The Second Patent Amendment Bill grants protection to indigenous knowledge and disallows patenting of cells and genes. But on the negative side, it will allow micro-organisms such as bacteria, virus and fungus to be patented, thus breaking down the moral barrier against patenting life forms.
THE Second Patent Amendment Bill has been passed by the Rajya Sabha (and will almost certainly clear the Lok Sabha in a few days). With that, one more piece of World Trade Oraganisation (WTO)-derived legislation will be put in place. The others have been the Plant Variety Protection and Farmers' Rights Act, 2001, and the Act on Geographical Indications, 1999. The latter is intended to provide protection for special products such as basmati rice and Darjeeling tea. The current Patent Bill was preceded by the First Patent Amendment Act, 2000, which was brought in to grant exclusive marketing rights (EMR) to drugs that had received a patent in any WTO member-country. India has committed itself to introducing product patents in the drug and agro-chemical sector, but only by 2005. The latest Patent Bill does not grant product patents. For the time being, the process patent regime will apply only in India. The Bill has important provisions pertaining to, apart from the chemical sector, genetic resources and indigenous knowledge.
First, the positive features of the Bill. Discoveries will not be patentable under the Indian law. In order to qualify for a patent, an invention will have to be demonstrated. The blurring of the distinction between discoveries and inventions in many legal systems, most notably that of the United States, has led to patents being granted on products of nature rather than inventions of the human mind. Plants and animals and species of plants and animals have been kept out of the purview of patents, so have plant varieties and seeds. New varieties of crops and their seeds are thus outside the patent system. Although the Indian law permits process patents, this will not apply to the crucial sector of food. Methods and processes of agriculture and horticulture cannot be patented, nor can any other biological processes.
Significantly, the provisions of the Bill disallow the patenting of cells, cell-lines and cell organelles such as mitochondria and genes. This is a very important and positive step and has to be seen in the context of the demand of the biotechnology industry to allow the patenting of cells and genes. The corporate sector has been putting pressure on countries to introduce cell and gene patents in their national legislation. The draft Indian law does not allow the patenting of plant or animal, and by inference, human genes.
THE life science industry wants patents on genes that it uses to make transgenic crop varieties, and after the human genome project identified the over 30,000 human genes, there has been a scramble to claim patents on them. The reason is the lucrative markets that would open up for the diagnosis and treatment of disease once the functions of various genes have been identified. If gene patents were to be allowed, the great promise of gene therapy for inherited disorders would be transferred solely to the hands of large corporations. At the ethical level, patenting human genes would mean granting a monopoly to the patent holder, on a common human heritage. Several groups and governments have seriously opposed this move. The Indian Bill has taken a correct stand and done well to disallow gene patents.
In addition to cells and genes, the Bill also blocks the patenting of interesting cell parts such as mitochondria, which are emerging as important research tools in genetic engineering and the transfer of genes. Mitochondria are little bodies inside cells that also contain genetic material. The kind of patents that were granted on the cell lines derived from the tumours of patients who had been operated in hospitals in the U.S., will not be possible under the Indian law. The provisions of the draft Act aim to keep important biological materials in the public domain so that all scientists and researchers can access them. This will enable research to serve public goals, rather than merely create products that can be accessed only by the rich.
Another strong feature of the Patent Bill is the protection it grants to indigenous (traditional) knowledge and to products derived from it. The Indian systems use medicines and treatments developed over generations by local communities. Plant-based products have become greatly sought after in this herbal era when the global sale of herbal products is slated to touch $5 trillion by the year 2020. Rampant biopiracy resulting in the patenting of turmeric- and neem-based products and countless other products based on the indigenous knowledge of communities across the world is cause for great concern to the developing countries whose knowledge is being pirated.
The present Bill addresses this problem in the domestic context. Specifically, it says that any invention which constitutes traditional knowledge or derives from traditional knowledge, or duplicates such knowledge, or joins up pieces of such knowledge, cannot be patented. This clause would prevent patents of the kind taken by Bloomberg in the U.S. on Phyllanthus amara, commonly called bhoomi amla. According to indigenous knowledge, bhoomi amla cures liver disorders, and it is used to treat everything from jaundice to sluggish livers. Bloomberg's U.S. patent is for a product based on Phyllanthus amara that cures hepatitis B and C. This kind of clear derivation and duplication of traditional knowledge presented as an invention would not be acceptable under the new Indian law.
The first step towards protecting indigenous knowledge and the healing properties of medicinal plants was taken in the first Patent Amendment Act, which granted EMRs. According to that Act, exclusive rights cannot be claimed on drugs that belong to the Indian systems of medicine. This protection for the knowledge of communities is a positive step and is similar to protection offered by legislation in other Asian nations such as Thailand and the Philippines.
The most negative feature of the patent law from the point of view of biological/ genetic resources is the provision that will allow micro-organisms such as bacteria, virus and fungus to be patented. This breaks down the moral barrier that has so far existed against the patenting of life forms. We will have to be careful that this precedence does not open the doors to the patenting of other, higher life forms such as plants and animals eventually. Civil society needs to be vigilant and the campaign against patents on life must continue with vigour. However, to mitigate the damage, Gene Campaign has submitted a list of definitions to be used for the purpose of the Act of what can be called a micro-organism and what cannot, as also what can and what cannot constitute an invention, plus special exemptions for sensitive sectors such as the environment, defence and food. It is hoped that it would become possible to include these qualifications at the rule-making stage so that the scope and impact of micro-organism patents is restricted to the maximum extent.
The Bill makes distinct concessions to the biotechnology sector. Process patents will be allowed on microbiological, biochemical and biotechnological processes. In this way, methods of genetic engineering, processes in the pharmaceutical industry using micro-organisms and related processes will become patentable. There is a curious detail in this section on what constitutes a patentable process that reflects the special adjustments made for the biotechnology sector. Processes and methods that would make plants resistant to disease and would increase their value or the value of their products, will be patentable. This provision appears to be tailor-made for the Bt cotton situation and other Bt and Bt-like approaches to introduce resistance to disease.
One thing has become evident from the post-WTO pieces of legislation that are coming in. There is a greater understanding among policy-makers of the central importance of genetic resources and the crucial need to have control over them to ensure the food and livelihood security of the Indian people. Civil society campaigns for strong farmers' rights over seeds have borne fruit and now there is a block on cell and gene patents and protection of indigenous knowledge. This trend will help at least to undo the worst damage inflicted by the unthinking or compromised position that India took in the Uruguay Round of the General Agreement on Tariffs and Trade.
Dr. Suman Sahai is convener of the Gene Campaign based in New Delhi.
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