Novartis versus the world
By Simon J Black
Published: 04/12/2007
Big Pharma takes on the world’s poor in a court case that could have drastic consequences for the fight against HIV-AIDSNext month in an Indian court a judge will hand down one of the must crucial verdicts of our young 21st century. Novartis, a multibillion-dollar Swiss pharmaceutical corporation, is challenging India’s patent law; a law that allows India’s generic drugs industry to produce cheap life-saving medicines for millions of the world’s poor. If Novartis’ challenge is successful, India’s role as the ‘pharmacy of the developing world’ will be put in serious jeopardy. And for the millions who rely on the country’s generic drugs, a Novartis victory could well be their death sentence.
At the core of this case is the question of patient rights and patent rights: the right of patient access to life-saving medicines and the right of corporations to make a profit. India’s Patents Act came into effect Jan 1st, 2005. An amendment to the act, section 3(d), stipulates that only genuinely new pharmaceutical innovations will be protected by patents; thus, new forms of already existing medicines will not receive patent protection from the Indian government. This law has allowed India’s generic drugs industry to continue to produce copies of expensive medicines and sell them at-cost, despite joining the World Trade Organization and being subject to a regime of intellectual property rights that heavily favours big pharmaceutical corporations at the expense of the world’s poor. With a growing economy and improved technological capacity, India is one of the few developing countries capable of manufacturing generic drugs; hence its importance to those who need access to affordable medicines in the developing world.
In 2003, Novartis launched Gleevec, a leukemia drug that costs roughly $2,600 per patient per month in the U.S. Soon after, generic versions of Gleevec became available in India, priced around $200 per patient per month. Novartis acted quickly and applied for patent protection for Gleevec at the Indian patent office. Under section 3(d), Novartis’ application was rejected. According to the patent office, Gleevec was not a genuinely new drug, merely a variation on an existing Novartis product. The corporation wasn’t happy and appealed the patent office’s ruling in the Indian High Court. But Novartis didn’t just challenge the Gleevec decision; it went after Section 3(d) of the Patents Act looking to score a big victory for Big Pharma.
Although Gleevec is a leukemia treatment, the extension of Novartis’ challenge to Section 3(d) jeopardizes the production of many generic drugs, including antiretrovirals that prolong the lives of people who are infected with HIV-AIDS. This is not the first time Novartis has challenged the generic drugs industry. In 2001, the corporation joined with 39 of its fellow pharma giants to challenge a similar patent law in South Africa. Sparking global protests, the group withdrew the legal challenge and South Africa continues to produce generics today.
Last week, after a long break the Indian High Court reconvened the Novartis case. Stephen Lewis has raised his voice in protest; Archbishop Desmond Tutu has urged Novartis to drop the case; hundreds of thousands have signed a global petition; Oxfam has organized an international campaign; but Novartis presses on. In a reply to its critics Novartis CEO, Daniel Vasella, has said: “We don’t want popularity awards, we want to serve our patients and remain competitive.” A verdict in Novartis’ favour will be a significant blow to the fight against the global HIV-AIDS pandemic. Sensing the urgency, Archbishop Desmond Tutu has said: “People, not profits, must be at the centre of patent law for medicines.” With a month to go before the court gives its verdict, shareholders and the broader public must act now to demand Novartis drop the case and act in the interest of the world’s poor, not its own bottom line.