Original Research

Ethnicity Statistics as Tricky Tools in “Post-Racial” Britain: Celebrating the Lives and Obscuring the Deaths of Mixed-Race Populations

Leifa Mayers

Grand Valley State University
mayersl@gvsu.edu

Abstract

Recently proposed alterations to the United States Patent Act would unsettle the US Supreme Court’s 2013 invalidation of isolated gene patents. Simultaneously, biotechnological advances have led to the increasing availability of preimplantation genetic testing (PGT), which enables the (de-)selection of embryos following in vitro fertilization and prior to implantation. This paper uses the patent debates as an opening through which to examine the nexus of patent law, technoscientific capitalism, and reproductive genetic technologies—specifically, a form of pre-implantation genetic testing (PGT-M) that identifies specific genetic sequences that contribute to disease. Using feminist science studies and reproductive justice frameworks, I argue that the gendered imaginary of “highrisk” investment and health risk management, coupled with the privatization of biomaterial disproportionately produced by women, may exacerbate racial and economic inequities in access to reproductive healthcare.

Keywords

patent law, biotechnology, genomic medicine, moral economy, reproductive justice

Introduction

In 2019 the ongoing debate over what kinds of inventions may be patented reached a crescendo. In January the United States Patent and Trademark Office (USPTO) issued revised guidance on patent eligibility. In April a proposed framework to alter Section 101 of the US Patent Act elicited a wave of feedback from industry stakeholders, government officials, scientific and medical organizations, and academics. In May a “bipartisan, bicameral” (Tillis 2019) draft bill was released, and in June the Intellectual Property Subcommittee of the US Senate Judiciary Committee held three hearings on “the State of Patent Eligibility in America.”¹ The proposed amendments to the Patent Act would eliminate the current prohibitions against patenting “laws of nature, natural phenomena, and abstract ideas,”² exceptions that have recently been upheld by the US Supreme Court.³ While proponents of the proposed changes to US patent law anticipate more expansive opportunities for innovation by pharmaceutical companies and investment in biotechnology, opponents caution against its invitation to companies that wish to patent specific, isolated genes and methods of comparing genetic sequences.

This paper uses the Section 101 debates as an opening through which to examine the nexus of patent law, technoscientific capitalism, and reproductive genetic (or “reprogenetic”) technologies—specifically, a form of pre-implantation genetic testing (PGT-M, formerly PGD) that identifies specific genetic sequences that contribute to disease. Scholars across fields of genetics, bioethics, and law have grappled with the reality of advancing biotechnology and its relationship to (assisted) reproduction (e.g., Deeney 2013; Munthe 2015; Padela and Apiricio 2019). Simultaneously, feminist scholars have argued that inequitable access to assisted reproductive technologies (ART) and genetic screening exacerbate existing health disparities in the United States (e.g., Markens 2017; Roberts 2017). Laura Mamo (2007, 2018) and Laura Briggs (2018), among others (e.g., Bhatia 2018), have considered gendered, racialized, and colonial entanglements of biotechnology and reproductive justice, in particular the implications of global ART markets for those who provide and receive biomaterial and reproductive labor. However, there is minimal research into the convergences of patent law, reprogenetic technologies, and reproductive justice.

I analyzed the 2019 Senate subcommittee hearings on the US Patent Act with attention to the mutual constitution of patent law and technoscientific capitalism. In the first part of the article, I provide a framework for understanding the intersections of emergent reprogenetic technologies and patent law through feminist theories of reproductive justice. Then, I use the Section 101 debates to uncover and contextualize the global capitalist logics of patent law as they intersect with burgeoning biotechnology markets and precision medicine applications. Ultimately, I examine the specific implications for reprogenetic technologies and argue that the gendered imaginary of “high-risk” investment and health risk management, coupled with the privatization of biomaterial disproportionately produced by women, may exacerbate racial and economic inequities in access to reproductive healthcare.

Reprogenetic Technologies and the Paradox of Choice

Reprogenetic technologies produce an interesting paradox: while genetic testing and selection procedures can be used to increase the chances of in vitro fertilization (IVF) success, and thereby lower costs, they increasingly operate coercively within a system that discourages reproduction among poor women and women of color and seeks to eradicate disability (Bridges 2009; Boardman and Hale 2018; Roberts 2017; Roberts and Jesudason 2013). More broadly, resourcing of the development, clinical trials, and applications of genetic testing technologies distorts and diverts (financial) attention from the social inequities that produce health disparities (Valdez 2021). Thus, while technological progress expands reproductive capacities for those who can afford ART procedures, it presents coercive possibilities for those who cannot.

