Who Owns You?: Science, Innovation, and the Gene Patent Wars

By David Koepsell

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

• Language: English
• Publisher: Wiley
• Release date: Apr 27, 2015
• ISBN: 9781118948484

Book preview

Introduction

Who owns you? It seems an odd and dated question. Slavery, after all, has been universally outlawed, and while exploitation and pockets of indentured servitude, human trafficking, and other modern forms of slavery continue, it is not a real concern for the majority of the human race, most especially those of you who can afford this book. You quite rightly need not fear being owned in the most traditional and reprehensible sense by which humans purchased, traded, and used other humans for labor over many millennia. So what is the fuss? No one owns me, so why should I care? Unfortunately, it is not so simple. New and more subtle forms of ownership have emerged in the past hundred years that now impact on essential qualities and features of each of us. When intellectual property laws were first conceived, the notion was to encourage the invention and authorship of useful and pleasing machines, devices, stories, music, and art. Until recently, thanks to creative interpretations and applications of patent laws, unaltered aspects of living things could be effectively owned. Patents were been issued, in surprisingly large numbers, on the essential building blocks of multiple life-forms, including humans—including you.

You and Your Genes

Before we begin to explore the ways in which patents have been used to claim rights over genes (which are parts of you), let us spend a little time getting to know what a gene is, and how genes relate to you, the species, and every other living thing. There is a more in-depth scientific discussion of genes in Chapter 3, so this will be just a very superficial introduction to get us into the topic, and then we will begin discussing the implications of gene patents ethically, socially, and politically, as well as the legal landscape which has, since the first edition of this book, changed rather significantly of late.

All living things are composed of complex molecules called proteins, as well as other mostly organic (meaning carbon-based) molecules. The instructions for building all of these molecules, and putting them together in the form they are in (as bacteria, monkeys, or elephants, for instance) are encoded in one very complex type of molecule typically known as deoxyribonucleic acid or DNA. We are all pretty much familiar with the depiction of the famous structure of DNA as a double helix, and many are familiar with the drama of that discovery by the scientists Francis Crick, James Watson, and their lesser-known but equally important colleagues Rosalind Franklin and Maurice Wilkins. In sum, DNA encodes the information used by each cell of every living thing to make it grow as it does and live as it does.¹

We are still in the midst of deciphering the complex code of DNA. Scientists are attempting to understand how certain parts of the code are responsible for our individual traits and characteristics, such as eye color, height, appearance, propensities for diseases, and genetic or hereditary diseases themselves. Human DNA has roughly three billion single elements, and we can think of each one of these three billion for now as a digit, or like a bit in computer code—the smallest unit of useful information in the code. Except, in DNA, each bit can have one of four different values (A, C, T, or G, standing for the four nucleic acids involved: adenine, cytosine, thymine, and guanine) whereas in binary computer code, bits are only 0 or 1. Like subroutines in computer code, strings within the three billion base pairs cause certain things to happen in methodical, determinable ways. One of the best understood subroutines is what we call a gene. For decades, scientists have labored under the working hypothesis that each gene codes a protein, which means that there are recognizable substrings within the DNA that cause cells to make specific proteins. Many of our features result from multiple genes working together to grow and enable systems to function. Thus, for instance, there are genes that cause the eyes of all color-sighted animals to grow and maintain functioning cones that enable all of those creatures to view things in color. The genes responsible are shared among all color-sighted humans, as well as all known color-sighted creatures in general, from fruit flies to elephants. Scientists still work under the presumption that every single element of our development and ongoing metabolism is largely directed and maintained by information in certain genes. So, for example, there are genes that produce brown eyes, for producing lactase (which digests milk products), etc.

Scientists are discovering that the one-gene one-protein hypothesis may be an oversimplification, and that the information that directs all of the complex development and functioning of an organism may also come in other useful units. Back in the 1980s and 1990s, a huge multinational science project was created to develop a road map of sorts for the three billion base pair code in human DNA. The Human Genome Project (HGP) aimed at mapping human DNA, and thus showing where the useful bits, conceived of as being genes, appeared in that long string of information. At the start of the HGP, scientists expected to find about 100 000 distinct human genes, but at its conclusion the number found was less than a quarter of that. It actually takes nearly 22 000 distinct genes to make a human. Many now believe that there are other useful ways that DNA stores and uses information, including in elements as short as a single base pair (a single-nucleotide polymorphism (SNP)) as well as larger chunks of genes that get shuffled or rearranged differently among individuals who share that gene. As well, many individual genes appear more than once in the whole genome (that three billion base pair–long sequence) and the number of times and places where that individual gene occurs, its copy-number variation (CNV), also seems to convey useful information that directs differentiation, development, and metabolism.²

