Building on 2015 rejection of Gilead's patent application for hepatitis C, legal challenge to Gilead's remaining patent in China that blocks hep C treatment for up to 13 million people

In a move that could strike down barriers to treatment for the exploding hepatitis C epidemic that kills 700,000 people every year, attorneys and scientists from the Initiative for Medicines, Access & Knowledge (I-MAK) filed a legal challenge against Gilead’s (NASDAQ:GILD) remaining patent for the hepatitis C medicine sofosbuvir in China. Branded as Sovaldi®, this patent covers the sofosbuvir base compound and is founded on previously published techniques, and does not meet the legal criteria for a patent. This new filing follows another legal challenge filed by I-MAK in 2015, which helped result in a rejection in June 2015 by China’s State Intellectual Property Office (SIPO) on the other critical patent application on sofosbuvir.

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Flawed patents on hepatitis C drugs latest to be challenged in global push for access

Five new challenges against patents on crucial new medicines to treat hepatitis C filed in India and Argentina are the latest in a global push to ensure access to affordable treatment. The patent challenges could remove barriers to production and distribution of affordable generic versions of direct-acting antiviral (DAA) medicines, including sofosbuvir, daclatasvir and velpatasvir.

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I-MAK, Indian Health Advocates Appeal Patent Office Reversal on Gilead’s Hepatitis C Drug

To ensure Gilead cannot claim existing public knowledge as its own and help the millions of people around the world with hepatitis C get the medicine they need to survive, the Initiative for Medicines, Access & Knowledge (I-MAK) and the Delhi Network of Positive People (DNP+) filed an appeal today with the Delhi High Court. I-MAK and DNP+ are appealing the Indian patent office’s deeply flawed about-face granting Gilead an unmerited patent for sofosbuvir, the base compound in its hepatitis C drug. Last year, the Indian patent office rejected Gilead’s patent, ruling that the main compound in sofosbuvir was a “molecule with minor changes” and has the “same use in treatment of HCV infection and flavivirus injection” compared with an earlier compound.

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Gilead denied patent for hepatitis C drug sofosbuvir in India

The Indian Patent Controller has today rejected one of Gilead’s key patent applications which covered the drug sofosbuvir, used to treat hepatitis C (HCV). The oral drug, which first received regulatory approval in the US in November 2013, and has been priced by Gilead at US$84,000 for a treatment course, or $1,000 per pill in the US, has caused a worldwide debate on the pricing of patented medicines. A study from Liverpool University showed that sofosbuvir could be produced for as little as $101 for a three-month treatment course.

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Gilead attempt to secure patent on hepatitis C drug opposed in India

Médecins Sans Frontières (MSF) supports the ‘patent opposition’ just filed at India’s Patent Office by the Initiative for Medicines, Access & Knowledge (I-MAK), which aims to prevent US pharmaceutical company Gilead/Pharmasset from gaining a patent in India on sofosbuvir, a drug for hepatitis C that is coming to market soon with an anticipated exorbitant price.

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