The Indian Patent Controller has today 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. 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.
MSF 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.
Below are responses to the news by Doctors Without Borders/ Médecins Sans Frontières (MSF), the Initiative for Medicines, Access &Knowledge (I-MAK.org), the Delhi Network of Positive People (DNP+), and Dr. Andrew Hill, Researcher at Liverpool University: