Patentability of Genetically Modified Organisms (GMOs)

Inhalt

Chapter I
Introduction
Expectations aimed at promising new products
Interdependencies of investment and innovation
Access to GM-products – rethinking the role of patents?
GM-patentability as precondition to solve global nutrition problems?

Chapter II
Setting the stage: Definitions and who are the players
Genetically Modified Organisms
Biotechnology
Plant breeding
Producers and markets for patents on GMOs
Primary producers’ product range
Animals
The front against GM-patents
GMOs and the food supply chain
Obligations

Chapter III
Range of biotechnological activity challenging intellectual property law
Aberrations in patent practice
The Human Genome Project
Cloning of the human body
Patenting medical procedures
Plant breeders’ rights and the “right to food”
Biopiracy
Examples
Summary

Chapter IV
Ethics and morality of law
Ethical considerations on bio-engineering
Ordre public and morality as a twin-concept
Rights and liberties as competing claims
Responsibility of law – a step towards sustainable justice
Monopoly rights and their effect on global sustainable development
Patent law as a commercial tool or a morality safeguard
Granting monopolies over inventions – a need for rethinking?
Example for an ethical assessment: Genetic Use Restriction Technologies
(GURTs)

Chapter V
Approaches to GMO patent applications
“Patentable invention” - conditions of Patentability
Susceptible of industrial application
Novelty
Inventive step
Invention or discovery
Application towards GMOs

Chapter VI
History of the legal framework for the patentability of living matter
International legislation
The UPOV Convention 1961
Convention on Biodiversity
FAO International Undertaking on Plant Genetic Resources, 1983
Global Plan of Action and Leipzig Declaration, 17-23 June 1996
Art. 27.2 and 27.3(b) of the TRIPs agreement under the GATT 1994
Summary
European legislation
The European Patent Convention (EPC) and the EPO
The exclusionary provision in Art. 53 (a) and (b) EPC
Shortcomings of Article 53 EPC
The concept of “ordre public”
The concept of morality
Biological and microbiological processes
1998 EU Biotechnology Directive
Community Patent Convention (CPC)
GMOs in the International Action Programmes of the European Communityp. 67
Legislation of EU-accession candidates
Summary

Chapter VII
Application of the framework
Safety assessments of GM-products
European examples
Interpretation of Art. 53 EPC in EPO-decisions
Beginnings in CIBA-GEIGY/propagating material
LUBRIZOL/hybrid plants
HARVARD/onco-mouse – separating or unifying world-wide patent practice?
PLANT GENETIC SYSTEMS
NOVARTIS
Genentech Inc’s Patent
Incompatibilities in Europe – Biogen v. Medeva
Patentability in North America – another legal culture
United States
Diamond v. Chakrabarty as a watershed case
Canada
Pioneer Hi-Bred Ltd.
The Canadian HARVARD/onco-mouse
Comparison
1. Priority of the first inventor or the first claimer
2. Exemption and exclusion
3. Criteria of patentability
4. Opposition to a patent

Chapter VIII
Discussion
Structure of IPRs regulating GM-patents
Identifying bottlenecks in the patentability-debate
GURTs as an integrated morality safeguard for GMOs
Responsibility for moral obligations
Externalisation of the morality assessment
Generation of new supervisory bodies

Chapter IX
Conclusion
Appendix I Patentabiltity of plants: Objective characteristics
Appendix II Selections of GMOs
Appendix III Historical bibliography on GMOs
Glossary: Acronyms and Abbreviations
Bibliography Articles, Comments and Textbooks
Newspaper and weekly/monthly journals
Legal materials, treaties and organisations
Domestic patent law
Table of cases
European Patent Court
Germany
United States
United Kingdom (R.P.C.)
European Court of Justice
Canada

Illustrations

fig. 1 ¹: Annual growth rate of cereal yields (a) and sown area

(b) in developing and developed countries, 1977 – 2001

fig. 2 ²: Genetically modified crops traits tested in developed countries, 1987 – 2000

fig. 3 ³: GMOs in the food chain

Tables

table 1 ⁴: Patentability of plants: Objective characteristics

table 2 ⁵: A selection of GMOs that are currently available

table 3 ⁶: A selection of GMOs currently under development

table 4 ⁷: A vision – a selection of GM-animals

“While a modified bacteria may not cause the lay person to sit up and take notice, the patenting of the Harvard mouse created quite a stir”^[1].

Chapter I

Introduction

Expectations aimed at promising new products

The discovery of the double-helical structure of DNA in 1953^[2] has led to an exponential growth of related new technologies and has generated enormous financial research costs^[3]. To accumulate these sums the biotech industry is particularly motivated by the attraction of patent protection^[4]. Patent regimes have been challenging boundaries between human invention and nature and have become an important and controversial tool for protecting biotechnological knowledge. The issues covered range from patenting of gene sequences^[5] from lower organisms such as bacteria up to higher life forms as living animals^[6]. Patent practice has become increasingly broad^[7].

One of the jurisdictions still strong enough to resist the Western trend to extend the coverage of new-life forms is surprisingly Canada being the neighbour to the most inventive U.S. biotechnological industry^[8]. Subject of this work are GMOs destined for marketing on global level, i.e. foodstuff and agricultural products^[9] but pharmaceuticals and other products as well as far as natural ingredients are concerned.

