Artful Prior Art and the Quality of DNA Patents

Abstract

In reviewing patent applications and prior art references in biotechnology, the patent system often focuses on the extent to which these documents explicitly disclose structural formulae for specific nucleic acid molecules. This Article argues that this approach to patentability has caused well-known generic and methodological references to be disregarded as potentially relevant prior art. To provide empirical support for this doctrinal argument, this Article also describes the creation and publication of an "artfully drafted" prior art reference that provides an enabling disclosure of more than 11 million DNA sequences on CD-ROM and has already been cited in a number of patents and patent applications. The reference is still too small to offer a complete solution to the problems caused by the patent system's approach. Because the size of the reference is constrained only by the capacity of the CD-ROM, however, the reference provides a "proof of concept" that may be generalized and extended as more capacious storage media become available.