What Novartis says: “price doesn’t affect access to medicines”.
In a statement issued in 2010, Novartis writes that “acknowledging innovation by granting a patent is unrelated to the access to medicines issue. Improving access to medicines is a matter of making medicines available.”
This is not the entire truth.
MSF’s field experience in many developing countries shows that when a patent is granted it has a direct bearing on access to affordable essential medicines. Granting a patent on a medicine provides the patent holder with a monopoly on that medicine, which in turn allows the company to charge a high price in the absence of any generic competition. In fact, improving access to medicines is a matter of not simply making the medicine available but also making it affordable for patients and governments to buy. When AIDS treatment first became available in the late 1990s, the price of first line patented AIDS medicines was - even after discounts – US$10,439 per patient per year. Millions died in developing countries, particularly in Africa, as prices were too high. Generic competition brought prices down making treatment possible. Patents on medicines are a key barrier to making medicines affordable, as it prevents access to those who cannot afford it.
What Novartis says: “this case will in no way impact access to medicines to poor countries”.
This is not true.
If Novartis succeeds in weakening the interpretation of Section 3(d) for the purpose of obtaining a patent on imatinib mesylate, the Indian Patent Office would have to apply the same standards of intellectual property protection as wealthier countries like the US, granting far more patents than required under international trade rules or envisioned by India’s lawmakers.
And it is not only about this particular medicine. The interpretation of the clause has a direct bearing on the examination of patent applications claiming salt forms, paediatric formulations and other formulations of AIDS drugs like fixed-dose combinations, such as the ones currently used by MSF in its medical projects. This case would allow these drugs to be patented.
And it’s not just about India. If generic competition on many essential drugs ends, then prices for these medicines will increase, both in India and across the developing world. This would have a devastating impact on not only people MSF treats, but also on people the world over who rely on affordable medicines manufactured in India. MSF buys 80% of the ARVs it uses to treat 170,000 people for HIV across the developing world from Indian generic manufacturers, and donors rely on Indian sources in the same proportions.
It is crucial to preserve the public health safeguards of Indian patent law – particularly Section 3(d). The future of generic production is largely dependant upon the outcome this case.
Imatinib mesylate is a crucial anti-cancer drug sold by Novartis in India for Rs.120,000 (US$ 2,400) per patient per month. Indian generic companies sell generic versions for Rs. 8,000 – 10,000 ($160 – 200) per patient per month.
What Novartis says: “Glivec has been granted a patent in nearly 40 countries and India should also follow suit”.
This is not what international intellectual property rules say.
Although the TRIPS Agreement obliges all members of the World Trade Organization, including India, to grant patents on medicines, nothing obliges developing countries to replicate patent systems of wealthy countries. An important flexibility in this respect is the right of WTO Member States to define the what deserves a patent, and what doesn’t in accordance with their particular national priorities. This is precisely what India did when it amended its Patents Act in 2005.
At the time of implementing TRIPS, India felt that many countries were granting a large number of patents on new uses and new forms of known medicines, which was creating longer patent barriers and high prices in developing countries. So, along with patent protection for new innovative medicines, Indian lawmakers introduced a specific provision, section 3(d), in its patent law that excludes from patentability new uses and new forms of known medicines. The system India has is not perfect, but it does prevent drug companies from getting unjustified 20 year monopolies every time they come up with a new use or a new form of a known medicine.
What Novartis says: “Section 3(d) – as it relates to evergreening – is not applicable at all to Glivec”.
Section 3(d) is about ensuring that innovation is rewarded with a patent only when it deserves to be.
Novartis is seeking a patent in India on the salt form of imatinib (Glivec). Claiming a patent on a salt form of an existing drug is a common practice of pharmaceutical companies to extend the patent life – and therefore the monopoly and the high prices – of their drugs. This is known as ‘evergreening’, and companies do this routinely to prevent generic competition.
An example of this is the HIV drug abacavir. Although the abacavir molecule was first developed and patented in the 1980s, pharmaceutical company GSK applied for a patent in 1997 on abacavir sulphate (salt form) in developing countries, with the intention of obtaining a patent monopoly until 2017. In the countries where the patent was granted, this has blocked access to affordable generic forms of abacavir.
What Novartis says: “medicines can be made available through access safeguards in international agreements and, in the case of essential and life-saving medicines, special pricing arrangements in developing countries”.
This is half-true.
Countries do indeed have the legal flexibility to issue compulsory licences to overcome drug patents where they hinder access to essential medicines – these are the ‘access safeguards’ Novartis is referring to. (do we want to say they’re under-used because of international pressure, even though they are totally lawful??)
But ‘special pricing arrangement’ measures – also known as tiered pricing, when companies charge high prices in wealthy countries, medium prices in middle-income countries and the lower prices in the poorest countries - have been proven to not be the most effective way to make medicines affordable. It is only with the arrival of generic competition that company prices are driven to the lowest level.
Novartis also seems to be implying here that countries can only act once patents have been granted. But countries can also take steps before it’s too late, and ensure that patent applications on routine and obvious improvements of medicines are not granted so that they do not disrupt supply of affordable generic medicines to patients. India has chosen to adopt this safeguard with the introduction of Section 3(d) in its patent law, while allowing patents to be granted on new medicines from 2005.
Notes for the editor:
The basic molecule imatinib was first patented in the US (US 5521184) in 1993. India signed the WTO TRIPS agreement in 1995 and opened up filing of product patent applications in India. In 1998, Novartis filed an application 1602/MAS/1998 on the mesylate salt of Imatinib. This case relates to the 1998 application.
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