On June 17, 1980, the banner headline on the front page of the New York Times read “Science May Patent New Forms of Life.” The article reported on the Supreme Court decision in Diamond v. Chakrabarty, a legal dispute that had captured public attention because of its underlying ontological question: what is life? The patent office, represented by then-patent commissioner Sidney Diamond, argued that life was a special category not subject to the patent laws. On the ground that living organisms were not patentable, the office had denied a patent to Ananda Chakrabarty for a laboratory-created bacterium with improved abilities to break down petrochemicals. In a 5-4 decision, widely seen as a change in patent doctrine, the United States Supreme Court disagreed, ruling that a living organism could be a “manufacture or composition of matter,” and therefore as patentable, ownable, and marketable as any other new gadget. The quality of being alive was irrelevant to patent law.

During the 1980s, following the guidance of the Chakrabarty majority, the patent office considered laboratory-created organisms, as “new products or processes of manufacturing,” whose “introduction . . . into the economy” under the protection of a patent might result in “increased employment and better lives for [American] citizens.” Granting patents to oysters, corn, and mice, it climbed the evolutionary ladder, declining to find any limit to the type of life that might be a patentable manufacture, short of the constitutional prohibition of human slavery.

Outside the patent office, the politics of life were drastically different. President Ronald Reagan and members of his Republican coalition organized themselves around the “sanctity of life” and anti-abortion policies. But as abortion became a hot-button issue in federal politics, the patent office and its divergent instrumentalist understanding of life were ignored. Without public discussion, the patent office was granted non-combatant status in the “abortion wars” of the late twentieth century.

Using its market-driven view of life, the United States patent office led the world in expanding patentable subject matter to include all mammals short of humans. It also granted patents to new technologies of abortion, virtually without objection from anti-abortion advocates. The patent office achieved this form of executive branch exceptionalism by operating in a perceived apolitical zone. I want to understand how this apolitical neutrality existed alongside debates over the patentability of life and despite the abortion wars that engulfed other executive agencies—and the consequences this position holds for patents and politics today.

Rethinking Diamond v. Chakrabarty

Diamond v. Chakrabarty is widely and correctly understood as a pivotal decision that undergirds the biotechnology industry in the United States. When Chakrabarty applied to patent his new bacterium in 1972, it was assumed in the patent office, in the inventive community, and by lawyers and scholars that living organisms were not patentable. United States law promises a patent to anyone who “invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” While arguably the statute encompasses a newly discovered useful plant or animal, the courts have declared such discoveries to be non-patentable products of nature. Thus, the patent commissioner ruled in 1889 that a fiber isolated from pine needles, found to be particularly useful, was nevertheless not a patentable invention, because it was simply “what nature has produced.”

Since 1836, all patent applications have been examined by a patent office employee to determine whether they meet the statutory requirements of patentability. The examiner who considered Chakrabarty’s application rejected it using the familiar product of nature rule, as the bacterium was a living organism. Because Chakrabarty had created a previously nonexistent bacterium by moving genetic material between existing strains, however, it was not clear that he was claiming simply “what nature has produced.”

To bolster the rejection, therefore, the examiner also relied upon a per se rule against patenting life. When General Electric (GE), Chakrabarty’s employer, appealed the rejection to the Board of Patent Appeals, a review panel within the patent office, the Board for the first time in a published opinion articulated what had been the received wisdom as patent office policy, affirming the rejection on the grounds that living organisms, no matter what their origin, could not be “manufactures or compositions of matter.” Life simply was not patentable.

The patent bureaucrats thus made a deliberate decision to declare life unpatentable in order to reject Chakrabarty’s application. This decision was a political move by the office, just as a decision to grant the application would have been. Existing patent law provided a readily identifiable approach to granting the patent. The Court of Customs and Patent Appeals, a patent-savvy court charged with hearing all appeals from denied patent applications, embraced that alternative when GE appealed the Board decision. Rejecting the per se rule, the court instead articulated a distinct vision of life. The new bacterial strain was simply “an industrial product used in an industrial process in a useful or technological art,” in this case, cleaning up oil spills. “Life,” the judges in the majority proclaimed, “is largely chemistry.” New and useful chemicals were patentable, thus, so were novel living organisms.

