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Pharma Vs India: A Case Of Life Or Death For The World’s Poor

  1. enquirewithin
    It’s a worrying time for the poor and the sick. Two cases brought to India’s courts by transnational pharmaceutical companies could massively effect whether people in the Global South can access life-saving medicines. The most significant of these involves Swiss drugmaker Novartis which was refused a patent in India for its anti-cancer drug Glivec (imatinib) and is now challenging the country’s patent law.

    ‘People are already dying because they can’t get treatment and if Novartis wins things will become worse,’ says Eldred Tellis, who runs a centre for drug users and people living with HIV in Mumbai. ‘They are targeting India because many quality generic drugs are produced here for many people.’

    Thanks to India’s 1970 Patents Act, around one-fifth of the world’s generic drugs – containing the same active ingredients as a patented drug but made by a different company at a fraction of the price – are made in the country. As well as supplying India’s huge population, these drugs are shipped to poor countries around the world.

    ‘We source 80 per cent of our global HIV medicines, as well as other medicines, from India – as do the Global Fund,’ says Michelle Childs, Director of Policy and Advocacy at Médecins Sans Frontières (MSF). ‘So what happens in India can immediately affect other countries and set a precedent for them.’

    The Problem With Patents

    Novartis is challenging a clause in the Indian law, ‘Section 3d,’ that prevents drugs being patented that are modifications of existing drugs, a tactic known as ‘evergreening’ used to extend patent periods. The company originally failed to patent Glivec in India as it was discovered before the country was forced to start patenting drugs in 2005. The latest patent application is based on a salt form of Glivec (imatinib mesylate), which, although being easier to absorb, is arguably no more effective.

    Studies have found the majority of global research and development (R&D) money is used to produce these minor variations, leading not only to high prices but a lack of genuinely new drugs.

    ‘About 85 per cent of all new drugs are proven to be little or no better, clinically, than existing drugs,’ says Donald Light, professor of comparative healthcare at the University of Medicine and Dentistry of New Jersey. ‘They are all better than placebo but they are not better than last year’s drug that was better than placebo.’

    This is at odds with the pharmaceutical industry argument that the patent system is there to allow companies to receive more money to make new medicines. Producing new drugs is, they say, such an expensive business that only the big companies can afford to do it.

    ‘These are potentially dangerous substances so you really need to do a lot of research,’ says Mark Grayson, deputy vice-president of Pharmaceutical Research and Manufacturers of America (PhRMA). ‘You need to do clinical trials, even after the drug is on the market; you need production plants to be sterile, drugs need to be safe, all these costs need to be borne and they are not cheap.’

    What they fail to mention is that the majority of R&D for developing new drugs is publicly funded. This was the case for Glivec, which was also awarded ‘orphan drug status’ in the US, allowing Novartis to receive tax breaks that paid for a large proportion of the clinical trials.

    ‘The vast majority of the original research on Glivec came from charities and the government,’ says Jamie Love, Director of Knowledge Ecology International (KEI), an intellectual property pressure group. ‘But at the very end Novartis comes in and gets a patent on it and makes a couple of billion dollars a year.’

    These mammoth profits are generated by aggressive pricing. When this court case began in 2006, Novartis sold Glivec for $2,200 per person per month, while the generic version was produced in India for a tenth of that price. That companies could be facing such huge losses to generic competition has wound up the neoliberal press in the US with the Wall Street Journal calling it a ‘drug disaster.’

    Countries are allowed by the World Trade Organization to produce generic drugs if there is a major public health imperative, a practice known as compulsory licensing. India issued its first compulsory licence in March, ordering German drugmaker Bayer to allow a generic manufacturer to make its cancer drug Nexavar (sorafenib) for one-thirtieth of the usual $5,000 price tag. India’s patent controller argued that not only had Bayer failed to make the drug ‘reasonably affordable’, it had failed to supply the drug in large enough quantities, a decision Bayer is challenging in the courts.

    ‘With a patent comes obligations, one of which is you make your medicine available in the quantities needed,’ says Michelle Childs.

    Targeting The Poor

    As these cases move through the Indian courts, the bottom line remains that they could significantly impact access to medicines for the world’s poor. If both Novartis and Bayer win, the floodgates could open for companies to challenge the laws and licences that allow generic drug production.

    With the vast majority of profits in the pharmaceutical sector being made in wealthy countries, why are poor countries being targeted so aggressively? The answer, like so many others, relates to inequality. While not currently profitable, poorer countries are seen as ‘emerging markets’ because of their burgeoning middle classes.

    ‘The drug companies see India as a market of 100 million, although that’s less than 10 per cent of the population,’ says Jamie Love. ‘These are the people they care about, as they are the ones with enough money.’

    This desire to keep the Indian élite onside may be why Novartis’s chairperson Daniel Vasella reportedly donated hundreds of ancient Indian sculptures to a Mumbai museum last month. But most of the people affected by high drug prices will never visit a museum. And most will die knowing nothing about patents, laws, licences or pharmaceutical companies.

    ‘The people we work with on the ground have no idea what’s going on right now in the courts,’ says Eldred Tellis. ‘But we do, and we know that Novartis losing is their best chance to live.’

