I Am My Own Man: The Ownership of Genetic Material

Our knowledge of DNA continues to expand and, by extension, so does our ability to manipulate it. Recently, researchers have created a viable organism with a chromosome incorporating pairs of synthetic bases. [1] Others have engineered an organism containing only the genes necessary for life. [2] In addition to advancing our understanding of the life sciences, which may indirectly enhance human welfare, working with genes also has direct applications to human health: for example, genetic testing allows us to more effectively diagnose and treat diseases. [3] Genetic engineering has been extremely useful in cancer research. [4] Outside of the field of human biology, genetically modified crops may be controversial, but they offer significant agricultural and economic benefits. [5]

Yet for all the benefits we stand to gain from our understanding of genetic information, it raises a host of issues which baffle both our legal system and our ethical code. One such issue, which implicates both the law and ethics, is: what does it mean to “own” a gene, and who should do so? This may seem like an intellectual abstraction, but the answer is of great practical importance to medicine and research.

Much legal scholarship considering the issue, including in this publication and on this blog, deals primarily with IP laws. [6] Following the Supreme Court’s decision in Diamond v. Chakrabrty, [7] which has been called the biotech industry’s Magna Carta, one may patent living organisms one has created. This is not restricted to micro-organisms (although patents on humans are prohibited by statute) [8] which has led to suits over, for example, patented mice used for research purposes. [9] The decision remains controversial, with many believing that living beings and their genes simply should not be subject to ownership, of which they consider patents a form. [10] (Arguably, patents are not true ownership but simply a right to prevent certain actions.) Others feared that such patents could hinder medical and scientific practice, with negative impacts on human health and well-being.[11] In 2013, the Court alleviated many of these concerns in Association for Molecular Pathology v. Myriad Genetics. [12] The Court held that one may not patent natural genes but that synthetic genes, including cDNA, are still patent eligible. This removed potential obstacles to genetic testing, and to medical treatment based on genetic analysis. Patents may still pose barriers to research in areas, such as protein synthesis or genetic engineering, which rely on cDNA or other artificial DNA. Such patents may also encourage research in such areas, however, through creating the prospect of a significant financial reward.

Patents aside, the concept of ownership is one way to address the difficult question of balancing individual privacy against encouraging potentially lifesaving medical developments. Although scientific inquiry depends on widespread access to data, many seem to believe that one has property rights over one’s own cells and the genes contained within, including the right to control use of data derived from those cells. [13] In a widely-cited decision, Moore v. Regents of the University of California, [14] the Supreme Court of California held that existing law did not grant such rights. [15] The court declined to extend the law to create one, reasoning that to grant such a right would greatly hinder research, that human biological materials should be regulated by statute rather than by common law causes of action, and that the doctrine of informed consent protected genetic donors from unauthorized use of their genes. [16] Other courts have since reached similar conclusions. [17] Perhaps in response to these decisions, a number of states have passed legislation declaring genetic information to be personal property. [18]

The issue becomes even more difficult writ large, dealing with ownership by a culture rather than by one person, particularly when that culture attaches spiritual value to genetic information. Such information is often shared, or used beyond the purpose of the original study, without the donors’ consent. [19] The practical implications of this were recently demonstrated by the San, a widely studied people living in southern Africa, who issued a code of ethics for those intending to study their genes. [20] Among other provisions, the code requires researchers to consult the San as to conclusions and whether to publish, and forbids re-use of data without permission. Thus, although such a code respects the dignity and values of other cultures, it to some extent constrains the independent analysis that underlies scientific practice. Similar approaches have been taken by indigenous peoples in Australia and Canada, [21] and have been proposed for Native Americans in the United States. [22]

Although discussions of genetic ownership tend to focus on medicine and research, there are other contexts in which genetic information could be valuable; for example, it is thought that some insurance companies have used it in evaluating the risk of potential insurees. [23] Other difficulties are likely to arise as genetic technology continues to advance; for example, one scholar has queried whether operative cloning could undermine traditional animal breeding, and whether an ownership model of animals’ DNA could preserve professions which rely on the value of those animals’ genetic characteristics. [24]

To regard genetic information as personal property may resolve many of the worries associated with uninhibited genetic research; for better or for worse, this approach seems to be gaining ascendancy among the general public and (to a lesser extent) the scientific community. Other difficulties are likely to arise, however, as the full extent of a ‘property right’ in one’s DNA becomes apparent. Popular attitudes towards DNA may harden or change over time, as the public becomes more familiar with genetics. We are far from resolving the debates, legal and philosophical, over the “ownership” of genes. Nevertheless, I suspect that the era of primarily self-regulated genetic research is drawing to a close.

