A New World Order for Addressing Patent Rights and Public Health

Can patent rights and public health coexist? This is a pressing global question in an era where the AIDS pandemic rages in countries that cannot afford to pay for the most effective—and patent-protected—AIDS treatment. Even in countries with higher levels of income, patent problems may nonetheless loom large in unanticipated situations that could turn deadly without access to patented drugs, such as the 2001 anthrax crisis or the potential avian flu epidemic. This article provides an important perspective on how international laws currently impact the intersection between patent rights and public health. This article begins with an explanation of patent requirements under TRIPS that most countries must abide by (as WTO members) regardless of their national commitments to public health. The recent compulsory licenses in Thailand and Brazil are used as illustrations of some of the TRIPS requirements, as well as what issues receive the most controversy. The article also highlights terms in subsequent TRIPS-plus agreements that may further impede access to public health. The last part provides an overview of recent international and national actions that respond to TRIPS-plus agreements. International discussions within the WIPO and WHO forum are discussed, as new proposals, including the proposed treaty for Access to Knowledge ( A2K ) and a Research and Development Treaty. India\u27s unique approach to limiting patentability to foster public health is also highlighted as an illustration of how nations may comply with TRIPS without sacrificing concern for public health. Finally, technological solutions to address the balance are also considered

Biopiracy and Beyond: A Consideration of Socio-Cultural Conflicts with Global Patent Policies

This Article provides afresh and multi-dimensioned approach to a long-standing claim of biopiracy patents made by developing countries and communities. The basic principles of patent law and policy are first established to provide a foundation from which to evaluate the claim that genetic resources and traditional knowledge from developing countries are being misappropriated in a variety of ways that are loosely referred to as biopiracy. The Article distinguishes rhetoric from reality in examining biopiracy allegations from the perspective of national patent laws, as well as international agreements. In addition, the Article explains the underlying conflicts, misconceptions, and historical biases that have predisposed some to biopiracy claims. Similarly, the Article presents a new perspective on how the present landscape of international agreements, as well as negotiation stances, has failed to lead to satisfactory resolution of biopiracy claims despite years of heated discussion within major international forums, including the World Trade Organization, the United Nations, and the Convention on Biological Diversity. In addition to explaining the dynamics behind the current stalemate, this Article provides a template for moving forward. As a first step, the Article advocates that the piracy lingo be jettisoned and that substantive discussion instead focus on issues that have mutual appeal to all countries. Drawing upon past success of issue-framing in the context of the access to medicine debate, this Article proposes new foci that nations might universally agree on. For example, this Article suggests a novel linkage between biopiracy patents and more general problems within Western patent law to help focus on issues of interest to all nations. In addition the Article proposes a new internet-based process for promoting meaningFul dialogue that will likely be more effective than current proposals because it avoids previous intransigent issues. This final proposal has broad application to many issues at the intersection of patent law and social policy, ranging from the proper scope of patentable subject matter, to the scope of exceptions from patent liability

Splicing Morality and Patent Law: Issues Arising from Mixing Mice and Men

This Article seeks to advance the discussion of the proper role of ethics and morality in the United States patent system by examining existing models of incorporating ethics into the context of patentability

Reexamining Eli Lilly v. Canada: A Human Rights Approach to Investor-State Disputes

This Article provides valuable insight to the broader discussion of reforming investor-state disputes. Many have noted that the system is in a crisis due to a lack of democratic accountability and inconsistent decisions, which create a chilling effect on legitimate domestic law and policy. Despite substantial discussion in recent years concerning how to reform investor-state disputes, there is only limited discussion concerning the extent to which such disputes challenge domestic intellectual property (IP) limits, as well as global IP norms. Moreover, even among those who recognize the challenge to IP limits, the relevance of human rights is generally not addressed. This Article begins to fill this gap from two angles. First, it aims to promote a better understanding of how such disputes undermine the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) at an important time when policymakers are recommending reliance on policy space under TRIPS. Second, it considers whether human rights might help to protect this policy space using the facts of Eli Lilly v. Canada

Drugged Out: How Cognitive Bias Hurts Drug Innovation

This Article hopes to provide a balanced picture of how current patent law and policy promotes mostly modest, yet high priced new drugs, as well as how cognitive biases have perpetuated this situation. This Article highlights the important interplay of cognitive biases not only by the frequently maligned industry but also previously presumed neutral parties, such as academics and policymakers. Most scholars would likely agree that considering how to optimize or at least not distort innovation is an important part of legal scholarship. However, to date, there has been little recognition, let alone robust discussion, of how patent and related laws promote problematic innovation of drugs, resulting in a situation where society is “drugged out” of necessary therapies. Although some scholars and policymakers have recognized that pharmaceutical innovation is mostly incremental, such recognition has thus far focused on proposing solutions outside the patent arena with no challenges to the fundamental patent law dialogue. This Article hopes to provide a first step toward doing so

Splicing Morality and Patent Law: Issues Arising from Mixing Mice and Men

This Article seeks to advance the discussion of the proper role of ethics and morality in the United States patent system by examining existing models of incorporating ethics into the context of patentability