Papers by Jerome Reichman
Social Science Research Network, 2009
A negative outcome will sink an entire research project, which, from the lab to the trial, may en... more A negative outcome will sink an entire research project, which, from the lab to the trial, may entail a loss of hundreds of millions of dollars. 5 The costs of such failures must then be made up from the few products that do succeed, which, according to some estimates, means that the aggregate breakeven costs of clinical trials for any successful new chemical entity may reach one billion dollars. 6 So one may suspect that there is a moral hazard here because if the pharmaceutical companies pay for the tests, they have a perverse incentive to paint the end results in the rosiest possible light. 7 The pharmaceutical companies have also lobbied successfully for regulatory relief from the burden of recouping the cumulative costs of clinical trial data in the form of a backdoor intellectual property right known in the United States as "marketing exclusivity" 8 and in the European Union as "data exclusivity." 9 By these means, originator pharmaceutical companies obtain a period of time, ranging from three to ten years, during which would-be generic producers of existing drugs cannot themselves obtain regulatory approval for a competing drug if they rely-directly or indirectly-on the results of the originator's own undisclosed test data, which will have been provided to governments 4.
Journal of Law Medicine & Ethics, 2009
In this Comment, the author traces the relevant legislative history pertaining to compulsory lice... more In this Comment, the author traces the relevant legislative history pertaining to compulsory licensing of patented pharmaceuticals from the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement of 1994 to the 2003 waiver to, and later proposed amendment of, article 31, which enables poor countries to obtain needed medicines from other countries that possess manufacturing capacity. The Comment then evaluates recent, controversial uses of the relevant legislative machinery as viewed from different critical perspectives. The Comment shows how developing countries seeking access to essential medicines can collaborate in ways that would avoid undermining incentives to innovation and other social costs attributed to compulsory licensing. It ends by defending the legality of recent measures taken to promote public health in developing countries, and by reminding developed countries that unilateral retaliation against such measures is demonstratably illegal under WTO foundational law and jurisprudence. I. How Compulsory Licensing Survived the TRIPS Agreement of 1994 Few topics in international intellectual property law have been as controversial in recent years as the one we are about to examine. In the 1980s and early 1990s, a Diplomatic Conference attempted to revise the oldest international convention providing some protection for patented inventions outside of the domestic laws. 1 Those efforts broke down, largely because developed and developing countries could not agree on the powers that governments should retain to issue compulsory licenses or on the grounds for which these powers could be exercised. 2 The failure of this Conference, held under the auspices of the World Intellectual Property Organization (WIPO), persuaded the technology-exporting countries to link future negotiations concerning international intellectual property protection to the Multilateral Trade Negotiations, known as the Uruguay Round, which got underway in 1986. 3 The end result was Annex IC of the Agreement Establishing the World Trade Organization of 1994, which incorporated a new, comprehensive and relatively elevated set of international minimum standards of patent protection into the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). 4
Cambridge University Press eBooks, May 5, 2016
A. Introduction: Emerging Role of the BRIC Countries The exact connection between intellectual pr... more A. Introduction: Emerging Role of the BRIC Countries The exact connection between intellectual property and economic development varies over time from country to country and region to region. 1 For example, one cannot doubt that intellectual property laws played a major role in United States development and economic growth over the past three decades. Yet, the moment one digs deeper, one discovers that, until 1982, the United States had one of the developed world's most procompetitive patent laws (i.e., least protective); until 1978, it had relatively weak copyright laws; and until the 1980s, it had an aggressively interventionist competition law along with a robust doctrine of patent misuse. 2 Somehow, the U.S. economy managed to survive and thrive in this relatively low protectionist, highly competitive environment. Similarly, Japan, India, China, Korea, Malaysia, and Brazil all managed to attain relatively high levels of economic growth without strong intellectual property rights. 3 Indeed, the astounding success of the Indian Pharmaceutical industry since the 1970s was achieved by means of a state policy that largely prohibited the patenting of medicinal
Cambridge University Press eBooks, May 5, 2016
Fordham Intellectual Property, Media & Entertainment Law Journal, 1993
Brooklyn journal of international law, 1993
Revue internationale de droit économique, 2002
University of Baltimore Law Review, 1989
Vanderbilt Journal of Transnational Law, 1996
Virginia Journal of International Law, 1996
Law and contemporary problems, 2003
For the environmental sciences perspective, see generally NATIONAL RESEARCH COUNCIL, ON THE FULL ... more For the environmental sciences perspective, see generally NATIONAL RESEARCH COUNCIL, ON THE FULL AND OPEN EXCHANGE OF SCIENTIFIC DATA (1995) [hereinafter FULL AND OPEN EXCHANGE] and NATIONAL RESEARCH COUNCIL, RESOLVING CONFLICTS ARISING FROM THE PRIVATIZATION OF ENVIRONMENTAL DATA 15-19 (2001) [hereinafter RESOLVING CONFLICTS], regarding scientists' views on the need for full and open access to environmental and earth science data. 9. See infra Part II.B. 10. We define "public domain" information as sources and types of data and information whose uses are not restricted by statutory intellectual property ("IP") laws and other legal regimes and that are accordingly available to the public for use without authorization. For analytical purposes, information in the public domain, including scientific data and information, may be divided into three major categories:
Edward Elgar Publishing eBooks, Mar 17, 2023
This panel was convened at 12:45 pm, Friday, April 11, by its moderator, Frederick M. Abbott of F... more This panel was convened at 12:45 pm, Friday, April 11, by its moderator, Frederick M. Abbott of Florida State University College of Law, who introduced the panelists: Gary N. Horlick of Georgetown University Law Center; James Love of Knowledge Ecology International; Jerome H. Reichman of Duke University School of Law; and Susan K. Sell of the Elliott School of International Affairs, George Washington University. ([dagger]) INTRODUCTORY REMARKS BY FREDERICK M. ABBOTT ([double dagger]) There is a long historical arc surrounding the question of host country protection of alien property. Traditionally there has been a distinction between trade agreements on one side, and investor protection agreements on the other. The former were multilateral, regional, or bilateral, while the latter were more typically bilateral. More recently, starting in the 1980s, there has been a trend toward incorporating investor and investment protection in bilateral, regional, and plurilateral trade agreements...
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Papers by Jerome Reichman