TRIPs

This Article reconsiders the drugs-for-the-developing world debate that has taken place in the shadow of free trade liberalization. For the last twenty years, this debate has centered on a supposedly zero-sum conflict between access to drugs for residents of the “third world” and incentives for pharmaceutical multinationals to invest in research and development. Underlying this debate is the assumption that the developing-world health crisis involves primarily a crisis of infectious disease. Because drugs for such ailments lack developed world markets, it is easy to imagine that robust pharmaceutical patents are globally necessary if the poor are to obtain any drugs at all. Global public health reality, however, is quite different. Mortality and morbidity in developing countries are increasingly attributable to those same non- communicable diseases (“NCDs”) that plague developed countries. Drugs for such conditions already have highly profitable developed world markets. Therefore, making developing-world populations pay patent-inflated prices encourages rent-seeking by multinationals rather than incentivization. While little noticed in the developed world, the importance of the NCD crisis has not been lost on developing world actors. This Article is the first to document a recent worldwide trend of developing-world courts and administrative agencies breaking with strict patent rights for NCD drugs. It argues that attentive policy makers can seize the opportunity provided by the crisis that developed world populism is creating for liberalizing globalization. If renegotiating free trade is
back on the agenda, they need only look to
what developing countries have already been doing, at least in the realm of
intellectual property rights.

The International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) entered into force in 2004. It is the most recent piece in the current regime complex on plant genetic resources. However, wherever there are several legally binding international agreements dealing with at least partially overlapping issues, a conflict between them may arise. Such conflicts narrow the leeway that parties to more than one of the treaties have for implementation and may thus also reduce the treaties' potential for reaching their objectives. Against this backdrop, this article investigates the legal relationships between the ITPGRFA, on the one hand, and the Agreement on Trade-Related Aspects of Intellectual Property Rights, the Union for the Protection of New Varieties of Plants and the Convention on Biological Diversity (CBD) on the other. It arrives at the conclusion that there are no conflicts between the ITPGRFA and any of those treaties at present, while negotiations conducted currently in the framework of the World Intellectual Property Organization and the CBD need carefully to avoid creating such legal conflicts.