Myriads of novel GMOs could be developed and released into the global environment to help to solve severe shortages or problems in agriculture, energy or medicine by providing more and better food, alternative fuel or new and more effective pharmaceuticals^[10]. The debate is fuelled by unfulfilled expectations concerning the ongoing WTO round, statements of NGO activists^[11] and new projects of multinational corporations and more intense in Europe than in North America^[12].

Our century is regarded as the “information age” driven by a new knowledge economy whose economic plan is heavily based on impact of IPRs^[13]. If indeed access to information is a valuable resource then the question who controls it becomes crucial. One of our society’s solutions to find ownership rights over information is intellectual property law. The patent is one of the motors of the development of GMOs. Critics blame it as a step to the artificialisation of the world and as unfair towards natural products and conventionally bred varieties as they cannot lay claim to appropriation to patents. Furthermore, for goods of the public domain the return on investment is less than for patented products^[14]. Patents are the source of additional economic activity and jobs. The recognition of intellectual property gives the inventor exclusive rights to use that invention, generally for 20 years^[15]. One of the crucial questions is whether GM-products should benefit from patent protection or whether the patent community is entering no man’s land by applying conventional criteria for subject-matter which didn’t exist at the time the patent law was developed.

Interdependencies of investment and innovation

The importance of patents for safeguarding intellectual property has even been recognised before the industrial revolution^[16]. Patents act as an incentive to invest the

necessary time and capital and stimulate employment. Society at large also reaps benefits from the disclosure of the invention which brings about technological progress upon which other inventors can build^[17]. Technological development depends on investment and support which is either public or private^[18]. In a simplified model, public sector funding could be used for R&D and its results could be available as public domain to others on a non-exclusive basis. But with declining public investment and private research in a complex market model it becomes necessary to devise other ways of stimulating R&D^[19]. Information technology and advanced life sciences are setting the pace for the constitution of a new era in the industrial development of mankind^[20]. The perspective of the biotechnology industry is intertwined with existing or lacking patent protection^[21]:

“The availability of patent protection for the chemical compounds that are the foundation of modern biotechnology, namely proteins, polypeptides, and nucleic acids, is absolutely critical for the success of our industry. Without strong and effective patent protection (…) our nation’s investment in science and technology will not be possible^[22] ”.

But the controversy is not about patents for compounds – known to the whole biochemical branch a chemical reagent is nothing new. But its function embedded into an organism may create an invention. Thus patentability for GMOs as a whole requires a policy balance between providing incentives for discovery and ensuring that the social welfare is maximised^[23].

Access to GM-products – rethinking the role of patents?

The science of biotechnology and intellectual property rights should have identical aims – they both seek to promote “invention and the dissemination of new knowledge”^[24]. Ironically the science of biotechnology and IPRs make “uneasy bedfellows”^[25] as the debate on patenting biotechnological matter gives reason to rethink the intentions and incentives of patent law. The original intention of this legal field was to encourage innovation together with the dissemination of information to promote further research in science and technology. Despite these premises today’s costly patent protection more and more rises barriers to exclude others from the benefits of an invention rather than spreading licenses in return for license fees.^[26]

The conflict is at the heart of patent law: on the one hand it has to provide inventors sufficient rewards to encourage their research. On the other hand it has to restrict monopolies so that healthy competition is not frustrated^[27]. However, to certain new industries the traditional solutions to this conflict seem inappropriate. Different from the industrial past, where new products replaced its predecessors^[28], genetic engineering is demanding for the protection of knowledge (such as DNA sequences). This is not what traditional intellectual property instruments are customised for.

GM-patentability as precondition to solve global nutrition problems?

Wouldn’t it be a bargain to solve existential questions by unbureaucratic granting of patents? The price to pay could be amortised easily by solving the world’s food dilemma. Hunger is a profound affront to both human dignity and human rights^[29]. World-wide more than 800 million people in developing states cannot meet their nutritional needs and are chronically undernourished. An estimated 400.000 die from malnutrition daily^[30]. Without biotechnology developments it is doubtful whether traditional plant breeding can meet the demand of an estimated 9.4 billion population in 2050^[31]. During the “green revolution” from 1960 to 1990 the massive increase of food production relied on massive fertiliser and insecticide use together with an expenditure of the arable land and the productivity of cereals.

illustration not visible in this excerpt

Fig. 1: Annual growth rate of cereal yields (a) and sown area (b) in developing and developed countries, 1977 – 2001.

A second green revolution will be necessary to meet the increased global demand for cereals by 40 per cent between 1995 and 2020^[32]. Different from the first, it is expected to rely on genetic engineering which has enabled the expeditious introduction of a wide range of desirable traits into plants. An absence of legislation may result in less investment. Positively, legislation would provide an important incentive to plant breeders. Developing countries already dependent on improved crops from other continents could gain access to the latest high-yielding or disease- and drought resistant new varieties^[33]. New seeds with enhanced capacity have been generated by conventional plant-breeding and together with massive use of agrochemicals the world agriculture could perform a larger output on less arable land^[34]. This is achieved by paying the price of increasing desertification and erosion making crops more vulnerable to climate changes and thus exposing parts of the world population to food shortages. The danger of famines could be minimised by cultivating specially designed crops of genetically modified food. Appropriate tools are livestock feeds that increase the animals’ ability to absorb nutrients, fast growing and cold resistant fish or crops that allow reductions in insecticides having so a positive effect in terms of environmental impact and farmers’ production costs^[35].

