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

Jamie Love james.love at keionline.org
Tue Oct 11 06:03:59 PDT 2011


Jérôme Martin,

No one appreciates being told they need permission from anyone to speak
freely on this or any other issue.  People should say that they think, and
think about what they say.

There is a very long and very relevant history to the development of the
patent pool that people should talk about.  One aspect is that the idea of a
patent pool was proposed and considered by all sorts of fora and entities
before it was embraced by UNITAID.  The African Union, a BRICS group,
CARICOM, ASEAN, and other regional developing country groups at various
times from 2002 to 2007 discussed creating various types of patent pools
similar to what UNITAID eventually set up.  The WHO and the Global Fund were
asked to sponsor the patent pool, for example, in 2005, some 6 years ago.
 The UK Commission for Africa considered a proposal.  There was also a
proposal to create a completely private patent pool, called the Essential
Medical Innovation Licensing Agency  (EMILA), that probably would have moved
forward if UNITAID did not embrace the patent pool, as it did quite
seriously in 2008.  One of the early launches of the UNITAID patent pool was
in the 2008 AIDS conference in Mexico.

UNITAID's interest in this was due to the leadership of Jorge Bermudez,  the
first UNITAID Executive Secretary. As a Brasilian negotiator at the WHO, it
was Bermudez who pushed to create the WHO CIPIH, which started the modern
efforts at the WHO to deal with IPR and innovation and access issues.
 UNITAID reached out to activists, and presented the patent pool work at a
zillion conferences and regional meetings, as I am sure that you know.  I
have repeatedly asked UNITAID to provide a list of the various meetings and
consultations that UNITAID held on this.  I think people should look at it,
when considering the allegations of lack of transparency and secrecy,
because these are relevant data points in how people evaluate the
motivations of the patent pool leadership, which have been questioned so
harshly in the petition.

During the 3 years between the Mexico AIDS Conference and the first
licenses, there was considerable confusion about what a pool would would
look like and do, since the collective management of IPR rights was
something fairly novel in this area.  Many thought it would be something
like a standards patent pool  - the most common model for a patent pool in
recent years.  There was some discussion about the relationship between
voluntary and non-voluntary licensing, and about how comprehensive would be
the geographic coverage, particularly in light  to the existing voluntary
Pharma company licensing programs, which were not comprehensive.

KEI had filed a competition complaint against Gilead in 2007, with the US
FTC, over its 2007 voluntary license.  The FTC thought the license was
actionable, except that the harm was to foreign consumers only, leaving the
FTC without jurisdiction under US law, as elaborated by recent US court
decisions.  We encouraged WIPO to discuss the cross broader enforcement of
anti-competitive contracts, under Article 40 of the TRIPS.  During this
period, we meet with Gilead, and lots of other patent owners, academics and
NGOs, to discuss the patent pool, as well as the donor prize fund proposal,
which several developing countries had proposed to the WHO, as a mechanism
to expand the geographic coverage of voluntary licenses.

In an ideal world, there would be no need for the patent pool. There would
be no big HIV problem, and if there was, developing countries would not be
granting patents right and left, and if they did, they would be granting
compulsory licenses right and left.  Having worked on these health and
patent issues since 1991, and extensively internationally since 1994, I
agree with those who say that it is difficult to do much of anything to
address IPR issues.  It is hard to change national laws, hard to stop bad
patents from being issued, hard to invalidate bad patents, hard to issue
compulsory licenses on good and bad patents, and hard to get voluntary
licenses.  Nothing is easy.  I think lacking from some of the criticism of
the MPP is just how hard is this issue, when trying to address the situation
in 150+ countries.

In considering the Medicines Patent Pool early on, the UNITAID Board make it
clear that the pool should not undermine the uses of compulsory licenses.
 This came from the NGOs on the UNITIAD board, many who were very active in
the IPR issues outside of UNTAID, and from developing country governments,
led by Brasil and Chile.  The decision on CLs was also backed up by Norway,
the UK and other board members.  So one negotiating objective for the MPP
was to make sure that the licenses could not be used to undermine CLs.

