Biotechnology and Intellectual Property Rights Essay
Biotechnology and Intellectual Property Rights
Modern Biotechnology and its Applications
property as well as the scope of rights with respect to those matters. For example, a proprietor of a house has legal rights to possess, use, modify, destroy, transfer, sell, or rent the house. Various laws and regulations may prohibit the homeowner from painting his house in various colours, operating a business from his home, or keeping a horse in his backyard.
Since properties are collections of legal rights, the property regime is a social institution that serves particular purposes in society (Feinman, 2000). We are pertinent to think of objects, such as, land, as the properties, but these objects only have their status as property in relation to people in society. If no people were around, land would not be someone’s property; it would just be the land. We mark borders and create deeds to represent the social and legal status of a person’s rights and duties with respect to the land.
Thus, the concept of property is a three-place relationship between an object, an individual (i.e. a person, group of people, or corporation), and society. Improvement and development of new ideas is primary to the progress of evidence based clinical practice. Intellectual property rights are basic to the protection of bioinformation and biotechnology but may hamper progress and dispersal of information. At the same time as the application of patents and copyrights are common place in companies profiting from information technology, their application in the field of biotechnology is less understood and publicized. Intellectual property (IP) is a term referring to a number of distinct types of creations of the mind for which property rights are documented—and the corresponding fields of law.
Under intellectual property law, owners are granted certain exclusive rights to a variety of indefinable assets, such as musical, literary, and artistic works; discoveries and inventions; and words, phrases, symbols, and designs. Common types of intellectual property include copyrights, trademarks, patents, industrial design rights and trade secrets in some jurisdictions (Murashige 2002). Although many of the legal principles governing intellectual property have evolved over centuries, it was not until the 19th century that the term intellectual property began to be used, and not until the late 20th century that it became usual in the United States.
The British Statute of Anne 1710 and the Statute of Monopolies 1623 are now seen as the origin of copyright and patent law respectively (Cimoli, 2002). Modern usage of the term intellectual property goes back at least as far as 1888 with the founding in Bern of the Swiss Federal Office for Intellectual Property. When the administrative secretariats recognized by the Paris Convention (1883) and the Berne Convention (1886) merged in 1893, they also located in Berne, and also adopted the term intellectual property in their new combined title, the United International Bureaux for the Protection of Intellectual Property.
The organization subsequently relocated to Geneva in 1960, and was succeeded in 1967 with the establishment of the World Intellectual Property Organization (WIPO) by treaty as an agency of the United Nations. It was only at this point that the term really began to be used in the United States (which had not been a party to the Berne Convention), and it did not enter popular usage until passage of the Bayh-Dole Act in 1980.
Biotechnology and Intellectual Property Rights
Historical Background “The history of patents does not begin with inventions, but to a certain extent with royal grants by Queen Elizabeth I (1558-1603) for command constitutional rights. Approximately 200 years after the end of Elizabeth’s preeminence, however, a patent represents a legal [right] obtained by an inventor providing for exclusive control over the production and sale of his mechanical or scientific invention the evolution of patents from royal privilege to common-law doctrine.” In 1818, the French liberal theorist, Benjamin Constant, argued against the recently introduced idea of “property which has been called intellectual.”
The term intellectual property can be found used in an October 1845 Massachusetts Circuit Court ruling in the patent case Davoll et al. v. Brown., in which Justice Charles L. Woodbury wrote that “only in this way can we protect intellectual property, the labors of the mind, productions and interests are as much a man’s own…as the wheat he cultivates, or the flocks he rears.” (1 Woodb. & M. 53, 3 West.L.J. 151, 7 F.Cas. 197, No. 3662, 2 Robb.Pat.Cas. 303, Merw.Pat.Inv. 414). The statement that “discoveries are property” goes back earlier. Section 1 of the French law of 1791 stated, “All new discoveries are the property of the author; to assure the inventor the property and temporary enjoyment of his discovery, there shall be delivered to him a patent for five, ten or fifteen years.” In Europe, French author
A. Nion mentioned propriété intellectuelle in his Droits civils des auteurs, artistes et inventeurs, published in 1846. The concept’s origins can potentially be traced back further. Jewish law includes several considerations whose effects are similar to those of modern intellectual property laws, though the notion of intellectual creations as property does not seem to exist – notably the principle of Hasagat Ge’vul (unfair encroachment) was used to justify limitedterm publisher (but not author) copyright in the 16th century.
The Talmud contains the prohibitions against certain mental crimes (further elaborated in the Shulchan Aruch), which some have interpreted as prohibiting theft of ideas, though the doctrine is principally concerned with fraud and deception, not property (Correa, 2001).
Objectives of Intellectual Property Copyright and its importance Intellectual property (IP) protects ideas. There are four main types of Intellectual property (IP): 1. 2. 3. 4. Patents protect the technical aspect of the product Trademarks protect signs of the trader Copyright protects creative material such as music and literature Design registration protects the visual appearance of the product.
Modern Biotechnology and its Applications
Copyright law varies between nations. In the UK it originated from the Statute of Anne 1709, before the passing of the Copyright Act in 1911. The Copyright, Designs and Patents Act of 1988 was statute until October 2003 when the EU issued a directive to acknowledge the impact of electronic information and the internet on IP. Copyright law acknowledges the creator of a work as the author with the right to govern how the work is disseminated and prevents distortion of the work by third parties. This applies to literary works (such as scientific papers) as well as artistic creations and even computer programs. Copyright is automatic in the UK on creation of an original work. It will protect the work itself but not the idea behind it.
Thus the idea of hip resurfacing would not be protected but the Birmingham Hip Resurfacing components would be. Commissioning or freelancing does not influence ownership which is still exclusive to the original author. For literary works such as scientific papers, computer programs, commercial documents and song lyrics the Copyright, Designs and Patents Act of 1988 states that the duration of copyright is 70 years from the time the work was written or first published in the public domain.
For typographical arrangements of published editions such as magazines, periodicals and journals, copyright duration is 25 years from the end of the calendar year of publication. A scientific paper prior to publication can be registered for copyright that will last for 70 years. On publication, the author transfers copyright to the journal which then holds the copyright for 25 years.
Thus the author has the right to be identified as the author of the work and to object to critical treatment. It is an offence to copy, adaptor show the work in public without the consent of the owner. However, the work can be copied for the purposes of research or educational purposes without infringing on the copyright. On submission of a manuscript for publication, most publishers require a transfer of copyright agreement. This allows the publisher to register a single copyright product (if the paper is attributed to multiple authors) and protects the author, editors and publishers from copyright violation due to unlawful duplication once the manuscript has been published as part of a journal.
Authors do not have to sign a transfer of copyright as a condition of publication and may retain copyright of their manuscript but would have to sign a formal statement licensing publication exclusively in the relevant journal. Most publishers would also expect authors to acknowledge that their work is original and has not previously been published to ensure no copyright infringement prior to publication (Elliott, 2007). Authors still retain the proprietary right of their work once the transfer of copyright has been signed over to a publisher since ‘moral rights’ are conferred to authors by the UK Copyright Act of 1988. Authors are therefore credited whenever the publishing house uses the work.
Authors can also reproduce their own papers provided the publisher is acknowledged and a citation provided to the original publication. Most publishers would require notification if the paper is to be used in a volume in which the author acts as editor or author. Policiesn regarding electronic postings on websites vary between publishers with some allowing pre-print postings on the web with a link to the publication and acknowledgement. Most
Biotechnology and Intellectual Property Rights publishers will allow broadcasting of the published article by the author provided it is for educational purposes and not open access to the general public (Coriat and Orsi, 2001). At the same time as copyright is an automatic process on conception of a body of work in the UK, a copyright notice will formalize this process. The copyright notice takes the form of a copyright symbol ©, the year the work is published or written and the name of the owner, e.g. Copyright © CB Hing 2007. Additional information such as ‘all rights reserved’ or ‘any unauthorized broadcasting, public performance, copyrighting or re-recording will constitute an infringement of copyright’ can also be added but are not a necessity to establish copyright.
