NATCO Pharmaceuticals is seeking permission from India's patent office to make cheaper generic copies of cancer drugs for export to poorer countries. The case is being closely watched by pharmaceutical giants around the world. Experts say a positive verdict could set a precedence allowing millions of people world-wide access to low-cost life-saving drugs.
Generic drugs can cost up to a fifth of patented versions
NATCO Pharmaceuticals, a company based in the southern Indian city of Hyderabad, wants to make generic copies of the cancer drugs developed by the giant pharma companies Pfizer and Roche. NATCO’s generic drugs would be the same as Pfizer’s “Sutent” and Roche’s “Tarceva” but they would be lower in cost.
NATCO is seeking a so-called "compulsory licence" to manufacture the generic cancer drugs from the Indian patent office.
If granted, the licence would allow the firm to sell drugs in less developed countries, such as Nepal.
“When India signed the WTO rules, it agreed to respect patents but there is a provision in the WTO rules that if a country that is less developed, e.g. Nepal, Bangladesh or Cambodia, buys any of these products it is exempted from buying the patents,” explained Rajeev Nannapaneni from NATCO Pharmaceuticals.
“As part of WTO negotiations, it was said that if products were being sold to such countries the firm could get a “compulsory licence”. We have applied for such a licence on this basis.”
In 2005, the World Trade Organisation started granting “compulsory licenses”, which allow generic drugs to be exported.
In October 2007, Canada became the first country to allow a company to manufacture a generic copy of a patented AIDS drug for export to Rwanda.
But the case is the first of its kind in India. And as Rajeev Nannapaneni explained the verdict is crucial as the country is one of the world’s biggest producers of generic drugs.
“If India is unable to supply products to the world then the overall supply of all the life-saving items will be curtailed. So the verdict will set a precedence for all future compulsory licences.”
Pharmaceutical companies have often argued that patents are crucial for further research and development.
Generic drugs much cheaper
However, health campaigners complain that patented drugs are usually so expensive that millions of poor people, especially in developing countries cannot afford them.
Shambhu Prasad Kadariya is from Cancer Society Nepal: “Medicines are really expensive for cancer patients in Nepal. Poor patients cannot buy them. We have to import the medicines.”
NATCO says it can make generic versions of cancer drugs at about a fifth of the present cost.
The ruling from the Indian patent office is due on Friday.