BACKGROUND: The Supreme Court case is the final act in a legal battle over the patentability of the salt form of the anti-cancer drug imatinib and section 3(d) of the Indian patent law that stretches back over five years. In 2006, the Indian patents office ruled that Novartis did not deserve a patent for imatinib mesylate, a salt form of a life-saving cancer drug, on the grounds that the application claimed a new form of a drug too old to be patentable in India (see notes below). The company then embarked on a series of lawsuits against the Indian government including the one that is currently pending before the Supreme Court. In this case Novartis is challenging a part of India’s patent law – Section 3(d) – which read with other provisions of the patent law and the Madras High Court decision says that a new form of a known medicine can only be patented if it is not obvious and shows significantly improved therapeutic efficacy over the known substance.
What Novartis says: “price doesn’t affect access to medicines”.
In its statement, Novartis writes “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 has found, during its field experience in working in many developing countries, that granting a patent has had 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. This is well documented. When AIDS treatment first became available in the late 1990s, the price of first line patented AIDS medicines was - even after discounts – US$10,439 per patient per year. Millions died in developing countries, particularly in Africa, as prices were too high. Generic competition brought prices down making treatment possible. In MSF’s experience, patents on medicines are a key barrier to making medicines affordable, as it prevents access to those who cannot afford it.
What Novartis says: “this case will in no way impact access to medicines to poor countries”.
This is not true. If Novartis succeeds in weakening the interpretation of section 3(d) for the purpose of obtaining a patent on imatinib mesylate, the Indian Patent Office would have to apply the same standards of intellectual property protection as wealthier countries like the US, granting far more patents than required under international trade rules or envisioned by India’s lawmakers.
It is not only about this particular medicine. The interpretation of the clause has a direct bearing on the examination of patent applications claiming salt forms, pediatric formulations and other improved formulations of AIDS drugs, the generic versions of which are currently used by MSF in its medical projects. This case would set a precedent in this regard.
This could lead to generic competition on many essential drugs ending entirely and prices for these in both India and developing countries increasing. This would have a devastating impact on not only people MSF treats, but also on people the world over who rely on affordable medicines manufactured in India. MSF buys 80% of the ARVs it uses to treat 170,000 people for HIV across the developing world from Indian generic manufacturers, and donors rely on Indian sources in similar proportions.
It is crucial to preserve the public health safeguards of Indian patent law – particularly Section 3(d). The future of generic production is largely dependant upon the outcome this case.
Imatinib mesylate is a crucial anti-cancer drug sold by Novartis in India for Rs.120,000 (US$ 2,400) per patient per month. Indian generic companies sell generic versions for Rs. 8 – 10,000 ($160 – 200) per patient per month.
What Novartis says: “Section 3(d) – as it relates to evergreening – is not applicable at all to Glivec”.
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 and well-known form of evergreening by pharmaceutical companies to extend the patent life – and monopoly – of their drugs. And companies do this routinely to prevent generic competition. An example of this is the AIDS 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. Where the patent was granted this has blocked access to affordable generic forms of abacavir in many developing countries.
What Novartis says: “Glivec has been granted a patent in nearly 40 countries and India should also follow suit”.
This is a mistaken interpretation of international intellectual property rules. Although the TRIPS Agreement obliges all members of the World Trade Organization to grant patents on medicines, nothing obliges developing countries like India to replicate patent systems of wealthy countries. An important flexibility in this respect is the right of WTO Member States like India to define the patentability criteria 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 becoming a key reason for 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: “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”.
While this is correct – countries have the legal flexibility to issue compulsory licences to generic producers on patented drugs where it hinders access to essential medicines – measures like tiered pricing in our experience are not the most effective way to make medicines affordable.
Novartis also seems to imply that countries can only act once patents are granted. However, a lesser known key TRIPS flexibility is the right of a country to take steps before a patent is granted to 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.