Like in other disciplines, for biotechnology, protection of intellectual property provides encouragement for innovations involving genetic engineering, in addition to according incentives for investments, which may lead to new products and processes. The general prerequisites for patentability, namely, novelty, inventiveness and industrial applicability (or utility) apply to biotechnology inventions as well. As a rule, though this may appear paradoxical, new biological material is patentable, if obtained through non-biological processes. Non-biological processes are defined as those where the hand of man had a part to play.
Article 27.3 (b) of TRIPs gives members the freedom to exclude plants, animals and “essentially biological processes” from patentability. However, it also states that micro-organisms and non-biological and micro-biological processes have to be patentable.
The wording is deliberately ambiguous, which gives countries some freedom to interpret this in their national legislation as they deem fit. This freedom of interpretation could be restricted during the mandatory review of this Article (see paragraph 3.12).
An enormous amount of debate is on-going on the question of patenting genes. The problems faced on this issue are related to philosophical, theological, ethical and moral objections regarding its implications on society.
There are two major and diverse views on the question of patenting genes. The first view is that a gene or a gene sub-fragment is already existing in nature; its identification is a discovery, not an invention, and therefore it is not patentable. The second view is that the skills required to construct full-length genes and define their function and utility are not straightforward and simple and, therefore, are patentable.
The second view has been accepted by patent authorities in US, Europe and Japan; the countries where biotechnology is most developed. With the isolation of more disease-related genes, the number of sequences for which patents will be filed, will increase in coming years. However, as the processes of gene-sequencing and cloning will become standardised and will eventually become ‘routine’, patenting genes may become more difficult.
One of the most controversial aspects of patenting human genes or sequences is the question of ownership of the data and rights of the donor. From the investors’ point of view, exclusivity gained through patenting is essential for commercial exploitation and for the development of new therapeutic and diagnostic tools. But when the rights to genetic data from people are sold (the right to one gene associated with obesity was sold for US$ 70 million), can the person or population from where the gene originated claim a share of the royalties?
Applications for patents on genetic data from populations in developing countries should consider at least the following factors:
• informed consent for the use of those data,
• rewards for indigenous groups in case of commercial exploitation,
• the cultural diversity and political rights of indigenous population should be respected in international agreements and in patent laws.
So far, none of this has happened, and developing countries should look into these issues.
Critics aver that patenting a human gene is equivalent to patenting life, which is counter to all norms of patentability. Biotech companies argue that they are only claiming the right to use genetic information to develop diagnostics and therapies and not for owning the rights over the genes. One position therefore could be that the gene itself is not patentable, but that a diagnostic kit based on a new gene can be patented. Other issues relate to setting up standards for genetic testing and the emotional issues of predicting diseases and the impact this may have on insurance schemes, employment, etc.
Box 16 Data on Gene Patents:
• 1175 human gene sequences have been patented (between 1981 and 1995);
• Only 16% of human DNA sequence patents filed have been issued so far (due to time lag for issue);
• Patentees are industry (75%), publicly funded research agencies such as NIH, US Department of Health, Pasteur Institute, Salk Institute (15%), and Universities (10%);
• Legal interpretations differ as to whether the patent protects only the sequence disclosed or whether it covers all possible forms of the gene.
Genetically Modified Organisms
In conventional breeding, whether in animals or plants, individuals are selected with beneficial traits and crossed. Genes mix randomly, leaving the final outcome to chance. The number of traits which can be introduced in the species by this process is limited. While the objective of biotechnology remains the same, i.e. to alter the genetic make-up to improve the species, the method used accelerates the process by isolating the DNA sequence responsible for a particular trait and introducing it in the same species or - and here lies a major difference with conventional breeding - in another unrelated species.
By using this technique, biotech scientists believe that plants can be modified to resist attack by pests, thereby ensuring less use of harmful pesticides, and to tolerate broad-spectrum herbicides. They believe that genetically modified agricultural products can be superior in terms of increased production and increased quality.
Box 17 Current Status of GM Foods
Countries growing GM crops are mainly the US (21 million hectares), Argentina (5 million hectares), Canada (3 million hectares) and Australia (0.2 million hectares). A few other countries have some experimental cultivation.
