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Intellectual property law: a primer for scientists.

Intellectual property (IP) is a generic legal term for patents, copyrights, and trademarks, which provide legal rights to protect ideas, the expression of ideas, and the inventors and creators of such ideas. A patent provides legal protection for a new invention, an application of a new idea, discovery, or concept that is useful. Copyright provides legal protection from copying for any creative work, as well as business and scientific publications, computer software, and compilations of information. A trademark provides rights to use symbols, particular words, logos, or other markings that indicate the source of a product or service. A further method of benefiting from an invention is simply to keep it secret, rather than to disclose it a trade secret. IP impinges on almost everything scientists do. As scientists are paid to come up with ideas and aspire to patent and/or publish their work, the protection of ideas and of written works especially should be of interest and concern to all.

Biochemistry↗

Has the implementation of the TRIPS Agreement in Latin America and the Caribbean produced intellectual property legislation that favours public health?

OBJECTIVE: The World Trade Organization's Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement establishes minimum standards for intellectual property rights, including patent protection for pharmaceuticals; therefore, it may make it difficult for developing countries to gain access to medicines, especially those countries that are the least developed. This study aims to determine whether implementation of the TRIPS Agreement in Latin American and Caribbean countries has generated patent legislation that is sensitive to public health needs. METHODS: Legislation in 11 Latin American and Caribbean countries was analysed. The variables considered in the analysis were: the term of patents issued, patentable subject matter, transition periods (that is, time until legislation was enacted), reversal of the burden of proof of patent infringement, exhaustion of rights, compulsory licensing and the early working exception (which allows a country to complete all procedures necessary to register a generic product before the original patent expires). FINDINGS: By 2000, all of the countries studied had reformed their legislation to conform to the agreement. Brazil and Argentina used the transition period until 2005 to grant patents in the pharmaceutical industry. All countries, except Panama, made use of the safeguards and flexibilities available through the agreement by including mechanisms for compulsory licensing in their legislation. Argentina; Bolivia, Colombia, Ecuador, Peru and Venezuela (countries that represented the Andean community); the Dominican Republic; and Panama included mechanisms to allow parallel importation. Mexico did not. Brazil only permits parallel importation after a compulsory licence has been issued. The early working exception is included in legislation in Brazil and the Dominican Republic. CONCLUSION: The countries in this study did not incorporate all of the mechanisms allowed for by the Agreement and are not adequately using the provisions that enable World Trade Organization (WTO) members to obtain better health for the public, particularly in regard to gaining access to medicines. This situation may deteriorate in future if other agreements establish more restrictive rules for intellectual property rights.

Caribbean Region↗

Intellectual property conundrum for the biological sciences.

Policy regarding academically generated biomedical intellectual property (IP) has been shaped by two important events: the Vannevar Bush report to then President Roosevelt in 1945 and the Bayh-Dole Act of 1980. This policy, which vests the intellectual property produced from federally funded biomedical research from the government to the academic institution, was designed to promote technology transfer and thus promote the health of the U.S. economy. However, the policy has led to significant challenges, particularly in implementation. Here it is argued that the difficulties are due to differences in the structure of motivations between biomedical scientists, institutional officials, and private sector entrepreneurs. Understanding these differences may lead to a review of policy with the goal of enhancing technology transfer for the future.

Biological Science Disciplines↗

The intellectual property cookbook: a guide for the novice health-care telemedicine provider working with industry.

Telemedicine is a new field and many health-care providers are developing their own products with the help of industry. Most practitioners are novices in the legal tools necessary to protect their own work with regard to any future commercialization. To summarize these issues for the telemedicine practitioner, a review of intellectual property protection has been performed. Intellectual property can be protected by tools such as copyrights, patents, non-disclosure and confidentiality agreements, integrated circuit topographies and industrial design. Knowledge of the intellectual property background should allow telemedicine providers to protect their own work when working with industry.

Copyright↗

FREEDOM TO OPERATE: Intellectual Property Protection in Plant Biology and Its Implications for the Conduct of Research.

▪ Abstract Research endeavors are being affected by issues involving intellectual property (patents, copyrights, and trademarks). The acquisition of rights in intellectual property by universities can result in the transfer of new innovations to the private sector, with the university recouping a share of the profits for support of further scientific research. Intellectual property rights available for new plant cultivars include plant patents, plant variety protection certificates, plant breeder's rights, and utility patents. Under the patent laws, there is no explicit exemption for research use, so researchers are increasingly being required to execute materials transfer agreements to obtain permission to use patented materials, such as techniques, genes, seeds, and cell lines, in laboratory research and in breeding programs. Research scientists must educate themselves on these issues so that they can make informed decisions regarding their research practices and the licensing of their discoveries.

patents↗

Intellectual property protection of plant biotechnology inventions.

