The Court held that:

1. The use of patented compounds in preclinical studies is exempted from patent infringement under the regulatory review exemption as long as there is a reasonable basis to believe that the compound tested could be the subject of a submission to the Food and Drug Authority (FDA) and the experiments will produce the types of information relevant for such submissions;
2. Additionally, the exemption covers the use of patented compounds in preclinical research, even when the patented compounds do not themselves become the subject of an FDA submission;
3. Similarly, the use of a patented compound in experiments not themselves included in a submission of information to the FDA does not, standing alone, render the use infringing.