Cancer patients across the country have heaved a sigh of relief on the decision against the exclusive marketing rights for Novartis' Gleevec, an anti-cancer drug, which allows them to have a wide choice of brands. The Lawyers Collective fight against Affordable Medicines and Treatment Campaign (AMTC) against Gleevec caused tremendous public outcry as prices rose in India from Rs 10,000 to 1.2. lakhs per month due to exclusive rights given to Novartis by the government.
According to Y.K. Sapru, founder, chairman of the Cancer Patients Aid Association who brought the challenge against Novartis, "This is a tremendous victory for patients. We will no longer worry whether our patients will live or die. The greed of Novartis has lost to what is right and just in the world."
A long battle ends for these cancer patients. During the transition period leading up to the introduction of a product patent regime in 2005, the government granted Novartis exclusive marketing rights (EMRs) to Gleevec. This EMR was challenged in the Supreme Court and the case is currently pending. The battle was also fought in Madras and Bombay High Courts, with courts rendering differing decisions. The uncertainty ends for patients suffering from chronic myeloid leukaemia, who will be able to access affordable versions of the life-saving drug from now on.
The decision is significant for future battles on medicines. The Patent Act does not allow patenting of new forms of known substances, strictly prohibiting patenting of derivatives, salts, polymorphs, combinations, etc. unless they differ significantly in properties with respect to efficacy. In this case, the Patent Controller ruled that Novartis had not demonstrated that there was a significant improvement in efficacy. The Controller also held that Gleevec was anticipated by prior publication and lacked an inventive step as it was a derivative of a known substance.
"We will not allow multinational drug companies to improperly extend their monopolies and price important medicines out of reach for the majority of Indians and the globally. We will continue to fight for patients, filing oppositions for life-saving drugs on behalf of patients," said Anand Grover, project director of Lawyers Collective who represented the Cancer Patients Aid Association in this matter.
Patients and health groups are watching carefully to see the next steps the government is taking on access to medicines. They are awaiting the findings of the Mashelkar Committee on the issue of new chemical entities, and whether the government will allow data exclusivity provisions to be introduced to the Drugs and Cosmetics Act. Both issues are expected to have critical impact on access to medicines for patients in India and globally.