Desde hace algún tiempo algunos sectores han proclamado una falsa dicotomía a saber: derecho de patentes vs apropiado acceso a los medicamentos, o monopolios derivados de patentes vs derecho a la salud. En realidad, se advierte que no se trata de un derecho versus el otro, sino de la existencia de una complementación de ambos.
Pero una cosa es proclamarlo y otra muy diferente es abordar esta temática compleja, desmenuzarla con seriedad y probar la complementariedad aludida.
En la presente obra los autores se han propuesto asumir el desafío de estudiar el delicado equilibrio entre el respeto a las patentes y el acceso a las medicinas esenciales, el contenido de cada uno de los derechos involucrados (propiedad y salud), los conflictos que se pueden suscitar entre ellos y el juicio de proporcionalidad como propuesta de solución.
Pablo Ianello en el capítulo II analiza la justificación de la propiedad y de las patentes sobre medicinas desde la filosofía moral y política. Presenta una revisión de las dos principales explicaciones filosóficas sobre la propiedad intelectual, mostrando los límites que éstas presentan. Posteriormente, brinda una aproximación jurídica al sistema de patentes en materia de medicamentos esenciales, describiendo el estado actual de la cuestión en relación con los instrumentos internacionales más importantes. Efectúa una interesante reflexión desde una óptica que resulta a menudo olvidada con respecto a qué derecho priorizar: si solamente lo de las generaciones actuales o también los derechos de las próximas generaciones, asumiendo que estas últimas serán quienes sufrirán las consecuencias de una disminución de la tasa de invención. Enfatiza que si los monopolios de las patentes cumplen una función de incentivar la investigación y el propósito es atacarlo sin suplantarlo, la investigación tenderá a decrecer por lo que se vería indefectiblemente afectado el derecho a la salud de las generaciones futuras.
Gustavo Schötz en el capítulo III se dedica a demostrar que, pese a lo que sostienen algunos, es posible alcanzar la convivencia armónica entre el derecho de salud de los pacientes, que requieren acceso a medicinas esenciales, y el derecho de propiedad intelectual de los titulares de patentes sobre esas medicinas.
Alienta el respeto de todos los miembros de la comunidad, procurando acreditar que el derecho a la salud de los pacientes no va en desmedro del respeto al derecho de propiedad del inventor y viceversa. Señala el problema de sucumbir al facilismo de sostener que ambos derechos entran en colisión y que únicamente se puede favorecer a uno en desmedro del otro.
Para poder vislumbrar una solución, Schötz en los capítulos IV y V se propuso analizar el contenido y eficacia de tales derechos afrontando la tarea de evaluar si el derecho de propiedad emanado de la patente puede ser caratulado como derecho humano como lo es el derecho a la salud.
Destaca que el derecho a la salud corresponde primeramente a los ciudadanos frente al Estado, señalando en este sentido que toda persona tiene derecho a la prevención, tratamiento y control de enfermedades. Efectúa una importante reflexión con respecto a aquellos que acusan al sistema de patentes como obstáculo al acceso a los medicamentos. Nos recuerda que existen múltiples prestaciones vinculadas con el derecho a la salud, citando a la vacunación universal, el acceso a estudios clínicos preventivos, el poder acceder a cirugías, transplantes, provisión de prótesis, internación, tratamientos de rehabilitación, etcétera. En este sentido, cita un documento explicativo de las Naciones Unidas que proclama que el grado de obligatoriedad de los Estados los obliga a adoptar medidas que sean necesarias para que toda persona tenga acceso a los establecimientos, bienes y servicios de salud, incluyendo a los preventivos, curativos y de rehabilitación, tratamiento apropiado de enfermedades, afecciones, lesiones y discapacidades frecuentes.
En otras palabras, es un llamado de atención a aquellas voces que parecen sostener que el derecho a la salud se agota en el suministro de medicación, carga que únicamente parece recaer sobre quienes se dedican al desarrollo de medicinas innovadoras, cuando en realidad hay distintos sectores involucrados y son varios los jugadores que deben verse comprometidos en esa misión.
A su vez, Schötz apropiadamente enfatiza que en relación al objeto del derecho al medicamento, no todas las medicinas son iguales, alertando que existen prioridades y urgencias. Solamente aquellos medicamentos que no pueden demorarse su administración merecen el rótulo de “medicina esencial”. Señala entonces que parece oportuno limitar el objeto del derecho humano al medicamento a las medicinas esenciales, expresando que sólo una pequeña cantidad de las medicinas esenciales están sujetas a patentes, lo cual tampoco implica su disfrute asegurado pues los problemas de acceso tienen más que ver con la infraestructura médica o la cadena de distribución.
En este sentido, indica que las empresas farmacéuticas sin dudas tienen una función en todo este esquema, consistente en la responsabilidad de colaborar con la vigencia del derecho a la salud, primariamente, cumpliendo su principal objetivo que es desarrollar y proveer medicinas eficaces. Pero enfatiza que es el Estado el protagonista esencial que debe velar por los enfermos, sin tener que necesariamente desconocer para tal fin el derecho de propiedad de los innovadores.
Nos recuerda que tanto la propiedad intelectual como los demás derechos tienen en común propender al bienestar de las personas. Sostiene que, de hecho, la finalidad de la concesión de la patente es en beneficio de la salud de los pacientes, ya que su objetivo primordial es lograr nuevos y mejores medicamentos.
Para no debatir solo en teoría, el autor citado en el capítulo X analiza un caso en particular, como lo fue la licencia compulsiva sobre el “Efavirenz” (antirretroviral contra el HIV) decretada por el gobierno brasileño, tratando de demostrar que tales derechos entran en un aparente conflicto cuando, en realidad, son intrínsecamente complementarios o cooperativos.
OCTAVIO MITELMAN
Citar: elDial.com - CC377E. Copyright 2020 - elDial.com - editorial Albrematica - Tucumán 1440 (1050) - Ciudad Autónoma de Buenos Aires - Argentina

