[Ethical obligations of the authors: references, criteria of originality, and redundant publication and the rights of intellectual property].
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How market smarts can protect property rights.
Intellectual property comprises an ever-increasing fraction of corporate wealth, but what's the good of that if an ever-increasing fraction of the property is copied or stolen? Faced with developing countries' limited and inadequately enforced patent and copyright laws, some companies are resorting to market-based strategies to protect their intellectual property. These include preempting or threatening competitors, embedding intellectual property in environments that can be protected, bundling insecure intellectual property with its more secure cousins, and actually entering the businesses that pose a threat. The authors urge companies coping with weak property rights to follow a decision tree when choosing which strategies to use and when: Start by thinking of the strategies that will protect your business's core. If, for example, a first-mover advantage is within reach, making yourself more committed to intellectual property could be the answer. If you and your rivals are equally matched, ask yourself, "Can those that threaten me with copying be copied in turn?" The knowledge that each of you can hurt the other may dampen the competitive intensity or even lead to voluntary sharing of property. If these solutions fail or don't apply, try forging a connection with a product or business closely related to your own. Doing so may prevent a valued asset from falling into a rival's hands or make the asset harder to misappropriate. This approach can even help you expand your piece of the market pie or reduce the cost of making the threatened product, perhaps to the point where you can compete against pirated goods. Finally, if there still doesn't seem to be a way of making money from your threatened product, you may choose to move into the very business that has hurt your own. Such strategies are behind the economics of successful companies like Intel and NBC, say the authors.
Copyright↗
Transfusion medicine technology transfer: traps to avoid.
Technology transfer is the process of commercializing technology and taking it from the laboratory to the marketplace. At some stage in the technology transfer process, a due diligence will be undertaken. A due diligence is an enquiry into the technology and, in particular, its ownership. Research organizations including hospitals, universities, and blood banks need to own the intellectual property that they seek to commercialize. They own the intellectual property created by their staff in the course of employment. But volunteers, students, and collaborators, not being members of staff, will own the intellectual property that they create. This gives rise to due diligence and ownership defects, when intellectual property may in fact be owned by someone other than the research organization that seeks to commercialize it. Joint ownership can sometimes prevent commercialization. An assignment of intellectual property from a volunteer or student may sometimes be required. Such an assignment, if it inadequately deals with all relevant issues, may be void pursuant to laws throughout the world. A void deed of assignment may expose the research organization to legal liabilities. The categories of technology transfer traps to be explored are (1) ownership issues arising from the participation of students and volunteers in research, (2) ownership issues arising from collaborative research relationships, (3) ownership issues arising from the participation in research of visitors from another research organization, and (4) ownership issues arising from inventions made by employees. Each of these is considered in the context of the legal and regulatory framework in Australia, Canada, the United States of America, and the United Kingdom.
Australia↗
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.
Anti-HIV Agents↗
Academic research: policies and practice.
The Bayh-Dole Act of 1980 allowed universities in the US to own and manage inventions obtained using federal funds. This Act laid the foundation for university technology transfer activities in most major research universities of the country. Consequently, the interaction between universities and industry has increased, and so has the sophistication in university intellectual property management. UIC's model for managing its intellectual property is efficient and successful, and is the one increasingly used by university technology transfer offices. The model deals with all aspects of UIC's intellectual property: disclosure, protection, marketing, negotiating and licensing, as well as intellectual property provisions in UIC's research agreements, material transfer agreements, option agreements, licensing agreements and others. In a pioneer effort, UIC has developed a policy on contracts for collecting natural product samples for drug discovery which includes royalty sharing and other important provisions. Accompanying this policy we have also drafted a standard contractual agreement for collectors.
Authorship↗
Managing the effect of TRIPS on availability of priority vaccines.
The stated purpose of intellectual property protection is to stimulate innovation. The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) requires all Members of the World Trade Organization (WTO) to enact national laws conferring minimum standards of intellectual property protection by certain deadlines. Critics of the Agreement fear that such action is inconsistent with ensuring access to medicines in the developing world. A WHO convened meeting on intellectual property rights and vaccines in developing countries, on which this paper is based, found no evidence that TRIPS has stimulated innovation in developing market vaccine development (where markets are weak) or that protection of intellectual property rights has had a negative effect on access to vaccines. However, access to future vaccines in the developing world could be threatened by compliance with TRIPS. The management of such threats requires adherence of all countries to the Doha Declaration on TRIPS, and the protections guaranteed by the Agreement itself, vigilance on TRIPS-plus elements of free trade agreements, developing frameworks for licensing and technology transfer, and promoting innovative vaccine development in developing countries. The role of international organizations in defining best practices, dissemination of information, and monitoring TRIPS impact will be crucial to ensuring optimal access to priority new vaccines for the developing world.