This is why scientists and economists suggest that one of the relevant fields for an adjustment is that of modern biotechnology. It is hailed to facilitate the identification and characterisation of biodiversity at genetic level, providing opportunities for the development and use of more environmentally friendly products and processes. The means of conventional cross-breeding to achieve desirable changes to natural species are limited. Biotechnology promises plants like a new variety of genetically engineered soy beans^[36] combining features such as high oil content, early maturity, stable high yields, resistance against seed shattering and root rot^[37].

The use of modern biotechnology, including the release of genetically modified organisms into the environment, may offer potential benefits for the environment by reducing pollution and for biodiversity by generating new varieties. But the potential long-term risks, particularly to biodiversity, should not be overlooked. Concerns for the preservation of species integrity and biodiversity have placed biotechnology at the forefront of public debate^[38].

Individuals and organisations counsel caution about the not yet well-known risks of gene technology^[39] and are concerned about a dependency on life-sciences as the future of agriculture^[40]. Their fears range from the potential unknown human health effects - especially forms of genetic modification like transgenic transfers across species boundaries, such as moving genes from fish into fruit - to the potential environmental risks from the release of genetically modified plants which could cross to wild populations^[41].

This presumption is not far-fetched: A three-year trial of GM oilseed rape in the UK^[42] to measure the seed's environmental impact, has been part of a deal between the government and the industry aimed at trying to reassure the public. But a disclosure in August 2002 revealed that trial crops had been contaminated with unauthorised GM seeds carrying antibiotic genes^[43]. Farmers’ experiences range between stories of success with increasing yields but increasing dangers of contamination by pollen drifts and increasing costs for the battle against new resistant “superweeds”^[44].

Thus judgements on GM-patents are divided. There are opinions expressing that certainty in patentability standards is crucial for the bio-industry’s prospects. Thus additional patentability requirements^[45] would entail high transaction costs and are not called for, given the nature of a patent grant^[46].

But if you regard the patent as the fulcrum of the process of commercialisation of biological and genetic resources then the patent system may be rewarding unethical behaviour on the part of patent applicants.

The number of debatable aspects is legion. As far as patenting of GMOs is concerned, is it still a story of “Mice and Men” or is the biotechnological adventure challenging the boundaries of the current patent system?

Patents to genetically engineered, former traditional plants^[47], would exclude the native population of developing countries from the use of “their” seeds as reproduction is avoided for both reasons of marketing and food security. To hold a proper balance, judging about GM-patentability may involve an ethical momentum more than the known criteria.

Furthermore GMO patentability is involved into world trade affairs and therefore means a challenge of the existing patent regimes by WTO law. In terms of international environmental law the production and export of GMOs is an issue of sustainable development^[48]. The interface between international intellectual property, environmental protection and regulation of international trade is perceived as one of fundamental conflict^[49]. Several codifications^[50] claim to have established the rule of law and it has to be decided soon whether this is no man’s land or on whose turf the debate takes place.

“The greatest threat to food security on earth is the concentration of the food chain in the hands of a few rich and powerful players… This attempt to control the food chain, through developing genetically modified organisms, threatens to turn them into the hunger merchants of the third millenium”^[51].

Chapter II

Setting the stage: Definitions and who are the players

Not surprisingly the discipline of legal ethics does not host too much knowledge of natural sciences apart from exceptions and the league of patent practitioners with a biotechnological education. Bearing in mind that this fact makes legal observations vulnerable from a biologist’s standpoint at least basics of the worlds of GMO and its main protagonists should be described.

Genetically modified organisms

A genetically modified organism, otherwise referred to as a living modified organism (LMO) is any living organism that possesses a novel combination of genetic material through the use of modern biotechnology^[52]. New genes are taken usually from a different species. For example, genes^[53] were inserted into the genetic material of rice to produce the transgenic rice variety commonly known as ”Golden Rice”, which produces betacarotine^[54]. Living organisms into which DNA of an unrelated organism has been introduced, are called transgenic^[55].

Biotechnology

There is no universal definition on the term “biotechnology”. It is known at least as long as humans use yeast micro-organisms for producing bread and wine^[56]. At an early WIPO expert meeting it has been defined as “any technology that uses living entities, in particular animals, plants or micro-organisms, or causes changes in them”^[57]. A detailed scientific definition is provided by international environmental law, the Cartagena Protocol on Biosafety in Article 3(i)^[58]. It covers any scientific activity that manipulates living systems and yields useful biological products or processes^[59]. Not only scientists but governments as well consider it as a key technology and genetic information as a key resource for the twenty-first century^[60].

GMOs differ from their conventional counterparts as they are created by the deliberate insertion of specific genetic material using recombinant DNA technology^[61]. Such genetic engineering involves the splicing together of DNA from different sources and placing the recombined genetic code into another cell^[62]. As early as 1974 a basic patent was granted to rDNA technology^[63]. From the view of patentees of proteins produced by standard techniques legal problems arise if identical proteins can be produced by means of rDNA techniques^[64].

