Current policy issues in the governance of the European patent system

The European Parliament has been working towards building a discussion platform and a resource for further policy actions in the field of intellectual property rights. The Science and Technology Options Assessment Panel has set the goal of further enlarging the area of investigation in light of recent policy developments at the European level. In particular, the current study covers current policy issues in the governance of the European patent system, such as the backlog issue, the enhancement of patent awareness within the European Parliament, patent enforcement, the regional dimension of intellectual property in Europe, patents and standardisation, the use of existing patents, and patents and competition. These issues were discussed in the conference with stakeholders from European to national patent offices, from private to public sector actors. As a result of the conference, it was stated the need for an IP strategy for Europ

Understanding the pharmaceutical patent system in Spain and Europe: a perspective from the need to take its protection-access tradeoff seriously

As a result of the doctoral research developed by the main author (Vargas-Chaves, 2017), it was identified the evolution and perspectives of the pharmaceutical patent in the international trade system, as well as it future legal research needs in this topic, both immediate and long-term. Furthermore, a number of problems of public health were highlighted in which the patent-term-extension mechanisms have produced a lack of access to medicines

Harmonization Without Consensus: Critical Reflections on Drafting a Substantive Patent Law Treaty

In this Article, we contend that the World Intellectual Property Organization\u27s proposed Substantive Patent Law Treaty (SPLT) is premature. Developing countries are struggling to adjust to the heightened standards of intellectual property protection required by the TRIPS Agreement of 1994. With TRIPS, at least, these countries obtained side payments (in the form of trade concessions) to offset the rising costs of knowledge products. A free-standing instrument, such as the SPLT, would shrink the remaining flexibilities in the TRIPS Agreement with no side payments and no concessions to the catch-up strategies of developing countries at different stages of technological advancement. More controversially, we argue that a deep harmonization would boomerang against even its developed country promoters by creating more problems than it would solve. There is no vision of a properly functioning patent system for the developed world that commands even the appearance of a consensus. The evidence shows, instead, that the worldwide intellectual property system has entered a brave new scientific epoch, in which experts have only tentative, divergent ideas about how best to treat a daunting array of new technologies. The proposals for reconciling the needs of different sectors, such as information technology and biotechnology, pose hard, unresolved issues at a time when the costs of litigation are rising at the expense of profits from innovation. These difficulties are compounded by the tendency of universities to push patenting up stream, generating new rights to core methodologies and research tools. As new approaches to new technologies emerge in different jurisdictions, there is a need to gather empirical evidence to determine which, if any, of these still experimental solutions are preferable over time. Our argument need not foreclose other less intrusive options and measures surveyed in the Article that can reduce the costs of delaying harmonization. However, the international community should not rush to freeze legal obligations regarding the protection of intellectual property. It should wait until economists and policymakers better understand the dynamics of innovation and the role that patent rights play in promoting progress and until there are mechanisms in place to keep international obligations responsive to developments in science, technology, and the organization of the creative community

Accessing other people's technology: do non-profit agencies need it? how to obtain it?

As patents and other forms of intellectual property become more pervasive in the next generation of biotechnologies, designing polices and practices to ensure sufficient freedom to operate (i.e., the ability to practice or use an innovation) will be crucial for non-profit agencies in the developed and developing world, especially those intent on developing improved seed varieties and other technologies destined for commercial release. Are non-profits exempt from intellectual property claims? What constitutes infringement of a patent? How does a non-profit establish its freedom to operate? We address these issues in this paper and evaluate various options for accessing other people's technologies. Options include cross- licensing agreements, research-only or cost-free licenses, market segmentation strategies, mergers or joint ventures, and patent pooling or clearinghouse mechanisms. Responding creatively to the new intellectual property environment will have far reaching consequences for the future of non-profit research.Biotechnology., Intellectual property.,

Intellectual Property and Intra-Community Trade

This Article will use recently decided intellectual property cases and other recent developments in European Community competition law to critically discuss the European Community\u27s traditional and strict pro-free trade approach in intellectual property cases. It will focus in particular on issues relating to the territorial nature of intellectual property rights. Part I of this Article examines the Court\u27s free trade approach in free movement cases involving patent rights. Part II explores patent rights in the context of technology Licensing Agreements, in particular in light of recent antitrust developments concerning vertical restraints. Part III discusses trademark issues. It first considers free movement rules and concludes with a brief discussion of trademark Licensing Agreements and antitrust law

An Examination of Patents, Licensing, Research Tools, and the Tragedy of the Anticommons in Biotechnology Innovation

