By Jonathan Kahn

A new phenomenon is emerging in biotechnology research and product development - the strategic use of race* as a genetic category to obtain patent protection and drug approval. The introduction of race into the field of patent law as an adjunct to biotechnological inventions may have profound implications for broader scientific and social understandings of race. When the federal government grants a patent to an invention that is based on an asserted or implied genetic basis for a particular racial group, it gives the imprimatur of the federal government to a potentially inappropriate characterization of race as genetic.1 As a recent editorial in Nature Biotechnology put it, "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."2 Beyond this, such patents are providing the basis for similarly race-based clinical trial designs, drug development, capital raising and marketing strategies that which imply that race is genetic to ever widening and powerful segments of society. As these new patents proliferate, commercial imperatives may be coming to eclipse scientific considerations of how or even whether to use racial categories in biotechnology.

A typical patent is divided into several sections. The "Claims" section presents a primary focus for investigation because it is the legal heart of a patent. The claims specify the legally operative scope of the patent, defining the formal legal boundaries of the territory covered by an invention. The "Abstract" is the basic summary presentation of the central purpose of the patent. Other sections typically include a "Background" or "Description of Invention," plus drawings or other technical support data.

A review of "Claims" and "Abstract" sections of gene-related patents and patent applications filed since 1976 indicates a significant trend toward using racial categories in gene-related patents, with a marked increase in just the past few years. The table on the following page identifies patents that use categories of race and ethnicity* in a manner that implies or asserts a genetic component to, or basis for, race.+ The specific categories are chosen to reflect those employed in the Office of Management and Budget's Revised Directive 15 on "Standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity," which governs the collection of data in federal and federally sponsored projects.3

The results indicate a remarkable trend toward the increasing use of racial and ethnic categories in relation to patenting gene-related biomedical innovations. The significance of this trend is not strictly statistical. Rather, it is indicative of an emerging phenomenon that deserves increased attention. This rise is clearly coincident both with an increase in genetic information being produced through such federally sponsored initiatives as the Human Genome and International Haplotype Map Projects, and also with rising federal emphases on requiring the use of racial and ethnic categories in the collection of data relating to clinical trials and drug applications.

The two columns of the table reflect the date classifications of patents and patent applications provided by the U.S. Patent and Trademark Office's (PTO) own web-based search engine. The table does not capture possible patent applications that may have been filed before 2001 and subsequently abandoned. Nonetheless, it remains highly suggestive of a recent and novel trend toward the increasing use of race in biotechnology patents. Thus, for example, of the twelve uses identified in granted patents, the earliest relates to diagnostic testing for the BRCA1 genetic mutation for breast cancer and was granted only in 1998. There has been a more than five-fold increase in the use of racial and ethnic categories in gene-related patent applications over existing patents issued since 1976. This is not because race has not previously been used in biomedical research, but rather because it is taking on increasing significance in the commercial world of biotechnology patenting.

While there are some overlapping uses (i.e. patents that use more than one OMB category) the trend remains powerful and clearly parallels the availability of vast new amounts of genetic information being produced and classified in federally sponsored data bases. The quantitative scope of the trend remains fully to be assessed, but its qualitative significance is already emerging.

How, exactly, is race being used in these patents? At the most pragmatic level, patent applicants appear to be invoking race in a strategically defensive manner to provide added protection against possible patent challenges. The structure of a typical Claims section of a patent begins with Claim #1 being as broad as possible. Successive claims generally provide a narrower and narrower focus to the territory covered by the patent. The idea here is that if the broadest claim is struck down by the patent examiner or a subsequent challenge, the narrower claims may still survive. Patent claims are thus structured something like a medieval castle, with an outer ring encompassing the most territory with successively smaller rings providing additional layers of protection back to the core area of the castle keep. Thus, a typical race-specific biotechnology patent may begin with a first claim that covers the use of a particular invention in a "mammal," the second claim may cover use in a "human," and the third claim may cover use in a "Caucasian" or "Asian" individual, etc.