In order to support the claim of copyright, the body of work can be registered with the UK Copyright Service in order to strengthen the claim of ownership in case of dispute. Supporting evidence for a claim of copyright includes all earlier drafts of the work, watermarks or electronic file comments as well as ‘footprints’ (calculations, mistakes etc.) (Crespi, 2000). Joint works should include an agreement between co-authors regarding ownership of copyright.
The principal author may claim copyright and take the work with them if they leave. In the event of one author leaving with joint ownership of copyright, the remaining authors must agree what will happen to the copyright (Murphy, 2002). If the work is produced during employment, the employer will own the work.
However, if the work is freelance or commissioned, rights will belong to the author of the work. Once copyright has expired, the author loses intellectual property rights to his work and it is freely available in the public domain. The work thus becomes public property and no other individual can claim copyright. An interesting exception in the UK is the copyright to ‘Peter Pan’. Lord Callaghan amended the 1988 Copyright Designs and Patents Act to allow the copyright for ‘Peter Pan’ indefinite status such that any royalties are passed on to Great Ormond Street Hospital. In October 2003, changes were made to the UK copyright law in response to a European Union directive and the impact of electronic information sharing (Coriat and Orsi, 2001).
This has meant that copying for commercial purposes where income will be generated is no longer allowed without the consent of the owner of copyright. However, copying for educational purposes, such as libraries, allows limited amounts of copying without the consent of the author. Thus copying research papers for scientific education would be allowed but copying papers to give to private patients would not as this potentially generates income and is classified as a commercial purpose (Azoulay et al., 2007). Intellectual property rights transcend countries and the Berne Convention for the Protection of Literary and Artistic Works was introduced in 1886 as an agreement between countries to uphold this.
The World Intellectual Property Organization (WIPO) administers the latest version of the convention, the Paris Act of 1971. There are approximately 147 members of the World Trade Organization that have agreed to the act, which protects the intellectual property of individuals’ resident to the member countries. Outside of those member countries, protection is afforded by a reciprocal agreement
Modern Biotechnology and its Applications
incentive. Consequently the author has rights to protect work from reproduction, adaptation and translation (http://www.iprcommission.org).
These exclusive rights allow owners of intellectual property to benefit from the property they have created, providing a financial incentive for the creation of an investment in intellectual property, and, in case of patents, pay associated research and development costs.
The existence of IP laws is credited with significant contributions toward
economic growth. Economists estimate that two-thirds of the value of large businesses in the U.S. can be traced to intangible assets. “IP-intensive industries” are estimated to generate 72 percent more value added (price minus material cost) per employee than “non-IP-intensive industries”.
A combined research project of the WIPO and the United Nations University measuring the impact of IP systems on six Asian countries found “a positive correlation between the strengthening of the IP system and subsequent economic growth.” Other models, such as the Nash equilibrium, would not expect that this correlation necessarily means causation: The Nash equilibrium model predicts that patent holders will prefer to operate in countries with stronger IP laws. In some of the cases, as was shown for Taiwan after the 1986 reform, the economic growth that comes with a stronger IP system might be due to an increase in stock capital from direct foreign investment (Mooney, 2000).
IPR in the Field of Plant Sciences
Plant breeders’ rights (PBR), also known as plant variety rights (PVR), are rights granted to the breeder of a new variety of plant that give them exclusive control over the propagating material (including seed, cuttings, divisions, tissue culture) and harvested material (cut flowers, fruit, foliage) of a new variety for a number of years (Pushpagandhan, 1996).With these rights, the breeder can choose to become the exclusive marketer of the variety, or to authorize the variety to others. In order to qualify for these exclusive rights by plant breeders’ rights, a variety must be new, distinct, uniform and stable. A variety is new if it has not been commercialized for more than one year in the country of protection.
A variety is different if it differs from all other known varieties by one or more important botanical characteristics, such as color, height, maturity, etc. A variety is homogeneous if the plant characteristics are consistent from plant to plant within the variety. A variety is stable if the plant characteristics are genetically fixed and therefore remain the same from generation to generation, or after a cycle of reproduction
Biotechnology and Intellectual Property Rights in the case of hybrid varieties. The breeder must also give the variety an acceptable “denomination,” which becomes its generic name and must be used by anyone who markets the variety (Warner, 2001). In general, plant variety rights are granted by national offices, after examination. Seed is submitted to the plant variety office, which grow it for one or more seasons, to ensure that it is distinct, stable, and uniform. If these tests are passed, exclusive rights are granted for a period of 20 years (or 25 years, for trees and vines).
Annual renewal fees are required to maintain the rights (Altieri, 2003).Breeders can bring suit to implement their rights and can recover damages for violation. Plant breeders’ rights contain exemptions from violation that are not recognized under patent law. Commonly, there is an exemption for farm-saved seed. Farmers may store the production in their own bins for their own use as seed, but this does not necessarily extend to brown-bag sales of seed. Further sales for propagation purposes are not allowed without the written approval of the breeder. There is also a breeders’ exemption (research exemption in the 1991 Act) that allows breeders to use protected varieties as sources of initial variation to create new varieties of plants (1978 Act), or for other experimental purposes (1991 Act).
There is also a provision for compulsory licensing to assure public access to protected varieties if the national interest requires it and the breeder is unable to meet the demand (Visser et al., 2002). The United States of America passed the Plant Patent Act in 1930 (US) at the urging of such notable figures as Thomas Edison and Luther Burbank’s widow. Plant patents provided a special form of patent protection, which relaxed certain requirements of the utility patent law as applied to asexually reproduced varieties of plants. In 1957, the French Government held a conference in Paris concerned with the protection of new varieties.
This led to the creation of the Union Internationale pour la Protection des Obtentions Végétales (UPOV) and adoption of the first text of the International Convention for the Protection of New Varieties of Plants (UPOV Convention) in 1961. The purpose of the Convention was to ensure that the member states party to the Convention acknowledges the achievements of breeders of new plant varieties by making available to them an exclusive property right, on the basis of a set of uniform and clearly defined principles. The Convention was revised in Geneva in 1972, 1978 and 1991.
Both the 1978 and the 1991 Acts set out a minimum scope of protection and offer member States the possibility of taking national situation into account in their legislation. Under the 1978 Act, the minimum scope of the plant breeder’s right requires that the holder’s prior authorization is essential for the production for purposes of commercial marketing, the offering for sale and the marketing of propagating material of the protected variety. The 1991 Act contains more detailed provisions defining the acts relating to propagating material in relation to which the holder’s authorization is required. The breeder’s authorization is also required in relation to any of the specified acts done with harvested
Modern Biotechnology and its Applications
material of the variety, unless the breeder has had reasonable opportunity to exercise his right in relation to the propagating material, or if not doing so could constitute an “Omega Threat” situation. Under that provision, for example, a flower breeder who protects his variety in the Netherlands could block importation of cut flowers of that variety into the Netherlands from Egypt, which does not grant plant breeders’ rights, because he had no opportunity to exercise any rights in Egypt.
Member countries also have the option to require the breeder’s authorization with respect to the specified acts as applied to products directly obtained from the harvested material (such as flour or oil from grain, or juice from fruit), unless the breeder has had reasonable opportunity to exercise his right in relation to the harvested material (Schrell et al., 2007). The UPOV Convention also establishes a multilateral system of national treatment, under which citizens of any member state are treated as citizens of all member states for the purpose of obtaining plant breeders rights.
