Data exclusivity provisions in India: Impact on public health

M.D. Janodia, A. Chauhan, S.M. Hakak, D. Sreedhar, V.S. Ligade, N. Udupa

Research output: Contribution to journalArticle

Abstract

One of the contentious issues of intellectual property rights is related to data exclusivity. Data exclusivity relates to protection of data generated by the innovator from disclosure to third party in order to prevent 'unfair commercial use'. The debate has serious implications for pharmaceutical companies where substantial amount of data is generated during discovery and development of a new drug. The data is in the form of clinical trials data, reports of pharmacological and toxicological profile of drug, its use and indications etc. This data which is submitted to regulatory authorities of concerned countries for marketing approval is generally referred by regulatory authorities for approval of generic medicine. Multinational companies based in developed countries argue that this data generated during drug discovery and development needs to be protected in the form of 'data exclusivity' which is mandated under Article 39.3 of TRIPS Agreement. Developing countries state that 'data exclusivity' is not mandatory according to TRIPS Agreement. So far India has not provided for 'data exclusivity'. India's position on 'data exclusivity' with respect to other countries of the world is subject to recommendations and suggestions of the committee set up by the Government of India to look into issue of 'data exclusivity' which is discussed in this article.

Original languageEnglish
Pages (from-to)442-446
Number of pages5
JournalJournal of Intellectual Property Rights
Volume13
Issue number5
Publication statusPublished - 09-2008

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public health
India
regulatory authority
drug
need development
innovator
intellectual property
right of ownership
pharmaceutical
drug use
indication
marketing
developing country
medicine

