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.
Table of Contents
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 Community
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
Research Objectives and Key Themes
This dissertation examines the current legal status of Genetically Modified Organisms (GMOs) regarding patentability, specifically analyzing whether existing intellectual property frameworks effectively balance the stimulation of innovation with ethical considerations, public good, and global food security. The core research question addresses whether the patent community is entering "no man's land" by applying conventional patent criteria to biotechnological inventions that were not envisioned when modern patent laws were established.
- Analysis of international and regional intellectual property frameworks (EPC, TRIPs, CBD) and their influence on GMO patentability.
- Evaluation of the conflict between private commercial incentives (R&D investment) and the public interest regarding global food security and biodiversity.
- Examination of the ethical and moral dimensions inherent in patenting life forms, including the concepts of ordre public and morality.
- Comparative analysis of patent practices and legal cultures between the European, North American, and Canadian jurisdictions.
- Investigation into the impact of emerging biotechnological tools like Genetic Use Restriction Technologies (GURTs) and their role in the morality debate.
Excerpt from the Book
Patentability of Genetically Modified Organisms – of “Mice and Men” or entering no man’s land?
The remarkable development and the application of new genetic technologies since the discovery of the double-helical structure of DNA in 1953 has been accompanied by profound changes in the way in which research is commercialised in the life sciences. After thousands of patents asserting rights over DNA sequences have been granted to researchers across the public and private sector, the current debate has moved a step further and challenges boundaries between human invention and nature about patenting entire life forms.
Biotechnology, today substantially driven by private company research, will be crucial to achieve goals of food security and health care by strengthening agricultural and medical capacities through the release of Genetically Modified Organisms. However, critics warn that another “green” or genetic revolution may entail on the environment.
One of the core points is that biotechnology as a key technology for the twenty-first century cannot do without an effective protection of investment and creativity. Since immense Research and Development effort is necessary to prepare the launch a GM-product (without having the guarantee that markets, society and foreign public policies will accept it) the biotechnological industry and its mostly Western home states call for rigorous intellectual property protection.
Summary of Chapters
Chapter I: Outlines the rise of biotechnology, the financial scale of R&D, and the controversy over whether conventional patent laws are suitable for governing genetically modified life forms.
Chapter II: Provides essential definitions and identifies the key stakeholders, ranging from private biotechnology firms and primary producers to farmers, consumers, and NGOs opposed to the patenting of life.
Chapter III: Explores the range of biotechnological activity that challenges intellectual property laws, covering human genome research, cloning, medical procedures, and the phenomenon of biopiracy.
Chapter IV: Discusses the ethical and moral dimensions of law, analyzing how society attempts to balance technological progress with human dignity and sustainable justice.
Chapter V: Detail the approaches to patent applications, focusing on the conditions of patentability such as novelty, inventive step, and industrial application.
Chapter VI: Traces the history of the legal framework, examining international treaties like UPOV and CBD, and the EU's legislative approach to GMOs.
Chapter VII: Applies the theoretical legal framework to specific cases and safety assessments, contrasting European and North American jurisdictional approaches.
Chapter VIII: Discusses the structure of IPRs regulating GM-patents and identifies bottlenecks in the patentability debate.
Chapter IX: Concludes that while patent protection for GMOs is broadly defensible, the balance between public and private interests remains precarious and requires further ethical and regulatory refinement.
Keywords
Genetically Modified Organisms (GMOs), Biotechnology, Patentability, Intellectual Property Rights (IPRs), Genetic Engineering, Biodiversity, Patent Law, Bioethics, Sustainable Development, Food Security, TRIPs, European Patent Convention (EPC), Human Genome Project.
Frequently Asked Questions
What is this dissertation primarily about?
The work investigates the legal and ethical challenges associated with the patentability of Genetically Modified Organisms (GMOs), questioning whether current intellectual property frameworks remain adequate in the era of advanced biotechnology.
What are the central thematic fields covered?
The study centers on the intersection of law, ethics, economics, and science, focusing on how patents drive innovation in life sciences while simultaneously impacting biodiversity, global food security, and human rights.
What is the primary objective of this study?
The aim is to assess whether existing criteria for patentability effectively balance the necessity of rewarding innovation with the requirement to protect the public interest and the integrity of natural resources.
Which research methods are employed?
The study conducts an ethical legal analysis, utilizing classic legal research alongside practical experiences gathered from scientific publications, academic conferences, and relevant institutional discourse.
What does the main body of the work cover?
It provides a comprehensive review of the definitions and stakeholders involved, an analysis of the international legal framework (including TRIPs, UPOV, and the EU Biotechnology Directive), and a comparative study of patent office practices in Europe, the U.S., and Canada.
Which keywords characterize this work?
Key terms include Patentability, GMOs, Biotechnology, Intellectual Property, Bioethics, Genetic Engineering, Sustainable Development, and the TRIPs Agreement.
How does the work address the moral dilemma of the "Harvard Mouse"?
It uses the "Harvard Onco-mouse" case as a key example of how patent offices struggle to interpret morality clauses, illustrating the tensions between narrow technical interpretations of patent law and broader societal concerns regarding animal suffering and environmental risk.
What is the role of GURTs in this patentability debate?
The work examines Genetic Use Restriction Technologies (GURTs), or "terminator genes," as a form of technological enforcement that mirrors and extends patent protection, further complicating the ethical and regulatory debate over whether such control mechanisms should be permissible under patent law.
- Quote paper
- Stefan Dimitrov (Author), 2002, Patentability of Genetically Modified Organisms (GMOs), Munich, GRIN Verlag, https://www.grin.com/document/13628
