Get 20M+ Full-Text Papers For Less Than $1.50/day. Start a 14-Day Trial for You or Your Team.

Learn More →

DeepDyve requires Javascript to function. Please enable Javascript on your browser to continue.

Access to Medicine Versus Test Data Exclusivity

Part of the Munich Studies on Innovation and Competition Book Series (volume 4)

DOI: 10.1007/978-3-662-49655-8

ISBN: 978-3-662-49654-1

Publisher: Springer Berlin Heidelberg - Springer Journals

Jul 26, 2016

LitStream

Chapter 1Introduction

Shaikh, Owais H.

Pages: 1 –19

[For the last three decades, since the start of the Uruguay Round of GATT negotiations, the issue of access to medicine has succeeded in remaining one of the most contentious topics in the debate surrounding intellectual property. From the Anthrax scare in the United States to the non-conformity...
LitStream

Chapter 2Test Data Exclusivity: Raison d’être

Shaikh, Owais H.

Pages: 21 –33

[As the question posed at the end of Sect. 1.1.1 reflects, the case for test data exclusivity is in need of an economic justification. The tension between dynamic competition, necessary to develop new products, and static competition, necessary to keep prices low in the market, makes it...
LitStream

Chapter 3Test Data Exclusivity and Art 39(3) TRIPS

Shaikh, Owais H.

Pages: 35 –92

[The TRIPS Agreement is the first multilateral IP treaty that obliges countries to confer protection to pharmaceutical test data. This protection is to be conferred according to Art 39, which relates to ‘Protection of Undisclosed Information’ and also addresses trade secrets generally. However,...
LitStream

Chapter 4Test Data Exclusivity in the US and the EU

Shaikh, Owais H.

Pages: 93 –128

[In this chapter, I will describe the test data exclusivity laws of the US and the EU, who are the pioneers of this protection. The chapter will highlight the various ways test data is protected to give a better understanding of how the test data exclusivity regimes function in these two...
LitStream

Chapter 5Index of Data Exclusivity and Access (IDEAS): Free Trade Agreements

Shaikh, Owais H.

Pages: 129 –192

[This chapter explores in depth, the test data exclusivity provisions in FTAs of the US, the EU and the EFTA countries through the unique Index of Test Data Exclusivity and Access (IDEAS). The aim of IDEAS is to determine the extent to which these provisions provide flexibility for access to...
LitStream

Chapter 6Index of Data Exclusivity and Access (IDEAS): National Laws

Shaikh, Owais H.

Pages: 193 –208

[The previous chapter presented an analysis of the test data exclusivity provisions in various FTAs using the unique IDEAS framework. In this chapter, I explore the national laws of the countries that are parties to these FTAs and determine, through IDEAS, how these countries implement their FTA...
LitStream

Chapter 7Test Data Exclusivity in FTAs and Access to Originator Pharmaceuticals

Shaikh, Owais H.

Pages: 209 –219

[In Chaps. 5 and 6, I have discussed the impact of test data exclusivity on the availability of generic pharmaceuticals. However, some FTA test data exclusivity provisions may also restrict access to originator pharmaceuticals in an FTA party as well. In this chapter, I focus on this possibility....
LitStream

Chapter 8Conclusions and Recommendations

Shaikh, Owais H.

Pages: 221 –232

[This study has highlighted the current state of affairs with regard to test data exclusivity protection. The world is much different today as compared to the year 1995. The success of countries, supporting the ‘misappropriation approach’ finally adopted in Art 39(3) TRIPS, appears to have lived...

results per page

Prev
1
Next

Browse All eBooks