[Ip-health] ViiV Voluntary Licensing Policypartial clarification on place of product

Baker, Brook b.baker at neu.edu
Wed Jul 21 06:22:44 PDT 2010


A colleague indicated that he had received the following partial clarification from ViiV about its geographical scope for manufacturing.

"The terms of the licences are such that a manufacturer in any one of the
69 countries can export to any other of the 69 countries. Also, although
ViiV doesn't have any IP on ARVs in India, their Indian licencees can
export from India to any of the 69 countries. If ViiV were ever granted a
patent on an ARV in India, they would clarify the situation further."

This statement is somewhat ambiguous for two reasons.  First, it is not clear why Indian generic manufacturers would seek to become Indian licensees if there are no patent bars to manufacture and export.  The implication is that Indian companies would need to become licensees merely to be permitted access to the 69 countries identified as licensed territories.  Of course, this raises the related question of how many of the licensed territories are actually covered by existing ViiV patents.  It's a little disingenuous to announce a licensing breakthrough for 69 countries if there are no operative patents in many of these LDC, low-income, and sub-Saharan African countries.

Second, there seems no legitimate purpose in delaying clarification about whether manufacturers in non-licensed countries can supply the licensed 69 countries.  Let's assume, just as an example, that Apotex, the only company that has used the cumbersome Paragraph 6 System would decide that it preferred to use this new ViiV license instead of going through Canada's labyrinthe procedures.  Shouldn't ViiV clarify Apotex's eligibility now, as a Canadian manufacturer, rather than wait to some distant point in time?

Professor Brook K. Baker
Health GAP (Global Access Project) &
Northeastern U. School of Law, Program on Human Rights and the Global Economy
Honorary Research Fellow, Faculty of Law, Univ. of KwaZulu Natal, SA
400 Huntington Ave.
Boston, MA 02115 USA
(w) 617-373-3217
(c) 617-259-0760
(f) 617-373-5056
b.baker at neu.edu
________________________________________
From: iplusa-bounces at lists.keionline.org [iplusa-bounces at lists.keionline.org] On Behalf Of Tido.von.SCHOENANGERER at geneva.msf.org [Tido.von.SCHOENANGERER at geneva.msf.org]
Sent: Tuesday, July 20, 2010 7:14 PM
To: Judit Rius Sanjuan
Cc: iplusa-bounces at lists.keionline.org; IplusA
Subject: Re: [iplusa] Fwd: ViiV Healthcare announces Voluntary License policy

I received the following clarification about the question of production:

"The terms of the licences are such that a manufacturer in any one of the
69 countries can export to any other of the 69 countries. Also, although
ViiV doesn't have any IP on ARVs in India, their Indian licencees can
export from India to any of the 69 countries. If ViiV were ever granted a
patent on an ARV in India, they would clarify the situation further."





             Judit Rius
             Sanjuan
             <judit.rius at keion                                          To
             line.org>                 Ethan Guillen
             Sent by:                  <ethan.guillen at essentialmedicine.or
             iplusa-bounces at li         g>
             sts.keionline.org                                          cc
                                       IplusA <iplusa at lists.keionline.org>
                                                                   Subject
             20/07/2010 19:50          Re: [iplusa] Fwd: ViiV Healthcare
                                       announces Voluntary License policy










I have not seen anything else. I have asked for more information and
waiting for reply.

On Jul 20, 2010, at 1:46 PM, Ethan Guillen wrote:

