Re: BBC debunks Ivermectin

 

Sad Story on Indian Generic Pharmaceutical Manufacturers

'This scheme is a lifesaver': India's drive to provide cheap drugs

Amrit Dhillon in The Guardian


 

Pharmacy stalls do a brisk trade opposite Delhi’s All India Institute of Medical Sciences. The Jan Aushadi scheme has provided a lifeline for many poor people. Photograph: Michael Safi


A taciturn, heavy-set man, Khawar Khan is not given to smiling. Only when he recalls the relief flooding the faces of customers after he has sold medicines at a twentieth of the cost in other chemists does he smile broadly.

“An autorickshaw wallah broke down here. Medicines for his wife used to cost him a catastrophic 10,000 (£111) rupees a month, his entire monthly salary. I gave him a month’s supply for 2,200 rupees. His relief was something to see,” says Khan.

Had the autorickshaw wallah not learned of Khan’s special pharmacy, stocked only with low-cost, generic medicines supplied by the government, he would have become one of the 55 million Indians pushed into poverty each year because of the cost of treating an illness.

The figure was provided by experts at the Public Health Foundation of India and published in the British Medical Journal. Of the 55 million, 38 million fell below the poverty line due to spending on medicines alone.

Khan’s little store is in the crowded and scruffy neighbourhood of Jamia Nagar in New Delhi. The floor is clean. Medicines are neatly stocked on the white shelves. The store is part of the Jan Aushadhi government project to provide generic medicines (identical to branded drugs but, since they don’t include research and development costs, substantially cheaper) to poor people in India so that the potentially ruinous medical costs of an illness can be managed.

Narendra Modi has injected fresh life into the Jan Aushadi scheme since his election as Indian prime minster in 2014. Photograph: Harish Tyagi/EPA

Started in 2008 by a previous government, the scheme foundered, mainly because pharmacies stocked so few drugs that hardly anyone bothered going to them. When the Narendra Modi government came to power in 2014, it gave the project a push, setting a target of 3,000 stores. From 97 pharmacies in 2014, there are now more than 3,000 countrywide.

This is a tiny figure for a country the size of India – some people have to travel long distances to find one – but it’s something. The only problem is providing the pharmacies with enough drugs.

“Most Jan Aushadhi stores have barely 100-150 formulations instead of the promised 600-plus medicines and their numbers are too small compared to the 550,000 pharmacies in India,” says the Public Health Foundation report.

Speak to the owners and they say even basic items, such as calcium supplements or oral rehydration salts, are often in short supply.

“I used to get only 30% of my orders from the government distributor. I hated sending patients away empty-handed, sometimes elderly people who had travelled 20 kilometres. Because I never had sufficient sales volume to make a profit, I was making a loss for a year. So I closed down last month,” says Shivdan Singh, whose shop was in Chhatarpur.

Khan is likewise failing to make a profit, but says he will give it another year before deciding what to do.

Advesh Kumar, deputy marketing manager of the Bureau of Pharma PSUs of India, the government agency that supplies the drugs, admits the stores lacked the full range of drugs. He says the bureau was not geared up to meet the demand generated by the sharp rise in the number of pharmacies.

“There is an undoubted shortage. Demand is higher than we anticipated. It’s also hard to predict which drugs will be needed. But we have got new software that will enable us to handle the issue better and we will plug the gap within two months,’ says Kumar.

As he sits in Khan’s store, Shazad Choudhury looks tense. Judging by the long list of prescriptions he has handed over to Khan, his entire extended family is ill with hypertension, diabetes, heart problems, kidney infections, uterus infections, and depression. Choudhury himself is recovering from a slipped disc.

“Look at all these medicines!” says Choudhury. “I’d be on the streets if I had to get these from a normal pharmacy. This scheme is a lifesaver. But it is tedious for me to keep waiting. There are two drugs I have been waiting for for a fortnight. The government must ensure the shops are fully stocked,” he says.

Outside the pharmacy, Kishore Dutt, a construction worker, is leaving, with medicines for his grandmother. He says some of his relatives told him to let his 82-year-old grandmother die because the medicines were too expensive. Poor families often have to make inhuman choices of this kind. Treat an elderly person, who may not even get better, and let the children go hungry? Or let that person die so that the children can eat and live?

Dutt heard about the Jan Aushadhi scheme and located Khan’s pharmacy. “I’m rushing back to my nani (grandmother). I hope these [drugs] will cure her,” he says.

Dutt was lucky that his grandmother’s doctor prescribed the generic name of the drugs. Many doctors in India, despite the Medical Council of India’s order to prescribe generic medicines, fail to do so. The perception that generic means no good and branded means good persists, even among doctors.

“The doctor down the road told a patient that generic drugs were ineffective. They need to be educated because they are doing a great disservice to the poor,” says Khan.

The Indian Pharmaceutical Sector

 

By Jill E. Sackman, PhD,Michael Kuchenreuther

Biopharma companies should not overlook India's growing market.

ABHIJITMORE/ROOM/GETTY IMAGES

Recognizing that emerging markets continue to play a significant role in terms of future growth, most major pharmaceutical companies have accelerated efforts to strengthen their presence within these markets through R&D investment, licensing deals, acquisitions, or other partnerships. However, with global markets facing dynamic demographic and disease trends, changing market demands, and evolving regulatory requirements, it has been hard for manufacturers to devise the strategies needed for success in each of these areas.


India, a member of the BRIC nations (Brazil, Russia, India, and China), is much more comparable to the United States in terms of market size and must be included in this list of promising potential markets for global pharmaceutical manufacturers. Recent changes in India’s population and economy have contributed to a shift in the country’s epidemiological profile towards ‘lifestyle’ diseases that are more prevalent in Western markets. Such changes have increased the demand for better healthcare and for medications that address chronic diseases. Furthermore, India’s own pharmaceutical industry, a recognized world leader in the production of generic drugs, offers manufacturing expertise to organizations looking to outsource or create networks of collaboration and discovery. However, a more granular assessment of India’s pharmaceutical market reveals growing concerns over patent protection, price capping, quality, and safety. Understanding this country’s complex market dynamics will be crucial for manufacturers exploring new opportunities for growth in India.

