[Ip-health] TWN Info: Gilead grants license to medicines pool, devil is in details

Riaz K Tayob riaz.tayob at gmail.com
Sat Jul 23 01:51:15 PDT 2011


Jamie

Thanks for this insightful input.

I would like to abstract this issue of critique away from bona fides, I 
do not think that is the substance of the critique, and in any event, as 
you point out motive is hard to assess, even with Gilead.

Your views are important and many of the ideas and issues you have 
developed and worked civil society to mobilise have been constructive 
and useful. But this raises the issue of how we judge reformist measures 
(within the system). Without malice, I have to scratch a sore spot - the 
Health Impact Fund as a comparator, which could easily be substituted 
with the MPP in principle (as a reformist measure).

Both the patent pool and HIF are market-type or market-based mechanism 
that deal with some of the challenges that the A2M movement faces. In 
the context of legal rights to issue CLs that are politically 
neutralised (I think you will recall that even the convenor of UNITAID, 
France, called the CL option you helped Thailand with the "nuclear 
option").

The South is effectively arguing about legal rights they have but cannot 
enjoy, not least because of Super 301 - that unilateral technology 
governance mechanism of the US that the EU seeks to emulate. Which until 
recently for many groups was under the radar despite its seminal 
importance.

It is true that the South states need to be called to account for not 
using their legal rights. However holding them responsible without a 
power analysis as to why they cannot use these rights is far too common 
a feature. For South states the equation in political economy is larger 
than just access to medicines and the North uses this to its full 
advantage.

In this context, it is easy to be permissive about alternatives that 
have potential to work. A sense of criticality from the South about 
alternatives, other than the South's neutralised rights, therefore needs 
much more careful consideration. That patent pools have the ability to 
allow for profits and to meet some of the needs of the A2M movement is 
not in doubt, in principle. In practice, as we see, there is a problem, 
as the article points out. However, there are contradictory movements 
here too. The NIH has made some interesting moves on the pool and this 
ought to be welcome as it opens up spaces for differently engaging with 
the innovation-property system. This is a process, not an event. And 
Ellen is well placed to manage the process of incremental change that 
the MPP needs as an institution to deliver on its mandate. This is no 
different from the HIF challenge regarding assessing health impacts, 
which would be a process that would start on some basis and then peeled 
onion-skin like to the core - one that hopefully works.

Without critical appraisal particularly from the South the MPP has even 
less of a means to bargain with companies. It has less of a means 
because the option of a CL is ab initio excluded from patent pooling 
arrangements. This point cannot be emphasised enough. The multiple 
constituencies of the MPP need to have their voices heard. To 
contextualise the criticality, aid can be seen as a palliative for not 
using CLs. With declining aid one would have expected more room for CLs 
not less. But this has not happened. Some radical activists in this 
context argue for felicity to past commitments but without even 
conceding the reality of health imperialism.

It is undeniable that lots of good can come out of the MPP, but this 
needs to be understood within the boundaries and spaces it operates (and 
if the MPP is getting criticised by the companies - non-participation - 
and some civil society - like the South - then it is a good indication 
that it is walking a good if tight-rope middle line). Like aid the MPP 
is a necessary palliative, but it does not deal with the issue of 
productive capacity to meet ones own needs in the South (a point that 
cannot be lost after the Swine Flu "pandemic"). And this is what is 
important - and which is why the political economy of CLs means so much 
to developing countries and South civil society.

The way you frame your conclusion if you are not for the MPP 'then what 
is the alternative strategy and is it working'? The issue is that we 
need to work on multiple levels and with multiple strategies (the MPP 
received a cool reception at the outset from some even though many 
progressive groups did support it). And the MPP is just one of the 
strategies. If we look at the Aid strategy of emphasising getting 
treatment (a necessary demand) as a response to the failure of the WTO 
Doha Declaration (or if you prefer the pyrrhic victory) then we can see 
that aid dependency is a strategy that does not work sustainably - and 
yet this is where most of the energy goes, even in a time of austerity. 
The point is that the critique from some in the South is a necessary 
interrogation of the process to have a holistic understanding of the 
peculiar location of these demands.

