Jane McCredie: Generic battlefield

INDIA has long been known as the “pharmacy of the poor” thanks to a thriving generic drugs industry that provides low-cost pharmaceuticals to countries throughout the developing world.

Indian generics account for more than 80% of drugs used to treat HIV/AIDS and the country is also the most important source of generic drugs for cancer and heart disease, according to an article in The Lancet.

The country owes its $20 billion generics industry to a legal framework that did not allow patenting of pharmaceuticals at all until 2005 and still limits the ability of companies to patent their drugs.

But that regime is increasingly under attack from big pharmaceutical companies seeking to protect their turf through legal challenges.

Earlier this year, I wrote about a judgement by India’s patent authority forcing Bayer to grant a licence to a local generics manufacturer for its cancer drug, sorafenib (Nexavar).

Indian law allows the granting of this kind of compulsory licence when, among other factors, a drug is not made available at a reasonably affordable price.

In this case, the local company planned to supply the drug at 8800 rupees (A$152) for one month’s supply, compared with the Bayer price of 280 000 rupees (A$4839).

A government employee on the lowest grade would have to work for three and a half years to pay for a month’s worth of the drug at the Bayer price, the judgement from the Controller of Patents said.

Well, Bayer this month headed back to court to appeal that decision, apparently with the backing of the US government, which has consistently opposed the granting of compulsory licences according to researchers from the University of London.

Swiss pharma giant Novartis is also before the courts in India this month, as part of its long-running battle to overturn the 2006 rejection of a patent application for its cancer medication, imatinib (Glivec).

Novartis’ beef is with sections of Indian patent law that seek to rein in the industry practice of “evergreening”: making slight adjustments to older medications in an attempt to extend patent protection.

“For six years, Novartis has been trying to browbeat India into changing a part of its patent law that protects people’s access to affordable medicines”, says Leena Menghaney from Médecins Sans Frontières (MSF), which has been campaigning against both the Novartis and Bayer legal actions.

MSF says one of the benefits of the competitive generics industry in India has been a dramatic fall in prices for HIV/AIDS drugs, bringing treatment within reach for many people in the developing world. A year’s supply of HIV/AIDS medications cost around $10 000 in 2000, but is now only about $150, the organisation says.

That generics industry is now under siege, not just from individual pharmaceutical companies, but also from a proposed free trade agreement between India and the European Union, with Europe seeking increased patent protection for drugs as part of the deal.

Interested parties are, of course, entitled to fight to protect their intellectual property, but the Indian generics industry is worth protecting too — at least until big pharma makes a genuine commitment to supply its products to the developing world at an affordable price.

Jane McCredie is a Sydney-based science and medicine writer.

Posted 17 September 2012