[Ip-health] Sankalp Rehabilitation Trust and Lawyers Collective respond to Sofosbuvir patent grant

Lorraine Misquith lorrainemisquith at gmail.com
Tue May 10 21:53:40 PDT 2016

*Sofosbuvir granted patent in India*

*Set-back for health groups but they vow to fight on*

In a decision that will have far-reaching implications for access to
affordable HCV treatment, on 9 May 2016, the Delhi Patent Office granted
Gilead, a US-based multinational pharmaceutical company, a patent on
Sofosbuvir in India. The pre-grant oppositions filed by Sankalp
Rehabilitiation Trust along with those filed by DNP+, I-MAK and three
Indian generic companies were rejected by the Deputy Patent Controller of
the Delhi Patent Office, Dr. Rajesh Dixit following hearings held from
23-25 February 2016. It may be recalled that a 13 January 2015 order of the
Delhi Patent Office rejecting the same patent on Sofosbuvir was remanded
back by the Delhi High Court on procedural grounds.

Responding to the order rejecting the pre-grant opposition, Eldred Tellis
from Sankalp Rehabilitation Trust said “This comes as a huge disappointment
to us. We know there was a lot of pressure to grant the patent considering
Gilead had already signed licensing deals with Indian companies but we
hoped to knock off the patent.” In September 2014, even before the patent
on Sofosbuvir was granted in India Gilead entered into licensing agreements
with 7 Indian companies which has now increased to 13. But most high-burden
and high-income countries are excluded from the scope of the license.
“Knocking off the patent would have meant that non-license companies could
have entered the market and forced further price reductions and potentially
also supply to countries left out of the licenses” he added.

It is estimated that 180 million people around the world are living with
HCV. HCV is primarily transmitted through blood-to-blood contact and may
also be transmitted through unprotected sex in high risk groups like MSM.
Up to 80% of people living with the virus develop chronic HCV, which, if
left untreated, can lead to life-threatening complications, such as liver
cirrhosis, liver failure and liver cancer. Sofosbuvir, a highly effective
and safe drug to treat HCV. It is now considered the back-bone of the
treatment regimen prescribed by the World Health Organisation and is also
listed on the WHO’s Essential Medicines List making it a high priority drug
for HCV treatment. Sofosbuvir based regimens with other direct acting
antivirals (DAAs) like Daclatasvir can cure 98% of people living with HCV
1, 2 and 3 genotypes, the most common genotypes in the world.

Sofosbuvir is priced excessively high in most high-income countries, around
84,000 USD for a 12 week course of treatment in the US and 76,000 USD in
France putting considerable strain on national health budgets and forcing
rationing of treatment to those who are most sick. In India, the same
treatment costs around Rs. 20,000 under the generic versions of Sofosbuvir.

“Prima facie the order lacks legal reasoning but we need to examine it
closely to figure out chart out a future course of action. We will explore
all options” said Anand Grover, Senior Counsel and Director, Lawyers
Collective who appeared for Sankalp Rehabilitation Trust. “There are other
patent applications pending on forms of Sofosbuvir so it is important for
us to stay on course and fight them out.”

India’s patent laws have long been attacked and sought to be weakened by
MNCs, whether through Special 301 reports or bilateral pressures which have
time and again targeted Section 3 (d) which prevents patent evergreening or
not issue compulsory licenses but health groups have been vigilant to these
moves. “Voluntary licenses are the new mantra, which is nothing but a
disguised attempt to thwart and control competition by generic companies.
It is truly worrisome how MNCs are setting the agenda on access to
medicines and the role of the government is being side-lined” said Anand
Grover. Eldred Tellis added “Patient groups have now become more isolated
in the battle for access to medicines but by no means deterred. We will
continue to challenge undeserving patents.”

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