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Indian Patent Act achieved balance between drug innovators & public health: Dr BR Jagashetty

Nandita Vijay, Bengaluru
Friday, October 13, 2017, 08:00 Hrs  [IST]

Indian Patent Act maintains a balance between the interest of the inventor of a drug and public health, said Dr BR Jagashetty, former National Adviser (Drugs Control) to MoHFW and CDSCO and former Karnataka state drugs controller.

“Our country is home to large population of below the poverty line. It may not be in a position to give full protection to the inventors to save poor patients. However, the Indian Patent law though not in consonance with the TRIPS Agreement for the developed world, is a well formulated subject to article 7 and 8 after following the standards of the Doha Declaration to provide medicine access to all”, he added.

Though the pharmaceutical patent was granted to product as well as process after the 2005 amendment, oppositions are coming from the developed economies on low cost generic medicines and compulsory licensing. It is the practice of allowing third parties to use the patented inventions without patentee permission, pointed out” Dr Jagashetty who holds a doctorate in Law degree on Patents.

In India, all drugs were generics before 2005 because there were no product patents for pharmaceuticals. India became fully TRIPS compliant in 2005 through the introduction of product patents, with legislation to safeguard public health. In particular, section 3(d) of India’s Patent Act was included to prevent the extension of patent protection through minor product modifications, unless a ‘significant enhancement of efficacy’ can be demonstrated.

The judgment in Novartis vs. Union of India case is seen as a game changer. Novartis took legal action against the Indian government by challenging the section 3(d) of the Patent Act. When this was rejected by Madras High Court, the company sought to have ‘Imatinib Mesylate’ recognized as patentable though it had no better efficacy. The Novartis case is important because it highlighted scores of patients being denied access to life-saving drugs because monopoly pricing was not acceptable globally. Further, the case showed that developing countries like India with some economic and political clout could fight the Big Pharma. This case enabled Indian pharma to manufacture cheaper generic drugs for treatment of blood cancer, explained Dr Jagashetty.

The Doha Declaration on TRIPS and Public Health set a firm foundation to be protect the public health needs against WTO’s intellectual property policies. In principle, the developing countries are adequately equipped with special provisions to protect their right to public health and access to medicines.

“While the TRIPS flexibilities’ in the Doha Declaration have a well-guided intent, yet the developing countries face internal and external barriers. They lack local production capabilities and experience in achieving economies of scale. TRIPS flexibilities and the Doha Declaration have set the stage, to overcome internal and external constraints. Therefore any government should formulate policies to ensure that innovation is critical to human life. Hence in my opinion India’s efforts on high standards of patents need to be appreciated”, he said.


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