There is not an inherent problem with looking at race in biomedical research. Many of the studies discussed in the "Background" sections of these patents, deal effectively with the nuances of variation in the relative frequencies of particular alleles (i.e. gene variants) across specified populations. In the legally operative Claims sections, however, all such nuance is lost as relative gene frequencies tend to be replaced by blanket assertions of efficacy or appropriateness for use in a specific race. The legal and commercial imperatives of patent law demand definitive and bounded categories of race to make the Claims appear stronger. Patent examiners in the PTO are unlikely to consider such slippage between claims of correlation and identity. Rather, they evaluate an application according to whether it meets the basic statutory criteria of novelty, non-obviousness, utility, and specification. The Claims thus supplant the more complex presentation of data in the underlying studies, in effect, distorting the science. The result is a patent that presents a simplistic conception of race as genetically constituted and bounded.

Racial categories can also be used more aggressively in patent law to expand or extend monopoly control over products and services. This is most evident in the case of the heart failure drug, BiDil. In June 2005, BiDil became the first drug ever approved by the FDA with a race specific indication: to treat heart failure in African Americans. Underlying the New Drug Application (NDA) submitted for this drug to the Food and Drug Administration (FDA) is a 2002 race-specific patent: to use the drug for treatment of heart failure in an African American patient.4 NitroMed, the corporate sponsor of BiDil, also holds the rights to an earlier patent to use BiDil in the general population regardless of race.5 This patent, however, expires in 2007, while the race-specific patent lasts until 2020, granting an additional thirteen years of monopoly control over the market for BiDil which NitroMed currently estimates as reaching $1-3 billion annually. Currently, BiDil is NitroMed's only product on the market.

NitroMed's second BiDil patent is premised on underlying assumptions regarding race and the genetic basis of heart disease. As NitroMed CEO, Michael Loberg put it, "Illnesses that seem identical in terms of symptoms...may actually be a group of diseases with distinct genetic pathways. This would help explain blacks' far higher mortality rates for a host of conditions, including diabetes, cancer and stroke."6 By granting such a patent, the Patent and Trademark Office (PTO) is not only stifling useful innovation, it is also giving the imprimatur of the federal government to the use of race as a genetic category. The story of BiDil is one of how race and ethnicity were used in conjunction with patent law and the drug approval process to bring a new drug to market. NitroMed conducted a race-specific clinical trial, A-HeFT (African-American Heart Failure Trial), to support its NDA submission. All indications from the trial results seem to show that the drug is highly effective at treating heart failure, but the single race design of the trial does not support any claims as to whether the drug works differently or better in African Americans than in anyone else.7 Indeed, designing a larger racially diverse clinical trial would have provided better information about BiDil's efficacy, most likely showing it worked in non-African Americans as well. Such a trial, however, would have threatened NitroMed's commercial interest in obtaining the extra thirteen years of patent protection ensured by a race-specific FDA approval.8

NitroMed's race-specific BiDil patent provided the underlying support that drove its subsequent development of a race-specific trial design, its campaign to raise money in capital markets, its approach to the FDA for race-specific approval, and its massive marketing campaign to third party payers, individual doctors, and the public at large.9 As biotechnology patents become racialized, they are thus coming to drive broader scientific, political, and public understandings and uses (or, perhaps, misunderstandings and misuses) of racial categories.

The dramatic rise of racial categories in biotechnology patents indicates that BiDil is not an anomaly. Recent reports of similar race-specific trials for the cancer drug Iressa and the statin Crestor, among others, would seem to indicate that BiDil is ushering in a new era of race-based medicine.10 A 2005 report from the Royal Society in the United Kingdom asserted that the promise of truly individualized pharmacogenomic therapies remains decades away.11 In the gap between present reality and future promises there may be various strategies for capitalizing on emerging genetic knowledge relating to drug response and efficacy. Targeting a racial audience presents a particularly attractive interim option because, at this point, the technology and resources do not exist to efficiently scan every individual's genetic profile. Instead, businesses may market the product to a particular social group that is hypothesized to have a higher prevalence of a relevant genetic variation. Patent protection provides an essential underpinning for such commercial ventures. As race is becoming more relevant to marketing drugs, it is becoming a salient component of underlying biotechnology patents.

