specialists in technology licensing, and specialists in the philosophy and ethics of science and medicine.
The committee met 6 times over a 14-month period. During five of these meetings, the committee invited experts to speak about issues under consideration. In addition, the committee held two workshops, one in Washington, D.C., and one in Bellagio, Italy. The committee also sponsored a survey of research scientists (described in Chapter 4) and conducted its own research on the patent landscape and licensing practices in biomedical research.
Several groups have examined the patent system in great depth (e.g., Federal Trade Commission, 2003; NRC, 2004). This current report does not aim to repeat such an analysis but rather focuses on the unique considerations that arise within the context of genomics and proteomics research.
The committee recognizes that there has been no comprehensive analysis of the impact of intellectual property on genomic and proteomic research involving plants and animals. This was not part of NIH’s charge to the committee, which was not composed to address it (although it did include an agricultural economist specializing in intellectual property to provide a perspective on that field). The survey conducted for the panel was limited to biomedical researchers, although the patent data presented in Chapter 4 do not distinguish between human and plant and animal-related material because of the lack of consistent discriminating terms in patent claims.
Some grounds exist for hypothesizing that freedom-to-operate issues are more pronounced in agriculture than they are in biomedical research. The field is not nearly as generously funded; prime research targets are much narrower (focusing on a few high-value crops and animal species); patent ownership is much more concentrated in a few public and private hands. The fact that a few cooperative intellectual property management schemes have emerged in agricultural biotechnology—the Public-Sector Intellectual Property Resource for Agriculture (PIPRA)and CAMBIO, Inc., for example—suggests that some obstacles are perceived, at least for public nonprofit researchers working on applications for nonaffluent markets (Wright and Pardey, 2005).7 The issues addressed by this committee may merit separate study in the agricultural research context.
In a survey of 90 plant biology researchers at four public land grant institutions (U.C. Berkeley, U.C. Davis, U.C. Riverside, and the University of Arizona) Zhen and Wright (2005) found that concern with freedom to operate is focused on a lack of easy and quick access to materials held by others. This is similar to the findings from the survey of biomedical researchers reported in Chapter 4.