Table of  Contents  I

TABLE OF  CONTENTS  

1  Introduction and Problem Definition  1

2  The TRIPs Agreement - An Overview.  2

2.1  Central Principles and General Regulations  2

2.2  The TRIPs Agreement and Intellectual Property Rights.  3

3  Implementation of Patent Protection in the TRIPs Agreement  5

3.1  Current Areas of Discussion.  5

3.2  Relevant Articles and Interpretation.  5

3.3  Problems of Interpretation in Terms of Patent Protection for Pharmaceutical Products  

   7

3.4  The Problem of Conflictive Interests between Industrialized and Developing Countries  

  and the Resulting Impact on LDC’s.  8

4  Doha Declaration (2001) to TRIPS and Public Health  11

4.1  Reasons for the Doha Declaration.  11

4.2  Content of the Doha Declaration  12

4.3  Interpretation of the Declaration and the “Paragraph 6 Solution  13

4.4  Negotiation Process between Developing and Industrial Countries  14

5  Post-Doha: Compulsory Licences for Countries with Insufficient or no  

  Manufacturing Capacity  16

5.1  Accomplishment of the Decision.  16

5.2  Content of the Decision  17

5.3  Critical Evaluation of the Decision  18

6  Case Study: Pharmaceutical Supply in Developing Countries.  20

6.1  Background.  20

6.2  Development of a Pharmaceutical Industry in Developing Countries.  20

6.3  Undersupply of pharmaceuticals - the Case of HIV/Aids.  21

6  4 Patent issues in access to HIV/AIDS drugs in Kenya  25

Table of  Contents  II

6.5  Resulting Problems  26

7  Conclusion  27

8  References  28

  Figures  

  FIGURES  

  Figure 1: The normative framework - the three pillars of the multilateral trade agreements.  

  Figure 2: Consequences of competition in the generics production (June 2000 - June 2006)  

Abbreveations IV

ABBREVIATIONS

EDL Essential Drugs List EU European Union GATS General Agreement on Trade in Services GATT General Agreement on Tariffs and Trade Inc. Incorporation LDC Least Developed Country NHI National Health Institute MSF Médecins Sans Frontiéres NGO Non-Governmental Organization R&D Research & Development TRIPs Agreement on Trade-Related Aspects of Intellectual Property Rights US United Staates VFA Verband Forschender Arzneimittelhersteller WIPO World Intellectual Property Organization WHO World Health Organization WTO World Trade Organization

1. Introduction and problem definition 1

1 Introduction and Problem Definition

Due to the ongoing globalisation process and the proceeding trade liberalisation the protection of intellectual property rights is becoming more and more important. The fastpaced technological progress and the shortened product life cycles call for a closer ¹ consideration of material goods in the world economy and the necessity to protect those. The further development of production techniques, well developed communication chains and the further development of new media enable the copying, imitating and the piracy of goods or make it even easier. To thwart those acts of piracy the protection of intellectual property rights has to be ensured. This is guaranteed by the TRIPs Agreement, the WTO’s ² Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs). This paper will focus on the patent protection as one main area of the TRIPs Agreement. Since the success and establishment of industries is dependent on a well-functioning and predictable patent system, it is important to refer to questions of patent protection. Especially the pharmaceutical sector is reliant on patent protection, which is emphasised by the ³ following quotation:

“Questions as to the patentability of inventions of pharmaceutical products or biotechnological products, the rights conferred by a patent or the possibility to grant compulsory licences resulted in barriers to the conclusion of a definitive agreement 4 on patent protection”

In light of this, since international conventions on patent protection left too much scope for interpretation, TRIPs was implemented to fill in the gaps in the international patent systems ⁵ by setting up uniform minimum protection standards.

The following article shall give an overview of the TRIPs Agreement and the concept to protect intellectual property. The pharmaceutical production and the abuse of rights are the main focus of this work. During the analysis of the articles and the exemplification of the conflictive interests of the developing and the industrial countries the problem of compulsory licences in the pharmaceutical sector will illustrate the problematic situation in the area of patent protection in pharmaceutics. Finally, case studies will be integrated to back up the findings.

¹ Cf. Staehelin (1997), p. 14.

² Cf. Stremmel (2004), p. 1.

³ Cf. Kolker (2000), p. 4.

⁴ Kolker (2000), p. 4.

⁵ Cf. Kolker (2000), p. 4.

3. Implementation of patent protection in the TRIPs agreement 2

2 The TRIPs Agreement - An Overview

2.1 Central Principles and General Regulations

The Agreement on Trade-Related Aspects of Intellectual Property Rights is one of the three pillars of the multilateral trade agreement that belong to the WTO. The further two ⁶ and the General agreements are the General Agreement on Tariffs and Trade (GATT) ⁷ Agreement on Trade in Services (GATS) . All member states of the WTO are also ⁸ contracting states of the three mentioned agreements.

