ABSTRACT
The importance of patents covering approved drugs has increased with the dramatic growth of the generic pharmaceutical industry in the United States and the resulting competition between innovator and generic pharmaceutical companies. This entry provides a general overview of how the U.S. patent system applies to the pharmaceutical industry, including its application to both innovator and generic pharmaceutical companies, with a particular focus on how the patent system interacts with certain provisions of regulatory low that govern drug approvals and how the generic pharmaceutical industry typically functions in the face of such patent and regulatory frameworks.