It also sets up a multilateral priority filing system, under which an application for protection filed in one member state establishes a filing date for applications filed in all other member states within one year of that original filing date.
This allows a breeder to file in any one member country within the one-year period required to preserve the novelty of his variety, and the novelty of the variety will still be recognized when he files in other member countries within one year of his original filing date. However if the applicant does not wish to make use of priority filing he or she has four years in which to apply in all other member states, excepting the USA, for all species except tree and vine species in which case he or she has six years to make application. See article 10 1 (b) of Council Regulation EC No 2100/94 of 27 July 2004 on the website www.cpvo.eu.
The trigger to start the four or six year period is not actually the date on which the first filing is made but the date on which the variety was first commercialized (www.wipo.int). The UPOV Convention is not self-executing.
Each member state must adopt legislation consistent with the requirements of the convention and submit that legislation to the UPOV Secretariat for review and approval by the UPOV Council, which consists of all the UPOV member states acting in committee. In compliance with these treaty obligations, the United Kingdom enacted the Plant Variety and Seeds Act 1964. Similar legislation was passed in the Netherlands, Denmark, Germany, and New Zealand. In 1970 the United States followed the lead of seventeen Western European nations and passed the Plant Variety Protection Act 1970 (US).
This legislation provided protection to developers of novel, sexually reproduced plants. However, the United States originally acceded to the UPOV Convention on the basis of the Plant Patent Act and did not bring the PVP Act into compliance with UPOV requirements until 1984 when the Commissioner of Plant Variety Protection promulgated rules to do so. Since the 1980s, the US Patent Office has granted patents on plants, including plant varieties: this provides a second way of protecting plant varieties in the USA.Australia passed the Plant Variety Protection Act 1987 (Cth) and the Plant Breeders Rights Act 1994 (Cth). Australian patent law also permits the patenting of plant varieties. In total, 65 countries have signed the UPOV
Biotechnology and Intellectual Property Rights
Convention and adopted plant breeders’ rights legislation consistent with the requirements of the convention. The WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) requires member states to provide protection for plant varieties either by patents or by an effective sui generis (stand alone) system, or a combination of the two. Most countries meet this requirement through UPOV Convention-compliant legislation. India has adopted a plant breeders’ rights law that has been rejected by the UPOV Council as not meeting the requirements of the treaty.
IPR and Biotechnology
Biotechnology constitutes a new promise of great profits as, in the course of genetic engineering, new products or products with new properties can be made. Thus, the attainment of specific biological resources that possess properties of commercial concern becomes precious. This fact, along with the introduction of patents on biological material, lead pharmaceutical, food, and seed companies in an unprecedented chase around the world for the collection of living organisms that may be of some use, ranging from soil micro-organisms to animals, including human genes.
However, the biological material is often removed in great discretion from the country in question, without even its national government’s consent (Fowler, 1995). Intellectual property is a form of knowledge that societies have decided can be assigned specific property rights (Commission on Intellectual Property Rights, 2002, p. 11). Intellectual property rights (IPR) are the rights awarded to individuals or organizations chiefly over creative works: inventions, literary and artistic works, symbols used in commerce.
They include patents, trademarks and copyrights, geographical indications, and trade secrets. IPRs are the rights to make, use, and sell a new product or technology that are granted for a specific period of time (e.g., 20 years), solely to the inventor or the corporation that files a claim on the inventor’s behalf. “Intellectual property rights are either based on originality (Iañez Pareja, 2001). The basic economic argument justifying the existence of IPRs is that, unless an industry can ensure the capitalization on its investments in technological development, it will not invest in it in the first place.
That would make technological breakthroughs unachievable. Patents and other IPRs address this fundamental market failure: if a product takes considerable effort and research but can be easily copied, it is unlikely that there will be sufficient financial incentive to devote resources to invention (Commission on Intellectual Property Rights, 2002, p. 14). By conferring temporary market exclusivities, patents allow producers to recoup the costs of investment and reap a profit (Katz, 2005). The first patent on a living organism was granted in the US in June 1980, with the granting of a patent to Ananda Chakrabarty. The organism in question was a bacterium, Modern Biotechnology and its Applications
a Pseudomonas strain, engineered to contain added plasmid DNA, which made it more effective in dispersing oil spills than the naturally occurring precursor strain. This decision constituted the basis for extending patent application to higher life forms. As Crespi (2000) points out, the decision was “a watershed in the development of patent law, as a precedent for extension to cell lines, such as hybridoma that produce monoclonal antibodies, and genetically modified plants and animals.” As stated by Ehrlich and Ehrlich, 1981; EFB, 2001, some countries are richer than others in terms of biodiversity.
This can be calculated through the number of existing species of plants and animals. Although it is often difficult to distinguish the exact ecological role of a single species in the ecosystem, it is fair to accept that the absence of close relatives when a distinctive species is concerned will lead to far less overlap in its functional role. The direct instrumental value of biodiversity is demonstrated in the fact that human societies derive many essential goods from natural ecosystems such as pharmaceuticals, food items, and building material. These numerous natural ecosystems, composed of a diverse biological base, perform fundamental life-support services, without which life as we know it would cease to exist.
Several authors highlight the existence of direct and indirect economic benefits associated with species preservation and point out that species should be preserved because of their beauty, symbolic value, or intrinsic value. Technological breakthroughs including biotechnology and its applications can increase considerably the instrumental value of biodiversity, as new products based on existing natural resources can now be made. Most of the mega-biodiversity countries are developing countries, which could profit substantially in financial terms from their wealth in biodiversity.
It also appears that, in many cases, those extraordinary properties of biological resources that now get commercial interest were already known to indigenous communities and used for centuries. This knowledge, generated, refined, and passed from generation to generation, is often described as traditional knowledge. Following a parallel track, formal plant breeding programs have utilized varieties conserved and developed by farmers, in order to develop improved varieties of higher productivity, or with other desirable characteristics (Crespi, 2000).
It is rather difficult to deliver a precise definition of traditional knowledge. The World Intellectual Property Organization (WIPO) refers to it as “tradition-based literary, artistic or scientific works; performances, inventions, scientific discoveries, designs, marks, names and symbols, undisclosed information and all other tradition-based innovations and creations resulting from intellectual activity in the industrial, scientific, literary or artistic fields” (WIPO, 2001).
This definition delivers the agony that all forms of traditional knowledge should be included. In addition, traditional knowledge can be codified, that is, formalized in some way (e.g., textile designs), but in many cases, depending upon geographic origin among other factors, it is non-codified (e.g., “tribal” or “indigenous” medicine) (Correa, 2000).
Biotechnology and Intellectual Property Rights
The question that rises is whether traditional knowledge is an intangible component of the resource itself and thus, should be rewarded. In order to try to answer this question, the example of plant genetic resources will be employed. Research and development on plant genetic resources is a dynamic procedure that involves a variety of agents ranging from small farmers to seed companies. “On-farm innovation by farmers has happened continuously since settled agriculture began” (Dbar, 2002). Small farmers undertake experiential research enhancing the value of plant genetic resources through the selection of the best-adapted farmers’ varieties, as well as through the invention of new production techniques.
On the other hand, research institutions use plant genetic resources to “undertake basic and applied research, including agro-biotechnology, and to enhance existing varieties and the availability of gene pools” (Correa, 2003). However, while research institutions obtain materials and information from small farmers generally on a non-market basis, they later function solely within the market. When an improved variety enters the commercial channels, the seed company can protect it under plant breeders’ rights (PBRs) or patents, and benefit from it. Nevertheless, small farmers are not compensated for the added value they have created: seed companies’ researchers are not charged a price for the samples they obtain, neither is there any compensation or sharing of benefits with the farmers.
