Editors: Norio Fujiki, M.D. & Darryl R.J. Macer, Ph.D.
Professor, Faculty of Law, Niigata University, JAPAN
The argument of the NIH is as follows: If the NIH published the data on the fragments without patents, then the courts would find that the data had been published and had already been in the public domain. In such a case, companies that later were successful in identifying DNA for making a useful protein would not get a patent for their products. However, if the NIH gets patents for their data, the NIH will give private companies licenses granting them exclusive rights to use the fragments. These companies would develop the fragments into medical products and treatments. Keeping the exclusive rights, the NIH is trying to develop US biotechnology and pharmaceutical industries (2).
Large companies with biotechnology interests disagree with the NIH's approach, because it interferes with their business opportunities. Some venture companies are welcoming the NIH's approach. For instance, Genome Corporation, established by Walter Gilbert, proposed that DNA data should be available to anyone at a reasonable price (3).
Many researchers have more remarkable objections. They say that if the NIH data were patented, it would be hard to access the NIH data. Limiting access will delay research in this field.
The first issue is whether the NIH data is patentable or not. In general, DNA sequences have been patentable. In the US Supreme Court, there was a famous ruling for the Chakrabarty case involving a genetically modified organism. The ruling was makes it clear what is patentable. The ruling shows that it does not matter whether the object being patented is living or not, but whether or not, it is a human-made invention.
Therefore, the existing patent applications for DNA products have different DNA sequences from natural sequences (6). Patent applications for DNA must point out how that DNA has been identified, purified and put in a different form from that in nature. In this sense, there are some questions whether NIH data is human-made or not.
The criteria for an invention to be patentable, specifies that it must be "novel", "non-obvious" and "useful". As for the novelty, NIH researchers verified their data to be novel by comparing it with the existing databases. As for non-obviousness, there are some negative opinions. Dr James Watson said that automatic procedures using computers can be done by anyone, even a monkey (7). Thus, it is questionable that the results gained by such automatic procedures can be recognised to be non-obvious. As for the usefulness, NIH researchers have not provided any new application for their DNA. They say that these DNA sequences can be used as markers for human genetic maps. It is critical that the DNA sequences are useful, because application as a marker is too broad to meet the above criterion of usefulness. In Nature, they published an editorial saying that newly discovered galaxies which are novel and found by non-obvious methods but without usefulness are not patentable (8).
The next issue is what influence NIH patents will have on basic research. Even if the patents would be granted, the patents do not extend to research which does not make profit. This rule has been already established through court cases in the USA. The NIH has said that all these sequences and clones are publicly available for this type of research (1). However, noncommercial research can easily be changed to commercial research, especially in the field of medicine. So, it is difficult to know where we should draw a line.
It has been an established tradition in basic research that researchers should publish their findings. There is the free flow of information among researchers and collaboration in production and utilisation of databases. For example, the Centre d'Etude du Polymorphisme Humain database (CEPH) in France stores data on DNA from 40 families, and it supplies materials on the condition that researchers in turn send back their data to the CEPH database (8, 10).
The third issue is whether international collaboration will continue. Now, the Human Genome Project has been put in practice as a worldwide joint activity. If the NIH keeps this approach, it will disintegrate international collaboration. There is a principle of territoriality over the patent system. Therefore, much confusion has appeared on international harmonization of the patent system. Actually, in GATT patent system is very controversial. The NIH's policy will make more confusion in international harmonization and cause worldwide joint research to splinter into competing national groups.
There are three major DNA databases: GENBANK¨, a database distributed by a private company in the USA EMBL, a database distributed by a nonprofit organisation in the EC and DDBJ, a database distributed by a national institute in Japan (11). Being different in their nationalities and finances, each database exchanges its data with one another. GENBANK¨ is available at a charge. EMBL is available free of charge, but commercial users must pay a surcharge. DDBJ is available free of charge. This collaboration is a well defined shared system and order for noncommercial users and for commercial users. The NIH's policy would disintegrate the above collaboration system.
The last issue is whether an alternative program can be found or not. The Human Genome Project is regarded as big science (12). In general, big science is regarded as a risky activity like the Hubble telescope project or the superconducting super collider project. However, it is certain that the Human Genome Project will succeed, because there is no risk in it. In this point of view, the Human Genome Project differs from other big science projects, but it should be regarded as a basic technological project like the Landsat activity which is providing remote-sensing data of all parts of the globe to all users on a non-discriminatory base.
As a non-specialist, I would like to suggest that researchers in genetics reconsider the Human Genome Project in this perspective. In the USA, there is a Land Remote-sensing Commercialisation Act, which says that data is available with reasonable charge and without restriction of copyright (13). This type of utilising database is an institutional model we should try to use.
1. Venter, J. Craig et al. (1992) "Sequence identification of 2,375 human brain genes", Nature 355: 632.
2. "Wholesale gene patenting by NIH stirs up a storm", Genetic Technology News 11 (1991), 2.
3. "Who owns the human genome?", Science 237 (1987), 358.
4. Moufang, Rainer (1989) "Patentability of genetic inventions in animals", IIC 20(6), 823.
5. Macer, Darryl R.J. Shaping Genes. Ethics, Law and Sceince of Using Genetic Technology in Medicine and Agriculture (Eubios Ethics Institute 1990).
6. Carey, Norman H. & Crawley, P.E. (1990) "Commercial exploitation of the human genome: what are the problems?", p. 133 in Human Genetic Information: Science, Law and Ethics (CIBA Foundation Symposium 149).
7. "Gene mapping lawyers", Inside R&D 20(44) (1991), 2.
8. "Free trade in human sequence data?", Nature 354 (1991), 171.
9. National Research Council, Mapping and Sequencing - The Human Genome (1988).
10. US Congress Office of Technology Assessment, Mapping Our Genes - The Genome Projects: How Big, How Fast? (1988).
11. "Genome databases", Science 254 (1991), 201.
12. Lee, Thomas F., The Human Genome Project - Cracking the Genome Code of Life (Plenum Press 1991).
13. 15 USC ¤4111-4301.