Rules versus Standards  for Patent Law in the Plant Sciences*

M.D. J ANIS

College of Law, University of Iowa, Iowa City, Iowa, USA

Abstract

After the 2001 US Supreme Court decision in JEM v Pioneer allowed patent protection for plants, the next stage in utility patent jurisprudence will likely feature the incremental refinement of key patent doctrines that determine whether the patent system will foster or thwart plant science innovation. This chapter examines the next stage of utility patent jurisprudence by focusing on the issues of enablement and experimental use. Patent law currently requires patent applicants to provide information to ‘enable’ others of ordinary skill in the art to make and use the claimed invention, but it does not provide an experimental use exemption. Since these practices will come under scrutiny in the second stage of jurisprudence, this chapter looks at the relative merits of rules versus standards. It determines that policymakers should allow doctrines like enablement to operate as flexible standards, because it is likely to be more efficient to develop the law incrementally, through case-specific judgements, than to engage in a complicated rule-making exercise.

Introduction

Patent law jurisprudence develops in loosely definable stages within technology areas. In plant sciences, US patent law jurisprudence has now progressed through its first stage. The Supreme Court’s landmark decision in J.E.M. Ag Supply v Pioneer Hi-Bred has confirmed that plants are eligible for protection under the US utility patent scheme, bringing closure to an initial round of debate over the eligibility provision of the utility patent statute and its relationship with the Plant Variety Protection Act (PVPA) and the Plant Patent Act (PPA).

* A slightly different version of this chapter appears in the Australian publication Law in Context (forthcoming 2007).

©CAB International 2007. Agricultural Biotechnology and Intellectual Property: Seeds of Change (ed. J.P. Kesan)

This chapter aims to comment briefly on the emerging, second stage of utility patent jurisprudence in plant sciences. Although the first stage dealt with threshold statutory interpretation questions, the second stage will be very different. It will be a calibration stage. It will be likely to feature the incremental refinement of the key patent doctrines that determine whether the patent system will foster or thwart plant sciences innovation. Mundane, hypertechnical and unspectacular, second-stage patent jurisprudence in plant sciences will none the less confront the most sensitive policy problems that arise within the patent system.

This chapter identifies two doctrines of patent scope that are likely to be implicated in calibrating the utility patent system for plant sciences: enablement and experimental use. It examines how those doctrines have been applied to date in plant sciences and offers some suggestions for the next steps in refining them to effectuate patent system calibration. Although these suggestions have implications for the substantive content of the doctrines, they are directed principally at rationalizing the process through which the doctrines might succeed as a calibration tool.