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.
In that case the examiner had rejected an application, inter alia, for failure to “enable the full scope” of the claimed method because it “has not [been] shown that the correlation between the claimed mutations and the risk of both sporadic and hereditary prostate cancers is significant in all populations.” This finding, in turn, was apparently based on the application’s disclosure that one of the relevant mutations was found in Caucasians, while another was found African Americans.
For the examiner, this meant that the same level of risk was not present in all racial populations, hence a lack of enablement. The examiner rejected the patent claims because they did not differentiate risk by racial group but simply covered “a method of screening a subject.” This is a real-life example of the exact same logic evident in Bragdon’s presentation. The examiner here was denying a patent application for its failure to use race as a biological construct. In order to succeed, the applicants would either have to add race in a manner they did not think valid, or take the time and money to appeal the decision. In this case, they appealed – and won.
In its March 2009 decision reversing the examiner’s rejection of the application, the BPAI found that “It is unnecessary for Appellants to prove with 100% certainty that a correlation exists between the . . . mutations and an increased prostate cancer risk. It is sufficient that that the evidence is “reasonably indicative” that a correlation is present.” It concluded that the same degree of risk need not be present in all races in order to make a claim to cover the method for use in a generic human subject.
One might hope that this common-sense result would send a message to PTO examiners to reconsider their understandings of the place of race in biotechnology patents. Unfortunately, this has not been the case. In April, 2010 another similar application rejection was also successfully appealed. Between Bragdon’s presentation and the multiple appeals, it is evident that the practice of requiring patent applicants to introduce race into their biotechnology patents has become routinized at the PTO.
We might take solace in the apparent readiness of the BPAI to correct this errant behavior. But not all applicants have the wherewithal to continue the prosecution of their patent up through the appeals process. The BPAI opinions, therefore, are just the tip of the iceberg. One must ask how many applicants simply accede to the examiners’ demands and incorporate racial categories into their patents in order to avoid the long, drawn-out process of appeal.
In this regard, patent #6,716,581, covering a method to screen for a genetic polymorphism to help determine susceptibility to colorectal cancer, offers a cautionary tale. In the original application, filed in April 2001, the first claim read: “A kit for determining whether a subject has, or is at risk of developing, colorectal cancer wherein said kit is used to amplify and/or determine the molecular structure of at least a portion of the MnSOD gene.” The application went on to enumerate a total of 35 claims, the very last of which introduced ethnicity, reading: “The method of claim 29; wherein the ethnicity of the subject is Hispanic.” Yet, by the time the application had gone through the prosecution process, the examiner had effectively forced the applicants to reconfigure the patent to foreground ethnicity. As ultimately issued, the first claim of the patent begins: “A method of determining relative age-related risk of colorectal cancer in a Hispanic subject, comprising ...”
The truly chilling aspect of this story are the questions it raises as to how many other applicants have given in to examiners’ demands that they include race in their biotechnology patents? How many others have gone against their better scientific judgment to appease an examiner? The implications go far beyond the mere issuance of narrower patents. Such patents can subsequently influence the design of clinical trials, the interpretations of the results and the marketing of end products.
The PTO is currently undergoing a process of internal review and reorganization. Now is the time for it to confront head on this misguided practice of injecting race into biotechnology patents. If race is to have a place in biotechnology patents it must not be casually imported as a social construct into biological contexts. Rather, any use of race –by applicant or examiner – must be rigorously defined and must clearly articulate and justify any purported relationship to underlying genetic attributes.
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Comment by Bob Hall, Jun 23rd, 2011 3:52am
How does one biologically determine or assign race to a subject? Race is a social category, usually self-assigned.
Bob Hall, Querétaro, México
Comment by Marc, Jun 17th, 2011 9:30am
Isn't a genetic predisposition among some races to certain conditions (cf. sickle cell anemia in Blacks, Tay Sachs in Jews, etc., and in contrast a lower prevalence of cystic fibrosis among Asians) uncontroversial? There are even conditions which are more prevalent in men than women (hemophilia) and vice-versa (lupus). Why should patent examiners ignore such facts?