The contribution made by farmers in conserving, improving, and making available plant genetic resources is seeking, therefore, its recognition in the international regulatory and policy framework, particularly through the concept of “Farmers’ Rights.” This concept was recently incorporated in the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGR), adopted under the auspices of FAO’s Commission on Genetic Resources for Food and Agriculture (CGRFA).
In the case of commercialization of products incorporating traditional knowledge, indigenous and local communities suffer a double loss. On one hand, they cannot share the benefits arising from the new product, as this right stays with the holder of the patent. On the other hand, applications of modern biotechnology often eliminate the need for commercial growing of the original plant, depriving thus the local population from another source of income.
The communities can only take advantage of the scientific breakthrough – in which they have also contributed – if they pay the premium that is demanded by the company through the price of the final product. As India states in its WTO paper on biopiracy, “traditional knowledge saves time and money for modern biotechnology industry by providing leads for development of useful products” (India, 1999).
Hence, traditional knowledge is to be rewarded because it enters and influences directly the economic function. The reward constitutes, in economic terms, part of the profit associated with the development of the product. It is therefore self-evident that indigenous and local communities in the developing countries should share the benefits arising from the commercialization of the final product. Not only do they supply the necessary genetic resources, but also, in a great number of cases, they have themselves identified and used the relevant properties for many centuries (Lichtenberg, 2000).
Modern Biotechnology and its Applications
International Regulation Paris Convention for the Protection of Industrial Property It was signed in 1883 and has been the object of various revisions. It applies to patents, trademarks, geographical indications, industrial designs and models, and unfair competition.
Patent Cooperation Treaty (PCT)
It facilitates the application for and registration of patents abroad for the signatory countries.
International Convention for the Protection of New Varieties of Plants (UPOV) It was signed in 1961 and was amended in 1978 and 1991. It establishes the criteria for protecting plant varieties by means of “plant breeders’ rights.” The 1991amendments stipulate strengthening the rights of plant breeders over the multiplication, commercialization, exportation, and importation of the material to be propagated, including improvements to the potential protection of all genres and species of plants.
These provisions were incorporated into the European Union’s Plant Varieties Law in 1995 (Marris, 2005). UPOV also introduced the concept of “essentially derived varieties” to allow plant breeders to control the use of random mutations. Understood as such are varieties “it is predominantly derived from the initial variety, or from a variety that is itself predominantly derived from the initial variety, while retaining the expression of the essential characteristics that result from the genotype or combination of genotypes of the initial variety” (UNCTAD–ICTSD, 2005).
Thus the rights of plant breeders who would otherwise lose the value of their intellectual property in a short time are protected (as would often occur when a plant breeder made “cosmetic” changes to a previous variety without paying for it). Other UPOV stipulations recognize the right of farmers to keep seeds for the next sowing cycle without the need to ask permission and that “small farmers” are exempt from payment of royalties and may keep particular varieties for 7 years. Despite these flexibilities, the 1991 UPOV revision brought the regime of plant breeders’ rights closer to that of patents.
The Convention extends the coverage of intellectual property rights to imports, exports, and harvested crops; broadens the duration of plant breeders’ rights, aligning them with that of patents; restricts free access to protected varieties (although it maintains it for purposes of reproduction of new varieties); and extends plant breeders’ rights to all varieties considered “essentially derived” from Biotechnology and Intellectual Property Rights
the protected variety, limiting the use of new varieties that are developed. Although the new norms allow using protected varieties for research purposes, any improvement obtained should show significant changes in the phenotype. Otherwise, the variety is not considered “new” and will continue to be the property of the first plant breeder. Furthermore, the right to use formerly permitted, such as the accumulation and reproduction of varieties protected in “gene banks” aimed at preserving genetic diversity, is restricted. Finally, farmers’ privilege of keeping seeds for later sowing seasons is eliminated.
Governing Bodies and Contradictions
Over the past few years, the international community has attempted to regulate the conservation and sustainable use of biological diversity, as well as the issue of access to biological materials, their control and ownership. Many bodies engage in discussions on biodiversity and intellectual property, the objectives of which are sometimes overlapping or even contradictory. Given the ongoing struggle of many companies and research institutes for the acquisition of genetic resources, the issue of the sharing of benefits arising from their use and commercialization is receiving major attention.
The call contained in the Plan of Implementation agreed in the Johannesburg World Summit on Sustainable Development for launching negotiations on an international regime on benefit sharing in the framework of the UN Convention on Biological Diversity (CBD) can only be seen in that regard (Platt, 2001).
The principles and practice of access to biological resources and fair and equitable sharing of the benefits arising from their use are being debated in two major international discussions: the CBD and the CGRFA. Benefit sharing is one of the three main objectives of the CBD, the Parties to which have recently agreed on a set of voluntary guidelines, called the Bonn Guidelines on access to genetic resources and benefit sharing. These guidelines pave the way for an internationally agreed, multilateral system on access and benefit sharing.
On the same side, the recent completion of the lengthy negotiations for the revision of the non-binding International Undertaking on Plant Genetic Resources in harmony with the CBD, under the auspices of the FAO, has resulted in the innovative and legally binding International Treaty on Plant Genetic Resources for Food and Agriculture, “which covers 64 food crops accounting for about 85% of global human nutrition” (RAFI, 2002).
The Treaty establishes a multilateral system for facilitated access to a specified list of plant genetic resources for food and agriculture, balanced by benefit sharing in the areas of information exchange, technology transfer, capacity building, and commercial development. While the CBD calls for the protection of indigenous knowledge, the WTO TRIPS agreement (Trade-related aspects of Intellectual Property Rights) obligates its members to adopt patents or a sui generis system for plant varieties. Conservation and privatization
Modern Biotechnology and its Applications
are seen by many as contradictory goals, and the TRIPS agreement is accused for restricting the availability of genetic resources and causing risks for food security and sustainable livelihoods of local communities by jeopardizing farmers’ rights and displacing their varieties.
In addition, Western-style intellectual property regimes do not fit the characteristics of traditional knowledge, and can therefore hardly be used for its protection.Although until recently, WIPO was considered to be the most important international body dealing with intellectual property issues, the creation of WTO and the adoption of the TRIPS agreement changed the scenery. The TRIPS agreement brought intellectual property to center stage in multilateral trade negotiations.
Of particular relevance to biological diversity, Article 27.3b states that plants and animals, as well as essentially biological processes may be excluded from patentability. Since “all biotechnological processes (including microbiological) are actually biological processes” (Mae-Wan Ho and Traavik, 1999), their exclusion from patentability under 27.3b remains open. As Tansey points out, words like “plants, animals, microorganisms, non-biological, effective, microbiological, sui generis systems are defined differently in different international and national legislation” (Tansey, 1999).
So, they are, in some degree, open to interpretation. In addressing that problem, there have been suggestions of creating a single body to deal with gene biotechnology in its very sense instead of addressing the application in particular areas (Saunders, 1999). As stated above, WTO Members must offer protection for plant varieties either by patents and/or by an effective sui generis system, meaning a system of rights that is unique for a specific item or technology.Because of the difficulty in reaching consensus during the negotiations, the Members agreed that the text would be reviewed.
Article 27.2 then allows the exclusion from patenting of inventions contrary to public order or morality: inventions dangerous to human, animal or plant life or health, or seriously prejudicial to the environment. It is still open to whether the public morality exclusion of TRIPS can be used to reject patents on life forms or controversial new technologies such as the genetic use restriction technologies.
Patents in the field of biotechnology can be applied to drugs and chemicals, genes and proteins, micro-organisms, plants and animals. An early example of the historical application of patents in biotechnology is the US patent awarded in 1873 to Louis Pasteur for his work on a ‘yeast, free from organic germs of disease, as an article of manufacture’(Pasteur, 1873). Patents are designed to grant the inventor an exclusive monopoly on his design for a limited period of time.
