Keterangan
This book aims to analyse whether the choices made by the Indonesian Government in response to Indonesia’s obligation under the TRIRIPs Agreement concerning biological resources are suitable for Indonesia in its current state of economic, social and cultural development, and national interest.
This book focuses on five lines of enquiry; (i) an investigation on current IPR policy in the field of biological resources, from theoretical perspectives; (ii) an investigation of the development of international and regional legal frameworks relevant to the issue of IPR and biological resources, and their implementation in several national jurisdictions; (iii) an analysis of the Indonesian legal framework and policy direction for the protection of IPR and biological resources, including the questions of implementation and potential implications; (iv) an investigation of the protection of IPR concerning genetic resources and related traditional knowledge from an Indonesian legal culture perspective; and (v) an identification of the appropriate and adequate legal policy and option for the protection on IPR on biological resources, including creating a fair, ethical and equitable biopartnership agreement.
This book finds that the existing Indonesian legal instruments governing IPR on genetic resources is insufficient in providing an adequate system of protection to enhance the Indonesian national interest and to gain the benefit from IPR protection for two main reasons: Firstly, Indonesia’s formal adoption of the IP system of the TRI Ps Agreement did not produce a policy suitable for Indonesia as a developing country.
The formal accession failed to take into account the real need of Indonesia as a developing country, and the need to address the problem of misappropriation of biological resources through IPR regime. Furthermore, this research also finds that in designing the current law on IPR, the legal drafters and decision makers paid less attention to current developments in international and regional forums to address the issue of IPR and genetic resources outside the WTO-TRI Ps Agreement.
Moreover, this book also finds that there is little evidence that Patent Act and PVP Act facilitate technological and agricultural economic development in Indonesia. Despite a number weaknesses in both laws, the policy adopted by the Government in the field of technology, the legal structure, legal substance, legal enforcement bodies and institution, including national technological capacity, have not been able to achieve these objectives.
Otherwise, these laws may have potential implications on certain sector of development, particularly in the public health, traditional small farm sectors, and the goal of conservation of genetic resources, and protection of traditional knowledge. Therefore, the Indonesian Government has failed to maximize the advantages from Patent and PVP systems to utilise all of Indonesia’s potential within the realms of genetic resources including related traditional knowledge.
Based upon these findings, this books provides several recommendations that may assist Indonesia in establishing sets of policy options in relation to IPR regulation of biological resources to balance between Indonesia’s international obligations and national interests.
This includes the disciplines of private law, particularly on IPR and contract law, public law and administrative law covering environmental law and access to genetic resources law and other relevant laws. Those sets of policy also should take into account the Indonesian legal culture, and the level of technological and economic development. More specifically, it recommends Indonesia to develop a fairer IPR and including PVP system, by modifying the existing laws, the inclusion of the provision regarding disclosure of origin of genetic resources in the patented inventions, defensive protection, developing a fair and equitable benefit sharing through biopartnership contract, and utilising IPR laws other than patents and PVP.
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Nurul Barizah hold a Bachelor of Laws (S.H.) degree from the Faculty of Law, Airlangga University, Surabaya, Indonesia (1990-1994). Under the Australian Development Scholarships (ADS) scheme, she completed her Master of Laws (LL.M) degree (2000-2001) and Doctor of Philosophy in Laws (Ph.D) degree (2005-2008) from the Faculty of Law, the University of Technology, Sydney (UTS). Currently, she is a senior law lecturer and researcher at the Faculty of Law, Airlangga University, Surabaya, Indonesia. Besides her academic position above, since 2009, she is a secretary of the Faculty of Law, Airlangga University as well as a head of Intellectual Property Rights Centre of the Faculty of Law, Airlangga University.