⁹ Figure 1: The normative framework - the three pillars of the multilateral trade agreements. The protection of intellectual property was implemented with the foundation of the WTO in 1995 by integrating the TRIPs Agreement within the WTO regulation framework. Under the former GATT 1947 regulation patent protection was not compulsory. Before the WTO was ¹⁰ had established and simultaneously the TRIPs Agreement was implemented, the WIPO ¹¹ sole responsibility with reference to intellectual property and its protection. The TRIPs Agreement is based on the principles of established conventions that were already dealing with the protection of intellectual property before the TRIPs implementation. These conventions are the following: Berner convention, Rome convention, Washington contract and Paris convention. All contracting states of the TRIPs Agreement are also ¹² members of the mentioned conventions.

⁶ In 1993 GATT 1967 was updated to GATT 1994. The existing GATT members became founding

members of the WTO. The WTO expanded its scope from traded goods to trade within the service

sector and intellectual property rights.

⁷ GATS entered into force as a treaty of the WTO in 1995. The treaty extends the multilateral trading

system to services, in the same way as GATT provides such a system for merchandise trade.

⁸ Cf. Geisel (2003), pp. 27-28.

⁹ According to Geisel (2003), pp. 27-28.

¹⁰ The WIPO was established in 1967 with the objective to foster the rights of intellectual property. The

WIPO had a consultant function and helped governments with questions of intellectual property in the

legislative. Since the TRIPs agreement was negotiated and implemented in the WTO regulation, the

WIPO sees itself affronted by loosing its former power and tries to win back its influence.

¹¹ Cf. Geisel (2003), pp. 27-28.

¹² Cf. Seiler (2000), p. 8.

3. Implementation of patent protection in the TRIPs agreement 3

The agreement consists of seven parts, which cover three main features: standards, enforcement and dispute settlement. The most important general regulations refer to the ¹³ The mainon-discrimination rule and the regulation of uniform minimum standards. objective of the TRIPs Agreement is the global harmonisation of intellectual property. The agreement established a global protective framework for intellectual property and sets up compulsive minimum standards for a multitude of intellectual property rights. Moreover, every contracting state is allowed to enact further laws that extend the degree of intellectual ¹⁴ With legal validity of the TRIPs Agreement the following property rights protection.

deadlines for implementation have been defined: 1) industrialised countries had to transpose all regulations within one year 2) developing countries was given an additional four-year deadline and 3) the least developing countries was granted a transitional period of 10 ¹⁵ After the ministerial conference in Doha the transitional period for the least years. ¹⁶ developing countries was elongated until 2016.

2.2 The TRIPs Agreement and Intellectual Property Rights

Since this paper focuses on the TRIPs Agreement both the term intellectual property and intellectual property rights will be explained briefly. The term intellectual property refers to ¹⁷ According to Khor (2006) “the rights given to people over the creations of their minds”. these rights are seen as a privilege which give the innovator or creator of a work a compensation for his research expenditure and development effort. Intellectual property can thus be seen as main term for immaterial goods which comprises inventions, concepts, intellectual works and more. Intellectual property rights are the rights that are linked to the immaterial goods and which include a temporary exploitation right. The exploitation right gives the owner of the intellectual property the right to use the intellectual property in a monopolistic manner during the specified period. Hence, competitors are debarred from producing and launching a comparable product at a lower price. Concerning immaterial goods one must be aware that immaterial goods are not generally protected by the laws. A legal order with appropriate rights like patent rights or copy rights must be given to a person ¹⁸ to protect the intellectual property.

¹³ WTO (2008 a) Intellectual property: protection and enforcement, Internet:

http://www.wto.org/english/tratop_e/trips_e/intel2_e.htm, 22.03.2008.

¹⁴ Cf. Staehelin (1997), pp. 25-31.

¹⁵ Cf. Harnisch (2006); pp. 49-50.

¹⁶ Cf. Sasdi (2004), p. 237.

¹⁷ WTO (2008 b), Internet: http://www.wto.org/english/tratop_e/trips_e/trips_e.htm, 22.03.2008.

¹⁸ Cf. Khor (2006), p. 5.

3. Implementation of patent protection in the TRIPs agreement 4

The areas that are covered by the TRIPs Agreement are: copyright and related links, trademarks including service marks, geographical indications, industrial designs, patents, layout designs (topographies) of integrated circuits, and undisclosed information including ¹⁹ Thus, nearly all existing instruments that are necessary for the protection of trade secrets.

²⁰ are implemented in an international contract and are anchored in the commercial rights

²¹ According to the introduction this paper will only focus on the patents. WTO regulations.

One common way to describe a patent may be the following: A patent is a legal document giving the patentee a twenty-year monopoly. According to Bently and Sherman (2004) patens are differing from the industry and branch of science, which means that patents are classified with regard to the nature of the protected interest, for example as a product patent, ²² process patent or product by process patent.

¹⁹ Cf. Seiler (2000), S. 8.

²⁰ Excluding rights of breeders and utility-models ("petty patents"), which are connected to innovations

that play a role in the area of living matter

²¹ Cf. Seiler (2000), p. 8.

²² Cf. Bently, Sherman (2004), pp. 350-351.