China has denied Gilead a patent on its blockbuster hepatitis C drug Solvaldi, paving the way for cheap generic versions to appear in the country.
Sovaldi (sofosbuvir) is a highly effective medicine, but Gilead has faced backlash across the world for its high price – a full twelve weeks of treatment costs $84,000.
The patent application was rejected following a pre-grant challenge filed by the Initiative for Medicines, Access & Knowledge (I-MAK).
“China’s rejection of a key patent on Sovaldi goes to show that there are serious questions about whether this drug merits patenting, and sends a strong signal to other countries that are currently reviewing patent applications for the drug,” says Rohit Malpani, director of policy and analysis for Médecins Sans Frontières’ access campaign.
“China could prove to be an important supplier for the raw materials as well as the finished product of Sovaldi. Increased competition from manufacturers in China could help push the price of the drug down, so that more people can access it. We hope that other countries where Gilead is seeking patents are watching closely.”
Rejections and challenges
This is not the first time Gilead has faced patent difficulties with Sovaldi – it has also been rejected in Egypt and India. A number of additional challenges have been filed in Argentina, Ukraine, Russia, and Brazil.
A $10 per-pill generic of the drug has also appeared in Bangladesh, and its manufacturer Incepta plans to market it in other nations where Gilead does not hold a patent.
The charity Doctors of the World has even filed a challenge in Europe, saying that the drug “is not sufficiently innovative to warrant a patent”.