1. Introduction to Intellectual Property
Introduction
The Meaning of "Intellectual Property"
Types of Intellectual Property Protection
Copyright
Trademarks
Trade Secrets
Patents
Requirements
Underlying Theory of Intellectual Property
Basis of Intellectual Property Law
The U.S. Patent System
United States Patent and Trademark Office
Supreme Court
Congress
Summary
References
2. Obtaining, Enforcing and Defending Patents
Obtaining Patent Protection
Patentable Subject Matter
Utility
Novelty
Nonobviousness
Written Description and Enablement
Enforcement of Patents
Types of Patent Infringement
Determination of Infringement
Remedies for Infringement
Defenses
Invalidity
Inequitable Conduct
Exhaustion
Exhaustion and Self-Replicating Technologies
Experimental Use
Five Important Facts to Remember About Patents
Summary
References
3. Gene Patents
History of Gene Patenting
Chakrabarty and the Rise of Gene Patents
Chakrabarty's Legacy
The Harvard Oncomouse and the Patenting of Higher Level Life Forms
The Current Controversy
Public Health Implications
Access to Medical Treatment
Quality of Medical Treatment
Innovation
Summary
References
4. Medical Procedure Patents
History of Medical Procedure Patents
The Patent Law Compromise
Who is Protected
The Loophole for Medical Devices
The Unenforceable Patent Right
Medical Procedure Patents as "Process" Under Section 101
A Possible Shift in the Trend: In re Bilski and the "Machine or Transformation" Test
Aftermath of Bilski
Immunizations: Classen Immunotherapies, Inc. v. Biogen
In Vitro Diagnostics: Prometheus Laboratories, Inc. v. Mayo Collaborative Services
Diagnostic Testing: Myriad Genetics v. Association for Molecular Pathology (AMP)
Public Health Implications
Ethical Issues


Academic Access
Patient Privacy
Access to Medical Treatment
Impact on Innovation
Infringement Liability
Summary
References
5. Rights and Roles of Universities and Inventors
Researcher and Inventor
Publish or Perish
Determining Inventorship
The Bayh-Dole Act: Stimulating Commercialization of University Research
IP Policies and Assignment Provisions
Stanford v. Roche
Government's March-in Rights
Effects of the Bayh-Dole Act
Technology Transfer: Transferring University Technology to the Private Sector
Summary
References
6. Drug Development: Managing the Patent and FDA Processes
Overview of Drug Development
Reconciling Patent Protection with the Drug Development Process
Extending the Life and Value of a Product
Patent Exclusivities
Patent Term Adjustments for Delays Due to USPTO Approval
Patent Term Extensions for Delays Due to Regulatory Approval
Nonpatent Exclusivities
New Chemical Entity Exclusivity
New Clinical Study Exclusivity
Generic Drug Exclusivity
Generic Biologic Exclusivity
Orphan Drug Exclusivity
Pediatric Exclusivity
Implications for the Public's Health
Misuse of Exclusivities
Disproportional Incentives
Minimal Health Benefits
Summary
References
7. Patent Battles Part I: The Hatch Waxman Act and Small-Molecule Drugs
Generic Drugs
Effect of Generic Drugs on the Market
The Hatch-Waxman Act
Restoring Patent Term and Providing Additional Market Exclusivity
Safe Harbor
Abbreviated New Drug Application (ANDA)
Consequences of the Hatch-Waxman Act
Evergreening
Patenting of Obvious Inventions
Authorized Generics
Pay-for-Delay Settlement Agreements
Multiple Orange Book Listings
Continuation Application Practice
Public Health Implications
Availability of Generics Drugs
Innovation of New Drugs
Summary
References


8. Patent Battles Part II: The Biosimilars Act and Biologics
Overview of Biologics
Regulation of Biologies in the United States
Biologics Price Competition and Innovation Act (The "Biosimilars Act")
Biosimilar Versus Interchangeable
Brand-Name Exclusivities
Generic Exclusivities
Patent Dispute Resolution
Public Health Implications
Access to Biosimilars
Achieving "Biosimilarity" or "Interchangeability" Status
Uncertain Exclusivity Timelines
Loop Holes for Brand-Name Biologics
Promoting Innovation
Summary
References
9. International Patent Law, Trade Law, and Access to Drugs
International Institutions Governing International Patent Law
World Intellectual Property Organization
World Trade Organization
Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement)
Exception to TRIPS: Compulsory Licensing
Doha Declaration
Amendment to TRIPS
Compulsory Licensing Case Studies
India's Patent Laws
Evergreening Patents and the Battle over Glivec
Compliance with TRIPS
Constitutional Validity of Section 3(d)
Patentability of Glivec
Compulsory Licensing in India
Why India is Important
Drug Pricing and Access to Medicines
Competition from Generics
Price Differentiation
Parallel Imports
Corporate Donations
Patents and Access to Drugs
Stimulating New Drug Innovation
Prize System: Health Impact Fund
Patent Pools
Open Source Model for Drug Discovery and Development
Summary
References.