Patents, profitability and access to medicines in TRIPS Regime in India-is there a way out?

M.D. Janodia, N. Udupa, J. Venkata Rao, P. Sureshwar

Research output: Contribution to journalArticle

Abstract

Indian Patent system has evolved over a period of time and since colonial rule various amendments have been made. Indian Patents Act 1970 that allowed only process patent in the fields of pharmaceuticals, food and agrochemicals was the driving force behind the success story of thriving Indian Pharmaceutical Industry and was modeled by various developing countries. With India becoming member country of WTO India was obliged to amend the Patents Act 1970, which was done by India by issuing an Ordinance in December 2004 and then subsequently passing the law on 23 March 2005. With this amendment of Patent Act, Indian pharma companies can no longer manufacture generic versions of patented drugs. Various forums have raised the issues of pros and cons of patent system in India. This paper tries to discuss the various aspects of patents, arguments in favor of justifying the cost of R&D for a new drug molecule, various arguments propounded by various forums and the flexibilities given by TRIPS and how these flexibilities can be used to support public health. © APTI.
Original languageEnglish
Pages (from-to)84-88
Number of pages5
JournalIndian Journal of Pharmaceutical Education and Research
Volume42
Issue number1
Publication statusPublished - 2008

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Patents
India
Pharmaceutical Preparations
Agrochemicals
Drug Industry
Developing Countries
Public Health
Costs and Cost Analysis
Food

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title = "Patents, profitability and access to medicines in TRIPS Regime in India-is there a way out?",
abstract = "Indian Patent system has evolved over a period of time and since colonial rule various amendments have been made. Indian Patents Act 1970 that allowed only process patent in the fields of pharmaceuticals, food and agrochemicals was the driving force behind the success story of thriving Indian Pharmaceutical Industry and was modeled by various developing countries. With India becoming member country of WTO India was obliged to amend the Patents Act 1970, which was done by India by issuing an Ordinance in December 2004 and then subsequently passing the law on 23 March 2005. With this amendment of Patent Act, Indian pharma companies can no longer manufacture generic versions of patented drugs. Various forums have raised the issues of pros and cons of patent system in India. This paper tries to discuss the various aspects of patents, arguments in favor of justifying the cost of R&D for a new drug molecule, various arguments propounded by various forums and the flexibilities given by TRIPS and how these flexibilities can be used to support public health. {\circledC} APTI.",
author = "M.D. Janodia and N. Udupa and {Venkata Rao}, J. and P. Sureshwar",
note = "Export Date: 10 November 2017 Correspondence Address: Udupa, N.; Department of Pharmacy Management, Manipal College of Pharmaceutical Sciences, Manipal 576 104, Karnataka, India; email: n.udupa@manipal.edu References: Ramakrishna, T., Basic Principles and Acquisition of Intellectual Property Rights CIPRA; (2003), 16. , National Law School of India University, First Edition; Narrain, S., A costly prescription (2005) Frontline, 22 (4), pp. 12-25. , Feb; Barton John, H., TRIPS and the global Pharmaceutical Market (2004) Health Affairs, 23 (3), pp. 146-154; Sengupta, A., (2005) Indian Patens Act-Jeopardizing the Lives of Millions, , http://www.phmovement.org/india/articles/indianpatentact.html, accessed at on March 17; Vasudeva, P.K., Indian