The Indian pharmaceutical industry : impact of changes in the IPR regime / Yaeko Mitsumori.
Mitsumori, Yaeko, author.
2018
HD9672.I52
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Title The Indian pharmaceutical industry : impact of changes in the IPR regime / Yaeko Mitsumori.
Author Mitsumori, Yaeko, author.
ISBN 9789811067907 (electronic book)
9811067902 (electronic book)
9811067899
9789811067891
Publication Details Singapore : Springer, [2018]
Language English
Description 1 online resource.
Call Number HD9672.I52
Dewey Decimal Classification 338.4/73621
Summary This study analyzes the impact of the revision of the Indian Patent Act (2005) on the Indian pharmaceutical industry, which has been achieving healthy growth over the past 30 to 40 years or more. As of 2005, the Indian pharmaceutical industry was ranked as No. 4 in the world in terms of volume and 15th in terms of value. WTO/TRIPS required India to revise its patent law, however, and to introduce product patents in the pharmaceutical field. Many not only in India but also in the world had argued that the local pharmaceutical industry could deteriorate once a strong patent law (such as a product patent) was introduced. However, the Indian pharmaceutical industry has continued to develop rapidly even after the revision of the patent law in 2005. This present study started with efforts to work out the reason the Indian pharmaceutical industry successfully expanded even after the introduction of product patents. The study found that a unique article (the so-called '3-d') inserted in the Patent Act 2005 might have played a role in diminishing or preventing a negative impact from the introduction of a strong patent system, such as a product patents. The study also considers that a change of the business model adopted by the Indian pharmaceutical industry might have contributed to diminishing the effect of the negative impact from the introduction of a strong patent law. This study also covers recent developments in India regarding intellectual property rights and the pharmaceutical industry. One is India's very first compulsory license granted to an Indian pharmaceutical company, Natco, against the large German pharmaceutical firm Bayer; and the second is the Supreme Court decision on Novartis' Gleevec. The study analyzes the fundamental problems that caused these two events: access to medicine and gaps in the concept of intellectual property in the pharmaceutical industry. As possible solutions to these fundamental issues, this book explores the ideas of voluntary licensing and tiered pricing. .-- Provided by publisher.
Bibliography, etc. Note Includes bibliographical references.
Access Note Access limited to authorized users.
Source of Description Online resource; title from PDF title page (viewed July 13, 2018).
Series SpringerBriefs in health care management and economics.
Available in Other Form Print version: 9789811067891
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Intro; Contents; Chapter 1: Introduction; 1.1 Background; 1.2 Trend of Indian Pharmaceutical Industry and Indian Patent Policies; 1.2.1 Trend of Indian Pharmaceutical Industry; 1.2.2 TRIPS Enforcement and Background to Introduction of Product Patents; 1.2.3 Discussion around Introduction of Product Patents into the Indian Patent Regime; 1.3 Research Subject and Objectives of This Study; References; Chapter 2: Historical Background and Current Status of Indian Pharmaceutical Industry and Indian Patents Regime; 2.1 Status of the Indian Pharmaceutical Industry

2.2 Remarkable Features of the Pharmaceutical Industry from the Perspective of Patent Protection2.3 Current Status of the Indian Pharmaceutical Industry; 2.3.1 Indian Pharmaceutical Companies vs. Foreign Pharmaceutical Companies; 2.3.2 Disease Profile in India; 2.3.3 Regulation of Drugs in India; 2.3.4 Medicines Purchasing Trend; 2.3.5 Advanced Technology in the Indian Pharmaceutical Industry; 2.3.6 Development of the Indian Pharmaceutical Industry; 2.4 Indian Patent Law; 2.4.1 Transition of Indian Patent Law; 2.4.2 Section 3 (d) of Patents (Amendment) Act, 2005 of India; 2.4.3 Mailbox

2.4.4 EMRReferences; Chapter 3: Research Subject and Methodology; 3.1 Setting up a Hypothesis; 3.2 Hypothesis; 3.3 Research Subject and Methodology; 3.4 Research Framework; References; Chapter 4: Analysis of Preceding Studies; 4.1 Developing Countries and Patent Law; 4.2 Impact of Introduction of Product Patents; 4.3 Section 3 (d) of Indian Patents (Amendment) Act, 2005; 4.4 Transition of Indian Pharmaceutical Industry Business Model; 4.5 Working Hypothesis; References; Chapter 5: Analysis of Indian Pharmaceutical Industry Indicators: Data Analysis; 5.1 Data Analysis Methodology

5.2 Indian Pharmaceutical Companies Stock Price Analysis5.3 Business Performance Analysis of Indian Pharmaceutical Companies: Trend of Sales and Profits; 5.4 Trend of R&D Investment in Indian Pharmaceutical Industry; 5.5 Development Pipeline Analysis; 5.6 Analysis of Patent Applications in India; 5.7 An Analysis of Medical Products Trade (Bulk/Intermediates and Formulations); 5.8 Development Model of Indian Pharmaceutical Industry; 5.9 Summary of This Chapter; References; Chapter 6: Analysis of Patents Act Enforcement After Introduction of Product Patents

6.1 Method of Analysis: Outlines of On-Site Interviews in India6.1.1 Pharmaceutical Industry Associations; 6.1.2 Pharmaceutical Industry in India; 6.1.3 Indian Government; 6.1.4 Universities; 6.1.5 Law Firms and Consulting Firms; 6.2 Views of Pharmaceutical Industry and the Indian Government; 6.2.1 IDMA; 6.2.2 IPA; 6.2.3 OPPI; 6.2.4 CSIR; 6.3 Patent Rejection Based on Section 3 (d); 6.3.1 Patent Rejection for Gleevec; 6.3.2 Roche vs. Cipla over Tarceva; 6.4 Monetization of R&D Outcomes; 6.4.1 New Subsidiaries for New Drug Discovery/Development; 6.4.2 Out-Licensing; 6.4.3 Drug Delivery Systems

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