The intellectual property protection of biotechnology-related subject matter is undergoing significant change and several countries have revised their legislation and/or patent practice as a result of challenges from industry and members of the public. Plant-related subject matter can be protected using plant variety protection, utility patents or, in the USA, by plant patent. Although easier to obtain than a utility patent, plant variety protection does not provide the same scope of protection. Protecting a plant using a utility patent is permitted only in countries that allow the patenting of higher life forms and requires a higher degree of experimental support than is required for plant variety protection, although the scope of protection is being steadily reduced.

Biotechnology↗

Data sharing and intellectual property in a genomic epidemiology network: policies for large-scale research collaboration.

Genomic epidemiology is a field of research that seeks to improve the prevention and management of common diseases through an understanding of their molecular origins. It involves studying thousands of individuals, often from different populations, with exacting techniques. The scale and complexity of such research has required the formation of research consortia. Members of these consortia need to agree on policies for managing shared resources and handling genetic data. Here we consider data-sharing and intellectual property policies for an international research consortium working on the genomic epidemiology of malaria. We outline specific guidelines governing how samples and data are transferred among its members; how results are released into the public domain; when to seek protection for intellectual property; and how intellectual property should be managed. We outline some pragmatic solutions founded on the basic principles of promoting innovation and access.

Access to Information↗

Intellectual property organizations and pharmaceutical patents in Africa.

This article builds on a previous study which found low numbers of patent applications for HIV antiretroviral drugs in African countries. A high level of variation was noted across individual countries, and consequently, the present study has sought to account for sources of the variation through statistical analyses. First, a correlation between the number of patents and HIV infection rate was observed (r=0.448, p<0.001). T-tests identified significantly higher numbers of patents in national members of two intellectual property organizations (IPOs)-African Regional Intellectual Property Orginisation (ARIPO) and the Organisation Africaine de la Propriété Intellectualle (OAPI)-than in countries who did not belong to an intellectual property organization. The relationship between IPO membership and number of patents was also statistically significant in a multivariate Poisson regression. These findings demonstrate that higher numbers of patents are found in countries where they are more easily filed. This has important policy implications given the worldwide trend toward increased recognition of pharmaceutical patents.

Africa↗

Sponsored research agreements, university and government licensing, and clinical trial agreements: special contractual and intellectual property rights considerations.

This article addresses contractual and intellectual property considerations that frequently arise in the drafting and negotiation of sponsored research agreements ("SRAs"), license agreements with universities (and other non-profit organizations) and the federal government, and clinical trial agreements. Each of these subjects is addressed separately, but most of the article is devoted to sponsored research, which is the driver for much of the innovation in the medical and life sciences industries.

Biomedical Research↗

What the publisher can teach the patient: intellectual property and privacy in an era of trusted privication.

This article begins with a premise that intellectual property and privacy have something significant and yet understated in common: both are about balancing a creator's desire to control a particular set of data with consumers' desires to access and redistribute that data. Both law and technology influence such balancing, making it more or less palatable to use data for particular purposes--whether one is an individual making a copy of a popular song for a friend, or a hospital selling a list of maternity ward patients to a day care service. In the shadow of the Internet's rapid development and concomitant easing of barriers to data sharing, holders of intellectual property are pairing increased legal protection with the technologies of "trusted systems." I describe how these technologies might allow more thorough mass distribution of data, while allowing publishers to retain unprecedented control over their wares. For instance, an e-Book seller might charge one price for a read-only copy that could not be printed or forwarded and charge an additional fee for each copy or printout made. Taking up the case of medical privacy, I then suggest that those who worry about the confidentiality of medical records, particularly as they are digitized by recent congressional mandate, might seek to augment comparatively paltry legal protections with trusted systems technologies. For instance, a trusted system could allow a patient to specify how and by whom her records could be used; within limits, she could allow full access to her primary care physician, while allowing only time-limited access to emergency care providers, non-personally identifiable access to medical researchers, and no access at all for marketing purposes. These technologies could allow for new kinds of privacy protection, without sacrificing the legitimate interests of the consumers of medical records.

Humans↗

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.

Biotechnology↗

Beyond the Ingelfinger Rule: the intellectual property ethics after the end of biomedical journals' monopoly.