Strategic Review, , http://www.members.tripod.com/israindia/isr/aug22/vasu.html, TRIPS council and India, accessed at, on 05-09-2004; http://www.indiatogether.org/combatlaw/vol4/issue2/patents.htm, accessed 19-10-2005; (2003) The Hindu, p. 10. , Tuesday, June; http://www.legalmediagroup.com/mip/default.asp?Page=1&SID=2416&ImgName=indiaspecial04.gif&=F=F, accessed on April 14, 2005; www.managingip.com-?Page=10&PUBID=34&ISS=14224&SID=494606&TYPE=20.htm; (accessed on 10-05-2005); Henry, G., (2002) Patents, Innovations and Access to New Pharmaceuticals, , http://www.levine.sscnet.ucla.edu/archive/grabowpatents/innov.pdf, July, accessed at, on 05-08-2005; Watkins, K.J., (2002) Fighting the Clock - Pharmaceutical and Biotechnology Companies Seek Ways to Reduce the Time Required to Discover and Develop Medicines, 80 (4), pp. 27-33. , http://www.pubs.acs.org/cen/coverstory/8004/8004pharmaceuticals.html, C&EN, accessed at, on 30-08-2005; TRIPS and its impact on Drug Prices and Healthcare in India (2005) IDMA Bulletin, 36 (6), p. 16. , Saradindu Bhaduri and Abhay Kumar, February; http://www.fda.gov/cder/handbook/index.htm, accessed on 24-11-2005; Mullins, C.D., Palumbo, F., Stuart, B., Projection of Drug Approvals, Patent Expirations and Generic Entry From 2000 to 2004, , http://www.aspe.hhs.gov/health/reports/Drug-papers/Mullins-Palumbo{\%}20paper-final.htm, A background report prepared for the Department of Health and Human Services Conference on Pharmaceutical Pricing Practices, Utilization and Costs, August 8-9, 2000, (accessed at, on 19-12-2005.htm; The Hatch-Waxman system: Suffering a Plague of bad behavior (2005) Houston Business and Tax Law Journal, , http://www.hbtlj.org/content/v05/v05Lechnerar.pdf, accessed at, on 17-04-2005; http://www.thunderbird.edu/pdf/about-us/caseseries/a03990015, accessed on 18-09-2004; Ranade, A., Das, S.B., Sectoral Reports: Pharmaceutical Industry - Update, , http://www.abnamro.co.in/Research/pdf/pharmaindy-rep-new.pdf, ABNAMRO report on Indian Pharmaceutical Industry accessed at, accessed 19-09-2004; (2005) Patents and Indian Patient, IDMA Bulletin, 36 (18), p. 11. , Pharma, May; Unveiling India's Pharmaceutical Future (2005) Ernst and Young Report, , http://eyaprimo.ey.com/natlmktgaprimoey/Attachments/Attachment42452.pdf, accessed at, on 20-12-2005; http://indiabudget.nic.in/es2001-02/chapt2002/chap107.pdf, accessed on 23-12-2005; Gross, A., (1999) Pacific Bridge Inc. Report, , http://www.pacificbridgemedical.com/publications/new_trends_in_India_pharmaceutical_market_1999.pdf, New Trends In India's Pharmaceutical Market, February, accessed at, on 20-07-2004; (2005) Ernst and Young Report, , http://eyaprimo.ey.com/natlmktgaprimoey/Attachments/Attachment42450.pdf, on, China and India - Risks and Returns in Asia's blockbuster Pharma Markets accessed at, on 20-12-2005; http://www.healthgap.org/press_releases/05/020105_HGAP_FS_INDIA_IPR.pdf, accessed 25-09-2005; , p. 7. , Report on The Pharmaceutical Sector in India Presented to International Trade Center, Geneva, Confederation of Indian Industry; http://www.atimes.com/atimes/South_Asia/GC24Df04, accessed on 06-10-2005; Patent and the Indian Pharmaceutical Industry, Business Briefing (2002) Pharmatech, p. 46. , Report by Nilesh Zacharias and Sandeep Farias; http://www.news-medical.net/?id=8684, accessed 25-03-2005UR - https://www.scopus.com/inward/record.uri?eid=2-s2.0-77956247201&partnerID=40&md5=b74156738ad323c30e6d5b0546fce82f",
year = "2008",
language = "English",
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pages = "84--88",
journal = "Indian Journal of Pharmaceutical Education and Research",
issn = "0019-5464",
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}

