[Ip-health] Urgent Action Needed: sofosbuvir patent opposition in India

Pauline Londeix pauline.londeix at gmail.com
Mon Jan 26 04:01:12 PST 2015

Dear friends and allies,

 We are writing to you about an urgent matter in connection with the
future of access to curative treatment of hepatitis C virus (HCV) to
all those who need it.

 As you may have heard, the Indian Patent Office rejected few days ago
in the first review one of the key patent applications for sofosbuvir
(Sovaldi). This is the medicine recently marketed by Gilead which is
priced exorbitantantly  out of reach of most countries, including the
wealthy ones (in the US: $ 1000 per tablet for a period of 12 weeks
for a total of $ 80,000 per course of treatment).

This opposition to one of the key patents for sofosbuvir (the patent
is only a minor modification of existing compounds that does not
deserve patent) was a success thanks to the mobilization of our
colleagues in civil society. If the decision stands and oppositions
that have been filed against another key sofosbuvir patent also
succeed, it could allow affordable generic versions of Sofosbuvir to
be available in many countries, included those excluded from licenses,
as was done following the Tenofovir patent opposition in India a few
years ago.

Unfortunately, instead of leaving the Indian Patent Office do its
work, Gilead has stepped up pressure on India last week, and they are
trying to reverse the decision of the Patent Office through the courts
. Gilead is currently in the process of putting pressure on the
Department of Industrial Policy in India, which oversees the patent
office, by using the argument that there will be no problem accessing
sofosbuvir in India or in other developing countries as Gilead issued
last September a voluntary license (VL) to Indian generic producers
enabling them to produce generic versions for some countries
determined by Gilead.

This license has been criticized by many groups of civil society and
experts working on the field of Intellectual property and access to
medicines. The VL poses a number of problems that call into question
whether Gilead really will allow access, or inhibit open generic
competition, which is proven to be the most effective way to bring
down the price of medications.. Problems with the VL include:

-       -   The exclusion of 50 developing countries from the
territories covered by the VL  (mainly middle income countries). These
include countries severely affected by the HCV epidemic and whom will
under no circumstances be able to afford the prices charged by Gilead.
This is even if there is no patent protection in those countries,

- Banning the sale of raw materials used in the manufacture of
generics outside few Indian generic producers selected by Gilead in
the VL,  including exclusion of manufacturers in countries where there
is no patent e.g Egypt,

- Anti-diversion measures in total violation of the principles of
human rights and medical ethics disclosing confidential data of the
patients. Even in countries included in the license these measures
permit the exclusions of all persons not eligible for government
programs to access treatment, as well as people who are treated in the
private sector and foreign residents...

Given the gravity of the current situation in India, and at the
request of our colleagues who are fighting there to maintain the
rejection of this patent which, if successful, could benefit all
patients around the world, we must act quickly. We need to tell Gilead
now as well as the India's Department of industrial Policy  that
people living with HCV and supporting organizations reject this
license, which remains insufficient to allow people who need treatment
in developing countries to gain access.

 Given the urgency of the letter we will send you, we wanted to notify
you with this email that you will receive a letter on Tuesday, January
27 (colleagues are drafting it) to which we would like you to add the
signature of your organization.

The turnaround time to sign on will be quite short (2-3days) so that
the letter could be sent before the end of the week.

We strongly encourage you to serve as relay of solidarity by sending
this email and the letter that will follow on Tuesday to all your
partner organizations in your country, your region or in the world to
collect the maximum signatures possible.

If you have any questions about what is happening in India, the
implications or the voluntary license from Gilead, please feel free to
contact us:

Othman Mellouk, International Treatment Prepardeness Coalition - ITPC
(o.mellouk at gmail.com)

Karyn Kaplan, Treatment Action Group - TAG
(karyn.kaplan at treatmentactiongroup.org)

Best Regards,

Karyn & Othman

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