The Ethics of Patenting Human Embryonic Stem Cells

Chapman • The eThiCs of paTenTing human embryoniC sTem Cells

[ 261 ]Kennedy Institute of Ethics Journal Vol. 19, No. 3, 261–288 © 2009 by The Johns Hopkins University Press

Audrey R. Chapman

The Ethics of Patenting Human Embryonic Stem Cells

ABSTRACT. Just as human embryonic stem cell research has generated contro-versy about the uses of human embryos for research and therapeutic applica-tions, human embryonic stem cell patents raise fundamental ethical issues. The United States Patent and Trademark Office has granted foundational patents, including a composition of matter (or product) patent to the Wisconsin Alumni Research Foundation (WARF), the University of Wisconsin-Madison’s intellectual property office. In contrast, the European Patent Office rejected the same WARF patent application for ethical reasons. This article assesses the appropriateness of these patents placing the discussion in the context of the deontological and consequentialist ethical issues related to human embryonic stem cell patenting. It advocates for a patent system that explicitly takes ethical factors into account and explores options for new types of intellectual property arrangements consistent with ethical concerns.

This article explores the ethical issues raised by human embryonic stem cell patenting. Although critiques of these patents have fo-cused primarily on their potentially detrimental effects on scientific

advancement, the patents raise broader ethical issues as well. It should be noted that the European Patent Office has refused to approve human embryonic stem cell patents on ethical grounds. One of the themes in this article is the appropriateness of, indeed the need for, the incorporation of an ethical component in patenting regimes. The article also considers options for intellectual property arrangements that would provide access for scientific researchers to foundational knowledge that hold significant implications for the public good.

The article is organized into five sections. The first section gives a brief overview of the embryonic stem cell field. The second section considers the feasibility of incorporating ethics into intellectual property norms.

kennedy insTiTuTe of eThiCs journal • sepTember 2009

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The third section provides a discussion of the substantive ethical concerns that human embryonic stem cell patents raise. The fourth section consid-ers utilitarian and consequentialist critiques related to the impact of the patents on scientific advancement. The fifth section reflects on the analysis and assesses some of the proposals for changes in the patent system to resolve the problems identified in the article.

BACKGROUND

In 1998 stem cell investigators at the University of Wisconsin success-fully isolated, cultured, and partially characterized human embryonic stem cells (hESCs) from blastocysts (Thomson et al. 1998). Embryonic stem cells are particularly promising for medical science because they are pluripotent—i.e., able to develop into virtually any type of tissue; they are more malleable than adult stem cells; they are able to continue to divide indefinitely without losing their genetic structure; and they offer insight into the earliest stages of human developmental biology. This research also offers the possibility for treatments, and potentially for cures, for devastat-ing diseases for which adequate therapies do not currently exist, such as spinal cord injuries; type 1 diabetes in children; nervous system diseases, including Parkinson’s disease, Alzheimer’s disease, and multiple sclerosis; primary immunodeficiency diseases; diseases of bone and cartilage; and some types of cancer. In addition, many scientists and medical practition-ers are anticipating that research on hESCs and perhaps other forms of pluripotent stem cells will provide the basis for clinical therapies for the functional repair and replacement of diseased tissues and organs.

However, hESC research has proven to be morally and politically con-troversial because the process of harvesting this type of stem cell results in the destruction of the embryo. This outcome is ethically problematic for people who accord the embryo a high moral status as well as for other persons who believe that nascent human life should not be destroyed for research purposes (Farley 2001; Meilaender 2001; Pontifical Academy of Life 2003; Cohen 2007, pp. 59–110; President’s Council on Bioeth-ics 2004, pp. 53–108). Nevertheless, not all ethicists or persons of faith have such ethical qualms. Many people, including those representing a variety of religious perspectives, believe that embryos should be treated with respect, but not be considered to have the full rights and standing of a human person. For others the moral commitment to healing and to relieving suffering caused by injury and illness takes precedence (Chap-man, Frankel, and Garfinkel 1999, pp. 11–22; Dorff 2002; Peters 2001; Mendiola 2001; Young 2001).


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Researchers working on hESCs have sought patents on their discov-eries. James Thomson, the developmental biologist at the University of Wisconsin who headed the team that was the first to isolate and culture hESCs, filed patents even before publishing his pioneering work (Herder 2006, p. 71). Once the patents were granted, he assigned them to the Wisconsin Alumni Research Foundation (WARF), the University of Wisconsin-Madison’s intellectual property and technology transfer office. WARF’s intellectual property portfolio includes three key patents from Thomson’s hESC research. The first, U.S. Patent No. 5,843,780, issued in 1998, is a composition of matter (or product) patent for the purified preparation of pluripotent primate and human embryonic stem cells. It confers control over the use, sales, research, and import into the United States of all pluripotent stem cells obtained from primates, both human and nonhuman, regardless of who makes them or how. The second, U.S. Patent No. 6,200,806, awarded in 2001, covers Thomson’s process of isolating human embryonic stem cells. It claims that Thomson is the in-ventor not only of the stem cells themselves but also of the resulting cell lines made from the cells. The third, U.S. Patent No. 7,029,913, granted in 2006, is a method for culturing hESCs without the contamination of using an animal feeder layer, and thereby will be central for human clini-cal applications.

In another landmark discovery in the stem cell field, in November 2007 two teams of researchers, one led by Shinya Yamanaka of Kyoto University and the other by James Thomson of the University of Wisconsin, were able to reprogram human skin cells into an earlier undifferentiated state with many of the characteristics of hESCs. Importantly, the development of these reprogrammed or induced pluripotent stem (iPS) cells does not require the destruction of human embryos, and thereby circumvents the controversy about the moral significance of early human embryos. It is unclear, however, whether hESC and iPS cells are completely comparable biologically and whether they will be clinically interchangeable. It may take years to understand fully what the capabilities and limitations of human iPS cells are. Moreover, the only way to evaluate iPS cells will be to compare them at each stage of research to hESCs (Holden and Vogel 2008; Cyranoski 2008a).

