[Ip-health] Key AIDS drugs’ patent applications rejected by In dian Patent Office

[Julie George]

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[ Picked text/plain from multipart/alternative ]
*Key AIDS drugs’ patent applications rejected by Indian Patent office*

1 September 2009, Mumbai.



Greetings from Lawyers Collective HIV/AIDS Unit, India!



We write to bring you an update of the patent applications in India relating
to tenofovir and darunavir.



In decisions that will have a positive impact access to cheaper, generic
medicines to many people living with HIV across the world, the Indian Patent
Office at New Delhi has rejected two patent applications filed by Gilead
Sciences, Inc. relating to tenofovir and one patent application filed by
Tibotec Pharmaceuticals, Inc. relating to darunavir.  The decisions were
delivered on pre-grant oppositions filed by Indian pharmaceutical companies.




As you are aware, tenofovir is a crucial antiretroviral for the treatment of
persons living with HIV.  The World Health Organization (WHO) recommends
tenofovir for use in first and second-line drug regimens in resource-poor
settings.  Tenofovir is commonly prescribed and widely available to persons
living with HIV in the United States and Europe. However, tenofovir remained
largely unavailable in developing countries until generic production was
commenced by Indian pharmaceutical companies. Darunavir, a protease
inhibitor boosted with ritonavir, is also an important second-line treatment
option.



Clearly concerned about the impact of a possible grant of patents on
tenofovir, a key AIDS drug, Indian PLHIV networks and Associação Brasileira
Interdisciplinar de AIDS (ABIA), a Brazilian non-governmental organization,
had filed pre-grant oppositions at the Delhi Patent Office to oppose the
grant of patents on tenofovir in India.



While the pre-grant oppositions filed by patients’ groups and several Indian
pharmaceutical companies were pending before the Delhi Patent Office, Gilead
Sciences, Inc. reportedly negotiated voluntary licences relating to
tenofovir with several Indian pharmaceutical companies.  However, the
contents of the voluntary licences remain undisclosed to the public and the
impact of these voluntary licences on access to tenofovir in several other
developing countries remains unclear.



The details of the patent applications that have been rejected are given
below:

(1)     tenofovir disoproxil (Indian Patent Application 2076/DEL/1997 =
WO/1998/004569) – an ester prodrug of tenofovir

(2)     tenofovir disoproxil fumarate (Indian Patent Application
896/DEL/2002A) [a divisional application in India of 2174/DEL/1998 =
WO/1999/005150] – a salt form of tenofovir disoproxil

(3)     pseudopolymorph of darunavir (Indian Patent Application
3598/DELNP/2004 = WO/2003/106461)



All these patent applications have been rejected by the Indian Patent Office
on the grounds that they lack inventive step and fail to satisfy the
requirement of enhanced efficacy under section 3(d) of the Patents Act,
1970.  Two of them have also been rejected on the ground of insufficiency of
description.



However, the battle is not yet over. Gilead Sciences, Inc. has already filed
divisional applications to both 2076/DEL/1997 and 896/DEL/2002.  These
patent applications are pending before the Indian Patent Office at New Delhi
.



In June this year, Brazil too rejected Gilead’s patent application for
tenofovir. However, patents relating to tenofovir and darunavir have been
granted in several countries and remain unchallenged.



We will make the copies of the decisions available on our website (
www.lawyerscollective.org) shortly.



In solidarity,

Lawyers Collective HIV/AIDS Unit