Among various grounds, data exclusivity is often criticised for impeding the correct functioning of the flexibilities guaranteed by the TRIPS Agreement in relation to compulsory licensing. Several commentators have noted that, in cases where a generic competitor obtains a non voluntary licence on a patented pharmaceutical compound, the impossibility of relying on the regulatory data submitted by a previous applicant prevents access to the market and therefore neutralises the effectiveness of the licence. By thoroughly looking at the relevant international provisions and state practices, this article brings into question the soundness of these claims. International legal sources, once rightly interpreted, rarely limit the possibility to waive data exclusivity in a more stringent manner than in patent regimes, so that the real threat to compulsory licensing lies in the political disparities between developed and developing countries rather than in the substantive law of data exclusivity.

This thesis picks up the journey from my Bachelor’s thesis where it was concluded that current legal protection of the Intellectual Property (IP) for “computer programs” and associated components is fractured and contains gaps that provides for legal uncertainty for the author/creator/inventor.1 The BSc thesis’ analysis covered IP protection provided through international treaties, statutory law and case law with a focus on the EU perspective. We now proceed to approach possible ways to modernize, update and improve the legal protection provided by Intellectual Property Rights (IPR) in the area of the more integrated “software solutions” of today’s IT business. I, the author, aim to take the reader along on a journey through the fragmented borderline between technology and law. The goal is to try and establish a common baseline for a more coherent, sustainable and manageable legal solution for IP protection for the author/creator/inventor of a “software solution”. As a fuller harmonization of IPRs for “software solutions” within EU most probably would remove the above mentioned issues and thereby benefit the author/creator/inventor.
1 Broman,

Copyright, patents and trademarks are well-known types of Intellectual Property (IP). However, there is another form of IP known as Geographical Indications (GIs). Foods, drinks and agricultural products can be certified as GIs. The quality of each GI is considered to exclusively or significantly derive from the
supposedly unique physical attributes of the defined and bounded locations from which they originate. The use of GIs discriminates between producers who are categorised as in-place or out-of-place. This determines the firms that are permitted to invoke economically valuable geographical names. Producers
of GIs rely on notions of place, boundaries and terroir to validate their claims to GI status. These are intrinsically geographical factors with which our discipline has long engaged. However, the GI system itself has rarely been studied from a geographical perspective. This paper interrogates the constructions of place, boundaries and terroir common to the conceptual infrastructure of all GIs. It employs Stilton Cheese – one of Britain’s most iconic territorial foods – to illustrate these ideas. The Stilton case also
shows that taken-for-granted ideas of place and production methods can be challenged by motivated adversaries who introduce new evidence in their quest to destabilise this GI. The overall aim of this work is to draw attention to the geographical infrastructure of this expanding regulatory system and more fully
reveal the interests served by the GI model.

The Indian pharmaceutical industry has undergone significant changes in light of the Trade Related Intellectual Property Rights (TRIPS) regulations since January, 1995. The onset of TRIPS has significantly impacted the export performance of Indian pharmaceutical firms. This is one of the pioneering research studies that present a comparative analysis of the determinants of export performance of Indian pharmaceutical industry during the transitory-TRIPS (1995-2004) and post-TRIPS
periods (2005-2014). Various determinants of export performance that were classified as knowledge-based resources and property-based resources were investigated using three different models of export performance. A sample of 211 Indian pharmaceutical firms for a period of twenty years (1995-2014) was considered for the study. The results indicate that various firm resources were more significant in the transitory-TRIPS period in comparison to the post-TRIPS period in all the three models of export performance for the Indian pharmaceutical industry. The conclusions presented in this research highlight the relative importance of different firm resources on export performance of Indian pharmaceutical firms during the transitory-TRIPS and post-TRIPS periods. The findings of this research will contribute to the growing evidence
regarding determinants of export performance in emerging economies.

