The Australian Medical Association Limited and state AMA entities comply with the Privacy Act 1988. Please refer to the AMA Privacy Policy to understand our commitment to you and information on how we store and protect your data.

×

Search

×

India’s generic drug laws under attack again

Big Pharma – like Big Tobacco – never give up. The campaigns over years by Novartis of Switzerland and Bayer of Germany against India’s health-friendly medicine patent laws are now in separate Indian courts where, according to Médecins Sans Frontières, success by the companies will devastate the supply of cheaper but essential medicines throughout the developing world.

16 Sep 2012

Big Pharma – like Big Tobacco – never give up.

The campaigns over years by Novartis of Switzerland and Bayer of Germany against India’s health-friendly medicine patent laws are now in separate Indian courts where, according to Médecins Sans Frontières, success by the companies will devastate the supply of cheaper but essential medicines throughout the developing world.

Protected by these laws, India is the world’s leading producer of the generic (and much more affordable) drugs used by MSF and similar NGOs in public health campaigns in scores of developing countries.

The Novartis action, in the Indian Supreme Court, challenges that part of Indian patent law (Sec.3d) that provides that a new form of medicine can only be patented if it shows significantly improved therapeutic efficacy over existing compounds. This helps prevent drug manufacturers from following the practice known as “evergreening”; that is, extending patent monopolies via additional patents on essentially the same medicines.

Novartis unsuccessfully challenged the law as a whole as being unconstitutional in the Indian High Court in 2006. It is now challenging the interpretation of Sec.3d in particular, the effect being (if the challenge is successful) that the law as a whole would lack substance.

Bayer is mounting an appeal in the Indian Intellectual Property Appellate Board to a decision in March by the Indian Patent Controller in favour of a licence to allow production of a generic version of its cancer drug sorafenib tosylate.

The effect of the decision has been that the cost of the generic is now about $170 a month, compared to the $5,500 a month charged formerly for the Bayer version. The generic is produced by the Indian generic manufacturer Natco, which pays Bayer a six percent royalty on sales.

MSF says that Bayer’s “predictable” appeal is part of its strategy to use litigation to protect price, rather than deal with the reality that its price is too high. It is not the use of a licence that should be challenged, MSF says, “but the continued pursuit of excessively high profits over public health needs”.

DN


Published: 16 Sep 2012