The proliferation of individualized reproductive interventions corresponds with a larger movement toward personalized medicine—and, more recently, precision medicine—which was ushered in with the Human Genome Project of the 1990s (Duster 2015; Juengst and McGowan 2018). Precision medicine is characterized by the (mostly unfulfilled) promise that genomic profiling would allow individuals to manage their health risk and take more responsibility for their health choices and behaviors (Juengst and McGowan 2018; Munthe 2015). With the individualization of health and wellness, individuals may experience increased pressure to manage their and their children’s genetic risk through genomic medicine (Roberts 2009, 2017; Rose 2001, 2006).

The broad category of reproductive genetic technologies includes carrier testing, non-invasive prenatal testing, and genetic testing of an early embryo following IVF. Whereas pre-implantation genetic testing for aneuploidy (PGT-A) looks for missing or extra chromosomes, PGT-M (monogenic/single-gene disorders) is used in conjunction with carrier testing (of aspiring biological parents) to exclude embryos with genetic sequences that contribute to a specific heritable condition (Collard 2021). Thus, PGT-M—and the newer, more controversial polygenic risk score— may be used by those who would not otherwise undergo IVF in an effort to identify and subsequently reduce the risk that a future child will be predisposed to disease (Genomic Prediction, n.d.; Loma Linda University Center for Fertility & IVF, n.d.; Orchid, n.d.).

Fertility clinics and genetic testing companies tout PGT-M as a mechanism for expanded reproductive choice and opportunity. For example, ORM Fertility, a fertility clinic in Portland, Oregon, offers an array of genetic testing technologies through its Sharing Healthy Genes program. In promoting PGT-M, the clinic’s website shares the story of heterosexual couple “Whitney and Brittany, who were concerned about passing on the gene for breast cancer to their future child. Using PGT, they were able to reduce that risk and have a healthy baby boy” (ORM Fertility, n.d.). The information “about each embryo’s genetic status” empowered the couple to “make an informed decision about which embryos to transfer to the uterus for potential pregnancy” (ORM Fertility, n.d.). Similarly, CooperGenomics, a genetic testing company, offers testimonials about how PGT provides “the opportunity to make an informed choice” (CooperGenomics, n.d.-a) and “make a better decision with all the information possible, especially about the risks of transferring each embryo” (CooperGenomics, n.d.-b). This narrative exemplifies dove-tailing discourses of risk and choice, through which consumers are simultaneously empowered with information and coerced into genetic self-regulation.

While some clinics and testing companies promote PGT as a tool of empowerment, many feminist and disability justice activists and scholars decry its eugenicist potential for de-selecting disability-related characteristics. Both the endorsement and critique of genetic selection and testing technologies underscore the privatization of reprogenetic medicine. The combined use of assisted reproductive and genetic selection technologies enable the de-selection of disability-linked characteristics, which reinforces both ableist discrimination and the regulation of reproduction (Boardman and Hale 2018; Roberts and Jesudason 2013). The de-selection of these characteristics, and the medical model of disability that informs it, obscure the social and political structures that individualize and stigmatize disability (Asch 2003; Parens and Asch 1999).

PGT-M can be viewed as a mechanism of future-oriented genetic control, or technology of optimization, on two levels: at the level of the genetically-defined family and at the population level. PGT-M has joined an array of genetic technologies in the knowledge economy and become part and parcel of the industry of genetic risk management. Expanded carrier testing screens for more than three hundred conditions and is increasingly marketed to heterosexual couples who would not otherwise seek IVF; upon identification of two recessive gene mutations corresponding to a single-gene disease, they may use IVF with PGT-M to avoid transmitting the disease to their offspring (Collard 2021; Johal, n.d.). Like direct-to-consumer genetic screening technologies such as those offered by 23andMe, carrier screening promises individuals personalized knowledge of their genetic risk. Unlike these screening technologies, PGT can be used to alter the chromosomal composition of the next generation by deselecting genetic contributors to disease.

Beyond the capacity to recombine genetic material of future generations, PGT-M is uniquely positioned as a contributor to biovalue through the transformation of “abnormal” IVF embryos into forms that support the vitality of other human beings (Collard 2021; Waldby 2000, 2008). Even as some embryos are identified as chromosomally or otherwise normal, and thereby fit for transfer to a uterus, the designation of other embryos as abnormal renders them commodifiable and circulatable within the “tissue economy” (Waldby 2000; Waldby and Mitchell 2006; Van Wagner et al. 2008). Depending on the specific mutation, these embryos may be disassembled and transported as human embryonic stem cell lines for the study of disease development (Collard 2021). Unlike embryos, stem cells are patentable and generate significant speculative investment, both public and private (Collard 2021; Waldby 2008). In this way, abnormal embryos accrue scientific and commercial value in their potential to “eradicate[e] abnormality from existing and future populations—at least among those who can pay for the cures they generate” (Collard 2021, 106).

