The use of biological methods (often genetic engineering and related advanced-molecular-biology applications) to produce products, processes, and related services. Generally, these are patentable under U.S. patent law.
freedom to operate (close)
The ability to undertake research and/or commercial development of a product without infringing the unlicensed intellectual or tangible property rights of others.
intellectual property (IP) (close)
Creative ideas and expressions of the human mind that have commercial value and are entitled to the legal protection of a property right. The major legal mechanisms for protecting intellectual property are copyrights, patents, and trademarks. IP rights enable owners to select who may access and use their intellectual property and to protect it from unauthorized use.
Information that enables a person to accomplish a particular task or to operate a particular device or process. Refer to trade secret.
A grant of permission to use an IP right within a defined time, context, market line, or territory. There are important distinctions between exclusive licenses and nonexclusive licenses. An exclusive license is “exclusive” as to a defined scope, that is, the license might not be the only license granted for a particular IP asset, as there might be many possible fields and scopes of use that can also be subject to exclusive licensing. In giving an exclusive license, the licensor promises that he or she will not grant other licenses of the same rights within the same scope or field covered by the exclusive license. The owner of IP rights may also grant any number of nonexclusive licenses covering rights within a defined scope. A patent license is a transfer of rights that does not amount to an assignment of the patent. A trademark or service mark can be validly licensed only if the licensor controls the nature and quality of the goods or services sold by the licensee under the licensed mark. Under copyright law, an exclusive licensee is the owner of a particular right of copyright, and he or she may sue for infringement of the licensed right. There is never more than a single copyright in a work regardless of the owner’s exclusive license of various rights to different persons.
patent (U.S.) (close)
A grant by the federal government to an inventor of the right to exclude others from making, using, or selling his or her invention. There are three kinds of patents in the United States: a standard utility patent on the functional aspects of products and processes; a design patent on the ornamental design of useful objects; and a plant patent on a new variety of a living plant. Patents do not protect ideas, only structures and methods that apply technological concepts. Each type of patent confers the right to exclude others from a precisely defined scope of technology, industrial design, or plant variety. In return for the right to exclude, an inventor must fully disclose the details of the invention to the public so that others can understand it and use it to further develop the technology. Once the patent expires, the public is entitled to make and use the invention and is entitled to a full and complete disclosure of how to do so.
research tools (close)
The term research tool includes the full range of tools that scientists may use in the laboratory, including cell lines, monoclonal antibodies, reagents, animal models, growth factors, combinatorial chemistry and DNA libraries, clones and cloning tools (such as PCR), methods, and laboratory equipment and machines. There is concern about the patenting of research tools, because such patents may inhibit the free undertaking of research.
Your source for expert commentary on IP management issues.
Krattiger A and I Potrykus. 2007. Golden Rice: A Product-Development Partnership in Agricultural Biotechnology and Humanitarian Licensing. In Executive Guide to Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices (Krattiger A, RT Mahoney, L Nelsen et al.). MIHR (Oxford, UK), PIPRA (Davis, USA), Oswaldo Cruz Foundation (Fiocruz, Rio de Janeiro, Brazil), and bioDevelopments-International Institute (Ithaca, USA). Available online at www.ipHandbook.org.
© 2007. A Krattiger and I Potrykus. Sharing the Art of IP Management: Photocopying and distribution through the Internet for noncommercial purposes is permitted and encouraged.
Golden Rice: A Product-Development Partnership in Agricultural Biotechnology and Humanitarian Licensing
IP (intellectual property) constraints are often perceived as barriers to market entry, especially when it comes to developing countries. This case study examines the IP management component in the development of Golden Rice1 (or beta-carotene-containing rice) and the transfer and introduction of Golden Rice to developing countries.
Rice, one of the most widely grown food crops, contains neither vitamin A nor beta-carotene, yet it is a staple food crop for billions of people, especially in Asia. Here, and in other developing countries, vita-min A deficiency (VAD) is a major problem affecting primarily children under age five and pregnant and lactating women. Thousands of impoverished people lose their eyesight because of VAD. Severe VAD (xerophthalmia, or night blindness) leads to permanent blindness: 500,000 people, 250,000 of them children, lose their sight every year due to VAD.2 The deficiency also leads to a depressed immune system that increases the incidence and severity of infectious diseases and infant mortality rates.
There are several avenues for mitigating VAD, including programs to fortify food with vitamin A and beta-carotene and to distribute vitamin A supplements to affected populations. For the supplement distribution, more than US$100 million are spent every year. An alternative, and complementary, approach is to insert relevant genes in rice. This allows farmers to grow beta-carotene-rich rice. By enhancing those varieties primarily grown or consumed by poor people, beta-carotene can be delivered at essentially no cost once the Golden Rice has been developed and bred into local varieties.
Interestingly, rice plants synthesize beta-carotene in foliage and other parts of the plant, but not in the grain, and all but two steps of the biosynthetic pathway are present in the grain. By the addition of only two genes, phytoene synthase (psy) and phytoene desaturase (crt I), the pathway is reconstituted and beta-carotene accumulates in the endosperm (the endosperm being the edible part of the grain).3
Intellectual Property Features of The Case
The development of Golden Rice led to a significant change in the relationship between the public sector and intellectual property. A freedom to operate (FTO) review of pro-Vitamin A-containing Golden Rice was commissioned by the International Rice Research Institute, a center of the Consultative Group on International Agricultural Research (CGIAR), with funding from the Rockefeller Foundation (led by one of us [AK]). The review showed that about 70 patents and patent applications were applicable to the improved rice when all patents issued in or applied for in all countries, including patents on commercially accessed research tools, were considered.4 The published analysis also showed, in accordance with analysis by Zeneca (which later merged with Novartis to form Syngenta) that, in practice, only a few, if any, patents pertaining to Golden Rice were applicable in developing countries, together with a few material transfer agreements.
