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| Hundreds of activists gathered in New Delhi to protest Novartis's attack on India's patent laws in 2007. MSF and others continue to oppose the legal case today. Photo: MSF |
Q: Why do millions of people rely on India for affordable medicines?
A: Drugs produced by 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 drugs that were patented in other countries, India became a key source of affordable medicines, such as antiretroviral medicines to treat HIV/AIDS.
80% of the medicines MSF uses to treat 170,000 HIV/AIDS patients in its projects today are sourced from Indian generic drug companies. And over 80% of all HIV/AIDS medicines bought by donors also come from India.
Q: What is the relationship between patents and affordable medicines?
A: When a drug 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 or selling the drug in that country for the duration of the patent’s term, which, according to World Trade Organization (WTO) rules is a minimum of 20 years. This in turn allows companies to charge high prices in countries where they hold patents, because there are no competitors in the market.
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/AIDS treatment down from US$10 000 per patient per year in 2000 to less than one percent of that figure today.
Q: Why does India grant patents on drugs now?
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, or TRIPS, which obliges WTO countries to grant patents on pharmaceuticals. To comply with this international obligation, India changed 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 be able to produce cheaper generic versions of these medicines.
Q: What does this mean for patients?
A: 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), peg-interferon (for Hepatitis C) already are.
The production of more affordable generic versions – which has been so instrumental in driving down the price of older AIDS medicines by 99% in the past ten years - will therefore have to wait until the patents expire or a country issues a compulsory licence in order to overcome the patent. In the meantime, patients who cannot afford the high prices must simply go without.
Q: Why did Novartis attempt to sue the Indian Government?
A: Novartis applied for a patent in 1996 in India on the cancer drug imatinib mesylate, which the company markets under the brand name Gleevec/Glivec in many countries. The patent was rejected in India in January 2006 on the grounds that the drug was merely a new form of an old drug, and therefore was not patentable under Indian patent law. 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 was therefore trying to have the patent decision overturned so that it could sell Gleevec at higher prices in India.
At the same time, Novartis was trying to challenge and overturn key public health provisions contained within the Indian patent law itself so that patents would be as easily granted in India as they are in most other countries. Specifically, Novartis was targeting section 3(d) of the Patent Law that prohibits ‘evergreening’- the 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 new.
Q: On what basis is Novartis claiming a patent on imatinib mesylate?
A: Novartis is basing its claim for a patent on the salt of imatinib based on the fact there is a 30% increase in the bioavailability of the drug 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 to improve bioavailability is known in pharmaceutical art and is an often-used form of evergreening. It is common knowledge in the pharmaceutical field – and therefore not something that deserves to be rewarded with a patent - that salts result in different solubility and, therefore, in different bioavailability.
Q: How is it possible for India to reject a patent that is granted in other countries?
A: There is no such thing as an international or global patent. Patent applications are examined by patent offices in individual countries, and each office deliberates whether a particular drug should be patented or not on the basis of local patent regulations. Fortunately, India designed its patent law so that the number of patents granted would be kept to a strict minimum. This was an effort to reward true innovation, which is the universal rationale behind the patent system to begin with.
Q: How does Section 3(d) safeguard access to medicines?
A: When framing its new patent legislation in 2005, the Indian Parliament sought to ensure that not only the requirement under international trade rules were met, but also provisions to protect public health and access to medicines were taken into account. It therefore included legal safeguards and guidance on how the patentability requirements should be applied.
These legal safeguards, and in particular section 3(d) are key to securing continued access to affordable generic medicines from India.
Q: Does India have the right to have this particular patent law?
A: In 2001, all WTO countries signed the Doha Declaration, which states “that the [TRIPS] Agreement can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all.” The same declaration allows countries to take measures to protect public health. India’s patent law is based on this declaration. India chose to design a patent law that contains a key public health safeguard, namely the provision that only truly new or innovative drugs should be patented.
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, undermining the case 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 five percent of all newly-patented drugs in Canada as ‘breakthrough.’ And a breakdown of over one thousand 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.
Q: What attempts is Novartis making to overturn the patent office decision over Gleevec ?
A: Having lost a first legal battle to have Section 3(d) completely removed from India’s Patents Act in 2007, Novartis launched fresh legal proceedings in 2009 at Supreme Court of India that are this time seeking to weaken this critical public health safeguard so that it becomes meaningless.
In this case, Novartis is trying to argue against the interpretation of efficacy of Section 3(d) which led to the original rejection of its patent application for Gleevec. 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.
Q: What does ‘efficacy’ mean?
A: Section 3(d) requires demonstration of increased therapeutic efficacy for a medicine to deserve a patent. 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. But Novartis is still challenging the law.
Q: What would happen if Novartis won this case?
A: If Novartis won the case, patents would be granted in India as broadly as they are in wealthy countries. India would no longer be able to supply much of the developing world with quality affordable medicines.
The example of HIV/AIDS medicines is a good illustration of the problem. Even though older drugs to treat HIV/AIDS have become affordable thanks to generic competition, the availability of newer and improved drugs is crucial, as people become resistant to the drug combinations they take after a certain amount of time and need to be switched to newer “second-line” drug regimens. Data from MSF’s projects illustrate this growing need. But today, many newer drugs are largely still only available from originator companies holding patents, which keeps prices high - several thousand dollars for one patient’s annual treatment.
If Novartis wins, more and more treatments will remain priced out of reach for the duration of the patent term – twenty years or more – including those drugs that 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 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 drug imatinib mesylate - are not granted routinely by Indian patent offices.
Given the potential 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.
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