India grants GILEAD a patent for sofosbuvir
Patent for sofosbuvir, hepatitis C $1000-per-pill treatment
The patent for sofosbuvir granted to Gilead this week raises many concerns. It gives Gilead an unlimited control over their licensed manufacturers. Rumors spread saying that the medication purchase will be restricted to Indian residents and that the amount of the medication one can buy will be limited. Apparently, only one bottle will be sold at once, and the next one could be obtained only four weeks later, and only if the empty bottle is returned. The bar-code system could also be implemented to improve the control over the medication purchase and use.
For the moment these are only rumors. Even if these measures are actually taken, the practical implementation will take time and in some rural areas of India will be simply impossible.
Patent for sofosbuvir: the end of medical tourism in India?
Sofosbuvir-based Indian generics (Ledifos, MyHep and others) are already sold only with hepatologist’s prescription. Their price – 20,000 rupees per bottle – seems extremely attractive to Americans and Europeans, but is sky-high for an average Indian. It is hard to image the bar-code scanning system in some areas that don’t even have electricity.
If these restrictive measures are taken, not only the new hepatitis C treatment will be out of most Indian’s reach, but it will also cut down drastically medical tourism in India.
Sofosbuvir patents have been rejected already in China, Egypt and Ukraine. It is probably not a simple coincidence that Gilead granted two licenses to the manufacturers in Egypt.
The patent oppositions have been filed in several other countries, including Argentina, Brazil, Russia and Thailand.
What’s the fuss about? Hepatitis C Facts
The liver-destroying virus of hepatitis C affects about 180 million people worldwide. It is primarily transmitted through blood-to-blood contact, even though sexual transmission is possible in high-risk groups. In 80% of the cases, the undetected and untreated hepatitis C infection becomes chronic and can thus lead to liver stiffness, liver cirrhosis, liver failure and liver cancer.
Hepatitis C is considered to be one of the most common causes of death from infectious disease, according to the study of Center for Disease Control and Prevention in the US. In 2013, the annual mortality from hepatitis C exceeded the total combined number of deaths from 60 other infectious diseases, including HIV, pneumococcal disease, and tuberculosis. Worse even, this data is based on death certificates which often state the immediate cause and overlook the root cause – hepatitis C – so the actual numbers of hepatitis C deaths might actually be even higher.
Sofosbuvir is a highly effective substance with minimal side affects. It is listed on the World Health Organisation Essential Medicines List, making it a high priority drug for hepatitis C treatment. Sofosbuvir-based drugs Sovaldi™ and Harvoni™ are FDA-approved in the US. The patent for sofosbuvir and its prodrugs belongs to Gilead Sciences.