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World Health Organization 2011

This report identifies and analyses trends in the local production of medicines in developing countries and related technology transfer. The objective is to assist the World Health Organization (WHO) in its support for Member States in implementing the global strategy and plan of action on public health innovation and intellectual property with particular reference to the promotion of capacity-building for local production in developing countries. The methodology of research included interviews with a range of stakeholders, including industry actors, operators of product development partnerships (PDPs), government officials and members of public health advocacy groups; review of literature and Internet resources; and participation in meetings with stakeholder groups in Africa, Asia and Latin America.

This report makes a number of recommendations. These are focused mainly on the role that WHO, working in partnership with others, can take with respect to transfer of technology and local production of medicines in developing countries.

 

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Global Health Programme Working Paper No. 7/2011, November 15, 2011

In the decade since the Doha Declaration was adopted, significant progress has been made in addressing problems associated with innovation and access to medicines, including through expanded financial support for procurement and distribution of treatments and vaccines and the establishment of new research and development (R&D) mechanisms. There has been enhanced cooperation among WHO, WIPO and the WTO. Nevertheless, significant gaps remain in placing the development and supply of medicines to the world’s population on a sustainable footing; gaps that are exacerbated by the present trend toward restrained government spending. This paper reflects on the political and legal constellation making progress on global public health matters difficult, and on economic and scientific trends in the medicines sector that may affect policy over the next decade. A sustainable medicines supply system should proceed from “first principles”, encompassing financing mechanisms to assure that essential medicines are provided for all, while affording opportunity to countries at all levels of development to offer access to advanced treatments on a fair compensation basis. Improved mechanisms to incentive R&D are necessary and feasible. First principles should encompass rational prescribing based on the best interests of the patient, and should attend to regulation and enforcement adequate to assure quality, safety and efficacy. Development of a sustainable system could require some modification to the WTO TRIPS Agreement, but this should not be a determinative factor in considering an improved international framework. A new mechanism for global coordination of medicines strategy may be helpful.

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ICTSD Programme on IPRs and Sustainable Development, No. 30, October 2010

Access to biological material with human pathogenic potential (pathogen materials) is important because research directed toward the development of new drugs and vaccines is dependent on scientific analysis of the underlying causes of disease. Member States of the World Health Organization (WHO) began to address problems associated with the sharing of pathogen materials when controversy arose in 2007 following Indonesia’s decision to withhold samples of biological material containing the H5N1 virus (avian flu) from WHO researchers. As a general proposition, states have sovereign rights of ownership and control over access to biological resources located within their territories and thus may determine the conditions of access to those resources. This includes ownership and control over access to pathogen materials. Sovereign control over pathogen materials and access to them is complicated by the fact that they have a tendency to spread geographically, and at some stage, to cross national borders in the absence of intentional human intervention. These sovereign rights, however, do not imply that the host state is not constrained by international legal obligations, such as the obligation to protect human rights related to life and health and the obligation to protect against harm to neighboring states. As a general proposition, states have sovereign rights of ownership and control over access to biological resources located within their territories and thus may determine the conditions of access to those resources. This includes ownership and control over access to pathogen materials. Sovereign control over pathogen materials and access to them is complicated by the fact that they have a tendency to spread geographically, and at some stage, to cross national borders in the absence of intentional human intervention. The ownership and control of pathogen materials are regulated at the international level by a set of norms involving: public international law, the Convention on Biological Diversity (CBD), the WHO Constitution and the International Health Regulations (IHR), the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and international human rights norms. Supplemental norms are under negotiation at the WHO (in the Intergovernmental Meeting on Pandemic Influenza Preparedness) under the CBD (in the Ad Hoc Open-Ended Working Group on Access and Benefit Sharing) and at the WTO (as part of the Doha Round). The reasons pathogen materials may, or may not, be subject to the regime established by the CBD are technically complex from a legal standpoint. Pathogen materials, as a general matter, probably are covered by the CBD, though this is not intended to suggest that the CBD is better equipped than the WHO to address the sharing of pathogen materials in the public health context, but rather addresses the existing or “default” legal situation. There is room for debate concerning whether the CBD, or at least its provisions on ABS, covers viruses, because of specific definitional language in the CBD. New rules related to pathogen materials sharing should most appropriately be negotiated at the WHO, because of the specific relationship to public health, which is most closely associated with the WHO charter. Protecting global health will require that countries share at least some categories of pathogen materials. An important element of the WHO negotiations is to define the availability of IPRs protection for the results of research and development. A negotiated framework must necessarily address the question of the extent to which recipients of such materials may apply for and obtain patents and/or the terms and conditions that will be applicable with respect to any patents obtained. Underlying the WHO negotiations is the question of affordable access to vaccines and treatments for developing countries, which is a presumed condition of a pathogen materials sharing obligation, at least among some WHO Member States. There is a real risk that the result will be a two-tiered system of access to pathogen materials: one addressing certain influenza viruses under the auspices of the WHO and another addressing pathogen materials more generally under the auspices of the ABS Protocol and/or the CBD. As a practical matter, subjecting states, economic operators and individuals to separate agreements covering the same subject matter may create confusion, particularly if the relationship between the agreements is not clearly specified and the rights and obligations are not in harmony. When public health interests are at stake, it is important to avoid a result that generates legal uncertainty and insecurity. Recognizing that negotiators at the WHO and the CBD are engaged in substantially independent and complex exercises each in their own right, greater attention should be focused on how the results of these exercises will relate to each other. Moreover, negotiators at the WHO should be cognizant of the fact that the current IGM-PIP negotiations are not taking place in a legal vacuum. This not only suggests that increased effort should be made to bring the current negotiations that address influenza viruses to a satisfactory conclusion, but also that these negotiations should be followed by a broadened effort to more generally address pathogen materials.

in INTERNATIONAL TRADE LAW AND THE GATTIWTO DISPUTE SETTLEMENT SYSTEM 415-37 (ed. E.-U. Petersmann), Kluwer Law International, 1997

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The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (the "TRIPS Agreement") has ushered in a new generation of legal issues that may ultimately find their way into the WTO dispute settlement arena. In light of the extensive coverage given to the WTO Dispute Settlement Understanding (DSU) elsewhere in this book, and the broad range of dispute-related issues raised by the TRIPS Agreement, this chapter will focus on issues that are more or less specific to the TRIPS Agreement.

The TRIPS Agreement is unique in the WTO context; it is the only WTO agreement that requires the members to affirmatively (or positively) incorporate complex substantive legal standards into national laws that govern both domestically-produced and imported goods. It relies for many of its rules on cross-reference to an existing body of multilateral conventions administered outside the WTO. The substantive rules imposed by the TRIPS Agreement are the subject of existing bodies of judicial opinion in the national and regional territories that are now subject to its discipline. Underlying the superficial certainty of the TRIPS Agreement substantive prescriptions are existing gulfs of interpretative difference regarding the meaning of many of its rules.


The TRIPS Agreement is unique in that it establishes minimum standards applicable to the enforcement of legislation by WTO members. The establishment of minimum enforcement standards necessarily implies that claims alleging the maintenance of inadequate enforcement procedures can and may be brought before the WTO Dispute Settlement Body, yet the TRIPS Agreement is silent on just how such a claim might be proven, e.g., where the threshold of inadequate enforcement might lie.


Identifying methods and sources of interpretation for the TRIPS Agreement's substantive requirements, as well as delimiting the appropriate threshold of adequate enforcement, are but two of the intriguing tasks facing the WTO Dispute Settlement Body.

in INTERNATIONAL TRADE LAW AND THE GATTIWTO DISPUTE SETTLEMENT SYSTEM 415-37 (ed. E.-U. Petersmann), Kluwer Law International, 1997

Download here

The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (the "TRIPS Agreement") has ushered in a new generation of legal issues that may ultimately find their way into the WTO dispute settlement arena. In light of the extensive coverage given to the WTO Dispute Settlement Understanding (DSU) elsewhere in this book, and the broad range of dispute-related issues raised by the TRIPS Agreement, this chapter will focus on issues that are more or less specific to the TRIPS Agreement.

The TRIPS Agreement is unique in the WTO context; it is the only WTO agreement that requires the members to affirmatively (or positively) incorporate complex substantive legal standards into national laws that govern both domestically-produced and imported goods. It relies for many of its rules on cross-reference to an existing body of multilateral conventions administered outside the WTO. The substantive rules imposed by the TRIPS Agreement are the subject of existing bodies of judicial opinion in the national and regional territories that are now subject to its discipline. Underlying the superficial certainty of the TRIPS Agreement substantive prescriptions are existing gulfs of interpretative difference regarding the meaning of many of its rules.


The TRIPS Agreement is unique in that it establishes minimum standards applicable to the enforcement of legislation by WTO members. The establishment of minimum enforcement standards necessarily implies that claims alleging the maintenance of inadequate enforcement procedures can and may be brought before the WTO Dispute Settlement Body, yet the TRIPS Agreement is silent on just how such a claim might be proven, e.g., where the threshold of inadequate enforcement might lie.


Identifying methods and sources of interpretation for the TRIPS Agreement's substantive requirements, as well as delimiting the appropriate threshold of adequate enforcement, are but two of the intriguing tasks facing the WTO Dispute Settlement Body.

in INTERNATIONAL TRADE LAW AND THE GATTIWTO DISPUTE SETTLEMENT SYSTEM 415-37 (ed. E.-U. Petersmann), Kluwer Law International, 1997

Download here

The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (the "TRIPS Agreement") has ushered in a new generation of legal issues that may ultimately find their way into the WTO dispute settlement arena. In light of the extensive coverage given to the WTO Dispute Settlement Understanding (DSU) elsewhere in this book, and the broad range of dispute-related issues raised by the TRIPS Agreement, this chapter will focus on issues that are more or less specific to the TRIPS Agreement.

The TRIPS Agreement is unique in the WTO context; it is the only WTO agreement that requires the members to affirmatively (or positively) incorporate complex substantive legal standards into national laws that govern both domestically-produced and imported goods. It relies for many of its rules on cross-reference to an existing body of multilateral conventions administered outside the WTO. The substantive rules imposed by the TRIPS Agreement are the subject of existing bodies of judicial opinion in the national and regional territories that are now subject to its discipline. Underlying the superficial certainty of the TRIPS Agreement substantive prescriptions are existing gulfs of interpretative difference regarding the meaning of many of its rules.


The TRIPS Agreement is unique in that it establishes minimum standards applicable to the enforcement of legislation by WTO members. The establishment of minimum enforcement standards necessarily implies that claims alleging the maintenance of inadequate enforcement procedures can and may be brought before the WTO Dispute Settlement Body, yet the TRIPS Agreement is silent on just how such a claim might be proven, e.g., where the threshold of inadequate enforcement might lie.


Identifying methods and sources of interpretation for the TRIPS Agreement's substantive requirements, as well as delimiting the appropriate threshold of adequate enforcement, are but two of the intriguing tasks facing the WTO Dispute Settlement Body.

in INTERNATIONAL TRADE LAW AND THE GATTIWTO DISPUTE SETTLEMENT SYSTEM 415-37 (ed. E.-U. Petersmann), Kluwer Law International, 1997

Download here

The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (the "TRIPS Agreement") has ushered in a new generation of legal issues that may ultimately find their way into the WTO dispute settlement arena. In light of the extensive coverage given to the WTO Dispute Settlement Understanding (DSU) elsewhere in this book, and the broad range of dispute-related issues raised by the TRIPS Agreement, this chapter will focus on issues that are more or less specific to the TRIPS Agreement.

The TRIPS Agreement is unique in the WTO context; it is the only WTO agreement that requires the members to affirmatively (or positively) incorporate complex substantive legal standards into national laws that govern both domestically-produced and imported goods. It relies for many of its rules on cross-reference to an existing body of multilateral conventions administered outside the WTO. The substantive rules imposed by the TRIPS Agreement are the subject of existing bodies of judicial opinion in the national and regional territories that are now subject to its discipline. Underlying the superficial certainty of the TRIPS Agreement substantive prescriptions are existing gulfs of interpretative difference regarding the meaning of many of its rules.


The TRIPS Agreement is unique in that it establishes minimum standards applicable to the enforcement of legislation by WTO members. The establishment of minimum enforcement standards necessarily implies that claims alleging the maintenance of inadequate enforcement procedures can and may be brought before the WTO Dispute Settlement Body, yet the TRIPS Agreement is silent on just how such a claim might be proven, e.g., where the threshold of inadequate enforcement might lie.


Identifying methods and sources of interpretation for the TRIPS Agreement's substantive requirements, as well as delimiting the appropriate threshold of adequate enforcement, are but two of the intriguing tasks facing the WTO Dispute Settlement Body.

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ICTSD Programme on IPRs and Sustainable Development, Issue Paper No. 24

This paper examines issues surrounding the development and transfer of technologies for addressing the problem of climate change based on the experience of developing countries in addressing problems of innovation and access in the field of medicines.

It looks at alternative energy resources (AERs) and climate change mitigation technologies (MTs), at the forms of intellectual property rights (IPRs) used to promote and protect innovation, and at the ways these IPRs may have different effects and implications for AERs/MTs as compared with pharmaceutical technologies. It is generally assumed that the originator pharmaceutical sector is highly dependent on strong patent protection, mainly because of the high cost involved in developing novel drug therapies and the low cost of reverse engineering these new drugs. Preliminary research suggests that most AERs/MTs industries may be less dependent on strong patent protection, and/or that patents are less likely to cause significant bottlenecks in the development and transfer of AERs/MTs. While it is premature to come to a definitive conclusion because researchers are only now focusing on the evidence, there is some basis for anticipating that IPRs will present fewer risks for developing countries in the context of climate change than for public health.

Developing country negotiators understood that the GATT Uruguay Round negotiations on trade related aspects of intellectual property rights would affect access to medicines. The resulting WTO TRIPS Agreement did, in fact, present serious risks to public health. These risks were addressed through negotiation of the Doha Declaration on the TRIPS Agreement and Public Health, the Article 31b is amendment and the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property. The “Doha Declaration process” broadly speaking has resulted in some positive movement.

There are a number of lessons that can be drawn from the public health-related negotiations, at the WTO and other forums that may be useful to developing country negotiators addressing IPRs and climate change. Some of these lessons are relatively straightforward: economic and political power substantially influences the outcome of negotiations; the involvement of NGOs and other stakeholders is essential; it is important to shape public opinion through effective communication. Other lessons may be somewhat less evident.

Public health negotiations suggest that zero-sum bargaining is unlikely to be productive from the standpoint of developing countries, and that appeal to “equity” as the basis for demanding concessions is not enough. The private sector in the developed countries controls most pharmaceutical technology and AERs/MTs. Governments in developed countries are unlikely to “order” that technology be transferred by the private sector. Developing countries therefore might usefully focus on establishing frameworks for mutually beneficial joint venture economic arrangements between developed and developing country enterprises that will stimulate innovation and concrete transfers of technology to address climate change.

To the extent possible, technology transfer commitments resulting from climate change negotiations should be specific and concrete. “Soft” commitments on transfer of technology typically do not bear fruit.

A number of developing countries and NGOs have proposed that a declaration comparable to the Doha Declaration on the TRIPS Agreement and Public Health be adopted with respect to IPRs and Climate Change. Even if current multilateral IPRs rules incorporate flexibilities and exceptions adequate to address most foreseeable obstacles to technology transfer, a declaration may be useful in the progressive development of international law so that it properly balances the rights of innovators and access by the public to the benefi ts arising from new technologies.

