Golden Rice: A Case Study in Intellectual Property Management and International Capacity Building

In order for agricultural biotechnology (agri-biotech) to play a larger role in the development of sustainable agricultural systems, intellectual property (IP) rights management must be addressed. These issues are not limited to developing countries. With increased globalization, the management of agri-biotech IP rights affects both developing and industrialized countries. In industrialized countries, for example, IP rights risk management entails protection of inventions via strong patent portfolios. For developing countries, IP rights risk management includes the acquisition of rights requisite for the use of inventions essential to the basic welfare of the population. Strategies are needed to bridge these disparate IP management paradigms to facilitate the successful transfer of the agri-biotech from an industrialized country source to a developing country recipient. This paper examines IP management linked to agri-biotech products. Further, this paper examines Golden Rice, a genetically engineered rice strain that accumulates beta-carotene (i.e., pro-vitamin A) in the endosperm tissue of grain, as a case study for IP management, with emphasis on the international movement of agri-biotech from industrialized to developing countries. Topics discussed include: the application of agri-biotech to international development; the challenge of transferring this technology from industrialized to developing countries; a method for evaluating the IP constraints impinging on the deployment of Golden Rice; industrialized/developing country perspectives vis-a-vis IP rights management; six shorter-term options for the management of IP connected to Golden Rice; and a longer-term proposed path to sustainable transfers of agri-biotech products

Golden Rice: A Case Study in Intellectual Property Management and International Capacity Building

The authors examine the management of risks associated with intellectual property linked to agri-biotech products, with emphasis on the international movement of agri-biotech intellectual property from industrialized to developing nations

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

Transgenic Crops, Biotechnology and Ownership Rights: What Scientists Need to Know

Ownership of intellectual and tangible property (IP/TP) rights in agricultural biotechnology (ag‐biotech) and transgenic plants has become critically important. For scientists in all institutions, whether industrialized or developing country, public or private sector, an understanding of IP/TP rights is fundamental in both research and development. Transgenic plants and ag‐biotech products embody numerous components and processes, each of which may have IP/TP rights attached. To identify these rights, a transgenic plant or ag‐biotech product must be dissected into its essential components and processes, with each ‘piece’ analysed under the IP/TP ‘microscope’. This product deconstruction is an integral step in product clearance (PC) analysis leading to freedom to operate (FTO). To facilitate a PC analysis, the following points are important: (1) knowing what one has and where it\u27s from, (2) organizing material transfer agreements and licences, (3) researching scientific and patent databases and relevant literature, (4) instituting a laboratory notebook policy, (5) keeping track of ownership of germplasm and plant genetic resources, and (6) promoting ongoing IP/TP management, awareness and training. However, a FTO opinion does not solve the IP/TP issues of releasing a transgenic plant or ag‐biotech product; rather, it is a management tool for assessing the risks of litigation. When transferring transgenic plants or ag‐biotech to developing nations, scientists from industrialized countries have the heightened responsibility of verifying that IP/TP issues are fully addressed and documented. Successful technology transfer goes beyond research, development and licensing; it is an holistic package leading to long‐term partnerships in international development. Managing IP/TP requires capacity‐building in scientists and technology transfer offices, in both industrialized and developing countries