The U.S. Culture Collection Network Responding to the Requirements of the Nagoya Protocol on Access and Benefit Sharing.

The U.S. Culture Collection Network held a meeting to share information about how culture collections are responding to the requirements of the recently enacted Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity (CBD). The meeting included representatives of many culture collections and other biological collections, the U.S. Department of State, U.S. Department of Agriculture, Secretariat of the CBD, interested scientific societies, and collection groups, including Scientific Collections International and the Global Genome Biodiversity Network. The participants learned about the policies of the United States and other countries regarding access to genetic resources, the definition of genetic resources, and the status of historical materials and genetic sequence information. Key topics included what constitutes access and how the CBD Access and Benefit-Sharing Clearing-House can help guide researchers through the process of obtaining Prior Informed Consent on Mutually Agreed Terms. U.S. scientists and their international collaborators are required to follow the regulations of other countries when working with microbes originally isolated outside the United States, and the local regulations required by the Nagoya Protocol vary by the country of origin of the genetic resource. Managers of diverse living collections in the United States described their holdings and their efforts to provide access to genetic resources. This meeting laid the foundation for cooperation in establishing a set of standard operating procedures for U.S. and international culture collections in response to the Nagoya Protocol.

Comment: 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 essential 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 demonstratably illegal under WTO foundational law and jurisprudence.

INTELLECTUAL PROPERTY IN THE TWENTY-FIRST CENTURY: WILL THE DEVELOPING COUNTRIES LEAD OR FOLLOW?

Developing countries, particularly the BRIC countries of Brazil, Russia, India, and China, should accommodate their national systems of innovation to the worldwide intellectual property (IP) regime emerging after the adoption of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) in a way that maximizes global economic welfare in the foreseeable future. As many developed countries' experience demonstrates, badly configured, over-protectionist IP regimes stifle innovation by making inputs to future innovation too costly and too cumbersome to sustain over time. More carefully considered IP regimes, however, are an important way to protect innovative small- and medium-sized firms from predatory, larger competitors. The challenge is for emerging economies to capture the benefits of IP without importing the serious problems that developed countries have themselves failed to solve. Emerging economies can attain this balance by pursuing a policy of counter-harmonization in which they take advantage of existing exemptions in international agreements governing IP to establish regional, local, and international practices that promote more innovative, flexible uses of IP. Such practices include a research exemption for experimental uses of IP, government imposed nonexclusive licensing, anti-blocking provisions, an essential facilities doctrine, and compulsory licenses. Additional tools include an ex ante regime of compensatory liability rules for small scale innovation and sensible exceptions, particularly for science as well as general fair use provisions, to the exclusive rights of domestic copyright laws. Emerging economies will have to overcome strong economic pressure to accept more restrictive IP regimes as part of free trade agreements as well as a lack of technical expertise and internal government coordination. However, emerging economies have already accrued enough experience to be aware of the strengths and weaknesses of various IP schemes and their own ability to tailor IP to local needs. Developing countries will need to take advantage of that experience and defend innovative practices at international dispute resolution forums. Through creative, determined efforts, the developing countries can avoid other countries' IP excesses while establishing the kind of IP norms that address the real conditions of creativity and innovation in today's digitally empowered universe of scientific discourse.

RETHINKING THE ROLE OF CLINICAL TRIAL DATA IN INTERNATIONAL INTELLECTUAL PROPERTY LAW: THE CASE FOR A PUBLIC GOODS APPROACH.

This article describes the growth and consequences of new intellectual property rights given to pharmaceutical developers, and it advocates treating clinical trials as a public good. Although the soaring cost of clinical trials is well known and discussed, too little attention is given to the underlying rationale for allowing drug developers to recoup their costs through the new intellectual property rights provided in multilateral, regional, and bilateral agreements. Known in the US as "market exclusivity" and in Europe as "data exclusivity," these rights prohibit would-be generic producers from obtaining regulatory approval based on the original producers' undisclosed test data. Market and data exclusivity is codified in US and European domestic law as well as the North American Free Trade Agreement (NAFTA) and, to a lesser degree, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Market and data exclusivity is binding an increasing number of developing countries via Free Trade Agreements (FTAs), which hinder developing countries from manufacturing generic drugs. At a minimum, negotiators should replace the norm of exclusive control over data with a liability rule, or take and pay rule, in which generic manufacturers can use original manufacturers' clinical trial data in exchange for reasonable compensation. A more fundamental solution requires questioning the status quo of proprietary clinical trial data. The conventional wisdom is that market and data exclusivity, and drug developers' consequent ability to limit competition from generics above and beyond patent protection, are a necessary incentive for drug developers to fund ever more expensive clinical trials. Clinical trial data, however, are public goods that will be undersupplied and over protected so long as private actors provide them. Moreover, manufacturers have an incentive to present clinical trial data so that they support regulatory approval at the expense of public health. Although liability rules are better than the status quo, they would not resolve the problem of treating a public good as proprietary. Governments should thus oversee and fund clinical trials as the public good that they are. Clinical tests should be awarded to the most qualified scientists through a competitive process, financed in part with the decrease in drug costs to governmental health care programs and in part with drug developers' contributions, selected to maximize social benefit, and made global via intergovernmental bodies to maximize social return. This would reduce the cost of redundant investigations to the global public health system, lower supply costs to drug consumers, and lower the breakeven point for investment in research to discover new drugs.