Public sector IP management in the life sciences: reconciling practice and policy

This chapter reviews the options for effective public sector management of intellectual property (IP) in the life sciences, focusing on the need for a judicious, pragmatic choice of options along two axes: (1) deployment of exclusive rights over technology and (2) use of market mechanisms to bring a new technology to the public. The essence of public sector IP management is finding the right settings along these two axes that will deliver tangible outcomes in line with defined public-interest objectives. Experience shows that ex ante assumptions about how to gain optimal leverage from exclusive rights, and the appropriate degree of reliance on market mechanisms, are unlikely to serve a public sector IP manager well. In clarifying objectives and the practical means of achieving them, pragmatic coordination between the practical and policy levels is essential. Public sector IP managers are more likely to be assessed against public interest expectations than their private sector colleagues. In IP management in the life sciences, policy and practice are ultimately two sides of the same coin; practitioners cannot hope, expect, or plan to operate outside the broader policy perspective. Policy-makers therefore need to consider the actual practice of IP management when assessing a policy framework for innovation in the life sciences. IP managers should be open to using legal mechanisms flexibly for inclusion, or exclusion, as required to achieve their goals. Finally, managers should seek mechanisms to pragmatically structure and promote partnerships with those who have the resources necessary to bring life-sciences innovation to the public. Such partnerships may be centered in the public, philanthropic, or private sectors, but more likely fall into a hybrid mix of these categories.Public Interest Intellectual Property Management, Agricultural Biotechnology, Developing Countries

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 product

The Legal Character and Practical Implementation of a TRIPS Waiver for COVID-19 Vaccines

Almost two years after initial proposals for a COVID-19 waiver of TRIPS obligations, a Ministerial decision adopted at the 12th Ministerial Conference in June 2022 waived obligations under Article 31(f) and the System for pharmaceutical export under the TRIPS Annex, and clarified existing options under TRIPS for increasing access to COVID-19 vaccines. As support for a more expansive pandemic waiver continues and WTO waivers remain legitimate mechanisms under WTO law, further waivers may be contemplated as viable options to address obstacles identified in the current pandemic or future health crises. This article explores what additional options are or may be open to Members under a COVID-19 waiver in its current or proposed forms, and the practical considerations for implementing them. To guide practical choices in selecting appropriate and adapted responses to public health and other crises, this article also investigates more theoretical questions about the nature of a waiver, its legal character and effect, and its interaction with other international agreements

Public sector IP management in the life sciences: reconciling practice and policy

This chapter reviews the options for effective public sector management of intellectual property (IP) in the life sciences, focusing on the need for a judicious, pragmatic choice of options along two axes: (1) deployment of exclusive rights over technology and (2) use of market mechanisms to bring a new technology to the public. The essence of public sector IP management is finding the right settings along these two axes that will deliver tangible outcomes in line with defined public-interest objectives. Experience shows that ex ante assumptions about how to gain optimal leverage from exclusive rights, and the appropriate degree of reliance on market mechanisms, are unlikely to serve a public sector IP manager well. In clarifying objectives and the practical means of achieving them, pragmatic coordination between the practical and policy levels is essential. Public sector IP managers are more likely to be assessed against public interest expectations than their private sector colleagues. In IP management in the life sciences, policy and practice are ultimately two sides of the same coin; practitioners cannot hope, expect, or plan to operate outside the broader policy perspective. Policy-makers therefore need to consider the actual practice of IP management when assessing a policy framework for innovation in the life sciences. IP managers should be open to using legal mechanisms flexibly for inclusion, or exclusion, as required to achieve their goals. Finally, managers should seek mechanisms to pragmatically structure and promote partnerships with those who have the resources necessary to bring life-sciences innovation to the public. Such partnerships may be centered in the public, philanthropic, or private sectors, but more likely fall into a hybrid mix of these categories