Intellectual Property Management Strategies to Accelerate the Development and Access of Vaccines and Diagnostics: Case Studies on Pandemic Influenza, Malaria and SARS

Achieving global access to vaccines, diagnostics, and pharmaceuticals remains a challenge. Throughout the developing world, intellectual property (IP) constraints complicate access to critically essential medical technologies and products. Vaccines for malaria and pandemic strains of influenza, as well as diagnostic and vaccine technologies for SARS, are not only relevant to global public health but are particularly critical to the needs of developing countries. A global access solution is urgently needed. This article offers a timely case‐by‐case analysis of preliminary patent landscape surveys and formulates options via patent pools and other forms of creative IP management to accelerate development and access. The analysis of the feasibility of patent pools reveals several impediments to patent pools: these include antitrust considerations, bargaining difficulties caused by asymmetric interests and asymmetric rights among IP holders (e.g. improvement vs. foundational patents), and the difficulties of securing financial support given the significant transaction costs associated with pools. Because of the above conceptual and operational hurdles, patent pools do not appear to be a feasible way to accelerate development. Other mechanisms, however, can ameliorate IP constraints. For example, a key IP constraint related to pandemic influenza vaccines R&D appears to have been resolved when Medimmune secured the assembly of all relevant reverse genetics IP and pledged broad access. Clearly, the landscape is complex and multidimensional. Licensing systems are not the only issue. Measures must also be taken to limit regulatory hurdles and enable the swift, legal production of pandemic influenza vaccines to meet the needs of developing countries. This is why a comprehensive analysis is so necessary. From a strictly legal perspective, IP systems work through the power to exclude. However, as this study’s exploration and formulation of creative licensing strategies reveals, it is also true that IP can be structured and managed to work through the “power to include.

The ‘Facilitator': Proposing a New Mechanism to Strengthen the Equitable and Sustainable Use of Biodiversity

The focus of the Convention on Biological Diversity on conservation, the sustainable use of the greatest possible diversity of biota, and the equitable sharing of the benefits derived therefrom, has broadened the opportunities and responsibilities of a range of entities that are involved with conservation. Countries seeking to market their genetic resources, as well as firms seeking access to these materials, are uncertain as to how to proceed under the new expectations brought about by the Convention, and the excitement stemming from prospecting revenues is having an unfortunate side-effect in emphasizing the perceived newness of this opportunity. The continued emphasis on newness discourages participation until a less risky standard practice emerge

The Intellectual and Technical Property Components of pro-Vitamin A Rice (GoldenRiceTM): A Preliminary Freedom-To-Operate Review

Rice is a staple food for millions of people, predominantly in Asia, but lacks essential nutritional components such as Vitamin A. This is very important for over 180 million children and women of child bearing age who suffer from Vitamin A deficiency in Asia alone. For this reason, an improvement was made under an effort led by Profs. Ingo Potrykus and Peter Beyer by inserting several genes into rice to produce an improved product called GoldenRice. Because GoldenRice has the potential to be easily integrated into the farming systems of the world\u27s poorer regions, the advent of GoldenRice promises to go a long way towards solving Asia\u27s Vitamin A deficiency problem in an effective, inexpensive, and sustainable way. As a result of the increasing complexity of the intellectual property (IP) framework under which the international agricultural development community operates, the Rockefeller Foundation funded an ISAAA project to conduct a selective Freedom-To-Operate (FTO) analysis of GoldenRice with the objectives of reviewing the IP and Technical Property (TP; or tangible property) components associated with GoldenRice; providing institutions interested in distributing GoldenRice with the information needed to develop strategic options for handling the proprietary science embedded in the product; and developing possible alternative strategies on how the IP/TP constraints could be managed effectively. Any FTO opinion is a risk management opinion and its results vary on a country-by-country basis. It is a dynamic opinion; never a definitive answer. Hence the present document serves as an analytical framework that can serve as the basis of a legal FTO review

Intellectual Property Management in Health and Agricultural Innovation: Executive Guide

