Four Lessons for Developing Countries from the Trade Negotiations Over Access to Medicines

After the Agreement on the Trade-Related Aspects of Intellectual Property Rights (TRIPS) came into operation in 1995 developing countries have found themselves in a process of continual negotiation over intellectual property rights and access to medicines. These negotiations have taken place in the World Trade Organization and in the context of free trade agreements. The paper suggests that the only real win for developing countries has been the Doha Declaration on the TRIPS Agreement and Public Health in 2001. What have been the lessons for developing countries in a decade of negotiations over access to medicines? Drawing on themes of rule complexity and regulatory ritualism the paper discusses four key lessons for developing countries. It concludes by arguing that developing countries will do better if they adopt a networked governance approach to negotiation rather than continuing to rely on traditional coalition formation.     

专利作为技术公共事物的治理之道——民主在无效宣告中的引入

专利权被普遍认为是私权,但其实现过程却迥异于理论认识。民主在专利权第二次评估过程中获得机制性设置,专利权的实践由此表现为社会参与的过程;基于各种可能的民主模型,这一过程的秩序获得了正义性价值。专利权无效宣告程序引入民主的理论可能,证立了专利作为技术公共事物治理之道的命题,即:向所有人开放、公开;对行政机构决策设定明确的限制条件;结果受控于司法监督。埃莉诺.奥斯特罗姆的公共事务治理之道为此提供了理论深化的智慧和启迪,局外人或权利外人的加入,使专利权无效的民主过程在生活中获致实践。     

Three statutory regimes at impasse： ＂Reverse payments＂ in ＂pay-for-delay＂ settlement agreements between brand-name and generic drug companies

Antitrust authorities in both the United States and Europe have expressed deep concern over settlements of antitrust cases in the pharmaceutical sector, settlements involving ＂reverse payments＂ from plaintiffs to defendants, large sums paid by branded pharmaceutical companies to generic competitors in exchange for promises to stay offthe market. Such ＂pay-for-delay＂ settlements have proliferated in the United States since Federal Circuit Courts of Appeals have found them unproblematic despite the Federal Trade Commission＇s persistently strong position that they violate the antitrust laws. These cases arise at the intersection of three statutory regimes seeking to promote innovation, three clusters of doctrine and policy that have interacted only to reach impasse： the Patent Act, the 1984 amendment to the Food, Drug, and Cosmetic Act, and finally the Sherman Anti-Trust Act. Antitrust is a late comer to the fierce competition over patented drugs, competition that permeates the approval process in the Food ＆ Drug Administration [FDA], competition that is restrained by these pay-for-delay settlement agreements. To set the stage, we begin with the Patent Act and its relationship to the FDA approval process. The story of pay-for-delay settlements then proceeds to the settlement agreements and their antitrust implications. We conclude that the best solution in these antitrust cases would be adoption of the FTC＇s approach of presumptive illegality. Together with an amendment proposed to fix the food and drug act, the presumptive illegality of pay-for-delay settlements under the antitrust laws would make the market for pharmaceuticals more price competitive, open weak patents to serious challenge, and as a result save consumers billions of dollars annually without taking from branded drug companies legitimately earned incentives to engage in research and development.     

Knowledge diffusion from university and public research. A comparison between US,Japan and Europe using patent citations

This paper estimates the process of diffusion and decay of knowledge from university, public laboratories and corporate patents in six countries and tests the differences across countries and across technological fields using data from the European Patent Office. It finds that university and public research patents are more cited relatively to companies’ patents. However these results are mainly driven by the Chemical, Drugs & Medical, and Mechanical fields and US universities. In Europe and Japan, where the great majority of patents from public research come from national agencies, there is no evidence of a superior fertility of university and public laboratory patents vis à vis corporate patents. The distribution of the citation lags shows that knowledge embedded in university and public research patents tends to diffuse more rapidly relative to corporate ones in particular in the US, Germany, France and Japan.

TRIPS agreement and public health crisis in developing countries： Problems and solutions

While the health crisis in developing world has caused innumerable deaths, the balance between patent protection and public health attracts lots of debates globally. This paper examines the legal background for the access problems of essential drugs in developing countries, evaluates TRIPS agreement and the WTO decisions in theory, argues both patent protection for pharmaceuticals and TRIPS agreement are the genuine causes for the access problem, then attempts to provide some suggestions and evaluations for the possible solutions. Though the development of national pharmaceutical industries, adoption of early working exemptions, compulsory license, parallel import, acquirements of generic drugs and discount drugs, amendments of TRIPS agreement are all beneficial measures, the access problem may only be solved at an international level.     