1 Yorke Zhang et al., A Semisynthetic Organism Engineered for the Stable Expansion of the Genetic Alphabet, 114 Proceedings Nat’l Acad. Scis. 1317 (2016); see Ian Sample, Organisms Created with Synthetic DNA Pave Way for Entirely New Life Forms, The Guardian (Jan. 24, 2017), 

2 Clyde A. Hutchison III et al., Design and Synthesis of a Minimal Bacterial Genome, 351 Science 1414 (2016)

3 See, e.g., Martha A. Nance, Genetic Counseling and Testing for Huntington’s Disease: A Historical Review, 174 Am. J. Med. Genetics 75 (2017); J. Martijn Bos, Jeffrey A. Towbin & Michael J. Ackerman, Diagnostic, Prognostic, and Therapeutic Implications of Genetic Testing for Hypertrophic Cardiomyopathy, 54 J. Am. C. Cardiology 201 (2009).

4 See Volkan I. Sayin & Thales Papagiannakopulous, Application of CRISPR-Mediated Genome Engineering in Cancer Research, 387 Cancer Letters 10 (2017)

5 Wilhelm Klümper & Martin Qaim, A Meta-Analysis of the Impacts of Genetically Modified Crops, PLoS One (Nov. 3, 2014); see also Laureates Letter Supporting Precision Agriculture (GMOs), Support Precision Agriculture (June 29, 2016) (criticizing Greenpeace’s hostility to genetically enhanced crops).

6 See, e.g., Clemens Kerle, International IP Protection for GMO – A Biotech Odyssey, 8 Colum. Sci. & Tech. L. Rev. 147 (2007); Darren Harber, Myriad: The Right Decision for the Wrong Reasons, Columbia Science & Technology Law Review (June 18, 2013).

7 447 U.S. 303 (1980).

8 Leahy-Smith America Invents Act, Pub. L. No 112-29, § 33(a), 125 Stat. 284, 340 (2011) (“Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.”).

9 See Heidi Ledford, Ugly Fights Over Mutant Mouse Patents Rise from the Dead, 543 Nature 296 (2017).

10 See, e.g., Jeffrey Sjorgen, Note, DNA: The Emergence of Who We Are and the Reemergence of Religious Commentary and Opposition to Genetic Patents, 17 Rutgers J. L. & Religion 482, 496-502 (2016) (describing religious objections to the patenting of living organisms or their genes); Margo A. Bagley, Patent First, Ask Questions Later: Morality and Biotechnology in Patent Law, 45 Wm. & Mary L. Rev. 469, 495-498 (2003) (describing opposition to patents on multicellular organisms).

11 See, e.g., Jonathan King & Doreen Stabinsky, Patents on Cells, Genes, and Organisms Undermine the Exchange of Scientific Ideas, Chron. Higher Educ., Feb. 5, 1999, at B6; Gene Patenting, American Medical Association,  (last visited Mar. 31, 2017, 11:35 PM).

12 133 S.Ct. 2107 (2013).

13 See, e.g., John M. Conley et al., A Trade Secret Model for Genomic Biobanking, 40 J. L. Med. & Ethics 612, 618-622 (2012) (describing attitudes towards repositories of human DNA and genetic data).

14 51 Cal.3d 120 (Cal. 1990)

15 Id. at 136-142.

16 Id. at 142-147.

17 Wash. Univ. v. Catalona, 437 F.Supp.2d 985, 997-999 (E.D. Mo. 2006); Greenberg v. Miami Children’s Hosp. Research Inst., 264 F.Supp.2d 1064, 1074-1076 (S.D. Fla. 2003).

18 Alexandra Winters, Article, Trespass to Culture: The Bioethics of Indigenous Populations’ Informed Consent in Mainstream Genetic Research Paradigms, 41 Am. Indian L. Rev. 231, 235 (2016) (citing Gary E. Marchant, Property Rights and Benefit-Sharing for DNA Donors?, 45 Jurimetrics J. 153, 160-161 (2005); Nat’l Conf. of St. Legislatures, http://www.ncsl.org/research/health/genetic-privacy-laws.aspx (last visited June 24, 2015)).

19 See id. at 237-242.

20 Linda Nordling, San People of Africa Draft Code of Ethics for Researchers, Science (last updated Mar. 22, 2017, 4:42 PM).

21 Id.

22 Winters, supra note 18, at 247-250.

23 But see Mark A. Hall & Stephen S. Rich, Laws Restricting Health Insurers’ Use of Genetic Information: Impact on Genetic Discrimination, 66 Am. J. Hum. Genetics 293, 302-304 (2000) (arguing that previous findings of widespread genetic discrimination were inaccurate). Although insurers’ use of genetic information is worrying in several respects, it may have potential benefits that are not widely recognized. See id. at 301-302, 305-306; Sandy Raeburn, Implications of Genetic Testing for the Insurance Industry: The UK Example, 5 Community Genetics 102, 107 (2002).

24 David S. Mader, Note, Wilbur’s Conundrum: Property in the DNA of Selectively Bred Animals, 86 Tex. L. Rev. 191 (2007).

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