Who Owns You?

Science, Innovation, and the Gene Patent Wars

David Koepsell

• Publisher: Wiley-Blackwell
• Year: 2015
• ISBN:
  9781118948484
• Edition: 2
• Topic: Diritto
• Subtopic: Diritto medico

The 2nd Edition of Who Owns You, David Koepsell's widely acclaimed exploration of the philosophical and legal problems of patenting human genes, is updated to reflect the most recent changes to the cultural and legal climate relating to the practice of gene patenting.

• Lays bare the theoretical assumptions that underpin the injustice of patents on unmodified genes
• Makes a unique argument for a commons-by-necessity, explaining how parts of the universe are simply not susceptible to monopoly claims
• Represents the only work that attempts to first define the nature of the genetic objects involved before any ethical conclusions are reached
• Provides the most comprehensive accounting of the various lawsuits, legislative changes, and the public debate surrounding AMP v. Myriad, the most significant case regarding gene patents

1
Individual and Collective Rights in Genomic Data
Preliminary Issues

Life on earth is bound together by a common heritage, centered around a molecule that is present in almost every living cell of every living creature. Deoxyribonucleic acid (DNA), composed of four base pairs, the nucleic acids thymine, adenine, cytosine, and guanine, encodes the data that directs, in conjunction with the environment, the development and metabolism of all nondependent living creatures. (There are ribonucleic acid (RNA)–based viruses and phages, but these are dependent upon other living creatures for their development and propagation.) DNA is composed of genes, each of which is a segment of an organism’s DNA (which for humans is three billion base pairs long). Each gene does something specific, encoding the instructions for a cell’s creation of a protein or an enzyme, which in turn is responsible for cell differentiation, development, and reproduction. The mechanisms are now well understood. We know what DNA does in a very basic sense. The task that science is now completing is developing a full understanding of the relation and role of each gene, and other information encoded in DNA, to the development, functioning, and reproduction of the whole organism. The human genome is of course the one that interests us most, and understanding the role of each gene in causing us to grow and function as we do will afford us greater prediction and control over human health.

The first stage of that degree of understanding was mapping the genome. Once we know where each individual gene falls on the three billion base pair chain, we can start to understand differences among individuals and how they relate to the health and particular characteristics of each organism. The Human Genome Project (HGP) began in the early 1990s as a publicly funded international project to develop that essential map. Along the way, something happened that was only vaguely anticipated and that has resulted in private ownership claims to portions of the human genome. Let us look carefully at the history of the HGP and the emergence of human gene patents before considering some of the ethical implications posed by this new trend.

The Current Conundrum

The human genome has been mapped, and daily more of its territory becomes known and understood. The current map of the human genome is general, giving us a high-level view of the landscape, but much of it remains virgin territory. We have yet to understand precisely how the expression of the data represented by the map helps make us who we are and function as we do. Even so, the outlines of the territories of the map are being claimed, with nearly a fifth of the genome now staked out by various parties, patented against the claims of other newcomers.¹ In fact, the ability to stake those claims was largely responsible for the early completion of the HGP, spurred on by market competitors and funded by the future value of ownership of DNA sequences and the pharmaceutical promise they hold.² While Craig Venter’s company, Celera Corp., was investing millions in developing new rapid sequencing technologies, part of its value statement and justification to its shareholders for the tremendous capital outlays was the proposition that genes discovered in the process could be patented and become part of Celera’s general portfolio of patents. As the US Patent and Trademark Office (PTO) began granting gene patents, other companies, individuals and institutions got into the act. Only after the fact did philosophers, lawyers, and activists begin to consider the practical, legal, and ethical implications of gene patents.

Numerous authors have since considered the practical and ethical issues involved in granting ownership over parts of the human genome. The range of considerations has spanned concerns over autonomy, dignity, economic efficiency, and other important ethical considerations. Most people, when confronted with the fact that their genetic code has been partly patented by a plethora of universities, corporations, and research institutes, visibly blanch and insist that it ought not to be so. It assuredly is so, and a quick search of the PTO filings will reveal thousands of patents currently owned on portions of your genome and mine.³ How can this be? Is it right? Don’t you own your own genetic code or isn’t it at least a commonly owned human good? These questions have been posed, and various ethicists, legislators, lawyers, and theologians have answered in differing ways. Some attempts have been made to reconcile these varied points of view into declarations, codes, and even laws meant to settle the ownership question, to create means of remuneration, or to prevent ownership of the human genome or its parts. For instance, in 2000, the PTO, concerned about “patent stacking” by which companies were filing patents on genes with no yet-known utility, imposed more stringent requirements for utility claims in gene patent applications. As well, some lawmakers have attempted to stop the patenting of genes altogether, as with Congress members Becerra and Weldon’s H.R. 977, “The Genomic Research and Accessibility Act,” which has not yet been passed. Still, thousands of new patents continued to be issued every year, and the public domain in the human genome continued to shrink.⁴