The core of the demands for CLs is access and productive capacity (of 
course with WHO tightening up the API market and being largely complicit 
with company interests it does not help matters much).

The MPP is therefore ambivalent. It has enormous potential and has set 
upon the path to realise this potential. Yet without vigilance it can 
end being a 3X5 that was a 4X8, which is good but simply is not good 
enough. And this, I hope is the attitude that should drive the 
understanding of critiques of the MPP. That said, it will also not do to 
have it roundly criticised by everyone in civil society - pockets of 
support are needed. But such support needs to be engaged, principled and 
critical where it needs to be. Reformists walk the tough line between 
engagement with powerful forces to get what is possible but risk the 
hell of the path of good intentions. I am certain that if workable A2M 
solutions through the MPP are the outcome then most critics would be 
very happy to have been proved wrong.

So how do we assess reformist measures when the equities of the 
situation are so stark against the legal rights of developing countries? 
And for the South, how do we be pragmatic when many we engage with 
undermine the political economy considerations?

Riaz

On 2011/07/22 06:31 PM, Jamie Love wrote:
> Sangeeta and others,
>
> A number of these analysis point out things people don't like about the
> Gilead license, and some even go so far as to suggest the patent pool is
> part of some effort to undermine compulsory licensing.   As someone who
> pushed hard for compulsory licensing of patents since the 1990s, and who
> worked on all of the early compulsory licenses on AIDS and cancer drugs, and
> who continues to advise pretty much everyone that there should be more
> compulsory licenses on medicines patents issued, and who thinks the time has
> come to eliminate legal monopolies on the sale of medicines entirely, I have
> a much different view of the role and importance of the patent pool.
>
> First, if countries were doing a better job of issuing compulsory licenses,
> there would be no reason to have a patent pool in the first place.   It is
> worth noting that few NGOs bring CL cases either.
>
> Second, in order to get a CL issued, there are both legal and political
> issues.  The political issues are in general much more important than the
> legal issues.   Legally, almost every country can issue licenses.  But some
> legal issues are worth thinking about.  One is the requirement in some
> national laws for prior efforts to obtain voluntary licenses.  Even when
> this is not a legal requirement, it may be a political requirement.
>
> Outside of the many CLs of dubious legality issued in SubSaharan Africa, few
> have been issued by developing countries   Latin America in particular has
> been lagging, as has China.
>
> What the patent pool has done is obtain licenses from one major AIDS drug
> developer.  There are plenty of problems with the licenses, as everyone,
> including the Patent Pool staff, acknowledge.   If Gilead did not issue the
> licenses, what then?  The patent pool would probably have disappeared. Some
> may welcome that possibility.  I don't see why.
>
> The reason the licenses are not everything everyone wants is because the
> Medicines Patent Pool had to do everything with smoke and mirrors.  Gilead
> was under no obligation politically or legally to have signed anything.   No
> other company signed anything.  Gilead could have just announced another
> non-pool voluntary license, like the last one, and gotten plenty of PR.  In
> this case, Gilead did not even seem to want much publicity, their own PR
> department was practically non-existent.  How many quotes do you have in the
> press from Gilead staff?
>
> Now that Gilead has signed a license, how does that change things?  Well,
> the most anticompetitive aspects of their earlier licenses have been
> eliminated.  It is clearly not a breach of the license to operate under a
> CL, and no one has to take the TDF license if they don't want it.  At least
> now you have the following:
>
> 1.  The Medicines Patent Pool has well established that it is trying to
> obtain licenses to patents on all important AIDS drugs for all developing
> countries.  The correspondence from the Pool is on their web page.
>
> 2.    The Gilead license demonstrates that is possible to license AIDS
> patents to the pool,on reasonable terms.
>
> 3.    A country excluded from the Gilead license, or companies that have yet
> to issue licenses, clearly need a response, by taking the refusals to
