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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Category: Research & Development
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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Data exclusivity for agrochemicals brooks no delay
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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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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Intellectual property (IP) protection – key to sustainable healthcare
A spate of actions of Indian stakeholders viz., industry, Government and the judiciary in the pharmaceutical space during the last five years or so, smack of a sense of fear bordering on possibility of Indian Industry being swallowed by MNCs. The trigger for inculcation of fear especially in the mind of Commerce Ministry [the nodal point for formulation of policy in regard to foreign direct investment and protection of intellectual property (IPR)] is a number of acquisitions of Indian pharmacy companies by MNCs in last few years. The Ministry is obsessed with a flawed notion that large-scale investment and acquisition of controlling stake by MNCs in existing companies would lead to their ‘dropping’ from their portfolio of production essential medicines...
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