As per reports, Modi – government is considering a proposal to grant data exclusivity (DE) for agrochemicals for a period of 5 years. This could be a precursor to grant of similar dispensation for pharmaceuticals. The development may come as a pleasant surprise to US and EU based multinationals in both these segments who – backed by their respective governments – have been pitching for this for a long time but constantly rebuffed by Indian lawmakers thus far, ostensibly on the ground that grant of DE would be TRIPs (trade related intellectual property rights) plus. So, what does the TRIPs agreement of WTO (1995) which India implemented vide an amendment to the Indian Patent Act (2005) – after leveraging the...
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Category: Data protection
Patent linkage and data exclusivity – are they TRIPs plus?
The testimony of Michael Froman, US Trade Representative (USTR) before Senate Finance Committee mentioning commitments given by prime minister Modi on intellectual property rights (IPR) issues during former’s recent visit to India has evoked strong reaction from domestic pharmaceutical industry and pro-health groups. The industry alleges that the government has given commitments that go much beyond India’s obligations under TRIPS (trade related intellectual property rights) agreement of WTO. The two areas of specific concern raised by it are (i) data exclusivity (ii) patent linkage; better known as TRIPs plus. The allegations are without basis. All that government promised was that concerns expressed by US industry over alleged poor enforcement of IPR laws will be brainstormed in the Working Group set...
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Undermining patents – now vide price control
A couple of years back, an internal committee of the department of pharmaceuticals (DoP) in the Ministry of Chemicals & Fertilizers had recommended a negotiated price mechanism for patented medicines in respect of government purchases and for use by insurance companies. This was junked. In January, 2014 government constituted an inter-ministerial committee with a much wider mandate to examine negotiating prices of patented medicines before these are allowed entry in the Indian market. Apart from DoP, this included representatives of health ministry, drug price regulator and department of industrial policy and promotion (DIPP) in Ministry of Commerce. The committee is actively pursuing this idea and has even asked manufacturers to submit all relevant data viz., costs, prices (in India and...
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India’s case at WTO may fail to sail
Even as India rejects the US contention of failing to protect IP rights, passing the TRIPS test might be tough In the recently released Special 301 report on trade and industry practices, the US Trade Representative (USTR) has stopped short of putting India on its Priority Foreign Country (PFC) list. Under Special 301, USTR tracks the intellectual property (IP) rights record of countries and lists them according to the strength of their IP environment. If, on review, it identifies substantial deterioration in any country’s IP regime, it gets downgraded to PFC status which carries with it trade and economic sanctions. India may have escaped being listed as such for now, but the Damocles sword hangs over the country as the...
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