India's Supreme Court has rejected granting patent protection to Novartis AG's blockbuster cancer drug Glivec, in a landmark judgment that delivers far-reaching ramifications for multinational pharmaceutical companies operating in India
Background:
India has around 30,000 cases of Chronic Myeloid Leukemia (CML) reported every year.
In 2001, Novartis introduced Glivec (Imatinib Mesylate) in India - A wonder drug producing remission in over 90% of CML patients. Novartis priced Glivec at US$ 2500 for 1 month's treatment to be taken life long to keep the patient alive. In a developing country like India where there is no health insurance for a vast majority of the population, the pricing of Glivec was just out of reach for nearly everyone. Fortunately, almost simultaneously, 9 Indian companies started manufacturing its generic versions priced at an affordable US$ 180 for 1 month's treatment.
In 1998, Novartis applied in India for a patent for Glivec and was granted Exclusive Marketing Rights (EMR) in January 2003. As a result Indian courts forbade 6 out of 9 generic producers to market Imatanib Mesylate.
As a result: The 3 generic companies could not cover the entire country, CPAA and other charitable agencies could not take up the burden of supplying the drug at subsidized rates or free. Thousands of CML patients suffered and many became bankrupt as they tried to buy Glivec and many even died.
CPAA went to the Supreme Court of India against granting of EMR to Novartis.
In March 2005, the Indian Parliament passed the Indian Patent Act.
In January 2006, The Patent Controller of India rejected the patent application of Novartis for Glivec after evaluating all the points raised by CPAA. As a result once again generic versions of Glivec were available in the Indian market at affordable prices.
In May 2006, Novartis appealed against this judgment and also filed a case against the Indian Patent Act. CPAA, MSF, Oxfam & other NGOs launched a global agitation against Novartis.
In case Novartis wins both these cases in India, not only will thousands of CML patients die but 100s of life saving drugs currently available at affordable prices will get patent protection and will become unaffordable to patients suffering from life threatening diseases such as TB, Aids etc. There will be more misery - more poverty, more agony and more deaths at global level, which will be a major catastrophe.
About Cancer Patients Aid Association (CPAA):
Established in 1969, CPAA has a tradition of untiring service to needy cancer patients from all over India, and even neighboring Bangladesh, Bhutan, Nepal and Pakistan. CPAA is an empathetic, reassuring, non-medical presence that has supported the treatment and overall needs of more than 3,00,000 cancer patients.
