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