The drug in question is called Sovaldi (genetic name sofosbuvir.) The drug is used to treat hepatitis C, and has, in some 90 percent of patients seemingly cured them of the condition. Powerful though the medication is, it comes at a high cost — in the U.S. it sells for $1,000 per pill. To complete a course, a daily dose over 12 weeks is required, at a cost of $84,000. The use of the drug is therefore potentially lucrative, given that some 150 million people globally are thought to have the liver disease.
Sofosbuvir is a nucleotide used in combination with other drugs for the treatment of hepatitis C virus infection. The drug stops the virus from replicating.
The parent was originally rejected by Indian authorities in January 2015. This was because the drug put forward was deemed to only be slightly different from the previous formulation, with the older version about to lose its patent.
However, on appeal, Gilead, the creators of the new drug, have won their case. The drug has been declared sufficiently novel under the Indian patent act. This was welcomed by some pharmaceutical organizations.
Many campaign groups had been calling for the drug to become a generic, on the basis that this would lower the cost of the medication, thereby increasing access to patients.
Speaking with Pharmaceutical Processing, Leena Menghaney, who is the head of Médecins Sans Frontières (MSF) in South Asia, stated: “This decision is a major blow to the access to drug movement. There has been excessive pressure building on the Indian government to dilute the independent functioning of the patent office to ensure that patent claims are granted far more easily to US firms.”
MSF cited proceedings in the U.S. where Gilead have been found to have infringed two patents by Merck in relation to the drug. This, according to MSF, infers the drug is not novel. This complicated case was recently featured by Digital Journal.
To promote the cause further, MSF has launched an “access campaign” using social media, including the Twitter account @MSF_access. To date the activity has received almost 1,000 followers.
MSF hopes that several Indian drugs companies will still enter the market with their own generic products. These products could, however, be subject to a judicial review based on how similar or otherwise they are to Sofosbuvir. Gilead has indicated it will work with other companies in India through a licencing deal, in order to ensure sufficient supply.
