Supreme Court of India reaffirms position of Indian Patent law

    On April 1st 2013, the Supreme Court of India dismissed Novartis’ appeal for a patent for its anti-cancer drug, Imatinib mesylate (Gleevec), in a decision that is being hailed as a triumphant victory for patients fighting for access to medicines. The Supreme Court’s decision related to the interpretation of section 3(d), a key public health safeguard introduced in the Patents Act, 1970 by Parliament in 2005, in recognition of the impact of product patents on access to medicines and to prevent what is known as ‘evergreening’.

    Novartis, in its representations before the court, had argued that better physico-chemical qualities, such as shape of the molecule, stability, hygroscopicity and solubility, would satisfy the test of enhanced efficacy.

    The Supreme Court, rejecting Novartis’ contention, observed that Section 3(d) was introduced in the Patents Act, 1970 to ensure that patents were not extended on spurious grounds and held that while the physio-chemical properties of the beta crystalline form of imatinib mesylate i.e. flow properties, decreased hygroscopicity and thermodynamic stability may be beneficial for patients in some manner but they do not meet the standard of efficacy required by Section 3(d).

    In this case it is pertinent to note that the approach adopted by the Indian Parliament with regard to adopting the current patenting standards is permitted by and provided for within the provisions of the TRIPS Agreement and other WTO/ international legal obligations/ rules accepted by India.

    By refusing patent monopolies on minor modifications to known molecules, the present judgment of the Indian Supreme Court, will facilitate early entry of generic medicines into the market. This would provideeasier access to medicines at affordable prices for the poor and hence the impact of the said judjment will be felt not only in India, but also across the developing world.

    The judgment is significant as it sends out a strong message to the world that while we respect international agreements, we also have a responsibility towards the poor and will not support any measure to extend patents beyond their normal lives.

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