Home > IP Topics Index > Putting Intellectual Property to Work: Experiences from Around the World > The IP Management of the PRSV-Resistant Papayas Developed by Cornell University and the University of Hawaii and Commercialized in Hawaii > Editor's Summary, Implications and Best Practices

The development and introduction of food biotechnology crops presents a set of specific issues related to freedom to operate (FTO) and the licensing of patented inventions. Although public sector institutions have conducted considerable research in this area, few have managed to bring genetically modified products to the market. Of the fifty or so agricultural biotechnology products already approved around the world (totaling some 100 million hectares, with a market value of over US$5.5 billion) few products have been developed by public sector institutions. One of these is papaya ring spot virus (PRSV) resistant papaya, developed by Cornell University and collaborators in Hawaii, including the University of Hawaii and U.S. Department of Agriculture (USDA).

There are a range of reasons for the slow progress by public sector institutions to commercialize agricultural biotechnology:

• constraints related to their business model (public sector entities, generally, are not geared towards product development)
• spiraling costs of dealing with biosafety and food safety approvals
• challenges related to IP management

This chapter is particularly relevant today, as many public sector institutions, particularly in developing countries such as India, Indonesia, Kenya and Brazil, are investing in the development of food biotechnology crops.

This chapter describes the specific experience related to the IP management component of the PRSV resistant papaya developed by a university and public sector collaborators. The successful results achieved by the Hawaiian Papaya Administrative Committee (PAC) may well serve as a model for distribution of future transgenic plant technologies. Hence, Hawaii’s transgenic papaya story is relevant for the worldwide plant biotechnology community.

This program began in 1995 when the consortium (PAC) retained an attorney (the author of this Chapter) to provide legal assistance on patent and licensing issues. An FTO revealed that several licenses were required. The challenge for the public sector licensees was significant: they needed fairly modest grants of patent rights, but needed substantial financial accommodation from the patent owners. Although the patent holders were generally sympathetic to the papaya growers, they had their own strategic interest which needed to be protected. But because of the significance of the papaya crop to the Hawaiian farmers, product success was essential in order to avoid significant negative economic impact. Hence in some cases, even the USDA provided assistance to motivate the patent holders to grant the necessary licenses.

Although the transgenic papaya licensing story is not of huge economic significance to worldwide agriculture, it is certainly an important event for the plant biotechnology industry. Many developing countries are in similar situations: they may need a few licenses from patent holders who may have other strategic interests and may view potential economic benefits of licenses to be small or insignificant. Yet the benefit of biotechnology to millions of farmers, in aggregate, could be tremendous. Papaya in Southeast Asia is the region’s second most important fruit, a critical source of Vitamin A; however, it suffers from pre-harvest losses of 30-40%, primarily due to PRSV.

Even if licenses were not required in developing countries for national production and consumption, an additional concern by many farmers and cooperatives would be to explore export markets. This would provide much value added and income for many farmers. The main concerns then for potential licensors would be the quality of the exports, the regulatory approval by the importing country authorities, product liability and possible patent infringement if the technology embedded in the transgenic crop is patented in the target export market. These are not easy matters to deal with and further complicate any licensing discussions and negotiations. It is in this context where this case study is so telling, and relevant.

As mentioned above, this case study may not represent events that are of great significance to global agriculture. However, as one of the first efforts to develop a transgenic fruit crop, procure the necessary licenses, and introduce the product into commerce, Hawaii’s transgenic papaya story is certainly an important event for the plant biotechnology industry. Indeed, the successful results achieved by PAC may well serve as a model for future transgenic plant technology.

Key Implications and Best Practices

Given that IP management is heavily context specific, these Key Implications and Best Practices are intended as starting points to be adapted to specific needs and circumstances.

For Government Policymakers

• The successful introduction of new technologies, particularly those developed by public sector institutions, will depend on the licensing practices of these institutions. For such practices to be supporting of the public mandate of these institutions, strong IP management capacity is necessary.

For Senior Management (university president, R&D manager, etc)

• Product development and commercialization may not be the primary goals f a public sector and academic organization, but when it is, freedom to operate (FTO) considerations must be addressed early.
• Such FTO aspects are a risk management tool that allows the institution to plan for and address the major liabilities, including product liabilities and those ensuing from possible patent infringement.

For Scientists

• Whenever possible, use non-patented materials and technologies. This will simplify the licensing negotiations and may significantly reduce the number of licenses for a specific product. This is only applicable if there is an option to choose from two or more technologies, methodologies or materials. Hence, it may still more efficient to use patented technologies because they possess significant advantages or benefits.

For Technology Transfer Officers

• Strategy is often more important than substance when approaching licensors. In other words, it can be of high importance to have growers associations or other “allies” join negotiations or at least intervene at the appropriate time.
• The importance of MTAs and other contractual obligations needs to be communicated clearly to scientists, especially those in charge of research groups (that is, principal investigators).
• Even in the absence of patents, one of the significant constraints may relate to tangible materials that were obtained from third parties, such as genes, vectors and plasmids. It is important to discuss with the technology transfer officers whether there may be any limitations to the use of such materials. For example, it might be advisable to have certain genes synthesized by commercial firms in order to avoid limitations imposed by material transfer agreements (MTAs).
• Even if a research license is obtained, this might not permit introduction of the product of research into a commercial product. Any effort to do could constitute patent infringement.
• The mode of patent infringement liability may not only be direct. Contributory infringement and inducement to infringe can also create liability. With complex biotechnological products, all possible modes of infringement liability ought to be considered and analyzed.