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

Tahir Amin tahir at i-mak.org
Mon Apr 24 11:35:50 PDT 2017


http://www.pharmabiz.com/PrintArticle.aspx?aid=101554&sid=1

Ramesh Shankar, Mumbai , *Friday, April 21, 2017, 08:00 Hrs  [IST]*

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.

-- 
Tahir Amin
Co-Founder and Director of Intellectual Property
Initiative for Medicines, Access & Knowledge (I-MAK)
*Website:* www.i-mak.org
*Email:* tahir at i-mak.org
*Skype: *tahirmamin
*Tel:* +1 917 455 6601/+44 771 853 9472



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