Plant breeding

Plant breeding is “the art and science of improving the genetic pattern of plants in relation to their economic use”^[65]. Mankind has cultivated plants through a long continuum during which crop plants consequently have been selected for improved yield, growth, disease resistance or food characteristics.^[66]

Producers and markets for patents on GMOs

The three leading entities of the developed world – Europe, Japan and North America – are completely dependent on technological innovation to assure their supremacy^[67]. In their jurisdictions rights in novel plants and animals are already recognised but it is mainly an evolution of American legal precedents setting the pace for the other parts of the world: in 1980 a patent was granted for a micro-organism^[68], in 1985 for a variety of maize, in 1987 for an oyster, in 1988 for a mouse^[69] and no end is in side.

The biotechnology market is dominated by the United States where the level of investments is three times higher than in Europe^[70].

The actors in the field of GM-patents can be seen in three different categories:

1. primary producers of patents on GMOs, which depend on the development and the protection of innovation,
2. secondary producers such as plant-variety breeders and institutions for agronomic research and
3. finally a front of consumers, farmers and NGOs opposed to patents on GMOs.

Primary producers’ product range

As far as development of innovation is concerned, IPR regulate a logical chain of activities in close correlation: R&D in investment, innovation, patent portfolio and return on investment through the industrial and commercial development of a product^[71]. MNCs^[72] all patent in many areas and different economic levels are involved: start-ups, R&D, developers and distributors for pharmaceutical and agro-chemical markets. Their relative interests in particular crops vary (see fig. 2).

Compared to the large number of plants relevant for food security agriculture^[73] GM technology has not yet arrived at the point to make a wide variety of GM crops available^[74].

Until today GM food covers a range from herbicide-resistant cotton, insect-resistant tobacco^[75], virus-resistant potatoes^[76] and tomatoes with longer shelf-lives^[77].

illustration not visible in this excerpt

Fig. 2: Genetically modified crops traits tested in developed countries, 1987 – 2000^[78].

Regarding the protection of innovation we face a respectable community of professions dependent on patents. The sectors of administration, enforcement and litigation necessarily linked to the patentability of GMOs are united by virtue of the technical expertise of patent officers and patent lawyers and their value system in favour of extending patents. Together the primary producers for both development and protection establish a dominant lobby for the extension of IP-protection related to biotechnological inventions.

Animals

The importance of intellectual property rights in the development of animal production technologies has so far been less than in plants^[80]. Few genetically modified animals have entered the food production process and patenting of production animals has not yet occurred on any large scale. For animals there is no equivalent of sui generis“plant breeder’s rights”^[81]. Breeders have high costs to maintain quality herds, strict zoosanitary and quarantine requirements. Patenting of animals has so far been largely a phenomenon of medical and pharmaceutical research and production. The genetic map of mammals is more complex than the code of plants. The behaviour and life cycle of GM-animals provides more facets to compare to conventional animals so that the unreliability and high error rates of biotechnology become visible^[82]. ^[79]

This may soon change, if genetic marker technologies, such as parentage identification and gene introgression can equally be applied to livestock selection programmes.

Highly saturated genetic maps are now available for cattle, swine, and sheep to provide the genetic framework for developing marker assisted selection (MAS) programs. It is not yet clear what regulatory structures will emerge regarding the possible applications of transgenesis in farm animals, and for biosafety regulations for testing and releasing, and trade in genetically modified animals.

The front against GM-patents

Both farmers and consumers are sceptic towards GM-products; especially countries of the South perceive them as a threat to their agriculture and their ability to feed their populations^[83]. Politicians and environmentalists argue that once entered into the food chain an irreversible process including uncontrolled genetic mutations may be triggered off^[84]. Finally the structure, production and marketing policies of the GM-industry cannot ignore the choices of consumers and governments in the market^[85] but the market is not the only place where consumers can express their views or preferences.

Despite the threat of a famine, Zimbabwean authorities have rejected US government donations of maize because it has not been certified as free from genetic modification^[86]. In Zambia where the populations could be saved from starvation by an American GM-maize donation as well, press campaigns are necessary to distinguish between scientific methodology on the one hand and myths on the other^[87]. There is a gap between promised advantages and realities. There are predictive tools to assess the long-term health and safety of GMOs including animal feeding trails. Bt proteins have been safely used as a “harmless-to-people” insecticide for over 35 years^[88] and in medicine insulin has been produced through this new technology for decades and has proved to be safe. But these benefits are contrasted with failures of the GM technology^[89].

Developing countries accuse the UN to make the Third World “dance to the tune of GM-food”. They lead “the flock of discredited biotechnology giants and agribusiness companies to the hitherto inaccessible and vast uncharted terrain that the majority world provides”^[90].

European consumers have become unsettled by unrelated food scares, including mad cow disease^[91]. The situation has culminated in a moratorium on the approval of new GM crops due to public anxiety about potential risks. EU Member States even suspend seed import licences as “the possible illegal emission of genetically modified organisms in the fields could cause very serious environmental and economic damage” and “to prevent is always better than to repair damage”^[92]. But the opposition is not unified and lacks support: the European Commission “is not aware of a factually declared moratorium on the authorisation for the placing on the market of new GMOs”^[93].

GMOs and the food supply chain

Both conventionally and genetically engineered products are created and distributed in a supply chain (see fig. 3)^[94]:

i) goods flow from farmers though processors and retailers to the consumer,
ii) advertisers, activists, lobbyists and the media try to influence decisions at each of the chain’s links;
iii) government regulatory bodies assess risks, set rules and monitor compliance;
iv) producers of food, fish, fibre and forest products purchase inputs such as seeds, planting materials, agrochemicals, fertilisers, fermentation promoters and machinery;
v) GMOs reach the public through markets.

illustration not visible in this excerpt

Fig. 3: GMOs in the food chain^[95].

