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Impact of Patent (Amendment) Act, 2005 on Indian Pharmaceutical Industry


Affiliations
1 Department of Commerce, Aligarh Muslim University, Aligarh — 202 002, Uttar Pradesh,, India
 

Since 1901, the Indian pharmaceutical industries have expanded and strengthened to become a significant supplier of healthcare items, meeting around 90% of the nation’s need for bulk pharmaceuticals, drugs intermediates, chemicals for the medicinal base, pharmaceutical compounds, medicinal formulas, drugs, tablets, orals, respules/capsules, and injectables. Indian pharmaceutical industry has embarked not only on national markets but it has an esteemed and illustrious position in international markets also. India is the world’s third-largest pharmaceutical manufacturer by volume and fourteenth-largest by value. The growth and empowerment of the pharmaceutical industry is totally attributed to the rules and principles governing the operations and evolution of the pharmaceutical industry in India. These rules are the controlling guidelines mandated by the Government of India, through the Acts and amendments made in the acts at various times. One of the major and most influential amendment is the Patent (Amendment) Act, 2005. This act has provided new dimensions and horizons to the Indian pharmaceutical industry and a good number or rational researches have been performed on this subject. It has thus been a fascination to dig the researcher’s points of views about how The Patent (Amendment) Act, 2005 after TRIPS has impacted the Indian pharmaceutical industry since this act has been passed. This survey paper is an attempt to bring out the deviations and modifications, Indian pharmaceutical industry has been gone through, since year 2005.

Keywords

Indian Pharmaceutical Industry, TRIPS, The Patent (Amendment) Act, 2005, Trade, Exports, Profitability.
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  • Act, The Patents (Amendment) Act, (Act XV of 2005), Government of India, 2005.

  • Watal J & Taubman A, The making of the TRIPS Agreement: Personal insights from the Uruguay Round Negotiations. World Trade Organization, 2015.

  • Mashelkar R A, India's R&D: Reaching for the top, Science, 307 (5714) (2005) 1415-1417.

  • WTO Agreement on Trade-Related Aspects of Intellectual Property Rights. Retrieved from World Trade Organisation, Legal Texts: https://www.wto.org/english/ docs_e/legal_e/ 31bis_trips_01_e.htm, 2017.

  • Teacher L, TRIPS Agreement on the Trade-Related Aspects of Intellectual Property. Retrieved from https://www.law teacher.net/acts/trips-agreement-intellectualproperty.php?vref=1, 2013.

  • Kumagai K, Introduction to TRIPs Agreement, Japan: Japan Patent Office, 2008.

  • CGPDTM, History of Indian Patent System. Retrieved from Official Website of Intellectual Property India: https://ipindia.gov.in/history-of-indian-patent-system.htm, 2019.

  • Drivers of Indian Pharmaceutical Exports, RBI Bulletin, July 2021, 49.

  • Gopakumar K M & Santosh M R, An unhealthy future for the Indian Pharmaceutical Industry, Third World Resurgence, 259 (2012) 9.

  • Nomani M Z M, Alhalboosi A K & Rauf M, Legal & intellectual property dimension of health & access to medicines in India, Indian journal of forensic medicine & toxicology, 14 (1) 2020.

  • Festa G, Rossi M, Kolte A & Marinelli L, The contribution of intellectual capital to financial stability in Indian pharmaceutical companies, Journal of Intellectual Capital, 2020.

  • Raju K D, World Trade Organization (WTO) Disputes, 2019.

  • Act, The Indian Patents and Designs Act, 1911, (Act II of 1911), 1911.

  • Act, Patent and Design Amendment Act (Act XXXII of 1950), Government of India, 1950.

  • Act, The Indian Patents and Designs Amendment Act (Act LXX of 1952), Government of India, 1952.

  • Act, The Patent Act, 1970 (XXXIX Act of 1970), Government of India, 1970.

  • Act, Patent Rules, 1972, Vide Not. No. 301(E), Government of India, 1972.

  • Act, TRIPS: Agreement on Trade-Related Aspects of Intellectual Property Rights. Marrakesh, Morocco: Annex 1C of the Marrakesh Agreement, World Trade Organisation.

  • Act, The Patents (Amendment) Act, (Act XVII of 1999), retrospectively enforced from 1/1/1995, Government of India, 1999.

