Is the Patent Office Forcing Race into Biotechnology Patents?

A review of recent patent applications to the United States Patent and Trademark Office (PTO) has uncovered a highly problematic new practice: PTO examiners are requiring applicants to include racial categories in the claims sections of some biotechnology patent submissions, where they provide the basis for subsequent research, development, and marketing of products developed from the patent. 

In a recent article in Nature Biotechnology, I explore the general contours of this phenomenon, which first came to light in a December 2008 presentation by PTO Quality Assurance Specialist Kathleen Bragdon titled “A Look at Personalized Medicine.” Taking an example of a treatment for breast cancer, the presentation argued that in cases where effectiveness for all races was not established, “a scope of enablement rejection must be considered.” In other words, the patent could cover only those racial groups that had been included in the underlying study. The implication was that race must be considered a genetically salient factor in biotechnology patent applications.

The critical responses Bragdon’s presentation prompted could have led the PTO to reconsider the relevance...