No scientific basis for patenting under TRIPS Article 27.3(b)

After subjecting Article 27.3(b) to rigorous scientific analysis, two eminent scientists conclude that there is no scientific basis to support the case for the patenting of life-forms which the Article sanctions.

Dr Mae-Wan Ho & Dr Terje Traavik

1. Introduction

ARTICLE 27.3(b) of the World Trade Organisation Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and its counterparts in the EU Directive are couched in undefined terms which are designed to allow the broadest categories of patents from genetic engineering and other new biotechnologies. It is incumbent on the proponents to define and defend the scientific basis of these terms, on which there is no general agreement. We have supplied a 'glossary' in order to help negotiators understand some of the dubious 'logic' behind the article.

2. 'Glossary' of terms

A microorganism is an organism that can be seen only under a microscope, usually an ordinary light microscope. It includes bacteria, mycoplasm, yeast, single-celled algae and protozoa. Multicellular organisms are normally not included. Viruses are also not automatically included, as many scientists do not classify them as organisms.

A cell line is a supposedly genetically uniform population of cells derived from one individual, or it could be a clone (theoretically genetically identical descendants) of one original cell. The genetic identity of all the cells is a fiction, as the genetic material is subject to many 'fluid genome' processes which constantly make cells different from one another.

A genome is the totality of all the genetic material (deoxyribonucleic acid or DNA) in an organism, which is organised in a precise way. In the case of viruses, most of them will have ribonucleic acid or RNA as the genetic material.

A gene is a stretch of genetic material (DNA or RNA) with a defined function in the organism or cell. It usually codes for a protein. There are many genes within a genome. For example, the human genome is estimated to contain 10,000 to 100,000 genes.

A DNA sequence refers to the sequence of bases in a stretch of DNA. DNA is a linear molecule consisting of units strung together. There are four different units, each identified by the specific base contained. There are four different bases, which are simply represented by the alphabets, A, T, C and G. An example of a DNA sequence is as follows: ATTTCCGCTACGCGTAA ... An RNA sequence is similar, except that the letter T is replaced by U.

The term 'essentially biological process' is scientifically suspect. Does it mean a process that occurs naturally or which is carried out by organisms? Similarly, a 'non-biological process' is difficult to define, as all processes in biotechnology involve biological processes of one kind or another. A weak case may be made on the ground that it is one that does not occur naturally, or which is not normally carried out by organisms.

A 'microbiological process' is presumably one that is carried out by microorganisms.

3. Patents under dispute

There are five kinds of patents involved in the TRIPS negotiations:

1. Patents on process which are, strictly speaking, allowed as inventions. The way this is abused is in the entire class of patents on extracts of plants which have been developed and used for millennia by indigenous communities. Examples are patents on extracts of the neem plant taken from India, and extracts of the bibiru and cunani from the Wapixana Indians in north Brazil. This class of patents can be excluded by an appropriate protection of indigenous knowledge, restriction on exports of plants (and animals) and agreements on ex situ collections.

2. Patents on discoveries, which should not be allowed, such as cell lines, genomes and genes which are derived from natural organisms. The most notorious of these are cell lines and genes belonging to indigenous peoples collected under the Human Genome Diversity Project and without proper informed consent. A US company, Coryll Cell Repositories, lists Amazonian Indian blood cells in a DNA kit priced at $500, which is openly advertised on the Internet. Another is the Biocyte patent on human umbilical cord cells which have been used freely for transplant purposes previously. These patents violate basic human rights. A growing number of patents on genomes of pathogenic bacteria and viruses are also obstructing the prompt diagnosis and treatment of dangerous diseases such as meningitis and tuberculosis.

3. Patents on transgenic plants, animals and microorganisms, which may be construed to be inventions as they constitute new constructs or gene combinations created in the laboratory. The patents on transgenic seeds are preventing farmers from saving seeds without paying royalties to the companies. As more and more seed companies are being bought up by the corporations, this introduces an effective seed monopoly that will marginalise family farmers all over the world and destroy agricultural biodiversity.

4. Patents on all microorganisms isolated or identified. These patents would have included any microorganism isolated from Yellowstone Park in the US, for example, subject to an agreement which was subsequently successfully challenged by The Edmonds Institute on behalf of civil society.

5. Patents on nuclear-transplant cloning and other in vitro reproductive techniques, and organisms resulting from those techniques. Examples are the nuclear-transplant technique that produced Dolly. This patent actually extends to the cloning of human beings.

4. Articles related to patents in TRIPS and EU Directive

4.1 Article 27.3(b) of TRIPS states that: 'Members may also exclude from patentability: (b) plants and animals other than microorganisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof...'