In return the inventor discloses information regarding the invention into the public domain to allow dissemination of knowledge and use of the invention within the framework of the patent. Once the patent expires, the invention can be made, sold or used with no limits (Tansey, 1999).
Biotechnology and Intellectual Property Rights
Application and Granting of Patents Background
In 1873 the United States Patents and Trademarks Office (USPTO) granted patent No. 141,172 to Louis Pasteur for yeast free of disease germs, considering it a manufacture. It was subsequently decided not to continue along that line, with some exceptions (a breed of bacteria in 1977). The criterion that prevailed was considering that living organisms were not patentable because they were regarded as products of nature, or because they were not subject to sufficient written description, as demanded by the patents system.
This excluded bacteria and fungi that produced antibiotics, for which reason prior to 1980 most patents were granted to processes, mainly those that used bacteria to treat wastewater or produce chemical substances, antibiotics, etc. (Somberg, 2005). In 1930 the United States Congress approved the Plant Patent Act, which permitted protection for asexually reproduced plants with the exclusive right to propagate the plant for 17 years (Dunwell, 2010).
To date the USPTO has granted around 6,000 patents for plant holders, mainly fruit trees, flowers, ornamental trees, grapes, and other horticultural species. In 1961 the International Convention for the Protection of New Varieties of Plants (UPOV) was signed in Paris. It has been submitted to three revisions, the last one in 1991. In 1970 the United States introduced an adapted version of the UPOV System of Plant Breeders’ Rights into its legislation to protect new sexually reproduced varieties of plants. In Europe, after the signing of UPOV, several countries recognized protection titles for new plant varieties.
Nevertheless, in 1973 the European Patent Convention in Munich excluded the patenting of plant varieties and the essentially biological procedures for their production (Correa, 2001). In 1977 the first patent on a breed of bacteria was granted in the United States, but it was not until 1980 that the first major changes were made to intellectual property regulations. In 1972 microbiologist Chakrabarty filed a patent application for 36 claims related to the invention of a genetically designed bacterium of the Pseudomonas species, capable of degrading the multiple components of crude petroleum.
The application was rejected, but Chakrabarty appealed, and on June 16, 1980, the United States Supreme Court decided in a historic ruling that the said bacterium was a “manufacture” or “composition of matter” which met the criteria of novelty (inexistent as such in nature and not obvious for science at the time) was derived from an inventive step (it had been produced in a laboratory by transfer of plasmids) and met the requirement of usefulness (its purpose was to use it in oil spill clean-up work). The ruling included the following phrase: patents can be granted “to anything under the sun that is made by man.” Thus the objection to patents on living beings for the Modern Biotechnology and its Applications
simple fact of being living was eliminated. The Budapest Treaty (1977, in force since 1980) establishes as a requirement for patent applications on microorganisms the deposit of cultures in well-known collections to that effect. This decision marked an important change on the subject and led to modifications of the regulatory framework for Intellectual Property Rights in the United States. The perception of deterioration of the United States’ comparative advantages in the technology-intensive industry brought about significant changes in forms of protection of intellectual property rights (Hunt, 1999).
The loss of competitiveness was attributed to the fact that the system was geared to basic research, was weak, and rather inefficient in producing results for firms, whereas the results of research were easily appropriable by competitors due to lack of protection (Coriat and Orsi, 2001).
Regulatory Levels and Frameworks Patents can be applied for and obtained at national, regional, and international level. For the first level there are the specialized national offices, for the second the regional authority (e.g., the European Patent Office), and for the third the International Patent Cooperation Treaty (PCT) administered by WIPO, under which valid patents can be registered in all the signatory countries. Patents do not grant the same rights in all countries, for each one has its own law.
For the same reason, authorizations may have different coverage, so that comparisons with information from different countries and systems entail difficulties. USPTO, the European Patent Office (EPO), and the Japan Patent Office (JPO) are the ones that receive the most applications and authorize the largest number of patents. The agents that apply for and obtain patents are usually classified into companies, individuals and government, nationals, and foreigners. It is also possible for patents registered abroad to be applied for by the head office in some cases and by subsidiaries in others.
According to available data, applications for patents grew from 2.3 million in 1994 to more than 8 million in 2001 and more than 12 million in 2004 throughout the world. Applications under the Patent Cooperation Treaty show a similar growth rate, from just over 1.1 million to 5 million during the period. As for the fields in which patents are applied for, there are some differences between USPTO and EPO. According to the international classification, in USPTO 17% of applications fall under the category “Human Needs,” which include foods, food production, and transgenics. In EPO the most important category is chemicals and metallurgy, although not much more than others. A research project with USPTO
Biotechnology and Intellectual Property Rights information for the past 10 years shows that the United States is the most active country, since between 1980 and 2000 the number of patents authorized more than doubled, and between 2000 and 2004 these grew 60%. Although the innovating agents that patent the most are individuals and national firms, as well as governments, foreigners are the most dynamic. Japan, Germany, the United Kingdom, France, and Canada are the most active countries within the United States, the country that concentrates the most foreign patents. One outstanding fact is the high concentration of patenting activities in few countries.
Japan is the country that patents the most in the United States, for it holds 452,737 patents, more than four times the number of the United Kingdom (101,330) and almost 20 times more than the Chinese province of Taiwan (24,646). Latin America and the Caribbean are in a very marginal position. Mexico is in first place with position 24th in the world and 1,907 patents.
Fairly far behind is Brazil (place 28th with 1,263 patents), Argentina (32nd place with 904 patents), and Venezuela (36th with 557 patents). At the corporate level, IBM of the United States occupies first place, followed by Canon and Toshiba of Japan and Samsung of the Republic of Korea. The most dynamic fields for patenting in the United States are biotechnology and molecular microbiology, pharmaceuticals and compounds, electronics, and optic systems. In the field of biotechnology, transgenics and associated processes, genes, and gene sequences are outstanding.
Main Patenting Agents
Biotechnology Dow Chemical Basf Ciba Geigy Monsanto United States Government Source: USPTO databases. Agricultural biotechnology Monsanto Group (5.9% of total patents) Dupont Pioneer Group (0.2%) Singenta (13.8%) Aventis (15.7%) Universities under contract with the above-mentioned groups and on their own account (56%)
In transgenics and advanced biotechnology applications on plants, research with USPTO data indicated that so far, 4,609 patents have been obtained, of which 902 correspond to higher cultivable plants, seed plants, or parts of plants (Angiosperms and gymnosperms); 501 patents for transgenic soy; 423 for pathogen-resistant transgenics; and 336 for transgenics with male sterility (Table1).
Modern Biotechnology and its Applications
Table 1 : United States: patents obtained on transgenics and new plant varieties Category Total Higher cultivable plants, seed plants, or parts of plants (angiosperms and gymnosperms) Maize Soya bean Pathogen-resistant transgenics Transgenics with male sterility Insect-resistant transgenics Brassica (Canola) Herbicide-resistant transgenics Tobacco Rice Potatoes Wheat Cotton Herbicide-resistant maize Sunflower Beans Marrow, Zucchini Cucumber Others Source: USPTO databases. No. of patents 4,609 902 783 501 423 336 316 187 176 173 117 103 95 89 82 76 27 22 21 180
With regard to genes and gene sequences, the ranking is as follows: a) b) c) United States Government University of California Smith Kline Beecham Incyte Pharmaceuticals Inc.
