The development of the genetic resources of biodiversity is known as biotechnology. Broadly defined, biotechnology includes any technique that uses living organisms or parts of organisms to make or modify products, to improve plants or animals, or to develop microorganisms for specific uses (Congress of the United States, Office of Technology Assessment, 1990). Mankind has used forms of biotechnology since the dawn of civilization. However, it has been the recent development of new biological techniques (e.g., recombinant DNA, cell fusion, and monoclonal antibody technology) which has raised fundamental social and moral questions and created problems in intellectual property rights.
Intellectual property protection for biotechnology is currently in a state of flux. Whilst it used to be the case that living organisms were largely excluded from protection, attitudes are now changing and increasingly biotechnology is receiving some form of protection. These changes have largely taken place in the USA and other industrialized countries, but as other countries wish to compete in the new biotechnological markets, they are likely to change their national laws in order to protect and encourage investment in biotechnology.
There is at the moment no clear international consensus on how biotechnology should be treated. Although bodies such as the World Intellectual Property Organization (WIPO, the United Nations permanent body primarily responsible for international cooperation in intellectual property), and the Organization for Economic Cooperation and Development (OECD) have conducted separate studies and produced various reports, these have only sought to make governments more aware of the potential problems and to offer some suggested solutions. In view of the highly controversial nature of providing intellectual property protection for biotechnology, it is likely that in the short term developments will be at a national and regional level.
There are currently two main systems of protection for biotechnology: rights in plant varieties, and patents. Both systems provide exclusive, time-limited rights of exploitation and are described in more detail below.
Keeping biotechnology 'secret' can also be a valuable form of protection. National treatment of trade secrets is diverse, and all attempts to harmonize trade secret laws in Europe, for example, have failed. Most jurisdictions do provide some form of protection against those who steal or use others' trade secrets unfairly. However, the problem with this form of protection is that the secret generally becomes public once the biotechnology is used commercially and thus the protection is lost.
It is conceivable that the law of copyright could afford some protection for biotechnology. Lines of genetic code are analogous to some extent with computer program code, which has now been incorporated into the copyright systems of most industrialised countries. However, this route to protection is fraught with practical and conceptual difficulties and is generally thought to be unsuitable. There is as yet no recorded case of biotechnologists claiming copyright in their inventions.
Trademarks are also unlikely to be of much use in protecting biotechnology, though they may of course prove important later in regard to marketing products, processes or services. An attempt to register the name of a plant or an animal as a trade mark is unlikely to be successful as public policy would prevent it (in England, registrations for names of varieties of roses have been removed from the Trade Mark Register for lack of distinctiveness and because of the likelihood of confusion).
Prior to the mid-1960s only a few countries (e.g., Germany, USA) gave any intellectual property protection to plant varieties. Because of pressure from their plant breeding industries, 10 western European countries entered into a diplomatic process in the early-1960s which eventually culminated in the formation of an International Union for the Protection of New Varieties of plants (UPOV) and the signing of a Convention (the UPOV Convention 1961). Since that time a number of other countries have become parties to the UPOV Convention (the full list of 19 parties appears in Table 31.3). Amendments were made to the UPOV Convention in 1978, principally to facilitate the entry of the USA.
The UPOV Convention requires that each member country must adopt national legislation to give at least 24 genera or species protection, in accordance with the provisions of the convention, within eight years of signing. A plant variety is protectable ("a protectable variety") under the UPOV system if it is distinct, uniform, stable (DUS) and satisfies a novelty requirement. Novelty and distinctiveness equate broadly to novelty under patent law, but are more leniently applied in comparison to the patent rule. Satisfaction of the DUS criteria is conducted by the national authority responsible, usually by growing the variety over at least two seasons. There is also an important requirement that the variety be maintained throughout the duration of protection. A country may apply the system to all genera or species, but there is no obligation to do so and thus the system has been extended only gradually. In addition, the UPOV Convention allows national legislation to discriminate against foreigners (including nationals of a UPOV Convention country) under the principle of reciprocity. Thus amongst the UPOV members there is still some disparity in protection.
