The Indian Patent Controller has rejected one of Gilead’s key patent applications which covered the drug sofosbuvir, used to treat hepatitis C (HCV).   The oral drug, which first received regulatory approval in the US in November 2013, and has been priced by Gilead at US$ 84,000 for a treatment course, or $1,000 per pill in the US, has caused a worldwide debate on the pricing of patented medicines.

Meanwhile, a study from Liverpool University showed that sofosbuvir could be produced for as little as $101 for a three-month treatment course.
 
Challenges to some of the most important patent applications on sofosbuvir (a ‘patent opposition’ - a form of citizen review allowed in many countries) were filed in India by the Initiative for Medicines, Access & Knowledge (I-MAK) and the Delhi Network of Positive People (DNP+) in November 2013 and March 2014.

Gilead has signed voluntary licence agreements with multiple generic producers in India, but these agreements impose many restrictions, including which countries can access the drugs produced under these licences, as well as invasive restrictions 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. 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. Countries where the drug is unaffordable, and which were excluded from the licences, should make every effort to import more affordable generic versions from other producers who did not sign a licence in India.

Meanwhile, the Médecins Sans Frontières (MSF) said that it is in the process of expanding treatment for people with hepatitis C in nine countries, and has been negotiating access to this medicine, which is expected to become the backbone of any HCV regimen in the coming years.
 
Commenting on the rejection of patent to Gilead, Dr Manica Balasegaram, executive director, MSF Access Campaign, said, “Sofosbuvir has proved to be a billion-dollar blockbuster drug and we hope today’s decision opens the floodgates for more open competition that could rapidly lower the price. This drug makes hepatitis C treatment more effective and easier for patients and doctors, so broad access to affordable versions will allow treatment to be scaled up dramatically.  Gilead’s drug access programme for developing countries is already showing its limitations, with the company planning to impose conditions for the supply and distribution of the drug to patients and treatment providers in developing countries, in order to protect the company’s ability to charge unaffordable prices in wealthy countries. Getting sofosbuvir out of the stronghold of Gilead’s monopoly will be crucial to expanding treatment for people with hepatitis C globally.

“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,” commented
Tahir Amin, lawyer and Director of the Initiative for Medicines, Access &Knowledge (I-MAK.org)

“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,” said Vikas Ahuja, Delhi Network of Positive People (DNP+)

“We know from various manufacturers in India that they could produce this drug in the future for as little as $101 for the full three month treatment course.  That’s roughly $1 per pill, which is a big improvement over the $1,000 per pill Gilead is charging in some countries. At the current prices, sofosbuvir is unaffordable for widespread use in most countries of the world,” said Dr. Andrew Hill, Senior Research Fellow, Department of Pharmacology and Therapeutics, Liverpool University.