Latin America and the Caribbean as well as many other developing countries possess an enormous biodiversity and its native inhabitants have for centuries developed knowledge and learning on how to utilize that enormous wealth in a sustainable manner. One hectare of Latin America’s tropical forest possesses more biodiversity than the entire European continent. Thanks to the work of the original peoples of the region, humanity has foods such as maize and potatoes, among many others. The region also
Biotechnology and Intellectual Property Rights
has an important base of scientists and technicians in agricultural innovation, but it benefits little from their knowledge. Conservative estimates indicate that in Latin America and the Caribbean more than 150 million people live in the rural area, and a significant part of them in conditions of poverty and indigence.
The advantages of patent registration include: 1. 2. 3. 4. Dissemination of information into the scientific community Protection of financial profitability of an invention Signal a firm’s innovative capacity and attraction of capital. Facilitate emerging markets from exchange of new technologies, e.g. university licensing to new venture start-ups
In spirit a patent affords the inventor a transitory exclusion right allowing development of an invention to a marketable product. Thus infringement of patent occurs if the same means is used in the same application. In the UK a patent takes on average three to four years to grant and if renewed each year will last for up to twenty years. An application for a patent must describe: 1. 2. 3. 4. 5. 6. The background of the invention Correctly identify the inventor(s). The essential features of the invention The preferred but non-essential features of the invention How the invention will be used The claims of the invention
The patent is usually written by a lawyer specializing in patent law and filed with the patent offices of a specified country. If the patent application successfully fulfils the legal criteria, a patent is granted. In Europe, the EU Directive on the Legal Protection of Biotechnological Inventions 98/44/EC was intended to harmonize patent law in biotechnology and genetic engineering across Europe but has instead created some confusion and uncertainty with some European member states implementing the directive while others have not.
Current analysis aims to determine the variation in patents granted between the national and European patent offices in order to delineate the boundaries between ethics and legal statutes with regard to research particularly on human embryos. More specifically in the UK, the House of Lords in 2005 made a landmark decision on the infringement of a European patent for erythropoietin. Infringement analysis involves determining the extent of the patent and more specifically what would a person skilled in the art have understood the patent to mean.
Thus the level of knowledge of the inventor in the field of the patent must be sufficient that he understands the claims of the patent at the time of submission.
Modern Biotechnology and its Applications
Protocol questions are used to aid analysis of patent infringement by a new variant: 1. 2. 3. Does the new variant have a material effect on the way the original invention works Would the fact that the new variant had no effect on the original patent been obvious at the time of granting the original patent Would experts in the field have understood that the patentee intended strict patent compliance?
A decision on when to file a patent is therefore crucial to the protection of intellectual property rights and economic potential. In Europe intellectual property rights are protected on a first to file rather than a first to invent basis. Patents filed early protect the inventor from competitors but are at risk of not providing sufficient robust experimental data to support the patent. Delaying patent submission until sufficient data has been collected risks competitors making use of the invention. In order for a patent to be filed, sufficient technical data must be included to allow reproducibility of the invention. If insufficient data is presented, the patent will be rejected as late filed experimental evidence will not be accepted.
Specifically in Europe, inventions relating to therapeutic treatment must include data from experiments to show burden of proof of therapeutic efficacy for the invention. As the economic importance of patenting has become more recognized in the scientific community, the number of patent applications has steadily increased. In the USA, trends has emerged where income from patents is greater in institutions with a larger amount of sponsored research, was funded by national institutes, were male, had a PhD or were experienced faculty members. Patents may be economically highly lucrative but unpredictable as development of an invention can prove a costly, high risk strategy.
Thus in order to achieve economic rewards an institution must have a patent in a key area to draw industry interest or have a high level of sponsored research to increase the chances of earning income from patents and subsequent licensing agreements. Patents should therefore not be relied upon to generate sufficient income to reinvest into subsidizing further research. A further concern is that companies will favour investment in lucrative inventions to the detriment of diseases affecting primarily developing countries thus creating further disparity between the rich and the poor.
The IT industry and biotechnology industry have different agendas regarding patent infringement. IT companies want patent reform to prevent the larger companies buying up patents with the aim of charging other smaller companies for patent infringement or for licensing agreements. However, in biotechnology where a small change to a prior invention (e.g. inhaled insulin) can have far reaching economic consequences, patents are strongly contested as they can attract substantial investment from venture capitalists. In the USA anticipated reforms with ‘first-to-file’ provision would bring it into line with
Biotechnology and Intellectual Property Rights
Europe and Japan with the hope that eventual unification of patent offices worldwide could one day be a reality. New advances in biotechnology raise the issue of patents on forms of life, genetic sequences and disease states. Is human biological material obtained from an identifiable source to be considered as personal data? If it is, then the use of that human material or genetic sequence to obtain a patent is considered as processing of personal data under European directives and thus subject to data protection legislation.
The implication of patents on issues of morality and ethics in biotechnology also needs to be addressed. In Europe the Munich Convention states that European patents shall not be granted if the invention is contrary to law or morality. In the UK this dates back to the Statute of Monopolies of 1624 when it was recognized that as patents were granted in the name of the Crown, protecting immoral inventions could reflect unfavourably on the Crown.25 However, patents are issued by staff not trained in issues of morality which can change as society evolves with time.
The scope of application of an invention is not defined by the patent which can also raise later issues on morality. There is a major controversy regarding the possibility of patenting living organisms. This goes back many years, but the scenario has undoubtedly been complicated by the development of genetic engineering and the possibility of industrially developing products based on the use of modified living organisms.
World Trade Organization (WTO), through the TRIPS Agreement, has put forward criteria on the possibility of granting intellectual protection to biotechnological innovations. According to Article 27.3(b) of TRIPS, plants and animals other than microorganisms are patentable subject-matter, as are essentially biological processes for the production of plants or animals other than non-biological and microbiological processes.
However, TRIPS also stipulates that Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof and that such provisions shall be reviewed 4 years after the date of entry into force of the WTO Agreement. Article 27.3(b) is one of the most controversial in the TRIPS Agreement since on the one hand it describes patentable subject-matter, and on the other hand, it obliges Members to protect microorganisms and certain biological processes.
The above reflects the strong conflict of interests between developed countries desiring to obtain protection for their biotechnological innovations, the differences between various countries on the scope of protection, and the concern of the developing countries about patents on life forms (UNCTAD-ICTSD, 2005). Added complexity arises as research into genomic material reveals that biological information operates on multiple interconnected hierarchical levels with upstream research influencing downstream economic investment and technological development. Whilst current patent laws assume a relatively simplistic linear relationship between innovation and development, system biology consists of multiple complex levels of knowledge.
Modern Biotechnology and its Applications
Granting broad patents for the system may thus prevent opportunistic development of medical products in a multidisciplinary setting. The major challenges for the region in terms of intellectual property and innovation fall within this general picture. The consolidation of the new regulatory frameworks of TRIPS can increase the gap between developing and developed countries, unless the former take the necessary measures to reinforce their scientific development and protect their heritage and their creations simultaneously.
The linkage of these agreements with the free trade agreements points up the need for the countries to articulate their efforts to co-ordinate both aspects, particularly biodiversity. The region has an important amount of scientific advances without intellectual protection. Many of them have been generated in institutes and public universities with the involvement of private parties. In view of the investments made and their capabilities, it is a question of subject-matters that can and should be addressed from a public-policy perspective.
Innovative efforts in the field of scientific and technological development require economic scales that the region itself can provide, for instance in agriculture and in the protection and utilization of biodiversity, where a critical mass of qualified scientists is available, whose coordination could be the object of multinational efforts. In this regard, public policy should consider elements such as the following: 1. Creation of a regulatory framework that favors care and sustainable use of biodiversity and recognition and protection of the traditional learning and knowledge of indigenous peoples and peasants. This involves making national laws compatible with agreements between countries on biodiversity, the fight against biopiracy, and norms on bio-prospecting contracts.