> license as a grounds for a CL.     This makes it far easier to get a CL, not
> far harder.  This is wrong to say that the Pool is undermining the CL
> process, when the opposite is true for all products and countries that are
> outside of the license.   The only way that one can claim the Pool
> undermines CLs are for the products and countries that have been licensed,
> since, yes, for those products, in those countries, the license can work
> against a CL.   But which is more important, getting CLs for the products
> and countries included in the license, or getting CLs for products and
> countries outside of the license?
>
> What I find missing from much of the criticism of the license is a strategy
> to obtain access to new AIDS drugs.  If people want the pool to disappear,
> what this the alternative strategy, and how is it working?
>
>
> On Fri, Jul 22, 2011 at 7:43 AM, Sangeeta<ssangeeta at myjaring.net>  wrote:
>
>>
>> On 12 July 2011, MPP and Unitaid announced a voluntary license agreement
>> between MPP and Gilead Sciences for the production of tenofovir,
>> emtricitabine, cobicistat and elvitegravir, as well as a combination of
>> these products called "Quad" for the treatment of HIV/AIDS. Tenofovir is
>> also licensed for use to treat Hepatitis B, common among the poor in many
>> developing countries.
>>
>> Please find below an analysis of the terms and conditions of the licenses.
>>
>> The analysis below is an updated version of a news report published by SUNS
>> on 21 July 2011.
>>
>> Regards
>> Sangeeta Shashikant
>> Third World Network
>>
>>
>> ----------------------------------------------------------------------------
>> ---------
>> TWN Info Service on Intellectual Property Issues
>> 22 July 2011
>> Third World Network
>> www.twnside.org.sg<http://www.twnside.org.sg>
>>
>> Gilead grants license to medicines pool, devil is in details
>> Published in SUNS #7195 Thursday 21 July 2011
>>
>> London/New Delhi, 20 Jul (Sangeeta Shashikant and K. M. Gopakumar) -- There
>> are mixed reactions to the first licensing agreement between Gilead
>> Sciences, one of the world's largest pharmaceutical companies, and the
>> Medicines Patent Pool (MPP), a Swiss foundation, for the production of some
>> HIV/AIDS medicines.
>>
>> The Medicines Patent Pool and UNITAID (an international drug purchasing
>> facility to provide medicines to the poor for HIV/AIDS, malaria and
>> tuberculosis) announced on 12 July, a voluntary license agreement between
>> MPP and Gilead Sciences for the production of tenofovir, emtricitabine,
>> cobicistat and elvitegravir, as well as a combination of these products
>> called "Quad" for the treatment of HIV/AIDS. Tenofovir is also licensed for
>> use to treat Hepatitis B, common among the poor in many developing
>> countries.
>>
>> Ellen t'Hoen, Executive Director of the Medicines Patent Pool, marked the
>> agreement as a "milestone in managing patents for public health", while
>> Stephen O'Brien, Minister of International Development for the United
>> Kingdom, welcomed the agreement and noted that the UK would continue to
>> support the Pool as an important contribution to ensuring that the largest
>> number of people living with HIV get access to the treatments they need.
>>
>> However, concerns were also voiced by others involved in seeking better
>> access to affordable medicines, as they pointed to the shortcomings of the
>> agreement reached. Medecins sans Frontieres (MSF) noted in its press
>> release
>> that "the agreement falls significantly short of what is needed to fully
>> meet the public health needs for HIV/AIDS".
>>
>> The MPP is an independent Swiss foundation based in Geneva and funded by
>> UNITAID under a five-year Memorandum of Understanding. It focuses on
>> negotiating with patent holders to interest them in licensing their
>> intellectual property to other producers to facilitate the production of
>> generic medicines initially for the treatment of HIV/AIDS.
>>
>> [In 2006, Brazil, Chile, France, Norway and the United Kingdom decided to
>> create UNITAID, an international drug purchasing facility financed with
>> resources that would be both sustainable and predictable. A tax on airline
>> tickets was chosen as the most appropriate means of providing sustainable
>> funding. There are 29 countries supporting UNITAID today and the three
>> diseases covered are HIV/AIDS, malaria and tuberculosis.]
>>
>> In July 2008, the UNITAID board decided to explore the possibility of
>> establishing a voluntary patent pool for medicines, and in December 2009,
>> agreed to create the MPP as a separate entity, which would focus on