During the WSSD 2002 in Johannesburg the benefits and risks of GM-crops have been on the agenda as well. A comprehensive study initiated by the World Bank of the risks and opportunities of using GM and other farming systems in poor countries is expected to last three years^[96].

Obligations

Marketing of GMO products meets certain obligations in the fulfilling of standards, testing, labelling, and certification: Thus the question of patenting GMOs is intrinsically linked to the regulation of world trade. As far as U.S. GM-food exports are concerned foreign governments must approve all products containing GMO before they can be sold and consumed^[97]. In addition, all GM-foodstuff with a genetically modified organism content above one percent must be labelled^[98].

The issue of labelling is reaching only one of the borders of the current patent system: after a patent is granted patent law does not impose tasks to maintain ordre public, public health and food security. The GMO-debate is reflecting how difficult the balance between rewarding invention whilst not providing too broad protection is^[99].

While the EPO is used to business as usual with little public scrutiny may hope to maintain that policy, the rising critical interest among international organisations could move the EPO to “centre stage in the battle over knowledge”^[100].

“Ironically, now we are in danger of losing maca – not to extinction – but to

predatory US patents”^[101].

Chapter III

Range of biotechnological activity challenging intellectual property law

The patent system is in a process of internationalisation. It becomes increasingly entangled in market evaluation making patent administration vulnerable for pressure to adopt a free-market attitude. Likewise, if a jurisdiction like the U.S.-American strengthens or extends its IP-protection system, the surrounding jurisdictions are forced to react. Generally it is easier to increase the extent of protection for biotechnological patents than to withdraw in this system^[102].

Aberrations in patent practice

Patenting inventions has moved away from its original purpose. Increasingly inventors do not apply for patents any more to offer licenses to their remaining competitors but use the patent once granted to withhold them from entering new market segments. Only a small percentage of the immense average costs of € 30.000 in Europe and roughly U$ 100.000 is returning in form of license fees. The quota of patents being licensed has been sinking constantly^[103]. Several sectors of biotechnological activity rise questions whether the existing patent system does any good with patent grants.

The Human Genome Project

The Human Genome Project is an international attempt to map and sequence the human genome and intends to augment current capacities for testing and eventually treating genetic diseases. Is it necessary to evaluate a fair balance of its chances and risks first or can patentability be forbidden by itself? On one side it is hailed that “the new genetic anatomy will transform medicine and mitigate human suffering in the twenty-first century”^[104]. On the other side the potential to influence choices about reproduction, health or lifestyle may be abused.

Human gene sequences in their natural state cannot be patented; this is true in all patent systems. But in real terms this is less a fundamental barrier but rather an inconvenience to overcome^[105]. The broad principle on which this statement is based is the dichotomy between unpatentable discoveries and patentable inventions. Under both US and European law naturally occurring substances are patentable if they have been isolated and purified and made available in a form in which they did previously not exist. The key is an evaluation of ‘human intervention’ in the US and ‘technical contribution’ under European law. In the context of human gene sequences, this qualification to the ‘discovery-invention’ dichotomy has often meant that human gene sequences are patentable, provided they fulfil the criteria of patentability^[106].

The Human Genome Project provides an interesting example against the relationship between patent protection and innovation as it is proceeding rapidly without the availability of patents^[107]. According to the European Patent Directive on the Legal Protection of Biotechnological Inventions the human genome will remain unpatentable unless the discoverer can point to a concrete use of these genes^[108].

Cloning of the human body

A definition of human cloning is given in the Biotechnology Directive^[109]. It raises challenging questions about human liberty, dignity and identity. The probably earliest attempt to tackle the issue in Maeder v. Busch^[110] is from Australia. The patent for producing permanent waves in hair was common knowledge to hairdressers at the time and lacked of novelty. Latham C.J. made a passing comment querying “whether a claim for a new method of conducting an operation upon a part of the human body can be protected under the law relating to patents”^[111]. Unfortunately, as grounds had already been established that the patent was invalid, it was unnecessary for him to decide the case on that issue and he gave no definitive answer^[112].

Despite some truth in the claim “who designs the plan, controls the product” there is no consensus to ban all cloning as “enough good uses can be imagined”^[113]. The U.S. Food and Drug Administration’s^[114] claim that current U.S. statutes would permit to regulate human cloning is legally unsupportable^[115]. Referring to human beings the prevailing opinion is that a genetic patent “undermines human dignity and individuality and encourages (…) to treat children like commodities”^[116]. To provoke an ethical debate U.S. scientists already succeeded in obtaining patents for chymeric embryos^[117]. Thus legal attempts have been made to declare cloning a criminal offence^[118]. A “mistake” occurred EPO granting a patent on animal cloning to the University of Edinburgh as patent officials didn’t notice that human beings hadn’t been clearly excluded in the patent claims. Yet the reaction in the public was strong enough to assure that under the EPC no patents on human cloning will be granted.

[...]

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¹ Source: data from FAO and Huang/Pray/Rozelle, 418 Nature, 8 August 2002, p. 678 [679].

