David Koepsell

For nearly two decades, nonengineered human DNA was patented without challenge. The US Supreme Court recently agreed that many of those patents do not fit accurately into any currently accepted scheme of intellectual property protection. One should consider: whether DNA fits into other forms of property protection (land, moveables, chattels, etc.); whether DNA warrants a new and unique form of property protection, or whether DNA belongs to the class of objects generally considered to be as “the commons.” Current schemes of patent protection for genes are entirely new, unwarranted by precedent, and utterly aberrant in applying the law of patent. Nonetheless, it bears examining how intellectual property schemes might serve as guidance for new forms of intellectual property protection for genes, if indeed those genes fit into classical dimensions of intellectual property. Private ownership of property has emerged as the dominant legal institution covering modes of possession.

In most traditions, the law is founded upon some extralegal view of morality. There are only a handful of cases prior to the 1970s that involved patenting nonhuman organisms. John Moore made several claims, but the one of most interest to us here was a claim for conversion, which means the unlawful use of another person's property for the enrichment of the person using the thing unlawfully. The cell line produced from Moore's spleen cells was eventually patented by the defendants. The potential market for products relating to that patent was estimated to be roughly $3 billion US dollars. The move from patenting hybridized plants, to genetically altered microorganisms, to human tissues and genes reflected the epitome of the fabled slippery slope. There is clearly a gap between our intuitions about the relations between our individual genomes, our identities, perceptions of privacy and personal autonomy, and the law.

US law has until recently treated unmodified and merely “isolated” genes as a form of intellectual property. Patents protect processes, methods, manufactures, and compositions of matter. Legal theorists and intellectual property scholars have similarly weighed in on the patentability of genes, often uncritical of the strained lines of reasoning that made first “isolated and purified” products of nature patentable, or simply weighing the costs vs. benefits. In the early fifteenth century, the first robust institutionalized forms of intellectual property protection emerged in Europe. This chapter examines the theory of intellectual property implicit in its historical development and looks more closely at the question of whether genes belong to the general category “intellectual property.” The purpose of intellectual property law is to encourage innovation, to discourage secret‐keeping, and to move new knowledge into the public domain after a period of time.

Recent rulings from the US Supreme Court seem to have effectively narrowed the trend toward allowing patents on artificially produced natural products. All objects must have a structural quality and a genetic quality, and if both are the result of some human intention and meet the other criteria of patent (new, useful, and nonobvious) then they may be patentable. There are millions of natural phenomena that are duplicated by man. Products and processes are mutually exclusive categories. No product is a process, and vice versa. This much, the patent law gets right. All objects are either products (continuants) or processes (occurants). There are two types of each: man‐made and natural, for the purposes of intellectual property law. Any discovery of a law or phenomenon of nature involves some degree of intention, some exercise of consciousness and directedness.

This chapter discusses some of the practical consequences of the recent and evolving situation in both science and industry, and forecasts how altering the law might affect each. It considers at least three possibilities: (1) justice demands eradicating patenting genes no matter what the consequences, (2) justice and economic efficiency demand altering the current system to meet both concerns, or (3) the economic effects of altering or eradicating the present system outweigh both the concerns of justice or economic efficiency, and so the status quo should be maintained. The chapter explores each of these possibilities with an eye toward actually proposing rational public policy scenarios that could be adopted. Open Source essentially amounts to the ideal methods of the sciences applied to products in the marketplace. DNA in its natural state is the object of discovery and therefore the domain of science.

The sciences of genetics and genomics are revealing more all the time regarding our statuses as individuals relative to our particular genomes. Geographical isolation is presumably the greatest factor in allowing for populations of a species to change genetically over time, in response to environmental pressures and genetic drift accelerated by the mechanism of sexual reproduction. In order to develop a robust account of what rights individual members of the human species might have to either their own particular DNA or the human genome in general, one need to explain the relations between individuals and species in regards to deoxyribonucleic acid (DNA). The fact that genes carry over from species to species does not mean that those genes are completely identical across all species. Laws and regulations exist that govern the use of human tissues and property rights over their products.

