By Jill McKeough
A major intellectual property issue for indigenous people has arisen recently with the report that the US patent office has issued a patent over the genetic material of a foreign citizen, an indigenous man of the Hagahai people of Papua New Guinea.
The patent claims a cell line containing unmodified Hagahai DNA and several methods for its use in detecting certain retroviruses. [P. Mooney, "Indigenous Person from Papua New Guinea claimed in US Government Patent", press release by Rural Advancement Foundation International, November 30, 1995.]
Although this patenting activity is being seriously opposed on a number of grounds, the legality of patenting "naturally occurring" information, such as a stretch of DNA, is greatly in doubt, without even considering the serious ethical and moral aspects of allowing third party (and foreign) ownership of someone's very genes.
The issues raised concern the fundamental questions of to what extent "bio-colonialism" and commodification of human life should be allowed, and at the other end of the spectrum the usual commercial issues as to what compensation, royalties or other remuneration may be allowed to the originators of the raw material, since there is "no concrete provision for the Hagahai to receive any compensation for becoming the property of the US government". [ibid]
The impetus towards patenting genetic material has arisen out of the Human Genome Project (HGP), the aim of which is to map and sequence over a 15-year period the estimated 100,000 genes which compose the human genome, with the intention of obtaining sufficient understanding so that any gene whose alteration is responsible for a disease will be easily identified and analysed. It may also be possible to use the information to manufacture diagnostic tests, and therapeutic proteins to identify and treat genetic disorders.
In 1995 an international group of scientists embarked upon the Human Genome Diversity Project (HGDP), which aims to draw blood and tissue samples from as many indigenous groups in the world as possible. This has been dubbed the "Vampire Project" by its opponents, of which there are many, including the Sami indigenous women from the Nordic countries, who denounced the project at the Beijing Women's Conference in August 1995.
While the HGP has highlighted the issues of patenting of gene sequences, gene therapies and other aspects of human life, the HGDP appears to be pursuing an aggressive patenting policy which, furthermore, has the overtones of all the worst aspects of colonialism.
The National Institute of Human Genome Research opened at the National Institute of Health (NIH) in Washington in 1990. Although research is coordinated from the US, many developed countries are involved in sequencing the genome.
Sequencing human genes has been performed by molecular geneticists since the early 1980s, but the HGP has the express aim of improving the coordination of international efforts to achieve the sequencing.
The patentability of the gene sequences being determined has become one of the most divisive issues surrounding the project since 1991, when a researcher at the NIH decided to file patent applications for the first fruits of the research, 2600 DNA strands related to certain genes from the human brain.
The US patent office rejected the applications on the basis that the sequences lacked novelty and utility and were "obvious" in that they could be derived from existing data. [C. Anderson, "NIH CDNA Patent Rejected: Backers Want to Amend Law", (1992) 359 Nature 263.]
Patent offices around the world have not yet decided whether stretches of DNA amount to an invention or are merely "discovery" of a sequence of genes.
If specifications are suitably drafted, patenting may be possible, and certainly the manufactured therapeutic and diagnostic products may be inventions. The issues are not simply legal ones, however, and even among the researchers there is disagreement. The first director of the HGP, James Watson (winner of the Nobel Prize for his seminal work, with Francis Crick, in identifying the DNA "spiral" while researching at Cambridge University in the 1950s) resigned, at least partly in order to express his opposition to the NIH decision to file for patent rights, which he denounces as "sheer lunacy". [P. Maddox, "The Case for the Human Genome", (1991) 352 Nature 14.]
The argument put by those in favour of applying for patent rights is to secure any property rights which may be forthcoming, because failure to obtain the rights in the first place may make them unretrievable later on. [C. Anderson, "Patents, Round Two", (1992) 355 Nature 665.]
In self-defence, the British Medical Research Council reluctantly began applying for patents on stretches of DNA. This policy was abandoned at the end of 1993, and the heads of four leading professional organisations of clinical geneticists wrote a joint letter to the European patent office and to senior UK government ministers asking for a prohibition on the patenting of human genes, arguing that it is morally unacceptable to patent an entity found in a natural state in the human body (even if legally possible) and that the HGP is a cooperative worldwide effort but the NIH's actions were making researchers increasingly reluctant to share information. [D. Dickson, (1993) 366 Nature 391.]
Some of these fears began to be realised when a UK hospital received a demand for US$6000 to use a gene for cystic fibrosis employed to screen patients for the disorder. Although the patent rights were not yet granted anywhere, the Toronto Hospital for Sick Children, where the gene was identified and sequenced, intends that those using the information pay royalties and licence fees. [A. Coghlan, "Patents", New Scientist, January 23, 1993, p4.]
While the Australian patent office takes the position that it will grant a patent to anything within legal limits, s 18(2) of the Patents Act 1990 expressly prohibits patent for human beings or biological processes for their creation. It is not clear whether a stretch of DNA is "human being" or an isolated part thereof which should be patentable.
