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Patents As Protection of Traditional Medical Knowledge?: A Law and Economics Analysis

ISBN-10: 1780680732
ISBN-13: 9781780680736
Edition: 2012
Authors: Petra Ebermann
List price: $83.00
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Description: The protection of traditional knowledge and the practices of local and indigenous groups have been discussed in various forums in recent times. International agreements - such as the Convention on Biological Diversity - address the importance of  More...

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Book details

List price: $83.00
Copyright year: 2012
Publisher: Intl Specialized Book Service Inc
Binding: Paperback
Pages: 168
Size: 6.25" wide x 9.25" long x 0.50" tall
Weight: 0.792
Language: English

The protection of traditional knowledge and the practices of local and indigenous groups have been discussed in various forums in recent times. International agreements - such as the Convention on Biological Diversity - address the importance of protecting traditional knowledge and practices, recognizing that this knowledge bears immense value in terms of its contribution to the conservation of biological diversity and its inputs to research and development in various fields. Experiences of the past - for example, the use of the Neem tree and the Turmeric plant - show that the benefits of traditional knowledge applications are allocated mainly to the follow-on developers and rarely to the original suppliers of the knowledge and practices. In the long term, this may result in restricted access to traditional knowledge to the detriment of social welfare. This book examines traditional knowledge protection in the area of traditional medical knowledge, which is often utilized in contemporary medicine and, consequently, is subject to patent protection. The book provides a comparative view of the current patent regimes in major economies - specifically the US and the EU - and the consequences of the application of these laws to traditional medical knowledge and follow-on innovation, as well as the impact on underlying economic principles and opposing interests. The economic analysis of law is used to evaluate the current situation by comparing the effects of adapted patent regimes to alternative liability regimes or contractual agreements. This comparative and interdisciplinary approach gives valuable insights and inputs for future discussion. (Series: European Studies in Law and Economics - Vol. 10)

