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

Press Release 13 May 2016

Patent and Health Experts Denounce Indian Patent Office’s Sofosbuvir Reversal, Vow to Fight for Public Health and Accountability to the Law

NEW YORK – 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.

“The facts of the case are undeniable: sofosbuvir, the base compound in Gilead’s hepatitis C drugs, was developed with previously published techniques that have been used repeatedly in other antiviral drugs,” said Tahir Amin, co-director of I-MAK. “Despite the growing pressure on India’s patent office from the U.S. trade regime and from Gilead’s manipulative licensing deals, we’re confident that we will win and ensure the Indian patent system stays accountable to the integrity of the law and to the public’s health.”

I-MAK and DNP+ have filed the appeal on the grounds that the Indian patent office’s latest and unfounded decision is contrary to the public interest, fails to assess the full scientific and legal evidence presented and ignores key Indian patent law and judicial precedents.

As recent news reports have detailed, the Indian patent office and officials at the highest levels of the Indian government are facing heavy pressure from the U.S. and pharmaceutical companies like Gilead to weaken patent laws and policies in favor of corporate interests. Following challenges by I-MAK and its partners, China, Ukraine and Egypt have already rejected Gilead’s sofosbuvir patents.

“The health and wellbeing of millions in India, and around the globe, depends on the rejection of unmerited patents, which create barriers to treatment and block access to life-saving drugs,” said Loon Gangte of the Delhi Network of Positive People and Regional Co-ordinator of ITPC-South Asia. “This latest decision by the Indian patent office will only deepen the public health crisis, and force millions of patients around the world to continue to pay exorbitantly high prices. Patients everywhere, including those countries with high HCV burden excluded by Gilead’s licenses deserve affordable access to care, so that they can lead healthy lives.”

Despite the company’s rhetoric, Gilead’s licensing deals – in India and other countries – are designed to serve the company and increase profits, not to serve patients and increase access to needed hepatitis C drugs. Like unmerited patents, these schemes manipulate the market, violate patients’ rights and block millions of people from getting life-saving medicines.

The hepatitis C virus, which the World Health Organization has called a “viral time bomb,” affects about 150 million people globally. This month, the Centers for Disease Control and Prevention released new data which found hepatitis C kills more Americans than any other infectious disease.


Since 2006, I-MAK has been working to increase access to medicines around the world. I-MAK’s legal work and research spans 49 countries, eight diseases and 20 therapies. I-MAK’s wins on high-impact cases on HIV drugs has saved health programs worldwide over $1 billion. In order to stay independent and exclusively represent the interests of patients and consumers, I-MAK does not accept funding from branded or generic pharmaceutical companies. Click here for more on I-MAK’s impact around the world.

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