Mandating Race: How the PTO is Forcing Race into Biotechnology Patents

Biotechnology patents have increasingly included race-specific claims since the completion of the Human Genome Project in 2003. Previous analyses of this phenomenon indicated two basic forces at work: first, some inventors were using race defensively, to buttress broader, non-race-specific claims; second, others were using race affirmatively to capture race-specific markets. 

A recent review of select patent prosecutions before the United States Patent and Trademark Office (PTO) indicates a troubling new dynamic at work in biotechnology patent prosecution: PTO examiners are requiring applicants to include racial categories in the claims sections of some of their biotechnology patent submissions.The use of race in the claims section of a patent is particularly important because this is the legally operative section of a patent that defines the “metes and bounds,” or territory, covered by the patent. The claims form the basis for subsequent research, development, and marketing of products developed form the patent. 

This paper explores the significance of having agents of the State (i.e. patent examiners) affirmatively requiring the use of race as, in effect, a genetic construct. The implications go far beyond the mere issuance of narrower patents because such patents can influence the design of clinical trials, the interpretations of the results and the marketing of end products.