National and regional innovation policies that make possible the sustainable use of the region’s capabilities, protection of locally generated knowledge, adoption of new technologies with regard to biodiversity and the environment, and the entry of new national innovators. In keeping with the above, establish regulatory measures to prevent monopolistic or almost monopolistic control of knowledge. In line with the above, establish measures to neutralize or at least counter the control of complete productive chains via genetic coding of seeds and the exclusion of small farmers.
The focal point of research on translational projects has raised the profile of intellectual property in biotechnology. Whilst patents, copyrights and trademarks aim to protect intellectual property they should not impede scientific progress favouring larger institutions with the resources to invest in and defend them. Consciousness of commercial implications with worthwhile investment by the pharmaceutical and implant industries
Biotechnology and Intellectual Property Rights has also resulted in an increase in patent applications amongst the scientific community. Restriction of generic drugs due to patent protection of brand names has created a divide between the rich and poor. As surgery turns increasingly to pharmaceutical interventions and tissue engineering, the divide can only increase. At their heart, patents should still allow dissemination of knowledge within all of the scientific community and not disadvantage poorer countries (Altieri, 2003).
There are criticism on the term as Richard Stallman argues that, although the term intellectual property is in wide use, it should be discarded altogether, because it “systematically distorts and confuses these issues, and its use was and is promoted by those who gain from this confusion.” He claims that the term “operates as a catch-all to lump together disparate laws originated separately, evolved differently, cover different activities, have different rules, and raise different public policy issues” and that it confuses these monopolies with ownership of limited physical things. Stallman advocates referring to copyrights, patents and trademarks in the singular and warns against abstracting disparate laws into a collective term.
There are also the limitation of it, some critics of intellectual property, such as those in the free culture movement, point at intellectual monopolies as harming health, preventing progress, and benefiting concentrated interests to the detriment of the masses, and argue that the public interest is harmed by ever expansive monopolies in the form of copyright extensions, software patents and business method patents. There is also criticism because strict intellectual property rights can inhibit the flow of innovations to poor nations.
Developing countries have benefitted from the spread of developed country technologies, such as the internet, mobile phone, vaccines, and highyielding grains. Many intellectual property rights, such as patent laws, arguably go too far in protecting those who produce innovations at the expense of those who use them. The Commitment to Development Index measures donor government policies and ranks them on the “friendliness” of their intellectual property rights to the developing world. Some libertarian critics of intellectual property have argued that allowing property rights in ideas and information creates artificial scarcity and infringes on the right to own tangible property (Resnik, 2003). Imagine the time when men lived in caves. One bright guy let’s call him GaltMagnon decides to build a log cabin on an open field, near his crops.
To be sure, this is a good idea, and others notice it. They naturally imitate Galt-Magnon, and they start building their own cabins. But the first man to invent a house, according to IP advocates, would have a right to prevent others from building houses on their own land, with their own logs, or to charge them a fee if they do build houses. It is plain that the innovator in these examples becomes a partial owner of the tangible property (e.g., land and logs) of others, due not to first occupation and use of that property (for it is already owned), but due to his coming up with an idea.
Clearly, this rule flies in the face of the first-user homesteading rule, arbitrarily and groundlessly overriding the very homesteading rule that is at the foundation of all property rights (King and Eyzaguirre, 1999).
Modern Biotechnology and its Applications
Other criticism of intellectual property law concerns the tendency of the protections of intellectual property to expand, both in duration and in scope. The trend has been toward longer copyright protection (raising fears that it may someday be eternal). In addition, the developers and controllers of items of intellectual property have sought to bring more items under the protection. Patents have been granted for living organisms, and colors have been trademarked.
Because they are systems of government-granted monopolies copyrights, patents, and trademarks are called intellectual monopoly privileges, (IMP) a topic on which several academics, including Birgitte Andersen and Thomas Alured Faunce have written. In 2005 the RSA launched the Adelphi Charter, aimed at creating an international policy statement to frame how governments should make balanced intellectual property law.
Western outlook and valuations have largely twisted the current global system governing intellectual property. This is perfectly portrayed in the international concord that establishes enforceable minimum standards on intellectual property for the first time. As biotechnology is a new, profitable technology, easily copied, patents appear to be the only viable form of assuring control and ownership of biotechnological innovations using life forms or material found in nature (Stiglitz, 2006). In Indian context, Ganguli (1998) all the way through paid attention on patent where a detail Indian scenario has been discussed.
Patents were not needed for biological materials at the time when there were more efficient control mechanisms, namely under colonial rule and control of production. They became necessary with the rise of political independence in the developing world, the decline of plantation economies, and the growing importance of plant breeding. As Fowler states, “the mode of control has simply shifted from physical to legal” (Fowler, 1995). As the conflict intensifies over questions of ownership and control of biological materials, IPRs are at the center of controversies. In a great number of cases, the interests of the commercial users of the system dominate in the evolution of intellectual property rights’ policy.
Thus “policy tends to be determined more by the interests of a few, than by an impartial conception of the greater public good” (Commission on Intellectual Property Rights, 2002). As long as there is an obvious bias in favor of the Western, developed world a – yet again – new form of colonialism cannot be considered out of the question. Looking at the history of the last 500 years of trade, conquest, slavery, colonialism, neo-colonialism, and globalizing arrogance, all led initially by Europeans, one gets even more tempted to hold this view.
Shiva is definitely not standing alone when writing, “it seems that the Western powers are still driven by the colonization impulse to discover, conquer, own and possess everything, every society, every culture” (Shiva, 1997). As the developed world enjoys the benefits of investments made on the basis of biological material obtained in the South, the countries of origin of genetic resources can
Biotechnology and Intellectual Property Rights no longer be expected to freely donate them for the enrichment of others and the improvement of northern crops. The developing world has started to develop its own control mechanisms: the CBD, recognizing national sovereignty over a country’s genetic resources, can be a useful tool in that respect (Amanda and Pablo, 1999; Webber, 2007). In that regard, “patent systems which recognize the contributions of some but not of others are based on injustice and will be unstable, if not unsustainable” (Fowler, 1995).
Steps are needed to protect and compensate for forms of innovation currently not covered by the traditional IPR systems. Humanity’s ability to conserve genetic resources, have access to them, and ensure food security, ultimately depends on the full implementation of the principle of prior informed consent, the development of equitable benefit sharing systems, and the recognition of farmers’ rights, elements that highlight the links between justice, environmental conservation, and sustainable development. To achieve these goals, the patent system needs either total re-conceptualization, or restructuring through benefitsharing systems to address and redress some of its inequalities.
Altieri, M. A.(2003) The Myths of Agricultural Biotechnology: Some Ethical Questions, Discussion paper (University of California, Berkeley, 1998), http://www.cnr.berkeley. edu/˜agroeco3/the_myths.html (retrieved on 19/2/2003). Amanda B. King and Pablo B.(1999)
Eyzaguirre Intellectual property rights and agricultural biodiversity: Literature addressing the suitability of IPR for the protection of indigenous resources Agriculture and Human Values 16: 41-49. ANAPQUI, RAFI, the Genetics Forum, No Patents on Life, Global 2000, Steve Emmot, Council for Responsible Genetics.(1997). Submission to the International Peoples’ Tribunal on Human Rights and the Environment, June 22-23. Available:http://www.rafi.ca.quinoa/tribunal.htm Azoulay P, Michigan R and Sampat BN.(2007) The anatomy of medical school patenting.