Why did the patent office decline to adopt a “life is chemistry” approach? Even though the Chakrabarty legal case unfolded in the years immediately after the Roe v. Wade decision when Americans were reacting to the new legal landscape of abortion, there is no indication that the patent office made its decision to defend a bright line rule against patenting life by any perceived need to align patent doctrine with a “pro-life” position. Its motives were less ontological than pragmatic. The patent office picked the less controversial option. The federal politics of life in the early 1970s, when Chakrabarty first applied for his patent, were not yet focused on abortion, but instead, on another hot debate closely relevant to Chakrabarty’s bacterium. In the early 1970s, scientists learned how to “splice” or recombine DNA to insert genes from one species into another. This type of “genetic engineering” sparked such intense controversy that leading scientists, concerned about safety, called for a moratorium on the practice. By denying Chakrabarty’s application, the patent office avoided becoming the first federal office to approve the patent.

When the Supreme Court overruled the office’s attempt to avoid controversy by denying the patent, the Court also created a powerful rationale for excusing the patent office from any controversy resulting from issuing patents. The Court chided the agency for creating a new rule against patenting life, a decision which it declared should be left to what it called the “political branches.”

According to the Court majority, the political branches that should decide whether life was patentable were “the Congress and the Executive.” Ignoring the inconvenient fact that patent commissioner Sidney Diamond was the politically appointed head of an executive branch agency, the Court implicitly carved the patent office out of the political executive branch, leaving it in an isolated apolitical zone in which it should consider living organisms as industrial products. The patent office was thus not only given the mandate to consider laboratory life as chemistry, but the mantle of apolitical neutrality to cloak its actions.

 

The patent office did not consider “life,” but only “technology,” and no amount of moral or political reasoning would change that new approach to living organisms.

 

Although it lost the case, the office had succeeded with its controversy-avoiding strategy. In 1988, the patent office issued the first patent on a mammal, the so-called Harvard oncomouse. In the patent office, all life short of human life was chemistry, and potentially patentable. “We are not patenting life… We are patenting technology,” one patent official said.

Criticism remained limited: in the sole amicus brief filed in support of the patent office’s position in Chakrabarty, biotechnology critic  Jeremy Rifkin had argued that any genetic engineering was a usurpation of the divine role and, further, that there was no scientifically or legally valid definition of life that would preclude the propertization of higher life forms, including humans, once life was considered patentable. The instrumental view of life could not co-exist with the sacred view. While Rifkin persisted in making that argument, and garnered some support over the decades, the argument that patenting life was inherently immoral or otherwise improper failed to gain much purchase in the “political branches” of Congress and the remainder of the executive branch. The patent office did not consider “life,” but only “technology,” and no amount of moral or political reasoning would change that new approach to living organisms.

Abortion Politics and the Patent Office

This discourse of neutrality powerfully supported the non-combatant status of the patent office during the late-twentieth-century abortion wars. The 1980s and 1990s were not, however, the first period during which abortion was a hotly debated sociolegal problem. Throughout United States history, the legal status and moral valence of abortion have changed repeatedly, although, as historian Carroll Smith-Rosenberg reminds us, abortion remains a “socio-sexual constant,” always practiced regardless of its legal, religious, or medical status.

A historical view of abortion-related patents provides perspective on the apolitical exceptionalism of the patent office in the late twentieth century. Just as the disputed status of biotechnology in the early 1970s spurred agency action to avoid controversy about life and its legal status, the patent office long had been taking the sociolegal status of abortion into account when deciding whether to grant or deny applications in this potentially controversial area of technology.

The legal status of abortion has changed radically over time, from an unregulated practice, to a regime of intense but incomplete criminalization, to a constitutionally protected right subject to a shifting set of regulations. When the patent system began in 1790, abortion was largely not a legal matter in the United States. Following English understanding, actions to terminate a pregnancy were legal before “quickening,” that is, before the pregnant woman felt the fetus move. Social disapproval focused on any preceding non-marital sexual activity, rather than on the destruction of a fetus.

Around the mid-nineteenth century, however, elite physicians agitated to criminalize abortion as part of their movement to professionalize. States criminalized abortion at an increasing rate after the Civil War, such that by the turn of the twentieth century, most states had done so. These new laws usually provided an exception for “therapeutic abortions,” that is, abortions performed by a physician in certain situations, most frequently to save a woman’s life.

Under this legal regime that persisted until about 1970, it thus always remained legal for doctors to perform some abortions. Abortion practice in this period included doctors performing legal therapeutic abortions, women attempting self-abortion, leading often to serious health consequences, and a thriving black market in illegal abortions, some of which were safe and effective, and others of which offered grave risk to vulnerable women.