>> increasing access to HIV medicines in developing countries.
>>
>> Unsurprisingly, many developed countries have trumpeted their support for
>> the MPP, as it advocates the use of voluntary measures to facilitate access
>> to medicines.
>>
>> [Developed countries such as the US and the EU have a long history of
>> criticizing and threatening retaliatory measures against developing
>> countries that use compulsory licenses to make treatments available to
>> their
>> local populations.]
>>
>> The approach taken by the MPP has given rise to concerns that while "Big
>> Pharma" gains publicity by participating in the pool, such a "voluntary"
>> mechanism is likely to further undermine the use of flexibilities (e. g.
>> compulsory licence) under the WTO agreement on intellectual property rights
>> to facilitate access to medicines. There are also concerns that the MPP may
>> undermine support and resources for patent oppositions in India, legitimize
>> "evergreening" practices, as well as segment developing-country markets.
>>
>> ["Evergreening" is a strategy often used by patent holders to lengthen the
>> period of monopoly that they have over a particular product. For example,
>> new patents for another 20 years are obtained for changes to a product
>> whose
>> patent term is expiring, and such changes are subject to a low standard of
>> "inventiveness" to justify a new patent, thus extending the product's
>> monopoly in the market. Many of the legal and technical steps taken to do
>> this have been widely criticized by public health advocates over the past
>> two decades. For example, patents are granted over fixed dose combinations
>> as well as over new uses or formulation of known products.]
>>
>> Several of these concerns appear to be justified in view of the terms and
>> conditions contained in the licenses agreed to by MPP and Gilead, leading
>> certain non-governmental groups to question whether "voluntary measures"
>> work to promote access to medicines.
>>
>> Health Gap, in its press statement, noted that the patent pool licenses are
>> "demonstrating the inherent limitations of voluntary measures to address
>> the
>> needs of affordable medicines".
>>
>> The licenses agreed to between MPP and Gilead Sciences are in three
>> documents. The first is the primary licensing agreement signed by the Pool
>> and Gilead, the second is an "amended and restated" sub-license agreement
>> for existing Gilead sub-licensees, while the third document is a
>> sub-license
>> agreement for new sub-licensees. This third license agreement is a
>> tripartite agreement among Gilead Sciences, MPP and the potential licensee
>> (in this case, Indian generic companies).
>>
>> The licenses cover tenofovir (TDF), cobicistat (COBI), elvitegravir (EVG)
>> and the Quad (a fixed-dose combination of TDF-COBI-EVG-emtricitabine).
>>
>> [TDF is a medicine used in combination with other antiretroviral (ARV)
>> medicines in first and second line regimens for treating HIV, as well as
>> for
>> Hepatitis B. TDF is recommended by the WHO to replace stavudine, a widely
>> used HIV treatment in the developing world that is less preferred due to
>> the
>> adverse side effects. Emtricitabine is an ARV medicine used in first and
>> second line treatment for adults. COBI and EVG are medical products that
>> are
>> in development and yet to be approved for use in HIV treatment.]
>>
>> In its press release, the MPP highlighted the key features of the licenses.
>> These include: licensing of products still in clinical development that
>> ensure speedier availability of such medicines in developing countries; key
>> flexibilities in intellectual property have been preserved; payment of
>> royalties between 3-5% of generic sales with royalties waived for any new
>> pediatric formulations; an increase in the geographical scope of the
>> licenses.
>>
>> The licenses allow for the supply of TDF and emtricitabine in 111
>> countries,
>> for cobicistat in 102 countries and for EVG and the Quad in 99 countries;
>> contain agreement to make publicly available the text of the licenses; and
>> termination clauses that allow the licensees to terminate the license for
>> one medicine, while retaining the license to produce the others.
>>
>> Despite these claims in the press release, the actual terms and conditions
>> of the licenses raise a variety of issues and concerns.
>>
>> A major critique of the licenses is that products produced under the
>> licenses are only for supply to a specific list of countries (listed in
>> Appendices to the licenses) and as such exclude from the scope of the