Prepared by and for policy-makers, leaders of public sector research establishments, technology transfer professionals, licensing executives, and scientists, this online resource offers up-to-date information and strategies for utilizing the power of both intellectual property and the public domain. Emphasis is placed on advancing innovation in health and agriculture, though many of the principles outlined here are broadly applicable across technology fields. Eschewing ideological debates and general proclamations, the authors always keep their eye on the practical side of IP management. The site is based on a comprehensive Handbook and Executive Guide that provide substantive discussions and analysis of the opportunities awaiting anyone in the field who wants to put intellectual property to work. This multi-volume work contains 153 chapters on a full range of IP topics and over 50 case studies, composed by over 200 authors from North, South, East, and West. If you are a policymaker, a senior administrator, a technology transfer manager, or a scientist, we invite you to use the companion site guide available at http://www.iphandbook.org/index.html The site guide distills the key points of each IP topic covered by the Handbook into simple language and places it in the context of evolving best practices specific to your professional role within the overall picture of IP management

Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices, Vol. 1

Prepared by and for policy-makers, leaders of public sector research establishments, technology transfer professionals, licensing executives, and scientists, this online resource offers up-to-date information and strategies for utilizing the power of both intellectual property and the public domain. Emphasis is placed on advancing innovation in health and agriculture, though many of the principles outlined here are broadly applicable across technology fields. Eschewing ideological debates and general proclamations, the authors always keep their eye on the practical side of IP management. The site is based on a comprehensive Handbook and Executive Guide that provide substantive discussions and analysis of the opportunities awaiting anyone in the field who wants to put intellectual property to work. This multi-volume work contains 153 chapters on a full range of IP topics and over 50 case studies, composed by over 200 authors from North, South, East, and West. If you are a policymaker, a senior administrator, a technology transfer manager, or a scientist, we invite you to use the companion site guide available at http://www.iphandbook.org/index.html The site guide distills the key points of each IP topic covered by the Handbook into simple language and places it in the context of evolving best practices specific to your professional role within the overall picture of IP management

Health Innovation Networks to Help Developing Countries Address Neglected Diseases

There is a great unmet need for health technologies to address diseases of the poor in developing countries. At the same time, there is a rapidly growing capability to undertake health innovation in many developing countries (Innovative Developing Countries - IDCs). The more advanced IDCs have the greatest capacity to develop, manufacture, ensure safety, and market new health products and to develop, test and introduce new health policies or strategies. They are distinguished by their rapidly growing strength in health innovation as illustrated by increasing patenting and publishing activities; increasing investments in technology by both the public and private research based sectors; rapidly growing number of health technology companies ; and proactive health systems able to analyze, evaluate and adopt new practices and technologies. This innovation capability provides a currently underleveraged opportunity to accelerate the development of new products, policies or strategies for diseases of the poor. We are therefore calling for the formation of an Initiative for Health Product Innovation in Developing Countries. Its primary mission will be to accelerate the translation of new knowledge into health innovations relevant to the diseases of the poor and to economic growth, taking into account national priorities and sensitivities. The Initiative could promote innovation, within and among IDCs, through programs to: (i) support research on health innovation systems; (ii) promote collaboration and coordination among countries to develop, disseminate and implement good practices and policies; and (iii) implement demonstration projects. Such an Initiative would help maximize existing and growing investments by developing countries in health research, and complement global efforts to address health disparities and achieve the Millennium Development Goals

Agricultural Biotechnology's Complementary Intellectual Assets

We formulate and test a hypothesis to explain the dramatic restructuring experienced recently by the plant breeding and seed industry. The reorganization can be explained in part by the desire to exploit complementarities between intellectual assets needed to create genetically modified organisms. This hypothesis is tested using data on agricultural biotechnology patents, notices for field tests of genetically modified organisms, and firm characteristics. The presence of complementarities is identified with a positive covariance in the unexplained variation of asset holdings. Results indicate that coordination of complementary assets have increased under the consolidation of the industry

A scientist’s perspective: The international arena

We need a good idea to bring about the change needed to make biotechnology flourish and deliver its promise to the world’s citizens at large. Biotechnology is at the heart of the long-term sustainability of our environment, is at the heart of our survival in the long term, and it represents an opportunity today to forge new partnerships for tomorrow