Relevant to the subject of this article, both the Japanese and Wisconsin teams quickly applied for patents. Using a fast track procedure, Kyoto University acquired a Japanese patent for Yamanaka’s work in September 2008, and there are also international, European, and U.S. patent applica-


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tions pending in Yamanaka’s name. WARF has applied for U.S. patents involving the iPSC research done in Thomson’s laboratory. In addition, there are several companies collecting iPSC patents and licenses for the commercialization of iPSC technology including iZumi Bio in San Fran-cisco, Fate Therapeutics, Stem Cell Technologies, and Embryome Sciences (Cyranoski 2008b; Resnick and Hopkins 2009).

INCORPORATING ETHICAL DIMENSIONS INTO INTELLECTUAL PROPERTY NORMS

The claim that intellectual property regimes should incorporate ethical dimensions may seem strange to those accustomed to an exclusively eco-nomic or legal approach, but intellectual property arrangements evolved to balance the moral and economic rights of creators and inventors with the wider interests and needs of society. Historically, a major justification for patents and copyrights is that incentives and rewards to inventors result in benefits for the society. The World Trade Organization’s Agree-ment on Trade-Related Aspects of Intellectual Property Rights (TRIPS), for example, provides the following rationale for intellectual property:

The protection and enforcement of intellectual property rights should con-tribute to the promotion of technological innovation, and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations. (World Trade Organization 1994, Part 1, Art. 7)

It is relevant to acknowledge, however, that in the U.S. ethical concerns are not usually seen as relevant to intellectual property policy and norms. There has only been one case where the United States Patent and Trade-mark Organization (PTO) rejected a patent claim primarily on ethical grounds. To bring attention to questions concerning the ethics of genetic engineering and the appropriateness of patenting of engineered life forms, two opponents of human gene patents, Stuart Newman and Jeremy Rifkin, filed a patent application in December 1997 for creating human-animal chimeras (humanzees) that could be up to 50 percent human with the pur-pose of implanting them into surrogate mothers. The patent was rejected by the PTO in part because “the broadest reasonable interpretation of the claimed inventions as a whole embrace a human being” (Wilson 2002, p. 54). Presumably this ruling reflected the U.S. Constitution’s Thirteenth Amendment prohibition against owning another person. Following the filing of the chimera-patent application, the PTO also issued an advisory


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indicating “that inventions directed to human/non-human chimeras could, under certain circumstances, not be patentable because, among other things, they would fail to meet the public policy and morality aspects of the utility requirements” (Seide and Stephens 2001, p. 67).

In contrast with the situation in the U.S., European patent law explicitly incorporates ethical screens that bar some forms of patenting, including, at least in some circumstances, the patenting of human embryonic stem cells. The Directive on the Legal Protection of Biotechnology Inventions, approved by the European Parliament in 1998, has a series of exclusions applying to life. Among them are plant and animal varieties along with essential biological processes for the production of plants or animals (European Parliament 1998, Art. 4(a) and (b)). Article 5 of the Directive excludes the human body and its elements: “The human body, at the vari-ous stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable invention” (European Parliament 1998, Art. 5(1)). The Directive also specifies that inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality (European Parliament 1998) and identifies the following list as examples:

(a) Processes for cloning human beings;(b) Processes for modifying the germ line genetic identity of human be-

ings;(c) Uses of human embryos for industrial or commercial purposes;(d) Processes for modifying the genetic identity of animals which are likely

to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes. (European Parliament 1998, Art. 6(2))

Although the Directive technically applies only to European Union member states, with the goal of harmonizing national biotech patent laws, the European Patent Office, which is independent of the EU, voluntarily incorporated the Directive’s rules in its implementing regulations. Like the Directive, Article 53 of the European Patent Convention on exceptions to patentability stipulates that European patents shall not be granted in respect of “inventions the publication or exploitation of which would be contrary to ordre public or morality” (European Patent Convention 2003, Art. 53(a)). Article 6(2)c of the Directive and its moral exclusions became Rule 23d(c) of the European Patent Convention (Porter et al. 2006, p. 653). A recent evaluation of the European experience with intellectual


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property and biotechnology importantly concludes that it is possible to have a workable patent system that excludes morally offensive inventions from patentability (Brody 2007, p. 106).

In 2004, the European Patent Office refused the WARF application for European embryonic stem cell patents because the invention involved the use of human embryos. WARF appealed this decision. On 27 November 2008 the European Patent Office’s Enlarged Board of Appeal rejected the claims of WARF’s European Patent Application (WARF News 2008a). The opinion of the Enlarged Board of Appeal focused on the European Patent Convention’s exclusion from patentability of an invention that nec-essarily involves the use and destruction of human embryos. The decision also reiterated that the European Patent Convention does not allow the patenting of inventions whose commercial exploitation would be contrary to public order or morality (European Patent Office 2008).