There was quite a bit of discussion about transparency.  KEI and others,
including several India NGOs, wanted the "offers" from UNITAID and the
responses to be public. UNITAID and the MPP was told that negotiations could
not take place with public offers and answers.  It was our view, and others,
that UNTAID was engaged in a norm setting activity, and it should be
transparent, and that we wanted to evidence of an offer and a refusal to
license, as something that could be used in a CL proceeding. Ok, the asks
and responses were public.  But what about the licensing terms themselves?
Here, the MPP was not that open about the private talks, and here we agree
with the petitioners, that the MPP should have and should in the future
publish proposed license terms, and accept comments from everyone, before
signing agreements.

I also think that in the run-up to the Gilead license, some of the
proponents of the MPP, including its own staff, could have been more clear
about the challenges of getting every country into the pool, so no one would
have been surprised when this did not in fact happen in the Gilead license.
 It was quite clear to KEI that comprehensive coverage of all developing
countries would not happen by simply offering a 5 percent or even a tiered
royalty method  (TRM) royalty.  The donor prize fund was a proposal to
provide an additional incentive to license to all countries.  UNITAID has
been asked to study this, and *any* other alternative strategy for expanding
the scope of the license.

On the topic of geographic scope and the LDC issue, I would like to bring up
the 2003 TAC voluntary license, which was the end game for the Hazel Tau
competition case in South Africa.

TAC entered an agreement with GSK and BI to license patents to some generic
companies to supply 47 sub-Saharan countries.  The license was designed to
cover exports, and contained a 5 percent royalty, including for exports to
LDCs and counties without patents.   TAC's leverage to obtain the license
was enhanced by the fact that the South Africa competition commission staff
had announced GSK and BI were in violation of the RSA competition laws.    I
think everyone will agree that the TACD agreement was a quite important for
people living in Africa with HIV.  However, it certainly would not meet some
of the standards set out in the petition against the MPP.  It did not permit
exports to North Africa or outside of Africa.   There were royalties from
exports from South Africa, even to LDC countries.   That said, it was more
pro-competitive than the 2007 Gilead license.  The license did not make it a
breach to peruse a CL or patent challenge elsewhere, or to supply a county
outside of the terms of the license, and overall it was considerably
shorter. The TAC settlement was also not a license. I have not seen the
actual licenses signed under the TAC agreement, and I don't know if they are
public or confidential.  (I am sure others can clarify this.)

In negotiations for licenses, there is what people want, and what you can
get.  In the beginning of the MPP negotiation, it was not clear that any
company would license anything of value to the pool.  The pool was seen by
GSK and the Gates Foundation as a big attack on exclusive rights.  In order
to put pressure on the companies, the pool staff engaged in an intense
effort to seduce the companies and charm governments that normally protect
them.  To that end, Ellen 't Hoen was able to ring up an impressive list of
endorsements, from the WHO, the G8, the White House, and many others. This
was harder than it looks, and deserved more credit than it has received from
NGOs.

On the one hand, the MPP is being asked to suck up to patent owners and OECD
countries, on the other hand, they are supposed to be a co-conspirator in
efforts to strip companies of their exclusive patent rights.  It is a tall
and confusing order, and at times, I think it is confusing to everyone,
including the MPP staff and the readers of this list.  I am impressed that
the MPP has pulled it off as well as it has.

It would be easier to get better terms from the licenses if more firepower
was focused on the patent owners than on the patent pool staff.  There has
been some NGO pressure on patent owners, but not as impressive to the patent
owners as what they saw from 1999 to 2003.

The NYC based I-MAK and several of the other groups signing the petition are
highly regarded for their tireless work on access to medicine issues.   But
some of the attacks on the patent pool about the process would be more
 persuasive if there had been efforts to be briefed by the MPP, and to
engage in the process. The early problem was just getting people to take
time to think about the issues.

The patent pool staff did have very talented and experienced Southern IPR
experts working with them on the licenses, and they invited activists such
as Zackie Achmat to join the MPP board. I encourage the MPP staff to share
some details of this, as well as a more complete list of the countless
meetings and briefings the have done.