>> licenses many developing countries, including countries with significant
>> populations of people living with HIV. Hence, the licensee (i. e. Indian
>> generic companies) cannot supply many developing countries that are
>> excluded
>> from the scope of the license. For example, except for Bolivia, Cuba,
>> Ecuador and El Salvador, no other South and Central American countries are
>> included in the licenses.
>>
>> Act-Up Paris, another organization, in its press release, noted: "In total
>> 5
>> million people living with HIV will be excluded from the Patent Pool.
>> Moreover, the agreement will exclude countries with important generic
>> manufacturing capacity, and limit the production of medicines to Indian
>> generic firms, thus restricting competition that lower the price of drugs.
>> Gilead has placed limits in excess of WTO rules to prohibit local
>> production
>> in poor countries".
>>
>> "The exclusion of all these countries in the first deal between a drug
>> company and the Patent Pool constitutes a dangerous precedent that risks
>> limiting the scope of the programme," it stressed.
>>
>> As a result, the MPP/Gilead licenses segment developing-country markets
>> between those that can be supplied under the licenses and those that are
>> not
>> covered by the licenses.
>>
>> [The list of countries excluded from the Patent Pool/Gilead deal for
>> Gilead's drugs already on the market -- in Asia: Malaysia, North Korea,
>> China, and the Philippines; in Latin America: Argentina, Brazil, Chile,
>> Colombia, Paraguay, Peru, Uruguay, and Venezuela; in Central America: Costa
>> Rica, Mexico, and Panama; in Middle East: Iran, Iraq, Lebanon, and Jordan;
>> in Eastern Europe and the Baltics: Albania, Azerbaijan, Belarus, Bulgaria,
>> Croatia, Czech Rep, Estonia, Hungary, Latvia, Lithuania, Montenegro,
>> Poland,
>> Republic of Kosovo, Republic of Macedonia, Romania, Russia, Serbia, Slovak
>> Rep, Turkey, and Ukraine; in Africa: Algeria, Egypt, Morocco, Tunisia, and
>> Libya; in Island Nations: Marshall Islands, and Micronesia. -- Source:
>> Act-Up Paris news release dated 18 July 2011.]
>>
>> [The list of countries excluded from the Patent Pool for Gilead drugs still
>> in trials
>> -- in Asia: Malaysia, North Korea, China, the Philippines, Kazakhstan, Sri
>> Lanka, Thailand, Turkmenistan, and Indonesia; in Latin America: Argentina,
>> Brazil, Chile, Colombia, Paraguay, Peru, Uruguay, Venezuela, Ecuador, and
>> El
>> Salvador; in Central America: Costa Rica, Mexico, and Panama; in Middle
>> East: Iran, Iraq, Lebanon, and Jordan; in Eastern Europe and Baltics:
>> Albania, Azerbaijan, Belarus, Bulgaria, Croatia, Czech Rep, Estonia,
>> Hungary, Latvia, Lithuania, Montenegro, Poland, Republic of Kosovo,
>> Republic
>> of Macedonia, Romania, Russia, Serbia, Slovak Rep, Turkey, and Ukraine; in
>> Africa: Algeria, Egypt, Morocco, Tunisia, Libya, Botswana, and Namibia; in
>> Island Nations: Marshall Islands, and Micronesia. -- Source: Act-Up Paris
>> news release dated 18 July 2011.]
>>
>> It could be argued that Section 10.3(d) of the licenses could reduce the
>> adverse effect of not being included in the scope of the license, as it
>> allows export to countries (outside the scope of the license) that have
>> issued compulsory license (CL) over the products concerned. However, that
>> flexibility is subject to several restrictions, in particular that the
>> licensee and Gilead Science must be in agreement with regard to the
>> existence, scope and content of such CL issued in the importing country
>> (with Gilead not unreasonably withholding its agreement) and/or the
>> government of India has issued a CL for the export of the product to a
>> country (outside the scope of the license), but the importing country must
>> have also issued a CL if a valid patent exists in its territory.
>>
>> Section 10.3(d) seems to suggest that even if there is no valid patent in a
>> country (outside the scope of the license), such a country cannot be
>> supplied under the voluntary licence granted unless India issues a
>> compulsory license to supply that country. This would then require
>> operationalising Section 92A of the Indian Patents Act which pertains to
>> mandatory compulsory license "to any country having insufficient or no
>> manufacturing capacity in the pharmaceutical sector for the concerned
>> product to address public health problems".
>>
>> Section 92A was incorporated to implement the 30 August 2003 WTO General
>> Council decision (that has been criticized for containing cumbersome
>> procedures) to facilitate exportation of patented medicines produced under
