After India, I-MAK files legal challenge against Gilead’s hepatitis C drug sofosbuvir in China

Media Article 21 Apr 2017

Ramesh Shankar, Mumbai
Friday, April 21, 2017

Close on the heels of filing four patent challenges in India, two on daclatasvir, one on velpatasvir and another on sofosbuvir, the international NGO– Initiative for Medicines, Access & Knowledge (I-MAK), in association with other NGOs, has filed a legal challenge against Gilead’s remaining patent for the hepatitis C medicine sofosbuvir in China.

Earlier in February this year, I-MAK in association with Delhi Network of Positive People (DNP+) and Médecins Sans Frontières (MSF) had filed four patent challenge cases in India.  Sofosbuvir, velpatasvir and daclatasvir are all crucial to the first line treatment options that cure people of hepatitis C and stop the progression of liver disease.

I-MAK’s legal challenges could have a far-reaching impact on the market for affordable medicines in China and around the world. In China, freeing sofosbuvir of its unmerited patents would open the door to affordable generic treatment, saving government health programs and consumers billions of dollars. Affordable treatment for just four million people – or just 46 per cent of those living with hepatitis C in the country – would save at least US$ 26.8 billion. If every person in China with hepatitis C was treated, the total potential savings of using generic sofosbuvir is at minimum US$ 59 billion, over half of China’s annual spending on prescription drugs.

“The lives of 80 million people around the globe are affected by a public health crisis that will not be solved until companies like Gilead can no longer claim existing public knowledge as their own,” said Priti Radha Krishtel, I-MAK co-founder and director of treatment access. “Gilead’s pursuit of illegitimate patents only serves to increase its record-breaking profits, at the expense of patient health and access to needed hepatitis C drugs.”

China serves an essential role in the global pharmaceutical drug supply chain, manufacturing more than 800,000 tons of pharmaceutical ingredients each year – more than any other country. More than 70 per cent of all active drug materials consumed in the US and Europe are imported from China and India. China provides roughly 43 per cent of the raw materials used to produce anti-infective medicine for the world, according to the World Bank’s Human Development Network. Removing all unjustified patents for sofosbuvir in China will help open the supply of raw materials to manufacturers around the country and get the drug to millions of people with hepatitis C worldwide who currently cannot get the medicine they need to get well.

To date, I-MAK has worked with partner organizations to remove patent barriers against sofosbuvir in 46 countries, including Argentina, Brazil, China, Egypt, India, Russia, Thailand, and Ukraine, and in Europe (covering 38 countries). On the heels of China’s prodrug rejection, Ukraine’s patent office followed suit and rejected a patent application for sofosbuvir by Gilead. Other countries such as Egypt have also rejected key patents on sofosbuvir.

The current lowest market price for a 12-week regimen of generic sofosbuvir produced by leading generic suppliers in India is around $250, and a University of Liverpool study found that generic manufacturers could produce a 12-week treatment course for as little as $62.

I-MAK is a team of lawyers and scientists at the leading edge of a global movement to ensure all people get the medicine they need to survive and lead healthy lives.

Branded as Sovaldi in China, 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. SIPO found that this patent, covering the prodrug which activates the otherwise inactive base compound in the body, did not deserve a patent under the law.

The hepatitis C virus, which the World Health Organization has called a “viral time bomb,” affects about 80 million people globally. When left untreated, the virus can lead to liver disease or liver cancer.

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