US group opposes Gilead’s patenting of hepatitis C drug in India

US drug-maker Gilead Sciences' patent application on hepatitis C drug sofosbuvir in India is facing opposition from a US legal group I-MAK (Initiative for Medicines, Access & Knowledge) on the ground that it is old known compound and has nothing new to offer.

What Gilead is trying to patent is an ''old science, known compound,'' Tahir Amin, lawyer and director of US-based I-MAK.org, said in a pre-grant petition filed with the Indian Patent Office at Kolkata.

''India's patent law doesn't give monopolies for old science or for compounds that are already in the public domain. We believe this patent on sofosbuvir does not deserve to be granted in India and have the legal grounds to prove it,'' he said in a statement by international humanitarian organisation MSF (Médecins Sans Frontières – Doctors without Borders), who support the patent opposition.

While Indian patent laws do not offer protection to immaterial changes to drugs formulas, I-MARK opted for a pre-grant opposition in order to block chances of Gilead obtaining a patent for sofosbuvir.

Section 3 (d) of the Indian Patents Act disallows companies from getting a fresh patent on cosmetic changes made on an existing drug or substance.

The patent opposition comes days ahead of an expected announcement by Gilead in India on the patent filing.

Gilead obtained Sofosbuvir, which is one of the several oral drugs used in the treatment of hepatitis C, with its acquisition of Pharmasset for over $11 billion in late 2011.

The drug has already been recommended for approvals in the European and the US markets, and is expected to be launched next year.

Sofosbuvir is reported to offer faster cure for hepatitis C than other treatments currently available, and in some forms of hepatitis C, it also eliminates the need to use the injectable drug pegylated interferon, which can be difficult to administer and causes many serious side-effects, says MSF.

''Gilead is expected to charge around $80,000 for one treatment course of sofosbuvir in the US. Even if offered at a fraction of this price in developing countries, this drug will be priced out of reach. The patent opposition - a form of citizen review allowed in many countries - offers technical grounds to show a drug does not merit patenting under India's Patents Act. This opposition was filed to ensure that affordable generic versions of sofosbuvir can be produced to help the millions of people infected with chronic hepatitis C in developing countries access the drug,'' MSF said.

The World Health Organization estimates there are 184 million people infected with hepatitis C worldwide, with the disease causing half a million deaths each year. A vast majority of these people live in developing countries where - with the exception of Brazil and Egypt - there is no provision for universal access to hepatitis C treatment in public healthcare programmes.

About 1 million deaths each year are attributed to viral hepatitis infections. Combined, hepatitis B virus and hepatitis C account for 78 per cent of the liver cancer in the world. More Americans died from hepatitis in the last decade than from HIV, and medical costs for hepatitis C are expected to double over the next 20 years to $85 billion.

Today's drug market for treatment is estimated at $20 billion, and according to the pharmaceutical industry consulting firm, Decision Resources, the drug market is expected grow to more than $23 billion by 2018. Current treatments, which generally include injections of the drug interferon (and can take up to a year), have a cure rate of 70 per cent to 75 per cent.