Internationalization and democratization interconnected: the Swedish and Finnish parliaments debating membership in the League of Nations in 1920

In the aftermath of the First World War, constitutions of European states were widely democratized and parliamentarized, and similar turns were expected in international relations as a consequence of the creation of the League of Nations. This comparative analysis of Swedish and Finnish parliamentary debates on the League membership focusing on conceptualizations of the national versus international demonstrates how democratization and internationalization merged discursively. This happened to a greater extent than in the British parliament or the First Assembly of the League. Such entanglements followed from the interconnectedness of constitutional and foreign policy questions during preceding disputes on constitutional reform when Britain and Germany had provided competing models, the determination of the ministries to reconfirm national constitutional compromises by joining an international organization of democratic nations, an exceptional possibility for parliamentarians to debate foreign policy and willingness among the leftist oppositions to extend the democratization and parliamentarization of the constitutions to the field of foreign policy. After a turn from German to British political models and under a Bolshevik threat, British internationalist arguments found a positive reception among the Swedish Liberal–Social Democratic coalition and the Finnish bourgeois coalition as well as half of the redefined Finnish Social Democratic Party. Rightist and far-leftist opponents of the League were left to the margins as the membership was used to redefine the polities as internationally oriented democracies.     

Political discourse networks and the conflict over software patents in Europe

In 2005, the European Parliament rejected the directive ‘on the patentability of computer‐implemented inventions’, which had been drafted and supported by the European Commission, the Council and well‐organised industrial interests, with an overwhelming majority. In this unusual case, a coalition of opponents of software patents prevailed over a strong industry‐led coalition. In this article, an explanation is developed based on political discourse showing that two stable and distinct discourse coalitions can be identified and measured over time. The apparently weak coalition of software patent opponents shows typical properties of a hegemonic discourse coalition. It presents itself as being more coherent, employs a better‐integrated set of frames and dominates key economic arguments, while the proponents of software patents are not as well‐organised. This configuration of the discourse gave leeway for an alternative course of political action by the European Parliament. The notion of discourse coalitions and related structural features of the discourse are operationalised by drawing on social network analysis. More specifically, discourse network analysis is introduced as a new methodology for the study of policy debates. The approach is capable of measuring empirical discourses both statically and in a longitudinal way, and is compatible with the policy network approach.     

Web 2.0, wikis, and the IP Community

Legal context: The emergence of new web-based programs being used in the fieldsof patent applications and IP legal information has opened upa range of new opportunities for IP-related legal processesand knowledge sharing. Key points: This article explains the background to Web 2.0 applicationsand explores the potential for the use of wikis in various areasof IP. It notes the limitations, as well as the possibilities,of wikis and explains how they work in practice. It outlinesthree recent examples of wikis in the IP world, explaining howthey work and the significance of their overall objectives. Practical significance: The adoption of this technology by official bodies suggestswider future use and the appearance of unofficial sites showsthat current developments have already reached a stage wheremany IP practitioners can begin to interact and share knowledgein a way that has not been considered previously. It is conceivablethat developments in this area will be rapid and it is in theinterests of users to familiarize themselves with the use ofthis new ‘social software’.     

The political transfer of parliamentary concepts and practices in the European periphery: the case of obstruction in late nineteenth- and early twentieth-century Finland

This article examines parliaments as transnational institutions. It uses Finland as an example to analyze how nineteenth- and early twentieth-century European representative assemblies were part of a joint publicity. This publicity, facilitated by the press, was actively used in developing and shaping national practices, especially in countries without an established parliamentary tradition. The transnational parliamentary publicity changed how parliaments functioned and deliberated. It was utilized in assemblies’ procedural formation and revision, democratization, and parliamentarization. The mediated models and examples were used selectively and innovatively to interpret, contextualize, and frame domestic political questions. The article examines the transfer of parliamentary obstruction from European parliaments to the four-estate Diet and the unicameral parliament of the Finnish Grand Duchy of the Russian Empire. Obstruction became part of the Finnish political repertoire soon after the Irish obstruction appeared in the British House of Commons in the late 1870s. Although no systematic obstruction campaigns were organized in early Finnish parliamentary life, the concept of obstruction was a rhetorical and ideological tool of the Finnish nationalists and socialists. The article positions Finnish discussions within wider European debates on parliaments, democratization, the rise of mass parties, and the problematic relationship between representative and deliberative aspects of parliamentary politics.     

An evolutionary step in intellectual property rights – Artificial intelligence and intellectual property

This article addresses and analyses the issues concerning the ownership of computer generated works within patents and copyright, and concludes that the current regime is woefully inadequate to deal with the growing use of more and more intuitive artificial intelligence systems in the production of such works. It considers the respective claims of interested parties to such rights before moving on to a consideration of the creation of a new legal personality to which such rights could be granted to resolve the difficulties inherent in the current system.