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Abstract:
Global trade and investment have become increasingly liberalized in recent decades. This liberalization has lately been accompanied by substantive new requirements for strong minimum standards of intellectual property (IP) protection, which moves the world economy toward harmonized private rights in knowledge goods. While this trend may have beneficial impacts in terms of innovation and technology diffusion, such impacts would not be evenly distributed across countries. Deep questions also arise about whether such globalization of rights to information will raise roadblocks to the national and international provision of such public goods as environmental protection, public health, education, and scientific advance. This article argues that the globalized IP regime will strongly affect prospects for technology transfer and competition in developing countries. In turn, these nations must determine how to implement such standards in a pro-competitive manner and to foster innovation and competition in their own markets. Developing countries may need to take the lead in policy experimentation and IP innovation in order to offset overly protectionist tendencies in the rich countries and to maintain the supply of global public goods in an emerging system of transnational innovation.

globalization of knowledge, intellectual property rights

Abstract:
The 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 free riding. Yet these same harmonized IP standards sharply curtailed the traditional capacity of suppliers of public goods, such as health care and nutrition, to address 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 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 net benefit 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 improved 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.

Abstract:
The entry into force of the 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 free riding. Yet these same harmonized IP standards sharply curtailed the traditional capacity of suppliers of public goods, such as health care and nutrition, to address 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 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 ¿net benefit¿ 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 medicines production and distribution.

The authors doubt that the international political environment would support renegotiation of an 'improved' 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.

public health, trade, WTO, TRIPS Agreement, pharmaceuticals

Abstract:
The WIPO Copyright Treaty (WCT) recognized the need to maintain a balance between the rights of authors and the larger public interest in updating copyright law in light of advances in information and communications technologies. But the translation of this balance into the domestic laws of the United States and European Union has not been fully successful. In the DMCA, Congress achieved a reasonable balance of competing interests in its creation of safe harbors for internet service providers. However, contrary to its apparent intention, Congress failed to achieve a similar balance of interests when establishing new rules forbidding circumvention of technical protection measures (TPMs) used by copyright owners to control access to and use of their works. The EU Copyright Directive spoke of a commitment to ensuring that certain public interest uses can be made of technically protected works but contains limits that seemingly undermine this commitment. As a result, national implementations of the Copyright Directive have not adequately facilitated public interest uses of technically protected content.

We believe that practical judicial and administrative measures can and should be devised to implement the spirit of the WCT in both the U.S. and EU without reopening the contentious debates that engulfed the process leading up to enactment of the DMCA and the EU Copyright Directive. To this end, we propose adoption of a "reverse notice and takedown" procedure to help achieve some of the balance in anti-circumvention rules that the WCT endorsed, but which implementing legislation has thus far failed to deliver. Under this regime, users would be able to give copyright owners notice of their desire to make public interest uses of technically protected copyrighted works, and rights holders would have the responsibility to take down the TPMs or otherwise enable these lawful uses.

A reverse notice and takedown regime would achieve for the anti-circumvention rules a comparable symmetry with the balance embedded in the ISP safe harbor rules. It would also effectuate the nascent, but not fully realized, legislative intent to permit public interest uses of technically protected digital content, while at the same time protecting copyright owners against circumvention of TPMs that would facilitate or lead to massive infringements. In the U.S., the most likely way to achieve this goal is through judicial interpretation of the anti-circumvention rules through case by case adjudication. In the EU, by contrast, member states could implement a reverse notice and takedown regime in the course of fulfilling their obligations under Article 6(4) of the Copyright Directive, which requires them to ensure that users of technically protected works can exercise certain public interest exceptions. Nations that have yet to implement the WCT may find our proposed reverse notice and takedown regime provides a far more balanced way to comply with the treaty than the approach being promoted by U.S. trade negotiators.

copyright, WIPO, Copyright Directive

Abstract:
Drug discovery is stagnating. Government agencies, industry analysts, and industry scientists have all noted that, despite significant increases in pharmaceutical R&D funding, the production of fundamentally new drugs - particularly drugs that work on new biological pathways and proteins - remains disappointingly low. To some extent, pharmaceutical firms are already embracing the prescription of new, more collaborative R&D organizational models suggested by industry analysts. In this Article, we build on collaborative strategies that firms are already employing by proposing a novel public-private collaboration that would help move upstream academic research across the valley of death that separates upstream research from downstream drug candidates. By exchanging trade secrecy for contract-based collaboration, our proposal would both protect intellectual property rights and enable many more researchers to search for potential drug candidates.

