Contents
Series Foreword
Author
Introduction
I. Protection
A. Patents
1. Introduction
i. Monopoly Powers
ii. Licensing Arrangements
Discussion
2. Patentability Requirements
i. The Structure of a Patent
ii. Patentable Subject Matter
iii. Prior Art
iv. Obviousness and Scale Factors
v. Recap
Discussion
3. Riding the Patent Office Pony
i. The Current State of the U.S. Patent Office
ii. Classification of Nanotechnology Patent Applications
iii. Security Review and Secrecy Orders
iv. Examination
v. Appeals
vi. "Special Applications"
Discussion
4. Infringement Issues
i. Patent Trolls
ii. Willful Infringement
iii. Evaluating Claim Scope
iv. Opinions of Counsel
v. Designing around Patents
vi. Reexamination of Patetns
vii. Declaratory Judgments
viii. Patent Thickets
ix. Assessment
Discussion
5. Nanotech Patents outside the United States
i. The Paris Convention
ii. The Patent Cooperation Treaty
Discussion
B. Copyrights
1. Introduction
Discussion
2. Copyright Requirements
i. Fixation
ii. Originality
iii. Creativity
iv. The Scope of Copyright
v. "Fair Use"
vi. Where Nanotechnology Fits
Discussion
3. Nanotech Creations as Artistic Works
i. Conventional Art
ii. Nanosized Sculpture
iii. Architectural Works
iv. Literary Works
v. Musical Works
Discussion
C. Integrated Circuit Topographies
Discussion
D. Trade Secrets
1. What is a Trade Secret?
2. Patent or Trade Secret?
3. Remedies
Discussion
E. Ownership of Nanotech Intellectual Property
1. The Nature of Property
2. Joint Ownership
3. Assignment Obligations
4. Government Interests
Discussion
Notes
II. Regulation
A. Delegation of Power to Agencies
1. Regulatory Agencies
2. Rulemaking
3. Use of Information by Agencies
4. Information Quality
Discussion
B. Examples of Regulation of Nanotechnology
1. Health and Safety Regulations
i. The U.S. Food and Drug Administration
ii. The Center for Biologics Evaluation and Research
iii. The Center for Devices and Radiological Health
iv. The Center for Drug Evaluation and Research
v. The Center for Food Safety and Applied Nutrition
vi. The Center for Veterinary Medicine
vii. National Center for Toxicological Research
viii. Classification of Medical Products
Discussion
2. Environmental Regulations
i. Nanotechnology and the Environment
Discussion
3. Regulation of Exports
i. Classification
ii. Export Administration Regulations
iii. Fundamental Research Exclusion
iv. International Traffic in Arms Regulations
v. Office of Foreign Asset Control
Discussion
C. Political and Judicial Control over Agency Action
i. Political Control by the Legislature
ii. Political Control by the Executive
iii. Judicial Control
Discussion
Notes
III. Liability
A. Introduction
1. Should Scientists Be Held Responsible for the Use of Their Creations?
2. The Application of Civil and Criminal Laws
3. The Importance of Context
Discussion
B. Civil Liability
1. Application of Negligence to Nanotechnology
i. Duty and Breach of Duty
ii. Causation
iii. Damages
iv. Defenses
v. Synopsis
Discussion
2. Strict Liability for Nanotechnology Products
i. Risks Associated with Nanoparticles
ii. The Concept of Strict Liability
iii. Learned Intermediaries
iv. Conclusion
Discussion
3. Warranty
i. Express Warranty
ii. Implied warranty of Merchantability
iii. Implied Warranty of Fitness for a Particular Purpose
iv. Disclaimer
Discussion
4. Class Actions
i. Class-Action Criteria
ii. Certification
iii. Class-Action Settlements
iv. Underlying Causes of Action
v. The Regulatory Role of Class Actions
vi. Attorney Fees
Discussion
5. Nanotechnology Business Organizations
i. Corporations
ii. Piercing the Corporate Veil
iii. Derivative Actions
Discussion
C. Criminal Liability
1. Crimes Using Nanotechnology
2. Definition of Crimes
3. Corporate Criminal Liability
4. Example: Application of U.S. Sentencing Guidelines to Nanotechnology Crimes
5. International Trends
6. Prevention and Detection of Crimes Using Nanotechnology
Discussion
Notes
Conclusion
Notes
Index
