By: Jinita Patel
Biotechnology today plays a vital role in all areas of pharmaceutical science, genetics, molecular biology, biochemistry, immunology, stem cell-related research embryology, and cell biology, bioremediation, and biodegradation.
Biotechnology covers the area of technology associated with living organisms. Broadly defined, biotechnology includes any technique that uses living organisms or parts of organisms to make or modify products, to improve plants or animals, or to develop microorganisms for specific uses. Biotechnological products have been used by mankind since ancient civilization. However, biotechnology has recently developed new biological techniques (e.g., recombinant DNA, cell fusion, and monoclonal antibody technology) which have raised fundamental social and moral questions and created problems in intellectual property rights.
Apart from the Pharmaceutical sectors, biotechnology innovations and research are involved in health care systems, agricultural industry, polymers & materials sectors, etc. Research & development in this area is relatively time-consuming and involves a large investment with the high risks involved with the outcome. To promote such results much more importance is secured with respect to patenting the invention in the said field and enabling the growing research sector to monetarily sustain itself.
A Biotechnology Patent Facilitation Cell (BPFC) was established by the Department of Biotechnology (DBT) in July 1999 in order to help the patent seekers.
BPFC has been obliged to the need of promotion of biotech research by:
- Creating awareness and understanding among biologists and biotechnologists, relating to patents and helps to understand the challenges, issues, and opportunities in this area
- Providing patenting facilities to biologists and biotechnologists in the country for filing Indian and foreign patents on a sustained basis.
- To keep a watch on development in the area of IPR and make important issues known to policymakers, bio-scientists, the biotech industry, bio researchers, etc.
Another government authority working for the same cause is the Council of Scientific and Industrial Research (CSIR) which has changed their earlier mantra of “publish or perish” to “patent or perish”. The Indian Government has under its “Science and Technology Policy-2003” highlighted below aspects:
- Science and technology regime and investments
- Strengthening of the infrastructure of Science and Technology in academic institutions
- The new funding mechanism for basic research
- Human resource development
- Technology development, transfer, and diffusion
- Promotion of innovation
- Autonomous Technology Transfer organizations would be created in academic institutes to facilitate the transfer of know-how generated in the industry
- Indigenous resources and traditional knowledge: Development of technologies that add value to India’s indigenous and native resources would be supported and the Indian share in the global herbal product market would be increased.\
- Generation and management of intellectual property: The fullest protection to competitive intellectual property from Indian R&D programs would be made
- Also included many other points like public awareness of science and technology, technologies for reducing natural hazards, etc.
Section 3(d) of the Patents Act, 1970 is one of the significant sections of the Patents Act, 1970, which plays an important role in the patenting of inventions in the field of biotechnology (more in the pharmaceutical sector).
Section 3(d) excludes the below from being invention under the Act, the basic discovery of a new form of known substances which does not result in enhancement of the known efficacy of that substance or the basic discovery of any new property or new use for a known substance or the mere use of a known process, the machine or apparatus unless such known process, the machine or apparatus results in a new product or employees at least one new reactant. Hence, while proceeding with the patent application for the biotechnological innovation the applicant might be called upon to establish that the applied invention has enhancement in efficacy and difference in properties over the existing product/substance.
Further Section 3(i) of the Indian Patent Act excludes medical treatment methods from being an invention. Section 3 (i) states that any process for the medicinal, surgical, curative, prophylactic (diagnostic, therapeutic) or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products shall not be considered as invention and hence is not patentable.
Table 1 – Patenting Life: Milestones in Biotech Patent Protection
| 1873 | Pasteur got US patent No. 141.072- “yeast an article of manufacture” |
| 1969 | Animal Breeding Methods – German Federal Supreme Courts accepts |
| 1975 | Microorganisms are patentable – German federal court |
| 1980 | Microorganisms become patentable in the US |
| 1985 | Plants, tissues, tissue culture, seeds become patentable – US PTO |
| 1987 | Multicellular organisms are patentable – US PTO |
| 1988 | European Patent Office grants first patent on a plant |
| 1995 | DNA not life but chemical and patentable – EPO declaration |
| 2001 | Patent filed for 4000 human genes and proteins and codes for them by Oxford GlycoScience |
As this sector has become one of the fastest-growing and emerging technological, knowledge-based industries with a turnover of almost US $ 2.13 billion and further in 2008-09, the biotechnological industries in India were estimated to be worth the US $ 2.51 billion.
Presently, India holds 2% of the market share in the global biotech sector as it is based on the rapid growth and evolution of these industries. India is among the top 12 biotech destinations in the world and ranks third in the Asia-Pacific region. India has the second-highest number of USFDA approved plants after the USA and largest producer of Recombinant Hepatitis B vaccines. The Government of India provides adequate scope to this sector by providing facilities for RESEARCH AND DEVELOPMENT in the field of biotechnology.