[Ip-health] DE in India - A response to James Love

[James Love]

I was asked by the lawyers collective to post this response to my
early note on the Indian debate over protection on pharmaceutical
test data.  The comment is signed by the Delhi Network of Positive
People, Lawyers Collective HIV/AIDS Unit, Alternative Law Forum, and
Center for Trade and Development.

Jamie

----- Original Message -----
From: aidslaw@lawyerscollective.org
To: James Love
Sent: Friday, October 13, 2006 6:57 PM
Subject: DE in India - A response to James Love

Indian health groups will continue to oppose Data Exclusivity

On October 10, 2006 a posting on the IP Health list serve entitled
=91India, TRIPS, TRIPS+, and new paradigms=92 discusses the issue of
political pressure on India to introduce a law that incorporates
=91Data Exclusivity=92 (DE) and advises Indian organizations on the
approach they should adopt. We were rather surprised that this
=91advice=92 was communicated to Indian groups through IPHealth rather
than through direct dialogues and consultations on the subject with
us. Indian organizations that have been researching and working on
the issue in the last decade greatly differ with the opinion
expressed by James Love of CPTech for the following reasons:

The data exclusivity debate in India

A debate on Data Exclusivity and India is very important, as India
currently is the largest supplier of affordable medicines to the
developing countries. Market exclusivity in any form =96 through
patents or data exclusivity =96 affects this supply. The developing
world is thus supporting India against such measures.

On Article 39.3 as Jamie Love has pointed out, DE is not a TRIPS
requirement. At the same time he calls this interpretation a
=91minimalist=92 or =91hard-line=92 position. Rather, we feel that this is
the only reasonable interpretation of Article 39.3. The Government of
India has also accepted that DE is not a TRIPS requirement. Despite
this James Love argues that the introduction of DE is inevitable; an
argument he supports only on the grounds of =91political realities=92
which we believe are significantly different from those perceived by
him.

Unlike other countries the DE debate in India has not cropped up in
the context of formal bilateral negotiations with the US but is
something that the Government of India is considering more as a
unilateral measure. There is no doubt that this is under indirect
pressure from the US and the EU, however the same can/should and is
in fact being countered through democratic and parliamentary
processes. Thus, comparing India=92s situation with the numerous
countries which introduced DE through free trade agreements is
inapposite.  Rather, India=92s situation is more akin to that of
countries like Brazil, which, solely within the context of
implementing Article 39.3 of TRIPS, considered and rejected DE.

The DE issue has arisen in the context of the implementation of TRIPS
in India and is a debate going on within and without government for
almost four years now. Many government officials themselves oppose
data exclusivity and a committee that has been appointed to look at
DE has been unable to come to a conclusion in favour of DE despite
immense (PHaRMA and USTR) lobbying and pressure.

The compensation liability model which the IP health posting argues
so strongly for, while it did make a brief appearance on the table,
has been rejected as unworkable by the government committee looking
at the issue. In any event, a compensation liability model is in fact
DE in another form. While we agree that the =91right of remuneration=92
recommended by CPtech may be the most reasonable formulation of this,
there is nothing to support the argument that the Indian government
or pharma would accept this formulation. In fact, the compensation
liability model as discussed by the government committee was not the
model that was suggested by CPtech but by European pharma through a
bureaucrat. In any case, as we have said, we are unable to agree that
there is any requirement at all for its introduction in Indian law.

The only context in which DE is now being discussed in India is that
of providing incentives for innovation and research =96 incentives
which have already been provided through product patent protection
which in any case have already threatened the supply of affordable
and accessible medication not only in India but to the entire world.
DE, in any form, would mean the introduction of further monopolistic
rights that would jeopardize generic manufacture in India and must be
rejected outright.

India IS different

It is difficult to imagine a universal strategy to deal with patents,
DE or any other IP issue that would automatically be applicable in
India. We understand that the views expressed in the posting are
based on the experience with IPR debates and battles in other
countries; however we find little to compare in their situation and
ours.

Other countries do not have a generic industry that is 15,000
manufacturers strong =96 an outcome of the different path that India
adopted on patents by allowing only for process patents rather than
product patents between 1970 and 2005. And clearly political lobbying
systems in India are significantly different from those of other
countries. This is clearly evident from the way unique provisions of
the Indian patent law that were debated and included in 2005 when
India became =91TRIPS-compliant.=92

If one were to argue on inevitabilities and =91how the world is=92,
Indian generic companies would never have announced affordable AIDS
drugs for the world; we would not have lobbied and fought in March
2005 for provisions like Section 3(d) to be introduced in Indian
Patent law which address evergreening; we would not file pre grant
oppositions for HIV and other essential drugs; we would not have
fought for and succeeded in having Novartis=92 patent application for
the anti cancer drug =91imatinib mesylate=92 rejected; and we would not
have succeeded in opposing DE and keeping alive a robust and public
debate on the issue between government, pharma and patient groups for
the past two years.

It would seem there are several =91firsts=92 in the Indian =91experiment=92=
 -
to argue then on inevitabilities is to ignore the battles and
victories of the past few years of Indian activists and groups and
the unique political, legal and economic realities of India. India=92s
political trajectory is different, it has always been so and civil
society in India will ensure that it will continue to be different.
Developing countries are looking at how India implements Article
39.3; and more importantly how it balances the concerns of industry,
government and patient groups. If once again the Indian government
takes the lead, as it did in the case of the Indian Patents Act in
2005, in interpreting and applying a different IP regime it would
strengthen the design of a TRIPS paradigm that is decidedly different
from the one that developed countries are under; one that properly
reflects and includes the concerns of developing countries.

We fully recognise that the fight against the introduction of DE will
be difficult, but that does not mean that we will not continue to
oppose =91TRIPS-PLUS=92 provisions in India. The =91political bullying=92
will never stop. Its DE today, it will be SPLT tomorrow. A clear
stand against such TRIPS-PLUS provisions will have to be taken as it
greatly affects future decisions regarding other TRIPS-PLUS laws/
treaties that impact public health.

For all the reasons above and more, we clearly and strongly reiterate
our complete opposition to the introduction of DE in any form in
Indian law. We continue to seek the support of international
colleagues in this opposition.

In solidarity,

Delhi Network of Positive People
Lawyers Collective HIV/AIDS Unit
Alternative Law Forum
Center for Trade and Development