PATENTABILITY OF HUMAN EMBRYONIC STEM CELLS IN INDIA
Main Article Content
Abstract
The hESC research with recent developments has become one of the most desirable research fields for the scientist. The reason behind such an approach is basically the great potential to treat and cure the human race of very incurable diseases. Countries around the world have amended their policies with regards to stem cells in such a way as to enhance the advantage as the stem cell market is a trillion-dollar market. The research procedure involving patentable invention is time-consuming and requires many expenses, so the investor is always keener to know if they will get any monetary benefit. Though the medical field promises about importance of stem cell and biotechnological research, there are concerns in some countries, such as India, about potential policy implications that would affect the patenting innovations in this industry. As India lacks a coherent legislative policy regarding stem cell patenting, it is creating more confusion for research in stem cell research. Often, researchers do not want to be involved in the said research because India lacks any specific laws in said fields apart from so-called guidelines provided in 2017 with an amendment to Drug and Cosmetic Act in 2019. Patent laws play a vital role in industrial advancement, thus helping a country's economy. To enter the race of development, countries worldwide have developed their patent laws so that they achieve maximum benefits out of it. In India, with patent laws, moral, cultural and religious beliefs also play a vital role in granting a patent, specifically in the Human Embryonic Stem Cell patent. The Article discusses topics that a researcher must be familiar with when discussing patentability issues. A few of these topics include the morality debate, stem cell and biotechnological research, and Stem cell research's patentability. Additionally, this Article identifies the discrepancies between the laws governing stem cell research within India.
Article Details
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
References
A.(2019, May 22). Placental stem cells can regenerate new heart cells after heart attack, study finds. ANI News. Retrieved from https://www.aninews.in/news/health/placental-stem-cells-can-regenerate-new-heart-cells-after-heart-attack-study-finds20190522160353/ (Last Accessed July 10, 2020)
Ahmad Alaie, S. (2015). Stem Cell Treatment as Innovation in Sustaining Socio-Economic Condition in Health Care Sector in India. Journal of Stem Cell Research & Therapy, 05(03), 1–7. Retrieved from https://www.longdom.org/open-access/stem-cell-treatment-as-innovation-in-sustaining-socioeconomic-condition-in-health-care-sector-in-india-2157-7633-1000269.pdf (Last Accessed July 5, 2020)
Asghar, W., El Assal, R., Shafiee, H., Anchan, R. M., & Demirci, U. (2014). Preserving human cells for regenerative, reproductive, and transfusion medicine. Biotechnology Journal, 9(7), 895–903. Retrieved from https://onlinelibrary.wiley.com/doi/abs/10.1002/biot.201300074 (Last Accessed October 19, 2020)
Basu, P. (2016, January). Ethical Issues Concerning Experimentation On Embryos And Foetuses : An Overview (Thesis). Retrieved from University of Calcutta. http://hdl.handle.net/10603/185855 (Last Accessed January 26,2021)
De Peppo, G. M., & Marolt, D. (2012). State of the Art in Stem Cell Research: Human Embryonic Stem Cells, Induced Pluripotent Stem Cells, and Tran differentiation. Journal of Blood Transfusion, 2012, 1–10. Retrieved from https://www.hindawi.com/journals/jbt/2012/317632/ (Last Accessed October 13, 2020)
Devaiah, V. H. (2010). Impact of bioethics on patentability of inventions. Indian Journal of Medical Ethics, 7(1), 14–18. Retrieved from https://pubmed.ncbi.nlm.nih.gov/20166289/ (Last Accessed October 20, 2020)
Devarapalli, P., Bhalke, S. L., Dharmadhikari, N. S., Mishra, V., Mago, N., Deshpande, N., & Hirwani, R. (2017). Induced Pluripotent Stem Cells: Inventors turning into competitors. Journal of Commercial Biotechnology, 22(4), 19–25. Retrieved from https://www.researchgate.net/publication/312469196_Induced_Pluripotent_Stem_Cells_Inventors_turning_into_competitors (Last Accessed January 13,2021)
Finkelstein, J., Parvanova, I., & Zhang, F. (2020). Informatics Approaches for Harmonized Intelligent Integration of Stem Cell Research. Stem Cells and Cloning: Advances and Applications, Volume 13, 1–20.Retrieved from https://pubmed.ncbi.nlm.nih.gov/32099411/
Gupta, R. (2018, December). Morality And Ethics Embracing Biotechnology Patents. 41–47. Retrieved from http://proceeding.conferenceworld.in/Pune_RISE-18-Conference/TJP5Q3leP729.pdf (Last Accessed January 14,2021)
H. Tallmadge, E. (2019). Nationalizing Trips: An Examination Through Exceptions. The John Marshall Review of Intellectual Property Law, 18, 285–324.Retrieved from https://repository.law.uic.edu/cgi/viewcontent.cgi?article=1457&context=ripl (Last Accessed January 12,2021)
Halliburton, M. (2017). India and the Patent Wars: Pharmaceuticals in the New Intellectual Property Regime (The Culture and Politics of Health Care Work) (Illustrated ed.). ILR Press.
