1994 – India signs the World Trade Organization (WTO)‘s Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement) which means that it must now start granting patents on medicines no later than 2005.
2003 – Novartis launches its imatinib mesylate as a blood cancer medicine (brand name: 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 – India changes its patent law to comply with the TRIPS Agreement, and medicines can now be patented. But the law stipulates that only true medical innovations will be granted patents. Section 3(d) of the law specifies that new forms and new uses of known substances cannot be patented, unless they demonstrate a significant increase in efficacy.
2005 - India’s patent office starts examining patent applications on medicines including Novartis’s patent application for imatinib mesylate.
January 2006 – Novartis’s patent application on imatinib mesylate (Gleevec) is rejected by an Indian patent office on several grounds, including on Section 3(d) that it is simply a new form of a known substance.
May 2006 - Novartis files two legal challenges in the Madras High Court. One is to appeal the rejection of the patent. The second is to have Section 3(d) of the Indian Patents Act declared contrary to the TRIPS Agreement and to the Indian Constitution.
December 2006 – Médecins Sans Frontières launches an international petition calling on Novartis to ‘Drop the case’. 450,000 people sign on but the company does not back down.
August 2007 – The Madras High Court rules against Novartis in its case to overturn Section 3(d) in India’s patent law. The Madras High Court also rules that ‘efficacy’ under Section 3(d) would require Novartis show an increase in therapeutic efficacy. MSF hands over its petition of close to half a million signatures to Novartis in Basel.
August 2007 – The scientist behind the discovery of imatinib, Brian Druker, writes an opinion piece publicly stating that “the price at which imatinib has been offered for sale by Novartis around the world has caused me considerable discomfort. Pharmaceutical companies that have invested in the development of medicines should achieve a return on their investments. But this does not mean the abuse of these exclusive rights by excessive prices and seeking patents over minor changes to extend monopoly prices. This goes against the spirit of the patent system and is not justified given the vital investments made by the public sector over decades that make the discovery of these medicines possible.”
June 2009 - The Intellectual Property Appellate Board which is responsible for hearing appeals on patent applications rejects Novartis’s appeal and confirms that imatinib mesylate does not deserve a patent, on the grounds that the company was unable to show significant increase in efficacy as required under Section 3(d) of India’s patent law.
August 2009 - Novartis approaches the Supreme Court of India in a new case – this time seeking to challenge the interpretation and application of Section 3(d) by Indian courts and patent offices.
September 2012 - Final hearings begin at the Supreme Court of India in New Delhi.
April 2013 - Final verdict delivered by the Supreme Court of India.
Last updated: 1 April 2013