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An economic analysis of unilateral refusals to license intellectual property.

The intellectual property laws in the United States provide the owners of intellectual property with discretion to license the right to use that property or to make or sell products that embody the intellectual property. However, the antitrust laws constrain the use of property, including intellectual property, by a firm with market power and may place limitations on the licensing of intellectual property. This paper focuses on one aspect of antitrust law, the so-called "essential facilities doctrine," which may impose a duty upon firms controlling an "essential facility" to make that facility available to their rivals. In the intellectual property context, an obligation to make property available is equivalent to a requirement for compulsory licensing. Compulsory licensing may embrace the requirement that the owner of software permit access to the underlying code so that others can develop compatible application programs. Compulsory licensing may undermine incentives for research and development by reducing the value of an innovation to the inventor. This paper shows that compulsory licensing also may reduce economic efficiency in the short run by facilitating the entry of inefficient producers and by promoting licensing arrangements that result in higher prices.

Costs and Cost Analysis

Patents and the nurse scholar, Part I: The basic philosophy of intellectual property.

Patenting intellectual property is important for a number of reasons. Health care products are designed to improve the effectiveness and efficiency of care. Without the patent, the property would most likely never enter into the public market for general use by either health care providers or clients. Products such as the specialized IV pole which also accommodates dependent drains (e.g. urinary drainage bags) (Rebar, 1991) or the premature infant pacifier (Engebretson & Wardell, 1991) are valuable assets to patient care. However, without patents to protect them as property, their value in the commercialization process would be nil. Therefore, the public benefits from this system for three reasons: (1) it encourages the inventor to make the invention; (2) the public is given the opportunity to use the invention; (3) the knowledge of the invention is made available to everyone; and (4) often royalties are returned to the institution for further research and development activities.

Clinical Nursing Research

Ethnobotany and intellectual property rights.

Contemporary intellectual property law permits only the patenting of an identified active principle from a plant, not the plant or folk information relating to medicinal properties of a plant. The most significant rights of indigenous peoples are those deriving from physical control of the plants and the knowledge pertaining to their use. This control can provide the basis for trade secret protection. Such agreements are enforceable in developed nations and should become so in developing nations. There have been recent efforts to strengthen indigenous peoples' rights over genetic resources and relevant folk knowledge but the most far-reaching of these are not yet a part of international law. Pharmaceutical patents combined with trade secrecy can allow firms to develop and market products and ensure that the nation and/or people from which the material or information was derived are properly rewarded. This does not provide protection from competition or with respect to derived knowledge nor does it act retrospectively. At present, rights under the United Nations Convention on Biodiversity are prospective only. These rights belong to the nation and there is little legal pressure for recompense to be shared with indigenous peoples. A uniform agreement that deals in a balanced way with the relative rights of indigenous peoples and of their governments should be developed by non-governmental organizations.

Drug Industry

Intellectual property and control.

The issue of intellectual property is viewed differently by different groups involved in biomedical research: researchers; academic institutions; corporate, government, and philanthropic sponsors; and society. The members of these groups do not always agree even among themselves; within government and academe, for instance, there are different and competing schools of thought. Many in academe believe that intellectual property rights are limited and that the openness and intellectual interdependence that marked and contributed to the rise of the research university are anathema to notions of intellectual ownership and control. In discussing this view, the author considers the issues of control that are implicit in concepts of ownership and property, concluding that any emphasis on profit and control constitutes a stance at variance with the outlook that has driven much of medicine's success throughout history. In supporting intellectual property claims, some suggest (often by implication) that medical advances would be less frequent or significant if exclusive control and access to profit were eliminated or reduced. The history of research, on the contrary, shows that university research for centuries yielded major results without the incentive of patents and still does. Another major concern is the open flow of information, which could be restricted by intellectual property controls. Sharing information is not merely a good deed, a commendable practice--such sharing tends to produce overwhelmingly good consequences for all those who share and for the society that is ultimately paying for the research enterprise.

Academic Medical Centers

The chief nurse executive and intellectual property law. Selected concerns.

At first, consideration of intellectual property law may seem a remote concern. However, CNEs have developed and led the advent of innovative work redesigns, unique measurement instruments, patient care documentation tools, and other administrative research and teaching originations. Consider intellectual property ownership and the rights to use or reproduce that "property" as soon as possible to avoid misunderstandings and potential infringements.

Commerce

Intellectual property issues in genomics.