    By Nick Harvey | Source: New InternationalistSunday, October 21, 2012


  1. al-k-mist
    Man, I want to cry
    Not at this article, but that the big companies do this, and get away with it(shame on you novartis, al hofmann would roll over in his grave knowing the superman S of Sandoz was connected with the novartis label)
    From monsantos poisoning of the food supply and the controling of the food suoply in america, to the fake ass pharmaceutical companies
    You know what gets me? is the people panhandling for a cancer cure...where does that money go? They have a hundred sources for those funds, yet they want pity and money, and they will not be giving the cancer drug to these people. If they do succeed, everyone who gives money will contribute to people NOT getting the same treatment rich people get
    Im sorry, but the fake justice, the inequality, it pisses me off, that nothing nonviolent could be done,
  2. Shanthi
    Ive no statistics to quote, no new information to share but I wanted to share my wonder (if thats the rite word for it) at how petty andin the moment the human race is...

    Till such time that we were struggling to find food the hunt kept us busy, soon enough we had simplified evrything enough to create complications- borders, morality, economies, what not - to keep himself engaged. Then these petty creations become so important that in the name of economy we create diseases, then cures for it and the victims are those how are still struggling to find food!!!!
  3. enquirewithin
    It is heart breaking, and in country with so much poverty, but this applies to the whole world, especially the 'developing' world. As Western science makes advances, corporate greed makes them unavailable for the majority of people. The pharmaceutical companies are as callous and uncaring as any drug cartel.


    Q: Why do millions of people rely on India for affordable medicines?

    A: Medicines produced by generic companies in India are among the cheapest in the world. That is because, until 2005, India did not grant patents on medicines. India is one of the few developing countries with production capacity to manufacture quality-assured generic medicines.

    By producing cheaper generic versions of medicines that were patented in other countries, India became a key source of affordable medicines, such as antiretroviral medicines (ARVs) to treat HIV and AIDS. Eighty percent of the medicines MSF uses to treat 170,000 people living with HIV in its projects today are sourced from Indian generic drug companies, and over 80 percent of all HIV and AIDS medicines bought by donors also come from India. In the case of treatment for pediatric AIDS, Indian generic producers supply over 90 percent of medicines used in developing countries. This is why India is known as the "pharmacy of the developing world."

    Q: What is the relationship between patents and affordable medicines?
    A: When a pharmaceutical company has a patent in a country, it means it has a monopoly in that country for a certain amount of time. This means it can prevent other companies from producing, selling, or importing the medicine in that country for the duration of the patent term, which, according to World Trade Organization (WTO) rules, is a minimum of 20 years. This in turn allows companies to charge high prices because there are no competitors in the market.

    In the absence of patents, multiple generic producers produce medicines, further driving the price down. Competition among different producers is the tried and tested way to bring prices down. Competition among generic manufacturers is what helped bring the cost of HIV and AIDS treatment down from over US$10,000 per patient per year in 2000 to $150 today. The absence of patents in India has also helped in the development of three-in-one HIV/AIDS medicines called fixed-dose combination pills, and formulations for children.

    Q: Aren’t patents needed to stimulate innovation for new drugs by pharmaceutical companies?
    A: An increasing number of studies have shown that while patent protection has increased over the last 20 years, the innovation rate has been falling, with an increase in the number of "me-too" drugs of little or no therapeutic gain. This undermines the case that is often made by the pharmaceutical industry that more patent protection would result in more investment in medical innovations.

    A study published in 2005 concluded that 68 percent of the 3,096 new products approved in France between 1981 and 2004 brought "nothing new" over previously available preparations. Similarly, the British Medical Journal published a study rating barely 5 percent of all newly patented drugs in Canada as "breakthrough." And a breakdown of over 1,000 new drugs approved by the US Food and Drug Administration between 1989 and 2000 revealed that over three quarters have no therapeutic benefit over existing products.

    In addition, the 2006 report of the World Health Organization’s Commission on Intellectual Property, Innovation, and Public Health also found that there was no evidence that the implementation of WTO rules on patents in developing countries significantly boosts research and development in pharmaceuticals for diseases affecting developing countries.

    Q: Does India not grant patents on medicines at all?
    A: As a WTO member, India has to comply with trade rules set by the WTO. One of these is the Agreement on Trade-Related Aspects of Intellectual Property Rights, or TRIPS, which obliges WTO member countries to grant patents on pharmaceuticals. To comply with this international obligation, India amended its patent law in 2005 and started to grant patents on medicines. As a result, when patents are granted in the country, Indian generic manufacturers are not able to produce cheaper generic versions of these medicines.

    This is already beginning to have a significant impact on access to affordable medicines, both in India and beyond, as newer medicines (invented after 1995) are highly likely to be patent protected in India—and many such as raltegravir (for HIV) and pegylated-interferon (for hepatitis C) already are.


