Dangers in the Biotech Age – the truth about Biotech Rights

The biotech industry’s recent discoveries have deepened our understanding of genetics and present next to indefinite opportunities to create new products and treatments by genetic manipulation. But these exciting discoveries also pose many challenging questions and immediate needs. Most people are unaware of the technologies being developed today and the enormous potential and risks they bring with them and thus there is an enormous need for education. The positive image that has been marketed by industry and the governments has mostly stood unchallenged and the general public have formed the idea that genetics do not involve any threats whatsoever. The aim of this paper is to enlighten the reader and to serve as a comprehensive guide to understanding the multifold problems and dangers associated with patents on genes and other basic biological products and processes. The paper examine whether the legal tools are well adapted to their purpose and promote scientific progress and continuous advancements or if they go beyond the law’s initial intentions and jeopardise…


1. Introduction
1.1 The purpose of this paper
1.2 Limitations
2. The Genomics industry
2.1 Present technology
2.2 Increased patenting
3. The ABC’s of Biotechnology
3.1 Genetic engineering
4. The patent protection
5. The Legal Foundation
5.1 International Regulation
5.1.1 General Agreement on Tariffs and Trade (GATT-Agreement), 1947
5.1.2 The Patent Cooperation Treaty (PCT) 1970 & the Patent Law Treaty (PLT) 2000
5.1.3 The European Patent Convention (EPC) 1972 & the European Patent Organisation (EPO) 1973
5.1.4 Convention on Biological Diversity, 5 June 1992
5.1.5 Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), 1994
5.2 Current Legislation
5.3 The path to biotech patents
5.4 The 1980 Bayh-Dole Act
5.5 Biotechnology Patent Act
5.6 Directive 98/44/EC on the Legal Protection of Biotechnological Invention
5.6.1 The Patentability Requirements Novelty Inventive step/Non-obviousness Industrial application/Utility
5.6.2 Written Description
5.6.3 Unpatentable inventions
5.7 Available types of patents
5.8 Problems brought forward
5.9 Patent appeals
5.10 ESTs
5.11 Algorithms
5.12 Teknonationalism
5.13 The Universities inventions
6. Further aspects of the patent requisites
6.1 Is the material novel?
6.2 Is there any inventive step?
6.3 The Utility requirement
6.4 Blocking patents
27. The various kinds of biotechnological inventions
7.1 Diagnostic-tools
7.1.1 Myriad Genetics
7.2 Research-tools
7.3 Gene therapy
7.4 Therapeutic Proteins
8. The Database Directive
9. The pro patent arguments
10. Trends within the biotech industry
10.1 Increased collaborations
10.2 Broad patents
10.3 Monopoly creation
10.3.1 Excessive Litigation
10.3.2 Monopoly pricing
10.3.3 Utilization of Grant-back clauses and Reach-through rights
11. Partial emendations
11.1 Harmonised International regulation
11.2 Altered patentability requirements
11.3 Open access databases
11.4 A reconstructed experimental exemption
11.5 Compulsory Licences
11.6 Patent-Pools
11.6.1 IP-Guidelines
11.6.2 Restricted competition
11.6.3 Biotechnology and patent pools
12. Moral and Ethics
12.1 Transgression of the law
12.2 Cloning and human stem-cell research
12.3 What should the future hold?
12.3.1 Transhumanism
13. Conclusion

Author: Mansson, Kristina

Source: Goteborg University

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