Han, X., Yu, L., Ren, J., Wang, M., Liu, Z., Hu, X., Hu, D., Chen, Y., Chen, L., Zhang, Y., Liu, Y., Zhang, X., He, H., & Gao, Z. (2017). Efficient and Fast Differentiation of Human Neural Stem Cells from Human Embryonic Stem Cells for Cell Therapy. Stem Cells International, 2017, 1–11.Retrieved from https://www.hindawi.com/journals/sci/2017/9405204/
Ikemoto, L. C. (2014). Can Human Embryonic Stem Cell Research Escape Its Troubled History? Hastings Center Report, 44(6), 7–8. Retrieved from https://onlinelibrary.wiley.com/doi/abs/10.1002/hast.380
Irving, D. N. (1999). When do human beings begin? scientific myths and scientific facts. International Journal of Sociology and Social Policy, 19(3/4), 22–46. Retrieved from https://www.princeton.edu/~prolife/articles/wdhbb.html#:~:text=Fact%206%3A%20These%20are%20a,%2Ddays%2C%20or%203%20weeks
Khan, F. A., Almohazey, D., Alomari, M., & Almofty, S. A. (2018). Isolation, Culture, and Functional Characterization of Human Embryonic Stem Cells: Current Trends and Challenges. Stem Cells International, 2018, 1–8. Retrieved from https://pubmed.ncbi.nlm.nih.gov/30254679/
Lahiry, S., Choudhury, S., Sinha, R., & Chatterjee, S. (2019). The National Guidelines for Stem Cell Research (2017): What academicians need to know? Perspectives in Clinical Research, 10(4), 148. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6801994/
Lévesque, M., Kim, J. R., Isasi, R., Knoppers, B. M., Plomer, A., & Joly, Y. (2014). Stem Cell Research Funding Policies and Dynamic Innovation: A Survey of Open Access and Commercialization Requirements. Stem Cell Reviews and Reports, 10(4), 455–471.Retrieved from https://pubmed.ncbi.nlm.nih.gov/24676713/
Ludwig, T. E., Kujak, A., Rauti, A., Andrzejewski, S., Langbehn, S., Mayfield, J., Fuller, J., Yashiro, Y., Hara, Y., & Bhattacharyya, A. (2018). 20 Years of Human Pluripotent Stem Cell Research: It All Started with Five Lines. Cell Stem Cell, 23(5), 644–648. Retrieved from https://pubmed.ncbi.nlm.nih.gov/30388422/
Lukomska, B., Stanaszek, L., Zuba-Surma, E., Legosz, P., Sarzynska, S., & Drela, K. (2019). Challenges and Controversies in Human Mesenchymal Stem Cell Therapy. Stem Cells International, 2019, 1–10.Retrieved from https://downloads.hindawi.com/journals/sci/2019/9628536.pdf
Millbank, J. (2016). Reflecting the ‘human nature’ of IVF embryos: disappearing women in ethics, law, and fertility practice. Journal of Law and the Biosciences, 4(1), 70–93. Retrieved from https://academic.oup.com/jlb/article/4/1/70/2566734
Mukhopadhyay, C., & Mathur, J. (2011). Prospects and Ethical Concerns of Embryonic Stem Cells Research-A Review. Veterinary World, 281. Retrieved from https://www.researchgate.net/profile/Dr_C_S_Mukhopadhyay/publication/235956178_Prospects_and_Ethical_Concerns_of_Embryonic_Stem_Cells_Research--_A_Review/links/00463514c8c5ae2706000000/Prospects-and-Ethical-Concerns-of-Embryonic-Stem-Cells-Research--A-Review.pdf
Parvatam, S., Bharadwaj, S., Radha, V., & Rao, M. (2020). The need to develop a framework for human-relevant research in India: Towards better disease models and drug discovery. Journal of Biosciences, 45(1), 1–14. Retrieved from https://link.springer.com/article/10.1007/s12038-020-00112-8#citeas
Patents (Amendment) Rules, 2019. (2019,September 17) Retrieved from http://ipindia.gov.in/writereaddata/Portal/News/569_1_The_Patent_Amendment_Rules_2019_.pdf
Robertson, J. A. (2001). Human embryonic stem cell research: ethical and legal issues. Nature Reviews Genetics, 2(1), 74–78.
Biotechnology (1st ed.). CABI.(Last Accessed January 13,2021)
Halliburton, M. (2017). India and the Patent Wars: Pharmaceuticals in the New Intellectual Property Regime (The Culture and Politics of Health Care Work) (Illustrated ed.). ILR Press.
World Intellectual Property Organization, & Organization, W. I. P. (2019). Patent Cooperation Treaty Yearly Review - 2019 (1st ed., Vol. 2019). World Intellectual Property Organization.
Singh, R., Sinha, S. K., & Kumar, S. (2019). Unfolding Intellectual Property Rights: A Practical Patent Guide for Researchers, Academicians and start-ups (1st ed., Vol. 1). Notion Press.
National Guidelines for Gene Therapy Product Development and Clinical Trials, 2019. (2019,November 1) (Last Accessed January 13, 2021)