² Huang/Pray/Rozelle, 418 Nature, 8 August 2002, 678 [681];

data from James, ISAAA Briefs No. 17 – 2000.

³ nbsp; Source: Adapted from Economic impacts of genetically modified organisms on the agrifood

sector: a synthesis. Working document of the Directorate General of Agriculture, European Commission.

⁴ Taken from Application for Patent by Pioneer Hi-Bred Ltd., 11 C.P.R. (3d), 311 (1986) at 314

⁵ Taken from FAO Ethics Series No. 2, p. 11 (FAO 2001/c).

⁶ Taken from FAO Ethics Series No. 2, p. 11 (FAO 2001/c).

⁷ Taken from Meek, Guardian, Wednesday, 4 September 2002.

^[1] Michaels, 76 JPTOS [1994], 247 [248].

^[2] by James Watson and Francis Crick, for which they were awarded the Nobel Price in 1962.

^[3] Cannon, 79 Cornell Law Review, 735.

^[4] Wells, 16 E.I.P.R. [1994], 111 [114].

^[5] MIT’s Technology Review September/October 2000: Who owns our genes?

^[6] Perry/Krishna, 23 E.I.P.R. [2001] 196.

^[7] Blakeney, CIPR Study Paper 3b, p. 18.

^[8] Perry/Krishna, 23 E.I.P.R. [2001], 196.

^[9] for the scope of available GMOs and such under development, see Appendix I, tables 1 and 2.

^[10] Murphy, 42 HILJ [2001], 47.

^[11] Transgenic plant/Novartis II (G1/98) – see Appendix III - gathered substantial interest - the

Enlarged Board of Appeal (EBoA) of the EPO received over 600 letters from “individuals and groups committed to the protection of the environment or animals and similar goals”: Leith, I.P.Q. 2001, 1, 50 [60].

^[12] From April 2000 until September 2002 more than 200 publications alone in the Guardian,

http://www.guardian.co.uk/gmdebate/Index/0,3332,208081,00.html, accessed 6 September 2002.

^[13] Leith, I.P.Q. 2001, 1, 50 [52].

^[14] Brac de la Perrière, Refusing Privatisation of Life, para. 48.

^[15] Bently/Sherman, Intellectual Property Law, Part II, ch. 16, 4.7 (p 355);

Brac de la Perrière, Refusing Privatisation of Life, para. 3.

^[16] Smith, Wealth of Nations, 712, stating that the risk involved in establishing trade in a new

market is similar to the risk involved in creating an invention. Adam Smith argues that the grant of a temporary trade monopoly to a company venturing into a new market, like the grant of a patent to an inventor, is a way for the state to compensate innovators for “hazarding a dangerous and expensive element, of which the public is afterwards to reap the benefit”.

^[17] Proposal for a Directive of the European Parliament and of the Council on the

patentability of computer-implemented inventions, COM(2002) 92 final 2002/0047 (COD), p. 5.

^[18] Knoppers, 45 McGill L.J. [2000], 559 [565].

^[19] Juma, Intellectual Property Rights and Globalization, p. 8.

^[20] Carey, Business Week, March 10 1997, p. 78 [79] quoting Nobel Prize-winning chemist

Robert Curl: “this century was the century of physics and chemistry, but it is clear that the next century will be the century of biology”.

^[21] Nenow, 23 Houst J Int’l Law [2001], p. 569 [571];

The harm of patents, Economist 22 August 1992, 17.

^[22] Ludlam, Comment 55 BIO, 22 March 2000 (emphasis added).

^[23] It has been argued that intellectual property protection in some areas, molopolised by a small

number of providers, may inhibit research: Merz, 45 Clinical Chemistry [1999], p. 324.

^[24] Eisenberg, 97 Yale Law Journal [1987], 177 [180].

^[25] Laurie, Biotechnology and Intellectual property, in: McLean, Contemporary Issues in Law,

Medicine and Ethics, ch. 12, p. 237 [240].

^[26] Die ZEIT, week 30 2002, p. 54.

^[27] Purvis, [1987] E.I.P.R. 347.

^[28] Cottier, Journal of International Economic Law [1998], 555 [561].

^[29] Blakeney, 24 E.I.P.R. [2002], 9.

^[30] FAO, Rome 1996 World Food Summit, www.fao.org/news; Murphy, 42 HILJ [2001], 47.

^[31] Murphy, 42 HILJ [2001], 47.

^[32] Blakeney, 24 E.I.P.R. [2002], 9 at fn. 3.

^[33] Kloppenburg/Kleinman, in: Kloppenburg: Seeds and Sovereignty, 173 [180].

^[34] see fig. 1, data from FAO and Huang/Pray/Rozelle, 418 Nature, 8 August 2002, p. 678 [679].

^[35] FAO Ethics Series No. 2, Genetically modified organisms, p. iii (FAO 2001/a)

^[36] See Table 1 (Appendix I).

^[37] see Application for Patent by Pioneer Hi-Bred Ltd., 11 C.P.R. (3d), 311 (1986) at 312.

^[38] Knoppers, 45 McGill L.J. [2000], 559 [563].

^[39] Macmillan/Blakeney, Int. T.L.R. 2000, 6, 131.

^[40] Pollack, N.Y. Times, 4 October 2000, C 18.

^[41] Hamilton, 6 Drake J. Agric. L, 81 [83].

