A recent unanimous opinion of the United State Supreme Court made clear that wide immunity from patent infringement is in place for preclinical research and experimentation that is reasonably related to the process of developing information needed for submission to the Food and Drug Administration (FDA). The decision handed down by SCOTUS reversed a lower court ruling which had found that the safe harbor provisions for non-infringement of 35 U.S.C. 271(e) of the 1984 Hatch-Waxman Act did not include drug screening that is not meant as a part of a FDA submission for the later identified drug candidate. The U.S. Supreme Court held that the Federal Circuit lower court interpretation of 271 (e) , which did not include research that is not submitted to the FDA, was improperly restrictive and inconsistent with the statute's safe harbor language. The court clarified the issue of intent by stating that basic scientific research done without intent to develop a specific drug or a reasonable belief that the composition will cause the physiological effect intended by the researcher to be induced cannot be considered reasonably related to the development and submission of information to the FDA. The decision is heartening for companies that do unlicensed research on pharmaceutical candidates. Additionally, the opinion is not restricted to patented drug compositions, but also includes therapeutic biolgics (antibodies) and medical devices requiring FDA approval. Among topics covered are safe harbor development, the Hatch-Waxman Act, related research, and the ongoing debate over tool infringement.