Introduction

This chapter provides an overview of work done in the WTO on IP and public health. Chapter X briefly covers important work done in this area outside the WTO, notably in the WHO.

The TRIPS Agreement represents an attempt at the multilateral level to achieve the difficult task of balancing the interest of providing incentives for research and development of new drugs with the interest of making these drugs as widely accessible as possible to patients needing them. Consequently, in setting minimum standards for the protection and enforcement of IPRs, the TRIPS Agreement recognizes the right of countries to take various kinds of measures to qualify or limit IPRs, including for public health purposes. If a Member wants to avail itself of these flexibilities under the Agreement, it may need to implement them into its domestic law in order to be in a position to make use of them. That is, the mere recognition of these flexibilities as legal options under the international TRIPS Agreement does not necessarily mean that Members' national laws already provide sufficient flexibility. Further, the TRIPS Agreement – and the IP system more generally – is only one element of the bigger challenge of access to medicines, which also includes such important factors as the public health system in general, drug regulatory authorities, financing, health insurance, infrastructure, procurement regimes and import tariffs applied to pharmaceutical products.

Introduction

The purpose of this chapter is to introduce the key features of the provisions of Part III, Sections 1 to 5, of the TRIPS Agreement entitled ‘Enforcement of Intellectual Property Rights’. This part of the Agreement elaborates in twenty-one articles the enforcement procedures that Members have to make available to permit prompt and effective action against infringements of IPRs covered by the TRIPS Agreement. It is divided into five sections:

• general obligations (Article 41);

• civil and administrative procedures and remedies (Articles 42 to 49);

• provisional measures (Article 50);

• special requirements related to border measures (Articles 51 to 60); and

• criminal procedures (Article 61).

Unlike the substantive standards for the protection of IPRs in Part II of the TRIPS Agreement, which draws extensively on the existing body of international IP law, Part III incorporates only a few relevant provisions from earlier treaties; these are mentioned briefly below.

Background

Concerns in the multilateral trading system about counterfeiting and piracy and the perception that the international IPR system lacked effective rules on enforcement pre-dated the negotiations on the TRIPS Agreement. As seen in Chapter I, a proposal on trade in counterfeit goods was developed in the GATT, in 1978, as part of the Tokyo Round of trade negotiations, but no agreement was reached at that time. Subsequent work led to the inclusion of a specific mandate on IPRs in the Uruguay Round negotiations, which included a call for the development of a multilateral framework of principles, rules and disciplines dealing with international trade in counterfeit goods. When adopted, the TRIPS Agreement was the first multilateral treaty with detailed rules on the enforcement of IPRs, although earlier IP treaties, notably the Paris and Berne Conventions, do have some provisions specifically on enforcement.

General

Part II of the TRIPS Agreement sets out the substantive standards for the protection of IP that WTO Members should follow. This chapter outlines the provisions of Section 1 of Part II (running from Article 9 to Article 14), which sets out the protection that Members must make available for literary and artistic works, performances, phonograms (or sound recordings) and broadcasts.

This section has to be read, like all other sections in Part II, together with the relevant provisions of certain pre-existing treaties in the area of international IP law that are incorporated by reference into the TRIPS Agreement. In the case of copyright, the relevant treaty is the Berne Convention; and on related rights, there are certain references to the Rome Convention. The relationship between the TRIPS Agreement and these Conventions is explained in section C3 below.

A note of caution: the provisions of the TRIPS Agreement stipulate the minimum level of protection that Members have to provide to nationals of other Members. In other words, they determine the obliga- tions that such countries have towards each other. Given the long history of international cooperation on copyright matters, the national laws in this area are often fairly similar. However, to answer any question the reader may have on how the law applies in any practical situation, the applicable national law will have to be consulted.

General

This chapter provides an overview of the TRIPS Agreement. It first explains the historical and legal background of the Agreement and its place in the World Trade Organization (WTO). It then turns to the general provisions and basic principles, as well as other provisions and institutional arrangements, that apply to all the categories of intellectual property rights (IPRs) covered by TRIPS. Chapters II to VII then discuss each of these categories in more detail.

However, in order to understand the TRIPS Agreement it is important to first review the background to the intellectual property (IP) system: what the main forms of IPRs are, why these ‘rights’ are recognized, and how they are protected. These questions have been at the core of IP policy discussions since the adoption of the earliest IP laws, and continue to spark active debate. This chapter attempts neither to summarize various relevant legal and economic theories, nor to survey the range of views presented in the debate, but merely highlights some of the general concepts and approaches.

IPRs can be characterized as rights given to persons over the creations of their minds. They usually take the form of a limited ‘exclusive right’ granted under national law to a creator over the use of the creation for a certain period of time. Such a right allows the creator to exclude others from using the creation in certain ways without the creator’s authoriza- tion. The right holder can then extract economic value from the IPRs by using them directly or by authorizing others to do so.

General

TRIPS includes a set of transparency mechanisms, which require Members to furnish extensive information about their IP laws and policies, and details about how IPRs are administered and enforced in their territories; these laws are also reviewed in detail in the TRIPS Council. The operation of these transparency mechanisms in the years since 1995 has yielded a uniquely comprehensive and systematic body of information that now covers some 130 jurisdictions (essentially all WTO Members other than LDCs, for whom these provisions do not yet apply).

The very purpose of these mechanisms is to enable understanding of national IP laws and policies; and in practice the TRIPS notifications and related TRIPS Council review materials are a useful and geographically broad resource for those – delegates, analysts, researchers, policy-makers – seeking detailed information on a wide range of questions of IP law, practice and policy. Other working documents and minutes of the Council's regular and special sessions also provide a wealth of information on Members’ policy positions and international debate on these matters. Furthermore, dispute settlement panel and Appellate Body reports dealing with the TRIPS Agreement shed light on the interpretation of its provisions.