India health and pharmaceutical market overview

India is the second most populous country in the world with about 1.27 billion people, and is projected to surpass China by 2028 (1). As the Indian population has continued to grow in recent years, so too has the country’s economy. Over the past decade, India’s economy grew above the Organization for Economic Co-operation and Development (OECD) average, which can be attributed to rising average income levels, an expanding middle class, and a drive toward urbanization (2). These socio-economic changes are contributing to a significant shift in India’s epidemiological profile. With working-age adults accounting for the majority of the overall population and more people becoming affluent and living longer, Indian health service users are facing increasing challenges associated with the prevention and treatment of chronic diseases such as obesity, heart disease, stroke, cancer, and diabetes (3).

At the same time, India continues to be challenged by a range of infectious disorders. Despite economic advancements, significant income inequality still exists throughout the country. In fact, per capita gross national income in India was only $3,391 in 2012 when adjusted by purchasing power parity (compared to $50,000 in US) (4).  In rural areas, where two-thirds of the nation’s citizens are located, hundreds of millions of people are still living in severe poverty, and vaccination coverage for children remains poor.

RELATED CONTENT Global Instability Affects the Pharma Market in Brazil1 The Affordable Care Act's Impact on Innovation in Biopharma2 More Global Report Topics3

Taken together, this high incidence of infectious and chronic disease and the large number of disadvantaged communities have created an even greater need for patient access to quality healthcare delivery as well as new and innovative therapeutic products. Historically, India has had one of the world’s lowest levels of health spending as a proportion of gross domestic product (GDP). In 2011, India’s total health expenditure was 3.9% of GDP (public expenditure was only 1.2% of GDP) compared to 10.1% of GDP, an average across all G-5 countries (4). The lack of government funding in healthcare has led to significant gaps in the quality and availability of public facilities and has pushed an increasing proportion of Indian patients to use private healthcare facilities that are associated with high costs. Where other countries have a well-established insurance sector that seeks to reduce this economic burden, health insurance in India is still in its infancy.

Approximately 243 million people are covered by different forms of government-sponsored insurance schemes while approximately 55 million rely on commercial insurers (5). With the vast majority of people in India uninsured, out-of-pocket payments are among the highest in the world. According to the World Health Organization (WHO), 70% of Indians are spending their entire out-of-pocket income on medicines and healthcare services (6). On top of this, most insurance plans only provide coverage for inpatient healthcare services and do not include coverage for outpatient treatments, including prescription medicines. Thus, it is no surprise that approximately 90% of India’s pharmaceutical market is currently made up of branded generic drugs (7).

Against this backdrop, India’s Ministry of Health has been focused on improving access to healthcare facilities, increasing population coverage by way of healthcare insurance, and creating initiatives for the prevention and early stage management of chronic diseases. In 2012, as part of the country’s 12th Five-Year Plan, the government proposed to double its public expenditure on healthcare to 2-3% of GDP in an effort to boost local access and affordability to quality healthcare. In light of these efforts, the Indian healthcare industry as a whole is expected to reach $158 billion by 2017 (8).
India’s pharmaceutical market accounts for about 10% of the global pharmaceutical industry in terms of volume and represents a major component of growth for the country’s healthcare industry (9). The Indian pharmaceutical market was estimated at $18.4 billion in 2012 and is expected to almost double by 2016. Although India’s market is currently dominated by generic drugs, rising incomes, enhanced medical infrastructure, and insurance coverage could provide a valuable opportunity for manufacturers’ higher-priced branded healthcare products moving forward.  

Key market challenges and considerations

Regulatory. Similar to many other countries, India’s medical regulatory structure is divided between national and state authorities. The Drug Controller General of India (DCGI) is the national authority responsible for the regulation of pharmaceuticals. The DCGI registers all imported drugs, new drugs, and biologicals in selected categories and has responsibility for approving clinical trials and quality standards in the country. Recently, these standards have come under question by FDA, citing quality-control problems ranging from data manipulation to sanitation. While FDA and regulatory bodies in other countries step up inspections of Indian plants in response to these developments, global manufacturers have had to reassess their contracted relations with these plants and give careful consideration to developing new strategic partnerships in this country moving forward (10).  

Concerns over quality and data integrity have also impacted manufacturers’ perception of India’s clinical trials system. India’s large and diverse patient pool and low drug trial costs have made the country an attractive destination for multinational pharmaceutical clinical trials. However, India has recently seen the number of clinical trials fall dramatically among allegations that protocols were not being conducted properly and that companies were taking advantage of disadvantaged patients (11). In response to these developments, manufacturers have been forced to either shift their trials to another country or encounter significant delays in clinical trial approval--both of which are holding their organizations back.

Market access and pricing. The high prevalence of self-pay generic drugs throughout the country has created little incentive for the development of certain market access disciplines such as health economics and outcome research (HEOR) and reimbursement. Government affairs and pricing functions, on the other hand, play an important role and have been broadly cited as the most crucial challenges global manufacturers face in the Indian marketplace.

India’s National Pharmaceutical Pricing Authority (NPPA) controls product pricing throughout the country. In 2013, the NPPA expanded the National List of Essential Medicines (NLEM) to include 652 drugs, a substantial increase over the 74 drugs previously listed. These products will now be subject to price controls that are projected to reduce prices by more than 20% for half the drugs (12). As if this did not challenge manufacturers enough, the Indian government recently decided to revise the NLEM later this year in response to complaints that the list should include all dosages, strengths, delivery mechanisms, and combinations of these previously identified drugs (13). The NPPA is also allowed to control prices of patented drugs that lie outside this list, and last month the government began exploring the possibility of using a reference pricing system for these products (14).  With intense generic competition already driving down drug prices in India, these additional controls pose a significant threat to international manufacturers’ ability to generate revenue.