There are a number of ways one could criticize the practice of patenting genes. This chapter argues that computer‐mediated expressions have revealed the false dichotomy in the law of intellectual property and that as new technologies emerge they will continue to pose problems for courts and innovators alike. This is because the range and nature of our expressions is increased with new technologies like computers, nanotechnology, and biotech. Genetic engineering and nanotechnology undermine the distinction between “clearly” patentable inventions and copyrightable works of authorship. Persons carry obligations, rights, moral duties, and are the objects of almost all our ethical and legal considerations. Health care in general has improved to enable us to make more careful predictions about risks and to make choices with greater information. Useful scientific data have emerged from the various “mapping” projects seeking to reveal the intricacies of genomes and phenotypes.

From the late 1980s, scientists began concentrating their search for genes presumed responsible for inherited tendencies to get ovarian and breast cancers on chromosome 17. The Berkeley group and others around the world were closing in on the sequence when Mark Skolnick, a founder of Myriad Genetics, announced successfully isolating and cloning the BRCA1 mutation. In 1994, Myriad and other cooperating parties first filed a patent for the BRCA1 mutation they isolated and then in 1995 they also filed patents for what is known as BRCA2, a related mutation. By 1996, Myriad developed and began marketing “BRCAnalysis™,” their predictive test for the presence of possibly cancer‐causing mutations. Shortly after the American Civil Liberties Union's (ACLU) filed its case against Myriad, a series of cases went up to the US Supreme Court that set the stage for its eventual decision in Myriad, and revisited the subject of Section 101 patent‐eligibility.

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. Except for some viruses that rely only on ribonucleic acid (RNA), all living things are built by the interaction of DNA and RNA within cells and their environments. There is no worldwide consensus yet as to whether portions of the human genome should be granted intellectual property protection, as indeed they are in the United States and a number of other nations. DNA posed numerous challenges to the legal framework for patent protection and may suggest developing an entirely new social and legal category recognizing its uniqueness.

Since the publication of South Park and Philosophy in 2007, Parker and Stone have made some additional forays into religious satire, poking fun at staunch supporters of the Catholic Church and “militant agnostics” among others. This chapter deals with the episodes 200 and 201 in which the “Cartoon Wars” controversy resurfaced, inspiring real‐life death threats aimed at Parker and Stone. Additionally, The Book of Mormon opened on Broadway. This musical comedy extends the obsession with Mormonism in several South Park episodes, featuring a playful, biting, yet loving portrayal of its adherents. South Park is a show born in blasphemy. In “All About Mormons,” Gary, the little Mormon kid, voices the lesson that Parker and Stone frequently teach in their messed‐up way. This same loving yet mocking attitude is displayed in spades in The Book of Mormon, illustrating even more clearly their love of Mormons while ridiculing their religion.

Human research ethics has developed in both theory and practice mostly from experiences in medical research. Human participants, however, are used in a much broader range of research than ethics committees oversee, including both basic and applied research at technical universities. Although mandated in the United States, the United Kingdom, Canada, and Australia, non-medical research involving humans need not receive ethics review in much of Europe, Asia, Latin America, and Africa. Our survey of the top 50 technical universities in the world shows that, where not specifically mandated by law, most technical universities do not employ ethics committees to review human studies. As the domains of basic and applied sciences expand, ethics committees are increasingly needed to guide and oversee all such research regardless of legal requirements. We offer as examples, from our experience as an ethics committee in a major European technical university, ways in which such a committee provides needed services and can help ensure more ethical studies involving humans outside the standard medical context. We provide some arguments for creating such committees, and in our supplemental article, we provide specific examples of cases and concerns that may confront technical, engineering, and design research, as well as outline the general framework we have used in creating our committee.