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ICTSD Programme on Dispute Settlement and Legal Aspects of International Trade, Issue Paper No. 8, April 2009

This paper addresses a World Trade Organization (WTO) dispute settlement remedy commonly known as 'cross-retaliation', and specifically the mechanism by which a WTO Member can suspend concessions in the field of trade-related intellectual property rights (TRIPS) to redress an injury suffered with respect to trade in goods or services. A WTO Member enforces compliance with a ruling by the Dispute Settlement Body (DSB) by suspending trade concessions enjoyed by the non-compliant Member. This might involve raising tariffs on products imported from the non-compliant Member. Economically powerful WTO Members are not likely to be harmed by the suspension of trade concessions in goods or services by substantially less powerful Members. The trade impact will be too small to 'induce compliance' and, equally important, the types of suspension that may be used in the fields of goods and services may cause economic harm to the less powerful Members using them. The WTO dispute settlement process strongly favors economically powerful countries, leaving most developing and least developed Members with few options for inducing compliance. Attention is increasingly being focused on the possibility for developing Members to suspend concessions relating to intellectual property rights (IPRs) as a means of inducing compliance by developed Members. Cross-retaliation is expressly contemplated by the WTO Dispute Settlement Understanding (DSU). WTO arbitrators have so far approved TRIPS cross-retaliation on two occasions: in favor of Ecuador (against the European Communities (EC)) and Antigua (against the United States (US)). Constructing and implementing a cross-retaliation program involving IPRs raises a substantial number of complex legal questions. The DSU establishes principles and procedures that must be respected. The various forms of IPR – copyright, patent, trademark, etc. – serve different social and industrial policy functions and have their own unique characteristics. There are multilateral and bilateral agreements and rules outside the WTO context that may influence the shaping of a cross-retaliation program. National constitutions and rules relating to property rights need to be addressed. This paper anticipates many legal questions raised by cross-retaliation in TRIPS and seeks to provide answers to them. It analyses the cross-cutting issues raised by external commitments and national IPRs-related rules, and looks at each major forms of IPR to suggest practical approaches to suspending (or not suspending) those forms. One of the difficult challenges less powerful WTO Members face in seeking to implement cross-retaliation in TRIPS is political pressure from industry groups as well as the governments of more powerful Members. While exporters of goods have not persuaded international media outlets that the suspension of tariff concessions is 'piracy of trade rights', IP-dependent industry groups use sophisticated and expensive propaganda campaigns that result in media portrayal of IPR suspension as 'piracy' and 'theft'. WTO Members must be prepared to deal with industry-induced media pressure.

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(1 W.I.P.O.J. 43 (2009)

This essay addresses the legitimacy of seizures by the customs authorities of some European Union member states of pharmaceutical products moving in transit through European ports and airports based on patents in force in the transit countries. Seizures have been directed to products off-patent in the countries of manufacture and destination. EU member state customs authorities have justified such seizures on the basis of a 2003 EU intellectual property border enforcement regulation. The seizures have generated intense controversy at the WTO and more widely among stakeholders interested in assuring affordable access to medicines. This essay argues that seizure of generic pharmaceutical products in transit contravenes GATT article V that obligates WTO Members to assure freedom of transit for goods passing through ports and airports, and obligates Members to refrain from imposing unreasonable regulations on such transit goods. It further argues that the seizures are fundamentally inconsistent with the Paris Convention principle of independence of patents that recognizes the sovereign right of states to adopt and implement patent protection as they consider appropriate, within the framework of a general set of rules. Rules permitting enforcement of transit country patents effectively deprives exporting and importing Paris Union and WTO Members of their right to make determinations regarding patents, and represents an overextension of patent jurisdiction by countries without a substantial interest in enforcement. Dutch court adoption of a manufacturing fiction to justify transit seizures – pretending that subject pharmaceuticals are manufactured in the Netherlands, when they clearly are not – represents a significant potential threat to the conduct of international trade. Each WTO Member might pretend that all manner of its domestic regulation – labor, environmental, social welfare – was violated in an exporting country when goods were manufactured, allowing the goods of that country to be seized in transit for a violation of transit country law. The international trading system could not function reasonably in such a fiction-laden environment. The seizure of generic pharmaceutical products in transit is inconsistent with the object and purpose of the Doha Declaration on the TRIPS Agreement and Public Health that promotes access to medicines for all.

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Over the past decade, government trade and finance ministries have increasingly turned toward negotiating bilateral and regional trading arrangements, and away from negotiations in multilateral forums like the WTO. There are several reasons for this shift, including changes in the global political environment and negotiating obstacles encountered by the multinational business community at the multilateral level. This shift appears to be an embedded phenomenon. Positive and negative aspects of preferential trading arrangements (PTAs) are in evidence. Trade creation-trade diversion economic analysis suggests the results may be net global welfare enhancing, although such analysis does not readily assess distributional effects. The global economy is enjoying a period of sustained and widely distributed economic growth, suggesting that the PTA phenomenon is not an immediate economic threat. On the negative side, the PTAs lead to administrative complexity, and may be somewhat destabilizing as businesses are encouraged to relocate. Some countries may suffer if left out, but this risk is ameliorated by the wide availability of potential negotiating partners. The PTA negotiating environment strongly favors powerful economic actors like the United States and European Union, which are largely dictating terms to developing (and developed) countries. Developing countries, particularly the less economically powerful, are losing autonomous decision-making authority. The consequences of this are difficult to quantify, and may raise questions better attuned to moral philosophers than economists. The WTO continues on its way, relegated to a less central status. A return to the WTO might reinvigorate the role of less powerful actors, but such return does not appear an immediate prospect. The PTA phenomenon, on balance, does not appear aggressively threatening. We may, however, be underestimating the positive role of multilateralism.

in INTERNATIONAL TRADE LAW AND THE GATTIWTO DISPUTE SETTLEMENT SYSTEM 415-37 (ed. E.-U. Petersmann), Kluwer Law International, 1997

Download here

The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (the "TRIPS Agreement") has ushered in a new generation of legal issues that may ultimately find their way into the WTO dispute settlement arena. In light of the extensive coverage given to the WTO Dispute Settlement Understanding (DSU) elsewhere in this book, and the broad range of dispute-related issues raised by the TRIPS Agreement, this chapter will focus on issues that are more or less specific to the TRIPS Agreement.

The TRIPS Agreement is unique in the WTO context; it is the only WTO agreement that requires the members to affirmatively (or positively) incorporate complex substantive legal standards into national laws that govern both domestically-produced and imported goods. It relies for many of its rules on cross-reference to an existing body of multilateral conventions administered outside the WTO. The substantive rules imposed by the TRIPS Agreement are the subject of existing bodies of judicial opinion in the national and regional territories that are now subject to its discipline. Underlying the superficial certainty of the TRIPS Agreement substantive prescriptions are existing gulfs of interpretative difference regarding the meaning of many of its rules.


The TRIPS Agreement is unique in that it establishes minimum standards applicable to the enforcement of legislation by WTO members. The establishment of minimum enforcement standards necessarily implies that claims alleging the maintenance of inadequate enforcement procedures can and may be brought before the WTO Dispute Settlement Body, yet the TRIPS Agreement is silent on just how such a claim might be proven, e.g., where the threshold of inadequate enforcement might lie.


Identifying methods and sources of interpretation for the TRIPS Agreement's substantive requirements, as well as delimiting the appropriate threshold of adequate enforcement, are but two of the intriguing tasks facing the WTO Dispute Settlement Body.

download here:  http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1915338

This paper addresses intellectual property issues that arise in the context of the accession process with a view toward assisting prospective WTO Members involved in negotiations. The Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS Agreement”) is one of the Multilateral Trade Agreements or MTAs to which all WTO Members are party. As an ordinary consequence of joining the WTO, a state or autonomous customs territory would be expected to become party to the TRIPS Agreement and take on the obligations applicable to other Members at their respective levels of development. However, the terms of the WTO Agreement do not expressly limit the “entry fee” imposed on newly acceding Members to an equivalence of concessions with existing Members. As a consequence of this, accession negotiations have been used by certain Members as a mechanism for securing commitment to obligations in the field of intellectual property rights (IPRs) that are more extensive than those established by the TRIPS Agreement.

For any country which has not been a Member of the WTO, there is a strong possibility that the national regime governing IPRs in place prior to the commencement of accession negotiations will be inconsistent with the requirements of the TRIPS Agreement. In this regard, the process of joining the WTO even at the same level of obligation as existing Members may require a substantial adjustment in national law and corresponding industrial policy. The impact of bringing national law into baseline or “normal” TRIPS Agreement compliance should not be underestimated.

A fundamental characteristic of the TRIPS Agreement is that WTO Members have flexibility regarding the manner in which obligations are implemented. This flexibility has been recognized by the WTO Appellate Body in the India-Mailbox decision. Countries acceding to the WTO may have limited experience in drafting and implementing IPRs law. The way in which such law is drafted may substantially affect social welfare interests within the country. Certain WTO Members will express strong opinions regarding what types of legislation satisfy TRIPS Agreement requirements. Those views are not necessarily shared by other Members. In addition, technical advisers regarding IPRs law may have materially different viewpoints regarding the way in which the interests of IPRs-holders and the general public should be balanced. It is therefore important to approach the process of legal reform cautiously, taking into account the different perspectives and objectives of WTO Members and technical advisers.

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Journal of International Economic Law, Vol. 10, pp. 921-87, 2007

The entry into force of the WTO TRIPS Agreement in 1995 transformed the international intellectual property system. The harmonization of basic intellectual property standards has operated to protect investment in innovation, limiting risks from unjustified free riding. Yet these same harmonized IP standards sharply curtailed the traditional capacity of suppliers of public goods, such as health care and nutrition, to address priority needs of less affluent members of society, particularly in (but not limited to) developing countries. In the Doha Declaration, the Waiver Decision of 30 August 2003 and the Article 31bis Protocol of Amendment, stakeholders concerned with re-opening policy space for the supply of newer pharmaceutical products pushed back against restrictive elements of the TRIPS Agreement. Governments around the world are in the process of deciding whether to ratify and accept the Article 31bis Amendment. Based on their Study for the International Trade Committee of the European Parliament, the authors argue that acceptance of the Amendment will provide a ¿net benefit¿ for countries seeking to improve access to medicines. At the insistence of WTO delegations acting on behalf of the originator pharmaceutical industry lobby, Article 31bis regrettably is saddled with unnecessary administrative hurdles. Nonetheless, through skillful lawyering, political determination and coordinated planning, the system can be made to work. Among other options, expeditious back-to-back compulsory licensing linked with pooled procurement strategies may effectively achieve economies of scale in medicines production and distribution. The authors doubt that the international political environment would support renegotiation of an 'improved' solution. They express concern that failure to bring the Amendment into force will open the door to a campaign to undermine the Waiver Decision. Recent events in Brazil and Thailand illustrate both the opportunities and risks associated with implementing TRIPS exception mechanisms, and help to inform views on the negotiating environment. Specific proposals for regional cooperation in implementing the Amendment are laid out, and the authors emphasize the importance of pursuing concrete transfer of technology measures in support of developing country pharmaceutical manufacturing. Over-reliance on private market mechanisms for the supply of public health goods leaves the international community with an unresolved collective action problem on a large scale.

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Annex 1

Annex 2

Annex 3

Annex 4

Annex 5

Annex 6

The overall conclusion of this study is that domestic pharmaceutical producers in Colombia will face increasing challenges from foreign enterprises if and as the market is further opened to competition. If there is a national interest in maintaining or improving the local and global market position of Colombian enterprises, steps should be considered to encourage upgrade of the facilities of private operators to meet standards prevalent among major international generics suppliers. Facilities upgrading would have positive consequences for the Colombian public in terms of improving the quality of products on costs, financial assistance to local firms will be required. Some restructuring of the local industry (in terms of consolidation) should be anticipated.

Strengthening Colombia’s domestic manufacturing industry should, over the long term, increase local private investment in R&D. Nonetheless, Colombia is presently at the low end of government funding for R&D programs, and at the low end of R&D as a percentage of GDP (reflecting low private investment in R&D). If Colombia seeks to take advantage of its strength in areas such as ownership of biodiverse resources, it should likely increase its public funding for R&D in sectors with potential opportunity. It might also consider promoting partnerships with firms and institutions from countries already heavily invested in biotechnology R&D, taking care in negotiations for fairly sharing in the commercial output of such ventures, and to promote training opportunities for its scientific community.

From an industrial policy standpoint, it is important to assess whether Colombia has a comparative advantage in the pharmaceutical sector that justifies government intervention and support in favor of local industry. Because government resources are scarce, it is sensible to allocate them toward industry sectors in which prospects for success in the global economy are higher. However, it also should be recognized that the pharmaceutical sector is not the same as other industry sectors. A strong local pharmaceutical industry can help to assure reasonably priced high quality medicines for local consumers, and it is important for public security. Particularly in times of public health emergency, a country runs substantial risk if it is wholly dependent on foreign sources of medicines supply. Maintaining a strong base of industrial capacity is important. Without a technologically sound local industry, the capacity to respond to public health threats may be jeopardized. This is not to suggest a policy of pharmaceutical “autarky” or self-sufficiency, but rather to emphasize that production capacity in pharmaceuticals raises different issues than production capacity in flowers or coffee. Economics and public health must be considered in tandem.

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China's transition from a statist to market economy over the past 15 years and its successful establishment of globally competitive industry are unprecedented historical events. Although China's entry into the WTO is not responsible for that transformation, it has played an important role. Accession to the WTO was used by the government as a means not only to stabilize access to foreign markets and increase the attractiveness of China to foreign investors but also to reorient internal policies in a way that deemphasized a profound shift in government attitudes.

However, the law of unintended consequences is always at work, and the rate of China's growth and success in world markets may have been unanticipated. Developing countries that for many years had pressed in the WTO for an agreement to eliminate textile quotas found themselves seeking to re-impose restrictions in the face of highly efficient Chinese producers. China is absorbing a large and increasing share of the world's natural resources, including oil and minerals, and Chinese demand is adding to global price and availability pressures.

China's trade relations with the rest of the world are not without friction. China maintains a large trade surplus with the United States and European Union. Politicians and economists express concern that this surplus is due, at least in part, to a Chinese policy of deliberately undervaluing its currency. In late 2005, largely in response to U.S. political pressures, China moved from a fixed currency conversion rate for the Yuan to a limited floating rate tied to a basket of currencies. This move provided modest relief from currency-related confrontation with the United States, which continues at a somewhat more subdued level.

This paper focuses on the legal and WTO governance implications of China's alleged failure to fulfill its obligations under the Agreement on Trade-Related Intellectual Property Rights (TRIPS Agreement). The significant escalation of interest by the United States and other developed countries in China's intellectual property rights enforcement activity merits special attention because of its systemic implications. This subject matter forms a critical part of China's continuing WTO dialogue with the United States, European Union, Japan, and Switzerland, and it tests the capacity of the WTO dispute settlement system to constrain state behaviors.

China appears to perceive that its national interest is not aligned with its TRIPS Agreement and Accession Protocol obligations. Though the United States may well initiate a WTO dispute settlement action, it seems unlikely that doing so will result in near-term changes to China's conduct. WTO dispute settlement is not designed to force immediate changes to government behaviors, particularly when the complained-against party is not overly concerned about the potential for withdrawal of concessions. Politicians and industry leaders who are demanding changes by China will almost certainly be frustrated at the WTO.

This response will raise two questions: will the United States be justified in imposing extra-WTO legal sanctions on China, and if this is justified, will it be a good idea? The answers to these questions, explored in this paper, are 'probably yes" and "probably no,' respectively. To paraphrase the title of Olivier Long's classic work on the GATT, this case may help define the limits of the law in the WTO system

in INTERNATIONAL TRADE LAW AND THE GATTIWTO DISPUTE SETTLEMENT SYSTEM 415-37 (ed. E.-U. Petersmann), Kluwer Law International, 1997

Download here

The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (the "TRIPS Agreement") has ushered in a new generation of legal issues that may ultimately find their way into the WTO dispute settlement arena. In light of the extensive coverage given to the WTO Dispute Settlement Understanding (DSU) elsewhere in this book, and the broad range of dispute-related issues raised by the TRIPS Agreement, this chapter will focus on issues that are more or less specific to the TRIPS Agreement.

The TRIPS Agreement is unique in the WTO context; it is the only WTO agreement that requires the members to affirmatively (or positively) incorporate complex substantive legal standards into national laws that govern both domestically-produced and imported goods. It relies for many of its rules on cross-reference to an existing body of multilateral conventions administered outside the WTO. The substantive rules imposed by the TRIPS Agreement are the subject of existing bodies of judicial opinion in the national and regional territories that are now subject to its discipline. Underlying the superficial certainty of the TRIPS Agreement substantive prescriptions are existing gulfs of interpretative difference regarding the meaning of many of its rules.


The TRIPS Agreement is unique in that it establishes minimum standards applicable to the enforcement of legislation by WTO members. The establishment of minimum enforcement standards necessarily implies that claims alleging the maintenance of inadequate enforcement procedures can and may be brought before the WTO Dispute Settlement Body, yet the TRIPS Agreement is silent on just how such a claim might be proven, e.g., where the threshold of inadequate enforcement might lie.