LIST OF CONTENTS
Certificate of Authorship/Originality » 5
Acknowledgment » 6
List of Contents » 10
Acronyms and Abbreviations » 17
Abstract » 21
Chapter 1 Introduction » 23
1.1. R Research Objectives » 23
1.2. R Research Context » 24
1.3. R Research Scope » 34
1.4. Organization of the Thesis » 36
1.5.1. Research methodology » 39
1.5.2. R Research sources » 39
1.6. Research Significance » 40
Chapter 2 Intellectual Property Rights and Their Relevance to Biological Resources; Theoretical Perspectives » 43
2.1. Introduction » 43
2.2. The Benefits of the Patent System; Including Biotechnology Patent » 46
2.3. Patent Policy Related to Genetic Resources; From Early History to Post TRI Ps Agreement » 51
2.3.1. Early History of Patent Law » 51
2.3.2. The TRI Ps Agreement » 54
2.4. The Concept of ‘Invention’; From International Convention to Practices in Several Jurisdiction » 55
2.4.1. The Paris Convention » 57
2.4.2. The TRI Ps Agreement » 58
2.4.3. Discovery v. Invention » 59
2.5. Inventions; between Theory and Practice » 70
2.5.1. Novelty and State of the Art » 70
2.5.2. Inventive step or ‘non obvious’ » 72
2.5.3. The Industrial Application or ‘Usefulness’ » 76
2.6. Patent Policy on Biotechnological Inventions; Misappropriation of Biological Resources and its Disadvantages Developing Countries » 78
2.7. The Flexibilities of the TRI Ps Agreement; Developing Policies for the Need of Developing Countries to Gain Benefit from IPR » 83
2.7.1. Excluding from Patentability Genetic Resources based Inventions » 83
2.7.1.1. Public Ordre and Morality Basis » 84
2.7.1.2. Medical Treatment Basis » 89
2.7.1.3. Excluding Plants and Animals and Essentially Biological Processes from Patent Protection » 92
2.7.1.4. Minimum Protection for Micro-organism » 94
2.7.2. Balancing the Interests of Innovator and the User of Technology through Justifiable Use » 97
2.7.2.1. The Use for Experimentation » 99
2.7.2.2. Compulsory License » 104
2.7.2.3. A Access to Samples of Patented Materials » 106
2.7.3. Protecting Developing Countries’ Interests on Biological Resources and Related Traditional Knowledge through Intellectual Property Rights other than by Patent Law » 107
2.7.3.1. Copyright Law » 107
2.7.3.2. Trade Secret Law » 110
2.7.3.4. Geographical Indication and Trademark Laws » 112
2.7.3.4. Plant Varieties Protection Law » 116
2.8. Current Development and Policy in Patent Law in Relation to the Protection of Biological Resources » 79
2.8.1. The Revision of Article 27 (3) of the TRI Ps Agreement » 116
2.8.2. Extending the Role of Patent from ‘Wealth Creation’ to ‘Wealth Distribution’ » 119
2.8.3. The Development of PIC, Disclosure of Origin and Benefit Sharing Principles of the CBD » 124
2.9. Conclusion » 129
Chapter 3 International and Regional Arrangements Relevant to the Protection of Intellectual Property Rights and Biological Resources » 131
3.1. Introduction » 131
3.2. International Arrangements » 132
3.2.1. The World Intellectual Property Organization (WIPO) » 133
3.2.2. The World Trade Organization (WTO); TRI Ps Agreement and Doha Ministerial Declaration (DMD) » 144
3.2.3. UPOV Convention (Union In Internationale Pour La Protection Des Obtentions Vegetables) or International Convention for Protection of New Varieties of Plants » 152
3.2.4. The United Nations Conference on Environmental Program; The Convention on Biological Diversity (CBD) » 157
3.2.5. The Food and Agriculture Organization (FAO);IUPGR and ITPGR » 161
3.2.6. The Like-Minded Mega-diverse Countries Group » 169
3.2.7. The United Nations–WSSD & Declaration of Indigenous People » 171
3.2.8. The UNESCO; Universal Declaration of Human Genome and Human Rights » 175
3.3. Regional and Sub-Regional Arrangements » 177
3.3.1. ASEAN (Association of South East Asian Nations) » 177
3.3.2. The Organization of African Unity (OAUAU) » 179
3.3.3. The Andean Community Nations » 183
3.3.4. The European Community Nations » 188
3.4. Conclusion » 192
Chapter 4 Protection of Intellectual Property, Genetic Resources and Related Traditional Knowledge, and Access to and Benefit Sharing; Selected Countries Model Laws » 195
4.1. Introduction » 195
4.2. India » 196
4.2.1. The Indian Patents Act and Its Amendment » 198
4.2.2. India’s Plant Varieties Protection and Farmers’ Rights Act of 2001 » 201
4.2.3. The Indian Biological Diversity Act of 2002 » 207
4.2. Australia » 212
4.3.1. The Australian Patent Act 1990 (Cth) » 213
4.3.2. Plant Breeders’ Right Act 1994 » 219
4.3.3. The Environment Protection and Biodiversity Conservation (EPBC) Act 1999 (Commonwealth), and Access to Biological Resources and Benefit Sharing » 222
4.3.4. The Gene Technology Act 2000 » 225
4.4. China » 227
4.4.1. The Chinese Patent Law » 228
4.4.2. Plant Varieties Protection » 231
4.4.3. The Protection of Traditional Medicines » 233
4.4.3.1. The Chinese Patent Law and the Protection of Traditional Medicines » 234
4.4.3.2. Protection of CTM other than by Patents » 237
4. 5. Brazil » 238
4.5.1. The Biodiversity Law » 240
4.5.2. Intellectual Property Law » 243
4.5.3. Equitable Benefit Sharing; Brazil’s Experience » 245
4.6. Conclusion » 246
Chapter 5 The Indonesian Intellectual Property Laws and Biological Resources Protection » 248
5.1. Introduction » 248
5.2. Indonesian Patent Law » 250
5.2.1. Indonesian Patent Law; General Overview » 250
5.2.2. Indonesian Patent Act and Patentability on Genetic Resources based Invention » 251
5.2.2.1. The Concept of ‘Invention’ » 252
5.2.2.2. Patentability Thresholds » 254
5.2.2.2.Novelty » 254
5.2.2.2.2. Inventive Step » 257
5.2.2.2.3. Industrial Applicability » 258
5.2.2.3. Patentability Exceptions » 259
5.2.2.3.1. Inventions which are contrary to Prevailing Regulations, Order Public and Morality » 259
5.2.2.3.2. Invention related to Method of Examination, Treatment, Medication or Surgery » 262
5.2.2.3.3. All Living Creatures; Except Micro-organism » 264
5.2.2.3.4. Essentially Biological Processes » 270
5.2.3. Patent, Disclosure of Origin, and Prior Informed Consent; Indonesian Position » 272
5.2.4. The Application of Patent on Public Health Exception » 274
5.3. Plant Varieties Protection Act and the Protection of Plant Genetic Resources in Indonesia » 276
5.3.1. The Indonesian PVP Act; General Overview » 276
5.3.2. The Requirements of Protection and its Exceptions » 277
5.3.3. Breeders’ Rights v. Farmers’ Rights » 280
5.3.4. Local Varieties » 282
5.3.5. The Application to National Security and Other Non Commercial Activities » 284
5.4. Bill on the Utilisation and Conservation of Genetic Resources » 284
5.4.1. The Bill on the Utilisation and Conservation of Genetic Resources; Background and Rationale » 284
5.4.2. The Owners of Genetic Resources » 286
5.4.3. The Role of the State and the Individual over Genetic Resources » 288
5.4.4. Intellectual Property Rights » 288
5.4.5. Access, Utilisation, Benefit Sharing and Technology Transfer » 289
5.4.6. National Genetic Resources Commission and Dispute Settlement » 290
5.5. The Protection of Genetic Resources through IPR Laws Other than Patent and PVP Acts » 291
5.5.1. The Indonesian Copyright Act and Protection on Genetic Data and Information » 291
5.5.2. The Indonesian Trade Secret Act and Protection on Traditional Medicinal Knowledge » 295
5.6. Other Related Laws on Access and Transfer Genetic Resources and Biotechnology in Indonesia » 296
5.6.1. License for Foreign Researchers and Access to Genetic Resources » 296
5.6.3. Biotechnology Regulation in Indonesia » 305
5.7. Conclusion » 307
Chapter 6 The Implementation of Intellectual Property Rights Protection Relevant to Biologiocal Resources; Possible Implications for Indonesia » 310
6.1. I Introduction » 310
6.2. The State of the DGIP and PVP Offices » 311