La acogida en el debate internacional de los Conocimientos Tradicionales, confirma, si no su configuracion como modalidad de los derechos de Propiedad Intelectual, la gestacion y rediseno de nuevos escenarios de disputa en torno a las creaciones del intelecto humano. Sin que pueda hablarse de una definicion acabada ni univoca, la demanda de proteccion se redimensiona entre reclamos frente usurpacion de conocimientos; en el orden doctrinal se justifica por la admisibilidad de la tutela de todas las creaciones intelectuales como mandato de la Organizacion Mundial de la Propiedad Intelectual (OMPI). Los esfuerzos por crear un regimen internacional de proteccion, es un tema en debate, pues se presenta como una opcion para lograr universalizar la tutela a traves de un instrumento de Derecho Internacional

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), in its design and implementation procedures, does not reflect a human rights approach. There is an ever-growing community of critical voices, however, requiring that human rights should serve as a corrective to intellectual property rights and their implementation in the context of TRIPS. The crucial question is, of course, how this goal may be accomplished. Under TRIPS, human rights constitute non-essential exceptions to intellectual property rights. However, obligations under international human rights law (IHRL) can only be a relevant consideration if either the World Trade Organisation (WTO) itself or its members, when acting as such—or both—are bound by IHRL. If this should be the case, the question as to the exact relationship between the norms under TRIPS and those of IHRL will arise. Is IHRL hierarchically superior to WTO law? This chapter will show that both the WTO and its members, as such, are the bearers of obligations under IHRL and that, in many instances, norms of IHRL will have to be held to rank above “international trade law”. This should have consequences in particular for the way the WTO enforces TRIPS within its dispute settlement system. The rules of treaty interpretation under customary international law (as codified in Article 31 of the Vienna Convention on the Law of Treaties of 1969) offer substantial scope for human rights considerations to play a role in WTO dispute settlement. Attempts at establishing conformity between TRIPS and IHRL should, moreover, take account of extraterritorial obligations flowing from the various UN human rights treaties, specifically also the International Covenant on Economic, Social and Cultural Rights (ICESCR) of 1966, and their implications for state conduct. States parties to the ICESCR are not only obliged to observe Covenant provisions where the effects of any of their actions are confined to the domestic level, but also if their conduct, for example within the WTO, affects the economic, social and cultural rights (ESCR) of populations in other countries. The Committee on Economic, Social and Cultural Rights (CESCR), the body of independent experts supervising implementation of the ICESCR—which so far has proven highly capable of advancing the cause of ESCR globally—should adopt a more proactive approach in defining extraterritorial obligations under the ICESCR, also in relation to WTO law, and should further be bold enough to adopt a clear stance in cases of conflict between TRIPS and IHRL.

Prompt and affordable access to essential medicines is a component of almost all domestic and global public health models. As is now well known, the availability and costs of both brand and generic drugs are a function of traditional patent law incentives. Less known, however, is that generic entry is controlled increasingly through an emerging form of global intellectual property law referred to as “linkage regulations.” Linkage regulations tie generic drug approval and, thus, access to essential medications to existing drug patents through potentially long and costly litigation. The linkage regime is in the process of rapidly spreading worldwide through international free trade agreements. Even so, very little is known about how the regulations work in developed nations let alone how they impact public health systems across international borders. The authors constitute a network of eleven health policy experts and practicing lawyers in nine countries including those with mature linkage regulations, those with new regulations, those without regulations but with practices that parallel linkage, and those where regulations are currently subject to intense public debate and litigation.

Territoriality is one of the important principles of trademark law; however, the principle of territoriality is problematic and leads to many conflicts in the era of globalized trade and e-commerce. The European Union (EU) and Switzerland have a doctrine of maximalist protection of Indications of Geographical Origin (IGOs) via public orchestrated registers that defy the territoriality principle. The EU and Switzerland face concomitant problems to promote rural development and authentic quality products based on their terroir. In contrast, the US and other New World countries are harnessing their existing trademark systems to protect IGOs and further innovation. US and other New World countries are also letting products with generic geographical names compete in their home and international markets. Specificity, protecting a sign only for designated goods or services, is another important principle of trademark law that can be and has been criticized. Without specificity, non-competitors would not be allowed to erode or tarnish the distinctiveness of a sign, no matter whether it is a trademark or IGO. The Geographical Indications (GI) provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) are the legal result of a political compromise between Old and New World countries. Where the two camps did not succeed multilaterally, they each have pursued their policy aspirations within their national jurisdiction and internationally via Free Trade Agreements (FTAs) and specialized bilateral IGO agreements. In 2019, the People's Republic of China (PRC), one of the most important growth markets for IGOs, signed a specific IGO agreement with the EU, and in 2020 an FTA with the US which includes preferential IGO-related provisions. These recent normative developments suggest that the PRC's IGO obligations are being rearranged. Combining the best of both systems, could create vital hybrids that could lead the way to new IGO standards for a future multilateral IGO agreement.