Identifying methods and sources of interpretation for the TRIPS Agreement's substantive requirements, as well as delimiting the appropriate threshold of adequate enforcement, are but two of the intriguing tasks facing the WTO Dispute Settlement Body.

download:  http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1922851

The patenting of biotechnological inventions potentially affects human rights in a number of ways. Human rights to identity and the practice of religion may be affected by the availability of patents on genetically modified human beings (or elements of the human body). Patents as mechanisms for market exclusion affect access to new medicines, including those based on biotechnological innovation. Access to medicines and health care are part of the panoply of human rights.

During the past decade, the international community has focused significant attention on the protection of biological diversity and the potential impact of patents and other intellectual property rights on that protection. All of mankind benefits from the preservation of biological diversity. Genetic resource stocks likely will be the source of future agricultural, medicinal and other innovations. The preservation of plant and animal species is important to the functioning and continuing evolution of the Earth’s ecosystem, and therefore to the preservation of human life. While the maintenance of biological diversity is not part of the traditional catalogue of protectable human rights, a generalized human interest in the preservation of such diversity might be considered part of the common human interest in the wellbeing of future generations.

Differentiated biological resources are concentrated in a group of megadiverse countries, almost all of which are developing countries. The geographic territories in which such resources are located are often populated by poor indigenous peoples. The exploitation of biological resources from territories inhabited by these individuals has the potential substantially to affect their economic well being. The maintenance of basic human rights, including rights to security, food and shelter, are dependent on a minimum level of economic welfare. The Convention on Biological Diversity (CBD) recognizes sovereign rights over biological resources located within national territories, in part with a view towards assuring that individuals benefit financially from biotechnological inventions derived from such resources. The potential for conflict between the objectives and terms of the CBD and the rules governing the international patent system has been debated since the conclusion of negotiations on the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) in late 1993. In 2006 this subject is on the active agenda of the WTO TRIPS Council, and it is being considered at the World Intellectual Property Organization (WIPO).

This chapter analyses the relationship between the CBD and the rules governing the international patent system with a view to making a recommendation regarding whether a multilaterally agreed mandatory requirement for disclosure of the source and origin of genetic resources in patent applications would aid in achieving greater complementarity. The chapter concludes that adoption of such a requirement would be useful. This chapter does not expressly address information referred to as ‘traditional knowledge’ except to the extent that such information is relevant to evaluating applications for patents on inventions under the generally applied criteria of patentability. Traditional knowledge may itself be protected as intellectual property distinct from patentable invention.

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Stanford Center for International Development, Working Paper No. 308, Dec. 2006

A powerful agenda for adoption of high levels of intellectual property protection, including related regulatory protection, is being advanced by the United States (and certain other developed countries) for developing countries, including developing and emerging market countries of Asia. This agenda essentially reflects a TRIPS II exercise, but is largely being carried out in bilateral and regional negotiations, as well as in WTO accession negotiations.

The TRIPS II agenda, as the TRIPS I agenda, is explained by strong mercantile interests seeking to increase technology and expression rents. Circumstances since the launch of the GATT Uruguay Round in 1986 have changed substantially. In 1986, OECD industries were principally concerned with preventing weak developing country industries from substituting low-cost and often lower quality “copied” versions of products on local markets, but were not threatened with competition in their home markets or with respect to originator and high-quality products. The OECD industry groups driving the TRIPS II agenda are (1) the copyright-dependent audio-visual industry concerned with unauthorized duplication and distribution of video and audio content and (2) the pharmaceutical (and agricultural chemical) industry concerned with competition from generic producers and, in a forward-looking sense, emerging originator enterprises.

This paper focuses on the implications of the TRIPS II agenda for the pharmaceutical sector in the Asian region. Copyright protection has significant implications for “access to knowledge”, in addition to entertainment, and this paper acknowledges the public welfare implications of developments with respect to copyright. However, the applicable legal norms and public welfare analysis differ substantially as between the copyright-dependent and patent-dependent industry sectors, and this paper will focus on the latter. TRIPS Agreement, TRIPS II, Pharmaceuticals, Asia, Trade, Investment, Public Health

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UNCTAD - ICTSD Project on IPRs and Sustainable Development, Issue Paper No. 12, Feb. 2006

During the past several years, the United States has concluded a substantial number of bilateral and regional free trade agreements (hereinafter “FTAs”), largely with developing countries. Each of those FTAs includes substantial commitments in the field of intellectual property rights (IPRs) and related regulatory matters. These commitments exceed those required by the TRIPS Agreement which establishes minimum substantive standards of protection and enforcement for all WTO Members.

There is a relatively consistent view among economists studying intellectual property rights that the interests of countries with respect to standards of protection varies depending upon the level of development and other characteristics of the country adopting such protection. The TRIPS Agreement provides some flexibility to WTO Members with respect to the level of protection, allowing developing countries a measure of leeway. Since there has been little enthusiasm at the WTO for raising standards of IPRs protection above that mandated by TRIPS, the United States has shifted its attention to other fora to accomplish its objective of securing greater levels of IPRs-based rents or royalties. The U.S. FTA policy weakly takes into account developmental interests. In some areas, such as the protection of pharmaceutical patent holders, U.S. policy threatens to cause harm to the interests of comparatively poor populations. 

IPRs and related regulatory standards deemed appropriate for the United States may not be appropriate for developing countries. Even so, within the United States the law establishes a particular balance between the interests of IPRs holders and consumers. Most U.S. IPRs rules are formulated in terms of general principles, with limitations and exceptions to them. The FTAs negotiated by the United States largely reflect the general rules of application, though not in all cases. What the FTAs do not adequately reflect is the interplay between rule, limitation and exception that establishes the balance. This is of special importance in areas such as public health regulation where incomplete familiarity with the flexibility inherent in the U.S. system may lead its trading partners to conclude that restrictive implementation of the FTAs is required. Differences in the capacity of the United States and many developing countries to create and manage legal infrastructure may lead to a disparity in the way FTA rules are implemented. 

In the negotiating process, developing countries should carefully consider whether the capacity of their domestic legal and regulatory system will permit them to balance interests as does the United States. It is probably unwise to accept commitments that will strain domestic capacity and which may lead to the application of rules in a more restrictive manner than the agreements require. If commitments are accepted, developing countries should pay careful attention to implementing them in a way which properly reflects the domestic public interest.

In conclusion, this study suggests that it is not only the public in developing countries that encounters risk from these FTAs. The U.S. public faces similar risks. The USTR assures the United States Congress that the agreements do not tie the hands of the domestic legislator. This is a position perhaps comfortably asserted within the more powerful of the parties to an FTA. Yet it is almost inevitable that when Congress considers changing domestic law, arguments will be made by industry groups that to do so may violate America’s international obligations and damage the national interest. Congress may choose to ignore U.S. international obligations, but it would be surprising if Congress were not at least somewhat reluctant to do so. The United States is increasingly bound by a set of highly restrictive intellectual property and regulatory commitments that may not over time be seen to be consistent with the American public interest.

download here:  http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1922823

We are considering the relationship between human rights and trade-related aspects of intellectual property rights (TRIPS). Intellectual property rights (IPRs) have always reflected a balancing of general public interests and private stakeholder interests, and in this sense IPRs take into account social welfare concerns as well as those of individual inventors and artists. While the balance struck in the TRIPS Agreement is flawed, it is capable of flexible interpretation and amendment. Human rights represent the values for establishing a global constitutional balance between the interests of the public and the private holders of IPRs.

We are collectively at a somewhat early stage of analyzing from a legal standpoint the relationship between human rights and the TRIPS Agreement. The observations in this paper reflect the preliminary nature of this inquiry. From a legal perspective, the sources of human rights relating to TRIPS are customary international law, the Universal Declaration of Human Rights, and various other human rights instruments including the International Covenant on Civil and Political Rights (lCCPR) and the International Covenant on Economic, Social and Cultural Rights (ICESCR). The Report prepared by the Office of the High Commissioner for Human Rights, entitled "The impact of the Agreement on Trade-Related Aspects on Intellectual Property Rights on human rights", insightfully surveys the relevant human rights instruments and their potential application to TRIPS issues.

The idea or concept of human rights as it applies to the field of IPRs involves something beyond the specific norms we may identify in human rights instruments or customary law. Human rights involve the shared perceptions of individuals regarding basic questions of right and wrong, fairness and equity. When an overwhelming part of the world's public perceives a situation as unjust, and expresses its concern, that shared perception itself becomes a part of our human rights dialogue, and informs public policy makers in their actions.

Human rights take on character, and become appropriately multidimensional in the context of specific cases, and reflect the spirit of the times. Lawyers may incline to be dismissive of public perception because the legal profession is by nature analytical, and the lawyer prides him or herself on objectivity and precision. Yet laws do not operate in clinical isolation from events, and events (particularly those of great moment) are rarely analytical and precise. One does not stop a war on a legal technicality. In the combating of social wrongs, it is the shared perception of the public, and the willingness of the public to take on the responsibility for setting things back in their proper order, that matters.

Meetings in the TRIPS Council on access to medicines that ultimately resulted in the Doha Declaration on the TRIPS Agreement and Public Health flowed largely from efforts by developing WTO Members to deal with public health problems affecting their people. The TRIPS Council did not begin taking access to medicines issues seriously because the OECD governments became more enlightened about the consequences of TRIPS and patents. Rather, this took place because the worldwide public did not accept that the rights of pharmaceutical industry patent holders should take precedence over the rights to life and health of millions of individuals. The human rights dimension will play a substantial role in the response of the WTO and other multilateral organizations to public health issues. It is precisely because fundamental human rights are at stake, and that these rights are paramount in public consciousness, that the legal situation will adapt.

in INTERNATIONAL TRADE LAW AND THE GATTIWTO DISPUTE SETTLEMENT SYSTEM 415-37 (ed. E.-U. Petersmann), Kluwer Law International, 1997

Download here

The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (the "TRIPS Agreement") has ushered in a new generation of legal issues that may ultimately find their way into the WTO dispute settlement arena. In light of the extensive coverage given to the WTO Dispute Settlement Understanding (DSU) elsewhere in this book, and the broad range of dispute-related issues raised by the TRIPS Agreement, this chapter will focus on issues that are more or less specific to the TRIPS Agreement.

The TRIPS Agreement is unique in the WTO context; it is the only WTO agreement that requires the members to affirmatively (or positively) incorporate complex substantive legal standards into national laws that govern both domestically-produced and imported goods. It relies for many of its rules on cross-reference to an existing body of multilateral conventions administered outside the WTO. The substantive rules imposed by the TRIPS Agreement are the subject of existing bodies of judicial opinion in the national and regional territories that are now subject to its discipline. Underlying the superficial certainty of the TRIPS Agreement substantive prescriptions are existing gulfs of interpretative difference regarding the meaning of many of its rules.


The TRIPS Agreement is unique in that it establishes minimum standards applicable to the enforcement of legislation by WTO members. The establishment of minimum enforcement standards necessarily implies that claims alleging the maintenance of inadequate enforcement procedures can and may be brought before the WTO Dispute Settlement Body, yet the TRIPS Agreement is silent on just how such a claim might be proven, e.g., where the threshold of inadequate enforcement might lie.


Identifying methods and sources of interpretation for the TRIPS Agreement's substantive requirements, as well as delimiting the appropriate threshold of adequate enforcement, are but two of the intriguing tasks facing the WTO Dispute Settlement Body.

Download here: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1913854

World Bank Working Paper No. 61 (2005)

The Doha Declaration on the TRIPS Agreement and Public Health (in its Paragraph 6) recognized that developing countries with insufficient or no manufacturing capacity in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. The WTO’s decision of August 30, 2003 set up a system intended to overcome these difficulties. The present work is a guide to the implementation of that system.

The first part gives the reader an understanding of the issues involved; the second part provides model documents for use by governments. Four model instruments of notification are included: three for notification of the WTO as required by the Decision and one for notification of the patent or right holder pursuant to Article 31 of the TRIPS Agreement. Because most countries will have to amend their legislation (typically their patent law) to implement the system, model amendment provisions have been provided both for exporting countries and for importing countries. All model documents contain their own detailed commentary.

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American Journal of International Law, Vol. 99, pp. 317-58, 2005

On August 30, 2003, the member countries of the WTO adopted the Decision on Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health. This Decision provides flexibility for the export of pharmaceutical products under compulsory license (which flexibility might otherwise have been limited by the terms of the TRIPS Agreement). This article analyzes negotiating strategies used by developing countries to achieve their objectives regarding the Decision at the WTO. The United States is pursuing the negotiation of bilateral and regional trade agreements that restrict the regulatory flexibility of developing (and developed) countries under the WTO TRIPS Agreement, Doha Declaration and Decision. This article considers whether developing countries might adapt strategies used effectively at the WTO to prevent further loss of regulatory flexibility in alternative negotiating fora.

download here:  http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1924481

 

In 1992 the Convention on Biological Diversity (CBD) was adopted at the Rio Conference. In 1994 the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) was adopted in Marrakech. From the outset, questions were raised as to whether there are conflicts or potential conflicts between the objectives and rules of these two international undertakings. These questions have been on the agenda of the WTO TRIPS Council and the Committee on Trade and Environment, they have been raised in the context of work programs and negotiations at the World Intellectual Property Organization (WIPO), they have been considered by the Conference of the Parties of the CBD, and they are the subject of numerous studies and reports by governments, intergovernmental and non-governmental organizations. This study attempts to clarify the issues at stake in analysis of the relationship between the TRIPS Agreement, related international patent system rules and the CBD. It examines the conflicts or potential conflicts between the objectives and rules of these international undertakings, and it makes certain recommendations regarding the promotion of complementarity among these systems. In terms of subject matter, this study considers only genetic resources and does not address "traditional knowledge".

This study first identifies the objectives of the international patent system as it is embodied in the TRIPS Agreement and WIPO Conventions, and how these objectives are implemented. Second, it identifies the objectives of the CBD and its method of implementation. Third, it identifies conflicts or potential conflicts between the objectives and methods of implementation of the two rule systems. Fourth, it examines proposals that have so far been made to ameliorate or resolve conflicts. Fifth, it suggests means for promoting complementarity between the two systems, including rule changes where necessary or appropriate.

The study concludes that promotion of the objectives of the CBD would be furthered by multilateral adoption of a mandatory requirement for the disclosure of the source and origin of genetic resources in patent applications. Such a requirement is appropriate to protect the interests of developing and developed countries which house genetic resource stocks. This requirement would be consistent with existing rules of the TRIPS Agreement. However, to give it effect it should be adopted as a new TRIPS Agreement rule. While national action to give effect to such a requirement is permitted under existing WIPO administrative treaties, establishing a mandatory multilateral standard under such treaties would also require amendment. The strength of any set of legal rules is dependent upon its enforceability. Therefore, it is important that states be obligated to provide for the effective enforcement of a mandatory disclosure requirement.

Existing patent law standards among advanced legal systems impose upon patent applicants affirmative duties with respect to the disclosure of information and establish penalties which include determinations of invalidity or provision for revocation of patents. Because the failure to disclose information regarding the source and origin of genetic resources may be relevant to the issue of patentability, including inventorship, it is appropriate that existing equitable doctrines that protect the integrity of the international patent system be extended to this area. It should not be an objective of prospective remedial measures to introduce insecurity into the international patent system, recognizing that patents are inherently insecure. Rather, the objective of prospective remedial measures should be to effectively encourage compliance with agreed upon rules, in this case designed to promote the objectives of the CBD.

download here:  http://papers.ssrn.com/sol3/papers.cfm?abstract_id=915556

The TRIPS Agreement emerged from the Uruguay Round negotiations as one of the three pillars of the WTO. This article offers a preliminary assessment of the first ten years under the TRIPS Agreement. Based on that assessment, it makes suggestions for the future.

The objective of the principal developed country demandeurs of the TRIPS Agreement was to increase information and technology rent payments from developing countries. Incomplete implementation and enforcement was anticipated. Taking this into account, the Agreement has resulted in a substantial transformation of legal infrastructure in developing countries and has increased rent payment outflows to the owners of intellectual property (IP) rights. From this standpoint, the TRIPS Agreement has been successful in accomplishing its objectives.