Like the legal status of abortion, the technology of abortion also changed over time. Women have long used both abortifacient substances and physical interventions to terminate pregnancy and turned to a range of practitioners for advice, herbal remedies, and procedures. During the nineteenth century, the safest and most reliable methods of abortion changed from abortifacients to physical interventions. By the turn of the twentieth century, doctors preferred to abort by a dilation and curettage (“D&C”) procedure, while midwives and other practitioners might use physical manipulation to induce miscarriage without curettage. D&C remained the preferred technique for doctors performing abortions until the 1970s, when they began to favor use of vacuum aspiration. Activists within the women’s health movement in the 1960s and 1970s also experimented with simpler techniques, such as menstrual extraction. By the late 1980s, a new approach to non-instrumental abortion, the “abortion pill,” offered another alternative.

Intriguingly, between 1850 and 1970, the period when abortion was disfavored in law and medicine, although not completely outlawed, the patent office issued virtually no patents on inventions specifically described as related to intentional pregnancy termination.[1] This absence of patents ended just as the public discussion about the legal status of abortion was changing rapidly.

The American Law Institute proposed model abortion reform legislation in 1959, designed to give doctors more discretion to perform therapeutic abortions. This legislation was rapidly adopted by twelve states, including California, where then-Governor Ronald Reagan signed the bill into law. By 1967, the American Medical Association (AMA), the largest professional organization of doctors, formally reversed its anti-abortion stance and endorsed abortion law reform. The reform movement, originated by doctors, was joined by women activists advocating complete repeal of abortion laws, which three states did in 1970.

 

As a bureaucratic solution, the office in the mid-1990s instituted the “Sensitive Application Warning System,” an informal internal system to flag potentially problematic applications.

 

Abruptly, and without any public discussion, abortion patents began to issue from the patent office in 1970, several years before Roe v. Wade declared all statutes criminalizing abortion to be unconstitutional. The first patent explicitly claiming an improved abortion technology was granted on an application filed in 1968. Another patent explicitly claiming an improved curette for use in abortions issued in 1972, and then in 1973 and 1974, about fifteen patents related to instrumental abortions issued.

This sharp transition indicates either that, previous to 1968, no such patents were sought, or that the patent office had declined to grant such patents. From the historical record, it is impossible to know how many applications related to abortion were filed with the patent office and denied (until 2000, all patent applications were kept secret). While the number of such patent applications may have been low, it strains credulity to conclude that no innovators in abortion-related technology sought patents during the previous century. Hundreds of thousands, perhaps millions, of women were paying for abortions every year during this period, and numerous practitioners specialized in abortions, creating a market for improved devices and medicines.[2] A closer look at issued patents from this period suggests that some abortion-related patents were sought, but were allowed only when drafted to minimize the connection between the claimed technology and the practice of abortion.

While the words “therapeutic abortion” were not used in any issued patents before 1970, patents did issue for instruments useful in performing abortions. For example, at the turn of the twentieth century, as D&C became the most popular medical technique for abortion, a cluster of patents issued to improved uterine curettes. While uterine curettage could be performed in other circumstances, such as to remove the afterbirth or an incomplete miscarriage, and to treat female infertility, curettes were strongly linked to abortion. In the 1960s, when a small-town family practitioner decided to start performing abortions in defiance of the law, he found the process of ordering curettes from his usual supplier “scary,” believing that the salesman would find it “obvious” that he was ordering such instruments for the purpose of performing abortions.

Given this strong association between curettes and abortion at mid-century, it is likely that these improved curettes were designed in order to better perform abortions. Their innovators, wishing to commercialize their inventions, may have deliberately used careful drafting to avoid a known, but informal, policy of the patent office to deny patents to explicitly abortion-related technologies. While some of these patents specify that the purpose of the claimed invention was the removal of the contents of the womb, sometimes describing the need for curettage after an abortion or miscarriage, other patents were much more vague about the possible use for these instruments, suggesting only “uterine purposes,” and, in all cases, leaving perhaps their most common and lucrative use unmentioned.

If the patent office was denying explicit abortion patents, and through trial and error, patent practitioners learned to work around this quiet prohibition, the question is why. The patent office had a rule that examiners could apply to deny abortion-related patents. Known as the “moral utility” doctrine, it was used to deny patents injurious to the “well-being, good policy [and] sound morals of society.” As long as the medical profession publicized its opinion that abortion was dangerous to women and harmful to society in almost all circumstances, no such patents issued, suggesting that the patent office found this doctrine a convenient means of staying away from public controversy.