Crops concerned are mainly soyabeans, maize, cotton, canola, rapeseed, and potatos.
1998 sales of GM crops were estimated to be over US$ 2 billion, an increase of over 20-fold since ‘94.
Hot debates surround the Genetically Modified Organisms (GMOs). They stem from concerns over the safety of such modified products to consumers and to the environment. Some of the concerns are related to lack of enough time-tested evidence for their safety to human health and environment. Moreover, there are concerns about possible undesirable gene transfer across different species, which could lead to creation of new resistant weeds, alter ecosystems by destroying all pests or evolve new varieties of pests and lead to a loss of biodiversity, normally ensured through nature’s selection process. A final objection is related to the denial of options and choices to the consumers of the food they want to consume.
Where this does the overall balance lie in this debate? The rational approach would be to evaluate the risks through scientific experimentation and validation to the utmost satisfaction of the strictest regulatory agencies and consumers. The problems and prospects need to be evaluated in an impassionate manner by the concerned parties.
Patents on Plants and Transgenic Plants
TRIPs Article 27.3 requires countries to have some form of protection for plant varieties in place, either via patents or via a sui generis system. Therefore, countries may choose for legislating a plant varieties’ protection Act. Breeders’ rights to control the production, sale and distribution of propagating material (seeds or cuttings) can also be granted protection under such legislation.
Many countries, including some in the European Community, classify plant varieties as unpatentable subject matter, even when the transgenic plant would satisfy the essential pre-requisites of novelty, inventiveness and utility. However, in most countries, patents are granted for processes and genetic materials used to create transgenic plants.
Since 1985 the US Patent and Trademark Office (USPTO) has allowed the patenting of plants. Plant patents have been granted by European Patent Office (EPO) from 1989. But in 1995, EPO severely restricted the scope of Plant Genetic Systems and allowed claims only on the herbicide-resistant gene and the process used. In Japan, plant patents are allowed, however, some disputes over territorial rights are brewing between Japanese Patent Office and the Ministry of Agriculture.
In 1987, in a case involving polyploid oysters, the USPTO ruled that animals could be patented. In spite of the potential of transgenic animals as useful ‘factories’ for therapeutic proteins at a future date, current uses of such patented animals are as experimental models for screening assays, for example the Oncomouse (used to screen compounds for anti-cancer activity). In 1988, the Harvard Oncomouse was granted a Patent by USPTO. The European Patent Office, after much debate, granted the Patent in 1992. But it is incorrect to conclude that there is universal agreement on the patentability of the Oncomouse; for instance Denmark has said ‘No’ to animal patents.
The debate centers on ethical and moral issues, as well as animal rights.
Biotechnology, particularly modern biotechnology, which is primarily based on the exploitation of the genetic engineering techniques, is in a relatively infant stage. Like in any other R&D activity, investment requirements are high and returns are never assured in terms of bankable products and processes of commercial utility. The time frame involved also could be long. Consequently, rewards for such risky investments have to be assured, and protection of intellectual property of the inventor or his sponsor is one system which will ensure returns on investments. The uncertainties inherent in biotechnological product development are common to both healthcare and agriculture-related biotechnology products and processes. There have been some successes, but the majority of companies survive of R&D funds, venture capital and sponsored projects from large corporations. Due to various concerns and ambiguities, including moral, ethical, theological and political factors, there has been no consensus on uniform standards for inventions in this area. This picture will become clearer in the coming years.
The practice of protecting one’s inventions through patents requires very careful and informed inputs. Drafting, filing, prosecuting, defending and maintaining patents require special expertise, which can be acquired only through professional training and practice. The first step is to ensure that there is an organization to impart adequate patent literacy to the scientists, to create an awareness of the usefulness of the system not only as a commercial tool, but also as a source of scientific and technical information within a legal framework. Keeping abreast of the developments in the patent arena also enables scientists to read into the future technological potential of many scientific discoveries.
The next five years are crucial to developing countries, as the fruits of science and technology will become ever more important in view of their commitment to join the global community in trade, commerce and industrial development.