>> a
>> compulsory license. The requirement of compulsory license would act as a
>> disincentive for generic companies to supply individual countries excluded
>> from the license.
>>
>> Further, the licenses are limited to Indian generic manufacturers. Other
>> generic manufacturers from developing countries that have capacity to
>> produce, such as in Thailand and in Brazil, have been excluded from the
>> scope of the license.
>>
>> The MPP/Gilead licenses also require that the active pharmaceutical
>> ingredients (API) for the products licensed are to be supplied only by
>> those
>> licensed by Gilead to produce those API or are produced by the licensee
>> under the license.
>>
>> In addition, one of the licence features highlighted is that the
>> termination
>> clauses allow the licensees to terminate the license for one medicine,
>> while
>> retaining the license to produce the others. However it should be noted
>> that
>> termination clauses are linked to restrictions.
>>
>> Even though the license provides the option to terminate any of the license
>> for API such termination would also result in the termination of the
>> license
>> to produce the product using the terminated API. For instance, the license
>> states that ³ any termination by Licensee of its license to TDF pursuant to
>> this Section 10.5 shall in turn terminate the license and rights granted to
>> licensee hereunder with respect TDF product and TDF Combination product,
>> and
>> any other product containing TDF².
>>
>> This suggest that the API license is bundled with the product and as such a
>> generic manufacturer would be unable to produce a TDF product under the
>> license using API produced by entities not licensed by Gilead.
>>
>> Further, the licenses impose restrictive conditions on the supply of APIs
>> and products to a country outside the scope of the licenses. Section 10.3 (
>> c) suggests that even when patents containing a valid claim have been held
>> invalid beyond the possibility of any further appeal in India and in the
>> country outside the scope of the licences, the licensee is only able to
>> supply such API or products after the licensee reaches agreement with
>> Gilead
>> that no valid patents exist and that the licensee has been able to obtain
>> applicable regulatory approval in such country.
>>
>> This suggests that supply to countries outside the scope of the license by
>> the licensee even after the patents are held to be invalid would need to be
>> agreeable to Gilead Sciences.
>>
>> [According to the definition section, reference to "Patents" includes not
>> only patents listed in the Appendix of the licenses but also to any other
>> patents and patent applications (and resulting patents therefrom) owned by
>> Gilead or exclusively licensed by Gilead from Japan Tobacco Agreement
>> covering APIs of products mentioned in the license. This broad definition
>> of
>> "Patents" thus covers any patent or patent application (existing and future
>> applications) containing the APIs of TDF, FTC, EVF, and COBI within the
>> scope of license].
>>
>> As such, the final disposal of patents in the license means the disposal of
>> not only the patents listed but also any other patents or patent
>> applications pertaining to the licensed molecules. This provision can
>> easily
>> be used to evergreen the license agreement.
>>
>> Another important issue is with regard to TDF's inclusion in the scope of
>> the license. Presently, there is no product patent protection for TDF in
>> India. The patent application filed by Gilead Sciences was successfully
>> opposed in 2009 by generic companies such as Cipla and civil society
>> organisations working on access to HIV/AIDS medicines using the pre-grant
>> opposition system in India. Gilead has filed an appeal against that
>> decision
>> but the appeal has yet to be heard.
>>
>> Appendix 2 to the licenses lists eight patent applications in India related
>> to TDF products and processes. Of these applications, at least three
>> applications, which include a product patent application, have been
>> rejected
>> at the pre-grant opposition stage, while three more such applications are
>> facing patent opposition before the Indian patent office.
>>
>> As such, it appears that the license granted is not for patents that have
>> been granted but on patent applications with questionable patent claims,
>> which are likely to be rejected during the opposition proceedings.
>>
>> Moreover, apart from India and Indonesia, Appendix 2 of the license
>> agreement does not cite any other foreign patent application with regard to
