Kyle Faget


Among the many amendments found in the Food and Drug Administration Amendment Act of 2007 (FDAAA) is a provision at the end of the act, Section 505(u), which grants chiral switches five years of market exclusivity under certain circumstances. Prior to Congressional enactment of the FDAAA, the Food and Drug Administration (FDA) refused to award new chemical entity (NCE) status to enantiomers of previously approved racemic mixtures. The FDA defines a new chemical entity ("NCE") as a drug that contains no active moiety that has been approved by the FDA in any other application submitted under Section 505(b) of the FDCA.3 According to the FDA, NCEs are by definition innovative and represent significant changes from already-approved drug products, such as a new use. Granting five years of market exclusivity to chiral switches mimics the exclusivity accorded to NCEs. This policy change may be rewarding innovation that has either gone unrecognized as patentable by the Federal Circuit or has been recognized as patentable under a unique set of qualifying standards by the Federal Circuit. From this perspective, it may appear as though Congress, by enacting Section 505(u), has somehow done an end-run around the patent system by allowing exclusivity where none has been previously offered. This Comment, however, argues that Section 505(u) will have a limited effect on drug development incentives and generic entrance into the marketplace because the ease with which most racemic mixtures may be resolved and the need for developing safe drugs in the first instance to gain FDA market approval points away from continued development of racemic drugs. In other words, Section 505(u) is time-limited because drug companies today are almost exclusively pursuing single enantiomer drugs.