[Ip-health] People living with hepatitis C and HIV challenge evergreening patents on lifesaving hepatitis C drugs in India

leena menghaney leenamenghaney at gmail.com
Mon Jul 9 02:34:01 PDT 2018

*People living with hepatitis C and HIV challenge evergreening patents on
lifesaving hepatitis C drugs in India*

*New Delhi, 9 July 2018:* Médecins Sans Frontières (MSF) welcomes two
patent oppositions filed by Delhi Network of Positive People (DNP+) before
the Indian patent office, challenging additional patent claims by US
pharmaceutical corporation-Gilead Sciences for the hepatitis C medicines
sofosbuvir and velpatasvir. These oppositions challenge Gilead’s patent
applications for the tablet formulation of the fixed-dose combination of
sofosbuvir/velpatasvir and the polymorph form of velpatasvir.

Velpatasvir, a direct acting antiviral (DAA), is one of the key medicines
used in combination with sofosbuvir for the oral treatment of people with
all six major genotypes of hepatitis C virus. Its effectiveness as a
pan-genotypic medicine makes it a key drug in the fight against hepatitis
C. Access to affordable generic sources of this medicine, and its
combination with sofosbuvir, are therefore critical for all countries with
a high burden of people living with hepatitis C. Sofosbuvir/velpatasvir was
launched in the United States by Gilead at over $74,000 for a 12-week
regimen in 2016.

The grounds for these two patent oppositions are based on provisions in the
Indian Patents Act that prevent patent evergreening, which restricts the
patentability of a host of secondary patents, i.e., new forms of known
substances, new property or new use of known substances, use of known
processes without showing any enhanced therapeutic efficacy, and admixtures
without synergistic effect.

India plays a critical role in supplying developing countries with
affordable, quality lifesaving generic medicines, largely because the
country’s patent law strikes a balance between promoting public health and
access to medicines, while also protecting companies’ intellectual property
rights by granting patents for true innovative developments. However, a
recent study on the Indian patent office has highlighted that a larger
number - over 70% of the patents analysed from 2009-2016 – are for marginal
improvements, many of which were granted erroneously even though India’s
Patents Act explicitly aims to protect against corporations being able to
‘evergreen’ their patent claims. This lack of rigorous assessment of the
patentability requirements in pharmaceuticals is a worrying development in

Through these patent oppositions, DNP+ aims to prevent such unmerited
patent applications from being granted and encourage open competition on
the combination of sofosbuvir and velpatasvir after the basic compound
patents have expired or are revoked in countries excluded from Gilead’s
license agreements.

*Quote from Paul Lhungdim, Delhi Network of Positive People *

“Just like Gilead attempted to patent different forms and combinations of
the key HIV drug tenofovir many years back, the corporation is again using
evergreening tactics to block affordable options of hep C drugs that other
countries can import in the future. With these patent challenges, we hope
to prevent Gilead from obtaining unmerited patent rights on sofosbuvir and
velpatasvir, which would allow them to continue charging exorbitant prices
from governments in many middle- and high-income countries.”

*Reading Material:*

Link to oppositions filed by DNP+:

1. Velpatasvir polymorph:

2. Sofosbuvir/Velpatasvir tablet:

Briefing Document: The grounds for opposing patent applications on
velpatasvir, July 2018,

Study on Pharmaceutical Patents granted in India: How our safeguards
against evergreening have failed, and why the system must be reformed


Leena Menghaney
Mobile: 9811365412

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