Abstract
Laws protecting the intellectual property (IP) are one of the most obscurely defined laws. All the members of the World Trade Organization abide by the legal agreement signed between the countries to regulate the IP rights between the member countries known as Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Developing countries especially India amended the Patent Act in 2005 in order to strengthen its administration revolving around IP Rights and tuned it according to the TRIPs Agreement, with an exceptional spotlight on the pharmaceuticals. The main idea behind this amendment was to prevent the process called evergreening. Evergreening is a process where pharmaceutical industries try to extend the duration of a patent under the disguise of increasing the therapeutic efficiency of the drug. Public access to the patented drug can also increase as an outcome of this act by shunning redundant guarding to the inventor. India pledged to curb evergreening which was evidently observed by the recent Supreme Court verdict on the case of Novartis AG v. Union of India (UOI) and Ors. The aim of this chapter is to provide a clear understanding of evergreening so that an unbiased view can be established both towards the best of public interest and protection of the inventor’s right.
This is a preview of subscription content, log in via an institution.
Buying options
Tax calculation will be finalised at checkout
Purchases are for personal use only
Learn about institutional subscriptionsReferences
Bansal IS, Sahu D, Bakshi G, Singh S (2009) Evergreening – a controversial issue in pharma milieu. J Intellect Prop Rights 14:299–306
Dhar B, Gopakumar KM (2006) Post-2005 TRIPS scenario in patent protection in the pharmaceutical sector: the case of the generic pharmaceutical industry in India. UNCTAD and IDRC, Geneva
Directive 2004/27/EC of the European Parliament and of the Council of 31st March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (2001) Off J Eur Union L 136:34–57
Domeij B (1998) Läkemedelspatent: patent på läkemedel i Europa ur ett rättsvetenskapligt och rättsekonomiskt perspektiv. Doctoral dissertation, Stockholm University, Sweden, Jure
Domeij B (2000) Pharmaceutical patents in Europe, vol 3. Martinus Nijhoff Publishers, Stockholm
Domeij B (2013) Anticompetitive marketing in the context of pharmaceutical switching. In: Lidgard HH (ed) Nordic perspectives on competition in innovation markets. Maria Magle Publishing, Lund, pp 129–144
Estavillo M (2012) India grants first compulsory licence, for bayer cancer drug. In: Intellectual property watch. http://www.ip-watch.org/2012/03/12/india-grants-first-compulsory-licence-for-bayer-cancer-drug. Accessed 28 Dec 2017
Granstrand O, Tietze F (2015) IP strategies and policies for and against evergreening. Centre for Technology Management working paper series, 1. ISSN, 2058–8887
Gunther J, Breuvart C (2005) Misuse of patent and drug regulatory approval systems in the pharmaceutical industry: an analysis of US and EU converging approaches. Eur Compet Law Rev 26(12):669
Mathur V (2012) Patenting of pharmaceuticals: an Indian perspective. Int J Drug Dev Res 4(3):27–34
Murphy F, Liberatore F (2009) Abuse of regulatory procedures: the AstraZeneca case: part 3. Eur Compet Law Rev 30(7):314–324
Novartis AG v. Natco Pharma and Others, Controller of Patents and Designs, Application No. 1602/MAS/1998 (2005) (India). http://indiankanoon.org/doc/1352538/ [hereinafter “Novartis v. Natco”]
Rosenberg D (2009) Critique of the European Commission’s sector inquiry into the pharmaceutical sector. Antitrust 24:35
Shadowen SD, Leffler KB, Lukens JT (2011) Bringing market discipline to pharmaceutical product reformulations. IIC-Int Rev Intellect Prop Compet Law 42(6):698
Singh HB, Jha A, Keswani C (eds) (2016) Intellectual property issues in biotechnology. CABI, Wallingford
Taggart JH (1993) The world pharmaceutical industry. Taylor & Francis Publishers, Routledge
The Intellectual Property India Website (n.d.). http://www.ipindia.nic.in. Accessed 9 Jul 2018
The Patents (Amendment) Act 2012, section 68 (2012). http://www.ipindia.nic.in/writereaddata/Portal/IPOAct/1_69_1_patent_2005.pdf. Accessed Dec 27 2018
Treaty, P.C (2001) Done at Washington on June 19, 1970, amended on September 28, 1979, modified on February 3, 1984, and on October 3, 2001
World Health Organization (2006) Public health, innovation and intellectual property rights: report of the Commission on Intellectual Property Rights, Innovation and Public Health. World Health Organization, Geneva
WTO Doha Ministerial Declaration (2001) WT/MIN (01)/DEC/2, 20 November 2001
Zimmermann J (1998) Pyrimidine derivatives and processes for the preparation thereof. U.S. Patent No. 5,521,184, Apr 28, 1998
Acknowledgements
Surbhi Shriti is grateful to CSIR, New Delhi, for financial assistance under UGC Fellowship scheme. Akansha Jain is grateful to Department of Science and Technology, Govt. of India, New Delhi, for financial assistance under Start-up Research Grant (Young Scientist) Scheme (YSS/2015/000773). Sampa Das acknowledges Indian National Science Academy for her Senior Scientist Fellowship.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2019 Springer Nature Singapore Pte Ltd.
About this chapter
Cite this chapter
Shriti, S., Jain, A., Das, S. (2019). Evergreening: An Equivocal Affair in Pharmaceutical Industries. In: Singh, H., Keswani, C., Singh, S. (eds) Intellectual Property Issues in Microbiology. Springer, Singapore. https://doi.org/10.1007/978-981-13-7466-1_17
Download citation
DOI: https://doi.org/10.1007/978-981-13-7466-1_17
Published:
Publisher Name: Springer, Singapore
Print ISBN: 978-981-13-7465-4
Online ISBN: 978-981-13-7466-1
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)