Controversy over intellectual property rights in the results of large-scale cDNA sequencing raises intriguing questions about the roles of the public and private sectors in genomics research, and about who stands to benefit (and who stands to lose) from the private appropriation of genomic information. While the US Patent and Trademark Office has rejected patent applications on cDNA fragments of unknown function from the National Institutes of Health, private firms have pursued three distinct strategies for exploiting unpatented cDNA sequence information: exclusive licensing, non-exclusive licensing and dedication to the public domain.

Biotechnology

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

Intellectual property considerations in the development and use of HRQL measures for clinical trial research.

As a result of the expanded use of health-related quality of life (HRQL) measures in clinical trial research, a variety of legal and ethical issues have surfaced. These issues can be put in the form of the following questions: (1) Under what circumstances should access to HRQL measures be restricted? (2) Under what circumstances is it appropriate for the developers of HRQL measures to assert their intellectual property rights to the instruments? (3) Under what circumstances is personal profit from the sale and use of HRQL measures legally and socially appropriate? Access to HRQL research is to be encouraged since this is necessary for this field to progress. However, the need for protection against misuse of ongoing work is real and may justify the assertion of intellectual property rights. HRQL measures developed entirely with public monies should remain in the public domain or be managed for the public good. Instruments developed with private funds or with a mix of public and private funds should be treated in a manner that reflects a fair balance between the rights of the private developer and those of the scientific community and the public. HRQL questionnaires are regularly being refined; such work is costly. Investigators continuing research directly related to instrument refinement might reasonably ask for compensation from those who wish to use their work.

Clinical Trials as Topic

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

The concept of intellectual property and its implication for oncology.

Oncologists and scientists in oncology centres work in an environment that seeks and promotes innovation and are under an ethical obligation to disseminate new knowledge for the benefit of society. That knowledge (which may give rise to intellectual property rights) may have substantial commercial value, and with it comes the need to protect employers' and employees' legitimate interests through patents and copyright. Employers and employees may not fully appreciate the legal and ethical obligations surrounding ownership of such knowledge, so both should co-operate in formulating policies which balance the need for disseminating new knowledge and the need to protect institutional interests. This is particularly appropriate for the new NHS trusts which may undertake research jointly with commercial organizations. This article outlines the important issues for consideration.

Copyright

University discoveries and intellectual property rights: from Bothrops jararaca bradykinin potentiating peptides to angiotensin converting enzyme inhibitors.

The academic basic research which led to the discovery of bradykinin potentiating peptides, the drug prototype for the new class of angiotensin converting enzyme inhibitors for the treatment of hypertension, is described. This case study is used to illustrate the situation of the academic scientist and his intellectual property rights for discoveries made at the University.

Angiotensin-Converting Enzyme Inhibitors

Intellectual property and networked health information: issues and principles.

Information networks offer enormous potential for improving the delivery of health care services, facilitating health-related decision-making, and contributing to better health. In addition, advanced information technologies offer important opportunities for new markets, targeted information products and services, greater accessibility, lower costs and prices, and more rapid and efficient distribution. Realizing the full potential of those information resources requires the resolution of significant intellectual property issues, some of which may be affected by special features of health information. For example, the government is a significant funder and originator of health-related information. In addition, much of that information is of great importance to the population and benefits not only individual users, but also employers, insurance companies, the government, and society as a whole. The government must therefore continue to provide particularly important health information to the public, and facilitate that information's accessibility and reliability, while avoiding unnecessary competition with private information providers. Congress and courts must modify or interpret current copyright law as necessary to guarantee that it does not interfere with innovation in tailored health information or exceed its constitutional boundaries and restrict access to information, as opposed to expression. Both producers and users of information must work with the government to educate the public about the availability of health information and the rights of and limitations upon users under copyright law.

Authorship

Intellectual property: the control of scientific information.

Control of scientific information is increasingly at the center of legal and administrative disputes, raising questions of sovereignty and secrecy, of proprietary rights over research. Disputes originate from efforts to extend the right of access to data at an early stage of research, from demands for information that threaten confidentiality, from proprietary interests in competitive areas of research, and from government restrictions on the free exchange of scientific ideas. They reflect policy changes with respect to information disclosure, university-industry collaboration, patent rights, and national security. A review of diverse situations that have led to disputes and of efforts to negotiate principles for controlling intellectual property suggests the problems of establishing such principles in the context of the changing role of science.

Confidentiality