Category: Research & Development

‘Branded Generics’ – an Indian innovation to fleece patients

During recent meetings of Modi with Trump, a sore point from the US side was its concern over alleged unsatisfactory record of India in regard  protection of intellectual property rights [IPRs] in the area of patent, copyright, trademark and data protection etc. Earlier, the 2017 Trade Policy Agenda unveiled by Trump administration on March 2, 2017 pushed for a stricter regime for IPRs and patents. While, agreeing that India’s reforms on IPR are encouraging, it said “India’s new National Intellectual Property Rights Policy [NIPRP] should protect US innovations”. India’s defense is based primarily on the flexibilities available to developing countries under WTO agreement on TRIPs [trade related intellectual property rights] to ensure availability of drugs to patients [majority of them...
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Pharma woes – remedy worse than disease

Prime Minister Narendra Modi has exhorted doctors to prescribe medicines using their generic names only and hinted that the government will enact a comprehensive legislation. There is nothing new about this pronouncement even as the need for giving a push to use of generic medicines and drugs has been in the air for close to five decades ever since the Patent Act [1970] was passed by the parliament. Last year, the Medical Council of India [MCI] which is expected to keep a watch on doctors had amended the relevant rule ‘mandating doctors to prescribe using the generic name to ensure a rational prescription and use of drugs.’ Modi’s proclamation catapults the issue to the centre-stage. Already, the union ministry of...
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IPR concerns – India should shed its intransigence

The 2017 Trade Policy Agenda unveiled by Trump administration on March 2 pushes for a stricter regime for intellectual property rights and patents. While, agreeing that India’s reforms on IPR are encouraging, the document says “India’s new National Intellectual Property Rights Policy [NIPRP] should protect US innovations”. Specifically, US concerns are articulated in recent observations of Patrick Kilbride, Executive Director (International IP) of US Chamber of Commerce’s Global Intellectual Property Centre (GIPC). He has lamented that IP-intensive American firms continue to face severe challenges in the Indian market concerning Section 3[d] of the Indian Patents Act and compulsory licensing [CL]. The GIPC, in its annual IPR report, has ranked India in the bottom three for having a weak IPR and...
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Can India survive Trump bombshell?

The election of Republican Party candidate Donald Trump as the next President of the US has sent shock waves across the world. All along, America has been a strong protagonist of free flow of international trade and investment in goods and services. If Trump acts on his electoral pronouncements, this will tantamount to a reversal of the existing US policy stance. It will herald an era of “protectionism”. So what are the major areas of concern for India? President-elect Donald Trump wants American companies to operate from within the US and achieve this aim by imposing an import tariff of 35% on those who set up manufacturing facilities in other countries. Such a high tariff will seriously impact India where...
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Can India survive Trump’s bombshell?

The republican candidate, Donald Trump has been elected by Americans on the promise of protecting their interests and doing all that is necessary to achieve this goal. All along, USA has been a strong protagonist of free flow of international trade and investment in goods and services and accordingly championed liberal policies to foster this [sans a tinge of protectionism in specific areas such as agriculture]. India has benefited hugely from such open policy stance. Now, if Trump were to act on his electoral pronouncements, this will tantamount to a drastic reversal of extant policy stance. It will herald an era of ‘protectionism’ adversely affecting developing countries like India which derive a good slice of its income by doing business...
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Agri ministry defies govt

While the intent of the government is to give a big push to commercialisation of GM crops, the agriculture ministry is against it. In December 2015, the Union Agriculture Ministry had issued a Cotton Seed Price Control Order under which it fixed the price of cotton seed sales all over the country at a uniform level and max trait fee (royalty) payable to the technology provider (TP). Given that the genetically modified (GM) Bt cotton accounts for 98% total cotton seeds used in India, the decision was directed primarily at this segment. The ministry also ordered a probe by the Competition Commission of India (CCI) – in to alleged ‘monopolistic’ practices by the Mahyco Monsanto Biotech (India) Private Limited (MMBL)...
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GM technology under siege

On May 18, 2016, the agriculture ministry issued an order that makes it mandatory for the GM [genetically modified] technology provider to license the technology to any seed company that approaches it. If the former does not give the license in 30 days, it is ‘deemed to have been given’ and the latter can use. At the same time, the order also makes it mandatory for the seed company to pay the trait license fee or royalty to the technology provider. Further, it caps the maximum royalty at 10% of the maximum retail price [MRP] for the first 5 years to be reduced by 10% from 6th year. It prescribes a 10-year life for every GM trait which implies that...
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IPRs – How India can escape ‘PWL’ tag?

India has time and again reiterated that it is in full compliance with its obligations under the multilateral agreement on trade related intellectual property rights (TRIPs) of the World Trade Organization [WTO]. At another extreme, the office of the US Trade Representative (USTR) argues with equal alacrity that there has been substantial deterioration in our intellectual property rights [IPR] regime. USTR has placed it under Priority Watch List [PWL] for two years in a row [2014 & 2015] under the Special 301 report on trade and industry practices. Meanwhile, US based multinational companies [MNCs] in pharmaceutical, biotechnology and agrochemical segments who invest billions of dollars in discovery and development of new products are putting pressure on USTR to continue India...
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Developers vs generics feud – can there be truce?

During 2009-2011, the EU customs authorities confiscated several Indian off-patent generic drug consignments going to Brazil via European ports and airports on grounds of alleged infringement of EU intellectual property rights [IPRs]. India together with Brazil filed a case against the EU in the World Trade Organization [WTO] protesting the action. India argued that the seizures were in violation of the multilateral Trade Related Intellectual Property Rights [TRIPS] agreement of the WTO, as the medicines were off-patent both in India as well as the country [read Brazil] to which these were being exported. In 2011, EU reached an understanding with India under which it would desist from such action [seizure of Indian drug consignments in transit to other countries] for...
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Dashing innovators’ hopes

Govt needs to shed its current intransigence. It should stop viewing patent laws from a prism that ‘only MNCs benefit from these’. Interacting with America’s top CEOs [including MNCs in pharmaceutical and agrochemical sectors] in September, 2015, Prime Minister Narendra Modi had assured “we are committed to protecting Intellectual Property Rights [IPRs] which is essential to fostering creativity”. These MNCs spend billions of dollars on research and development to discover and develop new medicines and crop protection products and have a fundamental interest in the protection of IPRs. They had flagged Section 3[d] of Patent [Amendment] Act 2005 and provision relating to grant of compulsory licenses as major concerns. However, from the draft of new National IPR policy, it appears...
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