Harmonization Without Consensus: Critical Reflections on Drafting a Substantive Patent Law Treaty

In this Article, we contend that the World Intellectual Property Organization\u27s proposed Substantive Patent Law Treaty (SPLT) is premature. Developing countries are struggling to adjust to the heightened standards of intellectual property protection required by the TRIPS Agreement of 1994. With TRIPS, at least, these countries obtained side payments (in the form of trade concessions) to offset the rising costs of knowledge products. A free-standing instrument, such as the SPLT, would shrink the remaining flexibilities in the TRIPS Agreement with no side payments and no concessions to the catch-up strategies of developing countries at different stages of technological advancement. More controversially, we argue that a deep harmonization would boomerang against even its developed country promoters by creating more problems than it would solve. There is no vision of a properly functioning patent system for the developed world that commands even the appearance of a consensus. The evidence shows, instead, that the worldwide intellectual property system has entered a brave new scientific epoch, in which experts have only tentative, divergent ideas about how best to treat a daunting array of new technologies. The proposals for reconciling the needs of different sectors, such as information technology and biotechnology, pose hard, unresolved issues at a time when the costs of litigation are rising at the expense of profits from innovation. These difficulties are compounded by the tendency of universities to push patenting up stream, generating new rights to core methodologies and research tools. As new approaches to new technologies emerge in different jurisdictions, there is a need to gather empirical evidence to determine which, if any, of these still experimental solutions are preferable over time. Our argument need not foreclose other less intrusive options and measures surveyed in the Article that can reduce the costs of delaying harmonization. However, the international community should not rush to freeze legal obligations regarding the protection of intellectual property. It should wait until economists and policymakers better understand the dynamics of innovation and the role that patent rights play in promoting progress and until there are mechanisms in place to keep international obligations responsive to developments in science, technology, and the organization of the creative community

The Bellagio Global Dialogues on Intellectual Property

Reviews Rockefeller's conference series on intellectual property and its efforts to promote policies and institutional capacities that better serve the poor, with a focus on food security and public health. Discusses global policy, development, and trade

An Economic Model for Bioprospecting Contracts

This paper explores the use of a micro-economic model to analyse the provisions and parties of bioprospecting contracts. It focuses on the pharmaceutical industry as the representative biodiversity buyer, presenting an original theoretical framework that explains the main contract characteristics or stylised facts. Against this background, it considers the main contractors involved in these private contracts, i.e. biodiversity sellers and biodiversity buyers, analysing both the magnitude and distribution of the respective payoffs. Particular attention is devoted to the different, mixed impacts of bioprospecting contracts and patenting on social welfare. The positive welfare impacts delivered by bioprospecting contracts are associated with the potential discovery of a new drug product, i.e. productivity gains, non-monetary benefit-sharing or transfers and royalty revenues. The negative welfare impact results from the legal creation of a monopoly and the related well-known effect on the consumer surplus. Finally, the potential redistribution effects are limited, and a potential enforcement of this objective may jeopardise the desirability of the contracts since this action would lead to a significant increase in the transaction costs.Bioprospecting Contract, Genetic Resource, Biodiversity Buyer, Biodiversity Seller, Patenting, Welfare Analysis, Benefit Sharing

Patent First, Litigate Later! The Scramble for Speculative and Overly Broad Genetic Patents: Implications for Access to Health Care and Biomedical Research

This paper will not directly address the ethical considerations of allowing patents on human genetic sequences, although this continues to be a controversial debate in itself. Rather, the aim is to consider the legality of such gene patents and the effects such patents have on biomedical research and health care delivery in definitive terms through an analysis of current developments and research relating to the subject. The operation of current intellectual property regimes regulating such patents will be examined, and amendments to these legal systems will be considered. An emphasis will be placed on identifying practical concerns rather than broad, general issues that do not directly address practical implications. In concluding our analysis, we propose a set of policy options which the patent system and public institutions may pursue to mitigate the excesses of an exuberant and liberal patent system

Patent First, Litigate Later! The Scramble for Speculative and Overly Broad Genetic Patents: Implications for Access to Health Care and Biomedical Research

