Table of Content
List of Abbreviations;
List of Tables;
List of Figures;
List of Cases;
List of Annexure;
CHAPTER - 1 Introduction and Research Methodology;
1.1 Introduction;
1.2 Statement of Problem and Research Significance;
1.3 Research Questions;
1.4 Research Hypotheses;
1.5 Research Methodology;
Tables;
CHAPTER - 2 Patents - A Tool for Progress of Scientific Innovations as well as for Competition;
2.1 Introduction;
2.2 Historical Development of Patents;
2.3 Development of Intellectual Law in India;
2.4 Globalization of Patent Laws;
2.5 Innovation activity and Pharmaceutical Industry;
2.6 Conclusions;
Tables;
CHAPTER-3 Patent Systems and the Business Policies of the Pharmaceutical Companies;
3.1 Introduction;
Offensive Business Strategies;
Defensive Business Strategies;
3.2 Patent Cluster's or thickets;
3.3 Introduction of New formulation;
3.4 Chiral Switches;
3.5 Aggressive Enforcement of Patent Rights;
3.6 Pseudo-generics;
3.7 Differential pricing mechanism;
3.8 Licensing and cross licensing;
3.9 Multiple / collaborative research;
a WIPO Re:Search - Sharing Innovation in the Fight Against Neglected Tropical Diseases;
b Drugs for Neglected Diseases Initiative – A Patient Needs-Driven & Innovative R&D Model;
c African Network for Drugs and Diagnostic Innovation (ANDI);
d Meningitis Vaccine Project;
e Open Source Drug Discovery of CSIR;
3.10 Conclusions;
Tables;
CHAPTER -4 Differential Pricing Policy and Pharmaceutical Industry;
4.1 Introduction;
4.2 Theory of Differential Pricing;
4.2a The methodology of Drug Pricing;
Ramsey Pricing Model;
Value based Pricing Model;
Two Part Pricing Model;
Patent Buyout Pricing Model;
Peak Load Pricing Model;
4.3 Differential Pricing and Pharmaceutical Industry a The pharmaceutical manufacturer sells the same product for different prices;
b Opening New Market;
c Threat of Compulsory Licensing;
d Competition From Generic Producers;
4.4 Prerequisite for Pharmaceutical manufacturer to implement the differential pricing;
4.5 Factors That Impede Use of Differential Pricing a Discontent With Prices In the Middle-Income Tier;
b Lack of Market Segmentation;
c Inefficient and 'Black-Box' Distribution Systems;
4.6 The Current State of Differential Pricing;
4.7 Conclusions;
Tables;
CHAPTER -5 TRIPS flexibilities - A Solution to Address the Need and Demand of Medicine;
5.1 Introduction;
5.2 Compulsory Licensing a Review of Compulsory Licensing System;
Australia;
Argentina;
Brazil;
Canada;
China;
India;
Indonesia;
USA;
b Potential dangers arising from Compulsory Licensing;
5.3 Parallel Imports and Exhaustion of Rights;
5.4 Patentable subject matter: Limitation on the Grant of Patents;
a) Non-patentable subject matter Use of Pharmaceutical Substances Incremental innovation (new form of existing drugs);
b) Other Conflicting Areas of Patentability: Scope for Proper Application of Patentability Standards;
Generic and specific patents (selection Patent and double Patenting);
Patents having claims related to Pharmacokinetic parameters;
Patents claiming pharmacopeial/analytical methods;
Packaging Method Patents;
5.5 Research and the Early Working Exceptions;
European Countries;
America;
Australia and New Zealand;
India;
Other Countries;
5.6 TRIPS-PLUS" IN US Free Trade Agreements;
a) Limiting the Extent of Test Data Protection (Data Exclusivity);
b) Patent Term Extensions;
c) Patent Linkage;
USA;
Canada;
South Korea;
Mexico;
Singapore;
Australia;
Europe;
India;
5.7 Conclusions;
5.8 Tables;
CHAPTER· 6 Health Policy and Pricing Systems: Global Scenario;
6.1 Introduction;
6.2 United States of America;
6.3 Canada;
6.4 Australia;
6.5 China;
6.6 Europe;
Germany;
Italy;
Spain;
France;
United Kingdom;
6.7 India;
6.8 Conclusions;
Tables;
CHAPTER- 7 Conclusions and Recommendations;
7.1 Conclusions;
7.2 Recommendations;
Guidelines to ensure for proper application for standard of Patentability;
Two tier examination mechanism for Pharmaceutical patents;
Proper application of "Utility" standard for Pharmaceutical Patents;
Changes in the Health / Regulatory System;
Patent linkage;
Data exclusivity;
Patent Term Extensions;
Drug Pricing Policy;
Need for Health Insurance;
Bibliography.