From the standpoint of developing countries, it is more difficult to identify positive effects. China is the major developing country success story of the past decade, and it has achieved its historic accomplishments in the face of intensive criticism of its IP regime. The TRIPS Agreement has come under harsh public scrutiny for the role attributed to it by the pharmaceutical industry in South Africa, ultimately leading to the Doha Declaration on the TRIPS Agreement and Public Health. As a consequence of a somewhat more balanced approach to TRIPS now achieved at the WTO, the United States in particular has shifted to bilateral and regional fora to obtain higher standards of protection and enforcement, calling into question the relevance of TRIPS Council deliberations.

This article makes several recommendations. First, that new agreements concerning IP rights be subject to objective prior impact assessment. Second, that WTO Members give greater recognition to the fact that IP rules have significantly different public welfare implications depending on their field of application and the level of development of the implementing country. As the TRIPS Agreement transition periods have largely expired, the manner by which the TRIPS Council assesses its rules and makes provision for TRIPS-plus and TRIPS-minus adjustments might be restructured along industrial subject matter and developmental lines, taking better account of the impact-in-fact of IP rules on societies.

In June 2004 a group of trade specialists was brought together at the World Trade Forum in Berne in a `preliminary stocktaking` exercise to assess the first ten years of the World Trade Organization.1 This article was prepared for that occasion and addresses the Agreement on Trade-Related Aspects of Intellectual Property Rights (the `TRIPS Agreement`) on its ten-year anniversary. 

in INTERNATIONAL TRADE LAW AND THE GATTIWTO DISPUTE SETTLEMENT SYSTEM 415-37 (ed. E.-U. Petersmann), Kluwer Law International, 1997

Download here

The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (the "TRIPS Agreement") has ushered in a new generation of legal issues that may ultimately find their way into the WTO dispute settlement arena. In light of the extensive coverage given to the WTO Dispute Settlement Understanding (DSU) elsewhere in this book, and the broad range of dispute-related issues raised by the TRIPS Agreement, this chapter will focus on issues that are more or less specific to the TRIPS Agreement.

The TRIPS Agreement is unique in the WTO context; it is the only WTO agreement that requires the members to affirmatively (or positively) incorporate complex substantive legal standards into national laws that govern both domestically-produced and imported goods. It relies for many of its rules on cross-reference to an existing body of multilateral conventions administered outside the WTO. The substantive rules imposed by the TRIPS Agreement are the subject of existing bodies of judicial opinion in the national and regional territories that are now subject to its discipline. Underlying the superficial certainty of the TRIPS Agreement substantive prescriptions are existing gulfs of interpretative difference regarding the meaning of many of its rules.


The TRIPS Agreement is unique in that it establishes minimum standards applicable to the enforcement of legislation by WTO members. The establishment of minimum enforcement standards necessarily implies that claims alleging the maintenance of inadequate enforcement procedures can and may be brought before the WTO Dispute Settlement Body, yet the TRIPS Agreement is silent on just how such a claim might be proven, e.g., where the threshold of inadequate enforcement might lie.


Identifying methods and sources of interpretation for the TRIPS Agreement's substantive requirements, as well as delimiting the appropriate threshold of adequate enforcement, are but two of the intriguing tasks facing the WTO Dispute Settlement Body.

Download Here:  http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1913965

In INTERNATIONAL PUBLIC GOODS AND TRANSFER OF TECHNOLOGY AFTER TRIPS 393-424 (K. Maskus and J. Reichman eds.)(Cambridge Univ. Press 2005)

The task of ensuring access to essential medicines presents a complex and embedded set of problems that will remain a persistent feature of the international governance landscape for the foreseeable future. The WHO’s recommended list of essential medicines has been developed with a view to aiding procurement authorities in determining the supplies needed to treat local populations. The price of medicines is a significant factor in determining what should be included on the list since there is small utility in recommending expensive therapies that are not affordable.

Nonetheless, the most recent WHO Essential Medicines list includes a significant number of antiretroviral medicines (ARVs) that are under patent. These drugs may not be affordable for many HIV-positive individuals, even taking into account recent price declines, unless public health budgets in developing countries are supplemented by international assistance.

The world community is presently confronted with tremendous public health challenges due to HIV/AIDS, malaria and tuberculosis. Yet, populations around the world, and especially in developing and least-developed countries, face heavy public health burdens from many sources, including other infectious diseases, diarrheal diseases, cancer, diabetes, heart and circulatory disease, and other conditions. While HIV/AIDS is the most immediate problem, it is not enough to address only this scourge.

Although there has been considerable public debate concerning the effect of patents on access to medicines, ensuring adequate supplies involves an extensive regulatory framework encompassing a multiplicity of factors. These include:

* Research and Development

* Safety and Efficacy (including Liability)

* Manufacturing Systems and Controls (Good Manufacturing Practices)

* Intellectual Property * Procurement, Distribution and Dispensing

* Health Care Personnel and Infrastructure

* Financing

Each of these elements in the essential medicines supply chain can and does act as a roadblock. Yet, each element is present for a reason. It is not helpful to supply inexpensive medicines if they are not safe and effective, or if they are prescribed to treat the wrong condition.

in INTERNATIONAL TRADE LAW AND THE GATTIWTO DISPUTE SETTLEMENT SYSTEM 415-37 (ed. E.-U. Petersmann), Kluwer Law International, 1997

Download here

The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (the "TRIPS Agreement") has ushered in a new generation of legal issues that may ultimately find their way into the WTO dispute settlement arena. In light of the extensive coverage given to the WTO Dispute Settlement Understanding (DSU) elsewhere in this book, and the broad range of dispute-related issues raised by the TRIPS Agreement, this chapter will focus on issues that are more or less specific to the TRIPS Agreement.

The TRIPS Agreement is unique in the WTO context; it is the only WTO agreement that requires the members to affirmatively (or positively) incorporate complex substantive legal standards into national laws that govern both domestically-produced and imported goods. It relies for many of its rules on cross-reference to an existing body of multilateral conventions administered outside the WTO. The substantive rules imposed by the TRIPS Agreement are the subject of existing bodies of judicial opinion in the national and regional territories that are now subject to its discipline. Underlying the superficial certainty of the TRIPS Agreement substantive prescriptions are existing gulfs of interpretative difference regarding the meaning of many of its rules.


The TRIPS Agreement is unique in that it establishes minimum standards applicable to the enforcement of legislation by WTO members. The establishment of minimum enforcement standards necessarily implies that claims alleging the maintenance of inadequate enforcement procedures can and may be brought before the WTO Dispute Settlement Body, yet the TRIPS Agreement is silent on just how such a claim might be proven, e.g., where the threshold of inadequate enforcement might lie.


Identifying methods and sources of interpretation for the TRIPS Agreement's substantive requirements, as well as delimiting the appropriate threshold of adequate enforcement, are but two of the intriguing tasks facing the WTO Dispute Settlement Body.

download here:  http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1920816

The jurisprudence developed by panels and the Appellate Body (AB) under the TRIPS Agreement during the first six-plus years of implementation reflects a cautious and gradualist approach to interpretation of the agreement. The decisions provide a collective reminder of the importance that WTO Members attach to the use of intellectual property as an instrument of industrial and social policy and the intention of those Members to maintain adequate flexibility to address domestic circumstances. The adoption by Ministers of the Declaration on the TRIPS Agreement and Public Health at Doha on 14 November 2001 was a seminal event in the evolution of WTO law, and will influence jurisprudence under the TRIPS Agreement.

The AB began the development of TRIPS jurisprudence by cutting back on what it viewed as a too-liberal approach to interpretation by a panel, insisting that the focus of interpretation be on the terms of the agreement, and not on the "expectations" of Members and private operators. This approach by the AB was heartening to commentators who worried that the flexibility inherent in the terms of the agreement might be limited by over-attention to the perceived interests of right holders. However, it is also apparent that an interpretative approach emphasizing the plain language of the text contains built-in limitations. The TRIPS Agreement was designed to permit a substantial measure of national discretion in its implementation, and adjudicators will not find the broadly drafted provisions of the agreement perfectly instructive in some contexts.

The complex nature of TRIPS Agreement interpretation became evident in the decision of the panel in the Canada Patent Protection of Pharmaceutical Products (Canada - Generic Pharmaceuticals) case. This case involved application of Article 30 of the TRIPS Agreement concerning exceptions to patents, and demonstrated how difficult application of a balancing text is in the context of the WTO. Although the panel labored courageously to establish the "plain meaning" of the terms of what it characterized as a three-pronged test under Article 30, in the final analysis it necessarily engaged in a subjective balancing of the interests represented. The most problematic TRIPS DSU decision is that of the AB in the United StatesSection 211 Omnibus Appropriations Act of 1998 (US Havana Club) case. Although the underlying subject matter of the case was inconsequential (being nothing more than a commonplace trademark dispute between two wealthy alcoholic beverage distillers), the AB's application of extremely rigorous national and MFN treatment standards may lead to more serious questions down the road.

Language and interpretation fundamentally involve subjective inquiry. In a national constitutional framework, there are checks and balances on the exercise of subjective authority that are expected to result in a proper reflection of the public interest. Since the WTO legal system does not contain comparable checks and balances, the review under the DSU of intellectual property legislation addressing important public policy issues will continue to present a challenge to the legitimacy
of WTO governance. The Ministerial Declaration on the TRIPS Agreement and Public Health represented the beginning of efforts to introduce checks and balances.

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In connection with the run-up to the Cancun Ministerial Conference, the author was asked whether there are grounds for recommending amendment of WTO TRIPS Agreement rules addressing competition. The general conclusion of the study is that the TRIPS Agreement in its present form provides substantial discretion to WTO Members in the formulation and application of competition rules regulating intellectual property, and this arrangement serves the best interests of developed and developing countries. Potential amendments were considered across a matrix of interested country groups: North-North, North-South, South-North and South-South. Although country groups with different interests might seek to modify TRIPS competition-related rules to their perceived advantage, there is little reason to believe that consensus would be reached on such changes. The study acknowledges that global welfare benefits might flow from a more highly integrated international competition regime with powers to investigate and enforce agreed upon rules. There is, however, little identifiable near-term impetus for building such a regime, whether at the WTO or elsewhere. Competition laws of certain developed countries expressly exempt conduct with wholly foreign effects from the application of rules regulating anticompetitive practices, including those concerning intellectual property. Such exemptions appear inconsistent with advocacy of liberal market principles, and they are damaging to developing country interests. As part of the Doha Development Round commitment to developing countries, a decision by developed countries to eliminate these exemptions would be constructive.

in INTERNATIONAL TRADE LAW AND THE GATTIWTO DISPUTE SETTLEMENT SYSTEM 415-37 (ed. E.-U. Petersmann), Kluwer Law International, 1997

Download here

The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (the "TRIPS Agreement") has ushered in a new generation of legal issues that may ultimately find their way into the WTO dispute settlement arena. In light of the extensive coverage given to the WTO Dispute Settlement Understanding (DSU) elsewhere in this book, and the broad range of dispute-related issues raised by the TRIPS Agreement, this chapter will focus on issues that are more or less specific to the TRIPS Agreement.

The TRIPS Agreement is unique in the WTO context; it is the only WTO agreement that requires the members to affirmatively (or positively) incorporate complex substantive legal standards into national laws that govern both domestically-produced and imported goods. It relies for many of its rules on cross-reference to an existing body of multilateral conventions administered outside the WTO. The substantive rules imposed by the TRIPS Agreement are the subject of existing bodies of judicial opinion in the national and regional territories that are now subject to its discipline. Underlying the superficial certainty of the TRIPS Agreement substantive prescriptions are existing gulfs of interpretative difference regarding the meaning of many of its rules.


The TRIPS Agreement is unique in that it establishes minimum standards applicable to the enforcement of legislation by WTO members. The establishment of minimum enforcement standards necessarily implies that claims alleging the maintenance of inadequate enforcement procedures can and may be brought before the WTO Dispute Settlement Body, yet the TRIPS Agreement is silent on just how such a claim might be proven, e.g., where the threshold of inadequate enforcement might lie.


Identifying methods and sources of interpretation for the TRIPS Agreement's substantive requirements, as well as delimiting the appropriate threshold of adequate enforcement, are but two of the intriguing tasks facing the WTO Dispute Settlement Body.

 download here:  http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1920887

 

As a general conclusion this case-study suggests that the dispute between Pernod Ricard, a France-based multinational distiller and distributor, and Bacardi-Martini, a US-based multinational distiller and distributor, should have been resolved as a private commercial dispute and not as a systemic test of world trade system rules. In this regard, third party arbitration or mediation under the auspices of an alternative dispute settlement forum may have proven quite helpful.

Each private actor in the case entered into a commercial venture fully cognizant of ownership risks inherent in claims to intangible property that had been taken by the government of Cuba in the early 1960s. Both private parties sought the protection of their home government external commercial apparatus to ameliorate the consequences of the risks knowingly undertaken. Both the European Commission and the US Trade Representative (USTR) co-operated in converting the private commercial dispute into an international political dispute. By politicizing the dispute, both the EU and US found themselves arguing legal positions that are most likely contrary to their longer term commercial interests.

The major problem, however, is that a victory for the EU in WTO dispute settlement, which as a practical matter it did not achieve, would have entitled it to withdraw trade concessions from the US to enforce compliance. The withdrawal of such concessions would not directly benefit Pernod Ricard, and would likely harm US private operators other than Bacardi-Martini. In sum, the acts of the two private operators in knowingly taking risks in entering into legally tainted commercial relationships would result in harm to private operators that had not been a party to the risk-taking.

On the positive side in regard to WTO dispute settlement, the European Commission may have viewed this as the only practical way to diffuse internal political pressure being exerted by Pernod Ricard under the guise of 'Cuba policy'. Either outcome at the WTO level would allow the Commission to take the position that the EU had exhausted avenues of recourse against the US in this matter, and thereby diffuse the dispute. Similarly, if the WTO dispute settlement decision had been adverse to the US, this would have provided a means by which the USTR could have resisted further pressures to act on behalf of its private constituent.

Because the decision of the Appellate Body requires only an insubstantial modification to US law, it is doubtful that it will have a significant impact on internal or external US policy. It is difficult at this stage to say whether an alternative dispute settlement forum might have accomplished a similar end, or for that matter whether an end has been accomplished. The case remains open in terms of compliance by the US with the ruling of the Appellate Body.

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The Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS Agreement”) is the first WTO agreement requiring Members to establish a relatively detailed set of substantive norms within their national legal systems, as well as requiring them to establish enforcement measures and procedures meeting minimum standards. The TRIPS Agreement is sometimes referred to as the first WTO agreement that prescribes “positive law”. This factor alone might account for a more than typical level of controversy as Members deal, in many cases, with adopting rather far-reaching changes to their national legal systems.

However, added to the uniquely “positive” aspect of the TRIPS Agreement is a negotiating history that for a long time was highly contentious, particularly as between developed and developing Members, and the fact that the TRIPS Agreement touches upon sensitive and important social issues. In the final analysis, it should not be surprising that the TRIPS Agreement has generated a considerable amount of controversy among WTO Members, even if to date much of that controversy has not resulted in formal dispute settlement proceedings.

The TRIPS Agreement addresses a wide range of intellectual property subject matter areas (copyright, trademark, patent, and so forth). It also covers competitive markets, enforcement measures, dispute settlement, and transitional arrangements. This Module provides an introduction to these various aspects of the TRIPS Agreement, and seeks to focus on the kinds of questions that should be asked when approaching dispute settlement. In some areas, the questions are answered, but the entire field of intellectual property rights protection, including enforcement measures, cannot be covered in a single Module or short course. Moreover, the questions will change along with the technologies that form the subject matter of intellectual property rights protection. The objective of this Module is to provide sufficient background so that as specific issues arise, the diplomat or lawyer understands how to approach them.

This Module begins by discussing some general principles or concepts applicable to the field of TRIPS dispute settlement. It then deals with the various substantive subject matter areas covered by the agreement. It turns to enforcement measures, and afterwards to specific aspects of the WTO dispute settlement process. Finally, the existing WTO jurisprudence is described.

