TWN Info Service on Intellectual Property Issues (Oct06/01)

10 October 2006

GSK SAYS PATENT APPLICATIONS RELATED TO COMBIVIR HAVE BEEN WITHDRAWN

An entry on the Glaxo Smith Kline website states:

“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The patent and patent applications relating to this specific formulation of Combivir have been withdrawn in all countries where it has been filed.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.”

Do also note the response of MSF (Doctors without borders on this issue).

Best Wishes
Sangeeta S.
Third World Network
Tel: +41 (0) 22 908 3550
Fax: +41 (0) 22 908 3551
Email: ssangeeta@myjaring.net

See entry dated August 10, 2006 titled “GSK patents and patent applications for Combivir” at http://www.gsk.com/media/archive.htm

“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The patent and patent applications relating to this specific formulation of Combivir have been withdrawn in all countries where it has been filed.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.”

RESPONSE OF MSF ON IP-HEALTH LIST SERV

Dear IP-Health readers,

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.