The Supreme Court held that the statute exempts from infringement all uses of compounds that are reasonably related to submission of information to the government under any law regulating the manufacture, use or distribution of drugs.
Story famously wrote that the intent of the legislature could not have been to punish someone who infringes "merely for [scientific] experiments, or for the purpose of ascertaining the sufficiency of the machine to produce its described effects."
In 2002, the Court of Appeals for the Federal Circuit dramatically limited the scope of the research exemption in Madey v. Duke University, 307 F.3d 1351, 1362 (Fed.
The court also precludes the defense where, regardless of profit motive, the research was done "in furtherance of the alleged infringer’s legitimate business."
[2] In Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005), the United States Supreme Court held that the use of patented compounds in preclinical studies is protected under 35 U.S.C §271(e)(1) if there is a reasonable basis to believe that the compound tested could be the subject of an FDA submission and if the experiments will produce the types of information relevant to an Investigational New Drug or New Drug Application.