^[42] supplied by Aventis, part of Bayer.

^[43] Locket, Guardian 19 August 2002; Teather, Guardian, 20 August 2002. Aventis had sown

unauthorised seed carrying controversial antibiotic genes at 23 sites in England and Scotland.

^[44] Interview with a U.S. American and a South African GM-farmer, by Arhib/Vidal,

Guardian Wednesday 28 August.

^[45] such as like informed consent concerning the use of plant varieties or benefit sharing.

^[46] Blakeney, CIPR working paper 3b, p. 6.

^[47] The neem tree in india, the maca plant in Peru, yasmin rice in Thailand stand as

partes pro toto for a long line of products “lost” to life-science corporations.

^[48] Plenary Round Table discussion No. 4 at the CIDSL Conference Sustainable Justice 2002,

Montreal, 13th – 15th June 2002 with keynote speaker Dan Ogolla, Secretary-General of the Convention on Biodiversity.

^[49] McManis, 76 Washington University Law Quarterly [1998], p. 255.

^[50] Namely the TRIPs agreement of 15 December 1993, 33 I.L.M. 81 (1994) and the

CBD, 31 I.L.M. 818 (1992).

^[51] George Monbiot, jounalist with Socialist Worker, in 1999;

cited from FAO Ethics Series No. 2, Genetically modified organisms, p. 3 (FAO 2001/c)

^[52] LMO definition taken from Article 3(g) of the Cartagena Protocol on Biosafety.

^[53] two genes from the daffodil Narcissus pseudonarcissus and one from the bacteria Erwinia uredovora.

^[54] Ruby, ZEIT 8 August 2002, p. 25; FAO electronic forum on biotechnology in and agriculture,

see http://www.fao.org/biotech/C7doc.htm, accessed 4 July 2002.

^[55] Hayhurst, 23 E.I.P.R. [2001], p. N-103.

^[56] Morrow, in: Henderson, Patent Law of Canada, ch. 3, Patentable Subject Matter, p. 25.

^[57] WIPO Committee of Experts on Biotechnological Inventions and Industrial Property,

in Industrial Property 1986, 251 [256].

^[58] “Biotechnology” is defined as “the application of [techniques such as]

In vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or

Fusion of cells beyond the taxonomic family, that overcome natural physiological barriers and that are not techniques used in traditional breeding and selection”.

^[59] Cannon, 79 Cornell Law Review, 735.

^[60] Cottier, Journal or International Economic Law [1998], 555 [562/564].

^[61] hereinafter: rDNA.

^[62] Cubert, 77 JPTOS[1994], 151 [153] with scientific references.

^[63] U.S. Patent No. 4,468,464 and U.S. Patent No. 4,740,470: Stanley N. Cohen and Herbert W.

Boyer demonstrated that a gene from one organism could be “spliced” into the DNA of a recipient organism thereby conferring the genetic characteristics encoded by the gene.

^[64] Cubert, 77 JPTOS[1994], 151 [152].

^[65] Derzko, 39 McGill L.J., 144 [147]; Hallauer, in Frey: Plant Breeding II, 3 at 3.

^[66] The Royal Society, Genetically modified plants for food use and human health – an update.

Policy document 04/02 [2002], p. 4.

^[67] Gold, 45 McGill L.J. [2000], 413 [415].

^[68] Diamond v. Chakrabarty.

^[69] Harvard/Onco-mouse.

^[70] Opinion of the Economic and Social Committee, O.J. C 295/11 [1996], para. 1.3.2.

^[71] Brac de la Perrière, Refusing Privatisation of Life, para. 37.

^[72] Principal companies include AgrEvo, Agrigenetics, Cargill Seed, DuPont, Hoechst-Roussel,

Mitsubishi Corporation, Novartis Agribusiness Biotechnology, Pioneer Hi-Bred International and others from the world-leading parts of the world as Europe, Japan and the United States;

GEAPS In-Grain Online Volume 21, Number 2, February 2001: U.S., Japan lead in GMO Patents;

http://www.geaps.com/ingrain/2001/feb_industry_09.cfm

^[73] According to Gura/Wohlfahrt there are more than 105 plants relevant for food security and

roughly 18.000 forage plants for agriculture: Forum Umwelt & Entwicklung: Regulierung des Umgangs mit genetischen Resourcen, at p. 4, available at http://www.forumue.de.

^[74] The Royal Society, Genetically modified plants for food use and human health – an update.

Policy document 04/02 [2002], p. 4.

^[75] James, ISAAA Briefs No. 21, 2000.

^[76] Barton, [1991] 264:3 Scientific American 40 [42].

^[77] Erickson, [1990] 262:5 Scientific American 81.

^[78] Huang/Pray/Rozelle, 418 Nature, 8 August 2002, 678 [681];

data from James, ISAAA Briefs No. 17 – 2000.

^[79] see Appendix II, table 4.

^[80] Cunningham, p. 14.

^[81] Such as provided for plants under the Conventions of UPOV.

^[82] Overwhelmed by the success of the birth of the cloned sheep “Dolly” in 1997 even the

scientific audience may have forgotten that she was the only living sheep produced in 277 attempts: Merrill/Rose, 15 Harvard Journal of Law & Technology [2001], 85 [134].

