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.