According to the so-called Ingelfinger Rule (IR), biomedical journals do not accept for publication papers which have already been publicized elsewhere. This rule was subjected to fierce criticism which was mainly based on the fact that authors transfer the intellectual rights of their work to the journals. With the emergence of the Internet, the scientific community has a golden opportunity to re-evaluate the IR concept. Scientists no longer have to depend on the debatable benefits (i.e. publicity and review) stemming from journal publications; rather they can be free to explore novel communication opportunities and, subsequently, to tackle the emerging intellectual property issues. This approach should take into account the tight bond between applied research and the world economy, the need for teamwork instead of individual effort for effective scientific research, and the added value of journal publications. Based on such an analysis, it would appear that the inherent characteristics of the Internet promote a re-assessment of the intellectual property theory on three levels: the cognitive (the way in which knowledge is made up from its building blocks), the morphological (the use of hypertext) and finally the sociological (the formation of virtual scientific communities). It is concluded that publishing on the Internet necessitates a different approach to the question of intellectual property based on the primal values of science. This can be achieved only if the scientific community embraces and nourishes the academic nature of the Internet as well as laying down the rules to control the dissemination of ideas without the intervention of non-scientific third parties.

Ethics, Medical↗

Thought police. Healthcare executives must carefully guard intellectual property developed in their facilities.

Healthcare executives should have a working knowledge of intellectual property law--the legal principle that, for a limited period, treats intangible ideas and concepts as if they were products or property. Not only should administrators be aware of how to protect their facilities' patents, trademarks, copyrights, and trade secrets, but they must also be sure that employees in their own facilities do not infringe on the intellectual property of others. A patent is granted when an inventor proposes a useful new process, machine, "article of manufacture," or composition of matter, including any new and useful improvement on existing items in these same categories. A trademark is a name, symbol, device, or combination thereof adopted and used by an institution to identify its goods or services and to distinguish them from its competitors' goods or services. Expressions of ideas and thoughts set forth in words, sentences, paragraphs, sketches, pictures, graphs, or any other means of conveying ideas or concepts commonly understood to be works of authorship--both published and unpublished--may be protected by a copyright. Trade secret law applies to those who might misappropriate information that has been given to them because of their special relationship with the holder of the trade secret (i.e., through employment, contract, or other fiduciary or trust relationship).

Confidentiality↗

Biotechnology as an intellectual property.

Recent advances in biotechnology have created many public policy and legal issues, one of the most significant of which is the treatment of biotechnological industrial products, particularly under the patent system. Patents represent one of several types of intellectual property; their ownership confers the right to exclude others from benefitting from the tangible products of a proprietary subject matter. Intellectual property law and its protections will play a major role in the rate at which biotechnology develops in the United States. In this article biotechnological intellectual property issues are reviewed in the context of their underlying legal requirements. The implications of other factors, such as international competition, research funding, and gene ownership, are also considered.

Biomedical Research↗

[Evolution of the international intellectual property rights system: patent protection for the pharmaceutical industry and access to medicines].

This article discusses the evolution of the international intellectual property rights system in three phases and the implications for public health, especially for the implementation of policies for access to medicines. During the first phase, characterized by the Paris and Berne Convention, signatory countries defined which technological fields should be protected (or not). Under the second phase, with the enforcement of the WTO TRIPS Agreement, countries are obliged to grant patent protection for all technological fields, including for the pharmaceutical industry. Within their national legislations, countries also have the opportunity to implement access to TRIPS flexibilities for medicines. With the third phase, characterized by the negotiation and signing of bilateral and regional free trade agreements, countries will have to implement TRIPS-plus provisions which may have negative implications for the TRIPS flexibilities as well as for policies for access to medicines. The authors conclude that the currently proposed international intellectual property rights system favors patent-holder rights and that a balance is needed between patent holders' and health rights.

Brazil↗

Intellectual property rights, moral imagination, and access to life-enhancing drugs.

Although the idea of intellectual property (IP) rights--proprietary rights to what one invents, writes, paints, composes or creates--is firmly embedded in Western thinking, these rights are now being challenged across the globe in a number of areas. This paper will focus on one of those challenges: government-sanctioned copying of patented drugs without permission or license of the patent owner in the name of national security, in health emergencies, or life-threatening epidemics. After discussing standard rights-based and utilitarian arguments defending intellectual property we will present another model. IP is almost always a result of a long history of of scientific or technological development and numbers of networks of creativity, not the act of a single person or a group of people at one moment in time. Thus thinking about and evaluating IP requires a traditional model of IP. It follows that the owner of those rights has some obligations to share that information or its outcomes. If that conclusion is applied to the distribution of antiretroviral drugs, what pharmaceutical companies are ethically required to do to increase access to these medicines in the developing world will have to be reanalyzed from a more systemic perspective.

Anti-HIV Agents↗

Intellectual property rights, agriculture, and rural communities.

The global extension of intellectual property rights (IPRs) in agriculture and the simultaneous move towards evolving community and farmers' rights have significant implications for the future of rural communities. While IPRs are based on individual interests, the movement for granting farmers' rights is becoming diluted towards assigning ownership rights in a similar fashion as IPRs. It is important to reframe the debate to ensure that communities can claim their role in national and international negotiations.

Agriculture↗