All Science Journal Classification (ASJC) codes

  • Law

Cite this

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title = "Data exclusivity provisions in India: Impact on public health",
abstract = "One of the contentious issues of intellectual property rights is related to data exclusivity. Data exclusivity relates to protection of data generated by the innovator from disclosure to third party in order to prevent 'unfair commercial use'. The debate has serious implications for pharmaceutical companies where substantial amount of data is generated during discovery and development of a new drug. The data is in the form of clinical trials data, reports of pharmacological and toxicological profile of drug, its use and indications etc. This data which is submitted to regulatory authorities of concerned countries for marketing approval is generally referred by regulatory authorities for approval of generic medicine. Multinational companies based in developed countries argue that this data generated during drug discovery and development needs to be protected in the form of 'data exclusivity' which is mandated under Article 39.3 of TRIPS Agreement. Developing countries state that 'data exclusivity' is not mandatory according to TRIPS Agreement. So far India has not provided for 'data exclusivity'. India's position on 'data exclusivity' with respect to other countries of the world is subject to recommendations and suggestions of the committee set up by the Government of India to look into issue of 'data exclusivity' which is discussed in this article.",
author = "M.D. Janodia and A. Chauhan and S.M. Hakak and D. Sreedhar and V.S. Ligade and N. Udupa",
note = "Export Date: 10 November 2017 Correspondence Address: Janodia, M. D.; Department of Pharmacy Management, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal 576 104, Karnataka, India; email: manthan.j@manipal.edu References: Ludwig, S.R., The Medicine chest: Data exclusivity - A necessary form of intellectual property (2007) Intellectual Property Today, p. 7. , August; Zbierska, K., Distinctions Between The European Union and the United States On Data Exclusivity, , Abstract of LLM Thesis (academic year 2005/2005), Munich Intellectual Property Law Centre; Perez, P.M., (2008) Intellectual Property and Pharmaceutical Data Exclusivity in the Context of Innovation and Market Access, , http://www.iprsonline.org/unctadictsd/bellagio/docs/Pugatch_Bellagio3.pdf, 10 March; (2000) International Federation of Pharmaceutical Manufacturers Association, p. 3. , http://www.ifpma.org/documents/NR83/DataExclusivity.pdf, Encouragement of New Clinical Drug Development: The Role of Data Exclusivity; Perez, P.M., Data Exclusivity: Implications for developing countries (2005) Bridges, 9 (6-7), p. 21. , www.ictsd.org; Correa, C.M., (2008) Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the TRIPS Agreement, , http://www.southcentre.org/publications/protection/protection.pdf, 10 March; Bishwajit, D., Gopakumar, K.M., Data exclusivity in pharmaceuticals: Little basis, false claims (2006) Economic and Political Weekly, p. 5075; Srinivas, K.R., (2008) Test Data Protection, Data Exclusivity and TRIPS: What Options for India?, , http://papers.ssrn.com/sol3/papers.cfm?abstract_id=935847, 11 March; (2000) TRIPS Article 39.3 Does Not Require Data Exclusivity Provisions - A Critical Issue for Access to Medicines, p. 5. , EGA Position Paper, July; http://www.wto.org/english/tratop_e/dda_e/dohaexplained_e.htm; Clift, C., Data protection and data exclusivity in pharmaceuticals and agrochemicals Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices, p. 434. , www.ipHandbook.org, edited by A Krattiger, R T Mahoney, L Nelsen, et al. (MIHR: Oxford, UK and PIPRA, Davis, USA); Grabowski, H., Data exclusivity for new biologicals, Duke University (2007) Department of Economics Working Paper, p. 3. , June; http://www.bio-medicine.org/medicine-news/DrugCompanies-Should-Not-Have- a-Monopoly-Over-ClinicalTrial-Data-18366-1/; Alfred, A., (2005) Data Exclusivity: The Implications for India, , www.articlealley.com/article_16562_18.html, November; Singh, N.M., (2004) Data Exclusivity - The Indian Perspective, , http://www.mondaq.com/article.asp?articleid=28531, September; Trenton, A., Sha, T., Introduction of the Bolar exemption in the EU and Japan (2007) Patent World, 195, p. 33; Data Exclusivity Japan, , http://www.asipi.org/LinkClick.aspx?fileticket=6UUtyeUxhzg{\%}3D&tabid= 114&mid=780#392,21; http://www.findlaw.com.au/article/9200.htm; http://www.wipo.int/edocs/mdocs/ip-conf-bg/en/wipo_ectk_sof_01/ wipo_ectk_sof_01_2_5.doc; http://www.ifpma.org/documents/NR83/DataExclusivity.pdf; Monopolizing clinical trial data: Implications and trends (2007) PLoS Med, 4 (2), pp. e2. , doi:10.1371/journal.pmed. 0040002; www.expresspharmaonline.com/20070228/market01.shtml; Trigueros Jose, R., Data exclusivity regulations explained (2007) World IP Contacts Handbook 2007 (Managing Intellectual Property) World IP Contacts Handbook, , http://works.bepress.eom/jose_trigueros/1, Country Reports, Mexico; http://www.who.int/intellectualproperty/topics/ip/en/Data.exclusivity. review.doc; Neroth, P., Profits, P., (2004) The Lancet, 364, p. 1208; http://www.gnaipr.com/Articles/data{\%}20exclusivity.pdf; Baker Brook, K., (2006) A Critical Analysis of India's Probable Data Exclusivity/data Compensation Provisions, , www.healthgap.org; Regulatory Data Protection - A Building Block for pharmaceutical R&D OPPI Position Paper, p. 9; (2007) Report on Steps to be taken by Government of India in the context of Data Protection Provisions of Article 39.3 of TRIPS Agreement, , http://www.chemicals.nic.in/DPBooklet.pdf, 31 May",
year = "2008",
month = "9",
language = "English",
volume = "13",
pages = "442--446",
journal = "Journal of Intellectual Property Rights",
issn = "0971-7544",
publisher = "National Institute of Science Communication and Information Resources (NISCAIR)",
number = "5",

}

Data exclusivity provisions in India: Impact on public health. / Janodia, M.D.; Chauhan, A.; Hakak, S.M.; Sreedhar, D.; Ligade, V.S.; Udupa, N.

In: Journal of Intellectual Property Rights, Vol. 13, No. 5, 09.2008, p. 442-446.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Data exclusivity provisions in India: Impact on public health

AU - Janodia, M.D.

AU - Chauhan, A.

AU - Hakak, S.M.

AU - Sreedhar, D.

AU - Ligade, V.S.

AU - Udupa, N.

