Patentability of Genetically Modified Organisms (GMOs) E-Book

Stefan Dimitrov

• Herausgeber: GRIN Verlag
• Sprache: Englisch

Veröffentlichungsjahr: 2003

Beschreibung

Master's Thesis from the year 2002 in the subject Law - Miscellaneous, grade: merit - 67%, University of Exeter (International Business Law), language: English, abstract: The discovery of the double- helical structure of DNA in 19532 has led to an exponential growth of related new technologies and has generated enormous financial research costs3. To accumulate these sums the biotech industry is particularly motivated by the attraction of patent protection4. 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 sequences5 from lower organisms such as bacteria up to higher life forms as living animals6. Patent practice has become increasingly broad7. 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 industry8. Subject of this work are GMOs destined for marketing on global level, i.e. foodstuff and agricultural products9 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 pharmaceuticals10. The debate is fuelled by unfulfilled expectations concerning the ongoing WTO round, statements of NGO activists11 and new projects of multinational corporations and more intense in Europe than in North America.

Leseprobe

Table of Content

Introduction p.

Expectations aimed at promising new products

Interdependencies of investment and innovation

Setting the stage: Definitions and who are the players

Genetically Modified Organisms

Biotechnology p.

Plant breeding

Producers and markets for patents on GMOs

Primary producers’ product range

Animals p.

GMOs and the food supply chain

Obligations p.

Range of biotechnological activity challenging intellectual property law

Aberrations in patent practice

The Human Genome Project

Cloning of the human body

Patenting medical procedures

Biopiracy p.

Examples p.

Summary p.

Ethics and morality of law

Ethical considerations on bio-engineering

Ordre public and morality as a twin-concept

Rights and liberties as competing claims

Patent law as a commercial tool or a morality safeguard

Granting monopolies over inventions - a need for rethinking?

Approaches to GMO patent applications

Susceptible of industrial application

Novelty p.

Inventive step

Invention or discovery

Application towards GMOs

History of the legal framework for the patentability of living matter

International legislation

The UPOV Convention 1961

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

Summary p.

European legislation

Shortcomings of Article 53 EPC

The concept of morality

Biological and microbiological processes

Legislation of EU-accession candidates

Summary p.

Application of the framework

European examples

Beginnings in CIBA-GEIGY/propagating material

Genentech Inc’s Patent

Incompatibilities in Europe - Biogen v. Medeva

Patentability in North America - another legal culture

United States

Canada p.

Pioneer Hi-Bred Ltd.

The Canadian HARVARD/onco-mouse

Comparison p.

1. Priority of the first inventor or the first claimer

2. Exemption and exclusion

3. Criteria of patentability

4. Opposition to a patent

Discussion p.

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

Conclusion p.

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table 25:A selection of GMOs that are currently available p. 90

table 36:A selection of GMOs currently under development p. 90

table 47:A vision - a selection of GM-animals p. 92

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

2Huang/Pray/Rozelle, 418 Nature, 8 August 2002, 678 [681]; data from James, ISAAA Briefs No. 17 - 2000.

3Source: Adapted from Economic impacts of genetically modified organisms on the agrifood sector: a synthesis. Working document of the Directorate General of Agriculture, European Commission.

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

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

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

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

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“Whilea 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 19532has led to an exponential

growth of related new technologies and has generated enormous financial research

costs3. To accumulate these sums the biotech industry is particularly motivated by the

attraction of patent protection4. 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 sequences5from lower organisms such as bacteria up to higher life

forms as living animals6. Patent practice has become increasingly broad7.

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 industry8. Subject of this work are GMOs destined for

marketing on global level, i.e. foodstuff and agricultural products9but 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

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

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

3Cannon, 79 Cornell Law Review, 735.

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

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

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

7Blakeney, CIPR Study Paper 3b, p. 18.

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

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

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pharmaceuticals10. The debate is fuelled by unfulfilled expectations concerning the

ongoing WTO round, statements of NGO activists11and new projects of multinational

corporations and more intense in Europe than in North America12.

Our century is regarded as the “information age” driven by a new knowledge economy

whose economic plan is heavily based on impact of IPRs13. 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 products14. 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 years15. 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 revolution16. Patents act as an incentive to invest the

10Murphy, 42 HILJ [2001], 47.

11Transgenic plant/Novartis II(G1/98) - seeAppendix 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].

12From 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.

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

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

15Bently/Sherman, Intellectual Property Law, Part II, ch. 16, 4.7 (p 355); Brac de la Perrière, Refusing Privatisation of Life, para. 3.

16Smith, 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”.

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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 build17. Technological development depends on

investment and support which is either public or private18. 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&D19. Information technology and advanced life sciences are setting the

pace for the constitution of a new era in the industrial development of mankind20. The

perspective of the biotechnology industry is intertwined with existing or lacking patent

protection21:

“The availability of patent protection for thechemical compoundsthat 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

possible22”.

But the controversy is not about patents forcompounds- 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 maximised23.

17Proposal 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.

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

19Juma, Intellectual Property Rights and Globalization, p. 8.

20Carey, 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”.

21Nenow, 23 Houst J Int’l Law [2001], p. 569 [571]; The harm of patents, Economist 22 August 1992, 17.

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

23It 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.

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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”25as 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 frustrated27. However, to certain new

industries the traditional solutions to this conflict seem inappropriate. Different from the

industrial past, where new products replaced its predecessors28, 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 rights29.

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

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

25Laurie, Biotechnology and Intellectual property, in: McLean, Contemporary Issues in Law, Medicine and Ethics, ch. 12, p. 237 [240].

26Die ZEIT, week 30 2002, p. 54.

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

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

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

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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 202032. 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 varieties33. 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 land34. 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

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

31Murphy, 42 HILJ [2001], 47.

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

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

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

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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 costs35.

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 beans36combining features such as high oil content, early maturity, stable high

yields, resistance against seed shattering and root rot37.

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 debate38.

Individuals and organisations counsel caution about the not yet well-known risks of

gene technology39and are concerned about a dependency on life-sciences as the future

of agriculture40. 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

populations41.

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

36See Table 1 (AppendixI).

37seeApplication for Patent by Pioneer Hi-Bred Ltd.,11 C.P.R. (3d), 311 (1986) at 312.

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

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

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

41Ha milton, 6 Drake J. Agric. L, 81 [83].

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This presumption is not far-fetched: A three-year trial of GM oilseed rape in the UK42to

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 genes43. 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