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 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.

Patent Information, Freedom to Operate and “Global Access”: A Case Study of Dengue Vaccines Under Development

This Global Challenges Report1 presents a “global access” freedom to operate (FTO) analysis2 of six vaccines under development against dengue hemorrhagic fever (hereinafter referred to as “dengue”), a Neglected Tropical Disease (NTD)3 endemic to tropical regions. Developing a vaccine against dengue is challenging because there are four closely related viruses that can cause the disease. Several vaccines are in various stages of development, including by developing country institutions from both the public and private sector. Clinical trials are underway on five candidate vaccines with encouraging results. After an extended executive summary (Section 1) and an introduction and description of the methodology (Section 2), the report reviews the scientific basis of the various vaccines under development (Section 3). A successful vaccine should immunize against all four types, and substantial progress towards the development of such a vaccine has been made in the last decade. The range of vaccines under development include live attenuated vaccines, live chimeric virus vaccines and live recombinant, DNA and subunit vaccines. Each type comes with its own unique challenges and benefits, though live attenuated vaccines have been the most successful to date4. Section 4 presents the patent situation relating to six of the dengue vaccines under development. Some 10,800 patents and patent applications were found to have “dengue” in the abstract, title, text or claims, corresponding to 4,500 patent families. Of these, 700 families were found to be outside the scope. Of the remaining 3,800 patent families, 55 patents or patent families were deemed pertinent to the six vaccines discussed in this report. The number of patent families related to a given vaccine ranged from five to 22. Most of these were filed in developed countries with only a small number also filed in select developing countries. Each of the patent groups occupied a well-defined space in the patent landscape, with little overlap in the specific technological field. This finding has important implications for IP management strategies in that few, if any, cross-licensing deals may be required to bring any given vaccine to market. This aspect is further discussed in Section 5 on the licensing status of the vaccines under development. The results of this “global access” FTO suggest that there are few major constraints related to patents that could complicate developing-country access to the vaccines under development. It should be noted that the analysis is limited to patent data and licensing information. Market considerations such as economies of scale, pricing and regulatory approval, or efficacy of the vaccine itself, are beyond its scope. Notwithstanding the relatively few patents applied for or issued in developing countries, an effective transfer of productive capacity of any of the vaccines to developing countries would require consideration of additional elements beyond patent data. Those include regulatory requirements, issues relating to know-how, and possible access to materials, such as cell lines. The report, nevertheless, identifies the state of product development, identifies key players, and the patent and licensing status, which together facilitate the development of effective strategies, including collaborations, as appropriate. These should enable early product deployment in areas where dengue most affects people’s lives and thus lead to accelerated access to dengue vaccines by those most in need. This report provides an informal guide for those wishing to better understand the important interplay of intellectual property (IP) with product development, manufacture and delivery (viz. access). It can be seen as an example of using patent information to address major global challenges, including access to medicines, and thus contribute to informed policy discussions, strategic research planning and technology transfer, and in that way, benefit humanity

Interface reduction for Hurty/Craig-Bampton substructured models: Review and improvements

The Hurty/Craig-Bampton method in structural dynamics represents the interior dynamics of each subcomponent in a substructured system with a truncated set of normal modes and retains all of the physical degrees of freedom at the substructure interfaces. This makes the assembly of substructures into a reduced-order system model relatively simple, but means that the reduced-order assembly will have as many interface degrees of freedom as the full model. When the full-model mesh is highly refined, and/or when the system is divided into many subcomponents, this can lead to an unacceptably large system of equations of motion. To overcome this, interface reduction methods aim to reduce the size of the Hurty/Craig-Bampton model by reducing the number of interface degrees of freedom. This research presents a survey of interface reduction methods for Hurty/Craig-Bampton models, and proposes improvements and generalizations to some of the methods. Some of these interface reductions operate on the assembled system-level matrices while others perform reduction locally by considering the uncoupled substructures. The advantages and disadvantages of these methods are highlighted and assessed through comparisons of results obtained from a variety of representative linear FE models.Accepted Author ManuscriptShip Hydromechanics and StructuresDynamics of Micro and Nano System