Biotechnology exploits biological materials, living or non-living, and is broadly classified as classical and modern biotechnology. The age-old fermentation process for producing alcohol, isolation of antibiotics from moulds or other micro-organisms are only a few examples of classical biotechnology. Modern biotechnology started with the gene splicing technology or genetic engineering which developed in the late seventies of the last century. By using genetic engineering, many useful things like human insulin, human growth factors, monoclonal antibodies, etc. have been developed.
The biotechnological inventions therefore include products and/ or processes of gene engineering technologies, methods of producing organisms, methods of isolation of microorganisms from culture medium, methods of mutation, cultures, mutants, transformants, plasmids, processes for making monoclonal antibodies, cell lines for making monoclonal antibodies, etc. While on the one side, biotechnological inventions have resolved many problems and branched out to several fields, on the other side, they have invoked many debates. The application of genetic engineering in plants and animals has resulted in exciting and yet debatable technological developments such as transgenic plants, animals and isolation of human genes for using them to produce medicaments.
Scientists across the world are using bioinformatics tools, ingenious techniques and genomes of organisms to probe the mysteries of biological processes and the living world thereby generating vast amounts of information which may provide the keys to new medical treatments, improved crops and so on.
However, there are some issues relating to patentability of biotechnological inventions which are of serious concern to the users of Patent System such as novelty, obviousness, industrial applicability, extent of disclosure and clarity in claims. In addition, a few special issues have also evolved such as those relating to moral and ethical concerns, environmental safety, issues relating to patenting of ESTs (Expressed Sequence Tags) of partial gene sequences, cloning of farm animals, stem cells, gene diagnostics, etc. Thus, the patenting of inventions in the field of biotechnology poses challenges to the applicants for patents as well as to the Patent Office. Therefore, there is an urgent need to put in place Guidelines to establish uniform and consistent practices in the examination of patent applications in the field of biotechnology and allied subjects under the Patents Act, 1970.Thus the guidelines are intended to help the examiners and controllers of the Patent Office so as to achieve uniformity and consistency.
However, these guidelines do not constitute rule making. In case of any conflict between these guidelines and the provisions of the Patents Act, 1970 and the Patents Rules, 2003, the said provisions of Act and Rules will prevail over these guidelines. The guidelines are subject to revision from time to time based on interpretations by a Court of Law, statutory amendments and valuable inputs from the stakeholders.
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