Obtaining Freedom to Operate
Fortunately, these potential—and arguably perceived— constraints were resolved in a few months in the year 2000 by a straightforward IP management strategy comprising four goals:
The patented key technologies for Golden Rice production include core patents related to the specific biosynthetic pathway. These patents were filed by the inventors, Potrykus and Beyer. Their work built on myriad other technologies that were published in issued patent documents and scientific literature. These core patents were licensed to Zeneca, which already owned its own plant-biotechnology-related patents. Zeneca then negotiated access to all possibly necessary patents, including intellectual property from Bayer AG, MonsantoCompany, Novartis AG, Orynova BV, and Zeneca Mogen BV.
All of these companies, including Zeneca (which, coincidentally, almost immediately merged with Novartis Agribusiness to form Syngenta), provided access to their technologies, free of charge, for defined humanitarian research and use of Golden Rice in developing countries. It is important to note that, contrary to what many commentators state, the licensing process was relatively uncomplicated, with the involvement of commercially experienced people.
Within a short time, 16 further licenses, including licenses with the right to further sublicense (for example, the license issued to IRRI), were issued to public sector licensees. Thus national programs in Bangladesh, China, India, Indonesia, the Philippines, South Africa, and Vietnam obtained licenses for use of the technology in local rice varieties important in VAD areas.
Terms of the humanitarian license agreement
The Golden Rice Humanitarian Board, although not a legal entity, provides a forum for discussion of strategic and tactical issues relating to the humanitarian project. Both Potrykus and Beyer have the right to issue licenses. Two licensees also have that right, as does Syngenta, which has not exercised its right. All the licenses are in the same form, as proposed by Syngenta and agreed to by the inventors.
The essential elements of the licenses include the following points:
Key Lessons Learned
The rapid resolution of the IP constraints surrounding Golden Rice demonstrated, first of all, how effective IP management, coupled with strong collaborations between the public and private sectors, can help achieve global access to new technologies and products for humanitarian goals. The IP constraints identified by Kryder and colleagues6 did not delay the development of the product, and their clarification and resolution required only managerial and influencing skills and the resulting goodwill of IP owners.
More specifically, three specific lessons have been learned:
From a broader perspective, the FTO review of Golden Rice, in particular before “commercial analysis,” served as a wake-up call to the public sector to pay more attention to IP management as a powerful tool for meeting public sector goals. Concern about potential constraints on public sector research and innovation in agriculture spurred the public sector’s interest in intellectual property. One important response was work that led to the formation of the Public Intellectual Property Resource for Agriculture (PIPRA). Supported by, among others, the Rockefeller and McKnight foundations, PIPRA is a public sector initiative that recognizes that continuing and enhancing relationships with the private sector, and between the public sector institutions, are critical components of the utilization of intellectual property to meet public sector goals. As part of its initial work, PIPRA began a study of the structure of IP ownership in agricultural biotechnology. In the words of the study’s authors, Richard C. Atkinson and colleagues: This study found that roughly one-fourth of the patented inventions were made by public-sector researchers, which is substantially larger than the IP portfolio held by any single agricultural biotechnology company. It is, however, highly fragmented across institutions and across technology categories. And much of this IP has been licensed, often under terms that are confidential but which have likely resulted in greatly restricted access to the underlying technologies.7 This study suggested that, apart from a few important exceptions, public-sector scientists have invented many of the types of technologies that are necessary to conduct basic biological research and develop new transgenic plant varieties. For instance, they have developed technologies to transfer genes into plant cells; have characterized specific DNA elements that drive unique patterns of gene expression; and have identified many genes that confer important plant traits. Such discoveries underscore the fact that public-sector research institutions have been significant sources of technological innovation.8
We believe that this study involving Golden Rice shows how public and private sector innovations can be put to work directly to help the poor with more focused public sector IP management. Indeed, IP management is merely one of the components needed to bring innovation to the poor.9 Other factors, such as regulatory requirements, can be much more costly and do constitute tremendous barriers to the poor benefiting from innovations that are becoming commonplace in much of the world.
All referenced Web sites were last accessed between 1 and 10 October 2007.
3 Potrykus I. 2001. Golden Rice and Beyond. Plant Physiology 125:1157–1161.
4 Kryder D, SP Kowalski and AF Krattiger. 2000. The Intellectual and Technical Property Components of pro-Vitamin A Rice (GoldenRice™): A Preliminary Freedom-to-Operate Review. ISAAA Briefs No 20. ISAAA: Ithaca, NY. www.isaaa.org/kc/bin/isaaa_briefs/index.htm.
5 Paine JA, Shipton CA, Chaggar S, Howells RM, Kennedy M, Vernon G, Wright SY, Hinchcliffe E, Adams JL, Silverstone a, Drake R. 2005. Improving the nutritional value of Golden Rice through increased pro-vitamin A content. Nature Biotechnology 23(4):482–487.
6 See supra note 4.
7 Only within the temporal and spatial limits allowed by the patent system (note added by the authors of this case study).
8 Atkinson RC, RN Beachy, G Conway, FA Cordova, MA Fox, KA Holbrook, DF Klessig, RL McCormick, PM McPherson, HR Rawlings III, R Rapson, LN Vanderhoef, JD Wiley and CE Young. 2003. Public Sector Collaboration for Agricultural IP Management. Science 301(5630):174–175.
9 Current Golden Rice transformation events in the humanitarian project’s development process were all designed and made by Syngenta to need access to no third party intellectual property.