[Ip-health] Flawed patents on hep C drugs latest to be challenged in global push for access

Joanna Keenan joanna.l.keenan at gmail.com
Tue Feb 14 01:53:43 PST 2017

Hi all

Please see below joint PR between I-MAK, DNP+ and MSF Access Campaign on
challenges to patents (patent oppositions) filed today in India on key hep
C drugs sofosbuvir, daclatasvir and velpatasvir.

*Flawed patents on hepatitis C drugs latest to be challenged in global push
for access*


New Delhi/New York, 13 February 2017–Five new challenges against patents on
crucial new medicines to treat hepatitis C filed in India and Argentina are
the latest in a global push to ensure access to affordable treatment. The
patent challenges could remove barriers to production and distribution of
affordable generic versions of direct-acting antiviral (DAA) medicines,
including sofosbuvir, daclatasvir and velpatasvir.

Today in India, the Initiative for Medicines, Access & Knowledge (I-MAK)
together with the Delhi Network of Positive People (DNP+) and supported by
Médecins Sans Frontières (MSF), filed four cases: two patent challenges on
daclatasvir, one on velpatasvir and a further challenge on sofosbuvir.
in Argentina, Fundación Grupo Efecto Positivo (FGEP) filed a patent
opposition on sofosbuvir with support from I-MAK.

Today’s filings are the latest attempts to overturn the abusive strategies
of pharmaceutical corporations like Gilead who exploit the flaws in the
patent system to obtain unjustified patents that block generic competition.

“80 million people worldwide are living with hepatitis C, and we need a
wide range of combination treatments available at an affordable price. With
patents blocking generic competition, treatment remains prohibitively
expensive in many countries,” said Jessica Burry, pharmacist for MSF’s
Access Campaign. “Sofosbuvir, velpatasvir and daclatasvir are all crucial
to our line-up of first line treatment options that cure people of
hepatitis C and stop the progression of liver disease.”

Patents on drugs not only prevent affordable generic versions from being
produced or imported, but also restrict progressive innovation that could
otherwise benefit patients. More than a decade ago, patent barriers were
overcome to allow generic competition of antiretroviral (ARV) drugs, used
to treat HIV, causing prices to drop by 99% and enabling more than 18
million people to access treatment today.  The lack of patent barriers also
enabled generic pharmaceutical producers to develop improved ARV
combination treatments and new formulations to serve unmet patient needs.

There are multiple patent barriers that prevent the manufacture or
importation of low-cost, quality DAA medicines, particularly in high- and
middle-income countries.  Patent challenges – or patent oppositions as
they’re more commonly known – are one strategy to open up access to
millions of people left without affordable treatment options, after other
strategies to directly engage pharmaceutical corporations have largely

“Together with civil society groups, we have filed legal challenges on
multiple invalid patents on three different hepatitis C drugs,” said Tahir
Amin, Director of Intellectual Property for I-MAK. "It is time to challenge
the unchecked power that pharmaceutical corporations hold through abuse of
the patent system.”

People living with HIV, in collaboration with health organisations and
legal aid groups, have already filed challenges to ‘evergreening’ patents
on the drug sofosbuvir in several countries. ‘Evergreening’ refers to the
practice of filing additional patents to extend the length of monopoly
control over a product, and these challenges have successfully reduced the
length of the monopoly for sofosbuvir in the EU and revoked a key patent on
sofosbuvir in China and Ukraine. Decisions on challenges to sofosbuvir
patents are pending in other countries, including Argentina, India, Brazil,
Russia and Thailand.

“By systematically applying pressure to remove patent and regulatory
barriers that stand in the way of production of more affordable generic
versions of direct-acting antiviral medicines used to treat hepatitis C,
civil society and vulnerable communities have already supported the
introduction of generic competition in India and Egypt, where prices
dropped to below USD $300 per 12-week treatment last year,” said Leena
Menghaney, Head of South Asia for MSF’s Access Campaign.  “But the benefits
of these price reductions are not available to all those who need
treatment, particularly those people living in middle-income countries with
high burdens of hepatitis C.”

Egyptian and Indian generic suppliers face multiple intellectual property
barriers in the registration and export of DAA medicines to several
middle-income countries. While licensing deals struck between Indian
generic companies and pharmaceutical corporations enable access to
lower-cost medicines for India and least-developed countries, by far the
greatest burden of hepatitis C disease is found in middle-income countries.
Many of these countries, including China, Ukraine, Thailand, Malaysia and
Brazil, are excluded from licensing agreements that could enable
importation of raw materials (active pharmaceutical ingredients, or APIs)
or finished formulations of DAA medicines.

“Despite the deadly toll of the hepatitis C epidemic, Gilead and
Bristol-Myers Squibb still have far too much control over who can access
their lifesaving DAA medicines, and the lack of access is ultimately
costing people their lives,” said Loon Gangte, Regional Coordinator,
International Treatment Preparedness Coalition-South Asia and Founder of
DNP+. “Millions of people in India can’t afford the generic treatments
strictly licensed by Gilead and BMS, and millions more people in high- and
middle-income countries can’t legally purchase the generic medicines
currently being produced in countries like India and Egypt.  We need a
sustainable supply of low-cost, quality hepatitis C medicines to save lives
and contain the disease in all countries.”


Additional Notes for Editors:

Gilead has licenced sofosbuvir and velpatasvir to 11 generic manufacturers
in India, but the number of countries able to access these generic versions
represents only half the global burden of disease. A detailed analysis of
the licensing agreement is available here:

Egyptian companies were not included in any licensing deals and have
freedom to operate and supply low cost generic DAAs where there are no
granted patents. Once patents are granted in a country, they have a
chilling effect on the introduction of more affordable DAAs that are
essential to create universal access to the cure for hepatitis C.

List of oppositions:

In India, two cases challenge the crystalline forms of sofosbuvir and
daclatasvir and should be rejected for not being in compliance with Indian
law.  India's law recognizes that crystalline forms of known medicines are
not inventions and should not be awarded patents. This approach was
confirmed by the Indian Supreme Court on 1 April 2013, which refused a
patent by holding that a crystalline form of a known pharmaceutically
active compound cannot be regarded as involving an inventive step (Novartis
vs Union of India).

A critical third opposition shows that the patent on velpatasvir is an
obvious structural change to an earlier hepatitis C drug, ledipasvir.  This
is a classic example of Gilead gaming the patent system in order to
strengthen its control on the hepatitis C market. The fourth opposition
also seeks to open up the supply of raw materials from India by challenging
the patent on the intermediate form of daclatasvir.

In Argentina, people living with HIV have challenged the patent on
sofosbuvir in light of evidence that discloses substantially similar
antiviral compounds for treating hepatitis C. Civil society has a strong
case as Gilead has also failed to fully disclose/describe the invention
claimed in a sufficient manner, a requirement of patent law that is often
ignored by pharmaceutical corporations.

Copy of these patent oppositions filed in India are available on Patent
Oppositions Database (an online platform that provides support, information
and collaborative tools for groups and individuals wanting to challenge
patents on medicines) and can be accessed using the following links:




*Joanna Keenan*

Press Officer

Médecins Sans Frontières - Access Campaign

P: +41 22 849 87 45

M: +41 79 203 13 02

E: joanna.keenan[at]geneva.msf.org

T: @joanna_keenan




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