The Supreme Court’s decisions in Bilski as well as in Alice have significantly reduced the level of patent protection provided to software and business methods in the U.S. Nevertheless, Article 27(1) TRIPS establishes that WTO countries must offer protection to any invention, whether product or process, without discrimination based on the field of technology. Is the U.S. currently in violation of its TRIPS obligations?

Although there is no clear understanding among WTO countries regarding whether Article 27(1) TRIPS covers software and business methods, the U.S. has consistently interpreted this provision as requiring these subject matters to be protected. This interpretation is found specifically in the context of the review of other countries’ IP laws when they became WTO members. Thus, it appears unlikely that the U.S. will be able to argue otherwise in future international negotiations or in the case of a possible WTO challenge to §101 of the U.S. patent code - as interpreted by the Alice and Bilski decisions. More importantly, this result exposes the U.S. to opposing strategies by other WTO countries that diminish its ability to promote TRIPS compliance in any significant way.     

The relevance of the conformity of the Alice and Bilski decisions to Article 27(1) TRIPS goes beyond the appropriate level of protection that must be provided to software and business methods to avoid a violation of international obligations on patentable subject matter. Much more is at stake. Indeed, NPE activity in the U.S. is highly dependent on the availability of enforceable software and business methods patents. The issuance of the decisions in Alice and Bilski appears to have seriously harmed the operation of these companies. However, the international perspective offered in this article raises the question of whether these two decisions indeed represent the last word on the eligibility of processes to receive patent protection, or whether there will be additional Supreme Court interventions to restore protection on software and business methods to a more intermediate level.

Finally, in recent years, there has been substantial discussion on patent reform to curtail NPE activity. However, the aftermath of the Alice and Bilski decisions seems to have reduced the urgency for legislative intervention in this area. This article highlights the fact that such a conclusion might be premature and that if it is, indeed, established that the operation of NPEs impedes innovation, patent reform might still be necessary to effectively limit the activity of these companies.

My lecturer wishes to explore the racial formation of Israel’s Eurocentered IP settlers’ regime through the interplay between the Zionist appropriations of Arab-Jewish TK [traditional knowledge] and folklore and the proliferation of  Ashkenazi [European Jewish] academic careers. Critical studies on the structure and meaning of Israeli academe have found out that it is mainly deployed by the Ashkenazi liberal-progressive hegemony as an arm of governance over Mizrahim [Jews who immigrated to Israel mainly from the Arab World] and Palestinians.

Salvaging Mizrahi cultures, the Israeli academe-regime has established a financial monopoly over the materiality of exotic Judaica discourse not only in scholarly knowledge production but also in the expert trade of intellectual, cultural and real properties. When it comes to protecting Mizrahi TK and folklore, WIPO’s 2002 post-TRIPS forum recommendations interrelating IP and TK are yet to arrive to Israel from Oman.  As is Israel’s compliance with the 1886 Berne Convention, or with the Hague 1954 Convention on the Protection of Cultural Property, or with the UNESCO 1970 Convention on the Means of Prohibiting and Preventing the Illicit Import, Export, and Transfer of Ownership of Cultural Property – when these treaties are scrutinized through the optics of collective Mizrahi IP.

My talk will be very preliminary – a collection of ruminations stemming out of my archival research into the Yemeni-Jewish scriptures and ornaments affair of the 1950s, its brief surface into the Israeli public sphere in the mid 1980s, and the possibilities for post-TRIPS Mizrahi activism against the appropriation and commodification of Mizrahi identity in light of the current postcolonial reshapings of the notion of authorship, and the repatriation of cultural properties from the Eurocenter back to communities of color. 