Similar dynamics are at work in Europe. In June 2005, over the strenuous objections of the European Council of Human Genetics (ESGH), the European Patent Office upheld a patent owned by Myriad Genetics relating to testing for the BRCA2 genetic mutation "for diagnosing a predisposition to breast cancer in Ashkenazi Jewish women."12 Opponents of the patent noted that the test is currently available for all women, regardless of ethnic or religious background. As a practical matter, this new patent means that women identified as Ashkenazi Jews will either have to pay a premium for the test or deny their identity. As with BiDil, here Myriad apparently is marking an ethnic group as genetically distinct primarily in order to extend patent protection - with potentially profound social and economic consequences.13

A "product of nature" cannot be patented. To be rendered patentable, it must be "purified and isolated" through human interventions to produce a substance that does not otherwise exists. Historically, this has involved complex chemicals such as adrenaline.14 In the genomic era, however, it has come to encompass engineered complementary DNA (cDNA), synthesized in vitro by using an enzyme (reverse transcriptase), which produces a molecule containing only those nucleotide sequences from the original DNA that code for proteins (exons). While clearly scientific and technical in origin, isolation and purification are distinctively legal concepts when it comes to granting a patent. The PTO has asserted that, "the inventor's discovery of a gene can be the basis for a patent of the genetic composition isolated from its natural state and processed through purifying steps that separate the gene from other molecules naturally associated with it. [emphasis added]"15

The PTO constructs cDNA as isolated, not only in the sense of separating exons from introns, but more powerfully, in the sense of separating the genetic material itself from nature. This is not a scientific process but a legal one. The scientist may create cDNA but the PTO draws the line between nature and artifice. Similarly, purification involves stripping the genetic material of its identity as a part of nature - purifying it of its "natural associations."

In contrast, race enters the world of biotechnology as a social construct, often in the form of OMB 15 classifications. It serves as an admitted surrogate for presumed underlying genetic variations in particular populations. In the patent and drug approval process necessary to bring the drug to market, race is implicitly recoded as a genetic category. The patent process takes race as a social category and recodes it as "natural" by according it legal force as a component of a biotechnological invention. As corporations and markets come to attach commercial value to race as genetic there will be increased incentives to produce more examples of race as genetic in a commercial context. It is almost as if social categories of race are being used as seed money to produce genetic race as a commodity. Social race here becomes analogous to a sort of raw material that the patent process refines (i.e. purifies and strips of its "social associations") into a "novel" and "useful" manufactured product composed of genetic race. In patenting race, biotechnological inventions actually produce, (or reproduce) race as genetic.

Patent law is supposed to promote the invention of new and useful products. In recent biotechnology patents, race and ethnicity are being exploited in new ways that do not spur the invention of new products, but rather the reinvention of existing products as racial or ethnic. In so doing, patent law both racializes the space of intellectual property, transforming it into a terrain for the re-naturalization of race as some sort of "objective" biological category, and commodifies race and ethnicity as goods to be patented and subjected to the dictates of market forces.