N1 - Export Date: 10 November 2017 Correspondence Address: Janodia, M. D.; Department of Pharmacy Management, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal 576 104, Karnataka, India; email: manthan.j@manipal.edu References: Ludwig, S.R., The Medicine chest: Data exclusivity - A necessary form of intellectual property (2007) Intellectual Property Today, p. 7. , August; Zbierska, K., Distinctions Between The European Union and the United States On Data Exclusivity, , Abstract of LLM Thesis (academic year 2005/2005), Munich Intellectual Property Law Centre; Perez, P.M., (2008) Intellectual Property and Pharmaceutical Data Exclusivity in the Context of Innovation and Market Access, , http://www.iprsonline.org/unctadictsd/bellagio/docs/Pugatch_Bellagio3.pdf, 10 March; (2000) International Federation of Pharmaceutical Manufacturers Association, p. 3. , http://www.ifpma.org/documents/NR83/DataExclusivity.pdf, Encouragement of New Clinical Drug Development: The Role of Data Exclusivity; Perez, P.M., Data Exclusivity: Implications for developing countries (2005) Bridges, 9 (6-7), p. 21. , www.ictsd.org; Correa, C.M., (2008) Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the TRIPS Agreement, , http://www.southcentre.org/publications/protection/protection.pdf, 10 March; Bishwajit, D., Gopakumar, K.M., Data exclusivity in pharmaceuticals: Little basis, false claims (2006) Economic and Political Weekly, p. 5075; Srinivas, K.R., (2008) Test Data Protection, Data Exclusivity and TRIPS: What Options for India?, , http://papers.ssrn.com/sol3/papers.cfm?abstract_id=935847, 11 March; (2000) TRIPS Article 39.3 Does Not Require Data Exclusivity Provisions - A Critical Issue for Access to Medicines, p. 5. , EGA Position Paper, July; http://www.wto.org/english/tratop_e/dda_e/dohaexplained_e.htm; Clift, C., Data protection and data exclusivity in pharmaceuticals and agrochemicals Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices, p. 434. , www.ipHandbook.org, edited by A Krattiger, R T Mahoney, L Nelsen, et al. (MIHR: Oxford, UK and PIPRA, Davis, USA); Grabowski, H., Data exclusivity for new biologicals, Duke University (2007) Department of Economics Working Paper, p. 3. , June; http://www.bio-medicine.org/medicine-news/DrugCompanies-Should-Not-Have- a-Monopoly-Over-ClinicalTrial-Data-18366-1/; Alfred, A., (2005) Data Exclusivity: The Implications for India, , www.articlealley.com/article_16562_18.html, November; Singh, N.M., (2004) Data Exclusivity - The Indian Perspective, , http://www.mondaq.com/article.asp?articleid=28531, September; Trenton, A., Sha, T., Introduction of the Bolar exemption in the EU and Japan (2007) Patent World, 195, p. 33; Data Exclusivity Japan, , http://www.asipi.org/LinkClick.aspx?fileticket=6UUtyeUxhzg%3D&tabid= 114&mid=780#392,21; http://www.findlaw.com.au/article/9200.htm; http://www.wipo.int/edocs/mdocs/ip-conf-bg/en/wipo_ectk_sof_01/ wipo_ectk_sof_01_2_5.doc; http://www.ifpma.org/documents/NR83/DataExclusivity.pdf; Monopolizing clinical trial data: Implications and trends (2007) PLoS Med, 4 (2), pp. e2. , doi:10.1371/journal.pmed. 0040002; www.expresspharmaonline.com/20070228/market01.shtml; Trigueros Jose, R., Data exclusivity regulations explained (2007) World IP Contacts Handbook 2007 (Managing Intellectual Property) World IP Contacts Handbook, , http://works.bepress.eom/jose_trigueros/1, Country Reports, Mexico; http://www.who.int/intellectualproperty/topics/ip/en/Data.exclusivity. review.doc; Neroth, P., Profits, P., (2004) The Lancet, 364, p. 1208; http://www.gnaipr.com/Articles/data%20exclusivity.pdf; Baker Brook, K., (2006) A Critical Analysis of India's Probable Data Exclusivity/data Compensation Provisions, , www.healthgap.org; Regulatory Data Protection - A Building Block for pharmaceutical R&D OPPI Position Paper, p. 9; (2007) Report on Steps to be taken by Government of India in the context of Data Protection Provisions of Article 39.3 of TRIPS Agreement, , http://www.chemicals.nic.in/DPBooklet.pdf, 31 May

PY - 2008/9

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