Intellectual property. Aside from pricing, patent protection has also come under the microscope as of late. In an effort to ensure greater accessibility to higher-cost, branded drugs, India, as well as other BRIC countries, has begun to allow generic-drug manufacturers to market these drugs at dramatically reduced costs without consequence through compulsory licenses.  While only one compulsory license has been approved by India’s government to date (Bayer’s Nexavar), other manufacturers have recently had their patents weakened, revoked, or rejected. While appeals to some of these rulings are still in process, precedents have been set, leading manufacturers to question their future investment in India.

Implications for successful market entry 

Despite the aforementioned challenges, major pharmaceutical companies recognize the long-term prospects of this market and continue launching new patented drugs and pursuing unique business opportunities in India. To encourage future investment, the government has made tax breaks available to the pharmaceutical sector, including a weighted tax deduction of 150% for any R&D expenditure incurred. In addition, the government recently declared that all drugs that offer some form of innovation would be exempt from price regulation for the first five years following approval. Here, innovation refers to drugs or drug delivery systems that arise from native R&D efforts or existing drugs that are improved upon by an Indian company. This measure is aimed to spur growth in the domestic pharmaceutical market and to ensure that pricing regulations do not turn global manufacturers away from India. Thus, companies that develop strategic partnerships with local businesses and outsource some of their R&D and manufacturing activities will be well-positioned to maximize revenue by avoiding steep price cuts. This opportunity for manufacturers will only apply, however, for those products that offer true innovation by providing economic and/or clinical value.

Uncertainty over patent security and obstacles to clinical trials are discouraging Western companies from conducting drug research in India. With that said, the government has already initiated clinical research reform efforts through new amendments and regulations that could quickly restore the growth of clinical trials throughout the country.  At the same time, there is speculation that a transfer of power in India’s upcoming election could dampen fears of additional compulsory licenses (15). Manufacturers should closely monitor these internal developments and react accordingly.

Moving forward

A growing middle class that is projected to see a significant rise in noncommunicable diseases provides an excellent opportunity for global companies to launch their premium products and expand their market share. India’s underdeveloped insurance industry and high poverty rates, however, require that manufacturers first develop a careful pricing strategy. Pricing products appropriately can go a long way towards ensuring future growth as well as avoiding disputes over patent protection and licensing agreements.  In a country that holds about one-fifth of the world’s population, India’s market is too big for pharmaceutical companies to shy away from, despite all of the hurdles placed in front of them.  

Novartis loses landmark patent case in India

India’s Supreme Court dealt a significant blow to Western drugs firms on Monday when it rejected an application by the Swiss pharmaceutical company Novartis to patent an anti-cancer drug.

Until recently patent and intellectual property disputes have been limited to HIV drugs as campaigners have accused Western firms of profiteering while poor patients in developing countries die. The Novartis ruling however marks a widening of the conflict to other proprietory drugs. Photo: Alamy

By Dean Nelson, in New Delhi

1:51PM BST 01 Apr 2013

22 Comments

The company said the decision raised serious, wider implications for the industry and reflected India’s ‘growing non-recognition’ of intellectual property.

Its ruling, however, was hailed by campaigners and Indian pharmaceutical firms as a victory for the country’s poor who cannot afford expensive Western medicines. Indian drug firms sell generic versions of Western drugs for up to one tenth of the price.

India’s trade minister Anand Sharma yesterday hailed the decision as an “historic judgment” which reinforced Indian laws preventing companies from extending patent protection unfairly by minor tweaks to their products, a process known in India as ‘ever-greening. Y.K Hamied, chairman of Cipla, one of India’s largest generic drugs companies, said the ruling will “pave the way for affordable medicines in India.”

Novartis however yesterday warned the ruling will discourage expensive investment in new drug treatments. The decision “provides clarification on Indian patent law and discourages innovative drug discovery essential to advancing medical science for patient," it said in a statement.

“The primary concern of this case was with India's growing non-recognition of intellectual property rights that sustain research and development for innovative medicines. As a leader in both innovative and generic medicines, Novartis strongly supports the contribution of generics to improving public health once drug patents expire,” it added.

The company had applied for a patent for a new tablet version of its anti-cancer drug Glivec, which had taken years to develop, it said. The Supreme Court however ruled that the tablet did not amount to an advance sufficient to merit a patent. Around 16,000 Indian cancer patients use Novartis' Glivec - 95 per cent free of charge, the company said, while an estimated 300,000 use cheaper Indfan versions.

Until recently patent and intellectual property disputes have been limited to HIV drugs as campaigners have accused Western firms of profiteering while poor patients in developing countries die.

The Novartis ruling however marks a widening of the conflict to other proprietory drugs. Merck, the US-based drugs company is facing a dispute with the Indian pharmaceutical firm Glenmark which has launched a generic version of its diabetes drug Januvia which is almost a third cheaper.

“It's all about interpretation of section 3(d) of the Indian Patent Act,” said Ran Chakrabarti, a commercial lawyer based in New Delhi.

“Essentially, it says that you can't tweak something that already exists and then patent it, if it doesn't enhance the known efficacy of that thing, or result in a new product. No doubt lawyers will have spent a lot of time pouring over the meaning of 'enhance', 'efficacy' and 'new product', but it looks as if the Supreme Court has ruled that this is old wine in a new bottle.

"Drug companies are going to have to come up with something pretty unique to get patent protection, and while that's good news for consumers, it pushes the threshold for innovation northwards,” he added.

