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PubMed2003

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?

Biotechnology↗
PubMed2006

Intellectual property and biotechnology: the U.S. internal experience--Part II.

Continuing the discussion begun in the March 2006 issue of the Kennedy Institute of Ethics Journal, this paper further documents the failure of the United States to adequately consider possible modifications in the traditional robust system of intellectual property rights as applied to biotechnology. It discusses concrete suggestions for alternative disclosure requirements, for exemptions for research tools, and for improved access to clinical advances. In each of these cases, the modifications might be more responsive to the full set of relevant values.

Access to Information↗
PubMed1996

Intellectual property rights, naturally derived bioactive compounds, and resource conservation. Meeting report.

The first Interim Annual Meeting of the American Society of Pharmacognosy was held October 20-22, 1994, in San Jose, Costa Rica. In the symposium, which was the main scientific focus of the meeting, speakers from both developed and developing countries presented their perspectives on issues regarding intellectual property rights in regard to drug development from natural sources, conservation of natural habitats, and international conventions on bioprospecting. Careful evaluation of existing policies, laws, and conventions; sensitivity to the respective world views of prospective partners; equitable sharing of benefits including scientific collaboration; and a sense of fairness will be necessary to ensure that the genetic resources of all countries will be developed for the benefit of humankind.

Conservation of Natural Resources↗
PubMed1998

Trade Related Aspects of Intellectual Property Rights (TRIPS) and the threat to patients: a plea for doctors to respond internationally.

Many recent international agreements sponsored by bodies such as the World Trade Organisation (WTO), aim to facilitate the global free flow of goods, services and capital, by opening markets under the threat of trade sanctions. Nation States signing such agreements, in particular the Trade Related Aspects of Intellectual Property Rights (TRIPS), agree to suffer a sovereignty deficit in order to enhance their trading prospects. In the resulting reorganization of trade, medicine may be marginalised as merely another industry that must open its regional doors in the interests of global corporate productivity. We make a plea for medical organizations to lobby in appropriate international forums to create "hard" norms that ensure such international trade agreements that adequately respect the demands of fundamental ethical principles of the doctor patient relationship, principles such as medical loyalty and beneficence.

Ethics, Medical↗
PubMed2004

The introduction of new vaccines into developing countries. III. The role of intellectual property.

The development of new vaccines that address the particular needs of developing countries has been proceeding slowly. A number of new public sector vaccine research and development initiatives have been launched to address this problem. These new initiatives find that they often wish to collaborate with the private sector and, in collaborating with the private sector, they must address issues of intellectual property (IP) management. It has not been well understood why IP management is important and how such management by public sector groups can best be conducted. IP management has become very important because vaccine research and development is driven by the regulatory process. The regulatory process has increased the cost of vaccine development to very high levels especially for the highly sophisticated new vaccines currently under development. Thus, investors seek IP protection for the required large investments. Conversely, we assert this concept as a new insight, IP rights are essential for mobilizing the significant funds necessary to meet regulatory requirements. Thus, IP rights are of value not only for investors but also for the public at large. In the absence of public sector mechanisms to carry out the functions that the private sector currently conducts, the public sector needs to increase its sophistication in IP management and needs to identify and implement strategies that will help the public sector to achieve its public health goals, especially for the poor and, among these individuals, the poor in developing countries. This paper suggests some strategies that might be used by the public sector to help achieve its public health goals, especially for the poor.

Charities↗
PubMedDate not supplied

[Intellectual property, patents and access to medication in developing countries].

Pharmaceutical industry depends on continuing research and innovation to survive. This is a highly uncertain process due to the fact that only one in 20,000 screened molecules becomes a new and effective medicine. This process takes about 10 years to complete at a cost of e 480,000 per new compound. It is absolutely mandatory that intellectual property rights be protected in order to allow for investment of revenues in research and development of new medicines destined to cure or alleviate all types of disease, including those mainly afflicting the population in developing countries. The investigative drive of pharmaceutical companies has given the sector a leadership role in the search for global health. This is a responsibility the sector acknowledges and for that reason numerous laboratories are active partners of governments, private foundations, international organizations and N.G.O.s in a myriad of initiatives focused on alleviating most urgent health needs in developing countries. However, the true and final solution of this problem will only be accomplished when the social and political issues plagueing these societies are tackled.

