• Pharmaceutical Manufacturers Be Warned -- Your Use of Your Competitors' Patented Research Tools and Methods May Not Be Covered by the FDA Exemption of the Patent Infringement
  • July 17, 2003 | Author: Robert M. Schulman
  • Law Firm: Hunton & Williams LLP - Washington Office
  • Ever since Congress passed 35 U.S.C. ยง271(e)(1) (also known as the "FDA exemption"), it has not been an act of infringement for a manufacturer to use a patented drug or medical device so long as that use was "reasonably related to the development and submission of information" to the FDA. The primary motivation for the passage of the exemption was to enable generic manufacturers to sell generic equivalents of patented drugs immediately upon expiration of the patent.