Patent law supports the “technologies of optimization”—that is, assemblages of practices, ways of thinking, and techniques that maximize health and approximate new norms of humanness—that are part and parcel of technomedicine, a new form of medicine that relies on increasingly advanced diagnostic and therapeutic technologies (Foster 2012, 374; Rose 2006, 9). The capitalization of human vitality and the promise of patentable invention are mutually constitutive, as researchers extract and biotech companies mobilize biovalue—the value derived from living beings and processes—in pursuit of speculative investment and profit (Waldby 2000; Rose 2006; Novas and Rose 2000). As reproductive bodies are the primary site of ART intervention and the generation of reproductive tissue for embryonic stem cell markets, women are compelled to adopt a “somatic ethic” (Rose 2008, 46) in support of these technologies of optimization.⁴ Moreover, women are rendered disproportionately responsible for the management of family- and population-level genetic health risk (Ettorre 2002; Foster 2012; Rose 2006). In this paper, I focus on reprogenetic technologies such as PGT-M as a primary site at which technologies of optimization and notions of reproductive choice and genomic risk converge.

Despite its disfavor among some medical professionals and critics, personalized medicine—including reprogenetic technologies—is still seen as a new, promising frontier for biotechnology industries that is threatened by recent developments in patent law. A 2019 Congressional Research Service report cautioned that recent Supreme Court decisions have “created uncertainty…as to whether innovations in medical diagnostics, personalized medicine, methods of treatment…are patenteligible” (2), and an article in The Hill warned that “the courts’ focus on subject matter eligibility as a mechanism to deny patents for [inventions in diagnostics and personalized medicine] will drive investment into research in these technologies to other areas. We will lose our edge in the world” (Stoll 2015). Patent law is critical to the technologization and capitalization of medicine, as it enables the continued synergies of venture capital, the biotechnology industry, and scientific inquiry (Rose 2006).

In the following section, I use the patent law debates to trace the logics through which the patent system upholds technoscientific capitalism—specifically, through insistence that patents are necessary for investment in “high-risk research and development endeavors.” ⁵ I explore how gendered notions of financial and health risk, present in the Section 101 debates, converge with patent law’s foundational dichotomies, such as private/public, culture/nature, and mind/body, which are both gendered and racialized. Then, I extrapolate from the Section 101 debates’ treatment of genetic technologies, generally, to the specific implications for reprogenetic technologies such as PGT-M. I argue that the patenting of reprogenetic technologies is justified in the name of consumer and reproductive choice, even as that choice is increasingly consolidated among those with geopolitical, class, and racial privilege.

Capitalization, Privatization, and the (Moral) Economies of Patent Law

Subsequent to the impactful US Supreme Court decisions of the 2010s, many government officials, industry stakeholders, and patent experts have expressed concern that US patent-eligible subject matter (PSM) law is “overly complicated, riddled by uncertainty, and…hostile to innovation” (Coons and Tillis 2019), unpredictable, or simply “a mess.”⁶ In 2016 the USPTO solicited feedback and received reform proposals from a number of organizations—including the American Bar Association, the Intellectual Property Owners Association, and the American Intellectual Property Law Association (Osenga 2018).⁷ The draft bill was positioned as an attempt to galvanize these alternative visions, and many of the most powerful voices—including intellectual property firms and pharmaceutical and biotechnology companies—were represented at the Senate subcommittee hearings.

The hearings reflect ongoing debate over the future of US patent law, with particular focus on Section 101 of the Patent Act and its implications for precision medicine, diagnostic methods, pharmaceutical treatments, quantum computing, and artificial intelligence. As applied to technomedicine, specifically, Senators Chris Coons and Thom Tillis (2019)—who drafted the reform bill—view the recent Supreme Court decisions as a threat to “American innovators and companies who are working to develop cures to deadly diseases and medical diagnostic tests that could benefit millions of people.” Thus, the debates provide unique insight into the nexus of technomedicine and patent law, which, as I will argue, has particular implications for the patenting of reprogenetic technologies.