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In August 2001 the first public meeting of the American Society of International Law Project on Human Rights and International Trade (‘Project’) was held at the World Trade Institute in Berne, Switzerland. One session of that meeting was devoted to the relationship between human rights and the WTO Agreement in Trade-Related Aspects of Intellectual Property Rights (‘TRIPS Agreement’). As part of the follow-up to that meeting, the team leading the Project decided it would be useful to consider several ‘case studies’ that would seek more specifically to identify and analyze situations in which human rights and trade rules interact with each other. This study looks at the manner in which human rights may affect the application of competition rules and principles in the context of the TRIPS Agreement.

The analysis begins by observing that rights to life and health are well recognized in human rights law, and that the right to health has been confirmed by the WTO Ministerial Conference in the Doha Declaration on the TRIPS Agreement and Public Health. It proceeds to demonstrate that the TRIPS Agreement rules governing competition provide substantial flexibility in terms of national policy, rule development, and application, and that this flexibility is sufficient to take into account human rights interests. The analysis turns to WTO Appellate Body jurisprudence for support for the proposition that Members are permitted to take into account non-trade interests in interpreting and applying TRIPS Agreement rules.

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The main WTO law-related focus of this essay is the treatment of compulsory licensing and parallel trade under the TRIPS Agreement, with emphasis on the AIDS crisis confronting Africa, Asia, and other parts of the world. There are two principal reasons for addressing this subject matter in some detail. First, and paramount, is the exigency of the present situation. Africa in particular, and developing countries in general, are facing a public health crisis of catastrophic proportions, and there is an urgency to assuring that the WTO acts to aid in addressing this crisis, and does not take steps to hinder governments as they seek to address it. Second, the conduct of the United States government and the pharmaceutical industry threatens the very fabric of the WTO - an institution that was formed to promote economic growth and peaceful trade relations following the Second World War. While the essential reasons for the WTO are today often obscured by rhetoric concerning its impact on non-trade concerns, the fact that the WTO provides the foundation for peaceful relations in world trade should not be overlooked. By acting irresponsibly, the US government undermines the WTO by providing ammunition to its critics. An institution designed to do good is portrayed as doing bad.

The decision by the United States government to use its economic power as a weapon against developing countries fighting a battle against a deadly plague would plausibly lead developing country government officials and common citizens to question the economic, social, and political foundations of the TRIPS Agreement. Would any developing country government deliberately negotiate away its discretion to take measures to redress a health crisis of the most severe magnitude? Indeed, would any government or any group of citizens deliberately enter into a legal agreement condemning itself to early death?

 

 

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This study accepts the consensus of experts that developing countries should make use of policy options such as compulsory licensing and parallel importation to increase the supply of low-price medicines and vaccines. The interests of the OECD and its consumers will not be undermined by such action since, inter alia, Pharma is not significantly dependent on profits from developing countries to pursue its research mission.

The Doha Declaration on the TRIPS Agreement and Public Health mandates that the agreement be interpreted in a manner that supports public health interests and promotes access to medicines for all. This study analyzes the TRIPS Agreement in light of that mandate.

As of January 1, 2005, developing countries (excluding least developed) will be required to implement and enforce pharmaceutical product patent protection and operationalize patents based on mailbox applications that were submitted during the TRIPS transition period. At that time, the world supply of low-price off patent medicines will decrease. Not only will supplies of low-price medicines within developing countries decrease, but supplies available for export by these countries will gradually diminish.

The Doha Declaration provides to least developed countries (LDCs) an extension until January 1, 2016, to implement or enforce pharmaceutical product patent protection. That extension will have a limited effect on supplies since LDCs will remain dependent on low price imports from developing countries that may no longer be available. LDCs might best take advantage of the transition period by increasing their intra-LDC capacities to make and trade medicines and vaccines, but there are practical obstacles to accomplishing this.

When the developing country transition period ends, the restriction imposed by Article 31(f) of the TRIPS Agreement on exports under compulsory license is likely to have a significant effect on the world supply of low price medicines and vaccines. If a predominant part of compulsory licensed production must supply the local market, the quantity of available exports will be limited. To remedy this problem, the TRIPS Agreement should be amended to delete Article 31(f). If Article 31(f) is not deleted, Article 30 of the TRIPS Agreement regarding exceptions to patent rights must be interpreted so as to permit making and export of pharmaceutical products and other public health related inventions to meet public health needs. The adoption of a formal interpretation by the WTO Ministerial Conference or General Council would provide legal security for countries following this approach. This study provides a detailed analysis of Article 30 indicating that such exception from the rights of patent holders is permitted, and suggests criteria on which implementation of this exception may be evaluated.

Article 8:1 of the TRIPS Agreement authorizes the adoption of necessary public health measures provided they are “consistent” with the terms of the TRIPS Agreement. There is no justification for the TRIPS safeguard to be more restrictive than the safeguards applicable to goods and services. Article 8:1 should be amended to permit the adoption of necessary public health measures inconsistent with the TRIPS Agreement.

Developing countries may consider revisiting the position many of them advocated during the GATT Uruguay Round, and propose amendment of Article 27:3(a) of the TRIPS Agreement to allow exception from patenting of public health related inventions, including medicines and vaccines.
Developing countries should implement the TRIPS Agreement recognizing that its provisions do not demand excessive levels of protection promoted by only a few OECD countries. Knowledgeable observers agree that meeting the public health needs of developing countries requires substantial subsidization from OECD countries and international organizations such as the IMF and World Bank. The Global Fund does not to date evidence that it will be adequately funded so as to address urgent developing country needs for public health supplies. Developing countries must be prepared for self-reliance, and this self-reliance requires increased capacity to produce low price medicines and vaccines, whether or not such products are under patent by Pharma enterprises. This intensifies the importance of interpreting and amending the TRIPS Agreement to reinforce developing country capacity to act in their own best interests.

Increasing attention must be devoted to research and development on medicines and vaccines of particular relevance to developing countries. Neither the market nor the TRIPS Agreement provides a solution for the lack of attention to this R & D. An option to be further explored is increasing the level of funding for publicly undertaken R & D.

in INTERNATIONAL TRADE LAW AND THE GATTIWTO DISPUTE SETTLEMENT SYSTEM 415-37 (ed. E.-U. Petersmann), Kluwer Law International, 1997

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The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (the "TRIPS Agreement") has ushered in a new generation of legal issues that may ultimately find their way into the WTO dispute settlement arena. In light of the extensive coverage given to the WTO Dispute Settlement Understanding (DSU) elsewhere in this book, and the broad range of dispute-related issues raised by the TRIPS Agreement, this chapter will focus on issues that are more or less specific to the TRIPS Agreement.

The TRIPS Agreement is unique in the WTO context; it is the only WTO agreement that requires the members to affirmatively (or positively) incorporate complex substantive legal standards into national laws that govern both domestically-produced and imported goods. It relies for many of its rules on cross-reference to an existing body of multilateral conventions administered outside the WTO. The substantive rules imposed by the TRIPS Agreement are the subject of existing bodies of judicial opinion in the national and regional territories that are now subject to its discipline. Underlying the superficial certainty of the TRIPS Agreement substantive prescriptions are existing gulfs of interpretative difference regarding the meaning of many of its rules.


The TRIPS Agreement is unique in that it establishes minimum standards applicable to the enforcement of legislation by WTO members. The establishment of minimum enforcement standards necessarily implies that claims alleging the maintenance of inadequate enforcement procedures can and may be brought before the WTO Dispute Settlement Body, yet the TRIPS Agreement is silent on just how such a claim might be proven, e.g., where the threshold of inadequate enforcement might lie.


Identifying methods and sources of interpretation for the TRIPS Agreement's substantive requirements, as well as delimiting the appropriate threshold of adequate enforcement, are but two of the intriguing tasks facing the WTO Dispute Settlement Body.

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The adoption by Ministers on 14 November 2001, in Doha, of the Ministerial Declaration on the TRIPS Agreement and Public Health marked a turning point in political and legal relations at the WTO. Developing country Members sent a clear signal that they would take steps to protect and advance their essential interests. These Members demonstrated that by establishing a coalition, and maintaining it throughout a negotiating process, they could prevent themselves from being outmaneuvered by the EU-US block.

The essence of the Declaration is captured in paragraph 4:

"We agree that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all."

The TRIPS Agreement is a flexible legal instrument, and the decision of Ministers will prove significant in supporting interpretations that promote the protection of public health. While the Declaration does not resolve developing country concerns regarding access to medicines and TRIPS, it is a significant milestone.

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Government trade ministers arrived at that the WTO Seattle Ministerial Conference in late November 1999 without preliminary agreement on the future course of multilateral trade negotiations, and they departed without reaching consensus on a new WTO agenda. There was ample warning that the WTO Ministerial Conference in Seattle would face serious difficulties, with or without the public protests that disrupted the meeting. Only a few months before, WTO Members had completed the selection of a new Director-General – in fact the selection of two new Director-Generals to serve sequentially – in a tortuous process that lasted nearly a year. The Seattle agenda included a host of divisive issues involving serious substantive differences that Members had been unable to resolve in months of pre-meeting negotiations. Beyond hope in some quarters that pressure to maintain “momentum” would cause Members to abandon or compromise strongly held views, it is not clear why the Seattle Ministerial might have been approached with optimism about a comprehensive result.

The failure to reach consensus on a WTO negotiating agenda in Seattle left considerable unfinished business on the table. In a number of areas, such as agriculture, existing WTO texts prescribed that negotiations would be resumed. Since the ministerial, the WTO General Council has agreed to move forward with negotiations in agriculture and services, at least to the extent of seeking to clarify the subject matter to be pursued. There has been no agreement on a future agenda for negotiations regarding trade-related aspects of intellectual property rights (or TRIPS), although a number of “built-in” agenda items remain before the TRIPS Council. The lack of agreement on a “new” TRIPS agenda is not surprising in view of the wide gulf in perspectives on this subject among WTO Members.

This essay seeks to explain the absence of consensus on TRIPS, and why the near-to-medium term prospects for the setting of an ambitious agenda are not too bright. It reflects in modest detail on the particular controversy surrounding the potential for non-violation nullification or impairment complaints to be brought in the TRIPS dispute settlement context. This essay suggests that WTO Members might be best served in the near term by concentrating their efforts on establishing improved multilateral mechanisms to aid in the transfer of information and technology to developing and newly-industrialized countries.

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Study of trade-related aspects of intellectual property rights (TRIPS) has formed an integral part of the work program of the Committee on International Trade Law of the International Law Association (ILA) since its inaugural meeting at the headquarters of the GATT in 1993. In June 1995 in Geneva, the Committee decided to undertake a specific work program regarding the exhaustion of rights and parallel importation. In August 1996 in Helsinki, the Committee considered a preliminary First Report on the Subject of Parallel Importation prepared and presented by this Rapporteur. At that meeting, the Committee authorized wide distribution of a final version of that First Report to interested parties for reaction and comment. This final version took into account comments of Committee members presented at or in connection with the Helsinki meeting.

At its June 1997 meeting at the headquarters of the World Intellectual Property Organization (WIPO) in Geneva, the Committee considered the First Report (Final) and the preliminary comments of interested parties. At that meeting, the Committee decided to convene a special meeting on the subject of the First Report to further consider the views of interested parties. This meeting was held in Geneva on November 6-7, 1998, at the Graduate Institute of International Studies. At the conclusion of this meeting, Committee members agreed that this Rapporteur should prepare in preliminary form a Second Report on the Subject of the Exhaustion of Rights and Parallel Importation. This preliminary Second Report would incorporate the results of the November 1998 meeting, and would provide a basis for discussion at a meeting of the Committee to be held at WIPO on June 25, 1999. The objective of the June 1999 discussion would be to seek a common Committee position, and to consider a recommendation to the ILA for discussion at its bienniel meeting in London in 2000.

This Rapporteur continues to support a rule of international exhaustion across the fields of IPRs. He believes that the multilateral adoption of such a rule would promote the efficient allocation of productive resources in the world trading system, and that it would advance the interests of developing countries in building globally competitive enterprises. This Rapporteur considers that the risk of anticompetitive behavior among producers remains high, and that rules permitting parallel trade discourage anticompetitive horizontal collusion that affects world markets. Opening markets to parallel trade would benefit consumers. Recent actions by competition authorities in the United States and the European Union involving integrated pharmaceutical manufacturers, among others, affirm the need for vigilance in the protection of competitive markets. This Rapporteur recognizes that there are special circumstances for which exceptions to a general rule of international exhaustion might be made in the interests of social welfare, but considers that existing WTO rules and principles provide adequate flexibility to implement such exceptions. 

This Second Report is divided into six parts. Following the introduction, the second part describes developments in the field of exhaustion of rights and parallel importation subsequent to completion of the First Report. The third part notes certain interested party reactions to the First Report, and presents this Rapporteur’s responses. The fourth part presents the results of the November 1998 meeting in Geneva, including a brief synopsis of each panelist’s presentation, followed by a brief Rapporteur’s analysis. The fifth part describes and analyzes the international exhaustion issue in the context of digital networks and electronic commerce, as well as in the context of the GATS. The sixth and final part presents the final draft recommendation by the Committee in this field.

in INTERNATIONAL TRADE LAW AND THE GATTIWTO DISPUTE SETTLEMENT SYSTEM 415-37 (ed. E.-U. Petersmann), Kluwer Law International, 1997

Download here

The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (the "TRIPS Agreement") has ushered in a new generation of legal issues that may ultimately find their way into the WTO dispute settlement arena. In light of the extensive coverage given to the WTO Dispute Settlement Understanding (DSU) elsewhere in this book, and the broad range of dispute-related issues raised by the TRIPS Agreement, this chapter will focus on issues that are more or less specific to the TRIPS Agreement.

The TRIPS Agreement is unique in the WTO context; it is the only WTO agreement that requires the members to affirmatively (or positively) incorporate complex substantive legal standards into national laws that govern both domestically-produced and imported goods. It relies for many of its rules on cross-reference to an existing body of multilateral conventions administered outside the WTO. The substantive rules imposed by the TRIPS Agreement are the subject of existing bodies of judicial opinion in the national and regional territories that are now subject to its discipline. Underlying the superficial certainty of the TRIPS Agreement substantive prescriptions are existing gulfs of interpretative difference regarding the meaning of many of its rules.


The TRIPS Agreement is unique in that it establishes minimum standards applicable to the enforcement of legislation by WTO members. The establishment of minimum enforcement standards necessarily implies that claims alleging the maintenance of inadequate enforcement procedures can and may be brought before the WTO Dispute Settlement Body, yet the TRIPS Agreement is silent on just how such a claim might be proven, e.g., where the threshold of inadequate enforcement might lie.


Identifying methods and sources of interpretation for the TRIPS Agreement's substantive requirements, as well as delimiting the appropriate threshold of adequate enforcement, are but two of the intriguing tasks facing the WTO Dispute Settlement Body.

download here:  http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1918772

This article analyzes the North American Free Trade Agreement (NAFTA) in the context of a broader project examining the causes and consequences of the legalization of world politics. Governments are continuously engaged in the process of negotiating international trade agreements, and in each case negotiators are confronted with choices regarding the best mode of legalization to accomplish their agreed upon objectives. By closely analyzing the choices made by governments over time and correlating those choices with the results achieved (in the context of stated objectives), political scientists and lawyers may aid in directing government negotiators to preferred legalization options.

The form of legalization represented in NAFTA is characteristic of a trend toward higher levels of precision, obligation, and delegation in international trade regulation that has been ongoing since the adoption of the General Agreement on Tariffs and Trade (GATT) in 1947. The specific institutional and juridical framework of NAFTA reflects particularized objectives of Canadian, Mexican, and U.S. trade negotiators, pursued under constraints imposed by their political negotiating environment. NAFTA embodies a high degree of precision and obligation and a moderate degree of delegation of decision-making authority. The legalization formula of the World Trade Organization (WTO) agreement is substantially similar. The charter of the European Union (EU), in contrast, embodies a high degree of obligation and delegation and a moderate level of precision. Though the negotiators of the NAFTA, WTO, and EU agreements adopted somewhat different institutional and juridical models, they each preferred "hard" law to "soft" law.

This article analyzes NAFTA and explains the preference for using hard law in international economic arrangements. It suggests that hard law reduces intergovernmental transaction costs associated with trade and investment, reduces private risk premiums associated with trade and investment, promotes transparency and provides corollary participation benefits, tends to restrain strategic political behaviors, and may increase the range of integration effects by encouraging private actions to enforce intergovernmental obligations.

