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THE
INAPPROPRIATENESS OF THE PATENT SYSTEM FOR by Tewolde Berhan Gebre Egziabher 1. Introduction Article 27.3(b) of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) allows the patenting of all life forms and life processes, and makes it particularly compulsory for World Trade Organisation (WTO) Members to patent micro-organisms and microbiological processes. It also makes it compulsory for them to either patent plant varieties, or to protect them through “an effective sui generis system,” or both through patent and through “an effective sui generis system”. TRIPs gives absolutely no reason why useful human interventions in machines and living things, which everybody knows are different, should be rewarded through the same system. A “patent” is only a document authorising the monopoly control of an object or a process. My problem is, therefore, not with the use of the term “patent”, but with the criteria for granting patents, which were developed as appropriate for tools and machines, being extended blindly into the realm of living things. This is complicated by the fact that TRIPs uses many of the important terms without defining them. The problems which arise from the differences between machines and living organisms are thus exacerbated by this lack of precision in the provisions. 2. The TRIPs Criteria for Patenting Article 27.1 of TRIPs states: “...patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step, and are capable of industrial application.” The use of the phrase, “inventive step”, to qualify “invention” immediately strikes one as tautological. This tautology is rectified by a footnote which states that “inventive step” means “non-obvious”. The use of the phrase, “capable of industrial application” also suggests that only those technologies that can be applied in factories can be patented. This restrictive interpretation is also dispelled by a footnote which states that “capable of industrial application” means “useful”. In this TRIPs provision on “Patentable Subject Matter”, the term “invention” and the distinction between “product” and “process” make the patenting system inappropriate for life forms and life processes. This claim that I am making has obviously to be substantiated. I will try to do that. 3. Invention and Discovery Article 27.1 of TRIPs states that it is inventions that are patentable. By implication, this means that discoveries are not. The word “invent” is not defined. We have thus to resort to a dictionary definition of the term. The Oxford Shorter Dictionary gives the word “discover” and the phrase “expose to view” as one set of optional meanings. I do not think that this is the intended meaning in TRIPs. Otherwise the whole Agreement is in serious trouble. For example, a child is born with a blank mind. As it grows up, it discovers everything. Everything could then be everybody’s “patentable subject matter”. WTO could not be established to enforce such an absurdity! Another meaning is given as “devise as an untruth”. This would make patenting a system of falsification. I am sure that this is not the sense intended by TRIPs. A third meaning is “found” or “institute”. Since institutions are not patentable, and since, even after the establishment of WTO, there has been no move in that direction, I can discount also this meaning. Otherwise, who would patent the WTO? There are also three interrelated meanings: “devise by means of the intellect or imagination”, “create, produce or construct by original thought or ingenuity” and “devise or originate a new art, instrument, process, etc.” All these three nuances of “invent” can apply as a requirement for patenting. They all have “devise” or “create” as the operative word. Both “devise” and “create” imply the making of something that did not exist, and in the context of Article 27.1, “something” means technology. Therefore, they exclude the sense of “discover”, even if what is discovered is a technology, e.g. an implement buried with some Egyptian Pharaoh of 7000 years ago. 4. Are we Inventing Life? Living things are made of only some of the elements that constitute the non-living world. It is, therefore, possible that life could be “invented”. Whether we believe this is possible or not is of little relevance to our present discussion. It is, however, important to note that no living thing has been obtained by human agency constructing it solely out of the non-living world. If someone invented a living organism in that manner, she/he would definitely be entitled to patent the invention, and perhaps revel in being a god (God?). What, then, are the claims for inventing life? Finding a hitherto “unknown”[1] trait or traits is said to be a patentable technology in some countries. Obviously, these countries accept that “discovery” is “invention”.
Determining the nucleic acid sequence of a gene is also said to enable patenting. Whether the nucleic acid sequence is known to anyone or even everyone or not at all will not make the slightest difference to the traits of the organism. Such a sequencing is, therefore, merely a discovery. It should not be patentable. In any case, many of the genes are the same across species. A given gene is, therefore, the same for many species. If I determine the nucleic acid sequence of a gene from a bacterium and patent it because of this fact, what would happen if another person determined the nucleic acid sequence of the same gene from a tree, whose patent should “protect” the gene? If I were to determine the nucleic acid sequence of the same gene in 2 different species, could I have two patents on the same gene? Or, will the first patent prevent further patents? Even assuming that I have sequenced a gene from a bacterium and it has not been sequenced in any other species, does that make it unique? No. This is because, to claim that, all other forms of life have to be examined. So far, scientists know all the nucleic acid sequences only for the bacterium Escherschia coli. And yet estimates of the number of species in the biosphere range from 10 to 60 million. Would we ever be certain that a gene is unique? When a specific gene (a nucleic acid sequence) is introduced into an organism, the introduced gene may be expressed (i.e. it may result in a trait new to that receiving organism). But, just as the gene existed in another organism, so did the trait it determines. Obviously, anyone who introduces a gene in this manner deserves to be rewarded for the technique used in introducing that gene or genes, and/or for the skill for doing so. The invention of the technique should be patentable, but neither the introduced gene, nor the expressed trait, are inventions and they should thus not be patentable. The particular skill is presumably rewarded through the salary payment system. But of course, to make the effort of patenting worthwhile, the technique will have to be one that can be used often enough, e.g. the gene gun, with differing genes and differing recipient organisms. If it is a once off technique, nobody would bother to patent it. The expression of the introduced gene is not always as predicted a priori. Its expression in its new host