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China turns down one of two Sovaldi patents

Advocacy group attempting to block drug in other emerging markets too

China flag thumbChina has refused to issue a patent on Gilead Sciences' hepatitis C virus therapy Sovaldi, raising the threat of generic competitors appearing on the market.

The challenge to the Chinese patent was filed by the Initiative for Medicines, Access & Knowledge (I-MAK), an advocacy group that is trying to overturn Gilead's intellectual property for Sovaldi (sofosbuvir) in not only China but also other emerging markets including Argentina, Brazil, India, Russia and Ukraine.

Together, these middle-income countries account for around 40% of the world's HCV cases but are notable in that they were excluded from a list of 91 countries that will have access to cheaper, Indian-made generics made under a Gilead license.

Sovaldi was launched in the US at a price of $84,000 for a 12-week course, and pent up demand quickly made the drug a blockbuster with sales of $10bn last year, but the Indian-made versions are being sold for under $1,000.

An opposition action spearheaded by I-MAK also resulted in Gilead being denied a Sovaldi patent in India earlier this year, although this has since been returned to India's patent office for a new hearing.

The organisation claims that Gilead's voluntary licence agreements "impose many restrictions, including which countries can access the drugs produced under these licences, as well as invasive restrictions on medical providers and patients with respect to distribution and use of the drug."

It also points out that middle-income countries still have widespread poverty and so many HCV patients on low incomes are being denied access. The World Health Organization has also called on Gilead and other companies making HCV drugs to lower prices for what it classes as essential medicines.

The Chinese decision was welcomed by Médecins Sans Frontières, which has been campaigning for freer access to Sovaldi and other drugs for HCV, which affects 150-185 million people worldwide.

"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," according to Rohit Malpani, who heads MSF's policy and analysis group.

As in India, the story in China is far from over - Gilead has another patent filed there and is also expected to appeal the rejection. Nevertheless, the verdicts in India and China suggest Gilead could have its work cut out defending its patent in other jurisdictions.

In the meantime, a low-cost generic is already being produced by Incepta Pharmaceuticals of Bangladesh, where Sovaldi is not protected by patents. Incepta is currently selling it mainly in the domestic market but has suggested it may ramp up production for export.

Article by
Phil Taylor

22nd June 2015

From: Sales



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