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A Just Order

Editorial in The Hindu

The Supreme Court order rejecting a plea to grant patent protection for Glivec, a cancer-fighting drug from Novartis, is a landmark. It will greatly strengthen the quest for access to affordable medicines in India. The decision affirms the idea that a patent regime loses its social relevance when a drug is priced beyond the reach of the vast majority of a country’s people. That pharmaceutical companies employ high pricing to limit the number of beneficiaries of “blockbuster” patented molecules and even older “evergreened” medicines is an irony, because making additional copies of a drug is not expensive. On the other hand, cost control and dispensing of essential medications in government-run health facilities is affected, because many States have no centralised procurement system. It is unsurprising, therefore, that less than 10 per cent of medicines sold in India are under patent, while the vast majority are branded generics. The court order should prompt producers of patented drugs to move towards liberal licensing and low cost manufacture in India, the pharmacy of the South that produces Rs.100,000 crore worth of medicines annually and sells nearly two thirds within the country. It is a matter of concern that at least a dozen pharmaceutical innovations used in the treatment of cancer, HIV/AIDS, and Hepatitis B and C are not affordable to even the upper middle classes, and impossible to access for the poor.

It would be a gross distortion to paint the Glivec order, which follows the compulsory licensing of Bayer’s drug Nexavar, as an innovation killer. There is evidence to show that major pharma companies recover more than the cost of innovation of a drug in a single year from the United States market alone. Moreover, the costing done by industry has come in for criticism from scientists and policymakers on the grounds that the bloated, irrelevant investments of recent decades are used as the baseline to make calculations. It should not, as the industry claims, cost a billion dollars (and take a dozen years) to produce a new drug; the informed estimate is a third of that figure. The contested field of drug discovery now calls for greater scrutiny of costs and therapeutic value, and control of prices through various legal avenues available under the Indian Patents Act and the Trade-Related Aspects of Intellectual Property Rights as confirmed by the Doha Declaration. It would naturally strengthen the case for grant of patents and consensus pricing, if the industry opens its books for verification. Until the golden mean is reached, governments with vast populations that are denied access to medicines due to economic reasons can justifiably use unilateral price control mechanisms.

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Calling big pharma’s bluff

 e

DWIJEN RANGNEKAR in the hindu

   

 

The lesson from the Supreme Court ruling on Gleevec is that pharmaceutical multinational corporations need to focus research on genuine innovations rather than on ways to evergreen their patents

The much awaited Supreme Court judgment on Gleevec has been delivered. Novartis has failed in reversing the rejection of its patent. And, predictably — like a scratched record — there have been suggestions that pharma investments in India will dry up and take flight to China. At each twist of this case, Novartis has produced such bluster. We need to pay attention to the judgment as it is a nuanced handling of difficult questions concerning a hastily drafted section — Section 3(d) of the Indian Patents Act, which allows new forms of existing drug formulations to be patented only if they result in increased efficacy. The judgment adopts a gentle caution in parsing out Section 3(d); yet, it is firm in reading 3(d) as a “second tier of qualifying standards” for patentability. Further, the judgment also stands out by reprimanding the “artful drafting” of patent applications adopted by big pharma.

CHRONOLOGY

To begin, it is useful to draw out some of the chronology concerning Gleevec that the judgment reveals. The story of the patent begins with Jurg Zimmerman’s invention of derivatives of N-phenyl-2- pyrimidine-amine, one of which in freebase form was called “Imatinib,” and together constituted a U.S. patent application (no. 5,521,184) granted on May 28, 1996 (which, the judgment terms “the Zimmermann Patent”). Subsequently, a European patent was also acquired. Later, a patent application was filed for the beta crystalline form of Imatinib Mesylate (the subject in dispute) in January 2000. Initially rejected, the patent was awarded in May 2005 following Novartis’s appeal to a U.S. appellate court. What is interesting is that the filings for new drug approval, submitted in April 1998, was for Gleevec, and a filing for original drug approval in February 2001 was for Imatinib Mesylate. Confusing as this may seem, the judgment highlights this to establish that Imatinib Mesylate was covered by the Zimmerman patent and that Gleevec was its market name. Any remaining doubt, the judgment notes, is extinguished by the application for patent term extension: “This application leaves no room for doubt that Imatinib Mesylate, marketed under the name Gleevec, was submitted for drug approval as covered by the Zimmermann patent.”

CONTEXT

One of the useful aspects of the judgment is in distilling the significance of “context” in giving meaning to statute. Early on, it notes that to understand the import of the various amendments introduced in the third amendment to the Patent Act, 1970 — to come into full compliance with TRIPS — it is “necessary to find out the concerns of Parliament … What was the mischief Parliament wanted to check and what were the objects it intended to achieve through these amendments?” In this respect, the judgment recalls not only the heated Parliamentary debate, but also the concerns of public health practitioners the world over, and of public statements and petitions from U.N. agencies and civil society organisations. With India being the leading global supplier of bulk drugs, formulations and generic Antiretrovirals (ARV), the global concerns layered domestic worries about affordability of drugs.

Evidence in a widely cited study by the National Institute of Health Care Management, Changing Patterns of Pharmaceutical Innovation, is telling. Between 1989 and 2000, the U.S. Food and Drug Authority approved 1,035 new drug applications — of these, 65 per cent contained active ingredients that were already on the market (i.e. incrementally modified drugs), 11 per cent were identical and only 15 per cent were considered a “highly innovative drug.” Mischief like this results in a patent thicket around a single molecule to delay generic entry which Section 3(d) seeks to avoid. Consequently, the Supreme Court heralds Section 3(d) as a “second tier of qualifying standards for chemical substances/pharmaceutical products in order to leave the door open for true and genuine inventions but, at the same time, to check any attempt at repetitive patenting or extension of the patent term on spurious grounds.”

The significance of this rendering of Section 3(d) is borne out in the Supreme Court’s mix of caution in parsing out the section and firm pronouncements on patent drafting. Section 3(d) states, the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such process results in a new product or employs at least one new reactant.

And, has the following explanation appended: For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.