    Q: Why did Novartis attempt to sue the Indian Government?
    A: Novartis applied for a patent in India on the cancer medicine imatinib mesylate, which the company markets under the brand name Gleevec/Glivec in many countries. In other countries at that time where Novartis had obtained a patent, Gleevec was sold at US$2,600 per patient per month. In India, generic versions of Gleevec in 2006 were available for less than $200 per patient per month. Novartis applied for a patent so that it could sell Gleevec at higher prices in India.

    The patent was rejected by the Indian patent office in January 2006 on the grounds that the medicine was merely a new form of an old medicine, and therefore was not patentable under Indian patent law. Novartis decided to challenge this decision.

    Q: On what basis is Novartis claiming a patent on imatinib mesylate, and why was it rejected?
    A: Novartis’s patent application was rejected in part because of Section 3(d) of India’s patents act. When India amended its patent legislation in 2005 to comply with international trade rules, the Indian Parliament included provisions to protect health and access to medicines.

    Section 3(d) is one of those provisions. It explicitly requires that patents should only be granted on medicines that are truly new and innovative. For new forms and new uses of existing medicines, Section 3(d) requires patent applicants to prove significantly improved efficacy before a patent can be granted.
    Imatinib mesylate (Gleevec) is the salt form (mesylate) of an older medicine, imatinib. Novartis claims it deserves a patent on imatinib mesylate based on the fact there is a 30 percent increase in the bioavailability of the medicine in this new form. But according to the guidelines for the examination of pharmaceutical patents developed by the World Health Organization, the selection of a salt of the active ingredient with the purpose of improving bioavailability is well known in pharmaceutical art and is an often-used form of what is known as "evergreening." Evergreening is a practice followed by multinational pharmaceutical companies to extend their patent terms by making minor changes in their existing medicines and claiming the medicine is then patentable.

    In sum, the Indian parliament introduced Section 3(d) to give explicit guidance on what did deserve a patent and what did not. When Novartis’s patent application on imatinib mesylate was first rejected by an Indian patent office, the company decided to challenge this part of the Indian patent law.

    Q: Why is this now before the Supreme Court?
    A: The Supreme Court case is the final act in a legal battle that stretches back over six years over India’s future capacity to act as the pharmacy of the developing world.

    After its patent application for imatinib mesylate was rejected, Novartis mounted a legal challenge to have Section 3(d) declared unconstitutional in the Madras High Court. In 2007, the High Court rejected Novartis’s plea. In 2009, the Intellectual Property Appellate Board also rejected the company’s appeal against the rejection of its patent application.

    Having lost its first legal battle to have Section 3(d) completely removed from India’s patent law in 2007, Novartis launched fresh legal proceedings in 2009 at the Supreme Court of India, this time seeking to weaken this critical public health safeguard so that it becomes meaningless.

    Q: How is Novartis trying to make Section 3(d) meaningless?
    A: Section 3(d) requires demonstration of increased therapeutic efficacy for a medicine to deserve a patent. In this case, Novartis is trying to argue against that "efficacy" should be interpreted differently by the Indian courts and patent offices. The interpretation of the definition of "efficacy" is therefore central to this case, and to the future of India’s role as pharmacy of the developing world.

    In its first legal battle in the Madras High Court, Novartis argued that increased bioavailability of the salt form of imatinib meant increased efficacy, entitling it to a patent on imatinib mesylate. But at the time, Madras High Court clarified efficacy to mean "therapeutic effect in healing a disease." The rejection of Novartis’s patent application was therefore confirmed.

    Q: What would happen if Novartis won this case?
    A: The implications of a Novartis victory in weakening the interpretation of Section 3(d) would not be limited to the patenting of imatinib mesylate or on cancer patients alone. If Novartis won the case, patents would be granted in India as broadly as they are in wealthy countries and on new formulations of known medicines already in use. India would no longer be able to supply much of the developing world with quality affordable medicines.

    The example of HIV and AIDS medicines is a good illustration of the potential impact of this decision. Even though first-line drugs to treat HIV have become affordable thanks to generic competition, the availability of second-line and improved formulations are crucial, as people gradually become resistant to their current combinations of HIV medicines and need to be switched to second-line medicine regimens. Some of these key medicines have gone into generic production in India but if Novartis wins then this generic production will be endangered, as many drug companies will push for their drugs to be patented in India.

    If Novartis win the case, more and more treatments will remain priced out of reach for the duration of the patent term—20 years or more—including those that are merely new forms of existing medicine and didn’t deserve a patent in the first place.

    Q: What is MSF’s role in this case?

    A: MSF is not a party to the Novartis case, but we stand in solidarity with the Cancer Patients Aid Association (CPAA) in its battle against Novartis. The CPAA is a party to this case and will be arguing for a strict interpretation of "efficacy" so that patents on new forms of known medicines—such as the one on the cancer medicine imatinib mesylate—are not granted routinely by Indian patent offices.

    Given the potentially huge ramifications on generic production and the availability of affordable medicines from India, MSF, along with many other treatment providers, patient groups, and affected communities has long appealed to Novartis to stop its attacks on the pharmacy of the developing world.

    Q&A: Patents in India and the Novartis Case | FEBRUARY 14, 2012
  4. Riya
    Good information...
  5. Riya

    Thanks for sharing this info...
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