This paper will not directly address the ethical considerations of allowing patents on human genetic sequences, although this continues to be a controversial debate in itself. Rather, the aim is to consider the legality of such gene patents and the effects such patents have on biomedical research and health care delivery in definitive terms through an analysis of current developments and research relating to the subject. The operation of current intellectual property regimes regulating such patents will be examined, and amendments to these legal systems will be considered. An emphasis will be placed on identifying practical concerns rather than broad, general issues that do not directly address practical implications. In concluding our analysis, we propose a set of policy options which the patent system and public institutions may pursue to mitigate the excesses of an exuberant and liberal patent system

The Forgotten Victim in the Human Gene Patenting Debate: Pharmaceutical Companies

Scientific innovation is crucial to the prosperity, security, and health of a nation. During the founding years of the United States, political leaders realized the need for such innovation and created the patent law system 2 as a means of protecting American citizens. The major goals of the United States patent law system are to provide the public with cutting-edge scientific discoveries and to enlighten the public as to how these discoveries can benefit society. In modern America, a substantial amount of patent protection is sought for inventions relating to the pharmaceutical industry. In recent decades, the pharmaceutical industry has expanded rapidly as researchers invent new and more effective drugs and products. The average life expectancy and quality of life of United States citizens has drastically increased in the past century, largely due to pharmaceutical innovation. Nonetheless, nearly sixty million people die each year, with many of these deaths caused by problems that pharmaceutical companies are striving to cure. In the late 1970s, scientific researchers began to view genetic material as a means of developing treatment options for a variety of human diseases. Today, approximately two-thirds of the new drugs that hit the market have been influenced by genetic research, and genetic material has been linked to more than 850 human diseases. Additionally, biotechnology investors have indicated-with their pocketbooks-that they believe that the future of disease prevention and treatment is tied to genetic research. Despite the fact that pharmaceutical companies have invested billions of dollars for development of gene-related cures and treatments for human illnesses, the general public and the United States District Court for the Southern District of New York wish to rein in the intellectual property rights afforded to these companies. Furthermore, the United States Court of Appeals for the Federal Circuit (C.A.F.C.) is divided in regard to DNA patentability and has indicated that any change to DNA-patenting policy would be most effectively propagated legislatively. In our society, there is a large disconnect between the supposed interests of the public and the pharmaceutical industry. In general, the public desires medical innovation but prefers to benefit from these medical advances at minimal cost. Meanwhile, the pharmaceutical industry is merely a business, and businesses are built on profit maximization. Because the pharmaceutical business is premised on seemingly altruistic purposes, the industry is an easy target for individuals who cannot afford its services. Due to the nature of the pharmaceutical industry, profit maximization benefits the general public. Therefore, decreasing pharmaceutical company profits necessarily has the unintended side effect of decreasing public health benefits. This complicated equilibrium has been convoluted further by the district court ruling, and the subsequent divided C.A.F.C. ruling, in the recent Myriad case. This Note will explore the seemingly contradictory interests of the general public, the pharmaceutical industry, and the research community regarding human gene patents. Part I will look at the recent Myriad decisions in light of previous beliefs about the patentability of genetic material. Part II will examine the effect of gene patenting on scientific research and innovation. Parts III and IV will explore the effect of gene patents on both the general public and the pharmaceutical industry, and will seek to understand the belief dissonance between these two factions. Part V will consider how Congress has handled similar problems in the past through legislation, specifically in regards to plant patents and biological drugs. Part VI will discuss the possibility of finding a solution to the gene patent problem that satisfies the research community, the general public, and the pharmaceutical industry. Ultimately, this Note will analyze the success of prior legislation in order to propose a course of action that will appease all parties involved in the human gene patenting debate

The Human Genome: A Patenting Dilemma

This Comment will address the conflict between the U.S. patent laws and biotechnology by focusing on the NIH patent application. The first part of this Comment discusses the objectives and statutory requirements of the patent system, which the NIH application purportedly did not meet. Next, this Comment focuses on the debate between NIH and its detractors. It explains NIH\u27s reasons for its actions and discusses the criticisms leveled at the agency. Finally, this Comment presents solutions to the problems that have been uncovered by this debate regarding the patentability of genes