Developing Countries↗
Do not put too much value on conventional medicines.
About 80% of the population of the developing countries still use traditional medicines for their health care. The rational use of traditional medicines in primary health care should be based on the Guidelines for the Assessment of Herbal Medicines as developed by the World Health Organization (WHO). The protection of intellectual property on traditional medicines should also be based on the guidelines for the protection of intellectual property on traditional medicines to be developed by the World Intellectual Property Organization (WIPO). The knowledge of traditional medicines hidden and lost should be researched and the loss of natural resources used as traditional medicines should be prevented. As a new emerging field in ethnopharmacology, treatment guidelines and evidence-based evaluation guidelines for ethnoergogenics, and protection guidelines of intellectual property for ethnoergogenics should be developed and put into practice according to guidelines of the WHO and WIPO, respectively.
Conservation of Natural Resources↗
Pharmaceutical patents and some international trade issues: Canada, the United States, and NAFTA.
This paper traces the evolution of a more aggressive US policy for the protection of the intellectual property rights of its citizens, individual and corporate, who do business aborad. It focuses on the pharmaceutical industry and, in particular, the harmonization of conflicting US and Canadian policies. In reconciling these policy differences, the United States unilaterally applied relatively new procedures authorized under section 301 and Special 301 of its trade laws. It also utilized the bilateral dispute mechanism mandating cooperation "in the Uruguay Round ... to improve protection of intellectual property," as provided in the Canada-United States Free Trade Agreement. These efforts were successful; Canada amended its patent law in 1993 to conform to current international practices. These changes were incorporated into the North American Free Trade Agreement (NAFTA), making it a state-of-the-art example of the protection of intellectual property rights. The intellectual property chapter of NAFTA will serve as the model for US intellectual property rights negotiations for the foreseeable future.
Canada↗
Biotechnology and food security in the 21st century.
Biotechnology can contribute to future food security if it benefits sustainable small-farm agriculture in developing countries. Presently, agrobiotechnology research cites ethical, safety, and intellectual property rights issues. Protection of intellectual property rights encourages private sector investment in agrobiotechnology, but in developing countries the needs of smallholder farmers and environmental conservation are unlikely to attract private funds. Public investment will be needed, and new and imaginative public-private collaboration can make the gene revolution beneficial to developing countries. This is crucial for the well-being of today's hungry people and future generations.
Agriculture↗
[Valorization of biological resources in tumour libraries].
The transfer and commercialization of biological materials, whether in the form of tumour samples, tissue samples or chemicals, and of the data base pertaining to such material have become a subject of considerable importance for both the private and public sectors involved in medical research. In order to fully appreciate and apprehend the process for the protection and the valuation of the transferred material, intellectual property law must be taken into account. As a result, a distinction is made between the tangible and intangible elements of the biological material and of the attached data base, thus providing the transferring entity the possibility to claim property rights to future intellectual property arising from the research regarding the transferred material. The transfer of biological material and attached data base without such contractual provisions can lead to the loss of this potential value as well as of physical and legal control over the material transferred by the providing entity. The intentions and the assumptions of the parties must be negotiated and written into terms of contract, at the risk of losing future value due to unexpressed assumptions concerning intangible property rights.
Databases, Factual↗
UK Commission concludes international patent laws hinder access to medicines in developing countries.
On 12 September 2002, the UK Commission on Intellectual Property Rights, an independent body established in May 2001 by the British government, released its report analyzing the impact of international agreements on patents. The report, Integrating Intellectual Property Rights and Developmental Policy, makes 55 recommendations "aimed at aligning [intellectual property] protection with the goal of reducing poverty".
Developing Countries↗
Thailand: successful challenge to invalid patent claim on antiretrovirals.
Thai people living with HIV/AIDS made legal history on 1 October 2002, when they won a lawsuit against the pharmaceutical giant Bristol Myers-Squibb (BMS). The plaintiffs, two people living with HIV/AIDS and a local NGO, the AIDS Access Foundation, lodged a complaint against BMS and Thailand's Department of Intellectual Property (DIP) in Thailand's Central Intellectual Property and International Trade Court (CIPITC). They claimed that the BMS patent registration for its buffered tablet formulation of the antiretroviral AIDS drug, dideoxy purine nucleoside (ddI, brand name Videx), was illegally amended in an attempt to claim a wider monopoly than the patent description justified.
Anti-HIV Agents↗
Patent prosecution in structural proteomics.
This paper presents a brief overview of intellectual property rights and the various areas in proteomics to which intellectual property rights may be applicable. Technology transfer, including licensing and business agreements, are not covered in this paper. Instead, issues and complications related to national and overseas patent prosecution in this relatively new field will be discussed.
