Revisiting racial patents in an era of precision medicine.

• Author: Kahn, Jonathan

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. (1) 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 [dollar]215 million proposal for the Precision Medicine Initiative as "a bold new research effort to revolutionize how we improve health and treat disease." (2)

In both cases, my animating concern has been to explore how the legal system of patent protection may be playing an inadvertent, or at least underappreciated, role in validating--and in some cases promoting--the construction of racial categories as biological or genetic constructs. The patent system is a particularly powerful, if obscure, site for such constructions because it accords legal force to the constructions of race as a genetic phenomenon that shapes practices from the lab, to the manufacturing facility, to the doctor's office, and to the market at large.

We see this most clearly in the original case study that led me to this area of inquiry: the story of BiDil, the first drug ever approved by the FDA with a race-specific indication--to treat heart failure in a "black" patient. (3) As I have shown, the underlying race-specific patent to BiDil drove how clinical trials were constructed, how data was framed and presented to the FDA and the public at large, and the way subsequent marketing programs attracted interest from doctors. (4) All this is based on scientific data that actually shows the drug would work in people regardless of race--indeed, the patent holder himself stated that he thought the drug would work in white people as well as black people. (5) Yet due to the legal and commercial advantages conferred by a race-specific patent, the corporate sponsors of BiDil racialized the drug, and by implication, biologized race--all with the active collaboration of the U.S. Patent and Trademark Office ("PTO") and the FDA. (6)

This dynamic is problematic for a number of reasons, not least of which is that it is scientifically ungrounded. As I noted in my original article, an editorial in Nature Biotechnology nicely disposed of this issue by stating that: "Race is simply a poor proxy for the environmental and genetic causes of disease or drug response.... Pooling people in race silos is akin to zoologists grouping raccoons, tigers and okapis on the basis that they are all stripey." (7) Beyond this, the reification of race as genetic has historically been a basis for oppression and stigmatization. Now more than ever, we must be on our guard against social, scientific, and legal practices that promote such misguided understandings.

In my original article on patenting race, I used the PTO patent search engine to query whether the "claims" section of any patents or patent applications referenced any of the basic racial and ethnic categories of the U.S. census (and cognate terms, such as "Caucasian" and "European" for "White," and "African" for "Black") or used the terms "Race," "Racial," "Ethnic," or "Ethnicity." (8) I then examined the patents to consider whether they used the terms in a manner that implied or asserted a genetic component to, or basis for, race. (9) Focusing on the claims section was particularly significant because the claims "specif[y] the legally operative scope of the patent, defining the formal legal boundaries of the territory covered by an invention." (10) Below are the results of this first search from 2006 (11):

Table 1. Racial and Ethnic Categories Mentioned in U.S. Patent Filings, 1976-2006 (12) Category Issued Patents: Patent Applications 1976 1997 1998-2005 filed from 2001-2005 Race 0 2 15 Ethnic 0 0 2 African-American/Black 0 4 11 Alaska Native 0 0 0 Asian 0 0 13 Caucasian/White 0 6 18 Hispanic/Latino 0 0 3 Native American 0 0 2 Pacific Islander 0 0 1 Total 0 12 65 Already in 2006, it was striking how the use of racial categories in patents and applications had burgeoned in the aftermath of the completion of the Human Genome Project. (13) The great initial irony here was that the post-genomic age was supposed to be a post-racial age. At a triumphant ceremony in 2000 announcing the completion of the first draft of the human genome, President Clinton declared: "I believe one of the great truths to emerge from this triumphant expedition inside the human genome is that in genetic terms, all human beings, regardless of race, are more than 99.9 percent the same." (14)

But as the 2006 tally of patents made clear, something else was going on. At least in the world of intellectual property, race seemed to be taking on a new and distinctive salience as a genetic marker capable of conferring legal and commercial advantage in the drive to develop new products for the biomedical marketplace. In the wake of BiDil's approval by the FDA, language of leaving race behind was superseded by language of using race as a stepping-stone to reach the promised land of personalized medicine. (15) And so patents geneticizing race continued to proliferate.

Coming back ten years later and conducting a similar search on the PTO's web site, the following results are present:

Table 2. Racial and Ethnic Categories Mentioned in U.S. Patent Filings, 2006 2016 (16) Category Issued Patents: Patent Applications 2006-2016 filed 2006-2016 Race 3 38 Ethnic 13 89 African-American / Black 8 71 Alaska Native 0 0 Asian 8 54 Caucasian/White 23 108 Hispanic/Latino 1 17 Native American 6 7 Pacific Islander 0 0 Total 63 384 From 1998 to 2005 there were twelve uses of racial and ethnic categories in granted patents. Between 2006 and 2016 that number grew to 63. Similarly, with respect to the use of racial and ethnic categories in patent applications filed, the number of uses rose from 65 in the years between 2001 and 2005 to 384 in the years between 2006 and 2016. Far from abating with new genomic discoveries, the use of racial categories in biomedical patenting has increased aggressively.

What we see happening here is the normalization and routinization of inserting racial and ethnic categories into biomedical patents over the past decade. At a time when, rhetorically, many scientists and policy makers have been asserting the irrelevance of race in genetic research, we see a very different story unfolding in the world of intellectual property. Race, it is clear, is now understood as a standard and acceptable means to strengthen or supplement existing patent protections, regardless of its implications for reifying race as genetic.

One particularly recent and typical example can be found in U.S. Patent No. 9,241,991, titled "Agents, Compositions, & Methods for Treating Pruritus & Related Skin Conditions." (17) As the abstract states: "This invention relates generally to a therapeutic use of TLR3 and TLR7 inhibitors to treat or reduce pruritus in a subject." (18) TLR3 and TLR7 are proteins that in humans are encoded by the TLR3 and TLR7 genes. Pruritus "is an unpleasant cutaneous sensation that evokes scratching behavior, which is distinct from pain that elicits withdrawal reflex of affected body." (19) The first (and most important) claim sets forth "[a] method of reducing pruritus in a subject, the method comprising administering to the subject a therapeutically effective amount of a toll-like receptor (TLR) 3 or TLR7 inhibitor, thereby reducing pruritus in the subject." (20) So far, so good. But then moving down near the end of the list we come across Claims 17-19 which state: "17. The method of claim 1, wherein the subject is a black African[;] 18. The method of claim 1, wherein the subject is a mammal[; and] 19. The method of claim 1, wherein the subject is a human." (21)

There are several things to note here. First, there is the qualification of "black" African. On the one hand, this clearly is intended to try to offer greater specificity than the geographic continental term "African." The implication being that "black" Africans can and should be distinguished from non-black Africans, whether those of more recent European or Indian settler populations in Southern Africa who do not code as "black," or those people from Northern Africa who might identify as Arab, Bedouin, or Berber, etc., who also do not generally code as "black." This specification is similar to that of "sub-Saharan African" also used in some patents as a qualifying term. But whereas "sub-Saharan African," while still problematic (see below), at least consistently uses geographic specifications for its population designator, "black African" mixes two taxonomies: geographic and racial. The patent never defines what is meant by the term "black." Is it purely a phenotypic description referring to skin color? If so, one could hardly say that dark skinned Africans have a uniform level of melanin in their skin that renders them all uniformly definable as "black." Indeed, how much melanin does it take to make an African into a "black" African? Of course, one might argue that the patent is merely employing terms that invoke common sense social understandings of who constitutes a "black African," but where else in complex biomedical patents do we ever see applicants similarly relying on such ill-defined "common sense" understanding of technical terms that are central to delineating the scope of the patent?

Beyond the ambiguity of the term "black African," there is the even more problematic...