MADRAS HC READING

Recall that the Madras High Court’s reading that efficacy is a pharmacological idea associated with the ability of a drug to produce a desired therapeutic effect independent of potency, i.e. “healing of disease.” And, the Intellectual Property Appellate Board (IPAB) had noted with respect to enhanced efficacy that “it is not possible to quantify this term by any general formula” and that an assessment would “vary from case to case.” In revisiting these readings, the Supreme Court also had the views of Shamnad Basheer (as an intervenor-cum-amicus) and Anand Grover (Counsel for Cancer Patients Aid Association). The latter had argued for a strict reading of 3(d) which would see efficacy entirely in pharmacological terms. While Basheer agreed that all advantageous properties may not qualify under 3(d), he held that increased safety and reduced toxicity should be seen favourably. Even as the Supreme Court recalls the concerns that author 3(d) — thus, urging a “strict and narrow reading” for medicines — it prefers to delay definitive pronouncement and allow for jurisprudence to develop on this matter. Yet, it is firm in noting that enhancements in the “physical properties” of a product would render a patent application foul of 3(d).

It is here that the evidence — either in the patent applications or submitted later through affidavits to Controller were found wanting in establishing enhanced efficacy. Take for instance the “Massimini” affidavit, filed before the Controller and directed at 3(d), where two points emanate. First, that the beta crystalline form of Imatinib Mesylate is highly soluble, and second that it demonstrates a number of improved physical properties (e.g. flow properties, thermodynamic stability). Yet, in probing, it becomes clear that the comparison is to Imatinib — and not Imatinib Mesylate, where the latter is the “known substance” in terms of 3(d). Which leaves the issue of increased bioavailability — and here the court finds “there is absolutely nothing on this score apart from the adroit submissions of the counsel” and dismisses the argument.

ON DRAFTING

A final aspect of the judgment that needs highlighting is the pronouncement concerning drafting. The careful interrogation of the sequence of events leading to the patent application for the beta crystalline form of Imatinib Mesylate opened up gaping holes in the claims made by Novartis. These included that Gleevec was “‘disclosed” in the Zimmerman patent and this point is also implied by Novartis’s legal notice to NATCO in the U.K. to stop production of its generic version, VEENAT. In response, Novartis argued that even while Gleevec could be claimed by the Zimmerman patent, it was not fully disclosed in an enabling manner. Thus, seeking to differentiate between claims and disclosure. This wonderful legalese was eloquently rejected by the Supreme Court; both, in terms of U.S. legal history that was cited and in terms of the argument’s merits. And it’s useful to quote at length: “We certainly do not wish the law of patent in this country to develop on lines where there may be a vast gap between the coverage and the disclosure under the patent; where the scope of the patent is determined not on the intrinsic worth of the invention but by the artful drafting of its claims by skilful lawyers, and where patents are traded as a commodity not for production and marketing of the patented products but to search for someone who may be sued for infringement of the patent.”

LAPSES

Looking back over the last several years, it is useful to recall the several lapses committed by Novartis. It failed to heed petitions by health groups and civil society to drop the case. For that matter it failed to also heed the wisdom of its own shareholders who urged it to withdraw the challenge. And at the Supreme Court along with losing the case, we also find that the Gleevec patent application “appears to be a loosely assembled, cut-and-paste job, drawing heavily upon the Zimmermann patent.”

The judgment should be well noted and celebrated. It recalls the context of 3(d) and reminds us of the matters of concern that punctuated its crafting. While the section may have been hastily drafted and insufficiently specified, it has the elements to withstand ever-greening. Pharma companies will always be rewarded for their inventive work and effort — and by drawing in a secondary qualifier, they will have to focus their efforts on genuine inventions rather than overlapping patents.

(Dwijen Rangnekar is Associate Professor of Law at the University of Warwick, U.K. E-mail: d.rangnekar@warwick.ac.uk)

Pharmaceutical companies putting health of world's poor at risk

India makes cheap medicines for poor people around the world. The EU, pharmaceutical firms and now the US are pressuring the 'pharmacy of the developing world' to change tack

Customers buy medicine at a pharmacy in Mumbai. Photograph: Kuni Takahashi/Getty Images

India is often called the pharmacy of the developing world, which is no great surprise as more than 50% of its $10bn annual generic medicine production is exported.

But the domestic drug industry behind India's role as global pharmacist stands to emerge rather poorly from the free trade agreement (FTA) that Europe is proposing for India. In late-stage negotiations over the terms of the long-awaited agreement, the EU is calling for intellectual property rights enforcement that goes well beyond India's obligations as a member of the World Trade Organisation and would make it all but impossible for generic drug manufacturers in the country to continue in their present structure.

This could delay the introduction of cheaper medicines in India and elsewhere at a time when the global financial crisis has already put the squeeze on life-saving medicines across the world (last year the Global Fund to Fight Aids, Tuberculosis and Malaria cancelled its 11th funding round due to the crisis).

Yet protests on the streets of Delhi against the unfair terms of the EU-India FTA have been little noticed in the west, where such agreements are increasingly being promoted as a route out of domestic crises. For European leaders, they represent a foreign policy counterpart to calls for a growth pact at home. In a recent editorial, however, the former EU high representative for foreign and security policy, Javier Solana, all but admits that a similar agreement that Europe is tying up with Peru and Colombia may be "denying their weaker citizens [human] rights in favour of the interests of business".

In India, such fears are perilously close to being realised, because the EU-India FTA negotiations are not the only way in which the health of Indian citizens is coming under attack from Europe. In an effort to boost falling profit margins in the west, and to prise open more profitable markets elsewhere, European pharmaceutical companies are also chipping away at India's judicial system.

Next month, the supreme court of India will hear final arguments in a long-running case between Swiss pharmaceutical giant Novartis and the Indian government. Novartis is seeking extended intellectual property protection for a marginally modified anti-cancer drug, Glivec, for which the original patent has run out. This is a practice known asevergreening, seen by many as an unfair way for pharmaceutical companies to maintain artificially high drug prices in developing markets. That is certainly the view of the Indian government, which, in 2005, inserted a clause into its intellectual property law deliberately intended to prevent the practice.

That clause has proven to be a literal lifesaver many times since, and it ensured thatNovartis's original case was thrown out of court in 2006. But Novartis has filed new litigation in an attempt to breach India's legal defences. The final ruling is next month and there is every chance Novartis may succeed. If it does, other pharmaceutical companies will be able to impose higher prices on drugs in India too.