But by the time the AMA changed its views in 1967, many doctors had come to view therapeutic abortion as a social benefit, in part because of the enormous toll on women’s health from black market and self-abortions. Immediately thereafter, the patent office began to issue patents claiming improvements in therapeutic abortion technology. Just as the patent office had followed the lead of scientists when considering whether to grant patents to laboratory life, it followed the lead of the most relevant profession, medicine, in considering whether to grant abortion-related patents, in each case refusing patents to disapproved technologies. Above all, it avoided controversy.

The Politics of Patents

These examples of the interplay between the patent office and technologies implicating the ontology of life in the late-twentieth-century United States illustrate both the strength of the current apolitical understanding of patents and the patent system and the unacknowledged politics of patents. This sense of neutrality, ratified by the court in 1980, has been maintained by a long-standing agency practice of refusing to grant patents to deeply contentious technologies. The office avoids controversy even as it does politics constitutively and continually.

 

Like the technological artifacts they represent, each issued patent is a political entity.

 

Since the patent system was created in 1790, patent bureaucrats have been making choices, granting or denying patent applications. Either way, they are doing politics—that is, creating power hierarchies by granting or denying an intangible property interest, often with tangible results. Too much attention to its political role threatens the functioning of the office, as the patent office learned early in its history, and as other parts of the administrative state know well. As a bureaucratic solution, the office in the mid-1990s instituted the “Sensitive Application Warning System,” an informal internal system to flag potentially problematic applications, so that staff could make the decision to grant or deny with full awareness of the possible public response.

The appeal and strength of the patent office’s perceived apolitical nature is understandable. The patent office is simply assumed to exist in a world apart, for largely the same reasons that science has also been considered apart from society—its claims to objectivity and a methodology based on fact-driven, non-teleogical discovery. Patent law deals with technology, technology is based on science, science is neutral, objective, and fact-driven—therefore patent law is also. These common assumptions undergird the narrative of patent office neutrality.

If, however, we acknowledge that patents have politics and that the patent office is always doing politics, then it is not natural or obvious that no one pickets the patent office, or that the Supreme Court carves out the patent office from the “political branches” of the executive and legislative. Instead, that apolitical status needs to be analyzed—where did it come from, what work is it doing, what is it hiding?

While many might applaud that the patent office has not suffered the disruptions that other expertise-based agencies have as a result of the abortion wars, there are also costs that need to be acknowledged. Just like science, technology, and other areas of law, the patent system does not exist in a separate realm. Like the technological artifacts they represent, each issued patent is a political entity, with significant real world consequences. The strategic moves of the patent office to maintain its perceived neutrality have consequences.

In the context of technologies of abortion, these consequences may have included the slower diffusion of safer abortion technologies during much of the nineteenth and twentieth centuries, as innovations were not published as patents. The patent system was created to promote the progress of the useful arts, and denying access to the patent system, or requiring inventors to disguise the uses of their inventions, may have slowed that progress. The granting of patents to a wide variety of living organisms, and then to human, animal and plant genes, has shaped the new biotechnology industry, led the courts in other countries to allow similar patents for fear of disadvantaging their economies, and is now creating the context for genomic medicine and global agriculture. As has been discussed by other scholars, the consequences have included a reconfiguration of world-wide agribusiness based on seed patents and arguably also an altered trajectory for medical research and health care, with negative consequences for public health and distributive justice.

As the patent office considers patent applications to new controversial technologies, such as the gene-editing methodology CRISPR, the patent office may claim that it is only considering “technology” and has no role in ethics or morality, leaving such considerations to “political branches.” Each patent granted or denied, however, is a political act. Granting the patent office the explicit power to consider the consequences of technologies, as some have suggested, would not newly politicize the patent office, but simply change the interpretation given to the patent office’s role by the agency and courts. Just as a woman’s personal choice to terminate a pregnancy has always also been a political choice, patents too have been and remain political.


Kara W. Swanson is Professor of Law at Northeastern University. She earned a B.S. in molecular biophysics and biochemistry (Yale University), followed by a master’s degree in biochemistry and a J.D. (University of California – Berkeley). She is a registered patent attorney and practiced law before earning a Ph.D. in the History of Science (Harvard University) and serving as Berger-Howe Legal History Fellow at Harvard Law School. Her scholarship focuses on the intersections among law, science, medicine, and technology, concentrating on the United States patent system, the regulation of reproduction and the body, and issues of gender and sexuality. She has published numerous articles in peer-reviewed journals and law reviews, such as Women’s Studies Quarterly, Technology & Culture, and the Yale Journal of Law & Feminism. Her research has been supported by the Mellon Foundation, the National Science Foundation, the National Endowment for the Humanities, and the Lemelson Center for the Study of Invention and earned awards from the Society for the History of Technology and the Association of American Law Schools, among others. Her book, Banking on the Body: The Market in Blood, Milk and Sperm in Modern America, (Harvard University Press, 2014), is a medicolegal history of property in the human body, as understood through the twentieth-century history of bankable body products. Her current book-in-progress is tentatively titled Inventing Citizens: Race, Gender and Patents.

