Gene Patents and the Product of Nature Doctrine

Gene patents have proven to be enormously controversial, evoking a strong response from many categories of skeptics. Objections have focused on the foreclosure of research, the potential denial of healthcare, or the proper application of the patent laws. Gene patents also tend to trigger an elemental response that lies at the core of almost every objection: You shouldn't be able to patent a gene! This article focuses on the latter point, restating it as a question of legal doctrine: Why is it that the law has routinely treated genes as patentable inventions rather than unpatentable natural phenomena?

Part II reviews the basics of patent law, with particular emphasis on patentable subject matter and the long-established product of nature doctrine. Part III discusses the understanding of genetics that is reflected in the patent case law, an understanding that has led the courts and the United States Patent and Trademark Office (USPTO) to find a material distinction between genes as usually claimed in patent applications and their naturally-occurring counterparts. Part IV reviews several recent legal developments that, taken together, may portend some future constraints on the virtually unfettered patentability that genes have enjoyed thus far. Finally, Part V offers some concluding thoughts on the policy implications of these developments.