The proposed EC Directive on Biotechnological Inventions contains (in Article 2.3) a very similar provision to s 18(2), following Article 53(a) of the European Patent Convention.
However, the Legal Affairs Committee of the European parliament, after considering the Biotechnology Directive, proposed a dramatic departure from the text by asking for an absolute ban on patenting human genes and gene therapies (on which much current medical and pharmaceutical research is based). [R. Nott, "The Proposed EC Directive on Biotechnological Inventions", (1994) 5 EIPR 191, 194]. It is clear that there is considerable opposition to patenting life in any form from various lobby groups across the European Community.
The "gene wars" have escalated, and the issues have escaped beyond the confines of the patent system. In October 1994 the US firm Human Genome Systems (HGS) announced that if scientists want to use the information held by the company on fragments of 35,000 human genes, they must enter into a contract to give HGS rights to commercial products developed using the data. [L. Dayton, "A Precarious Climb on the DNA Ladder", Sydney Morning Herald, January 7, 1995, p. 14.]
Thus the willingness to regard the information as property and exploit it as such is not dependent on obtaining patent rights, although this would greatly reinforce the position of those seeking to assert such proprietary notions over the building blocks of human life.
Not only human genetic material is targeted by "gene hunters". An important aspect of Aboriginal heritage is knowledge of harvesting techniques and uses for traditional foods, for example, abalone, now a keenly sought food among the wider community.
The obtaining of genetic material from animals and plants and acquiring monopoly rights over the organisms or some genetically altered version thereof, or some product derived therefrom, is also becoming a common practice. A US patent on a pesticide derived from the seeds of the neem tree (Azadirachta indica, a native of India) is being opposed by a coalition of pressure groups because its pesticidal properties have been used for centuries by the people living where the tree grows.
If nothing else, it seems that the patent must fail for want of novelty! "The patent, owned by the giant seed company W.R. Grace, has become a cause celebre in the fight to prevent rich nations from plundering the biological resources and traditional knowledge of developing countries." [K. Kleiner, "Pesticide Tree Ends up in Court", New Scientist, September 16, 1995, p.7.]
The modification of hereditary material allowed by recombinant DNA is being applied to the improvement of plants, particularly food crops, to fish culturing and the prevention and control of fish diseases, to the area of food additives (since many flavours and other attributes of food can be cloned and thus be advertised as "natural" products) and in the treatment of toxic waste and pollution control.
Some have expressed fears that the development of new animals and plants (with monopoly rights over their exploitation) will harm the developing world and the cash crops relied upon by indigenous peoples, rather than offer new hope of improved crops and food sources.
The concept of a "farmer's privilege" is a feature of plant varieties protection legislation which may allow farmers to use seed or otherwise propagate protected plant varieties [See Plant Breeders Rights Act 1994 (Cth) s 17] and a more radical form of this extending to transgenic animals has been proposed for insertion into the EC Directive on Biotechnological Inventions. [R, Nott, "The Proposed Directive on Biotechnological Inventions" [1994 5 EIPR 191.]
Farmers say that patents on new crops threaten their livelihoods, because the right to keep and re-sow crops is not allowed under patent law, and animals bred from a patented animal cannot be used by the farmer.
Opposing patents is a lengthy and time-consuming process. The holders of rights are large industrial corporations which can afford to resist challenges. Furthermore, crops engineered by biotechnology are often based on DNA obtained from species used in the developing world. "If the industry were then to sell its engineered crops back to the developing world, it would be threatening the heritage of the very countries from which they obtained the extra gene in the first place." [B. Watts, "A Matter of Life and Patents", New Scientist, January 12, 1991, p. 38, 42.]
A related concern is the loss of biodiversity as commercial crops come to dominate the market due to factors such as appearance, uniform ripening (or even flavour) and growers abandon traditional varieties in favour of hybrids, possibly leading to the loss of some varieties entirely.
Dramatic examples of damage to vulnerable economies depending on very few cash crops have been provided by the genetic engineering of plants which are superior in some way or will grow in climates where they do not usually thrive.
In June 1995 the first crop of a genetically altered rapeseed plant was harvested in the US. The plant has been altered to produce an oil more usually extracted from coconuts and palm kernels, a vital cash crop for several developing nations. [K. Kleiner, "Altered Crop Threatens Poor Nations", New Scientist, June 17, 1995, p. 10.]
The Philippines sugar industry has been affected by the development of high-fructose varieties of corn produced by US plant breeders. The promise offered by biotechnology, of feeding more people and increasing productivity in developing countries, may prove to be entirely hollow if their existing livelihood is undermined.
[Reprinted from Human Rights Defender, December 1995. Jill McKeough is associate professor, Faculty of Law, University of NSW.]