NAFTA was designed to promote market liberalization and to encourage capital flows, not to create a political union. Precise rules were adopted along with regional institutions that lack the power to adopt supplementary legislation. The agreement manifests a high level of obligation by way of terms that import binding commitment; these terms are not offset by exceptional opt-out provisions. However, a moderate level of authority is delegated to dispute-settlement mechanisms. There was no political support for a strong regional judicial body that would significantly restrict the autonomy of the parties. The creation of such a judicial body would have raised serious constitutional issues within the parties and may have precluded the conclusion of an agreement. The European Community (EC) treaty-the charter of the EU-employs a different legalization formula than employed by NAFTA or the WTO agreement. Hard legalization in the EU trade context is achieved by a relatively imprecise charter coupled with a high degree of delegation to institutions that may promulgate secondary legislation with more precise content. The objective of providing rules that more adequately address second- and third-generation trade barriers is achieved, but only through a continuing legislative and judicial process. The EU contemplates achieving substantially broader social objectives than NAFTA or the WTOY Neither the parties to NAFTA nor the members of the WTO had the political option of establishing the high level of delegation represented in the EU institutions, and neither arrangement sought to broadly address social issues. Determining whether the legalization formula in NAFTA or in the EU is better suited to achieving its objectives is not feasible at this stage. The objectives of the arrangements are not the same, which argues against directly comparing the formulas.

A counter-example to the NAFTA/WTO formula is represented by the Asia Pacific Economic Cooperation (APEC) forum. APEC is characterized by low levels of precision, delegation, and obligation. I I The APEC formula was adopted in the context of historically nonlegalized cultures and by governments that had not agreed on particular objectives. APEC is not a successful model of regional economic integration. It may be viewed as a failed experiment in alternative legalization or as a transitional model serving as a predicate to harder legalization.

NAFTA has so far been implemented largely in accordance with its terms, despite the period of economic turbulence generated by the Mexican peso crisis of 1994-95. The period of NAFTA implementation has witnessed substantial increases in cross border trade among its parties and significantly heightened transborder capital flows. On their face, these developments might suggest that NAFTA has aided in achieving the economic objectives of its parties; however, the parties have maintained political policies supportive of NAFTA's objectives throughout this period. The period of
NAFTA implementation has coincided with sustained economic expansion in the United States, the dominant economic actor in the arrangement. It may plausibly be argued that the parties would have achieved the same objectives, with comparable results, without NAFTA. NAFTA has yet to face sustained circumstances in which legal norms and political policies diverge, and the durability of its legalization effects are thus relatively indeterminate.

The implementation of NAFTA has yielded certain unanticipated results. The transnational
(investor-to-state) investment-related dispute settlement mechanism has been invoked by private investors in circumstances that were not contemplated by NAFTA negotiators. This lends support to the postulate that transnational dispute settlement may broaden the scope of subject matter affected by an international trade agreement. The record of NAFTA implementation to date supports the use of hard law instruments in international economic relations.

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WTO governance has traditionally reflected the interests of producers channeled through government trade negotiators. The producer-driven governance model is not suited to the highly integrated international society of the 21st century. The WTO governance structure should be adapted to account for more diverse interests, including those of marginalized developing countries, NGOs, and individuals. One aspect of this adaptation should involve more highly integrated relations between the WTO and other multilateral institutions. The inter-institutional relationship that has evolved between the WTO and the World Intellectual Property Organization (WIPO) since the conclusion of the Uruguay Round evidences a number of characteristics that might usefully form the basis for relations between the WTO and other international organizations. The WTO-WIPO relationship effectively enhances the breadth of subject matter interests and the administrative capacity of each organization, and it provides a suitable forum for the negotiation of incremental and experimental intellectual property rules that are needed in response to technological change. A second aspect of institutional adaptation concerns increasing the participation of wider segments of international society in multilateral rule-making. The WIPO Internet Domain Name Process was a unique governance exercise that employed elements of direct democracy at the international level and the management of an organizational bureaucracy (the WIPO International Bureau). This type of process might usefully be employed in other contexts, such as by the FAO/WHO in developing health and safety guidelines in connection with genetically modified organisms (GMOs).

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This article examines the complex relationship between the institutions and legal rules of the NAFTA and the World Trade Organization. The juridical relationship between the NAFTA and WTO Agreement is of considerable interest from the standpoints of policy and technical analysis of legal norms. As a matter of policy, a decision by NAFTA negotiators whether to accord legal priority to the NAFTA or WTO would appear to involve a choice whether to accord a greater degree of attention and concern to more narrow regional economic and political interests, or to broader multilateral interests. In light of the importance that trade policy makers have ascribed to the potential for conflict between the regional and multilateral integration models, NAFTA negotiators might have been expected to make a clear choice in this hierarchy of interests. Evidence from the text of the NAFTA and from the early NAFTA dispute settlement panel reports suggests that no such overarching policy determination was made or that, if it was made, the determination was implemented in an uncertain manner.

The uncertainty surrounding the relationship between the NAFTA and WTO Agreement may reflect the dynamic political tensions faced by the NAFTA negotiators, tensions that continue to influence the formation and implementation of policy in the NAFTA Parties. On one side, the NAFTA was and is portrayed by its proponents as a means of accelerating integration on the North American continent in a way that is consistent with the political and social interests of a variety of disparate groups, including the business community, labor unions and environmentalists. The NAFTA is politically justified by its attention to interests that are more difficult to address at the WTO multilateral level. If the results of NAFTA negotiations are placed beneath WTO Agreement norms, then in theory this attention to regionally-specific interests might be jeopardized by the superiority of more generalized WTO norms. There are, therefore, political and social motivations for advocating priority for the NAFTA. On the other side, NAFTA negotiators were and remain well aware of concerns among GATT-WTO Members about efforts by particular countries and regions to gain advantages by extending regional preferences. NAFTA negotiators would be hesitant to make a clear statement of regional legal preference that might galvanize opposition to the agreement, or that might jeopardize future multilateral negotiations. NAFTA negotiators may well have maintained a preference for multilateralism among themselves, yet nevertheless have been reluctant to clearly express such preference in the NAFTA because this might be found objectionable by interest groups within the region whose support was required to assure successful conclusion of the agreement. Though the NAFTA-WTO hierarchy of norms is uncertain, and while such uncertainty is bound to lead to or exacerbate future NAFTA disputes, the political and social forces that impelled the initial state of ambiguity have not dissipated. While interests in political stability and economic efficiency might be enhanced through the clarification of this matter by the NAFTA Parties through the adoption of a clarifying amendment or an inter-governmental understanding, the Parties may be in no more favorable position to agree on such a clarification in the year 2000 than they were in 1993.

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This article concerns the avoidance and settlement of trade disputes between Japan and the United States. There are three aspects to the question of dispute settlement and avoidance between Japan and the United States that deserve close attention.

First, the Agreement Establishing the World Trade Organization (WTO) and its related agreements move the General Agreement on Tariffs and Trade 1947 (GATT) system along the continuum from a soft law to a hard law system. There is an increased level of detail in the WTO legal instruments, and dispute settlement procedures are redesigned to reduce political influence in the outcome of proceedings. The WTO legal instruments are intended to channel trade disputes into the WTO dispute settlement forum. The evolution of the GATT legal system should attract Japanese and U.S. trade officials to the WTO dispute settlement forum, and compel its use, in a large number of contexts.

Nevertheless, there are important gaps in the WTO rule system, and these gaps are not always filled by alternative bilateral and minilateral trade instruments. These include the absence of minimum rules on the maintenance of competitive domestic markets, the absence of adequate sectoral coverage among members to the General Agreement on Trade in Services (GATS), the absence of rules on the treatment of foreign investors (including with respect to corporate governance), the absence of adequate scope of coverage of the plurilateral WTO Government Procurement Agreement, the absence of adequate rules governing civil offset arrangements, and so forth. Many of the trade disputes between Japan and the United States involve these "gap" areas. Though such disputes might in theory be resolved under a non-violation nullification or impairment action in the WTO Dispute Settlement Understanding (DSU), the lack of clarity of the WTO system in applying the non-violation rules makes such solutions problematic on all sides.

Improvement in the system for the avoidance and settlement of trade and investment disputes between Japan and the United States may be brought about gradually through the enlargement and refinement of the rule system governing relations between the two countries. This enlargement and refinement will not necessarily take place in the WTO. There are a variety of bilateral, minilateral and multilateral fora in which more complete systems may be negotiated, including the North American Free Trade Agreement (NAFTA), Asia Pacific Economic Cooperation (APEC) forum and the Organization for Economic Cooperation and Development (OECD), and the choice of forum will vary according to context. The enlargement and refinement of the rule system will be affected by limitations arising out of system incompatibilities.

Second, there are good faith differences between Japan and the United States concerning the desirable level of government intervention in the domestic and international marketplace. These good faith differences lead to disputes concerning whether actions by governments are taken in order to protect against foreign competition, or are taken instead to promote desirable national domestic policy goals, such as stability in employment. In addition, some differences between Japan and the United States involve the behaviors of consumers, enterprises and political parties which are deeply entrenched. Even assuming that trade officials in both countries can adequately identify ways in which economic practices of Japan and the United States could be made more compatible, and even assuming that such changes were on both sides concluded to be desirable, it is not necessarily within the power of trade officials to mandate such changes.

When system changes are impracticable, and system incompatibilities lead to an imbalance in trade relations, some form of adjustment mechanism may be desirable as a means of diffusing trade friction. Identifying entrenched system incompatibilities and creating an adjustment mechanism present a challenge to trade officials.

Third, the trend of Japan-U.S. relations over the past several decades has been to solve trade disputes through market access agreements that are either explicitly or implicitly enforced by governments. Such agreements are anticompetitive, in effect promoting market allocation by potential private competitors. These solutions are suboptimal from a competitive market standpoint, though they may be preferable to a closed market alternative. This criticism of managed market access arrangements assumes a preference for open competitive international markets. Whether Japanese and U.S. trade officials in fact share this preference on a theoretical basis is an important question.

It should be clear ab initio that there is no "magic bullet" solution to trade and investment conflicts between Japan and the United States. These conflicts may in fact become more intense as the "China problem" more directly affects bilateral Japanese-U.S. relations. An incomplete rule system cannot be made complete overnight. Major macroeconomic policy differences cannot be dismissed by each side as aberrational thinking. Suboptimal market allocation solutions must be replaced with better solutions. If this were easy or convenient, it would already have been done.

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The European Court of Justice (ECJ) has been asked to decide whether its own seminal jurisprudence on the prerequisites of the completed internal market may be extended into the international arena of trade, or should instead be mandatorily restricted to the European Union (EU) market itself.

The ECJ perceived in the 1960s that completion of the internal market as promised by the Treaty of Rome would be threatened if trade mark holders and other holders of intellectual property rights (IPRs) might use those rights to partition the internal market when tariffs and quotas were eliminated within the Community. From that early date the Court has been addressed by attacks against its intra-Union exhaustion doctrine from many sides.

The Court now is asked to define EU policy on the subject of the international or worldwide exhaustion of IPRs under the guise of a seemingly minor question of interpretation-namely whether Article 7 of the Trade Marks Directive of 1989 should be understood to have limited the power of the Member States to adopt their own rules regarding international exhaustion in respect of trade marks. Yet underlying this seemingly minor question lies years of intensive lobbying of the Member State governments and the Commission by industry groups concerned to assure that the E.U. does not adopt a policy of international exhaustion, not only in the field of trade marks, but also in the fields of copyright, patent and related rights.

A series of Directives has been set up, each with similar text on the question of exhaustion-each with text that fails to address the international exhaustion issue. Now the Trojan Horse has been wheeled into Luxembourg and the Court is asked to construe the text of the Trade Marks Directive. Is the ECJ prepared to foreclose an open world market in IPRs protected goods on the basis of this record? Is the ECJ prepared to open the door in the side of this Trojan Horse?

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CHINA IN THE WORLD TRADING SYSTEM: DEFINING THE PRINCIPLES OF ENGAGEMENT, pp. 1-43, F.M. Abbott, ed., Kluwer Law International 1998

China's prospective membership in the World Trade Organization is one of the most significant developments relating to international institutions to take place in the past several decades. It comes in the midst of the broad transformation of post-World War II command economies to market orientation. It comes shortly after the transition of the GATT into a more comprehensive international economic organization, based on the rule of law. It represents the potential integration of over one-fifth of the world's population into the primary system established for the purpose of enhancing worldwide economic growth and employment. It will transform the WTO into an inclusive organization, and the WTO may become a less comfortable place from an OECD country standpoint than it has been for the past 50 years. China's prospective entry into the WTO is an opportunity and a challenge for China, for the United States and other industrialized states, and for the WTO.

Despite grounds for concern, the advantages to the United States and other countries of bringing China into the WTO system seem obvious. China would agree to open its huge internal market to foreign goods and services. China would provide assurances of fair treatment to importers and foreign service providers. China would agree to be bound by the rule of law in the conduct of its trade relations. China would be anchored in the global economy in ways that would encourage stability in external security relations. On China's side, the advantages of membership in the WTO also seem obvious. As its economy gains strength and becomes more competitive with OECD economies, it would reduce the risk of being arbitrarily shut out of export markets. It would less likely be subject to ad hoc decisions by foreign governments about whether it would continue to enjoy trade privileges. The security of its access to foreign capital markets and foreign direct investment would be enhanced. It would have access to neutral dispute settlement. The integration of China into the WTO also means international economic relations will be playing a greater role in its external world view. Stable external economic relations are becoming increasingly important to the vitality of China's economy. Military-security relations and concerns of the Cold War era are being translated into economic relations and concerns. On the whole, this transition appears to be a positive one for the international community.

There appears to be a consensus among United States and European Union trade negotiators strongly in favor of China's accession to the WTO, but on the condition that China accept the 'fundamental rules' applicable to WTO Members, and that China accept a level of commitments that 'is commensurate to the size and importance of that economy." This approach appears to have merit.

The use of transitional arrangements intended to bring China's market access commitments in line with those of other major WTO economies appears to be a reasonable course. The OECD business community and financial markets are incessantly anxious for immediate results. Yet it is useful to recall that the member states of the European Economic Community agreed to liberalize the Community services market in 1957/58, and that major progress had been largely unrealized until implementation of the 1992 Plan. Whether China's services markets are open in 5 years, 10 years, or even 15 years, is not a burning question for the international economic system; provided that China is committed to meeting a defined timetable which ultimately produces a substantive result commensurate with that of other WTO Members.

The end of the Cold War era is demanding more inclusive international economic institutions. The widening of membership in these institutions cannot be accomplished without some element of risk. This risk should be welcomed in a trade-off against the greater risk of isolating and alienating the major economic and political powers whose transition to market orientation may otherwise portend a very positive contribution to the international community.

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Abstract: The First Report on Parallel Imports approaches the exhaustion/parallel imports question in broad economic terms, asking whether there may be an economic and social welfare benefit to permitting IPRs holders to block parallel imports that outweighs the potential harm to liberal trade. The Report addresses each major form of IPR (patent, trademark and copyright) separately. It concludes with respect to each form that the evidence of benefits that might flow from allowing parallel imports to be blocked is insufficient to justify the potential inhibition of trade. The Report observes that most objectives which IPRs holders seek to achieve by the allocation of geographic markets can be attained through less trade restrictive means, namely through the vertical allocation of distribution territories by contract. The interests of the developing countries are a focus of the Report. Some economists have suggested that allowing rules on parallel information to enforce price discrimination in favor of developing countries may increase global economic welfare. The Report concludes that developing and developed countries are better served by open markets and the operation of comparative advantage. The Report recommends that the WTO adopt a rule precluding governments from blocking parallel imports save in certain exceptional cases, and it also suggests that further study of this issue would be desirable.

