An Analysis of the Transformation of Mega-Pharma’s Business Model toward the Emerging Market

Yaeko Mitsumori

Abstract


The Trade-Related Aspects of Intellectual Property Rights(TRIPS) requires all member countries of the World Trade Organization (WTO) to introduce a TRIPS-compatible patent law into their countries. Due to the enforcement of TRIPS in 1995, India in 2005 revised its patent law and enacted the Patents (Amendment) Act, 2005. The 2005 ACT included product patent in pharmaceutical field. Due to the new patent law with product patent protection, large foreign capital pharmaceutical companies one after another re-entered the Indian market and started engaging in both R&D and production targeting the Indian market. However recent data shows the number of patent applications has been declining over the past several years and the number of patented drugs launched in India did not increase so rapidly. This study analyzes transitions of business models of foreign pharmaceutical companies in India based on the patent application data, and the trend of patented drugs in the market. A data analysis and a series of interviews with stakeholders were conducted. As a result of both a quantitative and a qualitative analysis, it was found that foreign pharmaceutical companies changed their strategies in the Indian pharmaceutical market. Since India was required to introduce product patents in the pharmaceutical area, there have been many arguments that once India introduces a product patent, the Indian pharmaceutical industry may decline due to the rapid introduction of foreign pharmaceutical products in the country; many academic papers were published in this context during that time. However, since 2005, when product patents were actually introduced in India, few academic papers were published. This study is unique as it discusses the effects of the introduction of product patents on the Indian pharmaceutical market.

Keywords


Intellectual Property; WTO/TRIPS; Developing Countries; Newly Developing Countries; Pharmaceuticals; Ever Greening.

References


Differding, Edmond. “The Drug Discovery and Development Industry in India-Two Decades of Proprietary Small-Molecule R&D.” ChemMedChem 12, no. 11 (June 1, 2017): 786–818. doi:10.1002/cmdc.201700043.

Nair, G. Gapakumar, et al. “Landmark Pharma Patent Jurisprudence in India,” Journal of Intellectual Property Rights, Vol. 19, March (2014): 79-88.

Singh, M. Prathiba. “Breaking the Anti-IP Myth,” Managing Intellectual Property, (September 2014).

Horner, Rory. "The impact of patents on innovation, technology transfer and health: A pre-and post-TRIPs analysis of India's pharmaceutical industry." New Political Economy 19, no. 3 (2014): 384-406. doi:10.1080/13563467.2013.796446.

Dhar, Biswajit, and Reji K. Joseph. “The Challenges, Opportunities and Performance of the Indian Pharmaceutical Industry Post-TRIPS.” ARCIALA Series on Intellectual Assets and Law in Asia (September 2019): 299–323. doi:10.1007/978-981-13-8102-7_13.

The Japan External Trade Organization (JETRO), Japan. Available online: https://www.jetro.go.jp/en/ (accesses on 24 May 2020).

United Nations, Available online: https://www.un.org/en/ (accesses on 24 May 2020).

OECD Economic Outlook Projection, 2020, Available online: http://www.oecd.org/economic-outlook/june-2020/ (accesses on 24 May 2020).

Bhojwani, H. R. "Developing innovative capacity in India to meet health needs." Innovation In Developing Countries To Meet Health Needs (2005): 112.

The Patent Act, India, 1970. Available online: http://www.ipindia.nic.in/writereaddata/Portal/IPOAct/1_31_1_patent-act-1970-11march2015.pdf (accesses on 24 May 2020).

Minato, Kazuki. “Background of Indian Pharmaceutical Industry and changes after TRIPS Agreement,” In Generic Medicine Market in Japan and Pharmaceutical Industry in India and China, edited by edited by Kubo, Kensuke, Japan, IDE-JETRO (2007): 21-54.

Yaeko Mitsumori, “Study on the roles of the Section 3d of Indian Patent Act for lightening negative impact of product patent introduction in 2005 on Indian pharmaceutical industry,” Technology and Economy, No. 526, Japan MOT Society, (December 2010): 50-57.

IBEF Ppharmaceuticals May 2019, IBEF (2019). Available online: https://www.ibef.org/industry/indian-pharmaceuticals-industry-analysis-presentation (accesses on 11 July 2020).

Seyedimany, Arian. “Stock Price Reactions on NASDAQ Stock Exchange for Special Dividend Announcements.” Emerging Science Journal 3, no. 6 (December 1, 2019): 382–388. doi:10.28991/esj-2019-01200.