Introduction

This chapter explains the provisions of Section 5 of Part II of the TRIPS Agreement entitled ‘Patents’. Section 5, which contains eight articles, from Article 27 to Article 34, sets out the obligations of Members with respect to standards concerning the availability, scope and use of patents. Starting with a general explanation of terms, this chapter goes on to explain each specific provision in this Section of the TRIPS Agreement.

What are patents?

The term ‘patent’ is not specifically defined in the TRIPS Agreement. A patent is the title given to the IPR that is granted to protect new inventions. A patent, which is granted by the authorities in a specified jurisdiction, gives its owner an exclusive right to prevent others from exploiting the patented invention in that jurisdiction for a limited period of time without his or her authorization, subject to a number of exceptions.

The term ‘invention’ is not defined in the TRIPS Agreement. One informal definition (used, for example, in some WIPO capacity building materials) characterizes an invention as a new solution to a technical problem. Other approaches to defining ‘invention’ can also be found in national laws. Many national laws exclude such material as scientific theories, aesthetic creations, schemes, and rules and methods for performing mental acts. These activities do not aim at any direct technical result but are rather of an abstract and intellectual character.

Preface

At the heart of the World Trade Organization (WTO), as an international organization, is a set of rules that regulate trade between nations: a body of agreements which have been negotiated and signed by governments of the majority of the world's trading nations, with the aim of promoting transparency, predictability and non-discrimination in trading relations. These agreements, covering trade in goods, trade in services and trade-related aspects of intellectual property rights, help to define and inform the multiple roles of the WTO, in administering the trade agreements, providing a forum for trade negotiations, handling trade disputes, monitoring national trade policies, providing technical assistance and capacity building for developing countries, and cooperating with other international organizations. Understanding these agreements and their practical, policy and legal contexts therefore provides significant insights into the WTO as an institution, its activities and international role, its partnerships with other organizations, and the way in which WTO Member governments identify and pursue their national interests through this intergovernmental forum.

When, in 1994, at the end of the Uruguay Round of trade negotiations, governments settled on the cluster of agreements that created and defined the WTO, the Agreement on Trade-Related Aspects of Intellectual Property Rights, or the TRIPS Agreement, was part of the package. The TRIPS Agreement was not negotiated as a stand-alone treaty, and did not enter into legal force on its own, but is one of the multilateral trade agreements (MTAs) that are integral to the overarching Marrakesh Agreement Establishing the World Trade Organization. This status means that when the TRIPS Agreement entered into force in 1995, it was as part of a composite set of trade agreements that are together binding on countries that choose to join the WTO as Members. The WTO Agreement also made disputes between Members about trade and intellectual property subject to the same dispute settlement mechanism as is used for a wide range of trade issues. But the TRIPS Agreement also incorporated significant elements of the established multilateral intellectual property agreements administered by the UN specialized agency for intellectual property, the World Intellectual Property Organization (WIPO). Hence the TRIPS Agreement has a dual character – an important element of international trade law, it also draws heavily on, and builds upon, the established heritage of international intellectual property (IP) law.

Current issues

The TRIPS Agreement was not envisaged as an entirely static legal instrument: TRIPS negotiators included several provisions within the Agreement that set out a work programme for the future – the so-called ‘built-in agenda'. And since the TRIPS Agreement entered into force, WTO Members have decided to elaborate and enhance these review processes. The most significant addition to these processes is the work on public health and access to medicines issues in line with the Doha Declaration on the TRIPS Agreement and Public Health, which is covered in Chapter IX. This chapter provides a general overview of the ongoing work in the TRIPS Council and other WTO bodies on other aspects of TRIPS and public policy as of the time of writing, focusing on the following issues, which have been the most prominent:

• GIs – the Article 23.4 negotiations on a system of notification and registration, a review of GI protection under Article 24.2, and work on the question of possibly extending to other products the protection provided to wine and spirits under Article 23 (so-called ‘GI extension').

• Biodiversity and traditional knowledge – the review of the provisions on what can broadly be called ‘biotechnology patenting' established under Article 27.3(b) of the TRIPS Agreement, and a wider slate of related issues, especially the work on the relationship between the TRIPS Agreement and the CBD, and the protection of TK and folklore.

• Non-violation complaints – the examination by the TRIPS Council of the scope and modalities of such disputes which is required under Article 64.3, and which has been considered by several Ministerial Conferences as mentioned in Chapter VIII, section C2.

• LDCs and TRIPS: specific recognition of the distinct context and interests of LDCs.

• Transfer of technology – the review mechanism set up by the TRIPS Council to monitor the implementation of the obligation, under Article 66.2, on developed country Members to provide incentives for technology transfer to LDCs.

• Electronic commerce and its implications for the TRIPS Agreement.

General

The TRIPS Agreement gives effect to a principle of transparency, founded on a system of notifications about how countries choose to implement TRIPS provisions. These notifications, built up since 1996, now amount to a useful collection of factual information about national IP systems, as well as specific details on key issues such as incentives for transfer of technology, and contact points within national systems. These notifications help the Council for TRIPS to monitor the operation of the Agreement and to promote understanding of Members’ IP policies.

These transparency provisions oblige WTO Members to

• notify to the Council for TRIPS their IP laws and regulations;

• establish and notify contact points in their administrations for the purposes of cooperation with each other aimed at the elimination of trade in infringing goods;

• notify the Council in the event that they wish to avail themselves of certain possibilities provided for in the Agreement that relate to the substantive obligations. These concern, for example, modifications of the criteria of eligibility for protection, exceptions to the MFN treatment, and protection of state emblems.