Gilead runs into India patent trouble
pharmafile | November 26, 2013 | News story | Sales and Marketing | Gilead, MSF, hepc, sofosbuvir, sovaldi
Gilead Sciences has run into heavy traffic in India as campaigners attempt to block the company’s patent there on new hepatitis C treatment sofosbuvir.
The US-based not-for-profit group Initiative for Medicines, Access & Knowledge (I-MAK) has filed a ‘patent opposition’ at India’s Patent Office and is supported by Médecins Sans Frontières (MSF).
Both groups are aghast at the treatment’s ‘anticipated exorbitant price’.
“Gilead is expected to charge around $80,000 for one treatment course of sofosbuvir in the US,” says a statement from MSF. “Even if offered at a fraction of this price in developing countries, this drug will be priced out of reach.”
‘Old science, existing compound,’ said Tahir Amin, lawyer and director of I-MAK. “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.”
The patent spat comes as European regulators are set to approve the drug, which would be marketed as Sovaldi, after the CHMP recommended it last week.
A key FDA panel has already given its own verdict on the drug, the first without interferon for hepatitis C, by recommending it for US use – and the FDA is due to make a final decision next month.
The patent opposition in India is a mechanism by which applicants can show the technical reasons why a drug does not merit patenting under the country’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 insists.
The campaigners suggest that they are fighting a wider battle for access to oral hepatitis C drugs which are expected to come to market in the coming year.
In some cases they will eliminate the need to use the injectable hepatitis C drug pegylated interferon – which has serious side effects and can be difficult to administer.
MSF says it has started providing hepatitis C treatment for a small number of people co-infected with HIV in its clinic in Mumbai, but the cost of $5,000 per patient – and the complexity of available treatments – means that patient numbers “remain extremely low despite considerable needs”.
“In our projects, we need access to medicines like sofosbuvir that are easier for patients to take so we can expand treatment to more people,” said Simon Janes, medical co-ordinator with MSF in India.
“If the drug is unaffordable, the majority of the most vulnerable groups will remain untreated,” he went on. “Treatment needs to be simple and affordable – preferably less than $500 to start with. An unaffordable price for this drug will have a chilling effect on funders and governments who need to start financing and providing treatment.”
Dr Andrew Hill, a pharmacologist at Liverpool University, has published a study showing that sofosbuvir could be produced for as little as $134 for a 12-week treatment course.
“The profit projections for the oral hepatitis C drugs are staggering, and stand in no relation to what it costs to make these drugs,” he said.
The World Health Organisation estimates there are 184 million people infected with hepatitis C worldwide, with the disease causing half a million deaths each year, the majority of them in developing countries.
Adam Hill
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