E-DRUG: GSK announces withdrawal of Combivir patent applications
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Dear e-druggers,
Please find below the text of GlaxoSmithKline (From GSK Website, under
News Archive, 10 August 2006 link: http://www.gsk.com/media/archive.htm) in
which the company states that it decided to withdraw all of its patents and
patent applications for Combivir. It further states that this decision was
made a while ago, and that the company had instructed its agents in June to
withdraw the patent applications in India and Thailand, specifically.
With this move, GSK seems to have responded positively to the demands of
the Thai and Indian groups of people living with AIDS and their supporters.
However the information MSF has received from both Thailand and India does
not entirely match with what the company is stating.
The patent office in Thailand apparently did not receive notice of the
patent application withdrawal until getting a letter on 8 August, not in
June, as the company stated (as also reported in the 21 August TNA article
below). This was in fact one day after a large protest by patient and
treatment advocacy groups took place outside the GSK offices in Bangkok and
in Bangalore, India, urging the company to withdraw the Combid/Combivir
patent applications. The Thai Commerce Ministry just yesterday in fact
sent a letter to the Thai Network of People Living With AIDS (TNP+) about
the patent withdrawal, attaching communication it received from GSK on 8
August, not June.
In India, GSK has not officially communicated about the patent application
withdrawal, and when the Manipur Network of People Living with HIV/AIDS /
Lawyers Collective HIV/AIDS Unit contacted the patent office, it found that
no official withdrawal has taken place. The Indian Network for People
Living with AIDS (INP+), has now requested an official confirmation from
GSK that it is withdrawing the application in India, and a copy of those
instructions that it has sent to the patent office.
It seems clear that the protests had a significant effect. It is important
that parties are allowed to raise concerns about patents and their effects
on public health before a patent is granted. The pre-grant opposition
process in particular is a crucial safeguard that needs to be protected.
MSF is concerned by the current move by Novartis in India to try challenge
a key safeguard of the Indian Patents Act, which prevents trivial patents.
In a hearing set for 26 September, Novartis will try to overturn a January
2006 ruling that set a precedent by denying the company's patent request
for the cancer drug Gleevec. The drug was not patentable under Indian law
because it was merely a new form of a known substance. These are also the
grounds on which the pre-grant oppositions to both GSK's patent application
for Combivir and Gilead's application for TDF were filed by Indian PLWHA
groups earlier this year. MSF supports this process.
Also find attached below an article from this week's Fortune Magazine on
the attempts to patent ARVs in India. Note that the article makes no
reference to the GSK patent applications having been withdrawn. [this has been deleted because it is identical to WBs posting this morning (patently unfair) Moderator]
Ellen 't Hoen
MSF Access to Essential Medicines Campaign
Ellen.T.HOEN@paris.msf.org
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From GSK Website, under News Archive, 10 August 2006 link:
http://www.gsk.com/media/archive.htm
GSK patents and patent applications for Combivir
GSK offices in Thailand and India have recently been subject to
demonstrations against GSK's patents applications for COMBID/COMBIVIR in
those countries.
Prior to these demonstrations GSK had decided to withdraw its patents and
patent applications directed to a specific formulation of Combivir. In June
2006 GSK instructed its agents in Thailand and India to withdraw the patent
applications.
The patent and patent applications relating to this specific formulation of
Combivir have been withdrawn in all countries where it has been filed.
Other patents and patent applications relevant to Combivir and other GSK
antiretrovirals are not affected.
It is worth noting that these applications were made more than 8 years ago.
A combination of in country delays and the impact of TRIPs have meant that
these applications have only recently been subject to active processing.
GSK supports the World Trade Organisation's Trade-Related Aspects of
Intellectual Property Rights (TRIPs) agreement, including the public health
safeguards it contains. However, GSK believes that focus on patents in
addressing the challenge of HIV/AIDS is misguided and counterproductive.
New medicines and vaccines to address the challenge of HIV/AIDS are
desperately needed and the patent system fundamentally stimulates the
necessary research and development. The root cause of many countries’
inability to address HIV/AIDS does not lie with the patent system but with
the consequences of poverty, and lack of political will, leading to a lack
of healthcare infrastructure and resources.
GSK recognises the challenge that HIV/AIDS has put on health systems and
seeks to work in partnership with governments and NGOs to address this
challenge. Dialogue with us on this issue prior to the recent
demonstrations in Thailand and India would have made them unnecessary.
GSK's commitment and contribution to the fight against HIV/AIDS embraces
four key areas - investment in research and development (R&D), preferential
pricing of our antiretrovirals (ARVs), community investment activities, and
partnerships that foster effective approaches against the disease and the
challenges it presents. Details of our approach and progress can be found
at: http://www.gsk.com/responsibility/cr_issues/dev_world_challenges.htm
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Glaxo withdraws AIDS drug patent application in Thailand
TNA 21 Aug 2006
BANGKOK, Aug 20 (TNA) - A phamarceutical giant decided to withdraw its
earlier application to seek a Thai patent for its anti-retroviral drug
Combid in a decision which will allow Thailand to produce a cheaper generic
version to treat AIDS patients, a senior government official said Sunday.
Commerce Ministry deputy permanent secretary Yanyong Phuangrach disclosed
that the Glaxo Group Limited Company informed the Intellectual Property
Department about its decision in its letter dated August 8.
The company provided no reason for its decision, but the move came after a
recent protest by hundreds of activists and HIV-infected patients at
Glaxo's Bangkok office.
They argued that the drug was not a newly researched product but simply a
combination of existing drugs.
The protestors also feared that the patent, if approved, would give the
UK-based company a monopoly on the sales of Combid in Thailand.
The withdrawal of Glaxo's patent application means that the Government
Pharmaceutical Organisation (GPO) will be able to continue production of
its generic version, known as Zilarvir, which is much cheaper.
Mr. Yanyong hailed Glaxo's decision as a good example of corporate
citizenship for other drug giants as the company has relinquished its
potentially huge financial gain in exchange for social contributions
benefiting Thailand. (TNA)-E001