> Has anyone seen any details or further analysis of how it would be
implemented?
>
> Thanks for passing on, Judit.
>
> On Fri, Jul 16, 2010 at 7:42 AM, Judit Rius Sanjuan
<judit.rius at keionline.org> wrote:
>
>
> Begin forwarded message:
>
>> From: "Manuel Goncalves" <manuel.a.goncalves at viivhealthcare.com>
>> Date: July 16, 2010 9:05:00 AM EDT
>> To: "sambo at nzila.net" <sambo at nzila.net>, "Billy Amoss"
<BAmoss at rostropovich.org>, "Wim Vandevelde" <wim-vandevelde at usa.net>,
"Elhadj As Sy" <esy at unicef.org>, "Nikos Dedes" <nikos.dedes at gmail.com>,
"olimbi hoxhaj" <hoxhajolimbi at gmail.com>, "Matthew Diver"
<MDiver at tapestrynetworks.com>, "Nick Hellmann" <nhellmann at pedaids.org>,
"RENAUDIN Stéphane" <stephane.renaudin at diplomatie.gouv.fr>,
"GONZALEZ-CANALI Gustavo" <gustavo.gonzalez-canali at diplomatie.gouv.fr>,
"patrice debre" <patricedebre at yahoo.fr>, "Jorge Torgal"
<jorgetorgal at gmail.com>, "David Ripin" <dripin at clintonfoundation.org>,
"Victor Zonana" <vzonana at globalhealthstrategies.com>,
"kevin.frost at amfar.org" <kevin.frost at amfar.org>, "David J
Quigley/NYO/NorthAmerica/MCKINSEY" <Maryann_Michelizzi at mckinsey.com>,
"Plumley, Ben" <bplumley at pgaf.org>, "John L. Barnes and Astrid Bonfield"
<John_L._Barnes_and_Astrid_Bonfie at mail.vresp.com>,
"GGoldsmith at tapestrynetworks.com" <GGoldsmith at tapestrynetworks.com>,
"Guillermo Chacon" <GChacon at latinoaids.org>, "Sarah Hamilton"
<sarah at fcaaids.org>, "Jorge Torgal" <jorgetorgal at gmail.com>,
"henrique.lecour at netcabo.pt" <henrique.lecour at netcabo.pt>,
"anafilgueiras1 at gmail.com" <anafilgueiras1 at gmail.com>, "Antonio Coutinho"
<coutinho at igc.gulbenkian.pt>, "Judit Rius Sanjuan"
<judit.rius at keionline.org>, "Carol Spahn" <cspahn at accordiafoundation.org>,
"Cátia Sá Guerreiro" <csguerreiro at sida.acs.min-saude.pt>, "David Ripin"
<dripin at clintonfoundation.org>, "Megan Strub" <MeganS at smartandstrong.com>,
"reganh at smartandstrong.com" <reganh at smartandstrong.com>, "Laurianne
Beauvais Remigereau" <laurianne.l.beauvais at gsk.com>, "Levin,Leon"
<Leon.Levin at righttocare.org>, "isanne at witshealth.co.za"
<isanne at witshealth.co.za>, "muraguri at aidskenya.org"
<muraguri at aidskenya.org>, "muchinap at unaids.org" <muchinap at unaids.org>,
"HBARROS at MED.UP.PT" <HBARROS at MED.UP.PT>
>> Subject: ViiV Healthcare announces Voluntary License policy
>>
>> Dear
>>
>> I attach for your attention an important announcement from ViiV
Healthcare about a new set of initiatives to improve access to HIV
medications for people living in the least developed countries.
>>
>> This marks a decision that, from today, we will extend our current
royalty free voluntary licence agreements to include all of ViiV
Healthcare’s current antiretroviral portfolio and our future pipeline.  As
access improves in the least developed countries, availability of second
and third line therapies is becoming a critical priority – this is why  we
are taking these steps today to meet the current and future needs of people
living with HIV in the least developed countries.
>> We have also extended the geographic reach of these voluntary licence
agreements to 69 countries - where 80% of all people with HIV live.  They
will now be made available to generic manufacturers for all least developed
countries, all low income countries and all of sub-Saharan Africa.
>>
>> Today, we have also extended our not for profit price commitment for our
ARV portfolio to government and international procurement agencies to these
69 countries.
>>
>> ViiV Healthcare is a specialist HIV company with a sustainable
commitment to delivering advanced treatment and care and improving access
to medicines for people living with HIV worldwide.
>>
>> Kind regards,
>>
>>
>
>>
>
>
> Judit Rius Sanjuan
> Attorney
> Knowledge Ecology International (KEI)
> www.keionline.org
> NYC Phone: 212 222 5180
> Washington DC Phone: 202 332 2670
>
>
> _______________________________________________
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>
>
>
>
> --
> Ethan Guillen
> Universities Allied for Essential Medicines
> 2625 Alcatraz Ave. #180
> Berkeley, CA 94705
> www.essentialmedicine.org

Judit Rius Sanjuan
Attorney
Knowledge Ecology International (KEI)
www.keionline.org
NYC Phone: 212 222 5180
Washington DC Phone: 202 332 2670


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