The Law and Strategy of Biotechnology Patents

Foreword

Preface

Acknowledgments

Part I: Introduction

1. General Information

1.1 Using the Patent Statute Requires Planning

1.2 An Overview of the Content and Chapters

1.3 A Brief Overview of the Patent Statute

1.4 A Case Study: The Production of Acetone with Clostridium Acetobutylicum

References

2. Patent Claims

2.1 The Central Role of Patent Claims

2.2 General Rules of Claim Interpretation

2.3 The Practical Interpretation of Patent Claims

2.4 Examples of Patent Claims in Biotechnology

References

3. The Legal Decision-Making Process

3.1 The Patent Application Process

3.2 Proceedings on Issued Patents

3.3 Miscellaneous Matters

References

4. Ownership of Tangible and Intellectual Property

4.1 Tangible Property versus Intangible Property

4.2 Trade Secret Issues

4.3 Ownership of Intellectual Property

References

Part II: Basic Requirements of Patentability

5. Patentable Subject Matter

5.1 Statutory Subject Matter

5.2 Practical Utility

5.3 Operability

References

6. Novelty and the Public Domain

6.1 The Anatomy of Anticipatory Prior Art

6.2 When Is Prior Art Properly Applied to a Claim?

6.3 Rule 1.131—Removing Prior Art by a Showing of Prior Inventorship

References

7. Nonobviousness

7.1 The Basic Test

7.2 The Scope and Content of the Prior Art

7.3 The Person Having Ordinary Skill in the Art

7.4 Differences between the Prior Art and the Claimed Invention—The Invention as a Whole

7.5 Objective Evidence of Nonobviousness

7.6 Prima Facie Obviousness

7.7 Inventive Step and Nonobviousness Compared

7.8 Conclusion

References

Part III: Special Issues in Biotechnology Patents

8. Disclosure Requirements

8.1 The Enablement Requirement and Claim Scope

8.2 The Best-Mode Requirement

8.3 The Deposit Requirement

8.4 The Written-Description Requirement

8.5 The Claim Definiteness Requirement

References

9. Collaborative Research

9.1 Inventorship Issues in Collaborative Research

9.2 Correcting Inventorship

9.3 Prior Art Issues in Collaborative Research

References

10. Competitive Research

10.1 Priority of Invention under the First-to-Invent System

10.2 Applying the First-to-invent System to Inventions Made Outside the United States

10.3 Interference Procedure: Initiation of Interferences

10.4 Priority under the First-to-File System

References

11. Plant Biotechnology

11.1 Plant Patents

11.2 The Plant Variety Protection Act of 1970

11.3 Trade Secrets

11.4 Plants as Tangible Property

11.5 Utility Patents

11.6 The Strategy of Protecting Plants

11.7 International Considerations in Plant Protection

References

12. Foreign Patents

12.1 Avoiding Forfeiture of Foreign Patent Rights

12.2 Choosing Where to File Foreign Applications

12.3 Strategy: Preserve Foreign Rights and Defer Foreign Costs

12.4 An Approach to Securing Foreign Patents

12.5 Conclusion

References

Part IV: Patent Litigation

13. Substantive Aspects of Patent Litigation

13.1 The Patent Grant

13.2 Patent Infringement

13.3 Patent Validity in the Courts

13.4 Patent Enforceability in the Courts

13.5 Estoppel Applied to the Accused Infringer

References

14. Procedural Aspects of Patent Litigation

14.1 Steps Taken Prior to a Lawsuit

14.2 Initiating the Suit

14.3 The Discovery Phase

14.4 Determination of the Issues

14.5 Alternative Dispute Resolution and Settlement

References

Index