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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Category: Technology & Innovations
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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Price control on Bt cotton – a retrograde move
In an unprecedented move, agriculture minister Radha Mohan Singh has passed orders to control the price of cotton seed sales all over the country during the ensuing Kharif season commencing April, 2016. Considering that genetically modified [GM] Bt cotton account for 98% of total cotton seeds used in India, the decision is directed primarily at this segment. The agriculture ministry feels that the price charged by seed companies is ‘exploitative’ besides varying from state to state; hence dire need to put a cap and make it ‘uniform’. It has also ordered a probe by the regulator Competition Commission of India [CCI] in to alleged ‘monopolistic’ practices by Mahyco Monsanto Biotech [India] Private Limited [MMBL] – a 50:50 joint venture between...
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New IPR policy dashes innovator’s hope
Modi’s exhortation on international fora Interacting with America’s top CEOs [including US based multinationals in pharmaceutical and agrochemical space] in September, 2015, Prime Minister Modi assured the global innovative industry that India will do all it can to protect intellectual property. He opined “We are committed to protecting Intellectual Property Rights [IPRs]. That is essential to fostering creativity”. In October, 2015, during his meeting with German Chancellor, Angela Merkel, he reiterated that “the government will soon come out with a comprehensive IPR policy.” Germany too is home to multinationals in pharmaceutical, agro-chemicals sectors spending billions of dollars on research and development [R&D] and like US, has a fundamental interest in protection of IPRs. The commitments made by Modi on international...
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Drug licensing must recognise patents
Once patent-linkage gets embedded in our law, cheap drugs won’t get market entry Nearly 30 months back, US drug multinational Merck Sharp & Dohme (MSD) had petitioned the Delhi High Court to restrain Indian firm Glenmark Pharmaceuticals from manufacturing and selling its anti-diabetes drugs viz., Zita and Zita-Met, which violated MSD’s patents. The drugs contain sitagliptin, for which MSD holds a patent in India. Though Glenmark claimed that it had used sitagliptin phosphate, on which MSD held no patent, the court remained unimpressed with the Indian pharma company’s attempt to paint the two compounds as fundamentally distinct. In its October 7 judgment, the High Court restrained Glenmark “by permanent injunction” from making, using, selling, distributing, advertising, exporting, offering for sale or dealing...
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Patent linkage – ‘must’ to safeguard holder’s rights
About 30 months back, the US drug multinational Merck Sharp Dohme (MSD) had petitioned the Delhi High Court [DHC] to restrain an Indian firm Glenmark Pharmaceuticals from manufacturing and selling its anti-diabetes drugs viz., Zita and Zita-Met which violated its patents in India. The drugs contain ‘Sitagliptin’ salt for which MSD has a patent in India. Then, the court had rejected the stance of MSD. However, in a landmark judgement delivered on October 7, 2015, reversing the earlier stance, a bench of DHC has “restrained Glenmark by decree of permanent injunction from making, using, selling, distributing, advertising, exporting, offering for sale or dealing in Sitagliptin phosphate monohydrate or any other salt of Sitagliptin in any form, alone or in combination...
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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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Compulsory License – use it under ‘rarest’ circumstance
A major area of concern flagged by US Trade Representative (USTR) in regard to ‘alleged’ non-observance of trade related intellectual property rights (TRIPs) by India relates to grant of compulsory licenses (CLs) by latter to generic Indian drug firms for the much-in-demand new drugs for which an innovator company holds a patent. The grant of a patent confers ‘exclusive rights’ on patent holder for manufacturing and marketing of a product. Thus, during the term of patent (20 years from the date filing patent application), any person keen to make and/or sell cannot do so without seeking prior consent of patent holder. A CL authorizes the concerned entity to manufacture and market a patented product even without prior consent from the...
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