Document Type

Article

Publication Date

2017

Publication Information

67 Case Western Reserve Law Review 1153 (2017)

Abstract

In 2006, I published an article examining the rising use of racial categories in biomedical patents in the aftermath of the successful completion of the Human Genome Project and the production of the first draft of a complete human genome. Ten years on, it now seems time to revisit the issue and consider it in light of the current era of “Precision Medicine” so prominently promoted by President Obama in his 2015 State of the Union address where he announced a $215 million proposal for the Precision Medicine Initiative as “a bold new research effort to revolutionize how we improve health and treat disease.”

In this article I show how the use of race has become normalized and routinized in the U.S. patent process. Just as the election of Donald Trump to the presidency has driven home to many that we do not live in a post-racial era politically, so too does the continuing proliferation of racial patents indicate that we are also not in a post-racial era scientifically. Yet, it is important to understand that the persistence of race in biomedical pa-tents is neither inevitable nor straightforward. As seen from the several examples examined in depth here, the geneticization of race through the patent process remains a relatively contingent and contested phenomenon. As shown in this Article, patent examiners’ responses to the use of racial categories in biomedical patents have varied widely. While in the majority of cases the use of race is not challenged, there are exceptions. Sometimes initial objections have been overcome by simple references to other regulatory authorities, such as the FDA, which appear to be unquestioningly accepted as sufficient to overcome objections. In other cases, a clearly stated objection to the indefiniteness of racial terms has been sufficient to compel an applicant to retreat and withdraw the racial claims.

Download

Share

COinS