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 of race to biotechnology patent claims. But despite the push-back, the PTO’s practice of requiring race continues, apparently unabated. This matters a lot – not only to inventors seeking to draft viable patent applications, but more broadly for our understandings of how racial categories are coming to play an increasingly significant role in biotechnology research and development. It also casts light on a great irony: As we claim to be making progress toward a promised land of personalized medicine, group categories of race seem to be gaining salience in both law and science.
The presentation involved only a hypothetical, but at the very time it was being made, a number of cases quite similar to it were making their way through the PTO process. One, pending before the Board of Patent Appeals and Interferences (BPAI), was contesting a patent examiner’s race-based rejection of an application covering a method of screening for a gene mutation that indicates an increased risk for prostate cancer.