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

Compliance of Canada’s Utility Doctrine with International Minimum Standards of Patent Protection

This article analyzes the Canadian court case of Eli Lilly v. Novopharm and the utility doctrine in Canada, and international standards of patent protection including TRIPS and NAFTA. The ‘‘promise of the patent’’ doctrine in Canada seeks to ensure that firms do not obtain a legal monopoly on the basis of speculative claims about increased utility — especially claims about therapeutic efficacy — that were unsubstantiated at the time of filing. Under this test, some of Eli Lilly’s patented pharmaceutical products have been invalidated retroactively

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

The Doha Round’s Public Health Legacy: Strategies for the Production and Diffusion of Patented Medicines Under the Amended TRIPS Provisions

This entry into force of the World Trade Organization (WTO) TRIPS Agreement in 1995 transformed the international intellectual property system. The harmonization of basic intellectual property standards has operated to protect investment in innovation, limiting risks from unjustified \u27free riding.\u27 Yet these same harmonized IP standards sharply curtailed the traditional capacity of suppliers of public goods, such as health care and nutrition, to address the priority needs of less affluent members of society, particularly in (but not limited to) developing countries. In the Doha Declaration, the Waiver Decision of 30 August 2003 and the Article 31bis Protocol of Amendment, stakeholders concerned with re-opening policy space for the supply of newer pharmaceutical products pushed back against the restrictive elements of the TRIPS Agreement. Governments around the world are in the process of deciding whether to ratify and accept the Article 31bis Amendment. Based on their Study for the International Trade Committee of the European Parliament, the authors argue that acceptance of the Amendment will provide a \u27net benefit\u27 for countries seeking to improve access to medicines. At the insistence of WTO delegations acting on behalf of the originator pharmaceutical industry lobby, Article 31bis regrettably is saddled with unnecessary administrative hurdles. Nonetheless, through skillful lawyering, political determination and coordinated planning, the system can be made to work. Among other options, expeditious back-to-back compulsory licensing linked with pooled procurement strategies may effectively achieve economies of scale in production and distribution of medicines. The authors doubt that the international political environment would support renegotiation of an \u27improved\u27 solution. They express concern that failure to bring the Amendment into force will open the door to a campaign to undermine the Waiver Decision. Recent events in Brazil and Thailand illustrate both the opportunities and risks associated with implementing TRIPS exception mechanisms, and help to inform views on the negotiating environment. Specific proposals for regional cooperation in implementing the Amendment are laid out, and the authors emphasize the importance of pursuing concrete transfer of technology measures in support of developing country pharmaceutical manufacturing. Over-reliance on private market mechanisms for the supply of public health goods leaves the international community with an unresolved collective action problem on a large scale

Intellectual Property in the Twenty-First Century: Will the Developing Countries Lead or Follow?

This article continues the author\u27s contributions on the subject of intellectual property protection in developing countries, and focuses on how those developing countries with growing technological prowess should accommodate their own national systems of innovation to the worldwide intellectual property regime emerging in the post-TRIPS period, with a view to maximizing global economic welfare in the foreseeable future

Design Protection and the Legislative Agenda

An argument is made that an appropriate design protection law is in the best interests of the US. Without such a design law, industries will continue to seek anti-competitive protection from the government

Rethinking the Role of Clinical Trial Data in International Intellectual Property Law: The Case for a Public Goods Approach

This article is a later version of the author\u27s presentation at the Eleventh Annual Honorable Helen Wilson Nies Memorial Lecture March 26, 2008. Clinical trials are currently used to test drugs; however, the risk and cost of clinical trials are increasing so drastically that the clinical trials may become unsustainable. This article evaluates the legal and economic trends of intellectual property protection for pharmaceutical clinical trial data. The protection of clinical trials has become an alternative to patents as market exclusivity encourages the development and testing of unpatentable pharmaceuticals. This author argues that clinical trials should be treated as a national and international public good instead of a private good and proposes that the government should oversee and fund the clinical trials to stimulate more innovative research and development with lower costs and better information