Over the course of three days in June 2019, forty-five testimonies were presented on behalf of scholars, bar associations, trade associations, private companies, and government officials. Thirty testimonies supported, and fifteen opposed, the proposed changes to Section 101. Proponents of the draft language alleged that the uncertainty in current patent law has impacted investment and innovation— particularly in biotechnology and medicine—and advocated for the elimination of all judicially created eligibility doctrine. Opponents encouraged the subcommittee to retain the prohibition on patenting “abstract ideas” and expressed concern about the patenting of genes.⁸

The hearing narratives crystallize a highly circumscribed model of the relationship between patenting, biotechnological innovation, financial risk, and consumer health. On both sides of the Section 101 debate, stakeholders reinforce the notion that patent eligibility rules and jurisprudence determine the development and marketability of biotechnologies, which in turn shape consumer access to healthpromoting and even life-saving medicines. The debates make visible the nexus of patent law’s underlying capitalist and masculinist logics, by which financial control of public resources is rewarded, and the gendered structure of contemporary biopolitics, which places disproportionate burden on women to manage their families’ genetic health risk. A more predictable patent framework is seen as the key to the liberation of capital; genetic patents mitigate biotechnology companies’ financial risk and enable scientific innovations that reduce the health risk faced by patients and advance consumer choice.

Patenting and the privatization of genetic material and methods

As reinforced in the Section 101 debates, the patent system’s false distinction between natural and inventive products facilitates the commercialization of (repro)genetic material and diagnostic methods. By distancing themselves from the patenting of genes, which remains controversial, biogenetic industry representatives were able to present genetic technologies as the next promising frontier of medicine and, by extension, patent law. When a Regeneron Pharmaceuticals representative spoke of “genetics sequencing efforts,” he was careful to clarify that “we are not talking about the patenting of genes. We are talking about the ground-breaking discoveries from our analysis of genetic data and the application of such for the benefit of patients.”⁹ This statement reflects the US Supreme Court’s distinction between a genetic sequence or DNA segment that exists in the human body, which is “a product of nature” ¹⁰ and therefore not patentable, and an “inventive concept” sufficient to “transform” the material into a patent eligible application. ¹¹ In other words, whereas the alteration of genes is patentable, the mere isolation of genes is not (Sherkow and Greely 2015).

Unlike European law, the US patent scheme does not prohibit either specific forms of gene selection or “inventions the publication or exploitation of which would be contrary to ‘ordre public’ or morality” (Bagley 2003). ¹² The silence on such questions, however, betrays a series of maneuvers that have given the US patent system a distinct set of political and economic logics (Nordberg et al. 2018; Parthasarathy 2017). Over the past four decades, US PSM law has advanced the commodification and privatization of biomaterial by focusing on the extent to which natural entities are manipulated by humans. As Dan Burk (2007, 2014) observes, this tightrope walk relies on a series of false dichotomies—namely, mind/body, culture/nature, and private/public—that advance the interests of private capital.

These dualisms are also racialized and gendered, as early patent law characterized invention as masculine, intellectual labor deserving of protection and contrasted with the reproductive and physical labor performed by former slaves and women. The inventor, or male “hero” (Pollack 2006, 606), worked independently to create new forms of knowledge through rational thought while women procreated, the contrast reinforcing the longstanding elevation of mind over body and reason over emotion (Burk 2007; Foster 2011). In contemporary patent law, this mind/body dichotomy converges with a gendered and racialized private/public and culture/nature dualism, which excludes femininized and Indigenous forms of knowledge production from legal protection. Knowledge related to domestic labor—such as cooking and clothing—as well as biomaterial and collectively created Indigenous knowledge are generally “relegated to the public domain as raw material open to exploitation by others” who can meet patentability requirements (Foster 2011, 310; Pollack 2006).

The nature/culture distinction, in particular, is foundational to the patenting of biotechnology and biomaterial and reinforced by the products of nature doctrine. This legal doctrine—which operationalizes the principle that “laws of nature, natural phenomena, and abstract ideas” ¹³ should be kept within the public domain—renders material discoveries that were insufficiently altered by humans patent ineligible (Bagley 2003). ¹⁴ The products of nature doctrine has been used to both protect and deny the patenting of biomaterial. In one case, the California Supreme Court found that a patient did not have rights to his bodily tissue, obtained without his consent, because the natural product was separable from the unique cell lines that were developed. ¹⁵ More recently, the US Supreme Court invalidated a set of diagnostic methods—treating a patient with a particular drug, determining its effect, and then adjusting the dosage—and Myriad Genetics’ BRCA1 and BRCA2 DNA patents as unpatentable claims to natural principles. ¹⁶

While the Myriad outcome was perceived by many as a victory for patients and the principle of genetic ownership, it did not challenge the nature/culture or public/private dichotomies or the ways in which patent law bolsters the gendering of biopolitics—and, specifically, the interpellation and exploitation of those who participate in biomedical and tissue economies. The grounding of patent eligibility in property law enables the designation of natural resources as public and those materials that are sufficiently transformed by human in(ter)vention as private (Waldby and Cooper 2008). When property claims arise from the addition of labor to natural resources, property rights are in effect transferred from those who produce biomaterial to scientists (Waldby and Cooper 2008, 2010).