6.3. Patent and PVP Acts; Enforcement and Legal Enforcement Bodies » 320
6.4. Patent and PVP Acts and the Problems of Implementation » 327
6.5. Patent and Problems of the Transfer of Technology in Indonesia » 328
6.6. Patent and Its Implication on Public Health Sector » 339
6.7. Patent and PVP System; their Implications on Agricultural Sector » 349
6.8. Patent and PVP System; their Implications on Traditional Knowledge » 352
6.9. Patent and Biopiracy Problems in Indonesia » 356
6.10. Conclusion » 360
Chapter 7 Protection of Intellectual Property Rights Concerning Genetic Resources and Related Traditional Knowledge; Indonesian Legal Culture » 362
7.1. Introduction » 362
7.2. The Concept of Intellectual Property under Indonesian Culture » 363
7.2.1. The Transplantation of Western IP laws in Indonesia » 366
7.2.2. The Protection of IPR under Islamic Thought » 370
7.2.3. The Protection of IPR on Biotechnological Inventions under Islamic Thought » 378
7.2.4. The Protection of IP Laws under the Concept of Adat and its Practice » 384
7.2.5. Protection of Biological Resources and Traditional Knowledge under Adat Law » 388
7.2.6. The Protection of IP over Genetic Resources from Other Religious Perspectives » 396
7.2.7. The Protection of Intellectual Property over Biological Resources from other Stakeholders Perspectives in Indonesia » 397
7.3. Conclusion » 399
Chapter 8 Analysing Sets of Policy Options for Indonesia in Relation to Intellectual Property Regulation of Biological Resources; Between International Obligations and National Interests » 401
8.1. Introduction » 401
8.2. Developing a Fairer Intellectual Property System » 402
8.2.1. Modification of Patent Law » 407
8.2.1.1. The Substantial Thresholds of Patentability » 407
8.2.1.2. Patenting Micro-organisms » 411
8.2.1.3. Unpatentable Inventions » 414
8.2.2. Defensive Protection of Traditional Knowledge » 416
8.2.3. Proposed US-Indo BFTA and Potential Implications on Intellectual Property Regulations of Biological Resources » 418
8.3. Developing a Fairer PVP Act through a Sui Generis Model » 421
8.3.1. Declaration of Origin of Genetic Resources » 427
8.3.2. Prior Informed Consent (PIC) » 427
8.4. Utilising IP Laws Other Than Patent and PVP » 433
8.4.1. Copyright Law » 433
8.4.2. Trade Secrets Law » 434
8.4.3. Trade Mark and Geographical Indication Law » 435
8.5. Establishing and Enforcing Environmental Law Framework on Management and Conservation of Genetic Resources » 436
8.6. Contract Law Governance; Toward a Fair, Ethical, and Equitable Solution » 440
8.6.1. Bio-Partnership Agreement » 441
8.6.2. Benefit Sharing Contact » 445
8.7. Conclusion » 446
Chapter 9 Conclusion and Recommendations » 448
9.1. Introduction » 448
9.2. Conclusion » 449
9.3. R Recommendations » 453
9.4. Concluding Remarks » 457
Bibliography » 459
1. Indonesian Laws and Regulations » 459
2. Laws and Regulations of Other Nations » 461
3. Conventions, Treaties, Declarations and Other International Agreements » 463
4. Regional Laws and Regulations » 465
5. Other Documents of International Organisations » 466
6. Books » 478
7. Chapters in Edited Books or Part of Books » 487
8. Journal Articles » 493
9. Discussion Papers, Seminar Papers, Coneference Papers, Working Papers, and Reports » 503
10.Internet Materials and Newspapers » 515
List of Tables » 524
Table 1: Certificate of Origin System for Genetic Resources in Different Jurisdictions » 524
Table 2: Comparison of UPOV 1978 Act and UPOV 1991 Act » 528
Table 3: Comparison of Principal Differences Between PVP under UPOV 1978 Act, UPOV 1991 Act and TRI Ps- Compatible Patent Laws » 529
Table 4: Classification of States Based on Their International IPR obligations » 531
Table 5: Achieving Societal Objectives under Different Sui Generis Systems » 533
Table 6: Treatment of Critical Issues in Genetic Resources Access by Country » 534