  • Act, The Patents (Amendment) Act, (Act XXXVIII of 2002), Government of India, 2002.

  • Act, The Patent (Amendment) Ordinance (Ord. VII of 2004), Government of India, 2004.

  • Act, The Patents (Amendment) Rules, 2006, Government of India, 2006.

  • Act, The Patents (Amendment) Rules, 2016, Government of India, 2016.

  • Act, The Patents (Amendment) Rules, 2019, Government of India, 2019.

  • Act, The Patents (Amendment) Rules, 2020, Government of India, 2020.

  • Act, The Patents (Amendment) Rules, 2021, Government of India, 2021.

  • Vogel C, The impact and the implications of TRIPS in a knowledge-based global economy: A developing country's perspective, Studies in Trade and Investment, 2 (2006) 47.

  • Bansal A K, Public interest in Intellectual Property Laws, Journal of the Indian Law Institute, 2013, 476.

  • IBEF, India's Vaccines Industry Can Grow from US$ 2 billion Up to US$ 5 billion by 2026: Report, https://www.ibef.org/news/indias-vaccines-industry-cangrow-from-us-2-billion-up-to-us-5-billion-by-2026-report, 2021.

  • Sudershan K, Muppani V R, Khan M & Ali A, Foreign direct investment and export performance of pharmaceutical firms in India: An empirical approach, International Journal of Economics and Finance, 4 (5) 2012.

  • Rai R K, Battling with TRIPS: Emerging firm strategies of Indian pharmaceutical industry Post-TRIPS, 2008.

  • IBEF, Indian Pharmaceutical Industry, Retrieved from Indian Brand Equity Foundation: https://www.ibef.org/industry/ pharmaceutical-india, 2022.

  • Annual Report, Department of Pharmaceuticals: Annual Report of 2021-22. Retrieved Online: https://pharmaceuticals.gov.in/annual-report, 2021.

  • Mahajan V, Is productivity of Indian Pharmaceutical industry affected with the introduction of Product Patent Act? Indian Growth and Development Review, 2020.

  • Haley G T & Haley U C V, The Effects of Patent-Law Changes on innovation: The Case of India’s Pharmaceutical Industry, Technological Forecasting and Social Change, 2012.

  • Vaidya M, Garg S, Singh C & Mahajan M M, Changing Dimensions of Drug Patents of Indian Pharmaceutical Industry, NOPR, 2018.

  • Dhanora M, Sharma R & Park W G, Technological Innovations and Market Power: A Study of Indian Pharmaceutical Industry, Millennial Asia, 12 (1) (2020) 5.

  • Sahasranamam S, Rentala S & Rose E L, Knowledge sources and international business activity in a changing innovation ecosystem: A study of the Indian Pharmaceutical Industry, Management and Organization Review, 15 (3) (2019) 595.

  • Gokhale P & Kannan S, Patenting Trends in Indian pharmaceutical Industry, Annals of Library and Information Studies (ALIS), 64 (4) (2018) 260.

  • Racherla U S, Historical Evolution of India’s Patent Regime and Its Impact on Innovation in the Indian Pharmaceutical Industry, In Innovation, Economic Development, and Intellectual Property in India and China, Springer, Singapore, 2019, 271-298.

  • Brooks C, Introductory Econometrics for Finance, Cambridge University Press, UK, 2008.

  • Chaudhuri S, The WTO and India's Pharmaceuticals Industry: Patent Protection, TRIPS and Developing Countries New Delhi: Oxford University Press, 2005, 39- 128.

  • Nair G G, Impact of TRIPS on Indian Pharmaceutical Industry, 2008.

  • Malhotra P, Development of India’s Pharmaceutical Industry, In Impact of TRIPS in India, Palgrave Macmillan, London, 2010, 57-79.

  • Kiran R & Mishra S, Changing Pragmatics of the Indian pharmaceutical Industry in the pre and post TRIPS Period, International Journal of Business and Management, 4 (9) (2009) 206.

  • Kiran R & Mishra S, Performance of the Indian Pharmaceutical Industry in post-TRIPS Period: A Firm Level Analysis, International Review of Business Research Papers, 5 (6) (2009) 148.

  • Dubey N, Sharma R K, Gupta H & Dubey N, Performance of the Indian pharmaceutical Industry pre and post TRIPS era: A Study, Asian Journal of Pharmacy & Life Science, 1 (2) (2011) 187.