The Global Use of Medicine in 2019 and Outlook to 2023 Institute Report, IQVIA, 2019. Available online: https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/the-global-use-of-medicine-in-2019-and-outlook-to-2023.pdf. (accesses on 29 January 2019).

History of Indian Patent System, IPO, India, 2020. Available online: http://www.ipindia.nic.in/history-of-indian-patent-system.htm. (accesses on 18 April 2020).

The Indian Patents and Designs Act, India, 1911. Available online: http://theindianlawyer.in/statutesnbareacts/acts/d42.html. (accesses on 23 April 2020).

MITSUMORI, Yaeko, and Akio NAGAHIRA. “Qualitative & Quantitative Analyses of Impact of a Safeguard Section of Indian Patent Law 2005.” International Journal of Japan Association for Management Systems 8, no. 1 (2016): 39–46. doi:10.14790/ijams.8.39.

WTO. TRIPS, “Which countries are using the general transition periods? Frequently asked questions about TRIPS (trade-related aspects of intellectual property rights) in the WTO, 2020. doi:10.4337/9781781006047.00016. Available online: https://www.wto.org/english/tratop_e/trips_e/tripfq_e.htm#Transition. (accesses on 11 April 2020).

Patent (Amended) Act, 2005 The Patents (Amendment) Act, India, 2005. Available online: http://ipindia.nic.in/writereaddata/ Portal/IPOAct/1_69_1_patent_2005.pdf. (accesses on 23 May 2020).

The Indian Patent Office (IPO), India, 2020. Available online: http://www.ipindia.nic.in/ (accesses on 23 April 2020).

India. Annual Report 2016-2017 Intellectual Property India, The Office Of The Controller General Of Patents, Designs, Trade Marks And Geographical Indications India, 2016. Available online: http://www.ipindia.nic.in/writereaddata/Portal /IPOAnnualReport/1_94_1_1_79_1_Annual_Report-2016-17_English.pdf. (accesses on 29 March 2020).

IPO Annual Reports 2002/2003 - 2016/2017. India. Available online: https://www.sebi.gov.in/sebiweb/home/HomeAction. do?doListing=yes&sid=4&ssid=24&smid=0 (accesses on 05 April 2020).

Nikkei Business Publication, Nikkei Bio Yearbook 2019, 2018. Available online: http://www.nikkeibp.com/adinfo/whatsnew/ (accesses on 05 April 2020).

Mitsumori, Yaeko. “India’s First Compulsory License: Its Impact on the Indian Pharmaceutical Market as well as the World Market,” In Proceedings of PICMET 2014, July 27-30, Ishikawa Japan, (2014): 1437-1443.

Patents (Amendment) Act, 1999. India. Available online: http://www.ipindia.nic.in/writereaddata/Portal/IPOAct/1_34_1_ patents-amendment-act-1999.PDF.(accesses on 25 March 2020).

IQVIA Patent Analysis– Brazil / India / Philippines by GMI Analyst Services (2017).

India. In the High Court of Judicature at Madras Dated: 06.08.2007 Coramthee Hon’ble Mr. Justice R. Balasubramanian and The Hon’ble Mrs. Justice Prabha Sridevan W.P. Nos. 247559 and 24760 of 2006.

Intellectual Property Appellate Board M.P. Nos 1 to 5/2007 in TA/1 to 5/2007/PT/CH and M.P.No.33/2008 IN TA/1/2007/PT/CH Friday This the 26th Day of June 2009, Indi, 2009.

In the Supreme Court of India Civil Appellate Jurisdiction CIVIL Appeal Ns. 2706-2716 of 2013, India.

Application for Compulsory License under Section 84(1) of the Patents Act, 1970 in Respect of Patent No. 215758, India, 1970.

MSF, India: Supreme Court delivers historic verdict in Novartis case India, April 2013. Available online: https://www.msf.org/indian-supreme-court-delivers-verdict-novartis-case. (accesses on 11 March 2020).

Harris, Gardiner and Thomas, Katie. “Low cost drugs in Poor Nations Get a Lift in Indian Court,” NYT April 2, 2013.

Fujii, Mitsuo, head of IPR division of Japan Pharmaceutical Manufacturing Association (JPMA), Interviewed by Yaeko Mitsumori, December 2018.


Full Text: PDF

DOI: 10.28991/esj-2020-01228

Refbacks

  • There are currently no refbacks.


Copyright (c) 2020 Yaeko Mitsumori