Nevertheless, there is no consensus in Europe on the morality of hESC research, nor is there a uniform European approach to the patentability of hESCs. One analysis of the spectrum of views on patentability identi-fies the UK Patent Office, the Swedish Patent Office, the European Group on Ethics, the European Patent Office, and the German Federal Patent Court as ranging from the most permissive to the most restrictive in their conflicting interpretations of excluded patents based on Articles 5 and 6 (Plomer, Taymor, and Scott 2008, p. 15). In a 2003 practice notice, the UK’s Intellectual Property Office drew a distinction between totipotent human cells that have the potential to develop into an entire human body and pluripotent stem cells, which do not. It stated it would grant patents for hESCs, provided they satisfy the normal requirements for patentabil-ity. The UK does not, however, grant patents for processes of obtaining stem cells from human embryos (Intellectual Property Office 2003). Just before the Enlarged Board ruled against the WARF patent application, the UK Intellectual Property Office filed an amicus curiae submission that argues that the absence of a clear consensus among member states on the morality of stem cell research and patenting should deter the European Patent Office from refusing to grant patents on moral grounds (Amicus Curiae Submission of the United Kingdom 2008).

It should be noted that the exemption language in the European Pat-ent Convention is also incorporated into the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Building on the precedent of the European Patent Convention, TRIPS allows members to exclude subject matter from patenting “to pro-


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tect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment” (Agreement on Trade-Related Aspects of Intellectual Property Rights 1994, §5, Art. 27(2)). Although the United States is a party to TRIPS, there have been few, if any, proposals on how these reservations might be incorporated into the U.S. patent system.

PRINCIPLE-BASED ISSUES RELATED TO THE PATENTING OF EMBRYONIC STEM CELLS

In contrast with the lawyers and economists who assume that ethics are extrinsic to patents, there is a group of ethicists and religious thinkers who believe that intellectual property norms, like other areas of life, should conform to broad moral principles. Their analyses have considered whether intellectual property developments are consistent with ethical principles and religious values such as avoiding the commodification of human life, protecting human dignity, and acknowledging the shared ownership of key social goods. Like other deontological thinkers, they assume that ethical obligations should trump other considerations, but their concerns sometimes seem more symbolic than substantive (Chapman 1999b, pp. 126–66). This section discusses several of the substantive ethical objec-tions to life patents to assess their application to human embryonic stem cell patents.

Ontological Controversy: What Is Being Patented?

Prior to 1980, some two hundred years of legal doctrine conceptualized life forms as “products of nature” rather than as a human invention and therefore ineligible for intellectual property protection. In the landmark 1980 Diamond v. Chakrabarty decision, however, the Supreme Court ruled that a genetically modified strain of bacteria capable of degrading compo-nents of crude oil and thus useful in cleaning up oil spills was patentable as a new and useful manufacture or composition of matter (Diamond v. Chakrabarty, 477 U.S. 303 (1980)). Although the decision affirmed that phenomena of nature in their natural state were not patentable, the Court identified a major exception—goods that have been transformed from their natural state through human intervention. Subsequently, the PTO, followed by the European and Japanese patent offices, began to grant biotechnology patents on new plant varieties, nonnaturally occurring nonhuman multicellular living organisms, including animals, and eventu-ally, discoveries of naturally occurring human gene sequences.


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Ethical concerns about the appropriateness of patenting life forms emerged quickly in both the religious and secular communities, but the U.S. Congress, both then and subsequently, refrained from taking up the issue and setting national policy. The lack of legislative guidelines left the PTO free to determine policy on narrow technical grounds. Baruch Brody’s review of the development of intellectual property norms applied to biotechnology in the U.S. offers extensive evidence that there were many opportunities, all missed, to modify the traditional robust system of intellectual property rights to make it more appropriate to living naturally occurring products (Brody 2006a; 2006b). Recently, the Supreme Court passed up yet another opportunity to clarify important issues related to life patents (Klein and Mahoney 2008). On one central issue, how much change from what is found in nature is required for a product to be pat-entable, the PTO and the courts came to accept the view that the isolation and purification of what occurs naturally is sufficient to make the product patentable (Brody 2006a, p. 11), but there is still often ambiguity as to the nature of what is being patented.

Opposition to the patenting of life forms in this country has proceeded intermittently on a variety of symbolic and substantive grounds. Beginning in 1980, when the General Secretaries of the National Council of Churches, the Synagogue Council of America, and the U.S. Catholic Conference wrote to President Carter shortly after the Chakrabarty decision, many groups within the religious community have expressed concerns about genetic patenting. This opposition often reflected a religiously grounded conviction that biological patents constitute a threat to the dignity and sanctity of life (Chapman 1999b, pp. 145–56). In 1995, the titular leaders of more than 80 religious denominations and faiths in the U.S.—including Protestant, Catholic, Jewish, Muslim, Buddhist, and Hindu—held a press conference to announce their opposition to the patenting of genetically engineered animals and human genes, cells, and organs (Chapman 1999b, pp. 125–31).

One recurrent issue in the debate on the patenting of genes is the nature of the thing that is being patented. Critics of the patenting of life gener-ally assume that genetic patents encompass the gene as a life form. On the other side of the issue, proponents of genetic patenting tend to deny that the actual gene as it occurs in nature is the subject of the patent. PTO decisions generally treat DNA sequences as chemical compounds, patent-able as compositions of matter, if they are isolated and purified (Eisenberg 1997, p. 125). Yet another line of argument is that what is being patented


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is knowledge of DNA, a form of information, rather than the gene itself (Peters 1999, p. 129).

