Protecting New Investments in Old Drugs


FDLI Update Magazine, 2009, Issue 2

By: Terry G. Mahn
In an earlier article, the author discussed the shift taking place since the 2003 Orange Book reforms with pioneer drug companies looking for new ways to protect old drugs. A creative approach followed by some pioneers has been to patent new drug features that would appear on drug labels in the form of patent protected language that generic manufacturers are then either forced to infringe, await expiration or seek Food and Drug Administration (FDA) permission to "carve out."