...Angeles) Legal Studies Paper No. 2005-18 August 2005 Facilitating Compulsory Licensing under TRIPS in Response to the AIDS Crisis in Developing Countries Professor Hans Henrik Lidgard Professor Jeffery Atik This paper can be downloaded without charge from the Social Science Research Network (SSRN) electronic library at: http://ssrn.com/abstract=794228 FACILITATING COMPULSORY LICENSING UNDER TRIPS IN RESPONSE TO THE AIDS CRISIS IN DEVELOPING COUNTRIES Hans Henrik Lidgard and Jeffery Atik1 Abstract The AIDS crisis in the developing world has become a priority for international collaboration. The challenge is to find a balance between the acknowledged need to protect large investments expended in developing new medicines and the goal of providing essential medicines to poor countries. Patent protection must prevent undue infringement yet at the same time allow solutions to humanitarian needs. Is compulsory licensing a way out? TRIPS originally restricted compulsory manufacturing licenses to the country experiencing a public health emergency – which was of little utility to countries lacking manufacturing capacity. The Doha agreement effectively permits twinned compulsory licensing – a distribution and use license in countries experiencing a public health emergency and a manufacturing-for-export license in countries possessing appropriate manufacturing capacity. These changes make possible, at least in principle, a greater source of supply of generic pharmaceuticals for use in...
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...American Business Law Journal Volume 45, Issue 2, 283–330, Summer 2008 The Impact of Compulsory Licensing on Foreign Direct Investment: A Collective Bargaining Approach Robert Birdn and Daniel R. Cahoynn I. INTRODUCTION The need to facilitate access to essential medicines for those with lifethreatening or fatal diseases like HIV, tuberculosis, and malaria has generated significant interest. Yet, an inevitable tension exists between the need for pharmaceutical companies to profit from their patented inventions and the desire to provide access for impoverished persons. Developing nations have attempted to resolve this tension through the issuance of patent compulsory licensesFauthorizations for government-approved generic copies1Fso that those in need of the n Assistant Professor of Business Law, School of Business, University of Connecticut. This article received the Holmes-Cardozo Award for Outstanding Submitted Conference Paper as well as the Ralph J. Bunche Best Paper Award at the Academy of Legal Studies in Business Annual Meeting, Indianapolis, IN, August 2007. Our thanks for comments and support go to Jayashree Watal, Peter Yu, Douglas Lippoldt, and the other participants at the University of Connecticut’s Center for International Business Education and Research Conference, ‘‘The Impact of Intellectual Property Rights on Innovation, Knowledge Diffusion, and Foreign Direct Investment in the Global Economy,’’ Storrs, CT, May 2007. Additional thanks to Anthony Kwasnica and...
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...The Impact of Globalization on the Health Sector in South Africa After the Apartheid era, massive inequalities in income, health status, access to health care and other social services continued to dominate in South Africa. The Apartheid era was a system of racial segregation that was implemented in South Africa from 1948 to 1994. Due to colonization, whites had ruled South Africa for several centuries, which resulted in the creation of a system that was constructed to serve as a legal framework for continued economic and political dominance by people of European descent (WHO 2003: Antiretroviral Therapy). The apartheid era came to an end as a consequence of both inner and global pressure and South Africa’s new democratic government. The new government claims that improving the access to health care is a main priority noting, “emphasis should be placed on reaching … the most vulnerable” (Department of Health 1997:13). Giving access to health care is becoming an even greater challenge. South Africa was, and is still facing an exploding HIV/AIDS epidemic that, if anything, is highly associated with health care demands. Today, there are more than 5.3 million people living with HIV/AIDS in South Africa, this accounts for more than 21.5% of the entire population (CIA World Fact book: 2006). This paper aims to understand how the health care sector has dealt with the challenges faced in dealing with immense inequalities and a growing epidemic in the context of globalization...
