[Ip-health] MSF: Pharma company Viiv’s attempt to secure patents for key HIV drugs opposed in India

Joanna Keenan joanna.l.keenan at gmail.com
Wed Feb 10 01:37:14 PST 2016


Pharma company Viiv’s attempt to secure patents for key HIV drugs
dolutegravir and cabotegravir opposed in India
‘Patent opposition’ seeks to ensure availability of affordable generics
https://www.msfaccess.org/about-us/media-room/press-releases/pharma-company-viivs-attempt-secure-patents-key-hiv-drugs-dolute

New Delhi/Geneva, 10 February, 2016—People living with HIV have opposed
patent applications in India for two important HIV medicines, dolutegravir
and cabotegravir.  Médecins Sans Frontières/ Doctors Without Borders (MSF)
supports these ‘patent oppositions,’ which have been filed to challenge an
attempt by ViiV Healthcare (a joint venture by Pfizer and GlaxoSmithKline)
to obtain monopoly rights in India while several of its patent claims are
questionable according to Indian patentability criteria.

The company has so far failed to make dolutegravir available in India for
people who have run out of other treatment options. Cabotegravir is still
in the clinical trial phase of development.
“Many of us have now developed resistance to existing medicines and are in
dire need of new drugs to stay alive,” said Anand Singh*, living with HIV
who filed the patent opposition. “Affordable generic medicines from India
have been one of the cornerstones for being able to put nearly 16 million
people on HIV treatment in developing countries.”

Dolutegravir has been available for use in the US and Europe for more than
two years, and is now part of first-line HIV treatment in the US as it
reduces virus levels faster, is very well tolerated and has a high barrier
to resistance. In developing countries, it is urgently needed for some
patients who have developed resistance to available first- and second-line
medicines. However, the drug is not available from ViiV in India as the
company has neither applied for registration in the country, nor makes the
drug available under ‘compassionate use’ programmes for dying patients in
India.

ViiV licensed dolutegravir to several Indian generic companies in 2014
under a voluntary licence signed between ViiV and the Medicines Patent
Pool, as well as at least one bilateral licence outside of the Medicines
Patent Pool. Yet, ViiV has effectively blocked access to the drug through
licence conditions that limit its supply to public sector entities and NGOs
in India with prior permission from the company – and not through private
sales. If ViiV now gets a patent for dolutegravir in India, open generic
competition among Indian producers would be blocked, keeping the drug out
of reach of patients who desperately need immediate access.

“People with HIV in India have had to deal with long delays and it has
taken years for new HIV drugs and monitoring tools to be introduced in the
treatment programme by the National AIDS Control Organisation (NACO),” said
Loon Gangte, of the Delhi Network of Positive People (DNP+). “Without
access to dolutegravir in the private sector, people living with HIV who
have developed resistance to existing HIV medicines will not be able to get
effective treatment they need to stay alive. The irony is that the drug
will be produced in India and exported to Africa, but won’t be available to
Indian patients who need it.”

The second drug, cabotegravir, with a similar structure as dolutegravir, is
still under development by ViiV.  Clinical trials are on-going to evaluate
this compound, which is being developed as an oral tablet but also as a
long-acting injectable formulation, which could make new treatment options
available for people living with HIV.

“Patents for these drugs would mean complete monopoly status for a company
which has already restricted the availability of an important HIV drug in
India,” said Leena Menghaney, Head of MSF’s Access Campaign in South Asia.
MSF relies on affordable medicines made in India to treat more than 200,000
people around the world living with HIV, and uses Indian generic medicines
to treat many other diseases and conditions, such as malaria and
tuberculosis. “The only way people living with HIV in India and across the
developing world will be able to access these new life saving HIV medicines
is if unrestricted competition among generic producers can take place.”

*Name changed to maintain anonymity

--

Background:

Dolutegravir (DTG), an integrase inhibitor, has been found to have a high
barrier to development of drug resistance. For HIV+ patients who have
failed treatment with most other antiretrovirals (ARV) and now require a
third-line regimen, treatment with a DTG-containing regimen is useful since
it has higher barrier to resistance than other options like raltegravir,
which can develop resistance quickly. DTG is now recommended as an
alternative first-line drug in the revised WHO guidelines for HIV
treatment, as it is a well-tolerated once-daily ARV that reduces virus
levels faster, has a high barrier to resistance and has few drug
interactions.

The patent application in question (3865/KOLNP/2007) filed jointly by the
pharmaceutical companies, GSK and Shionogi, is at a critical stage of
examination before the Kolkata Patent Office.

ViiV Healthcare acquired exclusive global rights to several integrase
inhibitor compounds, including dolutegravir from a Japanese pharmaceutical
company, Shionogi & Co. Ltd. Shionogi receives ongoing royalties and has
10% equity in ViiV Healthcare. ViiV Healthcare is a company established in
November 2009 by GlaxoSmithKline (GSK) and Pfizer.

ViiV Healthcare, under a licence to the Medicines Patent Pool (MPP), has
placed India on a list of royalty countries where the drug can be supplied
by generic companies (sub-licensees) but only to Indian public sector
entities and NGOs, with the prior approval from the company. Generic
companies like Aurobindo are now manufacturing the drug in India, but only
for export to other countries as it is not yet registered in India.

In 2013, the Delhi Network of Positive People (DNP+) filed the first
opposition against the grant of the application that claimed a vast number
of integrase inhibitor compounds – an important class of HIV medicines. A
markush claim is a common form of evergreening by companies that claim
millions of compounds in a single patent application without disclosing
which exact medicine they are planning to put into development and
production.



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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