The Novartis case coincides with a third major assault on India's pharmaceutical industry: the final spear in a triple-pronged attack on its generic drug manufacturers by the west.

This involves the attempt by German pharmaceutical company Bayer to revoke the recent granting of a compulsory licence for an Indian firm, Natco Pharma. The licence was to produce a cheaper version of its anti-cancer drug Sorafenib. Bayer does not manufacture the drug in India, and imports in such small volumes that only a tiny fraction of potential patients could benefit. For its brand, Sorafenib, Bayer has charged Indian patients about $69,000 for a year of treatment, an unaffordable amount for most Indian households. Under the licence, Natco will sell the same medicine at 3% of this price, while paying a licence fee – and still make a profit.

But now Barack Obama's administration has weighed in on behalf of Bayer's battle for continued monopoly pricing. Testifying before the House of Representatives subcommittee on intellectual property on 27 June, the deputy director of the US Patent and Trademark Office said US officials are "constantly being there on the ground" pressuring the Indian government to desist from compulsory licensing.

It is not only Indian patients who stand to suffer from this triple-pronged attack. So, too, will charities such as Médecins Sans Frontières, which relies on Indian generic producers to supply 80% of the antiretrovirals it uses around the world. As MSF spokeswoman Leena Menghaney puts it, India is "literally the lifeline of patients in the developing world". In 2006, MSF launched an international campaign against Novartis, signed by half a million people, including Archbishop Desmond Tutu and the author John le Carré, to get Novartis to drop their pursuit of what the campaign argues is exploitation.

The campaign may not have reckoned on the scale of the assault under way, however. It is not only the pharmaceutical industry that needs to be addressed but the continued and ruthless lobbying by western politicians to secure the profitability of their own industries.

We ought to be asking why governments in the rich world still seem happy to checkmate the lives of poor people to save their political skins. And why the pharmaceutical industry sees India as such a threat. Could it be that they detect the whiff of real competition?

• Hans Lofgren is associate professor in politics at Deakin University, Melbourne. He is the editor of two forthcoming volumes (Palgrave Macmillan and Social Science Press) on pharmaceutical policy and access to medicines in India and the global south

Big pharma is cut out by India's plan to bring medicine to masses

Ambitious $5bn push deals blow to global firms with focus on generic alternatives above branded drugs

NIKHIL KUMAR 

 

 

FRIDAY 06 JULY 2012

India is planning a multibillion-dollar push to bring free medicines to the hundreds of millions of its citizens who, despite the country's economic revival, still languish without access to the very basics of health care.

The $5bn initiative, which is slated to be rolled out by the end of this year, will offer 348 essential drugs to patients across the country. In a blow to the West's big pharmaceutical firms, the planned scheme will largely cut out branded drugs, opting instead for cheaper generic alternatives.

News of the plan comes as the Congress-led administration in Delhi attempts to shore up public support after a raft of corruption scandals and crushing electoral losses in state polls. A recent report confirming a slowdown in economic growth has only served to sharpen criticism of the government.

Now, Delhi is plotting a multi-billion dollar health-care drive, using its network of government-funded hospitals and clinics to deliver free drugs across a country where, despite the much-vaunted boom of recent years, more than two million young children die every year from preventable infections, according to Unicef.

Infant mortality stands at 63 per 1,000 live births, while a recent paper in the Lancet medical journal said that of the nearly five million children under five who succumbed to preventable diseases such as pneumonia, diarrhoea and malaria in 2010, almost half had come from five countries: Nigeria, the Democratic Republic of Congo, Pakistan and, notably, China and India.

All the while, the Indian state spends so little on health care as a proportion of GDP that only a handful of countries fare worse, according to the OECD.

The bulk of the cash for the free medicine plan will come from central coffers, while state governments will be asked to shell out an additional third of the required funds. The Ministry of Health and Family Welfare said it had put forward proposals worth around $3.64bn. The additional funding – from the states – will boost the investment to around $4.9bn, signalling, if approved, "a giant step in vastly expanding the access to medicines", the Ministry said. A template already exists in the western state of Rajasthan and Tamil Nadu in the south, where health schemes are reported to have been successful.

The focus on generic medicines chimes both with the need for affordability and the dynamics of India's pharmaceutical market. Generics – or cheaper copies of expensive branded medicines whose patents have run out – accounted for around 90 per cent of the total drug sales in the country in 2010, according to Reuters data.

The gulf between the cost of branded drugs and generic alternatives is often vast. The Rajasthan state government, for instance, buys the generic version of a popular cholesterol drug for just over 6 rupees (7p) for a strip of 10 tablets, according to official figures quoted by India's Economic Times newspaper. In contrast, consumers opting for a branded alternative face costs of 103 rupees.

Although reports indicate that doctors participating in the planned scheme will be able to use 5 per cent of the sanctioned funds to buy medicines absent from the approved list of 348 generic drugs, the initiative presents a fresh challenge for global pharmaceutical giants such as GlaxoSmithKline and Pfizer.

Big pharma, as that end of the industry is known, is already struggling to forge new avenues for growth. Being locked out of a major initiative in a key emerging market won't help.

"Without a doubt, it is a considerable blow to an already beleaguered industry, recently the subject of several disadvantageous decisions in India," KPMG's European head of chemicals and pharmaceuticals, Chris Stirling, told Reuters.

"Pharmaceutical firms are likely to rethink their emerging markets strategies carefully to take account of this development, and any similar copycat moves across other geographies."

India's patent ruling on cancer may open door for cheaper HIV drugs

It is only the second time a nation has issued a compulsory license for a cancer drug after Thailand did so on four drugs between 2006 and 2008, also on affordability grounds. (Reuters photo)

Reuters | Mar 13, 2012, 08.04PM IST

India's move to strip German drugmaker Bayer of its exclusive rights to a cancer drug has set a precedent that could extend to other treatments, including modern HIV/AIDS drugs, in a major blow to global pharmaceutical firms, experts say.