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...A “Calibrated Approach”: Pharmaceutical FDI and the Evolution of Indian Patent Law Web version: August 2007 Authors: Katherine Connor Linton and Nicholas Corrado1 Abstract India has charted its own intellectual property (IP) path over the last 35 years, attempting to foster the growth of a domestic pharmaceutical industry and access to medicine while, more recently, also addressing the requirements of the international IP regime. Multinational companies (MNCs) have responded to India’s movement towards compliance with the W TO intellectual property agreement, TRIPS, by increasing the quantity and quality of foreign direct investment (FDI) in the areas of pharmaceutical research and development (R&D) and manufacturing. By contrast, MNCs have adopted a more cautious attitude toward the patenting and commercialization of new pharmaceutical products in India, waiting to see how Indian courts and patent offices interpret the new laws, and awaiting the enactment of longdebated data protection legislation. The ultimate success of the Indian “calibrated approach” to fostering the domestic industry and access to medicine while also addressing international IP requirements remains to be seen. 1 Katherine Connor Linton (katherine.linton@usitc.gov) is the International Trade Analyst for Intellectual Property and Nicholas Corrado was a law student intern in the Office of Industries of the U.S. International Trade Commission (USITC). The views expressed are those of Ms. Linton and...
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...GlaxoSmithKline and AIDS Drugs for Africa GlaxoSmithKline Pharmaceuticals Ltd Trimester 1 Project – Division D Prepared By (Group 4) :Nakul Agarwal Sanket Guhagarkar Tanvi Gupta Piyush Jain Saurabh Jain (D004) (D020) (D026) (D029) (D030) Table of Contents Company Overview....................................................................................................................... 1 HIV / AIDS in Africa ................................................................................................................... 1 Core interest of GSK in Africa .................................................................................................... 1 Criticism of GSK ......................................................................................................................... 1 Access to Medicine (ATM) Outlook ............................................................................................ 2 Governance .................................................................................................................................... 2 Management Structures....................................................................................................... 3 Performance Management & Incentives ............................................................................. 3 Stakeholder Engagement..................................................................................................... 4 Innovation in General Access to Medicine...
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...World Market Strategies for Drugs to Fight Aids Jérôme Dumoulin, Yves-Antoine Flori, Philippe Vinard, Thomas Borel Key words: AIDS; drugs; price; developing countries. Abstract Faced with a situation where the market is unstable and the political context is crucial, we propose a three-part analysis. In the first part, an overview of the chronology of the main events shows that the evolution of the price of ARVs is interlinked with numerous issues of pharmaceutical patent rights. In the second part, we analyse the positions of stakeholders: how they behave in the market and influence market regulations. In the third part, we propose three scenarios which are both simplified interpretations of stakeholders’ strategies and options for the future. The first scenario is the status quo, where prices are high. The second scenario is driven by multinational companies who work to enlarge the markets by price differentiation and product diversification. The third scenario is driven by International Organisations which achieve a political consensus to enlarge access to ARV drugs through broader international financing and a systematic opening of the market to generics. Résumé Face à une situation de marché instable où le contexte politique est primordial, nous proposons une analyse en trois parties. Dans la première partie une esquisse de la chronologie des événements montre que l’évolution des prix des 214 Economics of A I DS and Access to H I V/A I DS Care… ARV est...
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...SYSTEMS APPROACH FOR THE USE OF EXECUTIVES, MANAGERS, AND POLICY MAKERS Eric Brewis 2 SWENSEN’S MUST ENGAGE IN MARKET PENETRATION AND DIVERSIFICATION TO RETAIN ITS LEADING POSITION IN THE THAILAND MARKET Kailee Douglas 13 DISNEYLAND PARIS: EUROPEANIZING A RESORT Amanda Louie 22 IKEA: A STRATEGY FOR SUCCESS Garret Luu 31 COMPULSORY LICENSING IN THAILAND Simran Mann 38 CHANGING POVERTY AND INEQUITY THROUGH BUSINESS Matthew R. Tanner 47 SWEDEN IS A NESTING GROUND FOR YOUNG START-UP ENTREPRENEURS James Whyte 56 Note from the Editor In business today, “globalization” is a key concept with the firms across nations intertwined as never before. With overseas customers, suppliers, operations, and competitors, today’s managers need an international outlook. Therefore, the mission of the University of Victoria’s Bachelor of Commerce program is to give students the essential knowledge and skills they need to be effective and successful managers in the global economy. At UVic Business, we ensure that our students develop an international perspective through direct experience with issues in management and organization. In fact, UVic Business has one of the largest international exchange programs in Canada with 55 active partnerships...