Acknowledgments
Introduction
Traditional Medical Knowledge, Biological Diversity and Intellectual Property Rights
The Concept of Traditional Medical Knowledge and the Impact of Biotechnology
A Definition of Traditional Medical Knowledge
Traditional and Indigenous Knowledge
Traditional Medical Knowledge
General Characteristics of Traditional Medical Knowledge
Traditional Knowledge Holders
Creation and Preservation
Ownership
The Role of Natural Resources in Pharmaceutical R&D
Overview
Pharmaceutical Biotechnology
Bioprospecting Research Project
The Value of Pharmaceutical Biotechnology and Traditional Medical Knowledge
The Value of Pharmaceutical Biotechnological R&D
The Value of Traditional Medical Knowledge
The Convention on Biological Diversity
Biological Diversity
Loss of Biodiversity
Consequences of Biodiversity Loss
Main Objectives of the CBD
Conservation and Sustainable Use
Access to Biological Resources and Benefit Sharing
National Sovereignty
The Tragedy of the Commons
The Role of Property Rights in Access and Benefit-Sharing Regulation
Article 8(j) CBD
The Elements of Traditional Knowledge Protection
Relationship with the Objectives
Form of Protection
Protection by Intellectual Property Rights
Positive and Negative Approaches to Protection
Trade-Related Intellectual Property Rights and Traditional Medical Knowledge
The TRIPS Agreement
Introduction
The International Legal Developments
The Economic Rationale of Intellectual Property Protection
Objectives of the TRIPS Agreement
Promotion of Free Trade
Promotion of Economic Development
Intellectual Property Rights and Developing Countries
General Principles of Non-Discrimination
National Treatment
Most-Favoured-Nation Clause
The International Legal and Economic Framework of Patents
Historical Development of Today's Patent Laws
Overview on TRIPS Rules on Patents
Patentable Subject Matter
Rules on Biotechnological Inventions and Biological Resources
Disclosure
The Economic Underlyings of Patenting
The Incentive-to-Invent Theory
Patent Scope
The Interaction Between Traditional Medical Knowledge, the TRIPS Agreement and the CBD
Traditional Knowledge in the TRIPS Context
Intellectual Property Rights and the CBD
Article 8(j) CBD - Preservation of and Respect for the Knowledge, Innovations and Practices of Traditional Communities
Conservation and Sustainable Use of Biodiversity
Article 15 CBD - Access to Genetic Resources and Fair and Equitable Benefit Sharing
Article 16 CBD - Access to and Transfer of Technology
Summary of the Main Results of Part 1
The Status Quo - Protection of Traditional Medical Knowledge and Biotechnological Inventions Undercurrent Patent Law
Patentability Criteria in the US and the EU
Legal Foundations for (Biotechnological) Patents in the US and the EU
Sources of US Patent Law
The Constitution
Federal Statutes and Regulations
Case Law
European Patent Law
The European Patent Convention
The Biotechnology Directive
National Laws and Court Decisions
Substantive Patent Requirements
Products of Nature
US Patent Law
European Patent Law
Novelty
The State of the Art in US Patent Law
The European Approach to Novelty
Inventive Step and Non-Obviousness
US Patent Law - Non-Obviousness
European Patent Law - Inventive Step
Utility and Industrial Application
US-Utility
EU - Industrial Application
Specification
Disclosure of the Invention
US Patent Law
Europe
Patent Claims
Claim Categories
Claim Drafting
Concluding Remarks
Biotechnological Patents on Pharmaceutical Drugs Developed in Bioprospecting Research Projects
The Patentability of Biotechnological Inventions Using Traditional Medical Knowledge
Natural Products Doctrine
Traditional Medical Knowledge as Invalidating Prior Art
The Neem Patents
Analysis of the Prior Art Assessment in the Neem Proceedings
The Standard of Disclosure
Non-Obviousness in Bioprospecting Research Projects
US Patent Law: The Standard of Non-Obviousness in the Aftermath of KSR
The Inventive Step Requirement in Europe: Neem and Hoodia
Analysis of the Results
The Importance of Patents for Pharmaceutical R&D
The Predictability of the Outcomes of Patent Proceedings
The Rights of the Providers of Traditional Medical Knowledge
The Patentability of Traditional Medical Knowledge
Products of Nature
Novelty and Non-Obviousness
Formal Requirements
The Owner of the Patent: The Concept of Joint Inventorship
Legal Definition of joint Inventorship
Requirements for Joint Inventorship in US Patent Law
Joint Inventorship Under the EPC
Joint Inventorship of Traditional Knowledge Groups and Pharmaceutical Companies
Analysis of the Results
The Public Good Problem
Suboptimal Rate of Innovation
Free-Riding
Allocation of Resources
Implementation of the CBD
Prior Informed Consent
Benefit Sharing
Disclosure of the Origin of the Source
Summary of the Main Results of Part 2
Protecting and Rewarding Traditional Medical Knowledge Contributions Under Property and Liability Regimes
The Property Rights-based Approach to Protection
The Construction of Traditional Knowledge Rights
Novel Interpretation of Existing Norms
Invention
Novelty and Inventive Step
Sui Generis Systems - Definition of New Rights for Indigenous Peoples
Implementation of Article 8(j) CBD Through Traditional Knowledge Rights
Interpretation and Infringement
Literal Infringement
The Doctrine of Equivalents
Implications for the Right of Traditional Knowledge Providers
Economic Analysis - The Effects of Patents in Cumulative Innovation Scenarios
Optimal Allocation of Rights and Division of Profits
Hold-Up and Anticommons
Conclusion
Co-Operation Between Indigenous Groups and Pharmaceutical Companies and Joint Inventorship
Modification of the Requirements
The Rights of Joint Inventors
Use of the Patented Invention
Sharing of Profits
Discussion
Conclusion on the Property Rights Approach
Benefit-Sharing Agreements and Liability Rules
Mandatory Benefit-Sharing Agreements as Conditions to Patentability
Benefit Sharing Under a Liability-Based Approach
Conditions of a Compensatory Liability Regime
Determination of the Value
Statutory Rules
Collective Rights Organizations
Impact of Benefit Sharing on Retail Costs of Pharmaceuticals
Conclusion on Benefit Sharing
Prior Informed Consent and Disclosure Requirements
The Content and Scope of the Requirements
Prior Informed Consent Requirement
Disclosure Requirements
Effects and Costs of Prior Informed Consent and Disclosure Requirements
The Sanction in Case of Non-Compliance
The Effects of Disclosure Requirements
The Effects of Prior Informed Consent
Compatibility with TRIPS
Prior Informed Consent
Disclosure Requirements
Substantive or Formal Requirements
Article 29 TRIPS
Article 62 TRIPS
Conclusion on Disclosure and Prior Informed Consent Requirements
Summary of the Results of Part 3
Conclusion. The Results of the Analysis and the Implications for Future Discussions
Bibliography
List of Cases
About the author
About the series

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