Biotechnology Intellectual Property Manual

Description

The aim of this Manual is to provide a practical guide to the identification, protection and management of biotechnology – related intellectual property (IP), thereby assisting in maximising the benefits gained from investment in research. The Manual is divided into nine main chapters, which outline aspects of the IP management process from conception of an idea through to its protection and subsequent successful commercialisation

Cover
Title Page
Copyright
Contents
Figures
1. Introduction
Chapter 1. Introduction
1.1 Outline
1.2 How to Use this Manual
1.3 Why Protect and Manage Intellectual Property
2. Intellectual Property
Chapter 2. Intellectual Property
2.1 Types of Intellectual Property
Figure 2-1: Patents v. trade secrets
2.2 International IP Law – International IP Treaties
Figure 2-2: PCT Timetable
2.3 Australian Patent Procedure
Figur e 2-3: Australian Patent Application Pr ocedur e
2.4 Invention v. Discovery
2.5 Patent Procedure in the United States and Europe
2.6 Prosecution Costs
Figure 2-4: Patent Filing Costs
Figure 2-5: Australian Patent Prosecution Costs (Standard Patents)
2.7 Patentability of Biotechnological Inventions
2.8 Breadth of Biotechnology Patent Claiming
2.9 Patentability of Methods of Medical Treatment of Humans
3. Searching
Chapter 3. Searching
3.1 Introduction
3.2 Patents as a Source of Information
3.3 Patentability Search
3.4 Infringement Search
3.5 Validity Search
3.6 State of the Art Search
Figure 3-1: Comparison of Main Search Types
3.7 Bibliographic Searches
3.8 How to Perform a Search
3.9 IP Informatics & Information: Web Access to IP Tools and Databases
Figure 3-2: Useful IP Web Sites
4. Development
Chapter 4. Development
4.1 Identifying Inventive Subject Matter
4.2 How to Read a Patent Specification
5. Strategic Management of IP Resources
Chapter 5. Strategic Management of IP Resources
5.1 Using IP in decision-making for R&D
5.2 Aligning IP and R&D with Business Strategy
Figure 5-1: Steps in Forming an R&D Strategy
5.3 IP Inventory Audit
5.4 Procedural Audit
5.5 Assessing the Competitive Landscape – IP Mapping
5.6 State of the Art Searches
5.7 Avoiding Infringement (Freedom to Operate)
5.8 Strategic Approaches to R&D and Patent Filing
Figure 5-2: IP Strategy – Checklist
6. Research Managementand Laboratory Practice
Chapter 6. Research Management and Laboratory Practice
6.1 Laboratory Notebooks
Figure 6-1: Laboratory Notebook – Checklist
6.2 Ownership of Invention
6.3 Agreements
6.4 What Form of IP Protection is Appropriate for Results of R&D?
Figure 6-2: IP Protection Decision Tree
6.5 IP Record Storage Practices
Figure 6-3: Protection of Confidential Information – Checklist
7. Decision to Patent
Chapter 7. Decision to Patent
7.1 Should a Patent Application be Filed?
Figure 7-1: Deciding to Patent – Checklist
7.2 When to File a Patent Application
7.3 Preparation of a Patent Specification
7.4 How to Use the Year After the First Filing Date
7.5 When to Publish
7.6 Review of Publications
Figure 7-2: Sound Management Practices in Relation to Publication
8. Commercial Exploitation
Chapter 8. Commercial Exploitation
8.1 Introduction
8.2 A Collaborative Approach to Commercialising IP
Figure 8-1: Confidentiality – Checklist
Figure 8-2: Confidentiality Agreements – Checklist
Figure 8-3: Material Transfer Agreement – Checklist
Figure 8-4: Due Diligence – Checklist
8.3 IP Valuation: How Venture Capitalists and Independent Valuers Value IP
8.4 Licensing
Figure 8-5: Mutual Benefits of Licensing
Figure 8-6: Whether to License – Checklist
Figure 8-7: Licence Agreement – Checklist
8.5 Defence of IP Rights
8.6 IP Insurance
8.7 Biotechnology IP Management and Issues Relating to Indigenous Peoples
9. Case Studies
Chapter 9. Case Studies
9.1 Case Study I: The Perils of Publication
Discussion Points
9.2 Case Study II: Dtect Pty Ltd
Discussion Points
9.3 Case Study III: International Genomics Alliance
Discussion Points
9.4 Case Study IV: Freedom to Operate – Review of Enabling Technology
Discussion Point
10. Appendices
Chapter 10. Appendices
10.1 Appendix I: Description of Microorganisms
10.2 Appendix II: TRIPS and Biotechnology
10.3 Appendix III: Manner of Manufacture
10.4 Appendix IV: A Test to Determine Obviousness
10.5 Appendix V: How to Read a Patent – Interpretation
10.6 Appendix VI: Novelty – Statutory Basis
10.7 Appendix VII: Patent Questionnaire
10.8 Appendix VIII: Statutes Relating to Commercialisation
11. Glossary of Acronymsand Abbreviations
Chapter 11. Glossary of Acronymsand Abbreviations
12. Index

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