The Forgotten Victim in the Human Gene Patenting Debate: Pharmaceutical Companies

Scientific innovation is crucial to the prosperity, security, and health of a nation. During the founding years of the United States, political leaders realized the need for such innovation and created the patent law system 2 as a means of protecting American citizens. The major goals of the United States patent law system are to provide the public with cutting-edge scientific discoveries and to enlighten the public as to how these discoveries can benefit society. In modern America, a substantial amount of patent protection is sought for inventions relating to the pharmaceutical industry. In recent decades, the pharmaceutical industry has expanded rapidly as researchers invent new and more effective drugs and products. The average life expectancy and quality of life of United States citizens has drastically increased in the past century, largely due to pharmaceutical innovation. Nonetheless, nearly sixty million people die each year, with many of these deaths caused by problems that pharmaceutical companies are striving to cure. In the late 1970s, scientific researchers began to view genetic material as a means of developing treatment options for a variety of human diseases. Today, approximately two-thirds of the new drugs that hit the market have been influenced by genetic research, and genetic material has been linked to more than 850 human diseases. Additionally, biotechnology investors have indicated-with their pocketbooks-that they believe that the future of disease prevention and treatment is tied to genetic research. Despite the fact that pharmaceutical companies have invested billions of dollars for development of gene-related cures and treatments for human illnesses, the general public and the United States District Court for the Southern District of New York wish to rein in the intellectual property rights afforded to these companies. Furthermore, the United States Court of Appeals for the Federal Circuit (C.A.F.C.) is divided in regard to DNA patentability and has indicated that any change to DNA-patenting policy would be most effectively propagated legislatively. In our society, there is a large disconnect between the supposed interests of the public and the pharmaceutical industry. In general, the public desires medical innovation but prefers to benefit from these medical advances at minimal cost. Meanwhile, the pharmaceutical industry is merely a business, and businesses are built on profit maximization. Because the pharmaceutical business is premised on seemingly altruistic purposes, the industry is an easy target for individuals who cannot afford its services. Due to the nature of the pharmaceutical industry, profit maximization benefits the general public. Therefore, decreasing pharmaceutical company profits necessarily has the unintended side effect of decreasing public health benefits. This complicated equilibrium has been convoluted further by the district court ruling, and the subsequent divided C.A.F.C. ruling, in the recent Myriad case. This Note will explore the seemingly contradictory interests of the general public, the pharmaceutical industry, and the research community regarding human gene patents. Part I will look at the recent Myriad decisions in light of previous beliefs about the patentability of genetic material. Part II will examine the effect of gene patenting on scientific research and innovation. Parts III and IV will explore the effect of gene patents on both the general public and the pharmaceutical industry, and will seek to understand the belief dissonance between these two factions. Part V will consider how Congress has handled similar problems in the past through legislation, specifically in regards to plant patents and biological drugs. Part VI will discuss the possibility of finding a solution to the gene patent problem that satisfies the research community, the general public, and the pharmaceutical industry. Ultimately, this Note will analyze the success of prior legislation in order to propose a course of action that will appease all parties involved in the human gene patenting debate

Patent First, Litigate Later! The Scramble for Speculative and Overly Broad Genetic Patents: Implications for Access to Health Care and Biomedical Research

One of the theoretical premises of the patent system is that it enhances the dissemination of valuable information by assuring creators of new inventions a limited monopoly for the exploitation of their inventions. As a tool of state policy, the patent system seeks to catalyze the industrialization of the state, disclosure of information by inventors, and ultimately, the enrichment of the public domain in a manner that benefits both the inventor and the Society. Consequently, the patent system is often characterized as a form of contract between the inventor and the state. As a consideration for disclosing the secret of the invention, so this theory says, the state grants the inventor limited monopoly over the use of the invention. The implicit assumption in this Simplified theoretical construction of a complex system is that the inventor and the society benefits mutually from the bargain