Defining Limits to the Application of the Statutory Experimental Use Exception within the Agricultural Biotechnology Industry

The Hatch–Waxman Act delineates a pathway for the approval of generic drugs by the Food and Drug Administration (FDA). In addition to an abbreviated generic drug approval process, the Hatch–Waxman Act added a new defense to patent infringement, a statutory experimental use exception. The statutory experimental use exception allows pharmaceutical companies to conduct research on patented technologies if the research might be used in a regulatory submission to the FDA. In a separate article, I argued that the statutory experimental use exception should apply to the agricultural biotechnology industry’s development of genetically engineered crops. Arguments were based on the Supreme Court’s broad interpretation of the underlying statute and the FDA’s regulation of genetically engineered (GE) crops. Such an application of the experimental use exception would have a potentially large impact on the patent valuations within the agricultural biotechnology industry.This Article describes the limitations of the statutory experimental use exception of the Hatch–Waxman Act in light of the patent strategies employed by the agricultural biotechnology industry. Based on these limitations, this Article argues that intellectual property protection is still valuable to agricultural biotechnology companies if the statutory experimental use defense were available to the industry. Part I describes the development of the statutory experimental use exception and its evolution. Part II explains the intellectual property protection necessary for the agricultural biotechnology industry due to the regulations and long development timelines. Part III analyzes the case law surrounding the statutory experimental use exception in light of GE crop intellectual property protection to describe the reach of the statutory experimental use exception within the industry.