>> TDF. This suggests that there is no valid patent or pending patent
>> applications in the other countries listed in Appendix 2 and as such,
>> Gilead
>> is seeking royalty from Indian generic companies for supplying to countries
>> that have no patent for TDF.
>>
>> On the issue of royalty, according to the terms of the licenses (Section
>> 4.9), royalties will have to be paid until the expiration or the date of
>> expiration of the last to expire ³Patent containing a valid claim covering
>> the manufacture, use, import, offer for sale or sale of API or the Product
>> in India².
>>
>> In addition the section adds that royalties do not have to be paid if ³all
>> Patents containing a valid claim² are "held invalid or unenforceable beyond
>> the possibility of any further appeal" in India and in the importing
>> country.
>>
>> According to the definition section, reference to "Patents" includes not
>> only patents listed in the Appendix of the licenses but also to any other
>> patents and patent applications (and resulting patents therefrom) owned by
>> Gilead or exclusively licensed by Gilead from Japan Tobacco Agreement
>> covering APIs of products mentioned in the license. This broad definition
>> of
>> "Patents" thus covers any patent or patent application (existing and future
>> applications) containing the APIs of TDF, FTC, EVF, and COBI within the
>> scope of license.
>>
>> As such, the final disposal of patents in the license means the disposal of
>> not only the patents listed but also any other patents or patent
>> applications (that have been filed or have yet to be filed) pertaining to
>> the licensed molecules.
>>
>> This means that royalties will have to be paid until expiration or
>> determination of validity on all patents and patent applications containing
>> a valid claim covering the manufacture, use, import, offer for sale of the
>> API or the Product. This could take many years and during these years
>> Gilead
>> will be allowed to claim royalties over questionable patent claims.
>>
>>
>> It also suggests that royalties would be paid while a patent application is
>> pending examination as well as in the interim period (i. e. after the
>> decision of the pre-grant opposition) before the final appeal is heard,
>> which could also take many years. Usually, during these periods, generic
>> manufacturers are free to produce generic versions without payment of any
>> royalties.
>>
>> [Cipla's opposition to the TDF patent application in India succeeded in
>> 2009
>> and although pending appeal, Cipla continues to produce generic versions
>> without any payment of royalties. Other major generic manufacturers produce
>> TDF under a voluntary license from Gilead Sciences.]
>>
>> Another concern with regard to the licenses is that it extends to
>> fixed-dose
>> combinations, pediatric formulations, as well as new uses such as the use
>> of
>> TDF for treatment of hepatitis B, thus implicitly legitimizing the practice
>> of "evergreening". The licenses also encourage such practice with its
>> provision for mandatory grant back by the licensee (i. e. the generic
>> manufacturer) to Gilead Sciences of improvements made on the licensed
>> products.
>>
>> India enacted a specific provision in its patent law, commonly referred to
>> as "Section 3(d)", to combat such a practice. Section 3(d), in combination
>> with provisions on pre-grant opposition in the Indian patent law has been
>> used on numerous occasions by generic companies as well as civil society
>> organisations to challenge and nullify patent applications that claim such
>> bad patents. As a result, many key medicines such as imatinib mesylate,
>> tenofovir, and nevirapine hemihydrate are currently not covered by patents
>> in India, giving Indian manufacturers the freedom to manufacture the
>> generic
>> versions of such products.
>>
>> In some cases, a pre-grant opposition challenge has resulted either in
>> withdrawals of applications such as the one for Lamivudine/zidovudine
>> combination or changes in patent claims.
>>
>> Following the success in India, groups in Thailand and Brazil have also
>> pursued a similar strategy to safeguard their access to generic medicines.
>>
>> However, the patent pool licenses could undermine the use of patent
>> oppositions, as it is likely to lead to much fewer such legal challenges to
>> bad patenting practices, particularly as Indian generic manufacturers may
>> simply opt for a voluntary license instead of engaging in an opposition
>> against multinational pharmaceutical companies such as Gilead Sciences.
>> This