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This special issue on trade-related aspects of intellectual property rights (TRIPS) is introduced with a perspective that focuses on the urgency of narrowing the gap in living standards between the rich nations and the poor. The 1997/98 world economic crisis highlights the question of whether creating an international market in intellectual property sufficiently addresses the interests of developing countries in the diffusion and use of knowledge. It is suggested that substantial intervention by international institutions with interests in promoting development is also required. The role of IPRs in economic development is analyzed, and this contribution points to a few areas in which consensus among international IPRs specialists is emerging. Among these is that the role of IPRs is context-sensitive, depending on the particular characteristics of countries in which IPRs systems are introduced, and depending on the specific industries in which these IPRs are employed. This context-sensitive role argues for flexible implementation of the TRIPS Agreement in developing and newly industrializing countries. In WTO implementation of the TRIPS Agreement (including a review of national laws and dispute settlement) and in forthcoming WTO TRIPS negotiations (in areas such as biotechnology and genetics, the digital environment and electronic commerce, exhaustion of rights, non-violation causes of actions, competition and investment), the specific interests of the developing countries must be given a priority. Just as developed countries have traditionally balanced the IPRs interests of producers, consumers, and the science and research communities, so also must the WTO balance respective global interests in technology and creativity. The author urges a more extensive role for institutions such as the World Bank in technology capacity-building.

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Governments are intricately intertwined in the development and maintenance of technology. This involvement ranges from the most embedded interest of government as provider of education, to its varietal allocation of tax burden based on type of activity (e.g., research and development), to its indirect subsidization of technology development through procurement activity (including in the military sector), to its direct subsidization of research and development activity, to its provision of technology transport infrastructure, to its grant and deprivation of rights in intellectual property, and to its imposition of technology transfer requirements in international trade.

The World Trade Organization (WTO), through its extension to the new areas of services and TRIPS, and in conjunction with pre-existing GATT coverage of subsidies, government procurement, and related areas, imposes a substantial set of rules governing this technology complex. From the standpoint of private intellectual property rights (IPRs) holders, governments and state enterprises become problematic, inter alia, when they preempt commercial opportunities through the diversion of IPRs. Two of the circumstances in which such diversion is likely to occur are examined in this chapter.

The first of the circumstances is that in which the government or state enterprise uses the IPRs of a private party without its authorization or consent. This chapter begins by examining the rules of the Paris Convention on the Protection of Industrial Property (Paris Convention) and those of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) that apply to the ownership by governments and state enterprises of patents. It then examines the provisions of those two international agreements relating to the use by governments and state enterprises of privately held patent rights without the consent of the rights holder. Though all forms of IPR may be used as instruments to promote technology development, this chapter focuses on the patent grant because it is the major form of IPR most specifically directed to the promotion of technology development in connection with private commercial exploitation. It is suggested that the Paris Convention and TRIPS Agreement, taken together, afford considerable leeway to governments in authorizing their state enterprises to make use of privately held patent rights without the consent or authorization of right holders.

Second, this chapter examines WTO rules regarding government mandated transfers of technology to states, state enterprises, and contractors, particularly in the context of the aerospace sector. The aerospace sector is selected because private enterprises in that sector are among those that have been subject to the most visible demands for technology transfer by governments. This chapter concludes that there is some ambiguity in the relevant WTO provisions in this area. This ambiguity may be addressed in WTO accession negotiations with prospective new WTO members, such as China. Whether and to what extent WTO law permits members to mandate transfers of technology to state and other domestic enterprises is a question the answer to which may divide developed and developing members.

in INTERNATIONAL TRADE LAW AND THE GATTIWTO DISPUTE SETTLEMENT SYSTEM 415-37 (ed. E.-U. Petersmann), Kluwer Law International, 1997

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The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (the "TRIPS Agreement") has ushered in a new generation of legal issues that may ultimately find their way into the WTO dispute settlement arena. In light of the extensive coverage given to the WTO Dispute Settlement Understanding (DSU) elsewhere in this book, and the broad range of dispute-related issues raised by the TRIPS Agreement, this chapter will focus on issues that are more or less specific to the TRIPS Agreement.

The TRIPS Agreement is unique in the WTO context; it is the only WTO agreement that requires the members to affirmatively (or positively) incorporate complex substantive legal standards into national laws that govern both domestically-produced and imported goods. It relies for many of its rules on cross-reference to an existing body of multilateral conventions administered outside the WTO. The substantive rules imposed by the TRIPS Agreement are the subject of existing bodies of judicial opinion in the national and regional territories that are now subject to its discipline. Underlying the superficial certainty of the TRIPS Agreement substantive prescriptions are existing gulfs of interpretative difference regarding the meaning of many of its rules.


The TRIPS Agreement is unique in that it establishes minimum standards applicable to the enforcement of legislation by WTO members. The establishment of minimum enforcement standards necessarily implies that claims alleging the maintenance of inadequate enforcement procedures can and may be brought before the WTO Dispute Settlement Body, yet the TRIPS Agreement is silent on just how such a claim might be proven, e.g., where the threshold of inadequate enforcement might lie.


Identifying methods and sources of interpretation for the TRIPS Agreement's substantive requirements, as well as delimiting the appropriate threshold of adequate enforcement, are but two of the intriguing tasks facing the WTO Dispute Settlement Body.

in INTERNATIONAL TRADE LAW AND THE GATTIWTO DISPUTE SETTLEMENT SYSTEM 415-37 (ed. E.-U. Petersmann), Kluwer Law International, 1997

Download here

The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (the "TRIPS Agreement") has ushered in a new generation of legal issues that may ultimately find their way into the WTO dispute settlement arena. In light of the extensive coverage given to the WTO Dispute Settlement Understanding (DSU) elsewhere in this book, and the broad range of dispute-related issues raised by the TRIPS Agreement, this chapter will focus on issues that are more or less specific to the TRIPS Agreement.

The TRIPS Agreement is unique in the WTO context; it is the only WTO agreement that requires the members to affirmatively (or positively) incorporate complex substantive legal standards into national laws that govern both domestically-produced and imported goods. It relies for many of its rules on cross-reference to an existing body of multilateral conventions administered outside the WTO. The substantive rules imposed by the TRIPS Agreement are the subject of existing bodies of judicial opinion in the national and regional territories that are now subject to its discipline. Underlying the superficial certainty of the TRIPS Agreement substantive prescriptions are existing gulfs of interpretative difference regarding the meaning of many of its rules.


The TRIPS Agreement is unique in that it establishes minimum standards applicable to the enforcement of legislation by WTO members. The establishment of minimum enforcement standards necessarily implies that claims alleging the maintenance of inadequate enforcement procedures can and may be brought before the WTO Dispute Settlement Body, yet the TRIPS Agreement is silent on just how such a claim might be proven, e.g., where the threshold of inadequate enforcement might lie.


Identifying methods and sources of interpretation for the TRIPS Agreement's substantive requirements, as well as delimiting the appropriate threshold of adequate enforcement, are but two of the intriguing tasks facing the WTO Dispute Settlement Body.

in INTERNATIONAL TRADE LAW AND THE GATTIWTO DISPUTE SETTLEMENT SYSTEM 415-37 (ed. E.-U. Petersmann), Kluwer Law International, 1997

Download here

The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (the "TRIPS Agreement") has ushered in a new generation of legal issues that may ultimately find their way into the WTO dispute settlement arena. In light of the extensive coverage given to the WTO Dispute Settlement Understanding (DSU) elsewhere in this book, and the broad range of dispute-related issues raised by the TRIPS Agreement, this chapter will focus on issues that are more or less specific to the TRIPS Agreement.

The TRIPS Agreement is unique in the WTO context; it is the only WTO agreement that requires the members to affirmatively (or positively) incorporate complex substantive legal standards into national laws that govern both domestically-produced and imported goods. It relies for many of its rules on cross-reference to an existing body of multilateral conventions administered outside the WTO. The substantive rules imposed by the TRIPS Agreement are the subject of existing bodies of judicial opinion in the national and regional territories that are now subject to its discipline. Underlying the superficial certainty of the TRIPS Agreement substantive prescriptions are existing gulfs of interpretative difference regarding the meaning of many of its rules.


The TRIPS Agreement is unique in that it establishes minimum standards applicable to the enforcement of legislation by WTO members. The establishment of minimum enforcement standards necessarily implies that claims alleging the maintenance of inadequate enforcement procedures can and may be brought before the WTO Dispute Settlement Body, yet the TRIPS Agreement is silent on just how such a claim might be proven, e.g., where the threshold of inadequate enforcement might lie.


Identifying methods and sources of interpretation for the TRIPS Agreement's substantive requirements, as well as delimiting the appropriate threshold of adequate enforcement, are but two of the intriguing tasks facing the WTO Dispute Settlement Body.

dowload here:  http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1918758

The creation of the NAFTA and the negotiation of the FTAA are profoundly important political and economic developments for the United States, just as the creation of the European Economic Community and the widening of the European Union are profoundly important political and economic developments on the other side of the Atlantic. Yet the logic of the western hemispheric integration process is not the logic of the European integration process. The historical situation of Europe is extraordinarily complex. Interstate violence played a central role in the creation and evolution of the European Union. The need for rapid post-World War II economic rebuilding of European industry and agriculture overshadowed purely national concerns and helped to overcome historical rivalries among the Member States and their citizens. The postwar threat of the Soviet empire provided a basis for Western European political cohesion that, in retrospect, may have been only dimly understood. Though the European Union is now struggling to find direction, there remains strong consensus that the core function of the Union in preserving European peace and security should remain intact.

If there is a logic to the western hemispheric integration process, it is a different logic than the logic of Europe. Interstate violence has played a very limited historical role among the nations of the western hemisphere. Internal strife, on the other hand, has plagued many nations of Latin America. Low rates of economic growth throughout the four decades following the Second World War worked great economic and social hardship. The promise of more rapid economic growth impelled a recent change in government attitudes towards trade and investment and paved the way for the FTAA negotiations.

The first draft of this article was prepared in early 1995 immediately following the Mexican peso crisis and was presented as part of a lecture series at U.C. Berkeley School of Law. The thesis of that draft was (1) that there was a net positive social welfare value to the NAFTA; (2) that there was a lack of political support for a socially progressive NAFTA in the United States that gave rise to doubts concerning its viability; and (3) that analytical tools developed by political and social scientists might assist public policy planners in the United States to address the underlying lack of support that threatened the NAFTA enterprise. Over the past two years the immediacy of the peso crisis has faded. The NAFTA increasingly appears as a component of a broader long-term hemispheric picture that is slowly coming into focus. For this reason, the focus of the article has changed.

This article is now directed to the steps that should be taken to build a foundation for the longer-term enterprise of western hemispheric integration. The article begins by reviewing the work of political and social scientists who have stressed that international and regional institution-building require the self-interest and support of key actors and interest groups involved in the process. The success of a regional integration effort may well depend on the presence of a sufficient confluence of self-interests among key actors and interest groups throughout economically important countries in a region. This article concentrates as a starting point on United States interest groups and political actors and considers whether these key actors and interest groups have a self-interest in the success of hemispheric integration. It suggests some ways that domestic support for the future western hemispheric integration process may be enhanced.

Ultimately, the process of building the FTAA will not be successful simply because it is supported in the United States, even though it will certainly fail from a lack of U.S. support. The building of a regional integration arrangement requires support from throughout a region. There remains ahead the very large task of identifying the key actors and interest groups throughout the nations of the prospective FTAA and their self-interests in the integration process. Western hemispheric economic integration can be undertaken in a socially responsible manner that will result in a net positive social welfare value for the people of the United States and the western hemisphere as a whole. The essential questions that must be addressed in the process of institution building concern the shape of the process: who will benefit and what will be its impact on the overall quality of life in the region? It certainly is not enough that a regional integration arrangement be built; an arrangement that promotes the social welfare interests of the people of this hemisphere must be built.

in INTERNATIONAL TRADE LAW AND THE GATTIWTO DISPUTE SETTLEMENT SYSTEM 415-37 (ed. E.-U. Petersmann), Kluwer Law International, 1997

Download here

The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (the "TRIPS Agreement") has ushered in a new generation of legal issues that may ultimately find their way into the WTO dispute settlement arena. In light of the extensive coverage given to the WTO Dispute Settlement Understanding (DSU) elsewhere in this book, and the broad range of dispute-related issues raised by the TRIPS Agreement, this chapter will focus on issues that are more or less specific to the TRIPS Agreement.

The TRIPS Agreement is unique in the WTO context; it is the only WTO agreement that requires the members to affirmatively (or positively) incorporate complex substantive legal standards into national laws that govern both domestically-produced and imported goods. It relies for many of its rules on cross-reference to an existing body of multilateral conventions administered outside the WTO. The substantive rules imposed by the TRIPS Agreement are the subject of existing bodies of judicial opinion in the national and regional territories that are now subject to its discipline. Underlying the superficial certainty of the TRIPS Agreement substantive prescriptions are existing gulfs of interpretative difference regarding the meaning of many of its rules.


The TRIPS Agreement is unique in that it establishes minimum standards applicable to the enforcement of legislation by WTO members. The establishment of minimum enforcement standards necessarily implies that claims alleging the maintenance of inadequate enforcement procedures can and may be brought before the WTO Dispute Settlement Body, yet the TRIPS Agreement is silent on just how such a claim might be proven, e.g., where the threshold of inadequate enforcement might lie.


Identifying methods and sources of interpretation for the TRIPS Agreement's substantive requirements, as well as delimiting the appropriate threshold of adequate enforcement, are but two of the intriguing tasks facing the WTO Dispute Settlement Body.

in INTERNATIONAL TRADE LAW AND THE GATTIWTO DISPUTE SETTLEMENT SYSTEM 415-37 (ed. E.-U. Petersmann), Kluwer Law International, 1997

Download here

The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (the "TRIPS Agreement") has ushered in a new generation of legal issues that may ultimately find their way into the WTO dispute settlement arena. In light of the extensive coverage given to the WTO Dispute Settlement Understanding (DSU) elsewhere in this book, and the broad range of dispute-related issues raised by the TRIPS Agreement, this chapter will focus on issues that are more or less specific to the TRIPS Agreement.

The TRIPS Agreement is unique in the WTO context; it is the only WTO agreement that requires the members to affirmatively (or positively) incorporate complex substantive legal standards into national laws that govern both domestically-produced and imported goods. It relies for many of its rules on cross-reference to an existing body of multilateral conventions administered outside the WTO. The substantive rules imposed by the TRIPS Agreement are the subject of existing bodies of judicial opinion in the national and regional territories that are now subject to its discipline. Underlying the superficial certainty of the TRIPS Agreement substantive prescriptions are existing gulfs of interpretative difference regarding the meaning of many of its rules.


The TRIPS Agreement is unique in that it establishes minimum standards applicable to the enforcement of legislation by WTO members. The establishment of minimum enforcement standards necessarily implies that claims alleging the maintenance of inadequate enforcement procedures can and may be brought before the WTO Dispute Settlement Body, yet the TRIPS Agreement is silent on just how such a claim might be proven, e.g., where the threshold of inadequate enforcement might lie.


Identifying methods and sources of interpretation for the TRIPS Agreement's substantive requirements, as well as delimiting the appropriate threshold of adequate enforcement, are but two of the intriguing tasks facing the WTO Dispute Settlement Body.

in INTERNATIONAL TRADE LAW AND THE GATTIWTO DISPUTE SETTLEMENT SYSTEM 415-37 (ed. E.-U. Petersmann), Kluwer Law International, 1997

Download here

The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (the "TRIPS Agreement") has ushered in a new generation of legal issues that may ultimately find their way into the WTO dispute settlement arena. In light of the extensive coverage given to the WTO Dispute Settlement Understanding (DSU) elsewhere in this book, and the broad range of dispute-related issues raised by the TRIPS Agreement, this chapter will focus on issues that are more or less specific to the TRIPS Agreement.

The TRIPS Agreement is unique in the WTO context; it is the only WTO agreement that requires the members to affirmatively (or positively) incorporate complex substantive legal standards into national laws that govern both domestically-produced and imported goods. It relies for many of its rules on cross-reference to an existing body of multilateral conventions administered outside the WTO. The substantive rules imposed by the TRIPS Agreement are the subject of existing bodies of judicial opinion in the national and regional territories that are now subject to its discipline. Underlying the superficial certainty of the TRIPS Agreement substantive prescriptions are existing gulfs of interpretative difference regarding the meaning of many of its rules.


The TRIPS Agreement is unique in that it establishes minimum standards applicable to the enforcement of legislation by WTO members. The establishment of minimum enforcement standards necessarily implies that claims alleging the maintenance of inadequate enforcement procedures can and may be brought before the WTO Dispute Settlement Body, yet the TRIPS Agreement is silent on just how such a claim might be proven, e.g., where the threshold of inadequate enforcement might lie.


