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Editorial

Protection of Biotechnology under Indian Laws

According to the eighth annual survey conducted by the Association of Biotechnology-Led Enterprises (ABLE) and Bio Spectrum, the Indian biotech industry grew threefold in just five years to report revenues of US$ 3 billion in 2009-10, a rise of 17 per cent over the previous year. Maintaining the momentum of the previous years, the Indian biotech industry grew 16.28 per cent in FY2014; the total industry size was US$ 5 billion at the end of the financial year and it reached US$ 7 billion in FY2015. Fast-paced growth is likely to continue; the industry is expected to increase in size to USD11.6 billion by 2017, driven by a range   of factors such as growing demand, intensive R & D activities and strong government initiatives (http://www.ibef.org/industry/biotechnology-india.aspx)

BIOTECHNOLOGY AND IPR

Biotechnology today plays a key role in virtually all areas of pharmaceutical science, genetics, molecular biology, biochemistry, immunology, stem cell related research embryology and cell biology, bioremediation and biodegradation.

The development of the genetic resources of biodiversity is known as biotechnology. 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 (Congress of the United States, Office of Technology Assessment, 1990). Mankind has used forms of biotechnology since the dawn of civilization. However, it has been the recent development of new biological techniques (e.g., recombinant DNA, cell fusion, and monoclonal antibody technology) which has raised fundamental social and moral questions and created problems in intellectual property rights. (http://www.ciesin.org/docs/008-265/008-265i.html)

Apart from Pharmaceutical sectors, the biotechnology innovations and research are instrumental in health care systems, agricultural industry, polymers & materials sectors, etc. Research & development in this area is relatively time consuming and involves huge investment with risk involved with the outcome. To promote such results much more importance is affixed with respect   to patenting the inventions in said field, and enabling the growing research sector to monetarily sustain itself.

In order to help the patent seekers, a Biotechnology Patent Facilitation Cell (BPFC)2 was established by the Department of Biotechnology (DBT) in July’1999. BPFC has been catering to the need of promotion of biotech research by:

  1. Creating awareness and understanding among biologists and biotechnologists, relating to patents and the challenges and opportunities in this area
  2. Providing patenting facilities to biologists and biotechnologists in the country for filing Indian and foreign patents on a sustained basis.
  3. Keeping a watch on development in the area of IPR and make important issues known to policymakers, bio-scientists, biotech industry, etc.

Another government authority working for the same cause is the Council of Scientific and Industrial research (CSIR) which has moved from 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:

  1. Science and technology governance and investments
  2. Optimal utilization of existing infrastructure and competence by networking of existing infrastructure.
  3. Strengthening of infrastructure of Science and Technology in academic institutions.
  4. New funding mechanism for basic research
  5. Human resource development.
  6. Technology development, transfer and diffusion
  7. Promotion of innovation.
  8. Autonomous Technology Transfer organizations would be created in academic institutes to facilitate transfer of know-how generated in industry.
  9. Indigenous resources and traditional knowledge: Development of technologies that add value to India’s indigenous resources would be supported and the Indian share in the global herbal product market would be increased.
  10. Technologies for mitigation and management of natural hazards
  11. Generation and management of intellectual property: The fullest protection to competitive intellectual property from Indian R&D programs would be made.
  12. Public awareness of science and technology
  13. International science and technology cooperation:
  14. Those international collaborative programs contributing directly to India’s scientific development and security objectives would been couraged.
  15. Fiscal measures: Innovative fiscal measures are planned and strategies for attracting higher levels of investments both public and private in science and technological development.
  16. One of the significant sections of the Patents Act, 1970, which plays an important role in the patenting of the inventions in the field of biotechnology (more in the pharmaceutical sector) is Section 3(d) of the Patents Act, 1970. The said sections excludes the below from being invention under the Act, the mere discovery of new form of known substances which does not result in enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substances or the mere use of a known process, machine or apparatus unless such known process, machine or apparatus results in a new product or employs 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.

    The Government Policies in Patenting

    Ministry of Science and Technology has issued the guidelines “Instructions for Technology Transfer and Intellectual Property Rights” (http://www.pfc.org.in/info/tt_ipr.htm), which would help in enhancing the motivation of scientists, research institutions and universities in projects funded by the Department of Science and Technology, Department of Biotechnology, Department of Scientific and Industrial Research and Department of Ocean Development. The salient features of the guidelines are reproduced below from the official website:

