Amidst exponential increase in demand for vaccination, Indian policy makers are looking for all possible options to ramp up supplies. A major hindrance in the way is the intellectual property rights (IPRs) associated with new drugs which are mostly discovered and developed by multinational pharmaceutical companies. For instance, Covishield (it accounts for about 90% of doses administered in India so far) was discovered and developed by Astra-Zeneca in collaboration with Oxford University; a license for its manufacture has been given to Pune based Serum Institute of India (SII). The most crucial of these rights – incorporated in the TRIPs (trade related intellectual property rights) Agreement of the World Trade Organization (WTO) that came into force in 1995 requiring compliance by...
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Category: Research & Development
Bridge the gap on patent rights
It’s unfortunate that the USTR, the US trade body, has put India on a ‘priority watch list’ for intellectual property rights violations. For now, the rift appears too wide and requires adjustments by both sides. Protection of IP rights isn’t always inimical to public interest The US Trade Representative (USTR) has placed India on its Priority Watch List (PWL), alleging lack of “sufficient measurable improvements” to its Intellectual Property (IP) framework on long-standing and new challenges that have negatively affected American right holders. It has warned of enforcement actions under Section 301 of the Trade Act or pursuant to the World Trade Organisation (WTO) or other trade agreement dispute settlement procedures, necessary to combat unfair trade practices. The long-standing IP challenges facing...
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Innovation is not exploitation
Controls on GM crops will curb access to new solutions needed to tackle climate change. Our farmers will be the biggest losers Bt cotton, the only Genetically Modified (GM) crop so far allowed for cultivation in India, is genetically tweaked to kill bollworms that ravage cotton crops. It promises substantial increase in return by saving on pesticide use and increase in crop yield. At the price paid for Bt cotton seed, including technology fee paid to biotech major Monsanto, farmers get handsome returns. Since its introduction, the use of Bt cotton in India has increased manifold with the area under coverage, leap-frogging from a mere 50,000 hectare to around 12 million hectare, covering major States such as Gujarat, Andhra Pradesh...
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GM seeds – controls block access to new solutions
Bt [Bacillus thuringiensis] cotton – the only genetically modified [GM] crop so far allowed for cultivation by farmers in India – is genetically tweaked to kill bollworms that ravage cotton crops. It promises substantial increase in return by saving on pesticide use and increase in crop yield. At the price paid for Bt cotton seed including technology fee [this is less than what the innovator viz. Monsanto charges even in China], farmers get handsome returns. Since, introduction [2002] the use of Bt cotton in India has increased manifold with area under coverage leapfrogging from a mere 50,000 hectare then to around 12 million hectare covering major states such as Gujarat, Andhra Pradesh, Maharashtra etc. At present, 98 per cent of...
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Invalidation of Monsanto patent – setback to agri-biotech innovations
A Division Bench [DB] of Delhi High Court [DHC] on April 11, 2018 invalidated a patent granted to Monsanto Technology LLC for its invention related to the gene sequence responsible for the Bt [Bacillus thuringiensis] trait that eradicate pests afflicting cotton plants. As per the Court, the gene sequence has been held to be a part of the seed, and hence un-patentable in terms of Section 3(j) of the Patents [Amendment] Act, 2005 that excludes higher life forms, like plants, animals, and their parts and essential biological processes from the realm of patentability. The DB has held that Section 3(j) prohibits grant of patents to Bt trait-induced varieties as they are parts of “seed”. The Court has held that the...
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IPR protection – why India ranks poorly?
According to the annual report prepared by the Global Innovation Policy Centre [GIPC] of the US Chambers of Commerce, India has increased its score in the International Intellectual Property [IIP] Index, from 25 per cent [8.75 out of 35] in the 5th edition of the Index to 30 per cent [12.03 out of 40] in the 6th edition. India now ranks 44th among 50 nations up from 43rd out of 45 countries last year. The report analyses the intellectual property [IP] climate in 50 world economies based on 40 unique indicators that benchmark activity critical to innovation development surrounding patent, trademark, copyright, and trade secrets protection. The improvement in the score reflects positive reform efforts on patentability of computer-implemented inventions [in July...
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Developed countries ride piggy back on WHO to thwart Indian drug export
In 2008, more than a dozen shipments carrying off-patent generic drug from India were detained by customs authorities in European Union [EU] countries on grounds of alleged infringement of EU intellectual property. The consignments were destined for Brazil transiting through the European ports and airports. India together with Brazil had taken the issue to WTO’s [World Trade Organization] disputes settlement body in May 2010 against the EU and Netherlands, where the shipments were detained. Other countries viz. Canada, Ecuador, China, Japan and Turkey had joined the dispute. India argued that the seizures violated 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...
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BRING TRANSPARENCY TO DRUG PRICING
Problems in the pharma sector must be tackled right at the source. Pharma multinational corporations must instill confidence about the veracity of their cost figures — whether low or high According to a recent study published in the Journal of the American Medical Association (JAMA), it costs a company just $648 million on an average in research and development to bring a cancer drug to the market — a small fraction of the $2.7 billion, the pharmaceutical industry claims, is the average cost of drug discovery. The report further shows that within about four years of approval (no drug is allowed to be marketed without taking prior registration from national regulator under relevant jurisdiction), revenue from sale of the drugs studied was, on an average, nine-fold...
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Are pharma MNCs fleecing patients?
According to a recent study published in the Journal of the American Medical Association [JAMA], it costs a company just $648 million on an average in research and development [R&D] to bring a cancer drug to the market — a small fraction of the $2.7 billion the pharmaceutical industry claims is the average cost of drug discovery. It further shows that within about four years of approval [no drug is allowed to be marketed without taking prior authorization/registration from national regulator under the relevant jurisdiction], revenue from the sale of the drugs studied was on average nine-fold higher than the R&D spending. Even accounting for what the money would have earned if invested in the market, the returns are seven times the costs. The...
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‘Branded generics’, where patients are fleeced
The 2017 Trade Policy Agenda unveiled by the Trump administration on March 2, 2017 pushed for a stricter regime for intellectual property rights (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 defence is based primarily on the flexibilities available to the developing countries under WTO agreement on Trips [trade-related intellectual property rights] to ensure availability of drugs to patients [majority of them are poor] at ‘affordable’ prices. If the concern for the poor is so overwhelming, then the government must ensure that on ground zero, patients should get medicines at prices they can afford. Are they really getting? The manufacturers of...
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