KEI did not know the details of the Gilead license until the last moment,
and we saw the licenses themselves when everyone else did.  We had hoped the
MPP would have based the negotiations on the EMILA license templates, which
themselves were part of an extensive open review process, and we were as
surprised as others that the MPP used the 2007 Gilead licenses as the
template.  That said, we thought the MPP had corrected identified the most
important issues to fix in those licenses, given their limited bargaining
power.

In terms of transparency, I would add a few additional points.  The NIH does
not reveal the royalties paid on its exclusive licenses.  DNDi does not
publish its license agreements.  The WHO TDR program refused to show me the
access provisions of its patent license agreements, during my review of TDR
for the Human Rights Council.  I look forward to seeking more effort to get
greater transparency of all of these agreements.

If the current controversy is truly about the substance and norms of the
MPP, then the conversation should be focusing on the future also, and in
particular, what role should the MPP play in getting access to patented
technologies, and what role will other strategies play.  If you accept that
you can't force patent owners to license everything to everyone for nothing,
then you have to explain the strategy for getting access.   I believe that
you push for the best terms you can, but know the difference between what
you want and what you need.  What I believe is most important is to get
clear transparent licensing asks and responses, to have open unbundled
licenses (including by not bundling know-how and patents), and to ensure
that no one signing a license is prevented from busting a patent or
obtaining and using a CL anywhere.   I also think that it is a mistake to
have licenses that limit production to India. I do think you have to accept
limited geographic coverage, if this is a serious negotiation with big drug
companies, unless you do something like the donor prize fund, or get more
pressure on the companies from developing country governments.  I think the
VL efforts should complement all other strategies, including those involving
busting patents, changing patent laws, and compulsory licensing, and the
more ambitious and transformative effort to change the business and trade
models for supporting R&D.


On Tue, Oct 11, 2011 at 5:06 AM, Jérôme Martin <jeromemartin at samizdat.net>
wrote:
James,

>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"?

I think the answer is in my fist email  :

       'Telling, as you just did, that some concerns are not accurate
without
justifying 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 adressit, 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 let's go on with the debate, in a way you are able off - I can see
that with your answer - but certainly not in the way of your first
email.


>We are saying what
>we honestly believe on something we have worked on for 9 years.

Many people are claiming the authorship of the Patent Pool these days.
If we want to be able to talk to each other in a constructive way, we
need to be able to put that aside.
The MPPF is not an activist project anymore, it is institutional, funded
by public money with results expected. There is no reason that we should
not treat it the way we treat other programs. There is a gap between the
ideal project you had and what it is now, and we have to remain a little
bit clear-sighted.
Having worked on for 9 years gives you an expertise and a legitimity.
But you also need to consider other points of view without disqualifying
them a priori : focusing during 9 years on precise themes may avoid to
see hudge problems than other experts and activists, though not working
inside for 9 years, point out. We have to be capable of still being
objective and to listen to others. For instance, the way the
Consultative Forum was organized and the program totally locked, in a
way that any debate was almost impossible, gives the impression that
expertise from other point of views are not very welcome.

Jérôme Martin
Act Up-Paris

Le lundi 10 octobre 2011 à 18:37 -0400, Jamie Love a écrit :
> 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 strae lundi 10
>         octobre 2011 à 18:37 -0400, Jamie Love a écrit :
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.
>         >
>
>
>
>         _______________________________________________
>         Ip-health mailing list
>         Ip-health at lists.keionline.org
>
http://lists.keionline.org/mailman/listinfo/ip-health_lists.keionline.org
>
>
>
>
> --
> 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 my MaxRoam number: +447937390810
> twitter.com/jamie_love
>
>
>         tegy 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.
>         >
>
>
>
>         _______________________________________________
>         Ip-health mailing list
>         Ip-health at lists.keionline.org
>
http://lists.keionline.org/mailman/listinfo/ip-health_lists.keionline.org
>
>
>
>
> --
> 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 my MaxRoam number: +447937390810
> twitter.com/jamie_love
>
>


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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
my MaxRoam number: +447937390810
twitter.com/jamie_love



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