Patents, profitability and access to medicines in TRIPS Regime in India-is there a way out? / Janodia, M.D.; Udupa, N.; Venkata Rao, J.; Sureshwar, P.

In: Indian Journal of Pharmaceutical Education and Research, Vol. 42, No. 1, 2008, p. 84-88.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Patents, profitability and access to medicines in TRIPS Regime in India-is there a way out?

AU - Janodia, M.D.

AU - Udupa, N.

AU - Venkata Rao, J.

AU - Sureshwar, P.

N1 - Export Date: 10 November 2017 Correspondence Address: Udupa, N.; Department of Pharmacy Management, Manipal College of Pharmaceutical Sciences, Manipal 576 104, Karnataka, India; email: n.udupa@manipal.edu References: Ramakrishna, T., Basic Principles and Acquisition of Intellectual Property Rights CIPRA; (2003), 16. , National Law School of India University, First Edition; Narrain, S., A costly prescription (2005) Frontline, 22 (4), pp. 12-25. , Feb; Barton John, H., TRIPS and the global Pharmaceutical Market (2004) Health Affairs, 23 (3), pp. 146-154; Sengupta, A., (2005) Indian Patens Act-Jeopardizing the Lives of Millions, , http://www.phmovement.org/india/articles/indianpatentact.html, accessed at on March 17; Vasudeva, P.K., Indian Strategic Review, , http://www.members.tripod.com/israindia/isr/aug22/vasu.html, TRIPS council and India, accessed at, on 05-09-2004; http://www.indiatogether.org/combatlaw/vol4/issue2/patents.htm, accessed 19-10-2005; (2003) The Hindu, p. 10. , Tuesday, June; http://www.legalmediagroup.com/mip/default.asp?Page=1&SID=2416&ImgName=indiaspecial04.gif&=F=F, accessed on April 14, 2005; www.managingip.com-?Page=10&PUBID=34&ISS=14224&SID=494606&TYPE=20.htm; (accessed on 10-05-2005); Henry, G., (2002) Patents, Innovations and Access to New Pharmaceuticals, , http://www.levine.sscnet.ucla.edu/archive/grabowpatents/innov.pdf, July, accessed at, on 05-08-2005; Watkins, K.J., (2002) Fighting the Clock - Pharmaceutical and Biotechnology Companies Seek Ways to Reduce the Time Required to Discover and Develop Medicines, 80 (4), pp. 27-33. , http://www.pubs.acs.org/cen/coverstory/8004/8004pharmaceuticals.html, C&EN, accessed at, on 30-08-2005; TRIPS and its impact on Drug Prices and Healthcare in India (2005) IDMA Bulletin, 36 (6), p. 16. , Saradindu Bhaduri and Abhay Kumar, February; http://www.fda.gov/cder/handbook/index.htm, accessed on 24-11-2005; Mullins, C.D., Palumbo, F., Stuart, B., Projection of Drug Approvals, Patent Expirations and Generic Entry From 2000 to 2004, , http://www.aspe.hhs.gov/health/reports/Drug-papers/Mullins-Palumbo%20paper-final.htm, A background report prepared for the Department of Health and Human Services Conference on Pharmaceutical Pricing Practices, Utilization and Costs, August 8-9, 2000, (accessed at, on 19-12-2005.htm; The Hatch-Waxman system: Suffering a Plague of bad behavior (2005) Houston Business and Tax Law Journal, , http://www.hbtlj.org/content/v05/v05Lechnerar.pdf, accessed at, on 17-04-2005; http://www.thunderbird.edu/pdf/about-us/caseseries/a03990015, accessed on 18-09-2004; Ranade, A., Das, S.B., Sectoral Reports: Pharmaceutical Industry - Update, , http://www.abnamro.co.in/Research/pdf/pharmaindy-rep-new.pdf, ABNAMRO report on Indian Pharmaceutical Industry accessed at, accessed 19-09-2004; (2005) Patents and Indian Patient, IDMA Bulletin, 36 (18), p. 11. , Pharma, May; Unveiling India's Pharmaceutical Future (2005) Ernst and Young Report, , http://eyaprimo.ey.com/natlmktgaprimoey/Attachments/Attachment42452.pdf, accessed at, on 20-12-2005; http://indiabudget.nic.in/es2001-02/chapt2002/chap107.pdf, accessed on 23-12-2005; Gross, A., (1999) Pacific Bridge Inc. Report, , http://www.pacificbridgemedical.com/publications/new_trends_in_India_pharmaceutical_market_1999.pdf, New Trends In India's Pharmaceutical Market, February, accessed at, on 20-07-2004; (2005) Ernst and Young Report, , http://eyaprimo.ey.com/natlmktgaprimoey/Attachments/Attachment42450.pdf, on, China and India - Risks and Returns in Asia's blockbuster Pharma Markets accessed at, on 20-12-2005; http://www.healthgap.org/press_releases/05/020105_HGAP_FS_INDIA_IPR.pdf, accessed 25-09-2005; , p. 7. , Report on The Pharmaceutical Sector in India Presented to International Trade Center, Geneva, Confederation of Indian Industry; http://www.atimes.com/atimes/South_Asia/GC24Df04, accessed on 06-10-2005; Patent and the Indian Pharmaceutical Industry, Business Briefing (2002) Pharmatech, p. 46. , Report by Nilesh Zacharias and Sandeep Farias; http://www.news-medical.net/?id=8684, accessed 25-03-2005UR - https://www.scopus.com/inward/record.uri?eid=2-s2.0-77956247201&partnerID=40&md5=b74156738ad323c30e6d5b0546fce82f

PY - 2008

Y1 - 2008

N2 - Indian Patent system has evolved over a period of time and since colonial rule various amendments have been made. Indian Patents Act 1970 that allowed only process patent in the fields of pharmaceuticals, food and agrochemicals was the driving force behind the success story of thriving Indian Pharmaceutical Industry and was modeled by various developing countries. With India becoming member country of WTO India was obliged to amend the Patents Act 1970, which was done by India by issuing an Ordinance in December 2004 and then subsequently passing the law on 23 March 2005. With this amendment of Patent Act, Indian pharma companies can no longer manufacture generic versions of patented drugs. Various forums have raised the issues of pros and cons of patent system in India. This paper tries to discuss the various aspects of patents, arguments in favor of justifying the cost of R&D for a new drug molecule, various arguments propounded by various forums and the flexibilities given by TRIPS and how these flexibilities can be used to support public health. © APTI.

AB - Indian Patent system has evolved over a period of time and since colonial rule various amendments have been made. Indian Patents Act 1970 that allowed only process patent in the fields of pharmaceuticals, food and agrochemicals was the driving force behind the success story of thriving Indian Pharmaceutical Industry and was modeled by various developing countries. With India becoming member country of WTO India was obliged to amend the Patents Act 1970, which was done by India by issuing an Ordinance in December 2004 and then subsequently passing the law on 23 March 2005. With this amendment of Patent Act, Indian pharma companies can no longer manufacture generic versions of patented drugs. Various forums have raised the issues of pros and cons of patent system in India. This paper tries to discuss the various aspects of patents, arguments in favor of justifying the cost of R&D for a new drug molecule, various arguments propounded by various forums and the flexibilities given by TRIPS and how these flexibilities can be used to support public health. © APTI.

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VL - 42

SP - 84

EP - 88

JO - Indian Journal of Pharmaceutical Education and Research

JF - Indian Journal of Pharmaceutical Education and Research

SN - 0019-5464

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ER -