India

Key dates on the Indian Patent Act and the Novartis Case

1994/1995

Creation of the World Trade Organization & entry into force of the TRIPS Agreement, which obliges developing countries to grant patents on medicines no later than 2005.

2003

Novartis launches Gleevec in the US at $2,600 per patient per month. Generic versions of Gleevec soon become available in India for under $200 per patient per month.

2005

Amendment of India's Patents Act: medicines can now be patented in India. However, the law stipulates that only true medical innovations will be protected by patents. Section 3(d) specifies that new forms of known substances do not deserve patents.

2006

January - Novartis' patent application on Gleevec rejected by Indian patent office, on the grounds that it is simply a new form of a known substance.

May - Novartis appeals patent office's decision in High Court in India. Novartis also challenges Section 3(d) of the Indian Patents Acts.

September - First hearing of the appeal and challenge. No decision made, but broader hearing set for later date.

2007

Next scheduled hearing in Chennai High Court in India.