China rejects patent on hepatitis C drug sofosbuvir

2015; 350 doi: http://dx.doi.org/10.1136/bmj.h3429 (Published 23 June 2015)

Cite this as: 2015;350:h3429

The Chinese patent office has rejected a patent application for the blockbuster hepatitis C treatment sofosbuvir, increasing the possibility of a generic version of the drug to become available in China.

The decision comes after a challenge by the Initiative for Medicines, Access and Knowledge (I-MAK), a US based group that campaigns for better access to affordable drugs. The group claimed that Gilead Sciences, the US biotechnology company that makes sofosbuvir, which recorded sales of more than $10bn in 2014, was seeking “illegitimate patents” for sofosbuvir and “blocking millions of people around the world from getting the treatment” for hepatitis C. It alleged that the base compound in sofosbuvir was not new and was already covered by earlier patents.

Key patents on sofosbuvir have already been rejected in Egypt and India.

I-MAK is also challenging patent applications for sofosbuvir in Argentina, Brazil, Russia, and Ukraine, countries which, along with China, the World Bank categorises as high income countries and are therefore unable to obtain generic versions of sofosbuvir through companies that Gilead has authorised to produce for 90 low and middle income countries.1

Sofosbuvir, along with other new antivirals, has been hailed as a cure for hepatitis C, which affects 150 million people worldwide and is responsible for between 350 000 and 500 000 deaths a year. But its high cost—around $80 000 (£52 500; €73 000) for a 12 week course of treatment—makes it prohibitive for many poorer countries.

The global humanitarian organisation Médecins Sans Frontières, said in statement that it was starting to scale up treatment of hepatitis C, with plans to expand treatment in nine countries. Rohit Malpani, director of policy and analysis for the charity’s access campaign, said, “China’s rejection of a key patent on sofosbuvir 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.

“China could prove to be an important supplier for the raw materials as well as the finished product of sofosbuvir. Increased competition from manufacturers in China could help push the price of sofosbuvir down, so that more people can access it. We hope that other countries where Gilead is seeking patents for sofosbuvir are watching closely.”

Jennifer Cohn, medical director of the access campaign, said, “This is good news for people with hepatitis C and will hopefully lead to more people in developing countries being able to access low cost versions of sofosbuvir. Gilead’s exorbitant pricing is preventing people from getting the treatment they need in both rich and poor countries. A cure for hepatitis C does nobody any good if nobody can afford it.”

Notes

Cite this as: BMJ 2015;350:h3429

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