Identifying methods and sources of interpretation for the TRIPS Agreement's substantive requirements, as well as delimiting the appropriate threshold of adequate enforcement, are but two of the intriguing tasks facing the WTO Dispute Settlement Body.

in INTERNATIONAL TRADE LAW AND THE GATTIWTO DISPUTE SETTLEMENT SYSTEM 415-37 (ed. E.-U. Petersmann), Kluwer Law International, 1997

Download here

The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (the "TRIPS Agreement") has ushered in a new generation of legal issues that may ultimately find their way into the WTO dispute settlement arena. In light of the extensive coverage given to the WTO Dispute Settlement Understanding (DSU) elsewhere in this book, and the broad range of dispute-related issues raised by the TRIPS Agreement, this chapter will focus on issues that are more or less specific to the TRIPS Agreement.

The TRIPS Agreement is unique in the WTO context; it is the only WTO agreement that requires the members to affirmatively (or positively) incorporate complex substantive legal standards into national laws that govern both domestically-produced and imported goods. It relies for many of its rules on cross-reference to an existing body of multilateral conventions administered outside the WTO. The substantive rules imposed by the TRIPS Agreement are the subject of existing bodies of judicial opinion in the national and regional territories that are now subject to its discipline. Underlying the superficial certainty of the TRIPS Agreement substantive prescriptions are existing gulfs of interpretative difference regarding the meaning of many of its rules.


The TRIPS Agreement is unique in that it establishes minimum standards applicable to the enforcement of legislation by WTO members. The establishment of minimum enforcement standards necessarily implies that claims alleging the maintenance of inadequate enforcement procedures can and may be brought before the WTO Dispute Settlement Body, yet the TRIPS Agreement is silent on just how such a claim might be proven, e.g., where the threshold of inadequate enforcement might lie.


Identifying methods and sources of interpretation for the TRIPS Agreement's substantive requirements, as well as delimiting the appropriate threshold of adequate enforcement, are but two of the intriguing tasks facing the WTO Dispute Settlement Body.

in INTERNATIONAL TRADE LAW AND THE GATTIWTO DISPUTE SETTLEMENT SYSTEM 415-37 (ed. E.-U. Petersmann), Kluwer Law International, 1997

Download here

The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (the "TRIPS Agreement") has ushered in a new generation of legal issues that may ultimately find their way into the WTO dispute settlement arena. In light of the extensive coverage given to the WTO Dispute Settlement Understanding (DSU) elsewhere in this book, and the broad range of dispute-related issues raised by the TRIPS Agreement, this chapter will focus on issues that are more or less specific to the TRIPS Agreement.

The TRIPS Agreement is unique in the WTO context; it is the only WTO agreement that requires the members to affirmatively (or positively) incorporate complex substantive legal standards into national laws that govern both domestically-produced and imported goods. It relies for many of its rules on cross-reference to an existing body of multilateral conventions administered outside the WTO. The substantive rules imposed by the TRIPS Agreement are the subject of existing bodies of judicial opinion in the national and regional territories that are now subject to its discipline. Underlying the superficial certainty of the TRIPS Agreement substantive prescriptions are existing gulfs of interpretative difference regarding the meaning of many of its rules.


The TRIPS Agreement is unique in that it establishes minimum standards applicable to the enforcement of legislation by WTO members. The establishment of minimum enforcement standards necessarily implies that claims alleging the maintenance of inadequate enforcement procedures can and may be brought before the WTO Dispute Settlement Body, yet the TRIPS Agreement is silent on just how such a claim might be proven, e.g., where the threshold of inadequate enforcement might lie.


Identifying methods and sources of interpretation for the TRIPS Agreement's substantive requirements, as well as delimiting the appropriate threshold of adequate enforcement, are but two of the intriguing tasks facing the WTO Dispute Settlement Body.

in INTERNATIONAL TRADE LAW AND THE GATTIWTO DISPUTE SETTLEMENT SYSTEM 415-37 (ed. E.-U. Petersmann), Kluwer Law International, 1997

Download here

The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (the "TRIPS Agreement") has ushered in a new generation of legal issues that may ultimately find their way into the WTO dispute settlement arena. In light of the extensive coverage given to the WTO Dispute Settlement Understanding (DSU) elsewhere in this book, and the broad range of dispute-related issues raised by the TRIPS Agreement, this chapter will focus on issues that are more or less specific to the TRIPS Agreement.

The TRIPS Agreement is unique in the WTO context; it is the only WTO agreement that requires the members to affirmatively (or positively) incorporate complex substantive legal standards into national laws that govern both domestically-produced and imported goods. It relies for many of its rules on cross-reference to an existing body of multilateral conventions administered outside the WTO. The substantive rules imposed by the TRIPS Agreement are the subject of existing bodies of judicial opinion in the national and regional territories that are now subject to its discipline. Underlying the superficial certainty of the TRIPS Agreement substantive prescriptions are existing gulfs of interpretative difference regarding the meaning of many of its rules.


The TRIPS Agreement is unique in that it establishes minimum standards applicable to the enforcement of legislation by WTO members. The establishment of minimum enforcement standards necessarily implies that claims alleging the maintenance of inadequate enforcement procedures can and may be brought before the WTO Dispute Settlement Body, yet the TRIPS Agreement is silent on just how such a claim might be proven, e.g., where the threshold of inadequate enforcement might lie.


Identifying methods and sources of interpretation for the TRIPS Agreement's substantive requirements, as well as delimiting the appropriate threshold of adequate enforcement, are but two of the intriguing tasks facing the WTO Dispute Settlement Body.

in INTERNATIONAL TRADE LAW AND THE GATTIWTO DISPUTE SETTLEMENT SYSTEM 415-37 (ed. E.-U. Petersmann), Kluwer Law International, 1997

Download here

The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (the "TRIPS Agreement") has ushered in a new generation of legal issues that may ultimately find their way into the WTO dispute settlement arena. In light of the extensive coverage given to the WTO Dispute Settlement Understanding (DSU) elsewhere in this book, and the broad range of dispute-related issues raised by the TRIPS Agreement, this chapter will focus on issues that are more or less specific to the TRIPS Agreement.

The TRIPS Agreement is unique in the WTO context; it is the only WTO agreement that requires the members to affirmatively (or positively) incorporate complex substantive legal standards into national laws that govern both domestically-produced and imported goods. It relies for many of its rules on cross-reference to an existing body of multilateral conventions administered outside the WTO. The substantive rules imposed by the TRIPS Agreement are the subject of existing bodies of judicial opinion in the national and regional territories that are now subject to its discipline. Underlying the superficial certainty of the TRIPS Agreement substantive prescriptions are existing gulfs of interpretative difference regarding the meaning of many of its rules.


The TRIPS Agreement is unique in that it establishes minimum standards applicable to the enforcement of legislation by WTO members. The establishment of minimum enforcement standards necessarily implies that claims alleging the maintenance of inadequate enforcement procedures can and may be brought before the WTO Dispute Settlement Body, yet the TRIPS Agreement is silent on just how such a claim might be proven, e.g., where the threshold of inadequate enforcement might lie.


Identifying methods and sources of interpretation for the TRIPS Agreement's substantive requirements, as well as delimiting the appropriate threshold of adequate enforcement, are but two of the intriguing tasks facing the WTO Dispute Settlement Body.

in PARLIAMENTARY PARTICIPATION IN THE MAKING AND OPERATION OF TREATIES: A COMPARATIVE STUDY 261, S. Riesenfeld & F. Abbott eds., Martinus Nijhoff 1994, also published in 67 Chi.-Kent Law Review No. 571, 1991

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This article will briefly describe the basic allocation of the treaty power in the United States and the status of treaty law in the municipal legal system. These matters are the subject of a number of excellent studies by American and foreign scholars. Our main concern, however, is with a particular feature of the constitutional landscape-the role which the Senate plays in the treaty-making process through the attachment of qualifications to resolutions of ratification; namely amendments, reservations, understandings, declarations, and provisos. We are concerned with the effect these conditions are accorded by the President, United States courts, and the international community. We are concerned with whether a minority of the Senate will be enabled to effect an influence on the international and domestic legal process greatly in excess of the constituency it represents. We believe that the phenomenon of Senate conditions must be carefully examined in the light of developments in the international legal system, and particularly the growing acceptance of individuals and individual rights as proper subjects of international law.

The Constitution of the United States speaks very briefly to the treaty-making power. This is not remarkable as the Constitution is on the whole a terse instrument. The U.S. Supreme Court has spoken infrequently on the respective roles of the Executive and Legislative branches in the treaty-making process. The development of the separation of powers with respect to the respective roles of the Legislative and Executive branches in the United States treaty-making process has therefore come primarily from the organic and continuous process of interaction between these political branches. This process of evolution has proceeded from President Washington's often quoted declaration that having once gone directly to the Senate to discuss a prospective treaty, he would be damned if he would ever do so again; to the endorsement by Congress of, and acquiescence by the Supreme Court to, the last-in-time doctrine and its implicit adoption of a partially dualist constitutional system; to the growing role of Senate reservations, understandings, declarations and provisos in the treaty-making process; and most recently to the prominence of the Congressional-Executive agreement and the “fast track” procedure.

Certain fundamental issues concerning the allocation of power between the Executive, Legislative and Judicial branches of government in the United States deserve particular attention in light of the rules of international law which impact on the American constitutional process. A most serious constitutional issue is whether the Senate (or the Congress) has the power to attach reservations or understandings to treaties which are not valid and effective under international law, and yet cause them to have binding effect in United States courts. Of particular concern are recent attempts by the Senate to expressly reserve the supremacy of the internal law of the United States with respect to important international legal instruments and to determine by declaration the non-self-executing character of various treaties. Of perhaps equal concern is whether the Senate (or the Congress) has the power to control the interpretation of treaties in a manner inconsistent with their international interpretation, yet with binding domestic effect. Our concerns are by no means limited to the field of human rights, although it is in this area that the most troubling manifestations of misguided Senate effort have emerged. As the international legal system continues the trend toward developing and protecting the rights and interests of individuals-in the fields of the environment, trade, communications and so forth-questions relating to the conditions under which such rights may be invoked in national courts will become of increasing importance. It is therefore of the utmost urgency to consider who will determine the scope of these rights and under what rules.

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This article addresses the relationship between the GATT, the European Community and other RTAs as and when trade in services and other 'new areas' are incorporated into the GATT framework. The article first discusses the conceptual justifications for RTAs (as an alternative to utopian global free trade) in order to provide background for considering whether the privileges accorded RTAs under the existing GATT framework should be extended to new areas and, if so, how far. It is observed that 'state of the art' tools of economic analysis do not provide adequate guidance as to the global welfare costs or benefits of RTAs so as to enable trade policy-makers to determine in advance their impact on global welfare, and that more subjective modes of analysis must be looked to for answers. The article then describes the GATT's historic tolerance of RTAs and how that tolerance is legislatively embodied in the General Agreement. It is noted that the existing (and controversial) formula providing a limited waiver for RTAs with respect to the GATT Most Favored Nation (“MFN”) principle (and trade in goods) cannot be readily transported and applied to the National Treatment principle and trade in services (with which the Uruguay Round negotiations are concerned). The EC's proposal for a new RTA waiver in its draft GATT Services Code proposal is analyzed and is found to be both unworkable and unwise. This article proposes a new formula for a GATT waiver or exemption which would be applicable to the EC and other RTAs. The new formula would rely on the concept of 'necessity' as a basis for the evaluation of RTA conduct which derogates from the general rules of the GATT. While certain guideposts may be provided to decision- makers with respect to the application of the proposed RTA waiver formula, it is clear that the myriad of contexts in which RTA derogations may arise will require the development of a new body (or common law) of interpretive decisions concerning RTA derogations - some of which, such as RTA measures designed for the primary purpose of providing unfair comparative advantages to local industry, will involve bright lines distinguishing the 'necessary' from the “merely convenient,” and others of which will involve careful balancing of interests.

This article then focuses specifically on the telecommunications sector of the services trade to provide a concrete reference point or 'case study' of potential RTA discriminations. Attention is focused on a particular RTA - the European Community - and its actions both with respect to liberalizing its internal telecommunications sector and its position in the GATT services/telecommunications negotiations. An attempt is made to apply both the EC's proposed RTA waiver and the formula proposed in this article to prospective EC conduct in its telecommunications sector. The results of this application illustrate the difficulties inherent in the EC formula as well as the elements of subjectivity inherent in the formula proposed in this article. Whatever waiver formula is adopted in the Uruguay Round negotiations, the discussion in this article will hopefully serve to illuminate the consideration of RTA actions within the new GATT framework as the new formula is implemented.

Succinctly stated, the central issue in this article is whether RTAs should be permitted to adopt rules which derogate from the National Treatment principle of the GATT in the application of new agreements covering trade in services and other 'new areas,' and therefore be allowed to discriminate in favor of member country enterprises for reasons having to do with the formation or maintenance of the RTAs. If so, by what legal standard should such derogations be evaluated? As the article will make clear, this issue is not a mere abstraction. The EC clearly has in mind that it will be enabled to liberalize its internal market for the benefit of domestic service providers without extending the benefits of that liberalization directly to non-Member State enterprises. Such discrimination would necessarily involve derogations from the National Treatment principle to which parties to a new GATT Services Code would otherwise be subject.

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22 Vand. J. of Transnat'l L. 689 (1989)

This article addresses industrialized countries' growing concerns over technology transfer and their efforts to obtain protection of intellectual property rights under the General Agreement on Tariffs and Trade (GATT). It analyzes the intellectual property problem in the context of the GATT framework and the weakness of current intellectual property protection. Developing countries do not accept the United States contention either that intellectual property is covered implicitly by the GATT or that the current lack of protection reflects a fundamental flaw in the General Agreement. The article focuses on this disagreement in laying out the framework for possible solutions, which include: 1) a separate GATT agreement or code; 2) a framework agreement by consensus decision; and 3) a formal amendment to the General Agreement. The author concludes that an amendment enacted through the GATT's article XXX(1) procedure, which would be effective upon two-thirds acceptance by the Contracting Parties on the Parties that accept it, would achieve the most realistic near-term solution to the intellectual property problem.

The article also focuses on the issue of GATT reciprocity, considering whether the industrialized countries will be under a duty to compensate the developing countries in the event that an agreement on intellectual property is reached. It concludes that the General Agreement should be analogized to a frustrated long-term commercial agreement, and suggests a compromise on the issue of compensation.

in INTERNATIONAL TRADE LAW AND THE GATTIWTO DISPUTE SETTLEMENT SYSTEM 415-37 (ed. E.-U. Petersmann), Kluwer Law International, 1997

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The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (the "TRIPS Agreement") has ushered in a new generation of legal issues that may ultimately find their way into the WTO dispute settlement arena. In light of the extensive coverage given to the WTO Dispute Settlement Understanding (DSU) elsewhere in this book, and the broad range of dispute-related issues raised by the TRIPS Agreement, this chapter will focus on issues that are more or less specific to the TRIPS Agreement.

The TRIPS Agreement is unique in the WTO context; it is the only WTO agreement that requires the members to affirmatively (or positively) incorporate complex substantive legal standards into national laws that govern both domestically-produced and imported goods. It relies for many of its rules on cross-reference to an existing body of multilateral conventions administered outside the WTO. The substantive rules imposed by the TRIPS Agreement are the subject of existing bodies of judicial opinion in the national and regional territories that are now subject to its discipline. Underlying the superficial certainty of the TRIPS Agreement substantive prescriptions are existing gulfs of interpretative difference regarding the meaning of many of its rules.


The TRIPS Agreement is unique in that it establishes minimum standards applicable to the enforcement of legislation by WTO members. The establishment of minimum enforcement standards necessarily implies that claims alleging the maintenance of inadequate enforcement procedures can and may be brought before the WTO Dispute Settlement Body, yet the TRIPS Agreement is silent on just how such a claim might be proven, e.g., where the threshold of inadequate enforcement might lie.


Identifying methods and sources of interpretation for the TRIPS Agreement's substantive requirements, as well as delimiting the appropriate threshold of adequate enforcement, are but two of the intriguing tasks facing the WTO Dispute Settlement Body.