Whatever the merit of the claims that genetic patents do not cover the living gene, it is more difficult to make distinctions between a naturally occurring and a new artificial entity derived via an isolated and purified manufacture with regard to the WARF composition of matter patent on embryonic stem cells. To be consistent, claims that what is being patented is not a product of nature but an “isolated and purified” version of a natural product should require that the resulting product have properties that do not occur in nature. In the case of Thomson’s patent for a puri-fied preparation of pluripotent primate and human embryonic stem cells, no changes are being claimed in the composition of embryonic stem cells equivalent to removing the non-coding introns to produce cDNA, as in gene patents. As described in the patent, the steps of purification and isola-tion do not change the characteristics of naturally occurring hESCs derived from embryos. Thomson’s major contribution is a method for isolating and culturing the cells, which is the subject of the second of his patents, and not the development of a new type of product transformed from its natural state through human intervention. As one critic observes:

It is a claim that reads very much like a description of the method involved in digging for gold, but which then claims the gold itself as an invention. The digging is supposed to have “purified” the gold, but the cell lines are valuable exactly because they are able to behave as they would ordinarily do in one, or several, of their ordinary roles in the developing embryo or in the mature organism that would ordinarily result from embryonic and fetal development. (McGee and Banger 2002, p. 254)

Commercialization and Commodification

Another concern, particularly shared by members of the religious com-munity with regard to gene patents, is that patenting will demean life by turning life forms into a commodity whose value will be determined by commercial considerations (Chapman 1999b, pp. 151–53). How valid is this criticism? In her book Contested Commodities, Margaret Jane Radin (1996, p. 6), a legal theorist, has examined the social process by which something that was previously valued in a noneconomic manner comes to be understood as an appropriate subject of free market transactions. She distinguishes between literal or narrow and broad or metaphorical senses of commodification. Commodification in the narrow sense describes events


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in which material goods and economic services are literally bought and sold. According to Radin, commodification also encompasses a worldview that conceives of human attributes as fungible owned objects even where no money literally changes hands (Radin 1996, pp. 12–13). Much like the religious critics of patenting, Radin believes that the way we conceive of things matters to who we are. She concurs that a commodified view of personhood undermines a Kantian conception of the person as an end-in-itself (Radin 1996, p. 92). Nevertheless, Radin recognizes that com-modification is not an all or nothing process. She introduces the useful concept of incomplete commodification. It refers to a situation in which only one segment of society accepts a commodified understanding.

There is disagreement on the question as to whether human gene patent-ing will promote commodification. Radin acknowledges in her book the potential corrupting influence of market rhetoric. E. Richard Gold (1996) goes farther in his book Body Parts, arguing that making any commod-ity, including human biological material, subject to property claims will translate its valuation into a market price. Moreover, he claims that market modes of valuation preempt other, more authentic and meaningful forms of valuation, such as valuing human DNA, blood, or tissue as inherently valuable in themselves and as being instrumentally valuable in aiding hu-man health. He supports the thesis through an analysis of legal decisions related to property rights and the ownership of human biological materials. According to Gold, property discourse—i.e., the sum of the assumptions, conceptions, and language used by judges, lawyers, and legislators in al-locating rights of control over goods—promotes economic modes of valu-ation because it assumes that proprietary goods are best allocated through the market. He therefore concludes that safeguarding noneconomic values related to the human body requires that human biological materials be treated as nonproprietary goods. To this end, he recommends constructing a method of allocating rights of control over these materials that takes both economic and noneconomic modes of valuation into account, but does not offer the specifics of such a scheme.

David Resnik’s discussion of the implications of the ownership of hESCs for commodification of human beings builds on Radin’s work. Resnik (2002) argues that ownership of hESCs implies only incomplete commodi-fication of human beings because there are important differences between parts and wholes. For him the fact that a part of a human being is treated as a commodity does not infer that a whole human being will also be commodified (Resnik 2002). He does point out though that if these parts


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are seen to have some essential or integral relationship to the whole, the commodification of a part may have broader implications. In this regard, he acknowledges that there may be at least a symbolic (or representative) causal relationship between a whole human being and his or her body parts. But he then concludes that such a symbolic relationship is not suf-ficient to make the claim that commodification of the part is equivalent to commodification of a human being (Resnik 2002, pp. 143–44).

A 2001 opinion of the European Group on Ethics in Science and New Technologies, an independent multidisciplinary body of experts providing advice to the European Commission, distinguishes between isolated stem cells that have not been modified and stem cells that have been genetically modified or modified by in vitro treatments. According to the opinion, cells so close to the human body, the fetus, or the embryo that they have been isolated from may be considered as a form of commercialization of the human body that contravenes the European Directive on Biotechnology. But it is unclear why the European Group concluded that the patenting of modified human stem cells would not raise similar ethical obstacles, and this view is not supported by the European Patent Office (European Group on Ethics in Science and New Technologies 2002, ¶ 2.3).

So what can be said about the implications of patenting hESCs for com-modification and commercialization, both the narrow question of what it means for the status of hESCs and the broader issue of the commodifica-tion and commercialization of the human body? In the years since Radin and Gold presented their views, the commercialization of human body parts has proceeded apace. For example, fertility clinics commonly offer upward of $5,000 for oocytes, with offers of significantly higher figures for eggs from women with specific desirable characteristics. In such a situation, it is becoming increasingly difficult to uphold the notion of the incomplete commodification of the human body. Following the European model of refusing to allow hESCs to become an unrestricted form of intel-lectual property leading to further commercialization would constitute an important symbolic act.

Implications for Human Dignity

Human dignity is widely considered to be a core concept related to human uniqueness and intrinsic worth. The European Patent Office re-stricts the subject matter eligible for intellectual property protection so as to screen inventions that are inconsistent with protecting human dignity. Provisions of the Directive of the European Parliament and of the Council


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on the legal protection of biotechnological inventions exclude inventions from patentability that offend against human dignity and ethical and moral principles recognized in member states (European Parliament 1998, ¶¶ 37–40).

