[Ip-health] Letter to UNITAID Board on Patent Pool Plan from the Lawyers Collective HIV/AIDS Unit

Fri Dec 11 10:21:01 2009

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[ Picked text/plain from multipart/alternative ]
10 December 2009

To

The Chair, UNITAID Board

Dr. Philippe Douste-Blazy

Special Adviser on Innovative Financing for Development

UN Under-Secretary General.

*Sub: *Concerns regarding the UNITAID Patent Pool Implementation Plan

Dear Dr. Douste-Blazy,

Greetings from Lawyers Collective HIV/AIDS Unit, India!

Lawyers Collective HIV/AIDS Unit (the Unit) was set up in 1998 premised on =
a
realisation that law, policy and judicial action based on the human rights
framework had a central role to play in effectively containing the HIV
epidemic.  The Unit provides free legal services to persons living with/
affected by HIV/AIDS and is involved in advocacy and policy research on
legal and human rights issues related to HIV/AIDS.  The Affordable Medicine=
s
and Treatment Campaign (AMTC) was launched in 2001 by the Unit, as the
inequity in access to lifesaving AIDS treatment was becoming an issue of
growing global outrage.

In 2005, given its obligations under the World Trade Organization=92s
Agreement on Trade Related Aspects of Intellectual Property (TRIPS), the
Indian Parliament enacted the Patents (Amendment) Act of 2005, introducing
product patent protection for pharmaceuticals.  With this Act, the ability
of the Indian pharmaceutical industry to continue providing affordable
medicines in India and throughout the developing world was placed in
jeopardy.  The Indian Parliament, mindful of the impact of patents on acces=
s
to medicines, made use of TRIPS flexibilities to retain and introduce key
public health safeguards in India=92s patent law.  These included:

=B7         *Patent Oppositions* allowing civil society and patients groups=
 to
challenge patent applications and granted patents;

=B7         A prohibition on *evergreening* (Section 3d) by recognising tha=
t
new forms, uses, combinations of existing medicines do not deserve patents;
and

=B7         Expansive *compulsory licensing* provisions.

Since 2005, the Unit has represented several patients=92 groups in utilisin=
g
these critical public health safeguards.  Our work includes successfully
opposing Novartis=92 patent application for *imatinib mesylate (Gleevec)* a=
nd
the consequent constitutional challenge to section 3(d).  We have also
represented patients=92 groups, both Indian and from other Global South
countries, in opposing patent applications relating to key HIV/AIDS drugs,
including *tenofovir*.

Over the past five years, Indian groups have taken the battle for access to
medicines to the multinational pharmaceutical companies by filing
oppositions, resisting legal challenges to undermine India=92s public healt=
h
safeguards or impose TRIPS-plus provisions and, in the process, demonstrate=
d
quite effectively the cracks and faults in the global intellectual property
system.  It is in the context of this battle for a more equitable global
paradigm for access to medicines that we write to express our grave concern=
s
about the outcome of the Patent Pool Implementation Plan.  Though we do not
have a copy of the proposed Implementation Plan, we have come to know
through various reports of certain key elements of the proposed
Implementation Plan, in respect of which we want to express our concerns.

We understand that the UNITAID Executive Board meets early next week to
discuss this Plan.   Our experience of opposing patent applications and
granted patents and the actions of multinational pharmaceutical companies
make us very wary of the impact of the UNITAID Patent Pool in ensuring
access to medicines for all those in the Global South who need them.  We ar=
e
of the view that voluntary licences, which the UNITAID Patent Pool
reportedly seeks to encourage, without adequate public health safeguards an=
d
public scrutiny, can actually encourage and strengthen the abuse of the
patent system by multinational pharmaceutical companies and allow them to
profit at the cost of millions of lives of people across the developing
countries.  We would like to voice our concerns by using the example of
Gilead=92s voluntary licences on *tenofovir*, a pre-1995 drug which should =
not
be patented in developing countries, and its patenting practices.

We choose the Gilead voluntary licences to discuss as these have been much
touted as good examples of licensing.  However, we believe picking the best
of the worst practices is hardly a standard to aspire to in promoting globa=
l
health equity.

As you are aware, *tenofovir* is a crucial antiretroviral for the treatment
of persons living with HIV.  The World Health Organization (WHO) now
recommends the use of *tenofovir* for use in first line drug regimens in
resource-poor settings.[i]<http://mail.google.com/mail/?ui=3D1&view=3Dpage&=
name=3Dgp&ver=3Dsh3fib53pgpk#_edn1>
 The WHO is also recommending early start of treatment, thus increasing
considerably the needs in developing countries for this medicine.  *
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.

Recognising the importance of access to this crucial medicine in developing
countries, Indian patients=92 groups filed challenges to Gilead=92s patent
applications in 2006.  Earlier this year, the Indian Patent Office rejected
two patent applications relating to *tenofovir* (*tenofovir disoproxil* and
*tenofovir disoproxil fumarate*) on several grounds, including that the
claims in these applications did not satisfy the patentability criteria of
inventive step and section 3(d) of the Indian patent law.  The Brazilian
Patent Office, too, had rejected similar patent applications relating to *
tenofovir*.

