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Spruson and Ferguson Patent and Trade Mark Attorneys, "Biotechnology Intellectual Property Manual"

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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