I have written in the past about the nature of intellectual property in general, arguing that there is no natural possessory right to expressions (man-made objects, intentionally produced)⁵ and that we are free to create laws regarding the ownership of expressions as we see fit. I have argued that the dichotomy that pitches “utilitarian” versus “esthetic” expressions, inherent in the distinct realms of copyright and patent, is confusing and ontologically unsound. In truth, expressions are all of a kind, falling along a spectrum, but in no sense are the natural categories of patent and copyright law mutually exclusive. I have argued that understanding the errors of the current ontology (our understanding of the nature of the objects themselves and their relations to each other) of intellectual property leaves us free to restructure our systems of ownership of expressions in more sensible and efficient ways to carry out better the goals of the authors of Article 1, Section 8 of the US Constitution. Given that intellectual property law is the currently accepted and yet most troubling context for discussing whether one ought to be able to exert property rights over the human genome or its parts, it is natural for me to begin with the methodology I have used in the past, namely, exploring the underlying ontological issues and assumptions and considering whether these have a sound basis, or whether we need a fresh perspective.

My methodology rests on a few general assumptions that I believe are uncontroversial, and while much of what follows depends in part on those assumptions, other elements of my argument are merely pragmatic, resting on no particular methodology. To be fair, I assume the following: (1) that while genes do not fully determine who we are, they are largely responsible for our individual traits, (2) that while we can never know anything with absolute certainty, science works because it accepts as true certain foundational beliefs, and (3) that justice is real, not merely invented by human preferences, but founded upon certain immutable, inherent natural kinds. For the philosophers reading this, this makes me more or less a genetic essentialist, a foundationalist, and a natural law theorist, if we must use labels. Nonetheless, while these assumptions work behind much of my argument, other less philosophical and more clearly pragmatic arguments discussed later lead to many of the same conclusions about gene patenting. Moreover, the arguments made by others who have addressed this issue also hinge upon various philosophical assumptions, and they have ranged over a variety of common themes. Whatever their underlying assumptions, the literature and ongoing debate regarding the ethics of genome ownership has so far centered on discussing the following issues:

1. Is the generic human genome part of some collective human heritage?
2. Can individuals exert property rights over their individual genomes?
3. Do patents and other forms of intellectual property protection fairly produce economic efficiencies and innovation?
4. Can states or communities justly regulate economic exploitation of populations’ genomes collected in databases?

All of these issues are important and worth considering, and viewpoints differ markedly. However, no one has adequately addressed a much more basic question that would frame each of these debates, namely, what are the relations among the following entities: individuals, populations, species, the generic “human genome,” and the specific genome of an individual and to what extent do their relations confer various rights, if any?

In other words, we need to work out the ontology of the aforementioned entities to better frame the context for the ethical debates about rights, genes, and property. Although there is clearly an inherent or assumed ontology underlying the present debate, our intuitions suggest that it is ill-conceived and worth reconsidering before we draw conclusions. For instance, the legal and social framework for ownership rights that has long been granted and recognized by patents seems at first glance to be unsound, and various attempts to clarify, restrain, or contain that framework have failed for one reason or another. Let us look at the science in light of that framework and those attempts to reconceive it and ask whether all of these efforts have jumped the gun and made erroneous ontological assumptions.

The Objects of Our Study

Except for some viruses that rely only on RNA, all living things are built by the interaction of DNA and RNA within cells and their environments. DNA was discovered well before its central function in reproduction, cell differentiation, development, and ongoing existence of organisms was fully realized. It consists of four bases—thymine, guanine, cytosine, and adenine—held together by a phosphate “backbone” and famously revealed by Watson and Crick to twist in a double helix. Because thymine always pairs with adenine and cytosine always pairs with guanine, replicating the three billion base pair length of a full human genome requires only enzymatic splitting of that DNA. In other words, when you split it in half down its length, two complete copies of the strand can form due to the natural pairing of the bases. Although part of a highly complex process, the simplicity and necessity of the structure of DNA, as revealed through the work of Watson, Crick, Wilkins, and Franklin, is immediately apparent. DNA is the code upon which the physical machine of an individual is built and upon which it builds its offspring. All of the mechanical functioning of the organism is bound up with this molecule in conjunction with scores of other ongoing cellular and biological processes and the environment, all nonetheless wholly dependent for their inception and continuation on that code.

Reproduction of all organisms involves the reproduction of the code of an organism’s DNA to produce a new organism. In the case of parthenogenesis—the way amoebas reproduce, by splitting themselves in two—the organism’s exact code is merely duplicated (although mutations inevitably occur over generations). In the case of sexual reproduction, the codes of two organisms are recombined into a new, unique individual. While biologists had noted that certain traits appear to be inherited by offspring with predictable frequencies, the mechanism of that inheritance was not fully understood until the role of DNA was revealed. The “genes” responsible for certain traits are instructions embedded within an entire DNA sequence to turn on and off the production of various proteins at various stages of development or function. The entire sequence, all three bill...