26 January 2006
In a stunning defeat to multinational pharmaceutical company Novartis AG today, the Patent Controller of Chennai ruled for the Cancer Patients Aid Association and drug companies in the controversial Gleevec matter. Gleevec, an anti-cancer drug also known as imatinib mesylate, 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.
The relief was visible in Mumbai today. "This is a tremendous victory for patients" stated Y.K. Sapru, Founder/Chairman of the Cancer Patients Aid Association who brought the challenge against Novartis. "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 today 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 today for patients suffering from chronic myeloid leukemia, 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.
The new battle for affordable medicines will play out in the courtroom. "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 Global South," said Anand Grover, Project Director of Lawyers Collective who represented the Cancer Patients Aid Association in this matter. "We will continue to fight for patients, filing oppositions for life-saving drugs on behalf of patients."
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 the Global South.
Thank you, as the press, for your continued support on this crucial issue.
Affordable Medicines and Treatment Campaign (AMTC)
For more information, please contact:
Cancer Patients Aid Association
Lawyers Collective HIV/AIDS Unit - Bangalore
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