There have been several analyses of whether patenting human genes diminishes human dignity. Of the various concerns that have been put forward claiming gene patenting violates human dignity, Baruch Brody (1999) identifies only two that he considers to raise relevant issues that have potential implications for human dignity. Brody recommends that applications to patent an entire set of genes, if ever proposed, should be rejected, because it would entail commodification of that which defines our identity. His second proposed restriction, related to protecting against eugenics, justifies not allowing the patenting of genetic modifications that are incompatible with protecting human dignity. Otherwise he does not find sound reasons to reject the patenting of a specific human gene on the grounds that it is incompatible with protecting human dignity (Brody 1999).

David Resnik also considers the question of whether human DNA patents can threaten human dignity. Like Brody, he believes that patents on whole human genomes would violate human dignity and should be banned. He also identifies a series of other types of patents that pose a plausible threat to human dignity because they could lead to exploitation, discrimination, or other practices that violate human dignity. The poten-tially problematic patents include patents on genes associated with person-ality, intelligence, height, or other desired traits; patents on human-animal hybrids; and patents on methods for enhancing the human genome or for eliminating “undesirable” traits. His recommendation, however, is not to try to avoid those threats at all costs, but instead to take precautionary measures to minimize risks through regulation, policies adopted by the PTO and other agencies, or legislation (Resnik 2004, pp. 93–129).

However, the patenting of human embryonic stem cells has greater implications for human dignity than the patenting of individual human genes. Certainly human embryonic stem cells are closer to the core of what makes us human than any one of the 20,000 to 25,000 genes constitut-ing the full human genome, many of which are shared with other species. No single gene or set of genes has been as yet identified which codes for “humanness” or essential human traits. If there were to be such a discov-ery, it is likely that there would be proposals to protect these genes from patenting and commercial exploitation.


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It can be argued that a composition of matter patent on hESCs is closer to patenting a full genome than it is to a single gene, something which Brody argued would be contrary to human dignity. Pluripotency is only one step away from totipotency. If provided with a trophoblast and placed in the right environment, pluripotent stem cells would have the potential of developing into an embryo and then a fetus.

There is also the intimate relationship between hESCs and the human embryos from which they are derived. A significant portion of the U.S. population believes that the embryo has the moral status of a person and that it is therefore wrong to destroy or harm an embryo even for beneficial medical applications. Just as this group opposes going forward with hESC research despite its potential benefits, the patenting of hESCs would most likely be deeply offensive to them. Advocates of hESC research frequently concur that the embryo deserves respect or respectful treatment but argue that the use of surplus embryos for significant medical research is consistent with that respect (Lebacqz 2001). Whatever position is taken regarding this latter claim, it is a different matter to destroy an embryo for medi-cal research so as to improve health or give life and for the purpose of commercialization. Support for hESC research does not directly translate into permissiveness for commercial and industrial uses with the risk of violating human dignity.

It is relevant here to note that guided by Rule 23 d (c), which prohibits the patenting of the human embryo on moral grounds, including human dignity concerns, the European Patent Office (EPO) has not granted a single patent with direct hESC claims. In rejecting applications from WARF and the University of Edinburgh, the EPO took a broad interpretation of this rule to exclude both patents detailing the process of extracting stem cells from a human blastocyst as well as patents relying on already-established hESC cell lines as their starting point. In contrast, adult stem cells have been deemed patentable, provided they satisfy the standard criteria of novelty, inventive step, and industrial application (utility) (Porter et al. 2006, p. 653).

UTILITARIAN AND CONSEQUENTIALIST ETHICAL ISSUES RELATED TO HESC RESEARCH AND APPLICATIONS

As previously noted, intellectual property regimes evolved historically as a kind of social covenant that sought to balance the moral and economic rights of creators and inventors with the wider interests and benefits of society. From an ethical perspective therefore the failure to facilitate sci-


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entific research and the development of useful and affordable products undermines the legitimacy of current arrangements. In this section, I evalu-ate whether this concern is a valid issue with regard to hESCs.

Appropriateness of Patenting hESCs

There have been persistent, if intermittently expressed, concerns regard-ing the inappropriateness of genetic patenting because of its impact on the sharing of scientific knowledge and on scientific progress (Eisenberg 2002, p. 1381). The most recent example is a lawsuit filed by the American Civil Liberties Union, joined by cancer patients, genetics professional associa-tions, and public interest law firms, against Myriad Genetics. The lawsuit seeks to invalidate the Myriad patent on the BRCA1 and 2 genes—linked to breast cancer—on the grounds that these gene patents stifle research, interfere with diagnostic testing, and limit women’s healthcare options. Some analysts foresee that this may be a landmark case with implications for the field of gene patenting (Sterling 2009).

Similar questions have been raised with regard to the patenting of hESCs. Given the absence of a significant experimental use exemption from infringement liability in U.S. patent law, patents on foundational discov-eries can impose barriers and burdensome additional costs on research. In particular, upstream patents may hinder subsequent research across a field if they accord a single-entity monopoly control of basic research discoveries (Rai and Eisenberg 2003, p. 296), which of course is the situ-ation with the WARF hESC patents. Recently, the question of the impact of the WARF patents on scientific research came up in the comments on the draft 2009 National Institutes of Health (NIH) Guidelines on Human Stem Cell Research. Respondents expressed concern that because the cells are subject to existing patents there will be insufficient competition in the licensing of such rights and suggested this could inhibit research, as well as increase the cost of any future clinical benefit. NIH responded that the Guidelines do not address the distribution of stem cell research; nor did the NIH amend the guidelines to do so. However, NIH made clear that it expected that stem cell research developed with NIH funds will be distributed in accordance with NIH’s existing policies and guidance, which encourage but do not require open and low cost licensing. NIH also encouraged others to refrain from imposing on the transfer of research tools, including stem cells, any conditions that hinder further biomedical research (NIH 2009). Unfortunately WARF’s history of aggressive and restrictive handling of its patent, which is detailed below, does not conform to NIH’s recommendations.


