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European Patent Of ce Member States Austria Denmark Hellenic Republic Liechtenstein Republic of Bulgaria Slovenia The Netherlands Belgium Cyprus Finland France Hungary Ireland Luxembourg Monaco Republic of Estonia Republic of Romania Spain Sweden The United Kingdom Turkey Czech Republic Germany Italy Portugal Slovak Republic Switzerland
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FIGURE 5.5 Member states of the European Patent Of ce as of 2003.
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are not patentable because they are either contrary to the public order or because of their moral implications. These technologies include processes for human cloning, for modifying the germ line genetic identity of humans, and for industrial and commercial use of human embryos. The directive also has provisions against patenting processes that modify the genetic identity of animals that are likely to cause them suffering without any sub stantial medical bene t to humans from the process. One of the greatest sources of contention over biotech patent rights at the international level is related to bioprospecting, which is the search for genetic material from among the biological resources of less developed countries. The aim of bioprospecting is to nd genetic material that can form the basis of new pharmaceuticals or agricultural products that can then be patented and placed on the global market. The concern is that the countries in which the prospecting is typically performed are least able to afford the new technology. Although they may have an abundance of trop ical rain forests and other biologically diverse ecosystems, underdeveloped countries often can t afford the drugs and agricultural products that have been developed from genetic material that they contributed. Ownership of biological resources is also an issue when it affects economies based on regional crops. For example, in 1997, U.S. re searchers at RiceTech, Inc. patented a form of jasmine rice that would grow in the U.S. RiceTech also won the trademark, jasmati for its rice. Farmers in Thailand responded by accusing the researchers of stealing the genetic material of their rice without the country s permission, and of us ing a trademark that intentionally confuses customers, thereby threaten ing their local rice economy. Thailand is the world s top rice exporter and jasmine or fragrant rice is its top grade, which is highly priced, and earns the country much-needed foreign exchange. The government of Thailand was joined by that of India and Pakistan in ghting the patent and trade mark protection granted RiceTech. Other attempts by U.S. companies to
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patent crops native to developing counties have also met with strong in ternational protest. One attempt to resolve intellectual property issues related to bioprospecting is to enact bene t sharing, which assumes that counties have sovereign rights over the exploitation of their genetic resources, including the right to determine conditions of access. Bene t sharing has been pro posed by international organization and conventions such as the Conven tion on Biological Diversity, the Common System on Access to Genetic Resources, and The International Bioethics Committee of The United Na tions Educational, Scienti c and Cultural Organization (UNESCO). Less clear is the ownership and control over the genetic information contained in the growing online genetic databases, some of which contains speci c data on DNA donated or otherwise provided by individuals. For example, in many cases the individuals who donates a sequence in the course of a clinical study may be unable to determine how much, if any, of their sequence contributes to an online sequence database.
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The patenting of DNA sequences and other genetic material is a relatively recent phenomenon dating back to a 1980 U.S. Supreme Court decision to allow genetically engineered living organisms to be patented. The organism that was patented was a genetically engineered bacterium for the bioreme diation of oil spills. Between 1981 and 1995, more than 1,000 human gene patents were granted worldwide, with the majority awarded by the U.S. Patent and Trade Of ce, as shown in Figure 5.6. By 2000, there were over 25,000 patents on DNA from a variety of species, from fruit ies to mice. The most famous organism patented in the U.S. is the Oncomouse, a hairless mouse genetically engineered for cancer research, patented in 1988 by Harvard University. The rst patent on a gene fragment was also issued in the U.S. in the same year. Both the patent on the Oncomouse and the patent on gene fragments have been the focus of an ongoing contro versy in the European Patent Of ce, and the Japanese Patent Of ce (JPO), among others. Patent families, which consist of all the patent documents associated with a single invention published in one country, can also be tracked to as sess the relative activity of DNA patents. International patent families are patent families for which protection has been sought in multiple countries. As shown in Figure 5.7, the United States has been the world leader in in ternational patent families of human DNA sequences, with 72 percent of international patent families in the years 1980 to 1999. Of the remaining 28 percent of activity, Japan is the leader with 34 percent, followed by Great Britain with 22 percent of international patent families. Germany
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