Duration of protection depends on national legislation and on the plant species to which the variety belongs, but is generally for 20-30 years. Grant of plant variety rights confers certain exclusive rights on the holder, including the exclusive right to sell the reproductive material (e.g. seed, cuttings, whole plants) of the protected variety. However the rights do not extend to consumption material (e.g. fruit, wheat seed grown for milling flour). Essentially the exclusive rights define what others may or may not do in relation to the protected varieties.
Plant breeders were for some time dissatisfied with the protection provided by the UPOV system. This eventually resulted in a major diplomatic conference in March 1991, at which the UPOV Convention was substantially revised. The new 1991 text will provide far greater protection than is afforded at present, most notably by requiring that all member countries apply the convention to all genera and species, by extending the exclusive rights to include harvested material (e.g., fruit, wheat grown for milling into flour) and, most controversially, by allowing enforcement against farm-saved seed (where a farmer produces further seed of the protected variety from the previous year's crop). However, until the national governments ratify the new convention the system will continue to be based on the 1978 text. There will be considerable national opposition to the strengthening of plant variety rights and thus these changes may take years before they are implemented and may even be superseded by greater availability of patent protection in the meantime.
A patent is a grant of exclusive rights for a limited time in respect of a new and useful invention. The exact requirements for grant of a patent, the scope of protection it provides and its duration differs depending on national legislation. However, generally the invention must be of patentable subject matter, novel (new), non-obvious (inventive), of industrial application and sufficiently disclosed. A patent will provide a wide range of legal rights, including the right to possess, use, transfer by sale or gift, and to exclude others from similar rights. Duration will be for around 20 years (although for only 17 years in the USA). These rights are generally restricted to the territorial jurisdiction of the country granting the patent and thus an inventor wishing to protect his/her invention in a number of countries will need to seek separate patents in each of those countries. Whilst the majority of countries provide some form of patent protection, only a few provide patent protection for biotechnology (these include: Australia, Bulgaria, Canada, Czechoslovakia, Hungary, Romania, Japan, the Soviet Union and the parties to the European Patent Convention). The reasons for this may differ, but generally it has been because biotechnology has been thought inappropriate for patent protection, either because the system was originally designed for mechanical inventions, or for technical or practical reasons, or for one or more ethical, religious or social concerns. In all the National Patent Offices where patents are granted for biotechnology there is a considerable backlog of pending applications. Even in those countries where patent protection is provided, the type and extent of that protection is different in nearly every national system.
It has largely been the USA which has broken new ground in providing the possibility of patent protection for "anything under the sun that is made by man". Patents have been granted for plants since 1930 in the USA, under The Plant Patent Act. However, prior to 1980, the US Patent Office would not grant utility patents (separate from The Plant Patent Act) living matter because it deemed products of nature not to be within the terms of the utility patent statute. That was until the landmark decision of the US Supreme Court in Diamond v Chakrabarty (from which the above quote is taken), which held that a particular genetically engineered bacterium was statutory subject matter for a utility patent. This decision has been the basis upon which patents have been granted for higher life forms. Subsequently it has been held that a utility patent may be granted for plants and a patent has been granted for an animal. Polyploid oysters, not naturally occurring, were held to be patentable subject matter and US Patent No.3,736,866, was issued in respect of a "transgenic nonhuman mammal all of whose germ cells and somatic cells contain a recombinant activated oncogene sequence introduced into the said mammal, or an ancestor of said animal, at an embryonic stage" - popularly known as the 'onco-mouse '.
Elsewhere, the treatment of applications for patents for living matter is far from certain. Whilst patents are granted in many countries for plants and microorganisms, it has been the issue of patents for animals which has been most controversial. Whilst it is not possible to summarize succinctly the position in the rest of the world, it is possible to describe the present approach of those countries which are party to the European Patent Convention (the EPC, see Table 31.3). The EPC is a regional arrangement entered into by 14 European countries for the purpose of making multiple applications for any of the member countries a great deal easier and to introduce a common system for patent protection. An application under the EPC is for a European patent, or Europatent, for short. If a Europatent is granted by the European Patent Office (EPO) it has the same effect, and is subject to the same conditions, as a national patent in each of the member countries designated in the application. In other words, through a single application a bundle of national patents can be obtained.
