In a landmark judgement, the Supreme Court has turned down the Swiss pharma major Novartis' plea for a patent on its chronic myeloid leukaemia drug imatinib mesylate (Glivec). In this long-drawn patent battle with the government of India, the Swiss pharma major challenged the sustainability of Section 3(d) of India's Patents Act which prohibits 'evergreening', the practice of multinational pharma companies to extend their patent terms by making small and trivial changes to existing molecules and thereby preventing manufacture of generic drugs.

The apex court's landmark verdict will paving way for more affordable life-saving cancer drugs for the patients in the country and elsewhere in the world. Drug companies in India can now roll out a generic version of the drug, which can cost about Rs. 10,000 a month - slashing the price by almost 92 per cent. Presently priced at a whopping Rs. 1.2 lakh for a month's dosage, Glivec is a major advance in treating chronic myeloid leukaemia, which kills 80-90 per cent of sufferers, and some gastrointestinal cancers.

The history of Novartis patent case goes back to 1993 when it patented the molecule imatinib. After the signing of the WTO TRIPS agreement by India in 1995, Novartis filed another patent application on the mesylate salt form of imatinib in 1998 at the Indian patent office in Chennai. In 2005 India amended its patent law to comply with the WTO TRIPS agreement but also included Section 3(d), an important health safeguard that does not allow companies to get patents on new forms of old medicines.

With the Chennai Patent Office's rejection of patent after 2005, Novartis approached the Madras High Court challenging the decision of Patent Office along with questioning the relevance of section 3(d) of Indian Patent Act.

In 2007, the Madras High Court rejected Novartis' challenge to section 3(d) and held that it had no jurisdiction to determine the issue of TRIPS compatibility. In determining the issue of constitutional validity, the court held that the word "efficacy" used in section 3(d) had a definite meaning in the pharmaceutical field. The case was then transferred from the Madras High Court to the Intellectual Property Appellate Board (IPAB), which in turn rejected the application.

Novartis appealed again, this time to the Indian Supreme Court in 2009 after the IPAB rejected its appeal for a patent on the beta-crystalline form of imatinib mesylate.