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GENEWATCH
NATURALLY OCCURRING GENES AND THE COMMONS BY NECESSITY By David Koepsell One frequent response to various arguments against gene patents is the claim that without such patents the biotech industry will falter. There is very little evidence for this, and recently the trend has been that corporations are seeking fewer patents on unmodified genes. This trend is no doubt motivated by recent shifts in the legal landscape creating greater uncertainty about the future of gene patenting in general. The decision by Judge Sweet in the AMP v. Myriad case, the report of the SACGHS, and the Department of Justice's recent amicus brief opposing patents on unmodified, but merely "isolated" genes have necessitated greater caution in patent filings. If these trends continue, only modified sequences are likely to remain patent-eligible. The DOJ's brief sets the standard pretty low for modification, given that they conclude that cDNA is sufficiently inventive to be patent-eligible; but all of this nit-picking and dithering around the edges of patent-eligibility for genes, and bargaining among parties who clearly believe that gene patents have some useful role in promoting innovation, seems odd to me. All of these arguments hinge on questions regarding the efficacy, efficiency, and role of gene patenting in encouraging innovation and economic growth. Utilitarian arguments are suspect to some of us with training in ethics, and of a particular ethical bent. Utilitarian arguments can justify all sorts of nasty things, as long as the overall good outweighs the harms caused. Utility can be a reason for doing something, but it cannot, in my estimation, ever suffice if rights are otherwise violated. Those who believe in rights (and the duties they imply) must reject the sole use of utility as an argument in favor of gene patents if they violate some particular right. In my book Who Owns You? The Corporate Gold Rush to Patent Your Genes, I considered the various utilitarian arguments proposed by gene patent proponents, but argued ultimately that these pragmatic justifications were outweighed by the fact that gene patents violate certain inviolable rights. I didn't arrive at those rights in the usual way. I concluded that even with gene patents, no one really "owns" you, nor can they claim to have any control over any one of us by virtue of their patents. Even while patents on unmodified genes prevent you from gaining information about your genome without paying monopolistic rents to patent holders, it is conceivable that this will be overcome by various technical possibilities, such as do-it-yourself whole genome sequencing. This is a remote and distant possibility (anticipated and prepared for by the heroic Steven Salzberg, of the University of Maryland), but it illustrates that the sort of control over individuals posed by patent ownership falls short of violating our individual autonomy over our bodies. Patents give to the patent-holder a right to exclude others from doing something. In the case of gene patents, they give their owners rights to prevent others from replicating the patented gene. In most of the valuable instances of these patents, that right enables a company (like Myriad) to prevent others from testing for the presence of a certain mutation of BRCA1 and 2 that causes an increased likelihood of breast and ovarian cancers. Granting such a right to exclude is not unique to intellectual property law. It also is a hallmark of real property law. The term "real property" at one time applied to all tangible goods, but now it is generally understood to mean simply "land." Many of us think that rights to ownership of land and other tangible objects is a natural right. The authors of the Declarati on of Independence, taking their cue from John Locke, believed that certain rights were inalienable. Locke expressed his view that "life, liberty, and property" were among the most crucial, inalienable, natural rights that inhere in all humans. The Declaration of Independence cites "life, liberty, and the pursuit of happiness," although clearly the laws that were established in the various states and protected by the Federal Government have long included rights to land and "moveables." But genes are clearly different, and patents provide a right to exclude that is different from the exclusion granted by real property law. You are still allowed to keep the genes in your body, you just have to pay fees to know about their existence if patented. Regardless of its alleged utility, does this exclusionary right violate any natural rights? I concluded that it does, and in so doing, expanded on existing theories about the nature of what lawyers and economists have long called "the commons." The notion of a "commons" in the Anglo-Saxon tradition dates back to the practice of sovereigns granting the public the right to use of certain parcels of the lands the monarch otherwise claimed ownership over. Those who had no land, but maybe had some sheep, could graze them on the commons. These were commoners. If they could erect a shelter, they could also own that enclosed shelter and live there. These ancient commons were what I call a "commons-by-choice," as they involve natural abilities of exclusivity. The sovereign could have fenced and guarded these lands, enclosing them, and excluding all others from their use. Exclusivity is a necessary feature of the rights to ownership of land and moveables. When I possess a hammer, or a house, I can physically exclude others from it. To dispossess me of these things requires violence, and the attempt to do so violates our natural rights to our property. The