According to the World Health Organisation (WHO), as many as 180 million people worldwide have been infected by the hepatitis C virus.
The ‘viral time bomb’ is ticking.
According to the World Health Organisation (WHO), as many as 180 million people worldwide have been infected by the hepatitis C virus, with 3-4 million being added to the list every year.
An estimated 1-4% of the Indian population is estimated to carry the virus.
In what will add to the woes of patients, the Indian Patent Office recently rejected the post-grant opposition to the granting of patent to F Hoffmann La Roche AG for Pegasys. This means that Roche will have a monopoly in the market, as no low-cost generic versions will be allowed entry.
Pegasys, generic name pegylated interferon alfa-2a, is one of the few effective drugs in the country to treat hepatitis and costs a huge Rs 8,73,600 for a 48-week course. Besides, it has to be taken with another drug ribavirin, which costs Rs 1,10,208 for a 48-week course. The other hepatitis C drug, Peg Intron (generic name pegylated interferon alfa-2b), by US major Schering Plough is also patented in India, and costs about Rs 8,000-10,000 for a weekly injection.
Even though domestic pharma companies have become aggressive on the research & development front, hepatitis C doesn’t seem to figure in their plans. Hepatitis C is the inflammation of the liver and can lead to liver cancer and liver cirrhosis if left untreated.
Eldred Tellis, director of Mumbai based Sankalp Rehabilitation Trust, the NGO that filed the post-grant opposition against the patent granted to Pegasys, asked, “How many Indians can afford to pay Rs 4,36,000 for a 24-week course?”
Leena Menghaney, project manager (India) at Medecins Sans Frontieres, an international medicines and humanitarian aid organisation, said that hepatitis C is a matter of growing concern in the country, especially in north eastern states such as Manipur.
Other drugs for the disease, interferon and ribavirin, have side effects such as skin rashes, nausea, depression, etc. Philip Abraham, consultant gastroenterologist at PD Hinduja Hospital, said, “Conventional interferon has to be given 3-5 times a week and is about 20-30% less effective than Pegasys. If the cost is taken into account, less than 8-10% of all hepatitis C patients in India can afford the treatment.”
Ajay Bhalla, consultant (gastroenterology) at Fortis Hospital in Noida, added that though research is being done globally on the virus, it is in very early stages. In India, major drugmakers like Sun Pharma, Dr Reddy’s Labs, Glenmark Pharma, etc, are focusing largely on money spinners like cancer, diabetes, etc. Wockhardt and Shanta Biotech were working on generic versions of pegylated interferon, but due to the patents, may not be able to launch low cost versions in the market anytime soon, says experts.
Gopakumar Nair, founder of patent firm Gopakumar Nair Associates, said, “The Indian socioeconomic scenario has to be kept in mind when granting patents. There is a very casual and random approach in the patent office when it comes to examining important sections like 3 (d) of the Indian Patent Act.”
According to Anuradha Salhotra, partner at intellectual property law firm Lall, Lahiri & Salhotra, the patent office’s decision is not the final word as patient rights groups can approach higher authorities like Intellectual Property Appellate Board.
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