A typology of intellectual property management for public health innovation and access: design considerations for policymakers.

This paper seeks to set the practical discipline of public interest intellectual property (IP) management in public health into its broader policy context. The most immediate and direct impact of IP systems on public welfare results not from international standards nor from national legislation - though these norms are fundamentally important - but rather from the accumulated impact of numerous practical choices whether or not to seek IP protection; where and where not; and how any exclusive rights are deployed, by whom, and to what end. IP management is the essentially practical exercise of limited exclusive rights over protected subject matter, the judicious use of those rights to leverage outcomes that advance an institution's or a firm's objectives. Exclusive rights are used to construct and define knowledge-based relationships, to leverage access to technology and other necessary resources, and to enhance market-based incentives. IP management choices range across a broad spectrum, spanning public domain strategies, open or exclusive licensing, and strong exclusivity. The idea of 'exclusive rights', as a specific legal mechanism, can run counter to expectations of greater openness and accessibility, but actual outcomes will depend very much on how these mechanisms are used in practice. For public interest or public sector institutions concerned with health research and development, particularly the development of new medicines, IP management choices can be just as critical as they are for private firms, although a predominant institutional concentration on advancing direct public interest objectives may lead to significantly different approaches in weighing and exercising practical choices for IP management: even so, a private sector approach should not be conflated with exclusivity as an end in itself, nor need public interest IP management eschew all leverage over IP. This paper offers a tentative framework for a richer typology of those choices, to give a sense of practical options available and the factors that might guide their application, but without advocating any particular approach.

The international patent system and biomedical research: reconciling aspiration, policy and practice.

This article reviews how the international environment shapes international patent law and practice with bearing on biomedical innovation. The cluster of issues is encapsulated in two core paradoxes. The first concerns how public goods, such as new pharmaceuticals, may be produced through the deliberate creation of private rights that exclude material from the public domain. The second paradox concerns how "technological neutrality" and overall policy balance in the application of general patent law principles requires technology-specific interventions by regulators. The article illustrates how centrifugal and centripetal trends influence diverse national approaches to applying patentability criteria for pharmaceutical products.