Developing Countries↗
PubMedDate not supplied

[The Human Genome Project and the right to intellectual property].

The Human Genome Project was designed to achieve two objectives. The scientific goal was the mapping and sequencing of the human genome and the social objective was to benefit the health and well-being of humanity. Although the first objective is nearing successful conclusion, the same cannot be said for the second, mainly because the benefits will take some time to be applicable and effective, but also due to the very nature of the project. The HGP also had a clear economic dimension, which has had a major bearing on its social side. Operating in the midst of these three dimensions is the right to intellectual property (although not just this right), which has facilitated the granting of patents on human genes. Put another way, the carrying out of the HGP has required the privatisation of knowledge of the human genome, and this can be considered an attack on the genetic heritage of mankind.

Human Genome Project↗
PubMed2005

Ethnobotany/ethnopharmacology and mass bioprospecting: issues on intellectual property and benefit-sharing.

Ethnobotany/ethnopharmacology has contributed to the discovery of many important plant-derived drugs. Field explorations to seek and document indigenous/traditional medical knowledge (IMK/TMK), and/or the biodiversity with which the IMK/TMK is attached, and its conversion into a commercialized product is known as bioprospecting or biodiversity prospecting. When performed in a large-scale operation, the effort is referred to as mass bioprospecting. Experiences from the mass bioprospecting efforts undertaken by the United States National Cancer Institute, the National Cooperative Drug Discovery Groups (NCDDG) and the International Cooperative Biodiversity Groups (ICBG) programs demonstrate that mass bioprospecting is a complex process, involving expertise from diverse areas of human endeavors, but central to it is the Memorandum of Agreement (MOA) that recognizes issues on genetic access, prior informed consent, intellectual property and the sharing of benefits that may arise as a result of the effort. Future mass bioprospecting endeavors must take heed of the lessons learned from past and present experiences in the planning for a successful mass bioprospecting venture.

Conservation of Natural Resources↗
PubMed1996

Biological diversity, indigenous knowledge, drug discovery and intellectual property rights: creating reciprocity and maintaining relationships.

When new plant-derived therapeutics based on indigenous knowledge are being explored, it is important that the pharmaceutical companies return benefits to the native populations and the local governments from which the research material was obtained. When a potentially marketable plant product is being developed, it is essential that equitable agreements have already been established between the pharmaceutical companies and the people and/or countries from which this indigenous knowledge was acquired. Equally important is the commitment to provide immediate reciprocity that will enhance the welfare, the biocultural diversity and the well-being of the forest peoples. These measures should commence when a research project begins and continue during its duration. The development of these measures must be based upon the expressed needs of the indigenous communities. The relationship between the stability of the rain forest biocultural diversity, the creation and development of agro-forest resources and the long term benefits to the forest people is highlighted. Examples of initiatives taken by Shaman Pharmaceuticals Inc. and the Healing Forest Conservancy are described and discussed in the context of exploring appropriate use of intellectual property law to address the ethical issues facing all business and research groups working in the tropics.

Awards and Prizes↗
PubMed2005

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.

Journal Article↗
PubMed2000

The intellectual property landscape in the field of plasmid-based gene therapy.

As plasmid-based gene therapy products progress through clinical trials commercial entities begin to focus on the intellectual property associated with the methods and specific compositions used in these therapies. As the number of patents covering gene therapy components and methods increases it becomes increasingly difficult for a single entity to collect all of the necessary rights to be able to offer gene therapy products to consumers. The present report briefly describes the relevance of patents to product commercialization and describes certain key patents that may affect the ultimate commercialization potential of this new and exciting technology.

Animals↗