organism may be different from its expression in its parent organism. Should it then be patentable? In other words, would it then be a discovery or an invention? I maintain that it would be a discovery. A comparison with the behaviour of water would help clarify this issue. Water, like all substances, reduces in volume as it cools down. However, when it turns to ice, it suddenly expands. That is why many a wine bottle put in the freezer and forgotten shatters. Simply because icy water at freezing behaves differently from liquid water at room temperature, can we say it is natural in one state, but invented in another? No. we can only say that, by freezing it, we discover additional properties of water. Similarly, the fact that one gene, when in the cell environment of one type of organism behaves differently from that when it is in the cell environment of another type of organism does not make its new behaviour an invention, only a discovery of an additional property. Besides, if a trait that is expressed is different from the one that had been expected a priori, it would only show a weakness in the prediction, not an invention. I do not believe that the patent system is aimed at rewarding weaknesses! 5. Some Problems Associated with Patenting Life If we ignore the biological objections to treating what is now being done with molecular biology (which studies, among others the physics and chemistry of nucleic acid sequences) and genetic engineering as “inventions” and, consequently support Article 27.3 of TRIPs, we create problems for the system of patenting. We will now look at some of these problems. 5.1. Product or Process? Article 27.1 of TRIPs states that both the product and the process of a technology shall be patented. What is a product and what is a process in a living organism? It seems to me that the way of introducing a gene into an organism is a process. If I want to make a carburettor, I use a combination of human hands, tools and machines. This is analogous to introducing the gene into an organism which did not have it before. Then the transgenic (genetically engineered) organism and the carburettor would both be products. My aim in inventing the product called carburettor is to carry out another process: that of burning fuel efficiently. Similarly, my aim of producing the product called transgenic organism is to have the process of, say, producing a measles vaccine in wheat. Now, the process of living takes over from the transgenic individual and makes it produce many more transgenic individuals through reproduction. This extra process has no mechanical counterpart or analogue. It is not caused by my introduction of the foreign gene. It is something in all life, something I have not influenced by my genetic engineering. This process substitutes in each generation the hand, the tool and the machine needed to make each carburettor. If the introduction of a gene is an invention, each ensuing generation becomes “self inventing” and creates the next generation. Is it then logical or fair, even if we ignore the distinction between inventing and discovering, that I say that I “invent” any generation beyond that particular individual into which I originally introduced the foreign gene? If I had had invented the reproduction process also, then all succeeding generations would have been my invention. The reproduction process, so essential to genetic engineering “products”, thus wipes out every “invention”. If I am to insist that I have the right to expropriate the biosphere and claim this “self invention” of my transgenic organism as being my creation, I should also be responsible for whatever happens through that process. In which case, I would be responsible for:
It is also usual to patent the use of specific biomolecules, which are outcomes of biological processes. For example, if aspirin had been discovered recently, its use would have been patented; there are now literally thousands of patented biomolecules. The extraction of biomolecules from living things is obviously a discovery, not an invention, since the biomolecules existed prior to being extracted. The method of extraction can, however, be an invention and patentable. Since the biomolecule existed before extraction, its properties also existed before extraction. The extraction process does not add anything to, or decrease anything from, its properties unless, of course, it introduces impurities, in which case it would be vandalism rather than invention. The use of a biomolecule is simply the result of recognising one existing useful property of the biomolecule. Patenting that use is, therefore, inconsistent with “invention” as a criterion. When Article 28 of TRIPs gives a monopoly control over the “making, using, offering for sale, selling or importing” a product, therefore, the provision should apply only to molecules constructed by humans, not those extracted. The practice of patenting so far, however, includes also those molecules extracted from living things. Even a biomolecule “constructed” becomes an invention only if it does not also exist in any organism or part of that organism, be that alive or dead. Otherwise, it becomes merely a synthesis of a biomolecule that is identical with what already exists. Of course the technique for the synthesis could be invented and patentable. 5.2. In Quest of Justice The use of biomolecules is often the same as that into which the organism or its part has long been put by some local or indigenous communities. Would it then be fair to patent that biomolecule while those who knew its use beforehand give it away free and get no benefit out of it? Assuming that the use is entirely new, is it fair that those who discover scientific truths, e.g. quarks and charms, cannot patent them, but someone who finds a new use for a naturally occurring enzyme can? If I patent a gene in an organism, is it fair that that one gene is used to prevent everybody also from getting hold of the thousands of other genes in that organism? In this age of extinction, it could be the sole source of those genes. In any case, even if extinction were not an issue, keeping others out should be possible only when ownership is absolute and complete. I should have the right to keep others out of my own house, but not out of the city I live in! 6. Conclusions It seems to me that society knows the distinction between discovery and invention. It is greed that makes individuals distort these meanings so that, in the name of invention, they can monopolise discoveries. But discoveries should also be rewarded. A system for such rewards should be developed. However, distorting the meaning of patenting in order to make it applicable to life only serves to attract the rejection of the whole system. Who ever worried about the legitimacy of patenting before the 1990’s, before it became known that the USA was allowing the patenting of living things? But now, opposition is growing all the time, opposition not only to the legitimacy, but also to the legality, of patenting.
[1] even “unknown” refers only to the “modern” sector; it is likely to be known to some local or indigenous communities.
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