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Stanford University’s licensing practices for another platform or foun-dational technology, the Cohen-Boyer patents, which cover the technique of recombinant DNA, offer a contrast with WARF. Stanford guided the development of the Cohen-Boyer licenses in a manner consistent with the public service ideals of the university. It also sought to enable genetic engineering technology to be commercialized for public benefit in an ade-quate and timely manner. Consistent with these goals, Stanford did not require other nonprofit research institutions to take a license to use the technology. It also made licenses and royalty rates inexpensive and attached minimal riders. Moreover, the university did not seek to extend the life of the original patents (Feldman, Colaianni, and Kang 2007).

If WARF had had more of a public interest orientation, it might have avoided challenges to its claims, but it did not. In October 2006, two public interest groups, the New York-based Public Patent Foundation and the California-based Foundation for Taxpayer and Consumer Rights, asked the PTO to revoke the patents on technical grounds, primarily that the methods described in Thomson’s claims were already published and available in the public domain (and therefore “prior art”). Several well-known stem cell scientists filed “declarations” to support the request for reexamination stating that Thomson’s derivation of hESCs was “obvious” at the time of discovery and therefore unpatentable since it involved taking an already known technology and applying it to human cells.1 Specifically they argued that Thomson applied the method, dating from 1981, used to harvest and culture mouse embryonic stem cells. The declarations also identified Ariff Bongso at the National University of Singapore as the first person to isolate human stem cells, with him doing so in 1994, several years before Thomson. Their position was that Thomson’s work deserves praise but not patents (Holden 2007).

The reexamination process proceeded in two stages. In a preliminary rul-ing made in March 2007, the PTO declared all three of the WARF patents to be invalid. The PTO found that the process Thomson/WARF described for isolating and maintaining a line of embryonic stem cells would have been obvious to people in the field at the time because of other scientists’ published work (Murray 2007). WARF then appealed the ruling and filed a series of amendments that narrowed somewhat the claims in its three hESC patents (WARF News 2007). In February 2008, the PTO took the unusual step of reversing its reexamination decision and upholding all three of the WARF patents. Its reanalysis concluded that the claims in the patents were not obvious in light of “prior art” (previous research and publications) (Blumenstyk 2008a & b).


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Implications for Scientific Research

As noted, WARF’s three foundational patents cover the most basic aspects of human embryonic stem cell activity. By virtue of its patents, WARF has the legal right to exclude anyone it chooses in the U.S. from making, using, developing other products with, or selling hESCs covered by its claims until 2015, regardless of who derives the stem cells or the process used. hESCs derived in another country become subject to the WARF patent if they are imported into the U.S. Unless they have a prior agreement with WARF, they are vulnerable to being sued for patent in-fringement.

WARF generally has been very vigorous in asserting its patent rights, but it also has facilitated access to and the distribution of hESCs lines in the academic community. WiCell, a non-profit subsidiary established by WARF, provides hESC stem cell lines to academic researchers for a fee. The fee was initially set at $5,000 for each line and then lowered to $500 after WiCell received a contract from NIH in 2001 to operate the National Stem Cell Bank. The provisions through which hESCs are now made available through this bank have streamlined the process and lowered researchers’ transaction costs associated with obtaining hESCs.

To obtain stem cell lines through the bank, scientists have to obtain a license in the form of a material transfer agreement (MTAs) or memoran-dum of understanding (MOU) that recognizes and extends WARF’s intel-lectual property rights. The template agreement confers a nontransferable right to maintain and use the Wisconsin materials within the laboratories of the recipient, with the restriction that it is done solely for noncommer-cial research purposes. The MOU explicitly prohibits research relating to commercial applications or the development of therapeutic applications without an additional much more expensive license. If the recipient makes a patentable discovery that eventually may provide commercial products that benefit public health, the MOU requires that the licensee grant WiCell and the University of Wisconsin a license to use the technology for non-commercial research purposes (WiCell Research Institute, Inc. 2005). The licenses also have reach-through- provisions that require sharing profits with WiCell or WARF (Herder 2006, p. 71).

Another way WARF exercises its control over the field is by requiring any researcher or institution deriving new stem cell lines to obtain licenses from WiCell for their distribution. Harvard University makes the 17 hESC lines derived by its scientists with private funding from the Howard Hughes Medical Institute available without cost to academic researchers, but in


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order to do so, the Harvard Stem Cell Institute first had to enter into a 12-year, $40 million licensing agreement with WARF (Hill 2002). As in the case of researchers applying for the WiCell lines, scientists requesting the Harvard lines first must execute a valid material transfer agreement, not with Harvard but with WiCell. The Harvard website specifying the requirements for access to their cells explicitly recognizes the WARF pat-ent claims (Harvard University 2007).

In contrast with the $500 WiCell charges academic researchers, corpora-tions are charged a much larger up front fee and also must pay substantial annual maintenance fees. Depending on the company’s size, the initial cost of a commercial license ranges from $100,000 to $250,000, plus an annual maintenance fee of upward of $25,000. In addition, commercial licenses require profit sharing arrangements. These fees appear to have discouraged some start-up companies. In May 2005, WARF was reported to have agreed to only seven commercial licenses for specific and limited applications (Wadman 2005, p. 273). By 2008 WARF completed 30 license agreements with 25 companies, including a May 2008 agreement with Invitrogen Corporation (WARF News 2008b).