Printed, expanded Hebrew version available here: 2007.
“Cultural Property Rights and the Racial Construction of the Mizrahi as a Trade-Mark: Notes on the Revolving Door of Israel’s Academe-Regime.” In 2007. A Rainbow of Opinions: The Mizrahi Democratic Rainbow’s First Decade. (Keshet Shel De`ot: `Asor LaKeshet HaDemokratit HaMizrahit, Hebrew) Pp. 198-204. Tel Aviv: November Press. REPRINTED IN 2008 Mahbarot Kolno`a Darom  (“South Cinema Notebooks”, Heb. – a Humanities periodical) 2:161-166.

This chapter considers the dynamics of trade negotiations in the knowledge economy, and the differences in cultural and economic interests that make these negotiations so strikingly contentious in relation to biological resources and associated knowledge. Divergent value systems lead to questioning of the legitimacy and equity of derivative or imitative innovation: can innovation become an act of unfair competition; what bright line divides biopiracy from legitimate trade? In the negotiating coinage of ‘knowledge diplomacy’ (Ryan, 1998), innovation is offset against the protection of heritage and traditional values; concerns that imitative innovation may be a form of misappropriation can lead to the withdrawal of knowledge resources from the common heritage or from a contested public domain to become ‘a form of national property’ (Kloppenburg, 1988) or a protected collective commons. Rifkin (2001) ponders the emergence of an ‘economy of granters of access’ – but the conditions of access can be determined by new or established notions of property right, as the contours and boundary of the common heritage and public domain mutate under the pressure of trade-related negotiations. What is at stake are the terms of access to technological knowledge (whether traditional or ‘high tech’), genetic resources (GR), traditional methods and product descriptions, descriptive or evocative language, and cultural expressions – in short, access to knowledge resources, the feedstocks of the knowledge economy.
These questions are explored by contrasting multilateral negotiations over GR with bilateral negotiations on trade in wine. The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is symbolic of a general reassessment of national ‘capital,’ but the ‘new’ economy is not necessarily seen as an idealized, technologically advanced economy. Genetic resources and related traditional knowledge (TK) are ‘enclosed’ because of their perceived value, or through fear of others unfairly appropriating their value: increasingly claims of unfair competition and illegitimate trade barriers in agriculture will be intertwined with the debate about access to GR and the fading ideal of ‘common heritage.’ Negotiators addressing trade in knowledge are dealing with the tension between the non-rivalrous quality of knowledge resources, and the instinct to enclose to appropriate its value that was notably articulated by Brand (1987): ‘[I]nformation wants to be free because it has become so cheap to distribute, copy, and recombine - too cheap to meter. It wants to be expensive because it can be immeasurably valuable to the recipient. That tension will not go away. It leads to endless wrenching debate about price, copyright, 'intellectual property', the moral rightness of casual distribution, because each round of new devices makes the tension worse, not better.’

This chapter sketches future scenarios of TRIPS implementation in developing countries by looking at past experience, current trends and by comparing historical and crosscountry patterns. The chapter focuses on the three largest emerging economies-Brazil, India and China (BICs), since they are those with the highest potential to shape the intellectual property regime. Through international contestation, domestic implementation and even novel rule-making, they have been able to ensure that some flexibilities in the implementation of TRIPS remain. Their domestic policies and coalition-building efforts have been followed by many other developing countries. Shifts in the political economies of Brazil and India towards 2025 due to increased patenting and rise in innovation could mean that they will calibrate or even drop their opposition to TRIPS. China will likely be an innovation giant by then and eager to join the club of proponents of strong and enforceable intellectual property (IP) rights. In the area of access and benefit sharing of genetic resources and related traditional knowledge (ABS), the BICs are likely to remain opposed to stringent IP, and could even become active rule-makers. A degree of homologation between the TRIPS and the Nagoya Protocol, which has codified ABS, appears likely. In general, access to health, as one of the typically contentious domains of IP law and policy, is likely to remain a hotly debated issue. Challenges to pharmaceutical patents by developing countries that use TRIPS flexibilities will continue, as will the efforts by industrialized countries to constrain the available flexibilities through bilateral and regional trade agreements. Overall, the domain of IP law and policy is likely to remain complex and dynamic, with different interests colliding. This may reduce the chances of new multilateral law-making-for instance in the area of substantive patent law, while increasing the chances of new rule-making through domestic practice by BICs in the shadow of the TRIPS.