  • Tancer R S, Investing in the Indian pharmaceutical Industry, Thunderbird, The American Graduate School of International Management, 1999.

  • Smith S E, Opening up to the World: India’s Pharmaceutical Companies Prepare for 2005, Asia/Pacific Research Center, Institute for International Studies, Stanford University, 1-46, 2000.

  • Lalitha N, Indian pharmaceutical Industry in WTO Regime: A SWOT analysis, Economic and Political Weekly, 3542- 3555, 2002.

  • Kubo K, Product Patents and Vertical Integration in the Post TRIPS Indian Pharmaceutical Industry, Iranian Journal of Pharmaceutical Research, 3 (2004) 146, http//are. berkeley. edu/jobmarket/ken. Pdf.

  • Chaturvedi K & Chataway J, Strategic integration of knowledge in Indian Pharmaceutical Firms: Creating competencies for innovation, International Journal of Business Innovation and Research, 1 (1-2) (2006) 27.

  • Basant R, Intellectual property rights regimes: Comparison of Pharma prices in India and Pakistan, Economic and Political Weekly, 3969-3977, 2007.

  • Gupta P K, Promising Achievements and New Challenges in Agriculture Biotechnology, Current Science, 93 (8) (2007) 1052.

  • Banerji S & Sengupta A, The effect of the Indian Patents (2005) Amendment on the Pharmaceutical Industry and Access to Medicines in India, Indian Journal of Intellectual Property Law, 4 (2011) 103.

  • Chatterjee M, Law on Pharmaceutical Patents, 2012.

  • Kalaskar P B & Sagar P N, Product Patent Regime Posed Indian Pharma Companies to Change Their Marketing Strategies: A Systematic Review, VSRD-International Journal Business Management and Research, 2 (6) (2012) 254.

  • Boldrin M & Levine D K, The Case Against Patents, Journal of Economic Perspectives, 27 (1) (2013) 3.

  • Sampath P G, Economic Aspects of Access to Medicines after 2005: Product Patents Protection and Emerging Firm Strategies in the Indian Pharmaceutical Industry, 2007.

  • Sharma S, New Patent Regime in India: Challenges and Future of the Pharmaceutical Industry, Technical Report, 2007.

  • Chaudhuri S, Park C & Gopakumar K M, Five Years into the Product Patent Regime: India’s Response, United Nations Development Programme, One United Nations Plaza, New York, NY, 2010.

  • Joseph R K, The R & D Scenario in the Indian Pharmaceutical Industry, 2012.

  • Juma C, Intellectual Property Rights and Globalization: Implications for Developing Countries, Science, Technology and Innovation Discussion Paper, 1999.

  • Bruche G, Emerging Indian Pharma Multinationals: Latecomer Catch-up Strategies In a Globalised High-tech Industry, European Journal of International Management, 6 (3) 2012 300.

  • Ray A S, Learning and Innovation in the Indian Pharmaceutical Industry: The Role of IPR & Other Policy Interventions, RECIIS – Electronic Journal of Communication, Information and Innovation in Health, 2(2), 71-77, 2008.

  • Mahajan M M, The Emergence of new R&D Paradigms in the Indian Pharmaceutical Industry: Post TRIPS Period, 2011.

  • Janodia M D, Rao J V, Pandey S, Sreedhar D, Ligade V S & Udupa N, Impact of Patents on Indian Pharma Industry’s Growth and Competency: A Viewpoint of Pharmaceutical Companies in India, 2009.

  • Ramanna A, IPRs and agriculture: South Asian Concerns, South Asia Economic Journal, 4 (1) (2003) 55.

  • Rangnekar D, No Pills for Poor People? Understanding the Disembowelment of India's Patent Regime, CSGR Working Paper 176/05, 2005.

  • Lanjouw J O, The Introduction of Pharmaceutical Product Patents in India, 1998.

  • Lanjouw J O, A New Global Patent Regime for Diseases: US and International Legal Issues, Harv J L & Tech, 16, 85, 2002.

  • Glasgow L J, Stretching the Limits of Intellectual Property Rights: Has The Pharmaceutical Industry Gone Too Far. Idea, 41, 227, 2001.

  • Adede A O, Streamlining Africa's responses to the impact of review and implementation of the TRIPs Agreement, International Centre for Trade and Sustainable Development, 2001.

