Judicial Developments in the US Hatch-Waxman Infringement Safe Harbor

April 01, 2010
This article examines recent developments in the implementation of the Hatch-Waxman Act, which gives pharmaceutical companies an exemption from infringement for the making, using, offering to sell or sale within the US, or the importation into the US, of “a patented invention ... solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs.”