Cross-retaliation, where a World Trade Organization (WTO) member whose rights have been infringed under one WTO Agreement retaliates against the offending member under another WTO Agreement, is seen by some commentators as a way to counteract the deficiencies of conventional trade retaliation and mitigate the asymmetry of power in the WTO dispute settlement system. However, the potential of cross retaliation as an effective remedy remains unclear. This article argues that a credible and probable threat of cross-agreement retaliation could provide a powerful incentive for ex ante compliance. The credibility of the threat is established by reference to the WTO Agreement that is targeted. The suspension of Trade-Related Aspects of Intellectual Property Rights (TRIPS) obligations, in particular, holds great promise. The probability of the threat depends on the likelihood of the Dispute Settlement Body (DSB) authorization to suspend concessions, the outcomes of previous threats, and actions to operationalize cross-retaliation.

WTO jurisprudence has fleshed out the requirements of Article 22.3 of the Dispute Settlement Understanding (DSU), allowing relatively safe assumptions as to the likelihood of DSB authorization to suspend concessions across agreements where significant economic disparities exist between the disputing parties. Previous cases featuring the threat of cross-retaliation reveal a modest influence on the policies of disputing parties. Finally, the operationalization of cross agreement retaliation pursuant to the TRIPS Agreement is riddled with legal and policy problems, mainly in connection with the personal and territorial scopes of the suspension, the justiciable nature of intellectual property (IP) rights, the quantification of the suspension, the continuous supply of IP-dependent goods, and the consistency of the suspension with other, non-WTO international obligations. However, these problems do not prohibit developing countries from reaping the benefits of asymmetric information, so long as they create the impression of carefully structured retaliation plans that are ready to be triggered in the event of DSB authorization.

Traduzione italiana di Massimo Izzo della recensione di Stephen A. Martin al libro: HILL, SCOTT J (2013). Confrontation with the unconscious: Jungian depth psychology and psychedelic experience. London, UK: Muswell Hill Press. xiii +252 pp. ISBN 978-1908995070

“Increasingly broad and vocal consortiums of nongovernmental organizations (NGOs) are challenging the ‘moral, political and economic legitimacy’ of TRIPS, focusing on provisions of the treaty that affect public health, human rights, biodiversity, and plant genetic resources. [...] many of these critiques have been leveled at intellectual property standards generally ... Yet it is striking that states, NGOs, and intergovernmental actors have specifically identified TRIPS and ‘TRIPS-plus’ bilateral agreements as the principal targets of their ire, challenging treaty bargains once thought settled at the conclusion of the Uruguay Round.”
(Laurence R. Helfer, 2004, ‘Regime Shifting: The TRIPS Agreement and New Dynamics of International Intellectual Property Lawmaking’, Yale Journal of International Law, 29(1)).
Critically evaluate this statement, with particular reference to on-going negotiations at TRIPS and other multilateral fora.

The process of globalization and the emergence of a rules-based multilateral trading system pose significant challenges to local pharmaceutical industries in developing countries. With the advent of global patent protection for pharmaceuticals, developing countries are facing a significant dilemma. It is necessary for these countries to comply with international intellectual property standards while simultaneously protecting their local industries and, thus, ensuring an affordable supply of drugs.
A better understanding of the nature of the Agreement on Trade Related Aspects of Intellectual Property (TRIPS Agreement) and its components could help to raise awareness of the need for a comprehensive innovation policy. It is widely accepted that intellectual property rights (IPRs) are economic assets. Furthermore, they are necessary to develop world-class standards of innovation and creativity. Designing policies for the promotion of R&D and the building up of innovation capacities in developing countries requires a well constructed patent regime. To this end, this thesis investigates the concept of Pharmaceutical Patent Protection in developing countries, its issues and prospects and illustrates the crucial role that patent strategies may play within processes of pharmaceutical innovation in favor of countries’ own national interest in perspective of public health.
The thesis examines an underlying research question:

Using the experience of India and Brazil, what are available options to incorporate in the current national Intellectual Property Rights (IPR) regime of Pakistan for transforming it from a mere TRIPS-compliant mechanism into an effective instrument for Pakistan in order to survive successfully in this Post-Trips era?
This thesis combines doctrinal analysis & comparative reviews research approach to answer the research question as identified for the study.
Brazil and India were in a similar position prior to becoming TRIPS compliant, so those countries’ experiences become an important basis for the analysis of the strategies for reforming TRIPS-compliant patent law in Pakistan with a focus on pharmaceutical patents from the public health perspective by utilizing permitted TRIPS Flexibilities effectively. Presently, the key policies, strategies and practices adopted by Brazil, India & certain other developing countries related to the pharmaceutical patent protection & key issues relevant to the revival of their local pharmaceutical industries are identified. For each of the various issues, this document presents key principles and options for the development of provisions in national patent laws of the developing countries like Pakistan. These principles aim to provide the basic concept on which more detailed provisions could be fashioned, after careful deliberation and consideration of the characteristics of the national legal system and patent law.
Moreover; this thesis also attempts to identify the provision of a fine-tuned IPRs system, which incorporates TRIPS flexibilities and the enabling of a reliable innovation system, which is tailored to the local realities and needs of the country. This policy will include, but is not limited to, policies complementing the IPRs regime. Since the patent system for a country is a public policy tool. Therefore each country must be able to design and operate its patent system in its own best national interest using the flexibilities of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
Based on an understanding of the TRIPS, its obligations, flexibilities under TRIPS, post-TRIPS environment and case studies of national innovation strategies of certain developing countries like India & Brazil, this thesis aims to give an overview of the TRIPS Agreement and its possible implications on the pharmaceutical sector in developing countries; what are the challenges and what are the options? And addresses the question that to what extent can lessons from national experiences be transferred to current policy developments for innovation in the pharmaceutical industry in a developing country context especially in case of Pakistan? The research findings aim to contribute significantly to the body of knowledge in relation to new developmental policies. Overall, it is hoped that these findings can promote innovation and ensure the sustainability of the local pharmaceutical industry in the developing world in general and in Pakistan in particular.
In short, this study suggests elements for the development of Public Health-Sensitive Patent System in developing countries with the special consideration to Pakistan. Analysis of particular cases and possible exceptions to the general recommendations made herein should be further undertaken and elaborated in the light of the National Law.


Note: Downloadable document is a Dissertation for the degree of Master of Pharmacy in Pharmaceutics.

Competition law provisions relating to intellectual property (IP) rights should play an enhanced role in facilitating the domestic and international transfer and dissemination of technology. IP-related competition rules in the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) create an obligation for Member States to apply competition law in the IP context. TRIPS competition rules should be read in a "prodevelopment" fashion – IP rights need to be read reductively, IP-related competition law expansively. Ten considerations for a "prodevelopment" IP-related competition law are formulated.

The obligation to work a patent in the patent granting country contributes to a variety of public policy goals such as technology transfer resulting in narrowing the deep North-South gap in development levels. With the advent of the TRIPS Agreement, pre-existing rights of country members to continue to treat non-working as an abuse has turned into a controversial and divisive debate. There are two competing views concerning local working of patents. On the one hand, TRIPS enthusiasts and MNCs articulate that article 27.1 of the TRIPS ban working obligations of patents in the granting country. On the other hand, unwilling partners of the TRIPS, mostly developing countries, continue to treat local working obligations in their national laws. The study analyses origin of the local working requirement in the patent system, negotiating history, flexibilities and implications of the provisions related to local working requirements in the TRIPS; from developing countries' perspective in general, and India in particular; to interpret it to advance its own public policy goals. The paper establishes that the national laws of the WTO member countries containing local working obligations and relatively broad powers for granting compulsory licence are not in contravention of the TRIPS.