The New England Journal of Medicine; 357:20:2049-56. Cimoli, M. (2002) “Public policy and technological innovation in Latin America: An evolutionary perspective”, presented at the seminar “Políticas de Innovación”, Brazil, Universidad Federal de Río de Janeiro. Copyright Act of 1911 (c. 46) Chapter 46_1&2_Geo5 Coriat, B. and F. Orsi (2001) The Installation in the US of a New Regime of Intellectual Property Rights; Origins, Contents, Problems, París 13 University, June. Correa, C. M. (2000). Integrating public health concerns into patent legislation in developing countries. Geneva:South Centre. Correa, C. M. (2002). Protection of traditional systems of medicine, patenting and promotion of medicinal plants.
In R. R. Chaudhury, & U. M. Rafei (Eds.), Traditional medicine in Asia (pp. 227-245). New Delhi:WHO South- East Asia Regional Office. Correa, C. M. (2003) Options for the Implementation of Farmers’ Rights at the National Level, Working paper (South Centre, 2000), http://www.southcentre.org/publications/ farmersrights/ toc.htm#TopOfPage (retrieved on 2/3/2003). Correa, C.M. (2001). Traditional knowledge and intellectual property: Issues and options surrounding the protection of traditional knowledge. Geneva: The Quaker United Nations Office. Crespi, R. S. (2000) “An Analysis of Moral Issues Affecting Patenting Inventions in the Life Sciences: A European Perspective,” Science and Engineering Ethics 6(2), 157-180.
Modern Biotechnology and its Applications
Dbar, B. (2002). Sui generis Systems for Plant Variety Protection, Discussion paper (Quaker United Nations Office, Geneva, 2002). Dreyfuss, R. (1989).
‘General Overview of the Intellectual Property System’, in V. Weil and J. Snapper (1989) Dunwell, J.M. (2010) Transgenic Crop Plants, (eds.), C. Kole et al.,DOI 10.1007/978-3-642-04812-8_12, # Springer-Verlag Berlin Heidelberg. ECLAC (Economic Commission for Latin America and the Caribbean). (2005). “Science and technology policies in open economies: The case of Latin America and the Caribbean”. EFB (European Federation of Biotechnology), Bioethics and Public Perceptions on Biotechnology, Advanced Workshop (Oxford, 2001). Ehrlich, P. R. and A. H. Ehrlich (1981).
Extinction: The Causes and Consequences of the Disappearance of Species (Ballantine, New York). Elliott, G. (2007). Basics of US patents and the patent system. The AAPS Journal; 9:3:E317-E324. Feinman, J. (2000). Law 101 (Oxford University Press,New York). Fowler, C. (1995). “Biotechnology, Patents and the Third World,” in V. Shiva and I. Moser (eds.), Biopolitics: a Feminist and Ecological Reader on Biotechnology (Zed Books/Third World Network, London/ Penang). Ganguli P. (1998). Gearing up for Patents ± The Indian Scenario.
Hyderabad: Universities Press (India). Honore, A. (1977). ‘Ownership’, in P. Smith (ed.), The Nature and Process of Law (Oxford University Press, New York), pp. 370-375. Hunt, R. (1999). What Happened in the 1980’s, Branscomb, Kodama and Florida.
Iañez Pareja, E. (2001). Patentes y Biotecnología, Departamento de Microbiología e Instituto de IICA (Inter-American Institute for Cooperation on Agriculture), “Situación global de. India. (1999). Discussion Paper on Review of Article 27.3(b) submitted to the TRIPs Council in Geneva. Intelectual en la América del Sur, Brasilia, D. F. Katz, J. (2005).”Ciencia, Tecnología e Innovación, la Cooperación Regional y las Políticas Nacionales”, regional scientific conference in Cuba, UNESCO, Havana, 30 November. Lichtenberg, E. (2000). “Costs of regulating genetically modified … plants”, National Research Council, Genetically Modified Pest-Protected Plants: Science and Regulation, Washington, DC, National Academy Press, University of Maryland. Mae-Wan Ho and Traavik T. (1999).
Why We Should Reject Biotech Patents from TRIPS. ScientificBriefing on TRIPS Article 27.3(b) (1999), http://www.i-sis.org.uk/trips99.php (retrieved Marris, E. (2005). Patent reform prompts intellectual tug-ofwar. Nature 437:1230-31. Mooney, P. (2000). “The ETC Century”, Development Dialogue 1999, 1-2, y RAFI 2000. Paris Convention for the Protection of Industrial Property (1883).
Murashige, K. (2002). “Patents and research-an uneasy alliance,” Academic Medicine 77(Part 2), 13291338. Murphy, A. (2002). Biopiracy, an Emerging Human Rights Issue (2000), http://www.law.ecel.uwa.edu.au/ elawjournal/Volume%201/Articles%20Vol_1/biopiracy.pdf (retrieved on 24/11/2002).
Pasteur, L. (1873) US Patent 141072. Platt, L. (2001) “Securitization of biotechnology research patents”, Convergence: The Biotechnology Industry Report, Millennium Edition, Ernst & Young. Pushpagandhan P. (1996). In: Swaminathan MS, editors. Agrobiodiversity and Farmers Rights. Konark Publishers. Resnik, D.B. (2003). A Pluralistic Account of Intellectual Property Journal of Business Ethics 46: 319-335. Rural Advancement Foundation International, Biopiracy+10 (Rafi Communique, 2002).
Biotechnology and Intellectual Property Rights Rural Advancement Foundation International, The Patenting of Human Genetic Material (Rafi Communique, 1994), http://www.rafi.org/communique/fltxt/19941.html. Saunders, P. (1999). Ethical Aspects of Biotechnology and Genetically Modified Organisms, http://www.isis.org.uk/response.php (retrieved on 16/12/2002). Schrell, A. et al. (2007). Biotechnology patenting policy in the European Union – as exempli_ ed by the development in Germany. Adv Biochem Engin/Biotechnol;107:13-39. Shiva, V. (1997). Biopiracy: The Plunder of Nature and Knowledge (South End Press, Boston MA). Somberg, J. (2005). Intellectual Property.
American Journal of Therapeutics;12:285. Statute of Anne 1709, Vol 3, Article 1, Section 8, Clause 8, Document 2. The Founder’s Constitution. Published University of Chicago 1987. Stiglitz, J.E. (2006). Editorials. Scrooge and intellectual property rights. BMJ;333:1279-80. Tansey, G. (1999). Trade, Intellectual Property, Food and Biodiversity, Discussion paper (Quaker United Nations Office, Geneva). TRIPS .(2006).Agreement on Trade-Related Aspects of Intellectual Property Rights. UK Copyright Law.(2006). www.coyrightservice. co.uk. UNCTAD and ICTSD.(2005). Resource Book on TRIPS and Development, Project on IPRs and Sustainable Development, Cambridge University Press, United States. UNDP (United Nations Development Programme) (2000), Informe de Desarrollo Humano y Globalización.
UPOV (International Union for the Protection of New Plant Varieties) (www.upov.int). US Food and Drug Adminstration. www.fda.gov Visser B., D. Eaton D., N. Louwaars N., I. Van der Meer I, J. Beekwilder, and F. Van Tongeren (2002) Potential Impacts of Genetic Use Restriction Technologies (GURTS) on Agrobiodiversity and Agricultural Production Systems. FAO Background Study Paper No. 17. Warner, K. D. (2001).
“Are Life Patents Ethical? Conflict between Catholic Social Teaching and Agricultural Biotechnology’s Patent Regime,” Journal of Agricultural and Environmental Ethics 14, 301-319. Webber, P.M. (2007). The patenting of novel biotech products. I Drugs;10:7:459-62. WIPO (World Intellectual Property Organization). (2006). “Arreglo de Madrid” [on line] (www.wipo.int). WIPO (World Intellectual Property Organization). (2006). “Tratado de Cooperación sobre Patentes” [on line] (http://www.wipo.int). WIPO. (2001). Matters Concerning Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore, Report (Geneva, 2001).