On Monday, the Indian Patent Office effectively ended Bayer's monopoly for its Nexavar drug and issued its first-ever compulsory license allowing local generic maker Natco Pharma to make and sell the drug cheaply in India.

It is only the second time a nation has issued a compulsory license for a cancer drug after Thailand did so on four drugs between 2006 and 2008, also on affordability grounds. Thailand also issued licenses for HIV/AIDS and heart disease treatments.

"This could well be the first of many compulsory rulings here," said Gopakumar G Nair, head of patent law firm Gopakumar Nair Associates and former president of the Indian Drug Manufacturers' Association.

"Global pharmaceutical manufacturers are likely to be worried as a result ... given that the wording in India's Patent Act that had been amended from 'reasonably priced' to 'reasonably affordable priced' has come into play now."

The new wording is seen as a lower threshold for compulsory licenses, which can be issued under world trade rules by nations that deem major life-saving drugs to be too costly. The licenses allow them to authorise the local manufacture or importation of much cheaper, generic versions.

Global drugmakers see emerging markets such as India as key growth opportunities, but remain concerned over intellectual property protection. Nair said HIV-related medicines were likely to be the most at risk by compulsory licenses in the future.

India has one of the world's fastest-growing rates of HIV and heart disease is also the country's biggest killer, but widespread poverty in Asia's third-largest economy makes many non-generic drugs unaffordable for millions.

Currently, Pfizer and GlaxoSmithKline sell a modern HIV/AIDS drug known as Selzentry through their joint venture firm ViiV Healthcare. The treatment costs more than 60,000 rupees for one month's dosage in India.

Bayer's Nexavar cancer drug costs around $5,500 a month in India, making it "not available to the public at a reasonably affordable price", the patent office ruled. About 40 percent of Indians live below the poverty line, government data shows.

A provision of the Indian Patents Act allows for a compulsory license to be awarded after three years of the grant of patent on drugs that are deemed to be too costly.

MORE TO COME?

Other patent rulings are imminent. A long-running case involving the granting of an Indian patent for Swiss drugmaker Novartis' cancer drug Glivec is expected to be heard in the country's Supreme Court this month.

The case does not involve the issue of compulsory license, but it has also pitted advocates of free trade and intellectual property rights against pro-generics campaigners who say a ruling in favour of Novartis could see other drugs in India priced outside of the reach of most of the population.

"This (Bayer) case might become a trend-setter, wherein generic players can make copies of patented products," said Siddhant Khandekar, analyst at ICICI Direct.

"While global giants might not like this, generic companies will benefit along with common people," he said, adding that the cancer treatment market in India was worth up to 30 billion rupees.

The Bayer case underscores the still fractious relationship between global pharmaceutical firms and India. Companies like Pfizer, GlaxoSmithKline and Novartis are eyeing India and other emerging markets, notably China, as a growth opportunity but worry about property protection in a country that is also a leading source of cheap copycat medicines.

"Big Pharma" has recently struck some alliances with Indian drugmakers to tap into their generics expertise, but these have also not always run smoothly, with Pfizer on Tuesday scrapping a partnership with India's Biocon Ltd.

In cancer treatments, India's Cipla Ltd, which has the second largest share of the local drugs market, may also benefit from the Bayer case. Cipla is fighting a Bayer suit for patent infringement after the Indian drugmaker launched a generic version of Nexavar in India in April 2010.

BAYER CONSIDERS OPTIONS

Natco's finance chief, Baskara Narayana, told Reuters that sales of the generic version of Nexavar, whose chemical name is sorafenib, were expected to be about 250 million to 300 million rupees a year once it is launched.

Bayer, which developed Nexavar with US biotech firm Onyx Pharmaceuticals, said it was evaluating its options.

"We are disappointed by the decision of the Patent Controller in India to grant a compulsory license for Nexavar," Bayer said in a statement.

Tapan Ray, director general of the Organisation of Pharmaceutical Producers of India, an industry group of multi-national drugmakers, said the Bayer ruling was disappointing.

"The solution to helping patients with innovative medicines does not lie in breaking patents or denying patent rights to the innovators," Ray said.

Pfizer has questioned the issue of affordability, saying many Indians are well off and can afford Western medicines.

"There is huge wealth in India," Pfizer CEO Ian Read told Reuters in London on Monday. "There are maybe 100 million people in India who have wealth equivalent to or greater than the average European or American, who don't pay for innovation. So this is going to have to be a discussion at some point."

But groups that campaign for cheap access to drugs in poor countries have welcomed the Bayer ruling.

Medecins Sans Frontieres said the ruling means that new medicines in India that are still under patent, including some of the latest treatments for HIV/AIDS, could potentially have generic versions produced for a fraction of the cost.

"It's a bold move by the government and it's a good judgment ... which will benefit people," said Dara Patel, secretary general of the Indian Drug Manufacturers' Association, an industry body of Indian companies.

"Drugs to treat heart-related diseases and HIV are costly," said Patel. "Compulsory licensing will make them available at one-fourth or one-fifth of the price, which is good."

EU closer to India trade deal

By Bari Bates in Asia Times Online

BRUSSELS - Behind closed doors, a trade deal affecting a fifth of the world's population has been quietly in the works for years. But while details of the free trade agreement (FTA) between the European Union and India remain ambiguous to the general public, concerns continue to mount over the effects such a deal could have on an unsuspecting third party: the affordable drug market of the developing world.

Negotiations have been underway for five years, with details on issues such as India's generic drug market sending delegates from both the EU and India through multiple rounds of deliberations in the hopes of settling on an FTA that would be "mutually beneficial and sustainable", especially given Europe's current economic climate.

Finally, the five-year ordeal seems to be moving toward a conclusion, according to the European External Action service. The latest EU-India summit took place on February 10 and was hailed by Jose Manuel Durao Barroso, president of the European Commission, as a "significant step forward".

The European Union is already India's primary trade partner and largest source of foreign direct investment (FDI), according to Barroso.