Intellectual Property↗
Impact of the World Trade Organization TRIPS agreement on the pharmaceutical industry in Thailand.
The 1994 World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) established minimum universal standards in all areas of intellectual property. It is intended to implement these standards globally through a WTO enforcement mechanism. The present article proposes a strategy for alleviating the potentially negative impact of TRIPS in Thailand in relation to the following: purchasers; prescribers and dispensers; producers; products; price control; patent-to-third-party; parallel imports; power of the customer; patentable new drugs; personnel; and prevention policies. The following TRIPS provisions are pertinent to the pharmaceutical industry in Thailand: the limited term of product and process patents; the conditions of protection; and the broad scope for compulsory licensing and enforcement procedures in the national patent system.
Commerce↗
Developing drugs for the developing world: an economic, legal, moral, and political dilemma.
This paper discusses the economic, legal, moral, and political difficulties in developing drugs for the developing world. It argues that large, global pharmaceutical companies have social responsibilities to the developing world, and that they may exercise these responsibilities by investing in research and development related to diseases that affect developing nations, offering discounts on drug prices, and initiating drug giveaways. However, these social responsibilities are not absolute requirements and may be balanced against other obligations and commitments in light of economic, social, legal, political, and other conditions. How a company decides to exercise its social responsibilities to the developing world depends on (1) the prospects for a reasonable profit and (2) the prospects for a productive business environment. Developing nations can either help or hinder the pharmaceutical industry's efforts to exercise social responsibility through various policies and practices. To insure that companies can make a reasonable profit, developing nations should honor pharmaceutical product patents and adhere to international intellectual property treaties, such as the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. To insure the companies have a good business environment, developing nations should try to promote the rule of law, ethical business practices, stable currencies, reliable banking systems, free and open markets, democracy, and other conditions conducive to business. Overall, this paper advocates for reciprocity and cooperation between pharmaceutical companies and developing nations to address the problem of developing drugs for the developing world. In pursuing this cooperative approach, developing nations may use a variety of other techniques to encourage pharmaceutical companies to act responsibly, such as subsidizing pharmaceutical research, helping to design and implement research protocols, providing a guaranteed market, and bulk buying.
Beneficence↗
Can patents deter innovation? The anticommons in biomedical research.
The "tragedy of the commons" metaphor helps explain why people overuse shared resources. However, the recent proliferation of intellectual property rights in biomedical research suggests a different tragedy, an "anticommons" in which people underuse scarce resources because too many owners can block each other. Privatization of biomedical research must be more carefully deployed to sustain both upstream research and downstream product development. Otherwise, more intellectual property rights may lead paradoxically to fewer useful products for improving human health.
Animals↗
Implications of bilateral free trade agreements on access to medicines.
The TRIPS Agreement of the World Trade Organization (WTO) mandated the introduction of protection of intellectual property rights, notably patents, for pharmaceutical products. While the implications for the access to medicines contained in the terms of this Agreement raised significant concerns, a recent new wave of free trade agreements, negotiated outside the WTO, requires even higher levels of intellectual property protection for medicines than those mandated by that Agreement. The measures involved include the extension of the patent term beyond 20 years; prohibition of use of test data on drug efficacy and safety for certain periods for the approval of generic products; the linkage between drug registration and patent protection; in some cases, limitations to the grounds for granting compulsory licences. This article reviews some of these measures that further limit the competition of generic products and discusses their possible implication for access to medicines.
Commerce↗
Is globalization good for your health?
Four points are made about globalization and health. First, economic integration is a powerful force for raising the incomes of poor countries. In the past 20 years several large developing countries have opened up to trade and investment, and they are growing well--faster than the rich countries. Second, there is no tendency for income inequality to increase in countries that open up. The higher growth that accompanies globalization in developing countries generally benefits poor people. Since there is a large literature linking income of the poor to health status, we can be reasonably confident that globalization has indirect positive effects on nutrition, infant mortality and other health issues related to income. Third, economic integration can obviously have adverse health effects as well: the transmission of AIDS through migration and travel is a dramatic recent example. However, both relatively closed and relatively open developing countries have severe AIDS problems. The practical solution lies in health policies, not in policies on economic integration. Likewise, free trade in tobacco will lead to increased smoking unless health-motivated disincentives are put in place. Global integration requires supporting institutions and policies. Fourth, the international architecture can be improved so that it is more beneficial to poor countries. For example, with regard to intellectual property rights, it may be practical for pharmaceutical innovators to choose to have intellectual property rights in either rich country markets or poor country ones, but not both. In this way incentives could be strong for research on diseases in both rich and poor countries.
Acquired Immunodeficiency Syndrome↗