    1. Ownership of Intellectual Property: Institutions shall be encouraged to seek protection of intellectual property rights in respect of the results of R&D. They may retain the ownership of such IPR. ‘Institutions’ would mean any technical, scientific or academic establishment where research is carried out through funding by the central/state government.
    2. Transfer of Technology: The institutions shall take the necessary steps to commercially exploit patents on exclusive or non-exclusive basis.
    3. Royalty to Inventors: The owner institution is permitted to retain the benefits and earnings generated out of the IPR. The institution may determine the share of inventor(s) and other persons from such actual earnings. However, such share(s) shall be limited to one third of the actual earnings.
    4. Norms for Private Industry: IPR generated through joint research by institution(s) and industrial concern(s) through joint efforts can be owned jointly by them as may be mutually agreed to by them through a written agreement. The institution and industrial concern may transfer the technology to a third party for commercialization on exclusive/non-exclusive basis. The third party, exclusively licensed to market the innovation in India, must manufacture the product in India. The joint owners may share the benefits and earnings arising out of commercial exploitation of the IPR. The institution may determine the share of the inventor(s) and other persons from such actual earnings. Such share(s) shall not exceed 1/3rd of the actual earnings.
    5. Patent Facilitating Fund: The owner institution(s) shall set apart no less than 25% of the revenue generated from IPR, to create a Patent Facilitating Fund. The fund shall be utilized by the owner for updating inventions, filing new patent applications and protecting the IP rights against infringement and for building competency in the area of IPR and related issues.
    6. Information: The institutions shall submit information relating to the details of the patent obtained the benefits and earnings arising out of IPR and the turnover of the products periodically to the department/Ministry which had provided funds.
    7. March in Rights: The Government shall have a royalty-free license for the use of intellectual property for the purposes of the Government of India
    8. Legislative Framework and Policies for the Protection of Biotechnology

    9. Environment Protection Act, 1986- The Environment Protection Act, 1986- The Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells 1989 (Rules, 1989) were first notified under the Environment (Protection) Act, 1986.
    10. EXIM Policy- Units undertaking to export their entire production of goods and services may be set up under Bio-Technology Park (BTP) scheme for manufacture of goods.
    11. Recombinant DNA Safety Guidelines established by The Department of Biotechnology- The guidelines cover areas of research involving genetically engineered organism. It also deals with genetic transformation of green plants, r DNA technology in vaccine development and on large scale production and deliberate/ accidental release of organisms, plants, animals and products derived by r DNA technology into the environment. The issues relating to Genetic Engineering of human embryos, use of embryos and foetus in research and human germ line genetherapy are excluded from the scope of the guidelines.
    12. Guidelines for Research in Transgenic Plants & Guidelines for Toxicity and Allergenicity Evaluation of Transgenic Seeds, Plants and Plant Parts, 1998 were given by Department of Biotechnology, Ministry of Science and Technology- The current guidelines cover areas of recombinant DNA research on plants including the development of transgenic plants and their growth in soil for molecular and field evaluation. The guidelines also deal with import and shipment of genetically modified plants for research use only.
    13. National Seed Policy, 2002- This policy aims and objects as, biotechnology will be a key factor in agricultural development in the coming decades. Genetic engineering/modification techniques hold enormous promise in developing crop varieties with a higher level of tolerance to biotic and abiotic stresses. A conducive atmosphere for application of frontier sciences in varietal development and for enhanced investments in research and development is a pressing requirement. At the same time, concerns relating to possible harm to human and animal health and bio-safety, as well as interests of farmers, must be addressed.
    14. Seeds Act, 1966- This Act provides for compulsory registration of seed on the basis of their performance, deregulation/ decontrol of seed industry/ processing units and imposition of more stringent penalties to check the sale o the spurious seeds.
    15. Drugs & Cosmetic Act 1940- An Act to regulate the import, manufacture, distribution and sale of drugs and cosmetics.
    16. Drug Policy, 2002- The main objectives of this policy are: -

    (i) Ensuring abundant availability at reasonable prices within the country of good quality essential pharmaceuticals of mass consumption;

    (ii) Strengthening the indigenous capability for cost effective quality production and exports of pharmaceuticals by reducing barriers to trade in the pharmaceutical sector;

    (iii) Strengthening the system of quality control over drug and pharmaceutical production and distribution to make quality an essential attribute of the Indian pharmaceutical industry and promoting rational use of pharmaceuticals;

    (iv) Encouraging R&D in the pharmaceutical sector in a manner compatible with the country’s needs and with particular focus on diseases endemic or relevant to India by creating an environment conducive to channelizing a higher level of investment into R&D in pharmaceuticals in India;

    (v) Creating an incentive framework for the pharmaceutical industry which promotes new investment into pharmaceutical industry and encourages the introduction of new technologies and new drugs.

    1. Biological Diversity Act, 2005- Provides for conservation of biological diversity, sustainable sharing of the benefits arising out of the use of biological resources, knowledge and related matters;
    2. National Guidelines of Stem Cell Research and Therapy 2007 were established by Department of Biotechnology and Indian Council of Medicalresearch. The main objectives are:

    (i) To lay down general principles for stem cell research and therapy keeping in view the ethical issues;

    (ii) To formulate specific guidelines for derivation, propagation, differentiation, characterization, banking, and use of human stem cells for research and therapy;

    (iii) These guidelines provide a mechanism to ensure that research with human stem cells is conducted in a responsible and ethically sensitive manner and complies with all regulatory requirements pertaining to biomedical research in general and stem cell research in Particular;

    • India is one of the first Asian countries to invest in agricultural biotechnology research and to set up a bio-safety system to regulate the approval of genetically modified (GM) crops. This provides the base for Agri-biotech companies (International Food Policy Research Institute – Publication “Economic Considerations of Biosafety and Biotechnology Regulations in India”)
    • The Indo-Australian Biotechnology Fund- to develop and support collaborative research activities and workshops;
    • APIDC Venture Capital launched India’s first biotechnology focused VC Fund of 37 million  UDS with investors Like IFC, Washington, APIDC, LIC, Andhra bank, Technology Development Board.

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