EU-India trade doubled to more than 67.9 billion euros (US$89.5 billion) in 2010 from 28.6 billion euros in 2003, while EU investment has tripled to three billion euros since 2003.

Barroso says the final agreement will be reached this autumn and, if passed, would signal the implementation of the world's largest trade agreement in the world, opening the doors for research and innovation, job creation, and countless business opportunities.

But some experts and activists are fiercely opposed to the deal, which they say will stunt the availability of affordable medicine in the developing world.

'Hands off our medicine'
These concerns aren't new; the issue has been on the radars of several organizations for years, with growing concerns over how the trade agreement is being reached and what it means for organizations who work to supply low-cost medicines to those in need.

As the FTA has evolved, certain measures such as data exclusivity have been taken off the table, though other potentially harmful provisions remain.

Initial opposition to the trade deal centered on issues of intellectual property rights and market access for large European businesses, with the not-for-profit group Corporate Europe Observatory (CEO) at the helm with a petition to halt the trade agreement altogether. The petition had the signatures of over 100 organizations as of December 2010, just prior to the 11th EU-India summit.

One of CEO's biggest concerns is that new trade rules could stall the distribution of generic drugs, thus keeping patented medicine prices high and increasing the overall cost of healthcare for households. According to Oxfam International, generic competition lowers medicine prices by 90-99%.

Most significantly, generic competition in India has lowered prices for first line antiretroviral drugs to US$100 per year for a single patient, down from $10,000 just 10 years ago for the same treatment.

Doctors Without Borders (known in French as Medecins Sans Frontieres, or MSF), an independent international medical humanitarian organization that delivers emergency aid, has also been steering opposition to the FTA's impact on generic drugs.

The organizations's campaign called for Europe to keep its "hands off our medicine" and issued a statement outlining risks associated with the widening net of enforcement provisions, which have serious implications for the availability of medicines.

If certain enforcement provisions related to intellectual property are included in the FTA, they could give large pharmaceutical companies the right to sue not only generic drug manufacturers but also generic drug suppliers and customers, MSF said.

Such measures could deter treatment providers from buying or supplying generic drugs, leaving the far more expensive brand drugs as the only option for people in desperate need.

The organization rallied in New Delhi on February 10 along with HIV-positive community members to call attention to the remaining provisions in the FTA that put the generic drug market in serious jeopardy.

Nearly 2,000 people strong, the protests included remarks from MSF president Unni Karunakara, who said, "We have watched too many people die in places where we work because the medicines they need are too expensive. We cannot allow this trade deal to shut down the pharmacy of the developing world."

Given that Europe posits itself as a world leader in development aid, the potential hypocrisy of the situation isn't lost: if these provisions are, in fact, included in the FTA, the EU stands to undermine its own large-scale aid efforts by limiting access to life-saving medications.

Besides the petition, CEO also launched legal action against the European Commission early last year, claiming that corporate lobby groups were given privileged access to information on the EU-India trade talks.

The organization alleged that 17 documents were released to industrial players but withheld from CEO because it would "undermine the EU's international relations".

CEO requested the documents in order to monitor the trade deal, which the organization believes leans much heavily towards the interests of large corporations at the expense of trade unions, non-governmental organizations and small enterprises.

CEO's Pia Eberhardt said that she expects a hearing within the first half of this year, though no formal date has been set. From that point, it will take roughly six additional months to reach a conclusion. But while the case circles the justice system, the FTA could slip through the cracks.

You are a Brand

Are you a Coke or a Pepsi?
Presenting yourself as a 'brand' may help you secure a job interview.

Remember the Pepsi Challenge? Take a group of punters, two cans of cola, cover up the labels, and get them to taste. Pepsi always wins; more people like the taste of Pepsi than Coke.

But walk into a supermarket and something weird happens. Coke outsells Pepsi. For quite a lot of us, the rational bit of our brain, which tells us Pepsi is nicer, gets overridden. An irrational, emotional bit, the bit that likes the sexy shape of the old Coke bottle, or that would like to teach the world to sing, takes control, and we buy Coke.

That’s the power of a brand, and people have them just like companies. And recruiting someone is like walking down that supermarket aisle. Loads of people apply, with roughly the same experience, skills and qualifications. Rationally, there’s not much to choose between them – candidates are a hundred cans of cola on a shelf. So how do employers pick who to interview?

They pick irrationally. Emotionally. On the basis of what they pick up about your personal brand. And most of that will come from the way you write your CV and cover letter. Not just getting your apostrophes in the right place (though that’s a good start), but your 'tone of voice’.

So for any decent job, an identikit CV means death. Start with 'I am a hard-working team player ...’ and, even if it’s true, you’ll sink back into the vat of candidate cola that’s slopping around. And avoid buzzwords. If you trained a load of people, say that; don’t say you 'upskilled a functional unit of direct reports’.

If I’m the employer, wading through them, I want someone who makes me take notice. Who sounds funny. Or brave. Or good company. Or caring. Someone who takes the risk of standing out from the crowd. If your hobby is the conservation of rare toads, drop that in. If you think the way your industry works is completely unsustainable, say so. Anything that will intrigue your reader into conversation will pay dividends. Because the aim of most job applications isn’t to get you a job, it’s to get an interview. Once you’re in the room you can show what a hard-working team player you are. By then you’ve got me hooked.

That’s why, for many big brands and smaller companies, how you reply to a job advert is the first filter.

They might have spent thousands on a recruitment campaign.

So if you don’t pick up on the tone of that ad, and send a generic CV, like most people do, it says you probably won’t pick up on the culture if you end up working there. It says you’re the wrong person.

You must put a bit more of yourself into your writing. Decide if you want to sound like a Coke, or a supermarket’s own brand.

If it’s the right place, and the right job for you, it will work.

And then you won’t kick yourself for being like Pepsi – competent, but unloved.

Neil Taylor is creative director of brand language consultancy The Writer (thewriter.com) and author of Brilliant Business Writing.