Race has long been used in biomedical research. The new development of using race in patent law can fully be understood only when viewed in relation to broader federal initiatives that shape the production and use of racial categories in biomedical research. Prominent among these are a wide array of federal mandates that dictate the characterization and application of genetically-based biomedical interventions, such as pharmaceuticals and diagnostic tests, in relation to socially defined categories of race. Key federal mandates include: the NIH Revitalization Act of 1993, (PL 103- 43), which directed the National Institutes of Health to establish guidelines for inclusion of women and minorities in clinical research; the Food and Drug Modernization Act of 1997 (111 Stat. 2296), which, in the context of drug development, directed that "the Secretary [of Health and Human Services] shall, in consultation with the Director of the National Institutes of Health and with representatives of the drug manufacturing industry, review and develop guidance, as appropriate, on the inclusion of women and minorities in clinical trials...;" and two subsequent Food and Drug Administration "Guidances for Industry." The first, a 1999 guidance titled "Population Pharmacokinetics," makes recommendations on the use of population pharmacokinetics in the drug development process to help identify differences in drug safety and efficacy among population subgroups, including race and ethnicity.16 The second, a 2005 guidance titled "Collection of Race and Ethnicity Data in Clinical Trials," recommends a standardized approach for collecting and reporting race and ethnicity information in clinical trials that produce data for applications to the FDA for drug approval.17 Underlying the standardization of data collection in all of these mandates are the racial and ethnic categories set forth in the Office of Management and Budget's Directive 15.

Collecting data on race for tracking such issues as health disparities, however, is fundamentally different from using racial categories in a genetic context. The former looks at race in relation to an array of social, environmental, and biological factors to understand disparities; the latter looks at race primarily as a molecular phenomenon. This is particularly so in drug trials that may not control for any of an array of social, economic or environmental factors that may bear on race in relation to health. The same federal directives that have produced valuable race-specific data to help understand the social phenomenon of health disparities are also producing data that are now being taken up for commercial purposes to use race as a crude genetic marker to exploit the gap between the present state of genetic technologies and the future promise of truly individualized genetic therapeutic interventions. Unlike biomedical research into possible correlations between genes and race, however, biotechnology patents tend to construct race as a clearly bounded, unproblematic genetic category. As racial patents proliferate, they may be coming to impose this conception of race-as-genetic onto the design of basic research, clinical trials, and product development.

As researchers derive new inventions based on mining existing genetic data bases, patent law provides powerful commercial incentives to conflate race and genetics. Scientific progress has always existed in a balance with commercial considerations. The rising strategic use of race to obtain extended patent protection for biotechnological inventions, however, portends a serious distortion of this relationship as commercial imperatives drive simplistic and scientifically weak conceptions of the complex relationships between social categories of race and genetics.


Jonathan Kahn is a professor at the Hamline University School of Law. He writes on issues in history, politics, and law and specializes in biotechnology implications for our ideas of identity and citizenship. Much of the material in this article is derived from Kahn's "Patenting Race" which appeared in Nature Biotechnology 24, 1349-1351 (2006).




1. Duster, T. Science 307, 1050-1051 (2005).

2. Editorial. Nature Biotechnology 23, 903 (2005).

3. U.S. Office of Management and Budget (OMB). Revisions to the Standards for the Classification of Federal Data on Race and Ethnicity. (30 October 1997).

4. U.S. Patent No. 6,465,463.

5. U.S. Patent No. 4,868,179.

6. Griffith, V. FDA backs ethnically targeted drug. Financial Times (9 March 2001).

7. Taylor, A. L. et al., N. Engl. J. Med. 351, 2049-2057 (2004).

8. Kahn, J. Yale J. Health Policy Law Ethics 4, 1-46 (2004).

9. Kahn, J. Yale J. Health Policy Law Ethics 4, 1-46 (2004).

10. Herper, M. Race-Based Medicine Arrives. Forbes, (10 May 2005).

11. Royal Society. Personalised medicines: hopes and realities. (Royal Society: London, UK, 2005)

12. Kienzlen, G.. BRCA2 Patent Upheld. The Scientist (1 July 2005.)

13. Gessen, M. Jewish Guinea Pigs.,( 26 July 2005).

14. See, e.g., Parke-Davis & Co. v. H.K. Mulford Co., 189 F. 95 (S.D.N.Y. 1911).

15. 66 Federal Register at 1093.

16. U.S. Food and Drug Administration. Guidance for Industry: Population Pharmacokinetics (February, 1999).

17. U.S. Food and Drug Administration. Guidance for Industry: Collection of Race and Ethnicity Data in Clinical Trials. (September, 2005).

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