Because women are compelled to participate in technologies of optimization, their biomaterial and genetic information are routinely furnished as natural resources to be commodified by those with greater power, access, and wealth (Burk 2007; Foster 2011, 2012). Even well-meaning women’s health advocacy “reinforces biopolitical obligations for women to donate bodily tissues and utilize medical technologies” (Foster 2012, 385), arguing that preserving gene sequences in the public domain would enable women’s access to the genetic information that may save their children’s lives.¹⁷ In the Section 101 debates, the interpellation of women into technologies of optimization is evident in repeated appeals to diagnostic testing technologies and treatment of diseases that disproportionately impact women, children, and fetuses—including breast cancer, gynecological cancer, non-invasive prenatal testing, and ultrasound imaging “used in neonatal care.”¹⁸

The false dichotomy of nature/culture—and, specifically, that of naturally occurring genetic sequences versus inventive concepts—enables the commercialization of genetic technologies and advancement of precision medicine. In the Section 101 debates, those advocating for the expansion of patent eligibility to isolated genes and their connections to disease and disability were careful to distinguish between “the patenting of genes as they exist in the body or in nature” and the “useful applications of genes and gene-based technologies.”¹⁹ A Novartis spokesperson described these applications as “the foundation of the future of medicine,” a future that “require[s] incentives [in the form of patents].” ²⁰ Those opposed to the Section 101 changes argued that lifting the prohibition against patenting laws of nature, natural phenomena, and abstract ideas would once again enable the patenting of isolated genes, as the USPTO allowed prior to Myriad. ²¹ However, this opposition does not address the fundamental structure of patent law in the US, by which public resources are privatized and commercialized to profit those with access to the means and meanings of invention. Moreover, as I will explore further below, such challenges leave intact the gendered and racialized logics of exploitation specific to the production and circulation of biomaterial.

The capitalist logics of patent law

The products of nature doctrine and its privatization and commercialization of genetic material and diagnostic methods is part and parcel of the systemic entanglement of patent law and capitalism. The Senate subcommittee hearings both underscore and advance the assumption that patents are necessary for financial investment in new technologies, and therefore technological innovation itself. Patrick Kilbride, representing the US Chamber of Commerce, situated intellectual property rights within private property law and a distinctly American form of global capitalism. He described the legal framework for private property as enabling the production of capital, which makes the US “an engine of growth for the entire world.” ²² US “leadership in global technology innovation” is important to maintain the nation-state’s status as “the most innovative country on the planet” (Coons quoted in Tillis 2019). Testimonies reinforced a simplistic relationship between patent law, capitalism, and American exceptionalism: Whereas pre-Myriad patent law was conducive to the flow of capital toward projects that bolster innovation, the “Supreme Court’s unconstitutional decisions have forced research funding away from isolated natural products and personal diagnostics.”²³

The contemporary US patent system assumes the primacy of free market capitalism in advancing economic and social progress (Parthasarathy 2017). Although the primary rule of PSM law is that “laws of nature, natural phenomena, and abstract ideas” are not patent eligible,²⁴ since the 1980s judges and scholars have focused primarily on the question of whether the patent would promote or “inhibit future innovation” (Chiang 2014, 1891).²⁵ This tautological logic of innovation enables patents’ continual creation of economic value; that is, patents are seen as necessary for innovation and reward that innovation with financial investment. Hyo Yoon Kang (2020) notes that patents mediate risk through a secondary market for the patent rights, which exists independent of the commodity market for the invention. Through “legal fiction” (Kang 2020, 65), patent rights become financial assets that are valued and exchanged according to the likelihood that the rights will hold up in court. Thus, the patent system itself has created intangible assets that are valued according to its own logics.

The patent system supports the “assetization” (Kang 2020) of genetic material and diagnostic methods, by which they are not only commodified but also become value-(re)generating in primary (i.e., commodity) and secondary markets. Nikolas Rose (2006) describes the capitalization of vitality, or the practices by which biotechnology companies structure scientific inquiry into, and financial valuation of, biological processes. With the ascent of the biotechnology industry in the 1990s and 2000s, a new “somatic ethic” (Rose 2008, 46) developed whereby individuals participate in the extraction of biovalue from their own bodies.

