[Ip-health] GSK announces withdrawal of Combivir patent

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From: Ellen T HOEN <Ellen.T.HOEN@paris.msf.org>=0D
Date: Tue, 19 Sep 2006 10:17:37=0D
To:Ip-health@lists.essential.org=0D
Subject: [Ip-health] GSK announces withdrawal of Combivir patent=0D
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Dear IP-Health readers,=0D
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Please find below the text of GlaxoSmithKline (From GSK Website, under=0D
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News Archive, 10 August 2006 link: http://www.gsk.com/media/archive.htm) in=
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which the company states that it decided to withdraw all of its patents and=
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patent applications for Combivir. It further states that this decision was=
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made a while ago, and that the company had instructed its agents in June to=
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withdraw the patent applications in India and Thailand, specifically.=0D
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With this move, GSK seems to have responded positively to the demands of=0D
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the Thai and Indian groups of people living with AIDS and their supporters.=
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However the information MSF has received from both Thailand and India does=
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not entirely match with what the company is stating.=0D
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The patent office in Thailand apparently did not receive notice of the=0D
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patent application withdrawal until getting a letter on 8 August, not in=0D
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June, as the company stated (as also reported in the 21 August TNA article=
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below). This was in fact one day after a large protest by patient and=0D
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treatment advocacy groups took place outside the GSK offices in Bangkok and=
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in Bangalore, India, urging the company to withdraw the Combid/Combivir=0D
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patent applications.  The Thai Commerce Ministry just yesterday in fact=0D
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sent a letter to the Thai Network of People Living With AIDS (TNP+) about=
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the patent withdrawal, attaching communication it received from GSK on 8=0D
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August, not June.=0D
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In India, GSK has not officially communicated about the patent application=
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withdrawal, and when the Manipur Network of People Living with HIV/AIDS /=
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Lawyers Collective HIV/AIDS Unit contacted the patent office, it found that=
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no official withdrawal has taken place.  The Indian Network for People=0D
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Living with AIDS (INP+), has now requested an official confirmation from=0D
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GSK that it is withdrawing the application in India, and a copy of those=0D
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instructions that it has sent to the patent office.=0D
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It seems clear that the protests had a significant effect. It is important=
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that parties are allowed to raise concerns about patents and their effects=
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on public health before a patent is granted.  The pre-grant opposition=0D
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process in particular is a crucial safeguard that needs to be protected.=0D
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MSF is concerned by the current move by Novartis in India to try challenge=
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a key safeguard of the Indian Patents Act, which prevents trivial patents.=
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In a hearing set for 26 September, Novartis will try to overturn a January=
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2006 ruling that set a precedent by denying the company's patent request=0D
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for the cancer drug Gleevec.  The drug was not patentable under Indian law=
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because it was merely a new form of a known substance.  These are also the=
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grounds on which the pre-grant oppositions to both GSK's patent application=
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for Combivir and Gilead's application for TDF were filed by Indian PLWHA=0D
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groups earlier this year.  MSF supports this process.=0D
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Also find attached below an article from this week's Fortune Magazine on=0D
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the attempts to patent ARVs in India. Note that the article makes no=0D
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reference to the GSK patent applications having been withdrawn. [this has=
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been deleted because it is identical to WBs posting this morning (patently=
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unfair) Moderator]=0D
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Ellen 't Hoen=0D
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MSF Access to Essential Medicines Campaign=0D
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Ellen.T.HOEN@paris.msf.org=0D
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>From GSK Website, under News Archive, 10 August 2006 link:=0D
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http://www.gsk.com/media/archive.htm=0D
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GSK patents and patent applications for Combivir=0D
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GSK offices in Thailand and India have recently been subject to=0D
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demonstrations against GSK's patents applications for COMBID/COMBIVIR in=0D
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those countries.=0D
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Prior to these demonstrations GSK had decided to withdraw its patents and=
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patent applications directed to a specific formulation of Combivir. In June=
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2006 GSK instructed its agents in Thailand and India to withdraw the patent=
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applications.=0D
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The patent and patent applications relating to this specific formulation of=
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Combivir have been withdrawn in all countries where it has been filed.=0D
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Other patents and patent applications relevant to Combivir and other GSK=0D
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antiretrovirals are not affected.=0D
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It is worth noting that these applications were made more than 8 years ago.=
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A combination of in country delays and the impact of TRIPs have meant that=
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these applications have only recently been subject to active processing.=0D
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GSK supports the World Trade Organisation's Trade-Related Aspects of=0D
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Intellectual Property Rights (TRIPs) agreement, including the public health=
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safeguards it contains. However, GSK believes that focus on patents in=0D
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addressing the challenge of HIV/AIDS is misguided and counterproductive.=0D
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New medicines and vaccines to address the challenge of HIV/AIDS are=0D
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desperately needed and the patent system fundamentally stimulates the=0D
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necessary research and development. The root cause of many countries=E2=80=
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inability to address HIV/AIDS does not lie with the patent system but with=
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the consequences of poverty, and lack of political will, leading to a lack=
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of healthcare infrastructure and resources.=0D
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GSK recognises the challenge that HIV/AIDS has put on health systems and=0D
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seeks to work in partnership with governments and NGOs to address this=0D
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challenge. Dialogue with us on this issue prior to the recent=0D
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demonstrations in Thailand and India would have made them unnecessary.=0D
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GSK's commitment and contribution to the fight against HIV/AIDS embraces=0D
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four key areas - investment in research and development (R&D), preferential=
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pricing of our antiretrovirals (ARVs), community investment activities, and=
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partnerships that foster effective approaches against the disease and the=
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challenges it presents. Details of our approach and progress can be found=
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at: http://www.gsk.com/responsibility/cr_issues/dev_world_challenges.htm=0D
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Glaxo withdraws AIDS drug patent application in Thailand=0D
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TNA 21 Aug 2006=0D
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BANGKOK, Aug 20 (TNA) - A phamarceutical giant decided to withdraw its=0D
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earlier application to seek a Thai patent for its anti-retroviral drug=0D
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Combid in a decision which will allow Thailand to produce a cheaper generic=
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version to treat AIDS patients, a senior government official said Sunday.=
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Commerce Ministry deputy permanent secretary Yanyong Phuangrach disclosed=
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that the Glaxo Group Limited Company informed the Intellectual Property=0D
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Department about its decision in its letter dated August 8.=0D
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The company provided no reason for its decision, but the move came after a=
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recent protest by hundreds of activists and HIV-infected patients at=0D
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Glaxo's Bangkok office.=0D
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They argued that the drug was not a newly researched product but simply a=
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combination of existing drugs.=0D
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The protestors also feared that the patent, if approved, would give the=0D
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UK-based company a monopoly on the sales of Combid in Thailand.=0D
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The withdrawal of Glaxo's patent application means that the Government=0D
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Pharmaceutical Organisation (GPO) will be able to continue production of=0D
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its generic version, known as Zilarvir, which is much cheaper.=0D
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Mr. Yanyong hailed Glaxo's decision as a good example of corporate=0D
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citizenship for other drug giants as the company has relinquished its=0D
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potentially huge financial gain in exchange for social contributions=0D
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benefiting Thailand. (TNA)-E001=0D
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