Was the FDA Exemption to Patent Infringement, 35 U.S.C. § 271(e)(1), Intended to Exempt a Pharmaceutical Manufacturer’s Activities in the Development of New Drugs?

Abstract

The FDA exemption was not created to assist in the generation of new drug candidates, which are included in the broad interpretation of the "reasonably related" language by the Supreme Court in Merck. Applying the Supreme Court's interpretation to the facts of Merck means that a pharmaceutical manufacturer may use the patented products and methods of another manufacturer to identify new drug candidates and not infringe. In fact there is almost no limit to what can be considered "reasonably related" to the development of information for submission to the FDA since a great deal of the research and development in the natural sciences is directed at identifying new drugs. Patented research tools are particularly vulnerable because they are often used in basic research that may now be considered "reasonably related" to submission to the FDA. Arguably, any use of the two research method patents at issue in Merck, the '997 and '237 patents, could be considered "reasonably related" under the Supreme Court's broad interpretation. Such development of new drugs using others' patented technology was not meant to fall under Congress's exemption to patent infringement.