October 30, 2014 | Cold Spring Harbor Laboratory Press

Research Use Exemptions to Patent Infringement for Drug Discovery and Development in the United States

1 min

Experiments with patented compounds or processes are sometimes necessary for Food and Drug Administration approval of a small-molecule drug, biologic, or medical device. The law exempts certain research and development activities using these patented compounds or processes. The two exemptions are (1) a judicially created exemption developed through case law and (2) an exemption created by the Hatch—Waxman Act (the “safe harbor” pro-vision). This article analyzes the history of these exemptions and how the courts have inter­preted their scope and provides future perspectives on protecting research and development activities from liability.