One strategy for reducing information costs connected with the experimental use exception is to develop a better understanding of the informal research norms and practices in biotechnology. Patent scholars have noted the potential benefits of such an approach in biotechnology patenting generally (Eisenberg, 1989; Rai, 1999). In other writings, I have advocated for such an approach to the experimental use doctrine in plant biotechnology patenting (Janis, 2001).

Even a casual analysis of anecdotal information suggests that there exists a repository of sources that might enrich the application of the experimental use doctrine in the plant sciences. For example, the literature contains references to a past era of public sector plant breeding research characterized as a ‘collegial system of exchange’ of germplasm among researchers, and contrasts the old norm to modern practices, which are said to be dominated by widespread claims of exclusive rights (Zohrabian et al ., 2003).

The old norm of free sharing deserves close study. Did research colleagues actually share germplasm freely without any limitations? Was it an implicit requirement that the recipient give credit, or that the recipient participate in reciprocal exchange? Was it expected that the recipient might use the material in a commercial breeding programme? In a breeding programme that would produce varieties that would be distributed freely to growers, who might, in turn, develop commercial varieties from them or otherwise benefit commercially? These questions are important to the exercise of developing information that will be useful in patent policy circles. Acknowledging the existence of a ‘collegial sharing’ regime is one thing; developing an understanding of the complex refinements and limitations on that collegiality is quite another. It is the latter, more challenging exercise that could provide relevant information for modern decision makers.

Anecdotal information about current practices is also obviously of great relevance, and may likewise yield a rich and complex array of results. For example, just as the past practice of ‘free’ exchange may not have been quite absolutely free, the modern practice of claiming exclusive rights is also more complex (less absolute) than the label might indicate. Consider the example of plant transformation methodologies, enabling technologies for the production of transgenic plants. Particle-mediated (‘gene gun’) transformation, one major transformation technology particularly suited for the production of genetically modified (GM) corn and other monocots, is subject to patent protection in the USA (e.g. US Patent 4,945,050 (Method for Transporting Substances into Living Cells and Tissues and Apparatus therefore); see generally Finer et al ., 1999). Another major transformation technology particularly effective in dicots, Agrobacterium -mediated transformation, is subject to many claims of patent protection (e.g. US Patent 6,051,757 (Regeneration of Plants Containing Genetically Engineered T-DNA) ) and, as we have seen, has played a central role in enablement cases in the plant biotechnology area.

One might draw the conclusion that these examples reflect the modern ‘exclusive rights’ norm in action, but this analysis is again too simplistic to be useful in crafting policy on the experimental use doctrine. Intellectual property rights (IPRs) are not self-enforcing, so a researcher’s decision to acquire IPRs tells us relatively little about norms of enforcement behaviour. However, anecdotal evidence about the patentees’ licensing practices on patented plant transformation equipment and techniques, and researchers’ behaviour in response to those practices, might well be informative.

Recent reports about a new transformation technique may give an indication of the complexity of modern norms of research behaviour in the plant biotechnology area. A group of researchers reported a new Agrobacterium -mediated transformation technique that is heralded as a breakthrough technology in that it appears to be a highly effective transformation technique for corn, which, as we have seen in the enablement cases, has long been considered recalcitrant to Agrobacterium -mediated transformation (Frame et al ., 2002). Reportedly, the group will make the technique freely available to researchers (Fitzgerald, 2003). The group had successfully transformed maize using Agrobacterium -mediated transformation relying on a proprietary vector, but decided that licensing the proprietary vector ‘for use on a broader scale was prohibitive’. Accordingly, the group turned to a public domain vector system, which proved to have other advantages. Perhaps this describes an exceptional practice, or perhaps it illustrates that the modern norm of exclusive rights is more nuanced and that experimental use doctrine should take account of that nuance.

It will be evident from this brief example that using the proposed approach will not result in a set of pristine rules for applying the experimental use exception. That, of course, is part of the very premise on which this approach is based: it trades off uncertainty for accuracy, and seeks to avoid the costly proposition of legislating deeply on experimental use.

Conclusion

Surprisingly, despite over two centuries of experience with the utility patent system, through multiple cycles of rapid technological progress, we still know relatively little about how to calibrate a patent system to accommodate a new technology area. We know that traditional patent doctrines such as enablement and experimental use are important, and in the emerging second-stage patent jurisprudence in the plant sciences, we have a few examples of how those doctrines may apply. However, we do not yet know enough to craft detailed, bright-line rules that precisely designate ex ante the level of disclosure that will be required to enable a transgenic plant invention, or the scope of experimentation that will be allowable in a plant biotechnology research setting. Rather than expending effort attempting to transform enablement and experimental use into rule-bound doctrines, we should allow both doctrines to continue to operate as flexible standards, and expend effort enriching the information base on which courts and the PTO can draw in applying those doctrines. This bottom-up approach to the doctrines of enablement and experimental use may prove the most productive as the jurisprudence of patent rights for plants continues to mature.

“References pertinent to this module of information are available in the book “Agricultural  Biotechnology and Intellectual Property.”