Читать книгу Generic Challenge: - Martin a. Voet - Страница 7
ОглавлениеContents
| Introduction |
| Chapter 1 Overview of Patents |
Edison Patent for the Electric Light Bulb
A Patent is a Sword, Not a Shield!
Patent Term Adjustments and Extensions
First-to-invent v. First-to-file
Patent Cooperation Treaty (PCT)
Claims Define the Scope of the Invention
Basic Requirements for Patentability
Post-expiration Patent Royalties
| Chapter 2 | Patent Enforcement and Infringement |
Infringement and Validity Opinions
To Litigate or Not to Litigate
Off-label Use Patent Infringement
Defenses to a Claim of Infringement
| Chapter 3 | Pharmaceutical, Biologic and Medical Device Patents |
Pharmaceutical Patents Generally
Hierarchy of Pharmaceutical Patents
| Chapter 4 | Overview of FDA |
Clinical Development: Phases I–IV
Drug Agencies Outside the U.S.
| Chapter 5 | Exclusivity for Brand Name Innovative Drug Products |
New Chemical Entity (NCE) Exclusivity
New Use/Condition of Use/Formulation Exclusivity
Qualified Infectious Disease Products (QIDP)
China, Australia, New Zealand and Canada
| Chapter 6 | Generic Drugs: Hatch Waxman Act |
Patents Listed in the Orange Book
Suits Following Patent Certification
Therapeutic Equivalence Rating
Litigation on Scope of Patent Use Codes
180-day Generic Product Exclusivity
Counterclaim to De-list from the Orange Book
Agreements between Innovators and Generics
Settlement Agreements in Europe
Orphan Exclusivity to Block Generic Approval?
Patent Challenges on the Increase
Inter Partes Review in Hatch Waxman Cases
| Chapter 7 | Generics for Biologic Drugs |
Early Approvals of Biologic Generics
Biosimilars and Interchangeables
Exclusivity for Branded Biologics (BLAs)
Patent Dispute Procedures for Biosimilars
Biosimilar Litigation under BPCIA
FDA Guidance on Biosimilar Development
European Regulation of Biosimilars
Biosimilars in India and Canada
| Chapter 8 | Putting it All Together: Product Life-Cycle Management |
U.S. Patent Term Adjustments and Extensions
Litigation over Patent Term Extensions
Scope of Patent Term Extensions
New Dosage Forms/Delivery/Conditions of Use
Orange Book Listing and De-listing
Over-The-Counter (OTC) Strategy
Examples of Life-Cycle Management
The Alphagan (brimonidine) Story
| Chapter 9 | Conclusions and Final Thoughts |
Drug Policy v. Industrial Policy
Uniform International Approval Standards
Price Controls and “free ride” Issues