The EPC provides that "plant or animal varieties or essentially biological processes for the production of plants or animals" are excluded from patent protection (although the exclusion is expressly stated not to apply to microbiological processes and products). These exclusions would appear to place unequivocal prohibition on Europatents for macrobiotechnology. However, the EPO has been taking an increasingly narrow view of these exclusions, and has held that they do not exclude all plants and animals per se, but only claims for varieties of plants or animals and that a process is not "essentially biological" if there has been substantial interference by man.
It is also important to note that there is currently before the European Parliament of the European Community (EC) a proposal for a Council Directive for harmonization of the legal protection provided for biotechnology in the EC. This does not propose to amend the EPC, but the present draft proposal would make even more opportunities available for patenting biotechnology and thus make the EC more attractive in terms of investment in biotechnology research.
There are three international intellectual property treaties which are of particular importance for the protection of biotechnology: the Paris Convention for the Protection of Industrial Property (the Paris Convention); the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure (the Deposit Treaty) and the Patent Cooperation Treaty (PCT) (see Table 31.3).
The Paris Convention was originally signed in 1883 by just 11 countries, but now the majority of countries who have any form of intellectual property law are parties to it. The keystone to the convention is the principle of national treatment: an applicant from one convention country shall have the same rights in a second convention country as a national of that second country. The convention covers patents and defines them so broadly that it permits application to any of the forms of industrial patents granted under the laws of the convention countries. The most important practical result of the convention is that it is possible to claim priority from an application made in a convention country for all subsequent convention countries within 12 months of the original filing.
The Deposit Treaty, as the full title suggests, is concerned with the deposit of examples of microorganisms for the purposes of patent applications. Applications for patents for biotechnology often face considerable difficulties in describing the nature of the invention sufficiently. The Deposit Treaty is a vehicle for solving these problems, primarily through the setting up of a series of International Depository Authorities (IDA) and through the recognition by all member countries of a deposit in a single IDA.
The PCT simplifies the process of filing patent applications simultaneously in a number of countries. Under the PCT a single application may be filed in one of the official receiving offices, designating any number of PCT member countries, which can eventually result in a national patent being granted in each of the designated states (and/or a Europatent). A prior-art search is performed by the receiving office and a report sent to the applicant. The application and report are published and the application will then move on either to an international preliminary examination followed by national examination, or alternatively straight to the national examination stage. Unfortunately, the eventual outcome is not a 'world patent' and there is no harmonization patent law under the PCT apart from the procedural aspects.
The Green Iguana Iguana iguana of Latin America is a highly prized source of meat and eggs. Green Iguanas are arboreal herbivores which can grow up to 2m in length and can weigh as much as 6kg (about 82% of the lizard is edible). They need about half as much food as a chicken or rabbit to produce the same amount of meat. The species is now widely threatened because of excess hunting and habitat destruction.
Research into the reproductive behavior of the Green Iguana was begun in 1983 and resulted in development of new management techniques for ranching. A 'genetic brood stock' of adult iguanas which are larger, faster growing and more productive has been developed. The research has largely been the work of the Pro Iguana Verde Foundation (formed by Dagmar Werner in 1985). The Foundation's programme for training and advice on Iguana ranching is called the Iguana Management Programme (IMP). The IMP is based in Costa Rica but it is intended to implement it throughout Latin America and possibly elsewhere.
The primary purpose of the IMP is to conserve living natural resources; its basic premise is that if farmers can raise iguanas as a food crop, the status of the wild species will be improved and forest clearance might be reduced. Farmers adopting iguana ranching would have to protect or re-establish areas of forest to provide food for stock. Research indicates that meat production per hectare by iguanas is approximately three times higher than by cattle. Income can be derived from selling iguanas and their products (meat, eggs, leather) and products from the forest.
