Book contents
- The Cambridge Handbook of Investment-Driven Intellectual Property
- The Cambridge Handbook of Investment-Driven Intellectual Property
- Copyright page
- Contents
- Figures and Tables
- Contributors
- Foreword
- Introduction
- I Creativity, Pluralism, and Fictitious Narratives
- Part I Science, Technology and Industry
- II Sui Generis Protection of Non-creative Databases
- III Test Data Exclusivity
- IV Copyright in Works Created by Artificial Intelligence
- V Plant Variety Protection and Investment
- VI Software Protection under Copyright Law
- VII Bilski and the Information Age a Decade Later
- VIII Pharmaceutical Patents and Evergreening
- Part II Culture and Entertainment
- Part III Signs, Images and Designs
III - Test Data Exclusivity
An Elusive Pursuit to Strike a Balance between Affordable Drugs and Investment Incentives
from Part I - Science, Technology and Industry
Published online by Cambridge University Press: 16 March 2023
- The Cambridge Handbook of Investment-Driven Intellectual Property
- The Cambridge Handbook of Investment-Driven Intellectual Property
- Copyright page
- Contents
- Figures and Tables
- Contributors
- Foreword
- Introduction
- I Creativity, Pluralism, and Fictitious Narratives
- Part I Science, Technology and Industry
- II Sui Generis Protection of Non-creative Databases
- III Test Data Exclusivity
- IV Copyright in Works Created by Artificial Intelligence
- V Plant Variety Protection and Investment
- VI Software Protection under Copyright Law
- VII Bilski and the Information Age a Decade Later
- VIII Pharmaceutical Patents and Evergreening
- Part II Culture and Entertainment
- Part III Signs, Images and Designs
Summary
Test data exclusivity (TDE) is a regulatory mechanism of suspending price competition in the drug market rationalised on the grounds of protecting innovation incentives of originator companies. Under international trade law, it is considered a subset of intellectual property (IP).1 While its impact on innovation remains ambiguous, TDE has been criticised at length as an impediment to affordable medicine and the right to health,2 an obstacle to transparency in medical research,3 a case of ‘ratcheting up’ of international IP standards,4 and a threat to TRIPS flexibilities.5
- Type
- Chapter
- Information
- Publisher: Cambridge University PressPrint publication year: 2023