Tuesday, March 25, 2014

Supreme Court’s decision on section 3(d) historic

Anand Grover in “The Times of India”, Chennai, on Tuesday. April 2 2013 reported that after 2005, India started granting product patents on medicines. However, section 3(d), one of the safe guards introduced by Parliament, seeks to prevent patenting of new forms of known substances unless they exhibit enhanced efficacy. Were it not for section 3 (d) , the standards for grant of product patents on medicines in India would be lower, almost identical to the standards in countries such as the United States and European Union, where a large number of patents are granted on minor modifications of a single medicine. Section 3 (d) also became the basis for the refusal of a patent to Novartis for the beta – crystalline form of imatinib mesylate, a drug used to treat chronic myeloid leukemia (CML), a type of blood cancer. In 1998, Novartis filed a patent application in India for this medicine. In 2005, the Chennai Patent Office heard patent oppositions to this application including one filed by the Cancer Patients Aid Association (CPAA). The CPAA challenge was spurred by great concern over the price Novartis set for its version of the drug (sold as Glivec) at Rs.1,20,000 ($2,400) per month as against generic versions that were available at a cost of around Rs. 8,000 to Rs 12,000 per month. The Indian Parliament has balanced India’s obligations under TRIPS with the right to health through Section 3 (d). The Supreme Court has unequivocally interpreted the true intention and spirit of this provision. It behooves the Indian Government to respect the Parliament and the Supreme Court and ensure that it does not sign away these hard fought victories by health and public interest groups in trade negotiations. +++++++++++++++++++++++++++++++++++++++++++++

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