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...Intellectual Property Rights 2014 1.Intellectual property rights: US set to punish India The Indian embassy in Washington DC too scheduled a briefing by its economic and commerce wings soon after the expected US action. TNN | Feb 10, 2014, 10.28PM IST WASHINGTON: It's not looking good between New Delhi and Washington. Tensions over the Khobragade episode are yet to fully dissipate, but the two sides are locking horns again over intellectual property rights. The Obama administration is scheduled to announce unspecified ''trade enforcement action'' against India on Monday evening (Tuesday am IST) Washington time. United States trade representative (USTR) Michael Froman and general counsel Timothy Reif will hold a news conference to announce action related to India, the USTR said earlier in the day in a head's up to journalists. The Indian embassy in Washington DC too scheduled a briefing by its economic and commerce wings soon after the expected US action. All this comes ahead of a re-scheduled visit to New Delhi of US energy secretary Ernesto Munoz, which was postponed from January because of the Khobragade row. 2.Hurdles in business growth forcing entrepreneurs to mass exodus Krithika Krishnamurthy, ET Bureau Mar 28, 2014, 04.30AM IST * (Starting up in India is easy…) Within the next six months, Bangalorebased technology entrepreneur Jay Krishnan will be heading east in search of a better place to locate his fast-growing business...
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...price. It claimed that the patent ought not have been granted in the first place. CIPLA's counsel, Arun Jaitley argued very persuasively in court that Roche's drug did not meet the requirements of section 3(d), a unique section introduced into India's patent regime in 2005 to prevent a phenomenon widely known as "evergreening". Under section 3(d), derivatives of existing pharmaceutical substances would not merit patent protection, unless such derivative was more "efficacious" than the earlier existing pharma substance. The section was challenged by Novartis as being violative of TRIPS and of the Indian constitution CIPLA also stressed that since the price differential between the patented drug and the generic version sold by CIPLA was extremely high, "public interest" demanded that no injunction be granted in favour of Roche. In a remarkably sophisticated and well researched judgment, Justice S Ravindra Bhat of the Delhi High Court ruled in favour of CIPLA. The matter is now under appeal. Unless Roche is able to demonstrate empirically that CIPLA's lower prices for Tarceva (the lung cancer drug in issue) does not really translate to increased access to poor patients, it is difficult to see how Justice Bhat's order will be overturned in appeal. The Rhetoric of ‘Patent Busting The verdict on one of the most keenly watched patent litigations was finally out last month. In a carefully nuanced and remarkably well-researched judgment, Justice S. Ravindra Bhat of the Delhi...
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...Patents and Biotechnology The patent system: supposed to promote scientific progress and technological development by providing incentives for inventors, investors, and entrepreneurs. The government grants inventors a private right, i.e. ownership of the invention for 20* years, in exchange for a public good, i.e. their disclosure of information about their invention in the patent application. In theory, granting inventors a limited monopoly on their inventions provides them with an attractive alternative to trade secrecy and encourages the dissemination of scientific and technical information. *less for certain kinds of patents (e.g. new drugs) Bio-tech Terminology DNA is a double-stranded helix composed of complementary nucleic acid base-pairs: adenine (A) pairs with thymine (T), and cytosine (C) pairs with guanine (G). DNA consists of sequences of nucleic acids, such as ACTTAGGAC. Proteins are composed of amino acids, which can fold to make complex structures (various tissues which form organs ,etc).… It takes three nucleic acid bases (or codon) to code for a single amino acid. A “gene” can be defined as the basic unit of heredity; it carries the information required to make one or more proteins. In human beings, genes include the base-pairs required to make a protein but not the regulatory sequences. Only a small percentage of human DNA, perhaps less than 5%, consists of genes. The human genome includes about 35,000 genes, which code for...
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...[FOreign Policy in latin America](Paper taken to writing clinic: hannah) | | Every country’s foreign policy consists of self-interest strategies chosen by the state to safeguard its national interests and to achieve its goals within international relations. Its goal is to interact with other countries and non-state actors. Foreign policies are designed by the government through high-level decision making processes. The US has been involved in foreign affairs with Latin America for some time now. How are the US and Latin America with Foreign Affairs? Are Latin Americans’ Intellectual Properties being robbed? Are Latin American countries being restored and growing? There are many other questions to ask regarding the foreign policy issues concerning Latin America. One huge problem with Foreign Affairs/Policies is the Drug Trafficking from Latin America into the United States. Cuba is not necessarily a drug producing country but it is a transit one. In 1998 nearly 7.2 metric tons of cocaine were seized in Colombia on its way to Cuba. Also, there was a 50% increase in drug over flight, which includes people carrying drugs as mules on planes and the dropping of drugs into American water from Cuban planes heading to the States (House Government Reform Committee) Castro had once said that he did not want the United States interfering with Cuban drug relations. Most American government officials believed him to be the main cause of drug transportation in and out of Cuba. Especially...