The HGP launched in its wake several other efforts to decipher the relations of the string of the whole genome to the information it encodes, the environment, and finally the phenotype, or the physical instances of each and every individual human. Your phenotype is the structure of your body and all its parts, including organs, tissues, metabolism, etc. Your genotype is the string of base pairs of your DNA, its complete structure that contributes significantly to your phenotype. One of these efforts was the HapMap Project, meant to map out the places of individual variation among individual human genomes. Another one of these is the CNV Map Project, which will capture the full range of CNVs, and their roles in phenotypic differences. The ultimate goal of producing all of these maps is a full understanding of all the means by which information is encoded in our genome, and how that information directs and maintains development and metabolism. A full understanding of the genome and its relationship to the environment and the organism should provide us ultimately with powerful new means of treatment of a variety of diseases, both inherited and environmental. Of course, the promise of deciphering all this information, and curing diseases, is attractive scientifically, morally, and also commercially. For decades, there was a land-rush of sorts going over the various maps of the human genome (and other genomes of other creatures too) and the stakes of the claims made were largely patents. Patents over genes and other parts of the genome are the highly prized and incredibly valuable end-points for many of those parties who are bridging the pure scientific research on the genome with commercialization. The result is that parts of you, and every other living human being, have been patented.³

Your Patented Parts

Yes, parts of you have been claimed by patents. Not your knee, not your femur, nor even your kidneys or spleen, but the building blocks of some of various parts, processes, or functions of every human being (and many other species, as we will see) have been claimed to varying degrees under the right of patent by universities, corporations, individuals and other researchers as their property, and they could exclude you until recently from certain uses of those building blocks. This is what a patent represents. It represents a government-granted monopoly to exploit an invention exclusively over the rights of all others.

Let us consider that and what it means to you, to others, to scientists, and to the institutions of science. When patents are granted, they give to the inventor (or whomever files for the patent and holds it) the exclusive right against all others to produce, reproduce or sell a product, or employ a process. So Pfizer, the company that owned the patent on Sertraline hydrochloride, or Zoloft™ as it is known on the market, had the exclusive right to synthesize and market that chemical as well as the exclusive use of whatever original processes it developed to synthesize it. It was a very profitable property right for Pfizer before the patent expired, as the drug has numerous uses and is widely prescribed. Only when a patent on a pharmaceutical expires, can others synthesize it and profit from its sale as a generic, as has happened with Zoloft™. The government-sponsored monopoly awarded by a patent is valuable, giving an exclusive right against all others over the thing patented and all copies of that thing.

Imagine, for instance, that you are the inventor of the bicycle, and that when invented nothing remotely bicycle-like has ever existed. Because your invention is novel, nonobvious, and useful, the government gives to you the right to produce all bicycles in the United States (and thanks to various treaties, other parts of the world where patent schemes exist) for a period of time. That period of time has been extended over the past couple of decades from 17 to 20 years. So for the next 20 years, you can profit from every bicycle sold in the United States.

The monopoly over a patented object constitutes a right to profit, but it also involves a loss of rights for others. Others may purchase your invention, they may take any individual one apart, or learn about its functioning (aided of course by the fact that the patent filing has made publicly available much of the object’s methods, processes, and construction), but no one may reproduce your invention without paying royalties, and especially not if they do so intending to enter it into the stream of commerce. The patent system strikes a bargain in order to spur innovation and invention, and to also benefit the public by moving inventions ultimately into the public domain. This bargain is supposed to provide an incentive for innovators to invest time and money into inventing new and useful things, bringing them to the marketplace with the protection of patents, and then in return, enriching society by making available to all the technique and technology utilized by the original inventor, and making it all free and open to all to use and continue to improve upon when the patent expires.

Make no mistake about it, the patent monopoly is strong. The only thing you have to demonstrate once you have successfully been granted a patent is that some other invention is substantially the same thing as the one you patented and then you can sue the latecomer, get damages for lost profits, and keep them from making and marketing their infringing product for the rest of the term of your patent. Your filing of the patent first is prima facie proof of your ownership of the invention, and the latecomer, no matter what his or her intention, must yield to you in the market. You own that swath of intellectual property. No one may infringe upon it without paying you some royalty or