This article is an abridged version of a chapter published in Intellectual Property in Context: Towards a Law and Society Perspective, William T. Gallagher and Deborah Halbert, eds. (Cambridge University Press, forthcoming).

 

[1] Counting abortion-related patents is unavoidably imprecise. While full texts of patents before 1970 are available for searching, problems with optical character recognition affect searches. The terms used for abortion during this period are numerous. I conducted searches using the following terms: “abortion,” “pregnancy and termination,” “amenorrhea,” “restor! and menses,” “miscarriage,” and “menstrual extraction.” These searches yield only one patent filed before 1968 that clearly states the invention is “intended for use…chiefly, as regards abortions.” This patent was issued to a resident of Germany for “double spoon pliers,” i.e., forceps, and was filed based on an earlier-filed German application. Konrad Steiglitz, “Double Spoon Pliers for Surgical Operations,” U.S. Patent 1,649,423, filed May 5, 1927, and issued Nov. 15, 1927.

[2] Demand may have been depressed by the opposition of the AMA to all medical patents (Joseph Gabriel, “A Thing Patented is a Thing Divulged,” Journal of the History of Medicine and Allied Sciences 64 (April 2009): 139-42), and by the fact that many innovators may have been illegal abortionists, and thus may have been unwilling to draw attention to themselves by commercializing or patenting abortion technologies. Note, however, that medical patents to other technologies continued to issue during this period, despite the AMA opposition, and that during parts of the criminalization era, illegal abortion practitioners were widely tolerated and advertised publicly, and abortifacient medicines and devices were openly sold at pharmacies.

Addditional References:

For complete references please see the chapter-length version of the article.

Margo A. Bagley, “Patent First, Ask Questions Later: Morality and Biotechnology in Patent Law,” William & Mary Law Review 45 (2003-4): 469-548.

Linda Greenhouse, “Science May Patent New Forms of Life, Justices Rule, 5 to 4,” New York Times, June 17, 1980.

Ryan Hagglund, “Patentability of Human-Animal Chimeras,” Santa Clara Computer & High Technology Law J. 25 (2008-09): 51-104.

Cynthia M. Ho, “Splicing Morality and Patent Law: Issues arising from Mixing Mice and Men,” Washington University Journal of Law & Policy 2 (2000): 247-86.

Sally Hughes, “Making Dollars out of DNA: The First Major Patent in Biotechnology and the Commercialization of Molecular Biology, 1974-1980,” Isis 92 (2001): 541-75.

Daniel J. Kevles, “Ananda Chakrabarty Wins a Patent: Biotechnology, Law and Society,” Historical Studies of the Physical & Biological Sciences 25 (1994): 111-35.

James C. Mohr, Abortion in America: The Origins and Evolution of National Policy, 1800-1900, (New York: Oxford University Press, 1978).

Shobita Parthasarathy, “The Patent is Political: The Consequences of Patenting the BRCA Genes in Great Britain,” Community Genetics 8 (2005): 235-42.

—————, Patent Politics: Life Forms, Markets and the Public Interest in the United States and Europe (Chicago: University of Chicago Press, 2017).

Leslie J. Reagan, When Abortion was a Crime: Women, Medicine, and Law in the United States, 1867-1973 (Berkeley: University of California Press, 1997).

Carroll Smith-Rosenberg, “The Abortion Movement and the AMA, 1850-1880,” in Carroll Smith-Rosenberg, Disorderly Conduct: Visions of Gender in Victorian America (New York: Knopf, 1985), 217-44.

Rickie Solinger, ed., Abortion Wars: A Half Century of Struggle, 1950-2000 (Berkeley: University of California Press, 1998).

Rick Weiss, “U.S. Denies Patent for a Too-Human Hybrid,” Washington Post (Feb. 13, 2005).

Image of the roof of the former patent office, which now houses the National Portrait Gallery and American Art Museum, from Flickr via Tim Evanson

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