Updated on 26 October 2012
Glivec has revolutionized the way certain cancers are treated. It has been granted a patent in 40 countries, including China, Russia, Mexico, Taiwan and all major developed countries. There is only one Glivec.
The beta crystal form of imatinib mesylate is the active ingredient of Glivec. No other drug comprising imatinib was available anywhere in the world before Glivec was launched. Scientists at Novartis developed the mesylate salt of imatinib and then the beta crystal form of imatinib mesylate to make it suitable for patients to take in a pill form that would deliver consistent, safe and effective levels of medicine. This process resulted in a viable drug which revolutionized cancer treatment. The patent filing claiming the beta crystal form of imatinib mesylate relates to the genuine product and represents the very first patent right filed in India claiming Glivec. One can arrive at the misconception of "evergreening" when referring to the present patent right only by ignoring these facts.
Another argument is that it will encourage other companies to opt for frivolous patents for minor modifications. What do you have to say?
We cannot speak for other companies, but many modifications made to existing drugs are far from frivolous. They can make the medicines safer and more effective for patients. The active substance of Glivec is the beta crystal form of Imatinib mesylate, being claimed in our patent application. Many leukaemia patients had no treatment option before Glivec became available. The drug turned a fatal disease killing its victims within three-to-five years into a non-fatal chronic disorder. From a patient perspective, this was not a minor modification.
Tell us about the access program for Glivec in detail? How patients are selected and what percentage of amounts is waived off? How many patients do you estimate to have benefited through this program?
Novartis has maintained its Glivec International Patient Assistance Program (GIPAP) in India for a decade. Assisting patients who cannot afford critical medicines is a priority for Novartis as demonstrated by our record, not only in India but in more than 80 other low- and middle-income countries. Since its inception, GIPAP has helped more than 40,000 patients worldwide. In India, 95 percent of those who are prescribed Glivec get it free of charge, and the rest are part of a generous co-pay program. GIPAP has helped more than 15,000 patients in India, and Novartis has donated, in this country alone, medicine valued at more than $1.7 billion.
Do you see Novartis setting up an R&D center in India in the near future?
Pharmaceutical companies looking to set up R&D centers anywhere in the world look for an ecosystem that fosters innovation. This is currently lacking in India.
Novartis and our generics business, Sandoz, which reaches more than 400 million people each year, are deeply committed to making low-cost generic medicines widely available around the world.