The new technology and expertise which have been incorporated into an iguana ranching model are being applied for an industrial purpose (i.e. agriculture) and are of commercial value; they thus fall within the area of intellectual property law as applied to biotechnology. The biotechnological components of the ranching model are the genetic brood stock (the Fundacion has 'bioengineered' an improved stock of Green Iguanas) and the husbandry procedures (egg laying and incubation, nutrition, disease control, release and harvesting). These are forms of 'original or traditional biotechnology', as opposed to 'new biotechnology' which is largely laboratory-based and dependent upon human manipulation of genetic material.
Intellectual property rights provide the means for compensating the Fundacion for its efforts. The technologies involved in the IMP are vulnerable to piracy. Much of the work of the Fundacion is contained in the genetic make-up of the Genetic Brood Stock. Once these Iguanas are transferred or sold the Fundacion loses its direct control over the animals. In addition, the success of the Iguana ranching model is dependent on the expertise to use the technologies efficiently; this is information which took years to develop but which can be pirated very easily once a license is purchased. The Fundacion needs to be able to disseminate its innovations and expertise in the security of knowing that it cannot be re-sold by pirates and that there will be no reduction of the licensing potential. Only internationally recognized intellectual property law can provide these types of protection.
Because of the uncertainties of the world's intellectual laws with regard to biotechnology the availability of protection for the most important components of the IMP is questionable. At present there is widespread discrimination against the application of intellectual property rights to natural genetic materials and in favor of human-modified genetic materials. This provides no incentives for exploitation of useful genetic materials in the natural environment, even though in developing countries natural resources are obvious subjects for investment. However, one important way to limit conversion of natural resources is to ensure that fair value is paid for current uses of the existing resource base. Intellectual property rights could be a means of influencing developing countries to maintain and develop diverse resources in return for the value that these resources render to the world community.
Regulated trading in wildlife products has the capacity of returning benefits to the users of natural habitats. It could do this if the trade were regulated in such a way as to support prices, much as is done at present with respect to agricultural commodities, where price supports provide incentives for maintaining land in its current state, as opposed to converting it to other purposes.
At present, there is no regulated trading mechanism of exactly this nature. There are, however, a number of existing international agreements which do seek to regulate trade in wildlife products. Early examples are the Western Hemisphere Convention and the 1950 Paris International Convention for Protection of Birds. These simply outlined in broad terms an obligation to control trade in wildlife products but created little structure within which these controls could be implemented. Both conventions consequently became 'sleeping treaties'. Undoubtedly the most important and effective convention which places some control on the economic exploitation of wildlife products and thereby protects biological diversity is the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES).
CITES is the most widely accepted of international treaties on the conservation of natural resources. The number of Parties has been steadily increasing from the initial signing of the convention in 1973 to a total of 113 in 1992 (Fig. 31. 1)
The convention attempts to prevent commercial trade in species of wildlife which are in danger of extinction and to control the trade in species which might become so if their trade was allowed to continue unchecked. It does this by means of two lists of species: Appendix I contains those species banned from international commercial trade and Appendix II, those for which trade may take place provided that export permits have been issued. Importing countries are obliged to ensure that all imports of Appendix II specimens are accompanied by correct export permits.
One of the main obligations of Parties is to submit to the Convention Secretariat annual reports of all of their trade in species included in the Appendices. The number of annual reports submitted is also shown in Fig. 31.1. These data are then compiled on a computer database and in this way it is possible to determine the global levels of trade in each species. At a fine level of resolution, the trade emanating from each range state can then be compared with what is known about the wild population in that country to enable an estimation of whether it is sustainable or whether it might be detrimental to its survival. At a coarser scale, the data can show long-term trends in trade levels or trade routes, which can be used to help in understanding and therefore controlling the trade.
The convention covers not only live animals and plants but also products and derivatives of the species listed. These range from whole skins and manufactured leather products, through ivory carvings, tortoiseshell jewelry, meat, seeds, and feathers to medicinal products extracted from plants such as ginseng. This causes problems for the implementation of the Convention because it is necessary for enforcement of officers to determine not only what species the product is derived from but also whether the species is included in the Appendices. In order to minimize the problems of identification, where numerous species are very