conducted for this study employed several approaches, which were statute, conceptual, and historical approaches. This study found that patent protection for biotechnological inventions has received justification since the Paris Convention. However, the current international patent policy has the potential to facilitate misappropriation of biodiversity and it is UUMJLS 11(2), July 2020 (203-224) 204 regarded as unfair. On the other hand, the equitable benefit sharing principle is still inadequate in dealing with such misappropriation. It advises the requirement of mandatory disclosure of origin to be regulated under national law as a legal basis for implementing the equitable benefit sharing principle.

PANORAMA INTERNACIONAL DAS PATENTES BIOTECNOLÓGICAS Meio Ambiente e Proteção ao Patrimônio Genético INTERNATIONAL OVERVIEW PATENT BIOTECH Environmental and Genetic Resources

A Biotecnologia movimenta bilhões de dólares anualmente e encontra especial proteção no direito das patentes. A patente, como título concedido ao inventor, tem na lei uma série de requisitos, bem como de vedações. Analisa-se o patenteamento de organismos vivos, no todo ou em parte, em especial a possibilidade de patentear material genético. Para tanto, avalia-se o assunto na legislação e em alguns posicionamentos de escritórios de patentes nos Estados Unidos, Europa e Brasil, destacando a importância das patentes na própria constituição da OMC. Por fim, conclui-se pela necessidade de se abordar o tema não apenas pelo viés comercial, mas também pelo enfoque da repartição de benefícios. Abstract: The Biotechnology move billions of dollars each year and is specially protected by patenting. The law establishes the requirements for granting patents, as well as lists the prohibitions. The situation of patents on living organisms, in whole or in part, in particular thepatentability of genetic material, is here examined. Therefore, we evaluate it in legislation and in some placements patent offices in the United States, Europe and Brazil. It also highlighted the importance of patents in the constitution of the WTO. Lastly, we conclude by the need to address the issue not only for commercial bias, but also the focus of benefit sharing.

Patent Harmonization in Biotechnology: Towards International Reconciliation of the Gene Patent Debate

Chicago Journal of International Law, 2015

Table of ContentsI. Introduction 690II. The Gene Patent Debate 692A. Primer on Gene Patents and Genes 693B. International Expansion of Gene Patentability 694C. Increased Challenges to Gene Patents 695III. The International Trend towards Harmonization 700A. The Trend towards Uniformity of Patent Protection 700B. The WTO and the TRIPS Agreement 701C. The Role of WIPO 703IV. Concerns with Differing Patentability Standards 704A. International Concern over Divergent Policies 7051. Private business and patent holder concerns 7052. Government and state concerns 7063. International access concerns 708B. Specific Concerns with Biotechnology and Gene Patents 709V. Resolving the Differing International Approaches to Gene Patents 710A. Potential Solutions Currently Available through InternationalOrganizations 7111. Use international organizations for substantive patent uniformity.......7122. Rely on the flexibilities inherent in TRIPS to ensure access to diagnostictests covered by gene patents ...

Genetic resources and intellectual property: a systematic analysis

2008

This paper provides a systematic overview of the legal and policy interaction between the intellectual property (IP) system and the governance of genetic resources (GR). It reviews the distinctive characteristics of GR and the implications for their governance, the diverse sets of value systems, perspectives and notions of ownership and control that are engaged, and the particular impact of biotechnology patents. The development of modern biotechnology, in particular the development of transgenic technologies, is mapped against parallel developments in patent law and policy and the policy implications of genetic diversity and the preservation of biological diversity as an end in itself. The paper maps the distinct forms of regulatory regimes applied to different forms of GR and considers the distinct characteristics of the human genome. A review of topical issues arising from legal regimes at the international, regional and domestic levels covers both IP and other legal mechanisms. It considers the specific regulatory issues raised, including questions of patentability and proposed linkages between access and benefit sharing obligations and the patent system. The paper reviews the interaction between the Convention on Biological Diversity (CBD) and the IP system, focussing on the implications of sovereignty over GR and the diffusion of GR, retroactivity, and the application of principles of prior informed consent, equitable benefit sharing and the transfer of technology, and reviews proposals for further hard law and soft law instruments, current as at 2008. The paper concludes with a consideration of the pivotal character of the notion of ‘equity’ and the policy and regulatory responses to perceived inequities arising from the rapidly evolving technological capacity to extract commercial and other benefits from GR. At the heart of the CBD is that the perception of inequitable returns to the original custodians from the downstream extraction of value from genetic resources would negate any incentive to conserve biodiversity in the first place and to use its components sustainably, a normative logic binding together the triple objectives of the treaty. Two broad aspects of equity are considered: fairness of process (procedural equity), and fairness of outcome (distributive equity). The patenting process may also become an equitable fulcrum, a locus for remedying claimed inequities in access to and use of genetic resource. Ideas of equity range from the relatively technical procedural question of whether a patent should be enforceable if it was obtained by inequitable conduct, to a broader sense that the patent system should be used to police distributive equity in the allocation of benefits derived from genetic resources. The impact of technology on perceived equities, and the extensive flow of GR between societies and jurisdictions, taken together make it highly desirable to establish an international and cross-cultural dispensation that is widely seen and accepted to be equitable.. But diverse value systems and different legal rights and interests intersect, overlap, abut and conflict, rendering complex and elusive any form of perceived fairness and equity in the allocation of the value appropriated through research. Source communities and individuals naturally attach high value to their GR, and this ‘value’ goes well beyond immediate economic exchange value and technological utility; it extends to an expectation that the inherent worth of GR be recognized, as an end in itself and as an element of the cultural identity of a community, and the personality of an individual. The call for equity in the dispensation of genetic resources therefore reaches beyond the specific framework of law and regulation to touch on core human rights and the essence of our genetic and cultural identities.