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...Pharmaceuticals and Life Sciences Global pharma looks to India: Prospects for growth Table of contents Introduction 03 Background 04 A fast growing economy An expanding pharmaceutical market Government-provided healthcare improving, but private healthcare dominates Domestic market overview 09 Background Consolidation underway, despite challenges Contract manufacturing Vaccines Over the counter market holds significant potential Reaching the untapped rural market Growing Research & Development 15 Overview Clinical trials Biotech and biosimilars on track for growth Other growth areas Bioinformatics 20 Stem cell research Medical devices Global Pharma’s evolving business models and options in India 23 Background Export-oriented business (Contract Research and Manufacturing Services) Licensing Franchising Joint ventures Wholly-owned subsidiaries Practical concerns 27 Infrastructure Tax environment Counterfeiting Intellectual property Conclusion 30 Related reading: Pharma 2020 31 References 32 Acronyms 38 Introduction The pharmaceutical industry’s main markets are under serious pressure. North America, Europe and Japan jointly account for 82% of audited and unaudited drug sales; total sales reached US$773 billion in 2008, according to IMS Health. Annual growth in the European Union (EU) has slowed to 5.8%, and sales are increasing at an even more sluggish rate...
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...Snapshot The Indian pharmaceutical industry is highly dynamic and offers great opportunities for both domestic and foreign companies. The industry is estimated to have generated revenue worth US$ 13.1 billion in FY 2011, according to a new Research and Market’s report, “Indian Pharma Sector Forecast 2014.” India will emerge as a leading global player in pharmaceutical industry by 2020, securing a place among the top five major global markets, according to Ikon Marketing Consultant (IMC). Also, Associated Chambers of Commerce and Industry (Assocham) has said it expects the Indian pharmaceutical industry to reach US$ 20 billion by 2015, making it one of the world's top 10 pharmaceuticals markets. India has a strong local manufacturing base and domestic players are developing substantial international presence. Healthcare is also one of the largest service sector industries in India, in terms of revenue and employment. Rising health awareness and increasing government expenditure on healthcare sector is driving growth in the sector. Medical tourism and health insurance are also on a rise, with significant growth in healthcare sector and establishment of large number of hospitals, both public and private. The Indian healthcare industry, estimated at US$ 50 billion, is expected to reach over US$ 75 billion by 2012, and US$ 100 billion by 2015. Talent Challenges While specialised talent is critical for any knowledge industry, it is more so within the pharmaceuticals industry. Companies...
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...prepared for the UNIDO Research Project “Public Goods for Economic Development”, by Rod Falvey and Neil Foster. Rod Falvey is Professor of International Economics, Leverhulme Centre for Research on Globalisation and Economic Policy, School of Economics, The University of Nottingham. Neil Foster is Assistant Professor of economics at the Department of Economics, University of Vienna. The publication has benefited from the valuable comments provided by Professor David Greenaway during the finalization of this publication. UNIDO intern Robert Lambertus van Lavieren provided assistance during various stages of preparing this publication. The authors are grateful to Michael Bailey for proofreading the final document. Comments and suggestions on the issues raised in this paper may be addressed to: Olga Memedovic Strategic Research and Economics Branch UNIDO P.O. Box 300 1400 Vienna Austria Tel: (+43-1) 26026-4676 Fax: (+43-1) 26026-6864 E-mail: omemedovic@unido.org This paper has not been formally edited. The designations employed and the presentation of material in this publication do not imply...
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...ADL 62 (Technology Management) Assignment – A ANS 1 (a) Economic analysis of technology. Economic analysis of technology deals with the evaluation of techno capitalism, technological diffusion, technology acceptance model, technology lifecycle, and technology transfer effects to the economy of a particular industry, group or country. Techno capitalism describes the changes in capitalism based on the changes in technology. Technological diffusion implies a form of 'conditional convergence' as lagging countries catch up with technological leaders. Technology Acceptance Model which deals more specifically with the prediction of the acceptability of an information system. The purpose of this model is to predict the acceptability of a tool and to identify the modifications which must be brought to the system in order to make it acceptable to users. Technology lifecycle is about the technological maturity of a product. Technology transfer is the process of sharing of skills, knowledge, technologies, methods of manufacturing, samples of manufacturing and facilities among governments and other institutions to ensure that scientific and technological developments are accessible to a wider range of users who can then further develop and exploit the technology into new products, processes, applications, materials or services. b) Technology and culture. Global organizations need to understand cultural differences if they want to successfully...
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