Současná Evropa
Současná Evropa
Contemporary Europe
ČESKY ENGLISH
Faculty of International Relations, University of Economics, Prague

Současná Evropa 2013/3

Patent Protection of European Pharmaceutical Innovations in India


[full text (PDF)]

Ludmila Štěrbová, Kamila Trojanová

India is a very important target market for European investors, including those from pharmaceutical industry, namely due to its production and sales opportunities. Production of pharmaceuticals and trade with them have some specific features that develop namely from the system of patent protection and enforcement and from the health system of individual countries. Indian legal system is in the field of intellectual property rights relatively complex and has important differences, including those in implementation of the TRIPS Agreement of the WTO. The goal of the future free trade agreement between India and EU is to negotiate the same level of the protection that pharmaceutical patents enjoy in the EU. It would support expansion of the European pharmaceutical industry at Asian market and would prevent losses from patent infringement or copying. Indian interests in this field are, however, contradictory, namely due to the necessity to protect national pharmaceutical industry, to support exportation of pharmaceuticals and to ensure access for people to cheap medicaments. The article analysis the Indian system of protection of pharmaceutical patents, its impacts on European pharmaceutical research oriented industry and potentials of the future free trade agreement in this area.

Keywords: European union, India, Patents, Pharmaceuticals

References:

1) AHMED, R. (2012). India Looks To Expand Drug-Price Controls. The Wall Street Journal. Dostupné z http://online.wsj.com/article/SB10000872396390443819404577633070809995582.html.

2) ANDERSON, K. (2002). Peculiarities of retaliation in WTO dispute settlement. In: World Trade Review, 1 (2), s. 123–134.

3) ANTANI, M. – KHUSBOO, B. (2009). India. V S. L. Klincewicz, Global Pharmacovigilance Laws & Regulations: The Essential Reference (s. 289). Washington: Food and Drug Law Institute (FDLI).

4) BASHEER, S. (2005). Inida‘s Tryst with TRIPS: The Patents (Amendment) Act. In: The Indian Journal of Law and Technology, s. 15–46.

5) BASHEER, S. (2006). Protection of Regulatory Data under Article 39.3 TRIPS, The Indian Context. Intellectual Property Institute (IPI) Forthcoming, s. 1–43.

6) BOSELEY, S. (2012). Does EU/India free trade agreement spell the end of cheap drugs for poor countries? In: The Guardian. Dostupné z www.guardian.co.uk/society/sarah-boseley-global-health/2012/feb/10/hiv-infection-pharmaceuticals-industry.

7) Business Standard (2011). India will not provide data exclusivity: Anand Sharma. In: Business Standard. Dostupné z www.business-standard.com/india/news/india-will-not-provide-data-exclusivity-anand-sharma/430285/.

8) Business Line (2012). Nearly 75,000 patent applications pending for review. Governemt of India, Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals. Dostupné z www.pharmaceuticals.gov.in/.

9) Business Standard. (2012). Breaking the patent. Business Standard, Delhi, s. 13.

10) CAPLING, A. (1999). Intellectual Property. V B. M. Hocking, Trade Politics. London: Routledge, s. 79–95.

11) CCI. (2012). The Competition Act. Competition Commission of India. Dostupné z www.cci.gov.in/index.php?option=com_content&task=view&id=18.

12) CDSCO (2012a). Central Drugs Standard Control Organisation. Dostupné z www.cdsco.nic.in/.

13) CDSCO. (2012b). List of drugs prohibited for manufacture and sale through Gazette Notifications under Section 26A of Drugs & Cosmetics Act 1940 by the Ministry of Health and Family Welfare. Central Drug Standard Control Organisation. Dostupné z www.cdsco.nic.in/drugs %20banned %20in %20thed %20country.pdf.

14) CG PDT. (2010). Annual Report 2009–2010. Dostupné z http://ipindia.gov.in/cgpdtm/AnnualReport_English_2009_2010.pdf.

15) CG PDT. (nedatováno). E-filing of Patent Application. Indian Patent Office. Dostupné z https://ipindiaonline.gov.in/on_line/.

16) CG PDT (2012a). History of Indian Patent System. Patent. Dostupné z http://ipindia.nic.in/ipr/patent/patents.htm.

17) CIHELKOVÁ, E. (2003). Vnější ekonomické vztahy Evropské unie (1. vydání. vyd.). Praha: C. H. Beck.

18) CORREA, C. M. (2002). Protection of the Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the TRIPS Agreement. South Percpectives Series, South Centre, s. 1–78.

19) CTRI (2012). Clinical Trials Registry – India. Dostupné z www.ctri.nic.in.

20) DE CASTRO, T. (2011). EU-India TRIPS-plus Agreement: A Real threat for the Developing World? In: Contemporary European Studies, s. 23–35.

21) EC (2006). Global Europe: competing in the world. External Trade. Dostupné z http://trade.ec.europa.eu/doclib/docs/2006/october/tradoc_130376.pdf.

22) EC (2011). Pharmaceutical Sector. DG Trade. Dostupné z http://trade.ec.europa.eu/doclib/docs/2012/january/tradoc_148988.pdf.

23) EC (2012). Joint Statement on the Outcome of the EU-India Trade Ministerial. External Trade. Dostupné z http://trade.ec.europa.eu/doclib/press/index.cfm?id=812.

24) ECONOMIST (2012). Taking pains: Indian patent rules infuriate Big Pharma. The Economist. Dostupné z www.economist.com/node/21562226.

