The US Supreme Court has agreed to review a lower court ruling concerning the breadth of patent protection for research experiments carried out by drug companies that infringe patents. The Drug Price Competition and Patent Term Extension Act, also known as the Hatch–Waxman Act, created a 'safe harbour' exemption that permits drug manufacturers to perform experiments needed to obtain FDA approval of their drugs without incurring liability for patent infringement, even if their activities infringe patent rights.

Biotechnology company Integra alleged that Merck and Scripps infringed patents owned by Integra relating to peptides involved in interactions between cell surfaces and the extracellular matrix. Scripps identified several potential antitumour peptide candidates and selected the most promising peptide by conducting experiments to evaluate the specificity, efficacy and toxicity of the peptide candidates for various diseases. The Appeals Court held that these activities did not fall under the safe harbour because they were exploratory in nature and not done solely for purposes reasonably related to the development and submission of information to the FDA. The court reasoned that the safe-harbour provision in the Hatch–Waxman Act was intended only to promote the growth of generic drugs.

This is a misunderstanding of the type of information required by the FDA for evaluating potential new drugs.

However, in a brief submitted to the Supreme Court by the government, it is argued that the current decision of the court of appeals reflects an incorrect view of the law, which is likely to restrict the development of new drugs. The brief holds that creating a distinction between preclinical and clinical research is a misreading of the law, and, in addition, that this is a misunderstanding of the type of information required by the FDA for evaluating potential new drugs.