The continued development of and affordable access to potentially life saving pharmaceuticals, gene therapies and diagnostics is unquestionably a socially important issue. However, crafting government policy to encourage the development of and allowing affordable access to those services and products is difficult. On one hand, the development of those services and products requires a large investment of funds because of the complexity, collaborative nature, and uncertainty of the development of those products and services. Accordingly, investors require the safety of strong and stable patent rights to ensure a return on their investment in the development of a commercial end-product or a research tool. On the other hand, patents may foreclose competition for a particular product or service and enable a company to exact a supra competitive price for that product or service, thus denying access to people unable to afford that product or service. In arriving at that supra competitive price, the company selling the commercial end product may have to include in that price a number of additional costs imposed by holders of patented research tools needed in the development of the commercial end-product. This Article examines whether the development of pharmaceuticals, gene therapies or diagnostics is being stifled by the inability of companies to access proprietary research tools needed for the development of those important products and services. This Article also evaluates proposals for alleviating problems in accessing proprietary research tools, and proposes recommendations to aid in the efficient transfer of that technology. First, this Article recommends that Congress enact a law similar to the proposed Genomic Science and Technology Innovation of Act of 2002, which requires the government to conduct a study of the effect of government policy on biotechnology innovation. Second, this Article recommends that the government encourage public and private parties to enter patent pools to efficiently transfer rights in biotechnology inventions. The government, in conjunction with private and public institutions, should create a publicly available database of proprietary research tools and licenses concerning those tools. The government should also modify the provision of the Bayh-Dole Act concerning reservation of a nonexclusive right to practice any patented invention created with federal funding. The modification would allow the government to transfer a non-exclusive license to a patented research tool developed with government funding to a patent pool created by industry participants if it is demonstrated that the owner of the patented research tool is unreasonably withholding the license of that tool from the pool. Any royalties resulting from the licensing of the research tool in the patent pool will be distributed to the owner of the patented research tool. Part I of this Article provides definitions for research tools and commercial applications. Part II discusses the costs, benefits, and purposes of patent law. Part III reviews university and private research and development, including the influence of the Bayh-Dole Act. Part IV examines the development of commercial applications of biotechnology research, including the role of venture capital and the use of licensing provisions requiring reach through royalties and exclusivity. Part V evaluates problems that may occur in attempting to develop commercial applications and licensing patents. Part VI reviews the Tragedy of the Anticommons theory. Part VII discusses research and analysis concerning the existence of the anticommons problem. Part VIII examines and analyzes potential solutions for solving the Tragedy of the Anticommons in biotechnology. Finally, Part IX offers recommendations for addressing an existing or developing Tragedy of the Anticommons

Intellectual Property Management Strategies to Accelerate the Development and Access of Vaccines and Diagnostics: Case Studies on Pandemic Influenza, Malaria and SARS

Achieving global access to vaccines, diagnostics, and pharmaceuticals remains a challenge. Throughout the developing world, intellectual property (IP) constraints complicate access to critically essential medical technologies and products. Vaccines for malaria and pandemic strains of influenza, as well as diagnostic and vaccine technologies for SARS, are not only relevant to global public health but are particularly critical to the needs of developing countries. A global access solution is urgently needed. This article offers a timely case‐by‐case analysis of preliminary patent landscape surveys and formulates options via patent pools and other forms of creative IP management to accelerate development and access. The analysis of the feasibility of patent pools reveals several impediments to patent pools: these include antitrust considerations, bargaining difficulties caused by asymmetric interests and asymmetric rights among IP holders (e.g. improvement vs. foundational patents), and the difficulties of securing financial support given the significant transaction costs associated with pools. Because of the above conceptual and operational hurdles, patent pools do not appear to be a feasible way to accelerate development. Other mechanisms, however, can ameliorate IP constraints. For example, a key IP constraint related to pandemic influenza vaccines R&D appears to have been resolved when Medimmune secured the assembly of all relevant reverse genetics IP and pledged broad access. Clearly, the landscape is complex and multidimensional. Licensing systems are not the only issue. Measures must also be taken to limit regulatory hurdles and enable the swift, legal production of pandemic influenza vaccines to meet the needs of developing countries. This is why a comprehensive analysis is so necessary. From a strictly legal perspective, IP systems work through the power to exclude. However, as this study’s exploration and formulation of creative licensing strategies reveals, it is also true that IP can be structured and managed to work through the “power to include.

The Doha Declaration Ten Years on and Its Impact on Access to Medicines and the Right to Health

Access to medicines is a human right, enshrined in legally binding international human rights treaties, select regional agreements and numerous national constitutions. The realization of access to medicines, including antiretroviral treatment, as part of the human right to health depends heavily on the legal framework for the production and distribution of medicines, including intellectual property rights. The adoption of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) within the framework of the World Trade Organization (WTO) changed dramatically the international landscape with regard to intellectual property, particularly in relation to access to medicines. Although one of the stated goals of the TRI PS Agreement was “to reduce tensions arising from intellectual property protection”, the possible conflict between such protection and essential public health objectives, particularly access to medicines, moved developing-country WTO Member States to request the Council for TRIPS to specifically consider the relationship between the TRI PS Agreement and public health in general, and access to medicines more specifically. After negotiations, in 2001 the 4th WTO Ministerial Conference adopted the Declaration on the TRIPS Agreement and Public Health. This Discussion Paper briefly describes the content of the Doha Declaration and examines its implications for the realization of the right to health. The Paper discusses a number of repercussions of the Doha Declaration with regard to the international discourse on the right to health and access to medicines, and its implications within the WTO system and for national legislation. It presents some examples of use of the flexibilities confirmed by the Doha Declaration, and discusses the issue of compulsory licences with regard to patents relating to products for non-communicable diseases. Finally, a number of conclusions and recommendations are presented

Competition Law Enforcement in China: Between Technocracy and Industrial Policy

The article provides a rare reconstruction of a number of early cases decided under the Chinese Anti-Monopoly Law. In particular, the article seeks to go behind the published decisions of the responsible authorities, to reconstruct their decision-making process in particular by identifying the sources of consultation and the arguments that various stakeholders presented to the authorities about what course of action to follow