As you may have just read, Gilead has now challenged these decisions of the
Indian Patent Office.

In 2006, in a matter of days after the patent oppositions to tenofovir were
filed, Gilead offered voluntary licenses to 11 Indian generic companies,
several of whom had also filed pre-grant oppositions against Gilead=92s
multiple patent applications.  Subsequently, as a condition of the voluntar=
y
licences, they withdrew their pre-grant oppositions.  The only patent
oppositions that survived were those filed by patients=92 groups and Indian
generic companies, who had not entered into voluntary licences with Gilead.
Thus, in India, Gilead used the voluntary licences to restrict opposition t=
o
its patent applications and the exercise of pre-grant oppositions, a
recognised procedural TRIPS-flexibility.  It is important to note that, in
2006, Indian generic companies were well on their way to producing generic =
*
tenofovir*, and there are no patent barriers in India with respect to *
tenofovir* till date.  Statements reportedly attributing the increase in
competition to the voluntary licences issued by Gilead therefore do not
present the entire picture on generic *tenofovir*.

Despite India being included in the voluntary licence, patient groups,
however, persisted in their oppositions.  As one of them noted, this was
because, =93*We know that the battles we are fighting in India are not just
for us but for patients across the developing and least developed world who
are entitled to access the best treatment options without discrimination*.=
=94
[ii]<http://mail.google.com/mail/?ui=3D1&view=3Dpage&name=3Dgp&ver=3Dsh3fib=
53pgpk#_edn2>

The decisions of the Indian and Brazilian Patent Offices on these patent
applications only serve to underscore how the adoption of strict
patentability criteria would actually ensure that only truly new and
inventive medicines are patented and thus obviate the need for voluntary
licences.  However, through the voluntary licences, Gilead profited from th=
e
mere filing of patent applications, which have subsequently been
rejected.  This
battle is, however, far from over.  Civil society groups have now discovere=
d
divisional applications filed by Gilead in both India and Brazil, which are
under examination.  The divisional patent applications and appeals are
obviously a strategy employed by Gilead to hold on to its royalty revenue
stream from the voluntary licences entered into with several Indian generic
companies on patents that do not even exist and to attempt to charge
exorbitant prices from the Brazilian healthcare system.

Further, the voluntary licences entered into by Gilead included the least
developing countries (LDCs), which are not even required to grant patents o=
n
pharmaceutical products until 2016.  In 97 of the 99 licensed countries to
which *tenofovir* can be exported on payment of royalty by the Indian
generic companies, Gilead had not even filed patent applications relating t=
o
*tenofovir*.[iii]<http://mail.google.com/mail/?ui=3D1&view=3Dpage&name=3Dgp=
&ver=3Dsh3fib53pgpk#_edn3>
 It should be noted that LDCs have until 2016 to comply with the TRIPS
deadline for granting patents on pharmaceutical products.  Gilead=92s
voluntary licence, thus, takes away from such LDCs the benefits of the 2016
deadline to comply with the TRIPS Agreement.

It is also important to note that Gilead excluded several developing
countries, including Argentina, Brazil, Bulgaria, Chile, China, Colombia,
Cost Rica, Ecuador, El Salvador, Fiji, Malaysia, Mexico, Paraguay, Peru,
Philippines, Sri Lanka, Uruguay and
Venezuela.[iv]<http://mail.google.com/mail/?ui=3D1&view=3Dpage&name=3Dgp&ve=
r=3Dsh3fib53pgpk#_edn4>
Thus, the products manufactured by Indian generic companies under the
voluntary licences cannot be exported to these countries.  It is apparent
that the list excludes several developing countries, who have an immediate
and huge need for access to *tenofovir*.  The exclusion allows Gilead to
continue to charge high prices in these countries.  The most striking
example is that of Brazil.  In Brazil, Gilead sells *tenofovir* for USD
1,387[v]<http://mail.google.com/mail/?ui=3D1&view=3Dpage&name=3Dgp&ver=3Dsh=
3fib53pgpk#_edn5>per
patient per year; in comparison, the cheapest available generic
version
manufactured in India costs only USD
99[vi]<http://mail.google.com/mail/?ui=3D1&view=3Dpage&name=3Dgp&ver=3Dsh3f=
ib53pgpk#_edn6>per
patient per year.
We apprehend that similar exclusions will be placed by the vested interests
of the multinational pharmaceutical companies in the licences negotiated by
the Patent Pool to the detriment of patients in developing countries.

Gilead=92s voluntary licence serves as an indicator of how the Patent Pool =
is
likely to work to the disadvantage of patients in the Global South.  It
provides several critical lessons, which we hope the Executive Board will
take into account while discussing the proposed Implementation Plan.  It
shows how companies use voluntary licences to divide up developing countrie=
s
based purely on considerations of profits and isolate patients in those
developing countries unfortunate enough to meet some artificial economic
criteria that is not reflective of their actual treatment needs.

The insistence by certain multinational pharmaceutical companies of
excluding certain developing countries and requiring additional negotiation=
s
or the creation of conditions and incentives for their inclusion in the Poo=
l
is actually a ploy to leave certain countries out of the Pool.  We are
gravely concerned that such exclusionary practices would run counter to the
objective of increasing access to medicines to those who require it.

We further note with concern that the =93Statement on Patent Pool Scope=94
issued on 8 December 2009 merely states that =93*the Patent Pool plan aims =
to
enable both low- and middle-income countries to benefit from the work of th=
e
Patent Pool*=94, but stops short of an assurance that all developing countr=
ies
would be included and benefit from the Patent Pool.

It is also our belief that the impact of voluntary licenses from the Patent
Pool on patent oppositions will be similar to what happened in the case of =
*
tenofovir*, *regardless* of whether this is a term of the Patent Pool
licences or not.  For us, the question then becomes whether the Patent pool
mechanism will promote abusive patenting practices by companies filing
multiple applications to create multiple and extended monopolies on
medicines whose patents they contribute to the pool.

The lack of consultation and transparency in the drafting and finalisation
of the UNITAID Patent Pool Implementation Plan further lends to our
misgivings about the Patent Pool.

We would therefore urge the Executive Board to ensure that the Patent Pool
Implementation Plan does not in any manner compromise the manner in which
countries are able to utilise the TRIPS flexibilities=97including that of
stricter patentability criteria, oppositions and compulsory licensing.
 Accountability
to patients and transparency should guide the work of international aid
agencies committed to ensuring access to medicines for patients.  Further,
if the proposed Implementation Plan is to gain any measure of legitimacy,
the finalisation of Patent Pool Implementation Plan ought to be done in a
transparent manner based on consultations with stakeholders, most
importantly patients=92 groups and civil society from the Global South.

It is indeed appropriate that we write this letter to the UNITAID Executive
Board on the occasion of World Human Rights Day.  Lawyers Collective
HIV/AIDS Unit is dedicated to the spirit of the late activist Dominic
D=92Souza, who said, =93*I live in the hope of a world that will be, if not=
 free
of disease, free of fear and discrimination.*=94  We firmly believe that th=
e
right to health and to access medicines is a right that must be enjoyed by
all persons in all developing countries without exclusion or discrimination=
.
We trust that the UNITAID Executive Board will examine and hold
consultations on the Patent Pool Implementation Plan from this critical
perspective of human rights.

In solidarity,

Julie George,

For Lawyers Collective HIV/AIDS Unit

------------------------------

[i]<http://mail.google.com/mail/?ui=3D1&view=3Dpage&name=3Dgp&ver=3Dsh3fib5=
3pgpk#_ednref1>=93New
HIV recommendations to improve health, reduce infections and save lives=94,=
 20
November 2009, *available at*
http://www.who.int/mediacentre/news/releases/2009/world_aids_20091130/en/in=
dex.html

[ii]<http://mail.google.com/mail/?ui=3D1&view=3Dpage&name=3Dgp&ver=3Dsh3fib=
53pgpk#_ednref2>
Neville
Selhore of Sahara, (a co-petitioner with the Brazilian groups in a pre-gran=
t
opposition to one of Gilead=92s tenofovir patent applications in India) quo=
ted
in =93Patent Denied in India=94, ABIA Press release, 4 September 2009.

[iii]<http://mail.google.com/mail/?ui=3D1&view=3Dpage&name=3Dgp&ver=3Dsh3fi=
b53pgpk#_ednref3>
=93Knowledge
Ecology International request for investigation into anticompetitive aspect=
s
of Gilead Voluntary Licences for patents on Tenofovir and Emtricitabine=94,=
* *12
February 2007, at page 13=9615.

[iv]<http://mail.google.com/mail/?ui=3D1&view=3Dpage&name=3Dgp&ver=3Dsh3fib=
53pgpk#_ednref4>=93Knowledge
Ecology International request for investigation into anticompetitive aspect=
s
of Gilead Voluntary Licences for patents on Tenofovir and Emtricitabine=94,=
 12
February 2007, at page 12.

[v]<http://mail.google.com/mail/?ui=3D1&view=3Dpage&name=3Dgp&ver=3Dsh3fib5=
3pgpk#_ednref5>
=93Patent
Denied in India=94, ABIA press release, 4 September 2009.

[vi]<http://mail.google.com/mail/?ui=3D1&view=3Dpage&name=3Dgp&ver=3Dsh3fib=
53pgpk#_ednref6>
Clinton
Foundation, Antiretroviral (ARV) Price List, 2009, *available at*
http://www.clintonfoundation.org/files/chaiarvpricelistaugust2009english.pd=
f.

Regards,
Prathibha.S
Lawyers Collective HIV/AIDS Unit