India denies Gilead patent for hepatitis C drug, sofosbuvir

Companies that have not signed any licence agreement with US pharma giant are now free to produce generic versions of the drug

By Kundan Pandey
Published: Friday 16 January 2015

The Indian Patent Controller, on Thursday, rejected one of Gilead’s key patent applications for the drug Sofosbuvir, used to treat hepatitis C (HCV). People campaigning for affordable medicine have welcomed the decision.

The oral drug first received regulatory approval in the US in November 2013, and has been priced by Gilead at US$84,000 for a treatment course ($1,000 per pill) in the US. It has caused a worldwide debate on the pricing of patented medicines. Interestingly, a study from Liverpool University showed that sofosbuvir could be produced for as little as $101 for a three-month treatment course. Sofosbuvir is a nucleotide analog inhibitor that blocks a specific protein needed by the hepatitis C virus to replicate itself.

Gilead has signed voluntary licence agreements with multiple generic producers in India—Cadila Healthcare Ltd, Cipla Ltd, Hetero Labs Ltd, Mylan Laboratories Ltd., Ranbaxy Laboratories Ltd, Sequent Scientific Ltd and Strides Arcolab Ltd. But these agreements impose many restrictions, including which countries can access the drugs produced under these licences, as well as invasive restriction on medical providers and patients with respect to distribution and use of the drug.

With the patent being denied, other companies that have not signed the licence are now free to produce the drug. Entry by additional generic manufacturers should increase the open competition needed to bring prices down dramatically, especially in those countries that have been excluded from the voluntary licence agreement, and thereby increase access to the medicine.
Health activists said the move will improve access to the drug. Executive director of Medicins Sans Frontieres (MSF) Access Campaign, Manica Balasegaram, says, “India’s status as the ‘pharmacy of the developing world’ is once again in the spotlight and this is a good opportunity for generic producers in India to swiftly ramp up production to levels needed to treat the 185 million people infected with hepatitis C worldwide.”
“The move to reject Gilead’s patent application really opens up the playing field, so we hope to now see many other generic companies starting to produce more affordable versions of this drug.  The bottom line here is that India’s patent law doesn’t give monopolies for old science, for compounds that are already in the public domain. Gilead’s strategy of charging as much as US$84,000 per treatment for a drug that is predicted to be simple and cheap to produce, and is now un-patentable in India, has been exposed for what it is – seeking to squeeze as much profit out of the sick as possible,” said MSF. 

Tahir Amin, lawyer and director of the Initiative for Medicines, Access & Knowledge ( which opposed the patent application, said, “This is a happy day for the millions of people who urgently need hepatitis C treatment across the globe. People with hepatitis C everywhere should be able to have access to this treatment, but millions of our friends in middle-income countries have been left out in the cold by Gilead. This decision provides hope that people in countries that have been excluded from Gilead’s licensing deals will be able to access low-cost generic versions of sofosbuvir.”

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