Compulsory Licensing of Patented Pharmaceutical Inventions: Evaluating the Options

In this Comment, the author traces the relevant legislative history pertaining to compulsory licensing of patented pharmaceuticals from the TRIPS 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 esential 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 demonstrably illegal under WTO foundational law and jurisprudence

A Compensatory Liability Regime to Promote the Exchange of Microbial Genetic Resources for Research and Benefit Sharing

Female rhesus macaques were immunized with HIV virus-like particles (HIV-VLPs) or HIV DNA administered as sequential combinations of mucosal (intranasal) and systemic (intramuscular) routes, according to homologous or heterologous prime-boost schedules. The results show that in rhesus macaques only the sequential intranasal and intramuscular administration of HIV-VLPs, and not the intranasal alone, is able to elicit humoral immune response at the systemic as well as the vaginal level.funding agencies|Simian Vaccine Evaluation Unit (SVEU) of the Division of AIDS||European Community|201433|</p

Database Protection in a Global Economy

In 1996, a database treaty that the European Commission had put forward, in connection with the WIPO negotiations on transmissions in cyberspace, ultimately failed to win the support of other regional groups. Since then, the inability of the United States Congress to enact any form of database legislation has stymied further multilateral undertakings on this topic. This impasse may soon be broken, however, owing to the change of Administrations and to the appointment of new committee chairmen in the United States House of Representatives. This article will discuss the prospects for an international regulatory framework for non copyrightable databases in the light of recent developments in the United States. Part 2 will locate the database problem within the larger context of international intellectual property protection, and it will demonstrate why the European Commission’s 1996 Directive on the legal protection of databases represented a radical departure from basic tenets of the classical intellectual property system handed down from the nineteenth century. Part 3 will compare the existing E.U. model of database protection with the two proposed models currently under consideration in the United States, from which any compromise formula is likely to be drawn. It ends with some reflections on the deeper legal and economic implications of these proposals. Part 4 will then explore the implications for the international intellectual property system likely to arise if the U.S. adopts a model of database protection that differs significantly from that of the E.U. It proposes an umbrella treaty to bridge the gap between high and low protectionist models. While a low protectionist outcome in the United States is by no means certain at the time of writing, a careful consideration of ways and means to reduce friction between countries that opt to provide different levels of protection in the global marketplace seems merited at the present juncture

Sharing by Design: Data and Decentralized Commons

Ambitious international data-sharing initiatives have existed for years in fields such as genomics, earth science, and astronomy. But to realize the promise of large-scale sharing of scientific data, intellectual property (IP), data privacy, national security, and other legal and policy obstacles must be overcome. While these issues have attracted significant attention in the corporate world, they have been less appreciated in academic and governmental settings, where solving issues of legal interoperability among data pools in different jurisdictions has taken a back seat to addressing technical challenges. Yet failing to account for legal and policy issues at the outset of a large transborder data-sharing project can lead to undue resource expenditures and data-sharing structures that may offer fewer benefits than hoped. We propose a framework to help planners create data-sharing arrangements with a focus on critical early-stage design decisions including options for legal interoperability

Intellectual Property, Open Science and Research Biobanks

In biomedical research and translational medicine, the ancient war between exclusivity (private control over information) and access to information is proposing again on a new battlefield: research biobanks. The latter are becoming increasingly important (one of the ten ideas changing the world, according to Time magazine) since they allow to collect, store and distribute in a secure and professional way a critical mass of human biological samples for research purposes. Tissues and related data are fundamental for the development of the biomedical research and the emerging field of translational medicine: they represent the “raw material” for every kind of biomedical study. For this reason, it is crucial to understand the boundaries of Intellectual Property (IP) in this prickly context. In fact, both data sharing and collaborative research have become an imperative in contemporary open science, whose development depends inextricably on: the opportunities to access and use data, the possibility of sharing practices between communities, the cross-checking of information and results and, chiefly, interactions with experts in different fields of knowledge. Data sharing allows both to spread the costs of analytical results that researchers cannot achieve working individually and, if properly managed, to avoid the duplication of research. These advantages are crucial: access to a common pool of pre-competitive data and the possibility to endorse follow-on research projects are fundamental for the progress of biomedicine. This is why the "open movement" is also spreading in the biobank's field. After an overview of the complex interactions among the different stakeholders involved in the process of information and data production, as well as of the main obstacles to the promotion of data sharing (i.e., the appropriability of biological samples and information, the privacy of participants, the lack of interoperability), we will firstly clarify some blurring in language, in particular concerning concepts often mixed up, such as “open source” and “open access”. The aim is to understand whether and to what extent we can apply these concepts to the biomedical field. Afterwards, adopting a comparative perspective, we will analyze the main features of the open models – in particular, the Open Research Data model – which have been proposed in literature for the promotion of data sharing in the field of research biobanks. After such an analysis, we will suggest some recommendations in order to rebalance the clash between exclusivity - the paradigm characterizing the evolution of intellectual property over the last three centuries - and the actual needs for access to knowledge. We argue that the key factor in this balance may come from the right interaction between IP, social norms and contracts. In particular, we need to combine the incentives and the reward mechanisms characterizing scientific communities with data sharing imperative

Patents for drugs and the right to development in international law

This article explores the connection of health to human and socio-economic development and the protection of pharmaceutical patents. It examines the concept of development and the right to development in international law in the context of access to medicines and patents protection. The provisions of the General Agreement on Tariffs and Trade (GATT) and the Agreement on Trade Related aspects of Intellectual Property Rights (TRIPS Agreement) that are significant to the pursuit of development are discussed. The article argues that there is a cognisable right to development in international law that is well recognised in international trade law and the pursuit of development should be duly taken into account in the negotiation and implementation of trade and IP agreements. The article highlights the potential danger in eroding the flexibilities in the TRIPS Agreement through the negotiation of free trade agreements and emphasises the need for IP and trade agreements to sufficiently accommodate and recognise legitimate measures genuinely taken to enhance national development. It is argued that developing countries should have a national IP implementation plan that can effectively enhance their human development objectives