Abstract:
In this Article, we contend that the World Intellectual Property Organization's 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.

patents, harmonization, intellectual property, development, innovation

Abstract:
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.

liability rules, clinical trial, clinical trial data, intellectual property, data exclusivity, pharmaceutical

Abstract:
The different developmental circumstances of the industrialized and developing countries call for different approaches to intellectual property rights protection. While increasingly high levels of protection may (or may not) be appropriate to the industrialized economies, developing country economies are more likely to benefit from strategies and rules which encourage building upon existing stocks of knowledge. TRIPS Agreement standards provide sufficient `wiggle room` to allow developing countries to pursue pro-competitive strategies, while still acting consistently with the TRIPS Agreement requirements of national and most favoured nation treatment. The decision of the WTO Appellate Body in the India-Mailbox case was a critical step in affirming the WTO-consistency of pursuing national and regional policies which take advantage of the absence of strict harmonization of IPRs standards at the worldwide level. The India-Mailbox decision suggests that the WTO will accord substantial deference to national and regional rules which manifest good faith compliance with the basic standards of the TRIPS Agreement. Developing countries that adopt pro-competitive IPRs-related strategies may move faster along the technology curve than countries that follow more protectionist strategies.

Abstract:
In drafting the assent-based paradigm of Article 2 of the U.C.C., Professor Karl Llewelyn established the concept of a "negotiated middle ground" with which to overcome unforeseen difficulties in relational contracts and to preserve the status of the parties over time.

In the emerging information economy, however, the efficiencies of electronic transactions have led the drafters of a proposed model law, the Uniform Computer Information Transactions Act (UCITA), based completely on prior U.C.C. Article 2B proposals, to break with the assent-driven model of contract formation altogether. [Our article, which was written prior to the removal of UCITA from the U.C.C. framework, is no less applicable to UCITA as a stand alone model law.] The goal of the drafters is to promote the growth of a new kind of market in which information goods defined by standard form contracts of adhesion compete with other, similarly defined information products in a perfectly free market.

This project presents an array of new problems whose optimal solutions can only be surmised. That, indeed, is the best reason for preferring a contractual approach which, by proceeding case by case, can gradually reveal the empirical foundations for more refined legislative solutions later on. Yet, little is gained by pretending that the model law merely represents some logical extension of the assent-driven model of contract formation embodied in the provisions of Article 2 concerning sales of goods. Such disingenuous pretensions breed mistrust by appearing to cover up the truth in order to vindicate the exercise of naked market power.

Critics and supporters alike should recognize that UCITA, formerly proposed U.C.C. Article 2B, presupposes a quest for a different kind of contracts model better suited to the information economy. It then becomes possible to consider ways of replacing the "negotiated middle ground" philosophy that underlies Article 2 with a "non-negotiable middle ground" capable of sustaining information transactions rooted in "click-on" and "shrinkwrap" licenses that suffer from a chronic lack of mutual assent. Unlike the tenets of Article 2, however, the philosophical grounding of the model law affects the future development of core sectors of the information-based economy. It must, therefore, mesh with intellectual property laws and policies in a way that suitably accommodates the national system of innovation.

The "public interest unconscionability" doctrine, whose contours we explore in this Article, would facilitate non-negotiable computerized information transactions without allowing content providers to disrupt the upstream operations of a research-based information economy. It would provide incentives from within the governing rules of contracts law for licensors to formulate standard form contracts that avoid undue conflicts with both state and federal intellectual property laws.

Abstract:
The different developmental circumstances of the industrialized and developing countries call for different approaches to intellectual property rights protection. While increasingly high levels of protection may (or may not) be appropriate to the industrialized economies, developing country economies are more likely to benefit from strategies and rules which encourage building upon existing stocks of knowledge. TRIPS Agreement standards provide sufficient 'wiggle room' to allow developing countries to pursue pro-competitive strategies, while still acting consistently with the TRIPS Agreement requirements of national and most favoured nation treatment. The decision of the WTO Appellate Body in the India-Mailbox case was a critical step in affirming the WTO-consistency of pursuing national and regional policies which take advantage of the absence of strict harmonization of IPRs standards at the worldwide level. The India-Mailbox decision suggests that the WTO will accord substantial deference to national and regional rules which manifest good faith compliance with the basic standards of the TRIPS Agreement. Developing countries that adopt pro-competitive IPRs-related strategies may move faster along the technology curve than countries that follow more protectionist strategies.