  • Walker S, The TRIPS Agreement, Sustainable Development & The Public Interest: Discussion Paper (No. 41). IUCN, 2001.

  • Lall S, & Albaladejo M, Indicators of Relative Importance of IPRs in Developing Countries, Background Paper for ICTSD/UNCTAD Capacity Building Project on TRIPS and Development (No. 85). Working Paper, 2002.

  • Zuniga M P & Combe E, Introducing patent protection in the pharmaceutical sector: A first evaluation of the Mexican case, Revue Région et Developpement, 16 (2002) 191.

  • Ehtesham S & Mansingh N, Conflicting Interests in Drug Pricing: Innovation v Social Needs, Current Science, (2008) 168.

  • Lanoszka A, The global politics of intellectual property rights and Pharmaceutical Drug Policies in developing countries, International Political Science Review, 24 (2) (2003) 181.

  • Pradhan J P, Liberalization, firm size and r&d performance: A firm level study of Indian Pharmaceutical industry, Journal of Indian School of Political Economy, 14 (4) (2003) 647.

  • Pradhan J P, New policy regime and small pharmaceutical firms, micro and small enterprises in India: The Era of Reforms, (2011) 227.

  • Aggarwal A, Export processing zones in India: Analysis of the export performance (No. 148), Working paper, 2004.

  • Brahmi P, Saxena S & Dhillon B S, The Protection of Plant Varieties and Farmers' Rights Act of India, Current Science, 86 (3) (2004) 392.

  • Sampath P G, Indian Pharma Within Global Reach?, UNUMERIT, Maastricht Economic and Social Research and Training Centre on Innovation and Technology, 2006, 1-44.

  • Reddy S, The Costs to India of Complying with World Intellectual Property Rights, 2006.

  • Raju P, WTO-TRIPS Obligations and Patent Amendments in India: A Critical Stocktaking, Journal of Intellectual Property Rights, 9 (2004) 242.

  • Bhaduri, S, TRIPS in India: Reasons and rhetorics, Vidyasagar University Journal of Commerce, 11 (2006) 28.

  • Cygnus Report on A Tough Time for Pharmaceutical SSI Units in India, 2006.

  • Chaudhuri S, Is product patent protection necessary in developing countries for innovation? R&D by Indian pharmaceutical companies after TRIPS, 2007.

  • Jayakumar K, Impact of acquisition on operating performance in Indian Pharmaceutical Industry, Indian Journal of Economics and Development, 1 (3) (2013) 67.

  • Khader F A, The Law of Patents, With a special focus on pharmaceuticals in India, Lexis Nexis Butterworths Wadhwa Nagpur, Guragon, 2009.


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  • Impact of Patent (Amendment) Act, 2005 on Indian Pharmaceutical Industry

Abstract Views: 134  |  PDF Views: 92

Authors

Keerti Singh
Department of Commerce, Aligarh Muslim University, Aligarh — 202 002, Uttar Pradesh,, India

Abstract


Since 1901, the Indian pharmaceutical industries have expanded and strengthened to become a significant supplier of healthcare items, meeting around 90% of the nation’s need for bulk pharmaceuticals, drugs intermediates, chemicals for the medicinal base, pharmaceutical compounds, medicinal formulas, drugs, tablets, orals, respules/capsules, and injectables. Indian pharmaceutical industry has embarked not only on national markets but it has an esteemed and illustrious position in international markets also. India is the world’s third-largest pharmaceutical manufacturer by volume and fourteenth-largest by value. The growth and empowerment of the pharmaceutical industry is totally attributed to the rules and principles governing the operations and evolution of the pharmaceutical industry in India. These rules are the controlling guidelines mandated by the Government of India, through the Acts and amendments made in the acts at various times. One of the major and most influential amendment is the Patent (Amendment) Act, 2005. This act has provided new dimensions and horizons to the Indian pharmaceutical industry and a good number or rational researches have been performed on this subject. It has thus been a fascination to dig the researcher’s points of views about how The Patent (Amendment) Act, 2005 after TRIPS has impacted the Indian pharmaceutical industry since this act has been passed. This survey paper is an attempt to bring out the deviations and modifications, Indian pharmaceutical industry has been gone through, since year 2005.

Keywords


Indian Pharmaceutical Industry, TRIPS, The Patent (Amendment) Act, 2005, Trade, Exports, Profitability.

References