DISSERTATION SYNOPSIS

TITLE
INTRODUCTION
Developed and developing countries disagree on many issues related to the obligations to
implement and enforce strong IPRs under TRIPS in field of pharmaceuticals. This
disagreement particularly relates to the outcome and effect of the obligation to make patent
available for pharmaceutical invention, the obligation to protect pharmaceutical test data
against unfair commercial usage, and the right of developing countries to adopt and invoke
certain legal measures that they consider effective in mitigating the negative effect,
particularly to public health, which stems from enforcing patent rights therein. On the one
hand, developipng countries have questioned the causal relationship between strong IPR and
increased technological innovation in and technology transfer to their pharmaceutical sector.
The argument is focused on the issue that such protection might indeed slow the process of
their development. Therefore, they advocate their right to invoke measure such as
compulsory licensing n various grounds. On the other hand, developed countries maintain
that adopting such measures under certain circumstances such as non working, refusal to
deal and high drug prices, is either illegal or ineffective.
Compared to more traditional intellectual property rights such as patents and copyrights, data
exclusivity is very unusual since it does not require any incentive activity for it to be granted.
Data exclusivity protection is instead only based on the fact that an investment has been made
by the originator in carrying out the necessary tests to demonstrate the safety and efficacy of
their new medicine. Although the TRIPS now require some protection for such data, it does
not require that exclusive rights be granted in the same way as patents or copyrights.
Developed countries pushed very hard during TRIPS negotiations to have data exclusivity
included in the TRIPS agreement as a new type of IPR. They succeeded in part as test data
are mentioned in section 7 but not entirely as TRIPS does not talk about exclusivity as such.
From the perspective of public health and access to medicines, it is preferable not to grant
data exclusivity or otherwise provides data protection beyond that mandated by TRIPS, it is
important to limit its potential negative implications on access to medicines.

Proponents of data exclusivity at times point out that data exclusivity does not have major
implications, since the period of data exclusivity would normally be shorter than the patent
duration. Yet, there are some questions as to whether data exclusivity could prevent the
registration of medicines produced under a compulsory license. If so, data exclusivity would
effectively render the compulsory license useless. Secondly, if a period of data exclusivity is
also granted when an existing medicine obtains marketing authorization (or registration) for a
second or new indication, data exclusivity could (be used to) extend the period of exclusivity
of the originator product. Finally, data exclusivity could prevent the registration of generic
versions of medicines even when there is no patent on a medicine, for example when a
pharmaceutical does not meet the standards for patentability (e.g. because it is not new),
when a country has no patent law, or when no patents are granted for pharmaceuticals. The
latter situation can arise in least developed World Trade Organization (WTO) Member
Countries, which do not have to grant patents for pharmaceuticals until 2016.
The protection of trade secrets is a well established concept, functionally related to the impact
of innovation in the evolution of the economy. Starting from the 19 th century, the industrial
revolution urged law makers to shape the notion of trade secrets as a specific asset deserving
legal protection.
The general definition of trade secrets is provided by Art 39.2 of TRIPS Agreement: Natural
and legal persons shall have the possibility of preventing information lawfully within their
control from being disclosed to, acquired by, or used by others without their consent in a
manner contrary to honest commercial practices so long as such information:
(a) Is secret in the sense that it is not, as a body or in the precise configuration and
assembly of its components, generally known among or readily accessible to persons
within the circles that normally deal with the kind of information in question;
(b) has commercial value because it is secret; and
(c) has been subject to reasonable steps under the circumstances, by the person lawfully
in control of the information, to keep it secret.
In todays economy, information and know-how representation the result of R&D
investments, creativity and business initiative- have become the key factor for developing and
maintaining secrets is their high degree if pervasiveness, in the sense of being potentially
relevant for virtually all businesses. In this scenario, a very large number of firms across all
industry sectors adopt pragmatically the oldest, an apparently simplest, mechanism to protect

such strategic assets: i.e. they keep them secret. Considered as an ancillary part of, or
excluded from, traditional intellectual property rights, trade secrets are not easy to categorise
because they result from the combination of different types of technical and commercial
information. Technical secrets may include drawings and designs, prototypes, manufacturing
process, not patentable or not patented inventions, know how, formulae or recipes, genetic
materials and fragrances; whereas commercial secrets may consist of customer and supplier
lists, business methods and strategies and cost and price information. Although difficult to
frame within a rigid definition, the recurrence of certain elements identifies the object of
protection: trade secrets include any information that has an economic value in which the
owner has a reasonable exploitation interest that is kept confidential and protected through
proper measures.
Trade secrets are valuable business assets to both innovative and non innovative firms. As
valuable business asset, it plays an important role in economic growth and fostering
innovation using trade secrecy
SCOPE OF WORK
This study investigates the legal and economic structure of data exclusivity in India.
Extensive surveys of the economic literature and of the legal framework of India are matched
by comparative analysis with advanced economies representing different economic, legal and
political models, namely European Union and United States of America. Based on the results
of the combined analysis, the study describes fragmented scenario, its commonly perceived
weaknesses and widespread appetite for a harmonized approach. The final recommendations
advocate for legislative initiative on data protection at the Indian and highlight the areas
where intervention would be most beneficial in terms of balanced economic growth and
competitiveness for the market.
OBJECTIVES
1. To understand the basic in and out of Trade Secret and its legal nature
2. To study the regulatory regime protecting the pharmaceutical regulatory data in India
with special emphasis to TRIPS.
3. To analyze the emerging trends of protection and sharing techniques of test data with
special reference to pharmaceutical industry in India.
4. To evaluate the ambit of test data and trade secrets in the light of public interest
5. To examine the suitability of existing remedies for unauthorised usage of test data.

RESEARCH PROBLEM
1. economic and political economy analyses as well as focusing on the potential
costs/benefits of the extent and scope of protection provided, including under various
scenarios of using particular safeguards such as compulsory licenses and parallel
importation.
2. legal policy analysis of the scope and extent of the minimum standards for the
protection of pharmaceuticals required by developing countries in order for them to
fulfil their obligations under the TRIPS Agreement.
3. determining what implications might be associated with the extension of strong patent
protection to developing countries mainly occur within a welfare framework, whether
static or dynamic
4.
RESEARCH QUESTION
RESEARCH METHODOLOGY
REVIEW OF LITERATURE
HYPOTHESIS
CHAPTERIZATION