The Scope and Issues of Trade Related Aspects of Intellectual Property Rights (TRIPS) in Indian Pharmaceutical Industry

By

ACKNOWLEDGEMENT

My thanks go out to all who have helped me complete this study and with whom this project may have not been possible. In particular, my gratitude goes out to friends, facilitator and family for extensive and helpful comments on early drafts. I am also deeply indebted to the authors who have shared my interest and preceded me. Their works provided me with a host of information to learn from and build upon, also served as examples to emulate.

DECLARATION

I, (Your name), would like to declare that all contents included in this thesis/dissertation stand for my individual work without any aid, & this thesis/dissertation has not been submitted for any examination at academic as well as professional level previously. It is also representing my very own views & not essentially which are associated with the university.

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ABSTRACT

In this thesis, an industry wide pharmaceutical innovation metrics creation takes place, based over characterisation and classification of Foreign Direct Investment (FDI) potential, in-house research and development and technology acquisition, patent activity analysis over the years, research and development directions assessment and innovation outcomes evaluation. The main aim behind conducting this research was to give a reflection over the learning adaption, building innovation and competence and for creation of linkages and complementarities with the pharmaceutical industry during the Post-TRIPs (Trade Related Intellectual Property Rights) period. With India, going through numerous difficulties and challenges for shaping up the strategies and pathways for learning acceleration, the research also makes an effort for the exploration of the actions and activities, strategies types and growth routes have helped in reaching the Pharmaceutical Industry innovation within a decade in India. Finally, what kind and how policies could be shaped that could lead the Indian society and state intervention to push innovation frontier further in the Pharmaceutical Industry of India. Indian businesses and state have preferred global pathways along with the specific innovative implications. This research assess the systematic link and connection of such implications, proposing that a considerable change in foreign and domestic firms operating in the industry of Pharmaceuticals, as reflected in the Research and Development expenditures activity, there has also been a key focus over the pathways leading to domestic markets innovation.

TABLE OF CONTENTS

ACKNOWLEDGEMENTii

DECLARATIONiii

ABSTRACTiv

CHAPTER 01: INTRODUCTION1

Background1

Aims and objectives2

Research Methodology3

Research Strategy3

Sampling Method5

CHAPTER 02: INDIAN PHARMACEUTICAL INDUSTRY - PRE AND POST TRIPS7

History of Past Legislation (Until 1995)7

A Basic Goal of the Policy Makers7

Changes in Legislation since the Signing of TRIPs13

Article 1.114

Article 39.315

Other Legislations and their Impact on Industry16

Amendments of the Indian Patents Act under the TRIPS Regime17

CHAPTER 03: IMPACT OF PATENT REGIME ON R&D WITH REFERENCE TO INDIAN PHARMACEUTICAL INDUSTRY20

Introduction20

New evidence of innovation21

Companies Analysis29

Wockhardt Life Sciences, Ltd. (India) (NL:)29

Glenmark Pharma Ltd.30

Cadilla Health Ltd.31

Aurobindo32

Ranbaxy Laboratories Ltd. (India) (NBB: RBXZ F)33

Torrent Pharma Ltd. (India)35

Dr. Reddy's Laboratories Ltd. (NYS: RDY)36

Sun Pharmaceutical Industries Ltd36

CHAPTER 04: EFFECTS OF POST TRIPS PATENT SYSTEM38

The Evaluation Process of Innovation Routes post-TRIPS38

Review of policies with evidence after the TRIPS performance39

The TRIPS Agreement40

Effect ...