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: Intellectual Property Rights
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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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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Is India’s intellectual property (IP) regime WTO compliant?
In the just released Special 301 report on trade and industry practices,the US Trade Representative (USTR) has stopped short of downgrading India to ‘Priority Foreign Country’ (PFC) list. Under Special 301, USTR tracks intellectual property (IP) rights record of countries and lists countries that could face trade sanctions and other countries whose IPR regimes are deemed to be areas of lesser concern. If on review, it identifies substantial deterioration in its IP regime, the country gets downgraded to PFC status. India may have escaped it for now, but ‘damocles sword’ hangs as USTR intends to conduct what it calls ‘out-of-cycle’ reviews to promote engagements on IPR challenges with India. Describing as unilateral probe under US law which India has not...
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Price control on ‘patented’ medicines – a tough call
All developing countries with preponderance of poor would like to ensure availability of medicines at affordable prices even if these happen to be product of new discoveries entailing much higher cost of supply. Discovery and development of new medicines involve huge effort in terms of both time and money to demonstrate their safety and efficacy through R&D and clinical trials conducted as per stringent regulatory requirements. The cost involved in carrying out these efforts have increased substantially due to escalating cost of materials & manpower and high failure rate on one hand and ever increasing bar of regulatory standards on the other. For a new medicine, this may be well over US$ 1 billion. An innovator company has a fundamental...
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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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A logical step to honour patents
Once wedded to patent, the government should take all steps to ensure that holder’s rights are fully protected In recent times, MNC pharmaceutical companies have approached Indian courts seeking to prevent regulatory authorities from granting market approval to generic companies for drugs they hold patent. Thus far, the courts have acted in a denial mode. In the 2010 Bayer-Cipla case, a division bench of the Delhi High Court had refused to ask the government to link the patent status of a drug to grant of market approval for generic version. Recently, US drug giant Merck Sharp & Dohme petitioned the court to restrain an Indian firm Glenmark from making and selling anti-diabetes drugs which violated its patents in India. Like...
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Don’t kill the goose that lays golden eggs
Though TRIPS allows patent laws to take care of public interest, this should not be pushed to a point whereby the very incentive to innovate is stifled The Supreme Court verdict in the Glivec case – the cancer treatment drug for which the Swiss major Novartis had sought a patent – has generated an air of exuberance amongst the ‘generic’ producers. It is good news for lakhs of patients who will have access to this drug at a fraction of the treatment cost offered by Novartis (already some generic companies are offering at one-tenth; this will go down further). Millions of patients in other parts of the developing world, especially Africa, also have reasons to rejoice even as Indian companies...
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