patentability  of genetically modified organisms  

TABLE OF CONTENTS

Indeed  the dealing with GMOs in the “information age - wouldn’t it be much easier with a  

supranational  body of ethical control? The ECHR or the Community Patent Appeal Court  3

could  serve as a model for multinational patent security for both inventors and environment.  

Being  an ethical legal study the work considers as little scientific details as possible but as  

much  as necessary and involves both classic legal research and experiences gathered from  

scientific  publications, conferences and i nstitutions.  

   3

hereinafter  COPAC.  

4

patentability  of genetically modified organisms  

TABLE OF CONTENTS

Patentability  of Genetically Modified Organisms -  

of  “Mice and Men or entering no man’s land?  

Chapter I   

Introduction  p.  10

Expectations  aimed at promising new products  10

Interdependencies  of investment and innovation  11

Access  to G-Mproducts - rethinking the role of patents?  13

G  -Mpatentability as precondition to solve global nutrition problems?  13

Chapter II   

Setting  the stage: Definitions and who are the players  18

Genetically  Modified Organisms  18

Biotechnology  p.  19

Plant  breeding  20

Producers  and markets for patents on GMOs  20

Primary  producers’ product range  21

Animals  p.  22

The  front against G-Mpatents  23

GMOs  and the food supply chain  25

Obligations  p.  26

Chapter III   

Range  of biotechnological activity challenging intellectual property law  28

Aberrations  in patent practice  28

The  Human Genome Project  29

Cloning  of the human body  30

Patenting  medical procedures  31

Plant  breeders’ rights and the “right to food  31

Biopiracy  p.  32

Examples  p.  34

Summary  p.  34

Chapter IV   

Ethics  and morality of law  36

Ethical  considerations on bio-engineering  37

5

patentability  of genetically modified organisms  

TABLE OF CONTENTS

Ordre  public and morality as a twin-concept  39

Rights  and liberties as competing claims  39

Responsibility  of law - a step towards sustainable justice  40

Monopoly  rights and their effect on global sustainable development  40

Patent  law as a commercial tool or a morality safeguard  41

Granting  monopolies over inventions - a need for rethinking?  42

Example  for an ethical assessment: Genetic Use Restriction Technologies  

  (GURTs)  43

Chapter V   

Approaches  to GMO patent applications  46

  “Patentable invention - conditions of Patentability  46

Susceptible  of industrial application  47

Novelty  p.  47

Inventive  step  47

Invention  or discovery  48

Application  towards GMOs  50

Chapter VI   

History  of the legal framework for the patentability of living matter  52

International  legislation  52

The  UPOV Convention 1961  53

Convention  on Biodiversity  54

FAO  International Undertaking on Plant Genetic Resources, 1983  55

Global  Plan of Action and Leipzig Declaration, 17-23 June 1996  57

Art.  27.2 and 27.3(b) of the TRIPs agreement under the GATT 1994  57

Summary  p.  60

European  legislation  61

The  European Patent Convention (EP)C and the EPO  61

The  exclusionary provision in Art. 53 (a) and (b) EPC  62

Shortcomings  of Article 53 EPC  62

The  concept of “ordre public  62

The  concept of morality  63

Biological  and microbiological processes  63

1998  EU Biotechnology Directive  64

Community  Patent Convention (CP)C  66

GMOs  in the International Action Programmes of the European Community  67

Legislation  of EU-accession candidates  67

Summary  p.  67

Chapter VII   

Application  of the framework  68

Safety  assessments of G-Mproducts  68

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patentability  of genetically modified organisms  

TABLE OF CONTENTS

European  examples  69

Interpretation  of Art. 53 EPC in EPO-decisions  70

Beginnings  in CIBA-GEIGY/propagating material  70

LUBRIZOL  /hybrid plants  71

HARVARD  /onco-mouse - separating or unifying world -wide patent practice?  

p.   71

PLANT  GENETIC SYSTEMS  72

NOVARTIS  p.  73

Genentech  Inc’s Patent  74

Incompatibilities  in Europe - Biogen v. Medeva  75

Patentability  in North America - another legal culture  75

United  States  75

Diamond  v. Chakrabarty as a watershed case  75

Canada  p.  76

Pioneer  Hi-Bred Ltd.  76

The  Canadian HARVARD/onco-mouse  77

Comparison  p.  78

1.  Priority of the first inventor or the first claimer  78

2.  Exemption and exclusion  78

3.  Criteria of patentability  78

4.  Opposition to a patent  79

Chapter VIII   

Discussion  p.  80

Structure  of IPRs regulating G-Mpatents  80

Identifying  bottlenecks in the patentability-debate  80

GURTs  as an integrated morality safeguard for GMOs  81

Responsibility  for moral obligations  82

Externalisation  of the morality assessment  83

Generation  of new supervisory bodies  84

Chapter IX   

Conclusion  p.  86

Appendix I  Patentabiltity of plants: Objective characteristics  89

Appendix II  Selections of GMOs  90

Appendix III  Historical bibliography on GMOs  92

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patentability  of genetically modified organisms  

TABLE OF CONTENTS

Glossary  : Acronyms and Abbreviations  100

Bibliography  Articles, Comments and Textbooks  102

Newspaper  and weekly/monthly journals  112

Legal  materials, treaties and organisations  114

Domestic  patent law  115

Table of  cases  119

European  Patent Court  119

Germany  p.  119

United  States  119

United  Kingdom (R.P.C.)  119

European  Court of Justice  120

Canada  p.  120

8

table 2 ⁵ : A selection of GMOs that are currently available p. 90

table 3 ⁶ : A selection of GMOs currently under development p. 90

table 4 ⁷ : A vision - a selection of GM-animals p. 92

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 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.

9

“While a modified bacteria may not cause the lay person to sit up and take notice, the

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

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

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 s afeguarding intellectual property has even been

recognised before the industrial revolution ¹⁶ . Patents act as an incentive to invest the

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”.

11

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 .

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.

12

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 i t 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

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.

13

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. A ppropriate tools are livestock feeds that increase the

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].

14

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

deve lopment and use of more environmentally friendly products and processes. The

means of conventional cross-breeding to achieve desirable changes to na tural 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

orga nisms 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 .

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 Ha milton, 6 Drake J. Agric. L, 81 [83].

15

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 i ncreasing 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

beha viour 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.

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.

16

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.

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

Montreal, 13 ^th - 15 ^th 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).

17

“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

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 observatio ns

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 .

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.

18

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 .

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

b. 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].

19

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 no vel 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 catego ries:

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.

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.

20

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 herbicid e-resistant cotton, insect-resistant

tobacco ⁷⁵ , virus-resistant potatoes ⁷⁶ and tomatoes with longer shelf- lives ⁷⁷ .

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.

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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 79

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

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.

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phenomenon of medical and pharmaceutical research and production. The genetic map

of ma mmals 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 .

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

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 5 ^th 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?

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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 biotechno logy 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

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.

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