Note. The status of the patentability of viruses needs to be discussed here, as viruses are not automatically included as microbiological. The non-exclusion of 'non-biological and microbiological processes' needs to be challenged as all biotech processes are biological and there is no sound reason to regard microbiological as anything but biological.

4.2 Article 4 of the EU Directive states:

1. The following shall not be patentable:
(a) plant and animal varieties
(b) essentially biological processes for the production of plants or animals.

2. Inventions which concern plants or animals shall be patentable if the technical feasilibity of the invention is not confined to a particular plant or animal variety.

3. Paragraph 1(b) shall be without prejudice to the patentability of inventions which concern a microbiological or other technical process or a product obtained by means of such a process.

Article 5 of the EU Directive: 1. The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions. 2. An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. 3. The industrial application of a sequenced or a partial sequence of a gene must be disclosed in the patent application.

Note. 'Essentially biological processes' could include transformation and transfection, processes used in creating transgenic organisms. The provision 'technical feasibility of the invention is not confined to a particular plant or animal' should be challenged, as without performing the actual experiment, it cannot be assumed that what works for one species works for another. In fact, this is very often not the case. The description 'a microbiological or other technical process' needs to be challenged, as a microbiological process is not a technical process and should not be patentable.

4.3 Both the TRIPS and EU Directive articles are designed to allow for the patentability of all categories of patents listed above. One positive aspect of the EU Directive is the inclusion of Article 6 which excludes from patenting, commercial exploitation contrary to 'ordre public or morality', such as use of human embryos for industrial or commercial purposes, cloning human beings, and modifications of animals causing substantial suffering without substantial medical benefit.

4.4 The EU Directive Article 4.1b appears to strongly exclude plant and animal varieties, but 4.3 makes clear that transgenic plants and animals are patentable, as they are produced by 'microbiological or other technical process'. But this point should be challenged, as transformation and transfection are biological processes. It is important to recognise that the patentability refers not to the process, but to the product of the process. That is because in many cases, the process is standard, such as base sequencing, or is covered by another patent, such as cloning.

4.5 Similarly, the EU Directive Article 5.1 appears to exclude the human body, cells and genes from patentability. But this is nullified by 5.2, where the copying process or the amplification process enables the copy of the gene or partial sequence or cell to be patented. This should be strongly challenged as the distinction between the putative original gene and cell in the body and the copy is a legal fiction. The very identification of the gene or cell involves processes of copying or amplification, so that it is actually the copies that are identified.

4.6 The EU Directive also explicitly extends the patentability of a process, say cloning, or technology, such as the transgenic technology, to all plant or animal varieties. So, in the case of nuclear transplant, the patent is protected for all other animals (though EU Directive Article 6 excludes human beings). In the case of the technology of using the Bt-toxin to protect plants, this is also extended to all plant varieties. This point should be strongly challenged for the reason given above: what works in one species may not work in another.

5. Critique on the patentability of genes or nucleic acid (DNA or RNA) sequence

5.1 The patentability of genes is justified on the ground that they have been subject to a microbiological or non-biological process, ie, gene sequencing, which is itself a standard process patentable and patented under existing patent laws for invention. So, the actual patented entity is the nucleic sequence itself and its putative function.

5.2 However, the DNA or RNA sequence is subject to change by mutation, deletion, insertion and rearrangement. Does it mean that, for example, if the sequence patented is ATCCAGGAACCTA... then variously mutated sequences such as AACCAGGAACCTA (single base substitution), ATAGGAACCTA (deletion of two bases), ATCCATCGGAACCTA (insertion of two bases) and AGACCTGAACCTA (inversion of five bases) are no longer covered?

5.3 The 'industrial application' stated in EU Directive Article 5.1, involves the functional side of the gene sequence, presumably qualifies it as an invention. It is important to realise, however, that the nucleic molecule by itself can do nothing. It can only have a function in a cell or organism. However, its function depends on which kind of cell it is in, where in the genome it is inserted, in what kind of genome and in which environment. In other words, its functions is uncertain and unpredictable. Under some circumstances such as gene-silencing, it has no function whatsoever. Thus, the patentability based on function is equally unscientific.  - (Third World Resurgence No. 106, June 1999)

Dr Mae-Wan Ho is a Reader in Biology at the Open University, UK, and a Fellow of the US National Genetics Foundation. Dr Terje Traavik is Professor of Virology at the University of Tromsš, Norway and Scientific Director of the Norwegian Institute of Gene Ecology.