US drug-maker Gilead Sciences’ patent application on hepatitis C drug sofosbuvir has been opposed at the Indian Patent Office by legal group I-MAK — Initiative for Medicines, Access & Knowledge.

The pre-grant opposition, where a patent application is opposed before a decision is taken, was filed at the Kolkata patent office. Gilead’s patent application has been opposed on the grounds that it is an “old science, known compound,” said Tahir Amin, lawyer and director of US-based

“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.

Amin’s reference is to the Indian Patents Act’s Section 3 (d) that disallows companies from getting a fresh bout of patent protection on an incremental development made on an existing drug or substance.

The patent opposition comes days before Gilead is expected to make an announcement in India, though details remained confidential. A query to Gilead on the pre-grant opposition had not received a response at the time the story was filed.

Sofosbuvir, the first of several oral hepatitis C drugs, came into Gilead’s fold after it decided to buy Pharmasset for over $11 billion in late 2011.

Approvals round the corner

The drug has been recommended for approvals in the European and the US markets, and is expected to be launched next year. In fact, Gilead expects a decision on marketing sofosbuvir in the US, early next month.

The drug cures hepatitis C in less time than the currently available treatment, and for some forms of hepatitis C, it 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, the note added.