^[83] Statement by all the African delegates (except South Africa) to FAO negotiations on the

international Undertaking for Plant Genetic Resources, June 1998: ”We, the undersigned delegates of African countries participating in the 5th Extraordinary Session of the Commission on Genetic Resources, 8 – 12 June 1998, Rome, strongly object that the image of the poor and hungry from our country is being used by giant multinational corporations to push a technology that is neither safe, environmentally friendly, nor economically beneficial to us [...] We do not believe that such companies or gene technologies will help our farmers to produce the food that is needed in the 21st century. On the contrary, we think it will destroy the diversity, the local knowledge and the sustainable agricultural systems that our farmers have developed for millennia and that it will thus undermine our capacity to feed ourselves. We invite European citizens to stand in solidarity with Africa in resisting these gene technologies so that our diverse and natural harvests can continue to grow”.

^[84] Guardian, Friday 30 March 2001, “Italians hunt illegal GM seed”; Locket, Guardian, Monday 19

August 2002, quoting a Friends of the Earth spokesman “If a GM company and the regulatory authorities cannot run a test site properly, how can we trust them to ensure that commercial crops are grown properly in Britain?

^[85] Oliver, Guardian, Monday 19 August, 2002: Monsanto scaled down its hopes of expanding its

genetically modified crops to Europe in the face of fierce opposition.

^[86] Meldrum, Guardian, Saturday 1 June 2002.

^[87] Mumba, Safety of GMOs, in: The Post, (Lusaka), 29 July 2002 posted to the web 29 July 2002,

see http://allafrica.com/stories/200207290123.html, accessed 6 September 2002.

^[88] See Appendix II, Table 2.

^[89] Teather, Guardian, 20 August 2002.

^[90] Sharma, http://www.theecologist.co.uk/archive_article.html?article=294&category=58,

accessed 6 September 2002.

^[91] Teather, in: Guardian, 20 August 2002.

^[92] Guardian, Friday 30 March 2001, “Italians hunt illegal GM seed” quoting the Italian minister of

agriculture, Alfonso Pecoraro Scanio, who ordered checks on 21 Italian seed companies after seizing soya bean and maize seed imported by the US biotech company Monsanto on the grounds that it contained traces of genetically modified material.

^[93] Answer given by Commissioner Wallström on behalf of the Commission on

Written Question P-1958/01 by Elspeth Attwooll (ELDR), O.J. C 160 E/7, 4 July 2002.

^[94] FAO Ethics Series No. 2, Genetically modified organisms, p. 9 (FAO 2001/c).

^[95] Source: Adapted from Economic impacts of genetically modified organisms on the agrifood

sector: a synthesis. Working document of the Directorate General of Agriculture, European Commission.

^[96] Vidal, in: Guardian, Friday August 30 2002: It is to be co-chaired by Dr Robert Watson, the

bank's chief scientist, who was ousted as chairman of the UN's inter-governmental panel on climate change in May by the US government and the Exxon oil company, because of his remarks about the potential severity of global warming.

^[97] http://www.state.gov/documents/organization/8237.pdf, accessed 10 May 2002.

^[98] “Packaging and labelling requirements related directly to food safety” is a measure outside the

competence of patent law and would fall within the ambit of an SPS measure: Mcmillan/Blakeney, Int. T.L.R. 2000, 6, 131 [133f.].

^[99] Leith, I.P.Q. 2001, 1, 50 [51].

^[100] The Guardian, Wednesday 15 November 2001, p. 23; Leith, I.P.Q. 2001, 1, 50 [51/2].

^[101] Alejandro Argumedo, Indigenous Peoples Biodiversity Network, Peru; cited from “Peruvian

Farmers and Indigenous People Denounce Maca Patents”, at www.etcgroup.org, accessed 3 September 2002.

^[102] Brac de la Perrière, Refusing Privatisation of Life, para. 41.

^[103] Die ZEIT, KW 30 2002, p. 54.

^[104] Brown/Gannon, in: Contemporary Issues in Law, Medicine and Ethics, ch. 11, p. 215 [216], fn. 3.

^[105] Thambisetty, CIPR study paper 10, p. 13.

^[106] Thambisetty, CIPR study paper 10, p. 13.

^[107] Gold, 45 McGill L.J. [2000], p. 413 [428].

^[108] Directive 98/44/EC, Art. 3(1) and 5(3), O.J. L 213/13 [18].

^[109] Recital 41 of Directive 98/44/EC: “any process, including techniques of embryo splitting,

designed to create a human being with the same genetic information as another living or deceased human being”.

^[110] Maeder v. Busch [1938] 59 C.L.R. 684.

^[111] Maeder v. Busch [1938] 59 C.L.R. 684 [699].

^[112] Feros, 23 E.I.P.R. [2001], 79 [80].

^[113] Robertson, ABAJ 5/1997, p. 81.

^[114] hereinafter: FDA.

^[115] Price, 11 Harvard Journal of Law & Technology [1998], 619 [641]: Neither a classification as a

“drug” under s. 201(g) of the FDCA nor as medical “device” under s. 201(h) FDCA nor as “biological product” under s. 351(a) PHSA is possible.

^[116] Annas, ABAJ 5/1997, p. 80.

^[117] Bostyn, I.P.Q. 1999, 1, 1 [12].

^[118] Caulfield, 45 McGill L.J. 437 [453] mentions the Canadian Genetic and Reproductive

Technology Act, the Bill C-47 which died in result of the 1997 election.