[Ip-health] First thoughts on the petition to the Medicines Patent Pool Foundation

Jamie Love james.love at keionline.org
Mon Oct 10 15:37:50 PDT 2011


Dear  Jérôme Martin,

Last I checked, I was an activist.  And, whether there are 200 or 200,000
signatures on a petition, part of having a "debate" is having people express
their opinions.    That includes the people who signed the petition.  That
also includes others.  To do justice to the issues raised in the petition
takes at least a little bit of time.

I noted some of the areas where we agree with the petition, and there are
other areas where I think the petition presents a compelling case.  In some
other areas, we don't think the petition presents a balanced view of the
license.  One concerns is this statement in the petition:

==========
3) The undermining of the free and full use of TRIPS flexibilities by
countries through restrictive provisions in the licences including:

(b) the imposition of restrictions on the use of compulsory licenses (CLs)
by requiring the prior permission of Gilead, thus affecting both importing
and exporting countries (and placing additional barriers on the use of the
August 30 Decision);
===========

It is true that the MPP sub-license does require an agreement, but not to
obtain a CL, but rather on such things as the "requirements of such law,
rule or regulation" and the "affect" on the agreement, or "regarding the
existence, scope and content of such compulsory license," noting that such
agreement may "not to be unreasonably withheld."

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

7.3 Law Compliance
(c) Conflicts. None of the parties shall be required to take any action or
perform any obligation under this Agreement to the extent that such action
or obligation is in direct conflict with any applicable law, rule or
regulation, including rights or obligations created as a result of a
government issuance of a compulsory license relating to API or Product,
provided, however, that Gilead and Licensee are in agreement (with such
agreement not to be unreasonably withheld) regarding (i) the requirements of
 such law, rule or regulation, and (ii) the affect that such law, rule or
regulation has on such action or obligation required under this Agreement.
----------------

10.3  Gilead Right to Terminate

(d) For further clarity, and notwithstanding anything to the contrary in
this Agreement, it shall not be deemed to be a breach of the Agreement for
Licensee to supply an API or Product outside the Territory into a country
where (i) the government of such country has issued a compulsory license
relating to such API or Product allowing for the importation of such API or
Product into such country, provided Licensee and Gilead are in agreement
(with such agreement not to be unreasonably withheld) regarding the
existence, scope and content of such compulsory license and/or (ii) the
Government of India has issued a compulsory license allowing for the export
of an API or Product from India and into such country, provided that (Y)
there are no Patents containing a valid claim covering the use, import,
offer for sale or sale of such API or such Product in such country or a
compulsory license has also been issued by the relevant authorities of such
country and (Z) Licensee and Gilead are in agreement (with such agreement
not to be unreasonably withheld) regarding the existence, scope and content
of such compulsory license.
-------------------------------------

Not to put too fine a point on it, but I think the petition will be read by
some to suggest that Gilead gets to agree on a compulsory license being
issued, and that certainty is not the case.  This is very important, and
worth focusing on.  Are there different ways to write such a clause?  Maybe.
 Do people have examples one can look at?  I personally did not think the
issue raised in the petition was a problem in the license.  Indeed, I
thought it was a very big achievement from the MPP to get this clause in the
license.  It changes the restrictive nature of the earlier Gilead license --
 the one that KEI had earlier (2007) filed an antitrust compliant about with
the FTC.

I do appreciate the point in the petition that Gilead can to raise paragraph
6 issues, but I don't think they will get far if the CL for export is issued
under India law.

Another point is the following.  The petition says the licenses harm LDCs
by:

---------------
(a) circumventing the 2016 TRIPS deadline for least developing countries
(LDCs) by allowing royalties on medicines supplied to them, even though
these countries do not have to impose patents on essential medicines until
2016;
--------------
Strictly speaking, one might (and some have) argue that the license only
requires royalties be paid in India, if India has a patent, and not in
countries where the product is exported to.  But I agree with the petition
on the broader point.  As a practical matter, by limiting production to
India, the license is designed to ensure that royalties are paid everywhere
in the licensed areas.  And I agree that it is unfortunate that the license
does this    But I don't think this has anything to do with the 2016 TRIPS
extension in LDCs, or for that matter, for LDC countries in general.  Almost
all LDCs already grant pharmaceutical product patents, and as the patent
landscape documents show, lots of patents are filed in LDC countries, not
only by big pharma, but even by Universities and generic drug companies.
 Moreover, I think that LDC countries are big beneficiaries of the voluntary
licenses, because you don't have to sort through the legal issues in LDCs --
 the voluntary license includes all of the LDCs.  Plus, even the paragraph 6
provisions are much easier for LDC countries to comply with.  So the
petition takes a general point about paying royalties everywhere, and makes
it look as if this is something attacking LDC countries.  I don't think that
deepens people's understanding of the license.

It is late for me, given some other big deadlines I have.  But we can
comment more later.  In general however, I don't want to sound entirely
negative, because we are not.  The petition raises lots of points, and often
does so with clarity and power.   We are not signing the petition, due to
some differences we have with the analysis, and in the tone and strategy,
including what we see as unnecessary attacks on the patent pool staff and
board.

>>So you should reconsider this public reaction : it is still time to accept
a legitimate and
>>constructive debate, and to act properly with your partners.

Jérôme Martin, I find parts of your note unnecessarily insulting.   But
given your suggestion to reconsider our public reaction and role in these
debates, I have to ask, what constraints do you recommend?  What is
"legitimate and constructive"?  We are saying what we honestly believe on
something we have worked on for 9 years.

I think the petition contributes to the debate, even though we don't agree
with everything it says.  I would hope you would listen to us, as we listen
to others.