Imposing additional constraints for hESC research, WARF has granted broad exclusive licenses for commercial development of several types of stem cell applications to Geron Inc., the California biotechnology corpo-ration that partially funded Thomson’s initial research. Exclusive licenses are generally more remunerative than nonexclusive licenses for the pat-ent holder, but they block access by other researchers. Geron’s exclusive licenses cover embryonic-stem-cell-derived cardiac, nervous system, and pancreatic cells therapeutics, three of the most promising areas of research for the development of diagnostics and therapeutics. Geron also holds nonexclusive rights to develop products and commercialize research find-ings that are based on other cell types (Pollack 2002). To work with these stem cell applications, other researchers first must negotiate fees and royal-ties with Geron and agree to sharing profits from their applications, and few researchers have been able or willing to do so (Loring and Campbell 2006). The WARF-Geron exclusive license agreement has been criticized by legal scholars Arti Rai and Rebecca Eisenberg. They view hESC as the type of broadly enabling technology that should be licensed nonexclusively in the interest of promoting future research (Rai and Eisenberg 2003, p. 303). Similarly, NIH (1999) has urged the nonexclusive licensing of unique research materials.


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The inclination of WARF to vigorously assert its patent rights is shown in its reaction to Proposition 71, a measure approved by voters in Califor-nia in 2004 to issue $3 billion in state bonds to underwrite hESC research over a 10-year period. California’s potential to provide grants of nearly $300,000,000 per year for hESC research amounts to nearly 10 times what the federal government was providing during the Bush administration, and the funds are not restricted to research with stem cell lines created before 9 August 2001, as federal grants were then. In 2006 the WARF general counsel announced that WARF would demand license fees and payments on all hESC research funded under Proposition 71 in California and furthermore would apply its commercial rate to the nonprofit and academic researchers being supported by California Institute for Regenera-tive Medicine (CIRM), the agency that distributes the stem cell research grants made available through state bond (Lauerman and Waters 2006). The ostensible reason for treating CIRM like a commercial entity was that CIRM was requiring a 25 percent royalty rate from revenues generated by the nonprofits it funds. WARF’s decision prompted the request for the PTO’s reexamination of WARF’s patents.

In January 2007, a few months after the patent challenge was filed, WARF announced three policy changes. In recognition of CIRM as a not-for-profit grant-making institution, WARF no longer expects CIRM to remit to WARF or WiCell any portion of payment that CIRM receives from its grantees. Other “clarifications” loosened its control and simplified its procedures for industry-sponsored research and academic and commercial licensing. Specifically, the new WARF policy enables industry-sponsored research at an academic or nonprofit institution to be pursued without a license, regardless of intellectual property rights passing from the research institution to the company. To facilitate collaborations within the hESC research community, the policy change allows easier and simpler cost-free cell transfers among researchers (WARF 2007). Making no mention of the patent challenge, Carl Gulbrandsen, the managing director of WARF, attributed the policy revisions to the fact that WARF was “learning how to establish appropri-ate market conditions,” and to that end, “WARF’s stem cell policies have evolved over the years, always in favor of increasing access and making it easier for scientists to move the technology forward” (WARF 2007).

Therapeutic Applications

Embryonic stem cell research is motivated in large part by the hope of developing new therapeutic applications for serious and often untreat-


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able medical conditions. The current business model of seeking broad intellectual property protection for stem cell discoveries will undoubtedly complicate such research efforts, and it also almost certainly will make the resulting therapies considerably more expensive. Under the current system patent holders can charge whatever they wish for their products, and therapies, particularly those that involve biotechnology, tend to come to market at high prices. In turn, cost considerations likely will be a bar-rier to access for many people.

This article has focused primarily on the impact of WARF’s foundational patents on the stem cell field, but the proliferation of other types of stem cell patents is also a problem. A 2005 survey conducted by the United Kingdom Stem Cell Initiative identified nearly 18,000 stem cell patents issued worldwide since 1994, two-thirds of them in the U.S. (Goozner 2006). The vast majority of the patents are likely to apply to adult stem cells, but there are also hESC patents in the mix. By June 2006, the PTO had granted 41 patents that claimed human embryonic stem cells in their title and front pages, sometimes with overlapping subject matter (Porter et al. 2006, p. 653). Researchers and companies have received patents for many different facets of hESC research, including a variety of methods for culturing hESCs, regulating differentiation into many different types of more specialized cell lineages, genetically modifying hESCs, and control-ling differentiation. A website, www.StemCellPatents.com (accessed 11 August 2009), lists more than 1400 U.S. stem cell patents, at least one third of which appear to be hESC related. A Washington-based law firm already has warned clients that “any company or research institution that plans to develop stem cells for therapeutic purposes may face a number of blocking patents and applications that will require licenses, if available” (Goozner 2006).

The policies of some of the states funding hESC research are also likely to encourage the proliferation of intellectual property claims and to impose various types of reach-through arrangements that will affect the field. Although the ostensible purpose behind state funding is to promote essential medical research for public benefit, several of the key states funding hESC research are encouraging patenting by grantees so that the state can share in the licensing fees and/or royalties as a way to recoup their investments. CIRM, for example, seeks to obtain a financial return on the public’s research investment through the recovery of 25 per-cent of revenues from the grantee organization’s share of revenues from licenses for CIRM-funded patented inventions when net revenues exceed


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$500,000 in the aggregate. CIRM also maintains a mandatory licensing provision or march-in authority to prevent underutilization of CIRM-funded inventions. It requires grantees to offer broad research exemptions, but only to researchers in the state (California Institute of Regenerative Medicine 2007). In exchange for funding, Connecticut also retains some basic licensing rights, including a 5 percent share of royalties and other income arising out of funded research (Connecticut 2007). Other states, including Massachusetts and New York, and research institutions have legal provisions that enable them to follow suit.

