A 12-week treatment with a combination of Sovaldi (sofosbuvir) and one or two other drugs can cure a hepatitis C infection. Gilead Sciences will allow Indian pharmaceutical firms to make and sell less-expensive generic versions of Sovaldi in 91 developing countries. In the United States and developed and middle-income parts of the world, however, Sovaldi can cost as much as $84,000 per treatment, or about $1,000 per pill.
This controversial high price is busting national health budgets in many countries. Now the Initiative for Medicines, Access and Knowledge (I-MAK) and local activists in Brazil, China, Russian, and Ukraine have filed challenges to the patent status for Solvadi. I-MAK, based in New York, has also filed a challenge in China without the support of local activist groups there. If a patent for a drug is denied, other companies can make less expensive generic versions.
Hepatitis C is a viral infection that affects about 150 million people worldwide and can lead to liver failure. I-MAK estimates that 59 million people in the countries where it has challenged the patents have hepatitis C.
The price that Gilead has proposed charging for Sovaldi in Brazil is $7,500 per treatment. In India, where the generic versions are available, the price for a treatment is $1,000. Even at the lower price for Sovaldi in Brazil, the government there is planning to reserve the drug only for people whose livers are already damaged.
A patent challenge for Solvadi was filed in Europe in February by the humanitarian group Doctors of the World. Demonstrators have held protests about the price of Sovaldi in Spain and France. India denied a patent for sofosbuvir in January, but drug patents have usually lost challenges in that country.
The World Health Organization put Sovaldi on its list of essential medications and has urged that the price be lowered in middle-income countries.
These patent challenges may not be successful. A drug may be protected by more than one patent. A low over-all cost for hepatitis C treatment may also be stymied by the relatively high cost of some of the drugs that Sovaldi must be used in conjunction with, which are also under patent.