 Jamie

On Mon, Oct 10, 2011 at 4:37 PM, Jérôme Martin <jeromemartin at samizdat.net>wrote:

> So, James, what do you suggest now ? To close the debate ? and to the
> stupid activists to shut up because YOU only know better ? Is it what
> that you call "moving forward" ? Do you think that all the activists
> that have signed are just silly ?
>
> This rhetoric is unbearable.
>
> Once again, we NEED answers to the questions otherwise we are not
> supporting anything and not going anywhere any longer.
>
> Telling, as you just did, that some concerns are not
> accurate without justifying it, asserting that the criticisms, questions
> and demands of 200 activists are not realistic, calling these crucial
> questions "technical" to explain that you have no time to adress it,
> adressing the concerns by the leitmotiv of the "pragmatism" ("this is
> not possible, trust me, I know better, and if we criticize and demand
> too many emprovements, it would destroy everything") : these has nothing
> to do with a balanced reaction in a legitimate debate.
>
> So you should reconsider this public reaction : it is still time to
> accept a legitimate and constructive debate, and to act properly with
> your partners.
>
> Jérôme Martin
> Act Up-Paris
>
> Le lundi 10 octobre 2011 à 14:51 -0400, Jamie Love a écrit :
> > Below is a link to a 2,227 word petition begin circulated about the
> > medicines patent pool, probably with considerable input from IMAK and the
> > ITPC.
> >
> > http://www.ipetitions.com/petition/mpp/
> >
> > The petition is highly critical of the MPP.  It has at this point a large
> > number of signatures.   While we agree with some parts of the long
> petition,
> > we disagree with other parts, and will not be signing the petition.   In
> our
> > opinion, some parts of the petition repeat assertions that are not
> accurate,
> > and do not provide a helpful or balanced view of what the Gilead licenses
> > did and did not do.  In some other areas, we agree with the concerns set
> out
> > in the petition, for example, as regards the importance of permitting
> > generic product outside of India -- a topic that we also think can be
> > modified.
> >
> > When we have some time to go over the technical details, we will comment
> > further.  But in general, the petition will be seen by many, including
> those
> > in UNITAID, as part of an effort to kill the patent pool, or remove its
> > current leadership.  If this effort succeeds, where does that leave
> > everyone?
> >
> > In theory, the licenses could have been better, and indeed, Gilead may
> agree
> > to further amendments -- for example, to allow products from some
> countries
> > outside of India.  However, the sweeping changes in the licenses that are
> > set out the petition, while desirable, were not about to happen, and I
> > think, won't happen, without something more substantial changing the
> > negotiation.    People can set the bar higher -- but setting the bar too
> > high means no licenses at this point.
> >
> > If the patent pool is stopped from negotiating further licenses, either
> > telling them to stop or by setting the bar too high to get further
> licenses,
> > I would ask, why is that a good thing?
> >
> > There are some people who want to (a) change national laws to eliminate
> > patents on drugs, and failing that to (b) invalidate patents that have
> been
> > granted, and failing that to obtain (c) voluntary or (d) compulsory
> licenses
> > (in different sequences).    No one that has signed the petition and no
> one
> > that has not signed the petition is going to eliminate all of the laws
> > requiring the granting of patents, even in LDC countries (Since 2001,
> there
> > has NOT been a rush to change patent laws in LDCs).  No one is going to
> > invalidate relevant patents on HIV drugs in 150 countries.  No one is
> going
> > to obtain compulsory license in all countries where patents exist, and
> > without some big change in the negotiating strategy, no one is going to
> > obtain voluntary licenses for all products and all countries.  For the
> tens
> > of millions of persons living with HIV, all of these mechanisms are
> > important.
> >
> > As I noted earlier, in some areas, we agree with the petition.  KEI has
> long
> > taken the position that the MPP should issue standardized licenses, and
> that
> > the various proposals for the license should be presented for everyone to
> > review  and comment, before they are signed.  The MPP is a norm setting
> > process, and it should be open and inclusive.
> >
> > The MPP can operate in a more transparent manner than it has, although,
> in
> > defense of the patent pool, it has had an open door, and always been
> willing
> > to meet with people, take calls, and answer questions.  It is only
> recently
> > than many groups have begun to engage on the technical details, and that
> > discussion has not always been well informed on some key issues.
> >
> > But even with a transparent process, there is the reality that the major
> > patent owners are not all ready to give up their patent claims in all
> > developing countries.  This is not the fault of the patent pool.   A good
> > strategy going forward needs to address this reality, and present a
> feasible
> > path for access to persons living with HIV.
> >
> > Without some game changing innovations in the negotiating strategy, the
> > patent pool licenses from big drug companies will only cover some
> products
> > and some countries.   In our opinion, the most important thing to push
> for
> > in the licenses is that the licenses are open, not bundled, and that they
> > freely permit license holders to challenge patents, patent laws, and
> obtain
> > compulsory licenses.   The MPP licenses did this.  The many countries
> left
> > outside of the license area have to have a strategy to obtain access to
> the
> > new drugs.  The MPP licenses do make them better off in one important way
> --
> > they create a competitive source of supplies, in the event that they can
> > obtain a paragraph 6 request from India to supply their markets.  No one
> > thinks this is perfect.  But people who are being negative should set out
> > the alternatives.
> >
>
>
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-- 
James Love.  Knowledge Ecology International
http://www.keionline.org, +1.202.332.2670, US Mobile: +1.202.361.3040,
Geneva Mobile: +41.76.413.6584, efax: +1.888.245.3140.  Sometimes I am using
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