Set against the gendered logics of patent law, the assetization of genetic technologies and material and accompanying somatic ethic produces a unique matrix of risk, whereby health risk management bolsters the financial potential of genetic patents. Upon creation, personal genomic information, embryos, or stem cells may be sold and resold across research, healthcare, and biotechnology sectors. Additionally, the patenting of testing technologies and information about specific gene sequences—such as those identified by PGT-M—may generate value within secondary intellectual property and venture capital markets (Geiger and Gross 2021). Therefore, I contend, consumers’ uptake of genetic risk management strategies may in fact mitigate the risk of “investing in innovation” (Kang 2020, 57), as either use of the testing technologies or the resulting biomaterial (or both) may result in profit.

In the following section, I describe how the Section 101 debates illustrate the gendering of the US patent system’s intersections with reprogenetic medicine. I juxtapose the gendered language of used to describe biotechnological innovation with the gendered and racialized materialities of genetic technologies. I argue that the patent system rewards inventors for “risky” investments that reinforce US exceptionalism while women consumers, specifically, are encouraged to extract genetic material and genomic information. Although patents purportedly democratize invention and enhance access to testing and treatment, they in fact enable the commodification and privatization of public biomaterial. Meanwhile, a stratified reprogenetic industry promises reproductive choice to some—with the implicit suggestion that they eliminate disability-linked characteristics—while discouraging the reproduction of those who cannot afford to manage their genetic risk (Roberts 2009, 2017; Rose 2001, 2006).

Gender and the Moral Economy of Hope, Choice, and Risk

The Section 101 debates advance two interrelated myths that uphold the imbrication of patents, capitalization, and technologization: that patents democratize invention, and that patents increase consumer access to beneficial (biotechnological) products. During the Senate subcommittee hearings, a US Chamber of Commerce representative described how intellectual property rights serve “the public interest in creativity and innovation” and allow all would-be inventors—regardless of financial or political means—access to a patent and ensuing financial investment and innovation: “In the democratized American system the inventive capacity of every citizen was liberated and could be put to work.” ²⁶ The notion that patents facilitate inclusivity both belies the realities of patent protection and consolidates the power of patent holders.

This myth reflects the widespread view that patent law facilitates both free trade and scientific knowledge production, and that privatization supports the free exchange of (formerly public) ideas and goods (Foster 2012). During the period of monopoly protection, inventors maintain control over their inventions and, in return, are required to publicly disclose the scientific basis of the invention. When patent rights expire, the invention may be integrated into the flow of the free market. However, critical scholars challenge the inevitability of private-public symbiosis and the notion that patent rights facilitate the production and sharing of scientific knowledge (Foster 2012; Parthasarathy 2017). As I explore further below, the privatization of public materials enables the exploitation of the knowledge and biomaterial of poor women and women of color, who may be excluded from the patented product’s benefits.

As reflected in the Section 101 debates, the patent system supports the commercialization and privatization of diagnostic tools and biomaterial through the promise of increased consumer access to technologies of optimization. Biotechnology organization and biopharmaceutical industry representatives drew connections between the “high-risk” pursuit of invention and the health risks that Americans face without these “life-saving” technologies.²⁷ Throughout the Section 101 debates, venture capital firms’ investments in the development of technologies that impact public health are described as “risky” but “necessary.”²⁸ Where the gendered foundation of the patent system—by which masculinized invention (and its financial support) is used to control feminized (reproductive) labor and public resources—converges with precision and (repro)genetic medicine, a gendered duality of risk emerges.

With a focus on diseases that impact women, infants, and fetuses—and embedded within biopolitical logics that disproportionately render the management of genetic risk the responsibility of women—the Section 101 debates feature this duality of risk. The “risk-taking and long-term investment” inherent in the patent system is viewed as the antidote to the risk posed by diseases such as breast and ovarian cancer, and the key to assessing individual genetic risk.²⁹ Without patents, the argument goes, venture capital will abandon the biotechnology industry, risk-sharing of “biotech inventions of great societal value” will no longer be possible, and patients may never receive “the next new cure or treatment.”³⁰ This “promise of future innovation to treat and/or cure disease” (Foster 2012, 375), or moral economy of hope, sustains both technologies of optimization and the award of patents. Inventors offer a story of potential profit and/or cure, patents validate this promise, and investor commitment both signals and enables the success of biotechnological inventions. Thus, patent law both facilitates and benefits from the promise of innovations that not only address disease but optimize human health.

Illustrating this moral economy of hope, Gonzalo Merino, speaking on behalf of Regeneron Pharmaceuticals, described the genetics sequencing work that enables them to make “tremendous advances in identifying new therapeutic indications, build better-informed clinical trials, shorten developmental timelines and advance precision medicine efforts.”³¹ Along with Merino, representatives of biopharmaceutical firms and research organizations such as Johnson & Johnson, Genentech, Inc., and the Pharmaceutical Research and Manufacturers of America suggested that mitigating corporate financial risk through patent protection will produce safer and more effective risk assessment, diagnosis, and treatment, increase “sharing of scientific information” with patients, and reduce healthcare costs.³²

While experienced differently by each, this “ethos of hope” (Rose 2006, 17) draws together scientists, healthcare practitioners, and patients. Sherry Knowles, a selfdescribed breast cancer survivor, went so far as to assert that she and “hundreds of thousands of other women” would have died in the absence of patent protection for the pharmaceuticals with which she was treated.³³ In the donation of biomaterial to research, two forms of hope may be experienced by the donor; Sarah Franklin (2006) describes how the donation of eggs and embryos to stem cell research signify the reciprocation of individual reproductive hope with the contribution to a collective hope for scientific breakthrough.

The dual hope for innovation and cure stimulates both circuits of capital and individuals’ uptake of technologies of optimization. Patent law facilitates the commodification of genetic material through its promise of information and treatment that will be universally accessible. However, the temporary monopoly that is granted through patenting ensures that access to testing and treatment will be restricted to those who can afford it. There is evidence that Myriad’s patents stifled clinical testing and academic research and decreased access to medical diagnostic tests even as testing costs increased (Keay 2012).³⁴ Rather than bring down the costs of genetic technologies, patents generally restrict options and reduce availability, thereby exacerbating race- and class-based disparities in access to healthcare. For example, Myriad’s gene sequence patent ensured that its testing technology would be the only one available.

Nevertheless, the gendered burden of technologies of optimization ensure that women will be routinely exhorted to manage their own and their (prospective) children’s health risk (Roberts 2017; Rose 2001, 2006). Women are invited to ascertain their genetic risk through discourse of choice and the promise of genetic information, even as their testing options are limited (Foster 2012). When mobilized to market reprogenetic technologies, this moral economy of hope reinforces the ableist notion that the eradication of disability will lead to a more desirable and just future (Clare 2017; Kafer 2013). Thus, gendered technologies of optimization bolster race- and class-based healthcare inequities and ableism.

At its intersections with reprogenetic technologies such as PGT, patent law— rather than democratizing innovation and benefiting consumers—may amplify existing reproductive healthcare disparities. As public goods are increasingly privatized and commodified, patent law enables the separation and transfer of genetic material from the body to the inventor and into “global circuits of capital” (Foster 2012, 373). Moreover, the designation of public resources as extractable enables the disproportionate exploitation of women through the imposition of increasingly mandatory reproductive “choice” and the expectation of genetic risk management. PGT-M, specifically, may operate as a technology of optimization through which genetic risk is both managed and becomes the pivot point for the production and circulation of biovalue. In turn, patent law incentivizes both the extraction and exchange of genetic information and material, including embryos produced during IVF and stem cells that may be derived from “abnormal” embryos, and makes health interventions available to the wealthiest consumers.

As patents for genetic testing technologies proliferate, technological advances are likely to harm rather than help those who cannot access its benefits. While many industry spokespeople promise increased access, the “privatization of the genomic commons” (Geiger and Gross 2021, 638) disproportionately harms poor women and women of color. As established in Myriad, patents are likely to narrow the options and increase the costs of reprogenetic technologies, which would most impact those with limited access to healthcare. Meanwhile, reproductive biomaterial—including genes for breast cancer research and eggs for fertility and stem cell research—is made available for patenting and circulation in global markets (Foster 2012, 392; Waldby and Cooper 2008, 67). While wealthy, white ART users are most likely to donate “abnormal” embryos to stem cell research, poor women in the US and elsewhere are increasingly recruited to sell their eggs to meet the demands of expanding stem cell research markets (Waldby 2008). Thus, poor, Black, and Indigenous women’s bodies and labor become “sites of extraction” (Foster 2012, 376) for medical experimentation and pharmaceutical development even as they are denied their benefits (Owens 2018; Waldby 2008).

Even assuming the ongoing exclusion of laws of nature, natural phenomena, and abstract ideas from patent eligibility, the recognition of particular forms of labor and private property ensures that research and development endeavors are protected while their purported beneficiaries are not. Nonetheless, PGT is marketed through the rhetoric of reproductive choice (Van Wagner et al. 2008). The promise of reproductive choice reinforces the patent system’s commodification of risk— industry support and financial protection for “high-risk” endeavors increases corollary to consumer desire to mitigate their individual genetic risk. Thus, a moral economy of hope, buoyed by rhetoric of reproductive choice and financial and genomic risk, bolsters patent law’s circuits of biocapitalist exploitation.

