Letter to the UNITAID Board on Patent Pool Implementation Plan from the Lawyers Collective HIV/AIDS Unit

[Guest guest]

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 Medicines 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's

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 access to medicines, made use of TRIPS

flexibilities to retain and introduce key public health safeguards in India's

patent law. These included:

* Patent Oppositions allowing civil society and patients groups to

challenge patent applications and granted patents;

* A prohibition on evergreening (Section 3d) by recognising that new

forms, uses, combinations of existing medicines do not deserve patents; and

* Expansive compulsory licensing provisions.

Since 2005, the Unit has represented several patients' groups in utilising these

critical public health safeguards. Our work includes successfully opposing

Novartis' patent application for imatinib mesylate (Gleevec) and the consequent

constitutional challenge to section 3(d). We have also represented patients'

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's public health safeguards or

impose TRIPS-plus provisions and, in the process, demonstrated 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 concerns 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 are of the view that voluntary

licences, which the UNITAID Patent Pool reportedly seeks to encourage, without

adequate public health safeguards and

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's 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 global 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.

<http://mail.google.com/mail/?ui=1 & view=page & name=gp & ver=sh3fib53pgpk#_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' groups filed challenges to Gilead's 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's multiple patent

applications.

Subsequently, as a condition of the voluntary licences, they withdrew their

pre-grant oppositions. The only patent oppositions that survived were those

filed by patients' 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 to 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, " 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. " [ii]

<http://mail.google.com/mail/?ui=1 & view=page & name=gp & ver=sh3fib53pgpk#_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 the mere filing of patent applications,

which have subsequently been rejected.

This battle is, however, far from over. Civil society groups have now

discovered 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 on

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 to tenofovir.[iii]

<http://mail.google.com/mail/?ui=1 & view=page & name=gp & ver=sh3fib53pgpk#_edn3>

It should be noted that LDCs have until 2016 to comply with the TRIPS

deadline for granting patents on pharmaceutical products. Gilead's

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=1 & view=page & name=gp & ver=sh3fib53pgpk#_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=1 & view=page & name=gp & ver=sh3fib53pgpk#_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=1 & view=page & name=gp & ver=sh3fib53pgpk#_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's 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 countries 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 negotiations or

the creation of conditions and incentives for their inclusion in the Pool 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 " Statement on Patent Pool Scope "

issued on 8 December 2009 merely states that " the Patent Pool plan aims to

enable both low- and middle-income countries to benefit from the work of the

Patent Pool " , but stops short of an assurance that all developing countries

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-including 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' 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'Souza, who said,

" I live in the hope of a world that will be, if not free of disease, free of

fear and dscrimination. " We firmly believe that the 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,

,

For Lawyers Collective HIV/AIDS Unit

_____

<http://mail.google.com/mail/?ui=1 & view=page & name=gp & ver=sh3fib53pgpk#_ednre

f1> " New HIV recommendations to improve health, reduce infections and

save lives " , 20 November 2009, available at

<http://www.who.int/mediacentre/news/releases/2009/world_aids_20091130/en/in

dex.html>

http://www.who.int/mediacentre/news/releases/2009/world_aids_20091130/en/ind

ex.html

<http://mail.google.com/mail/?ui=1 & view=page & name=gp & ver=sh3fib53pgpk#_ednre

f2> [ii] Neville Selhore of Sahara, (a co-petitioner with the Brazilian

groups in a pre-grant opposition to one of Gilead's tenofovir patent

applications in India) quoted in " Patent Denied in India " , ABIA Press

release, 4 September 2009.

<http://mail.google.com/mail/?ui=1 & view=page & name=gp & ver=sh3fib53pgpk#_ednre

f3> [iii] " Knowledge Ecology International request for investigation into

anticompetitive aspects of Gilead Voluntary Licences for patents on

Tenofovir and Emtricitabine " , 12 February 2007, at page 13-15.

<http://mail.google.com/mail/?ui=1 & view=page & name=gp & ver=sh3fib53pgpk#_ednre

f4> [iv] " Knowledge Ecology International request for investigation into

anticompetitive aspects of Gilead Voluntary Licences for patents on

Tenofovir and Emtricitabine " , 12 February 2007, at page 12.

<http://mail.google.com/mail/?ui=1 & view=page & name=gp & ver=sh3fib53pgpk#_ednre

f5> [v] " Patent Denied in India " , ABIA press release, 4 September 2009.

<http://mail.google.com/mail/?ui=1 & view=page & name=gp & ver=sh3fib53pgpk#_ednre

f6> [vi] Clinton Foundation, Antiretroviral (ARV) Price List, 2009,

available at

<http://www.clintonfoundation.org/files/chaiarvpricelistaugust2009english.pd

f>

http://www.clintonfoundation.org/files/chaiarvpricelistaugust2009english.pdf