Paper

Journal of Generic Medicines (2008) 5, 111–119. doi:10.1057/palgrave.jgm.4950102; published online 18 December 2007

Impact of the Amended Indian Patent Act on the Indian pharmaceutical industry

Bakthavathsalan Vijayaraghavan1 and Poonam Raghuvanshi2

Correspondence: Bakthavathsalan Vijayaraghavan, Ranbaxy, Inc 600 College Road East Princeton NJ 08540, USA. Tel: +1 609 720 8025; Fax:+1 609 514 9779; E-mail: vijaya.raghavan@ranbaxy.com

1holds a doctorate in Synthetic Organic Chemistry from the University of Delhi. He joined Ranbaxy's Chemical Research in 1990 and rose to be a group leader. He moved to Ranbaxy's Intellectual Property function in 2001 and is currently Senior Director of Intellectual Property there.

2holds a doctorate in pharmaceutical chemistry from Hamdard University, New Delhi. She started her career as a Development Scientist with Dabur, India in 1994. After a year in Dabur, she joined the United Nations International Center for Genetic Engineering and Biotechnology, New Delhi, as a scientist. She joined Ranbaxy's Intellectual Property function in 1999 as a group leader and is now an associate director there.

Received 13 November 2007; Revised 13 November 2007; Published online 18 December 2007.

Top

Abstract

It has been more than two years since the Indian Patent Act of 1970 (the Act) was amended to make it compliant with the Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement. The amendments were made amidst much expectation, protest and confusion. Despite having had ten years to put the amendments together, the Indian Government had to resort to a hurried Presidential Ordinance in December 2004 to amend the Patent Act. In March 2005, after an invigorating public debate involving all stakeholders, legislators were able to come out with amendments that attempted to strike a balance between promoting innovation and ensuring that Indians had continued access to affordable medicines and so that India remained the 'pharmacy' of the developing world. The amendments changed the paradigm under which most, if not all, Indian pharmaceutical companies built their businesses. Now that the first product patent in the pharmaceutical sector has been granted (Patent No. 198952 granted on 21st February, 2006 to Roche, on pegylated interferon-alpha conjugates) and a challenge to a key amendment has come to an unsuccessful end at the Madras High Court, this paper takes a look at what the impact of the amendments have been so far and what they could be in the future.

Keywords:

India, TRIPS, Patent Act, generics, pharmaceuticals

Extra navigation

.

Association resources

ADVERTISEMENT
GPhA 2009 Annual Meeting, 23-25 Feb 2009, Naples, Florida, USA
World Generic Medicines Congress Europe 2009, 24-27 Feb 2009, London
PipeLine