25) CHOTHANI, P. – SHAH, P. (2010). Recent Developments in the Indian IP Laws. LANDSLIDE, s. 45–47.

26) KOSHY, S. (1995). The Effects of TRIPs on Indian Patent Law: A Pharmaceutical Industry Perspective. In: Boston University Journal of Science & Technology Law, s. 4.

27) KPMG (2006). KPMG India Pharmaceuticals. The Indian Pharmaceutical Industry: Collaboration for Growth. Dostupné z www.in.kpmg.com/pdf/Indian %20pharma %20outlook.pdf.

28) MALHOTRA, P. (2010). Impact of TRIPS in India. Basingstoke, UK: Palgrave Macmillan.

29) V. Manicka Thevar Vs. Messrs. Star Plough Works (1965), Melur, AIR 1965 Mad 327, 1965 (1) MadLJ 406. Dostupné z www.legalpundits.com/cl_content_search.do?operation=clcontent&searchval=97E75A53-E46B-4909-914F-273923AA30ED.

30) MEHL, A. B. (2006). The Hatch-Waxman Act and Market Exclusivity for Generic Drug Manufacturers: An Entilement or an Incentive? Chicago-Kent Review, s. 649–677.

31) Ministry of Health and Food Welfare (2011). National List of Essential Meidicnes of India. Central Drugs Standard Control Organisation.

Dostupné z www.cdsco.nic.in/data_bank.htm.

32) MITTAL, A (2010). Patent Linkage in India: Current Scenarion and Need for Deliberation. In: Journal of Intellectual Property Rights, s. 187–196.

33) MYERS, S. B. (2008). A Healthy Solution for Patients and Patents: How India‘s Legal Victory Against a Pharmaceutical Giant Reconciles Human Rights with Intellecual Property Rights. In: Vanderbilt Journal of Entertainment and Technology Law, s. 762–798.

34) NOVARTIS INDIA (2012). Glivec Patent Case in India: Facts v. Fiction. Novartis India. Dostupné z www.novartis.com/downloads/newsroom/glivec-information-center/Fact_vs_fiction_of_Glivec_India_Case.pdf.

35) PLANNING COMMISSION (2007). Eleventh Five Year Plan: 2007–2012. Volume III: Agriculture, Rural Development, Industry, Services, and Physical Infrustructure. Planning Commission Government of India. Dostupné z http://planningcommission.nic.in/plans/planrel/fiveyr/11th/11_v3/11th_vol3.pdf.

36) RANJAN, P. (2008). Medical Patents and Expropriation in International Investment Law – with Special Reference to India. Manchester Journal of International Economic Law, s. 72–104.

37) REDDY, P. (2008). Death of the ‘six year rule’ in Indian patent law jurisprudence. Spicy Intellectual Property. Dostupné z http://spicyipindia.blogspot.cz/2008/12/death-of-six-year-rule-in-indian-patent.html.

38) SHARMA, A. (Volume 3 2007). Data Exclusivity With Regard To Clinical Data. The Indian Journal of Law and Technology, s. 82–104.

39) SHARMA, E. K. (2012). Roche patent revocation may have a bearing on other cases. In: Business Today. Dostupné z http://businesstoday.intoday.in/story/roche-patent-revocation-may-have-a-bearing-on-other-cases/1/189621.html.

40) SINGH, K. (2012). Local Regulations Keep Foreign PhramaCos on Tenterhooks. In: Economic Times, Delhi, s. 12.

41) SINHA, K. (2012). Govt to bring essential medicines under price control. Times of India: http://articles.timesofindia.indiatimes.com/2012-09-28/india/34147534_1_price-control-nlem-essential-medicines

42) Subramanian, A. (2003). India as User and Creator of Intellectual Property: The Chalanges Post-Doha. V A. Mattoo, & R. M. Stern, India and the WTO. Washington: The Inetrnational Bank for Reconstruction and Development/The World Bank, s. 169–195.

43) ŠTĚRBOVÁ, L. – Kalínská, E. – Taušer, J. – Žamberský, P. (2007). Mezinárodní obchod pro 2MO301. Praha: VŠE, Nakladatelství Oeconomica.

44) The Gazette of India (1999). The Patent (Amendment) Act 1999. Dostupné z http://ipindia.nic.in/ipr/patent/patact_99.PDF.

45) The Gazette of India. (2002). The Patents (Amendment) Act 2002. Dostupné z http://ipindia.nic.in/ipr/patent/patentg.pdf.

46) The Gazette of India. (2005). The Patents (Amendment) Act 2005. Dostupné z http://ipindia.nic.in/ipr/patent/patent_2005.pdf.

47) UNCTAD (2012). World Investment Report 2012: Towards a New Generation of Investment Policies. United Nations Conference on Trade and Development. Dostupné z www.unctad-docs.org/files/UNCTAD-WIR2012-Full-en.pdf.

48) UNITAID (2012). UNITAID. How Unitaid came about? Dostupné z www.unitaid.eu.

49) USTR (2012). 2012 Special 301 Report. United States Trade Representative. Dostupné z www.ustr.gov/sites/default/files/2012 %20Special %20301 %20Report.pdf.

50) WIPO (2012a). PCT: The International Patent System. The PCT Applicant‘s Guide. Dostupné z www.wipo.int/pct/en/appguide/index.jsp#I.

51) WIPO (2012b) Statistical Country Profiles India. Dostupné z www.wipo.int/ipstats/en/statistics/country_profile/countries/in.html.

52) WTO (2008). European Communities