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Biotechnology and IPR 19 June for the reference
- 1. Biotechnology and Intellectual PropertyRights Dr. Bindu Vijay Assistant Professor of Science and Technology Gujarat National Law University
- 2. Overview of presentation •Biotechnology • Biotechnology sectors • Biotechnology industry and marketsize • Importance of intellectual property rights in biotechnology • IPR instruments applicable to biotechnology • IPR issues in biotechnology • Conclusions
- 3. What is biotechnology? •Article 2 of the Convention on Biological Diversity (1992) defines the term as “any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use.” Article 2 of the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity (2010) uses the same definition. • The term “modern biotechnology” is also defined in Article 3 of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, adopted in 2000, as “the application of: a) in vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or b) fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection.”
- 4. So Biotechnology includes Biotechnologyincludes: • Recombinant DNA and Genetic Engineering • Cell Cultures • Bioremediation techniques • Enzymes and Biocatalysts, peptides • Biofuels • Nitrogen Fixation • Fermentation • BioPharmaceuticals including biosimilars and biologics • Gene editing
- 5. Biotechnology industry andmarket size • As of 2023, the Indian biotechnology industry was valued at over 92 billion U.S. dollars. The industry was expected to reach a market value of 300 billion dollars by 2030. • The growth of the industry would be driven by the increasing demand for vaccines and biopharmaceuticals in the domestic and international markets (A.Minhas) • India’s Biotechnology sector is categorised into Biopharmaceuticals, Bio agriculture, Bio IT and Bio Services.
- 6. Why legal protectionis needed for Biotechnology?
- 7. Intellectual property inbiotechnology • In the field of biotechnology, intellectual property refers to the innovative processes and products that are an outcome of the development of genetic engineering techniques using restriction enzymes to create recombinant DNA (rDNA). • The characterization of these research results as intellectual properties which encourages industries to allocate labor, research and development (R&D) units, and funding to facilitate the production of commercially marketable items
- 8. Why IPR isneeded in Biotechnology? • Very similar to other fields of technology, legal protection is also needed in the biotechnology sector as the processes that are involved in it are none other than human creations and human creativity when applied and practiced is in great need of being protected from the rising threats of biopiracy and exploitation of traditional knowledge
- 9. IPR instruments applicableto biotechnology • Plant variety protection (in India, the Protection of Plant Varieties and Farmers' Rights Act, 2001 was adopted to provide intellectual property right protection for new plant varieties). • Patents • Trade secret • Copy right • Trade mark • The most common IPR in biotechnology include patents and farmers right.
- 10. INTELLECTUAL PROPERTY RIGHTSISSUES IN BIOTECHNOLOGY • Issues of patentibility gene patenting ( Invention and not discovery) organism patenting • Issues of ownership (who owns cells/tissues/organs from which patentable products are developed) • Issues of sharing cost and benefits (Taq polymerase and Yellowstone) • Issues of ethics ( morality of patenting of life forms)
- 11. Conclusion • IPR ismeant for the promoting the cause of innovations and technology. • Biotechnological advancement and innovations helped in improvement of quality of life of human beings and advancement of societies. • As advances in the biotechnology field continue and new challenges arise, it can be expected that IPR will continue to evolve in order to address such challenges and ensure that there remains appropriate protection for biotechnology inventions.