Challenging the Nexus of Capitalism and Patent Law

The relationships between patent law, genetic testing technologies, and precision medicine are continually (re)written (Ray 2023). In 2015 the Federal Circuit Court of Appeals applied the two-part Alice Corp v. CLS Bank International (2014) test for subject matter eligibility to a method of non-invasive prenatal testing developed by Sequenom.³⁵ The determination that the method of using cell-free fetal DNA from the amniotic fluid of a pregnant woman to diagnose fetal genetic conditions did not constitute an inventive application of a natural phenomenon would seem to corroborate Rebecca Eisenberg’s contention that “diagnostic applications are not patent eligible” (2015, 257). However, others suggest that genetic testing and precision medicine have benefited from recent jurisprudence, both in terms of innovation and patient access (Ray 2023). In 2020 the same Federal Circuit Court validated a patent for a method of identifying and separating cell-free fetal DNA from maternal DNA within maternal plasma; the court reasoned that the method was sufficiently inventive because the maternal blood plasma composition was altered by such separation.³⁶

While those opposing changes to Section 101 may be tempted to endorse the judicial reading of PSM law consistent with Myriad and subsequent cases, this interpretation would not challenge the fundamental logics of the US patent system. Prominent proposals to intervene in the symbiotic relationship of genetic technologies, patent law, and technoscientific capitalism fail to disrupt the capitalist underpinnings of patent law. Rather, they call for increased competition for publicly available biomaterial and the deferral of patent ownership in hopes that testing and treatment will become more accessible to more people (Foster 2012). For example, an open public domain model calls for the restriction of patenting in favor of the free exchange of scientific ideas and materials, including “natural” resources (Foster 2012). However, this model replicates the ideals central to free market capitalism—namely, the notion that free trade and competition will spur innovation (Foster 2012). Such proposals do not attend to the ways in which different groups of women are differently situated in these networked relations of power, impacted by both increased pressure to manage their families’ genetic futures and their uneven access to reproductive technology markets (Foster 2012; Waldby 2008).

With PGT-M squarely in focus, I urge a two-pronged approach to the intersections of patent law and reprogenetic technologies through which both genetic information and biomaterial may be produced for circulation in national and global markets. In addition to addressing the capitalist underpinnings of patent law, I suggest that a feminist framework must also account for the specific technologies of optimization (e.g., PGT-M) and moral economy of hope, choice, and risk through which gendered and racialized subjects are differently interpellated into interconnected patent and technoscientific markets.

Feminist scholars have critiqued the private/public dichotomy in patent law and proposed alternatives. Laura Foster advocates for a “protective public domain” (2012, 379) model that would keep natural resources in the public domain and available for research while recognizing communities’ differential access to the public domain and hegemonic knowledge production. In order to address the patent system’s racialized and gendered foundations and its rootedness in property law, Catherine Waldby and Melinda Cooper (2008, 2010) suggest recognizing women’s donations of biomaterial (including eggs and stem cells) as a form of reproductive labor—and, more precisely, regenerative labor in the case of stem cells. This conceptual expansion would disrupt the culture/nature and mind/body dichotomies that privilege masculinized forms of in(ter)vention and deprive donors of property rights (Foster 2012).

In the context of PGT-M, a hybrid protective public domain and reproductive labor model would require the reconceptualization of the time and biomaterial— including “abnormal” embryos from which stem cells are derived—put toward research in terms of labor. Further, it would recognize and address the gendered, racialized, classed, and ableist power relations that structure scientific knowledge production and access to technology within the financialized patent system. I argue that, in order for these interconnected interventions to be successful at the interface of PGT-M and patent law, they must center the moral economy of hope that animates technoscientific capitalism and reprogenetic technologies.

First, this approach must expose and disrupt the assumption that patent protection is necessary to technological innovation, as well as the teleological narratives of progress that justify increased intervention into the human genome. Second, this approach must recognize the moral economy of hope, choice, and risk that sustains the relationship between patenting and financial investment and the operation of PGT-M as a technology of optimization. The information that is produced through carrier screening and the genetic de-selection that is enabled by PGT-M in conjunction with IVF are positioned as not only hallmarks of technomedical innovation but also the required—and differentially accessible— choice for responsible consumers. The questioning of both positions, as well as the collusion of such choices with the eradication of disabled characteristics, may at least forestall the further entanglement of capitalism and patent law.

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