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What future for India’s Patent Act? Novartis vs. Union of India

Update on Novartis vs. Union of India, Cancer Patients Aid Association & others in relation to the interpretation of Section 3(d) of the Indian Patent Act

Swiss multinational pharmaceutical company Novartis took the Indian government to court six years ago, in an effort to overturn Section 3(d) of the country’s Patents Act, 1970 that was designed to prevent the patenting of new uses and new forms of known medicines by enshrining the strict patentability criteria to be applied by India’s patent offices. Now Novartis is at it again and is targeting Section 3(d) once more through continuing litigation against the Government of India.

The latest legal challenge in the Supreme Court brought by Novartis against the Indian government has the potential to severely affect access to affordable essential medicines for millions of people across the developing world.

The final arguments are set to start on 28 February 2012 - in a case that will determine if the key health safeguard enshrined in India’s patent law - Section 3(d) - can continue to ensure that patents are only granted on medicines that are truly new and inventive.

If Novartis succeeds in changing the interpretation of Section 3(d) for the purpose of obtaining a patent on imatinib mesylate, a cancer drug, India may 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. 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 people the world over who rely on affordable medicines manufactured in India.

Long-standing battle with critical implications for generic production and supply

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.  In 2006, the Indian patent office rejected Novartis’ patent application for the anti-cancer drug imatinib mesylate - a beta crystalline salt form of imatinib. The application was rejected on the grounds that it lacked novelty, was obvious, and was un-patentable under Section 3(d) of India’s Patents Act, 1970.

After Novartis mounted a legal challenge to have Section 3(d) declared unconstitutional in the Madras High Court in India, MSF launched an international campaign calling on the company to DROP THE CASE, attracting close to half a million signatures. The legal challenge by Novartis is reminiscent of its case against the South African government in 1999 along with 38 other pharmaceutical companies in their attempt to challenge South Africa’s pro-health amendments to its patent law at the time.

In 2007, the Madras High Court rejected Novartis’ plea and in 2009 the Indian Patents Appellate Board rejected its appeal against the rejection of its patent application on imatinib mesylate.

But the company is not backing down. After failing to have Section 3(d) struck down, they are now again seeking to limits its effect. In 2009, Novartis filed a special leave petition in the Supreme Court against the Indian government in relation to the patentability criteria to be applied to imatinib mesylate.

It is this case that is now before the Indian Supreme Court.  Its outcome has wide ramifications for generic production and access to medicines across the developing world.  MSF purchases over 80% of the medicines it uses across the developing world to treat HIV and AIDS from India, and international donors rely on affordable Indian generic medicines in similar proportions for their aid programmes.

But if Novartis is successful and the requirements for granting a patent are lowered in India, many more medicines – even those that show no increased therapeutic efficacy – will be patentable in India, and this vital source of affordable medicines will be threatened.

If the substance is taken out of Section 3(d), abusive ‘evergreening’ practices - where pharmaceutical companies maintain artificially high prices on medicines for longer by ever-extending patent protection thanks to minor modifications to existing drugs – will be much easier in the future.

If, by contrast, the high standards for patentability are upheld, generic production will continue to drive the price of life-saving medicines down.

Multinational pharmaceutical companies like Novartis will find it difficult to argue that routine and well known improvements - such as new forms of existing medicines that result in improved stability, enhanced bioavailability, increased solubility, improved flow properties and lower hygroscopicity - meet the efficacy requirements of Section 3(d).

Last updated: 13 February 2012