>> is likely to result not only in bad patents continuing to remain valid, but
>> also even more aggressive use of "evergreening" practices by pharmaceutical
>> manufacturers.
>>
>> Several conditions in the licenses would restrict use of critical TRIPS
>> flexibilities, such as parallel importation.
>>
>> [Parallel import is the import and resale in a country without the consent
>> of the patent holder of a patented product when that product has been
>> legitimately put in the market of the exporting country under a parallel
>> patent.]
>>
>> The licenses explicitly require the licensee to guarantee that there will
>> be
>> no diversion of API or other chemical entities generated during the process
>> of manufacturing of API or the products outside of India except as
>> expressly
>> permitted by Gilead Sciences.
>>
>> Further, third party resellers would also need to enter into agreement with
>> the licensee to ensure that the terms of the licenses (signed between the
>> licensee and Gilead) are also abided by such resellers. The agreement
>> between the licensee and the resellers would have to be notified to Gilead
>> in writing, with copies provided to Gilead for its review. Gilead has the
>> right to terminate the right of the licensee to sell to such reseller.
>>
>> Effectively, the terms of the licenses are quite stringent, presumably to
>> ensure that flexibilities such as parallel importation are not used by
>> countries to import products that are produced under the license.
>>
>> The terms of the licenses also require that the licensee produces API and
>> products consistently with applicable Indian manufacturing standards,
>> standards of the importing country and additional standards either set by
>> the WHO pre-qualification or European Medicines Agency or the US Food and
>> Drug Administration. This requirement effectively is likely to limit the
>> use
>> of the licenses to more advanced Indian generic companies, while excluding
>> the small and medium sized industry that produce quality generic medicines.
>>
>> THREATS TO ACCESS TO MEDICINES CONTINUE
>>
>> In June 2011, at a UN meeting in New York, the international community
>> committed that at latest 15 million people will be on antiretroviral
>> therapies by 2015.
>>
>> However, it is difficult to hope that this target would be achieved, as the
>> war against generics continues and actions of multinational pharmaceutical
>> companies continue to deny treatment to large segments of populations
>> living
>> with HIV.
>>
>> Act-Up Paris noted in its press release of 18 July that: "... the European
>> Commission ... have been pushing trade policies (including free trade and
>> so-called anti-counterfeiting agreements) that aim to block the fabrication
>> and the export of generic drugs. Without low-cost medicine, global
>> commitments to achieve Universal Access to treatment will not be
>> reachable".
>> It further noted that Gilead's announcement cannot hide the war against
>> generic medicines, pointing out that the MPP/Gilead agreement excludes many
>> countries.
>>
>> MSF, in a press release on its report on HIV drug pricing (on 18 July),
>> noted: "Several pharmaceutical companies have abandoned HIV drug discount
>> programmes in middle-income countries".
>>
>> It further said that "Tibotec/Johnson&  Johnson exclude all countries
>> classified as Œmiddle-income' from their price reductions; Abbott excludes
>> low-income and lower middle-income countries from discounts for one of its
>> drugs; and ViiV (Pfizer and GlaxoSmithKline) no longer offers reduced
>> prices
>> to middle-income countries, even when programmes are fully funded by the
>> Global Fund to Fight AIDS, TB and Malaria or the US government's PEPFAR
>> programme."
>>
>> MSF also noted Merck's announcement that it will no longer issue price
>> discounts for 49 middle-income countries for its new drug raltegravir.
>> Today, Brazil is paying $5,870 per patient per year (ppy) for just this one
>> HIV drug; in least-developed countries, Merck charges $675 ppy for the
>> drug,
>> which is already four times the price of the recommended triple first-line
>> combination (TDF/3TC/EFV).
>>
>> "This development comes on the heels of a number of developing countries
>> being excluded from (the July) agreement between drug company Gilead and
>> MPP," MSF added. +
>>
>>
>>
>>
>>
>>
>> _______________________________________________
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>> Ip-health at lists.keionline.org
>> http://lists.keionline.org/mailman/listinfo/ip-health_lists.keionline.org
>>
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