mixing of my labor with a parcel of land, its use, and my ability to quietly enjoy that use, are all elements of basic Lockean theory about rights to property. Intellectual property is utterly unlike real property. The exclusivity created by the laws of patent (which emerged much later than those regarding real property), is artificial, not natural. The state must grant, through some process of registration, review, and agreement, a limited period of exclusivity- a new and unnatural monopoly right. There is simply no natural way to exclude others from using ideas. But not all ideas can become the subject of patents. The courts have long recognized that laws of nature and abstract ideas, for instance, cannot be eligible for patent protection. I contend that this is not simply a good, pragmatic idea, but rather in accord with natural law. Abstract ideas and laws of nature are incapable of enclosure or exclusivity because they belong quite clearly to what I call the "commons-by-necessity." Unlike the commons-by-choice, the commons-by-necessity includes any part of the universe that is incapable of enclosure. Laws of nature, like F=ma or E=mc2, are parts of the fabric of the natural universe, having nothing to do with human invention. It is impossible to enclose and monopolize or otherwise exclude others from participating in them, utilizing them, or knowing about them. "Abstract ideas" are likewise commons-by-necessity. The necessity here is not pragmatic but logical. There are simply some parts of the universe that cannot be enclosed, and thus that are not amenable to ownership or exclusivity of any kind. While the commons-by-choice could be owned through valid, useful possession, the commons-by-necessity can never be. Attempts by states, through patent laws or other means, to exclude anyone from utilizing commons-by-necessity, or to grant exclusive use to anyone over these sorts of commons, are unethical. This is not because of the consequences; as I mentioned above, this is not a utilitarian argument. Abstract ideas, natural phenomena, and natural laws cannot be contained, cannot be exclusively controlled, and no rights may inhere for any one individual over them. Unlike the rights that inhere over real property, there is no manner in which anyone may claim an exclusive right over the commons-by-necessity. Instead, we all necessarily share equal rights of access to these commons, not because some sovereign says we do, but because we are entitled to free, equal and open access to instrumental use of nature's parts so long as that use does not interfere with anyone else's rights. This is consistent with John Stuart Mill's "Liberty" or "Harm" principle, which defines our rights to liberty as broadly as possible, to the extent that those liberties do not interfere with anyone else's. This is a fundamental notion of modern liberal democracy.

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There is thus an ethical reason why the Supreme Court has specifically excluded abstract ideas, physical phenomena, and laws of nature from patent-eligibility (in the seminal cases of Diamond v. Diehr and Chakrabarty). These are all commons-by-necessity, free for use by any and all. No sovereign could contain them, nor could any individual. Unmodified DNA is, I contend, such a commons-by-necessity, just as gaseous oxygen, the laws of gravity, the theory of relativity, and all other naturally-occurring laws and phenomena are. The genes that patent attorneys claim are modified through isolation, and thus somehow inventive, have pre-existed human intention. Nature isolates them with promoter and stop codons, signaling the process of transcription, characterizing them as genes long before we ever developed theories about their existence, or confirmed them through modern genetics. Identifying the sequence of naturally-occurring genetic mutations, and using those discovery to help people anticipate, treat, and maybe even cure diseases is very useful, and there are frequently inventive processes and products involved, but the sequences over which companies like Myriad have claimed exclusive ownership belong not just to the "common heritage of mankind," but to an un-encloseable commons-by-necessity. If we accept that there are such things as commons-by-necessity, and that while rights to real property are grounded in natural facts, no rights can ever obtain to certain parts of the universe (like genes, laws of nature, physical phenomena, and abstract ideas), then we must reject the practice of numerous gene patents covering merely "isolated" genes as unethical. Certainly, some reject the notion that there are any ethical norms that are grounded as I claim in natural states of affairs, and for some, ethics is something entirely man-made. For those, I ask: On what basis are rights to life, liberty, or property based, and under which claims of utility would you be willing to trade away any of these basic human rights? If we are serious about our rights and recognize that some are inviolable, then we must reject laws that seek to set aside or curtail those rights for mere utility. Our mutual rights to access all commons-by-necessity, including genes, must outweigh the desires by some to monopolize them, even if their claims about practical necessity, innovation, and profit are true. Genes must remain in the public domain, and it is not only contrary to established law, but more importantly, it is unethical to allow patents on genes that evolved due to natural processes.

David Koepsell, PhD, JD, is Assistant Professor of Philosophy at Delft University of Technology and author of Who Owns You? The Corporte Gold Rush to Patent Your Genes.