Many analysts anticipate more aggressive patent behavior by WARF and other patent holders as clinical therapies emerge (Herder 2006, p. 79). Alan Trounson, president of CIRM, has warned that patents could delay development of therapies with hESC cells (apparently without acknowl-edging that CIRM’s own policies are likely to contribute to the problem). He also expressed concern that a biotech company may get a monopoly on certain therapies (Holden 2008, p. 1603). Also any company holding a patent for a therapy would be able to control its distribution and cost.

REFLECTIONS

The analysis in this article shows the need for a new approach to managing scientific discoveries with significant potential public benefit or moral sensitivity. A variety of types of intellectual property approaches for biotechnology have been put forward to overcome the type of scientific advancement and utilitarian problems noted here. Josephine Johnston and Angela Wasunna’s survey of potential proposals for change in patent law published in a recent Hastings Center Special Report is perhaps the most insightful and comprehensive review. Their menu of options with relevance to hESCs includes proposals for revising and tightening the pat-entability criteria, restricting patenting by researchers whose research was supported through public funding, encouraging and facilitating individuals and organizations to place their invention in the public realm, establishing a broad research exemption for general purposes or for specific kinds of research that protects scientists from liability for infringing on patents, discouraging exclusive licensing whereby a single assignee has sole rights to a particular discovery or invention, and enabling patent owners to attach conditions to licenses that require the licensee to do certain things that are in the public interest (Johnston and Wasunna 2007, S23–26). Many of these proposals would require legislation to enact. Fiona Murray has put forward a proposal for the development of an open commons for hESC


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research, combined with strong incentives for commercial research invest-ments. According to Murray, such a scheme would not mean eschewing patent rights, but instead would require a commitment by academic institu-tions to allow wide-reaching reciprocal exemptions for the free exchange of materials for research purposes, with relevant stipulations built into commercial licenses. She envisions that these terms could be extended to for-profit researchers, with an agreement to negotiate effective commercial terms if and when products were identified, while federal agencies could expand their investments in institutions that facilitate the rapid exchange, validation, and comparative analysis of stem cells (Murray 2007).

Although these and other proposals would address the utilitarian and scientific advancement issues, they would not address the broader deon-tological ethical concerns noted in the article. One option to do so would be to follow the European model and establish ethical screens that exclude some forms of patenting that are contrary to morality and the public inter-est. The U.S. could begin this process by adopting and implementing the language in TRIPS and thereby harmonizing U.S. patent policy with other TRIPS member countries. As noted, TRIPS allows members to exclude subject matter from patenting “to protect ordre public or morality, includ-ing to protect human, animal or plant life or health or to avoid serious prejudice to the environment” (World Trade Organization 1994, §5, Art. 27(2)). The exemptions can be broadly or narrowly framed.

The transition to the Obama administration’s new embryonic stem cell policies that remove the federal funding restrictions imposed by President Bush and increase funding for stem cell research would be a propitious time to do so. This change in federal policy has predictably provoked a backlash from opponents of hESC research. It may also generate greater awareness of related issues, including policies regarding the patenting of hESCs. There is considerable overlap between the communities oppos-ing embryonic stem cell research and the groups that previously raised issues about the ethical and theological inappropriateness of life patents (Chapman 1999a, pp. 7–42, & b, pp. 125–65; Mitchell 1999). It is likely that these groups will find the patenting of embryonic stem cell lines to be even more ethically and theologically offensive than the patenting of human genes. Restricting some types of patents on ethical grounds might be viewed as a way to make hESC research somewhat more ethically ac-ceptable.

The introduction of moral considerations into decisions about the granting of patents would raise complex issues about the goals, ethical


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grounding, and criteria to apply. It would also require the incorporation of an expert body into the patent system with the requisite ethics training to make relevant determinations. A third issue would be whether moral and public interest screens should be linked solely with exclusion from patent-ing or whether in some instances moral constraints on the way patents can be used would be sufficient or more appropriate. This would depend in part on whether the technology in question is morally problematic or is a foundational discovery with broad public interest implications.

Baruch Brody’s (2007) recent study of the European experience shows that it is possible to have a workable patent system that excludes many biotechnological inventions from patentability on the grounds that they are morally offensive. Brody’s research, however, also points to the need for well-articulated criteria, preferably emanating from a well-developed theoretical framework, something he believes the European system lacks. Brody is also critical of the narrow European approach to either patent or exclude subject matter and thinks there are other options for handling ethically sensitive or problematic patents.

The European experience also points to the need for attempting to formulate broad accord on these matters before instituting a new policy. Continuing disagreements within Europe over the interpretation of the relevant rules about patent exclusions underscore the difficulties of achieving consensus within a pluralistic cultural and social environment. A participatory, inclusive, and transparent process to shape such an ap-proach would therefore be important. Ethical screens should be formulated through an ethical process.

I thank Christophe Renaud for the background research he conducted for this article, members of the Hartford Ethics Group for their comments on an earlier draft of the article, and several anonymous reviewers for their valuable input.

NOTES

1. To be eligible for patent protection in the U.S., a patent has to meet three criteria established by Congress: novelty, utility, and non-obviousness. As interpreted by the PTO, to be “novel” an invention must not have been known and available to the public at the time of the application. “Utility” refers to usefulness. To qualify, a proposed patent must specify a concrete function, service, or purpose. “Non-obviousness” has a technical definition: an invention cannot obtain a patent if the differences between its subject matter and the prior art are such that “the subject matter as a whole would


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have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains” (35 United States Code, Sec. 103).

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The Ethics of Patenting Human Embryonic Stem Cells

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