KEI comment on the Medicines Patent Pool license and MoU with ViiV Healthcare
28 February 2013
FYI: James Love (james.love@keionline.org, +1.202.361.3040), Krista Cox (krista.cox@keionline.org, +1.202.332.2670) or Thiru Balasubramaniam (thiru@keionline.org).
The 27 February 2013 agreements between the Medicines Patent Pool (MPP) and ViiV Healthcare, a joint venture of GlaxoSmithKline, Pfizer, and Shionogi will expand access to affordable pediatric formulas for HIV/AIDS.
The License and the MOU between ViiV and the MPP for Abacavir are online here: http://www.medicinespatentpool.org/licensing/current-licences/. The licenses and the MoU were reviewed by the MPP Governance Board, and by a 12 member Expert Advisory Group (EAG) chaired by Maximilliano Santa Cruz of the National Institute of Industrial Property in Chile. The EAG includes many well known and highly regarded experts from different disciplines including for example Professor Carlos Correa and Jonathan Berger from Section 27 in South Africa. The MPP documentation about the decision are available here: http://www.medicinespatentpool.org/who-we-are2/governance/governance-decisions/.
The following are KEI’s initial comments on the 42 page Abacavir license and the four page MoU.
KEI’s comments on the Abacavir license
GSK, Pfizer and Shionogi deserve credit and goodwill for entering into a license with the Medicines Patent Pool that includes patents on Abacavir, an important drug for HIV/AIDS that is particularly useful for pediatric AIDS. The geographic coverage of the license is broader than any other license from a drug company, and includes several countries in Latin America than did not previously benefit from an MPP license from a drug company. According to the MPP, the geographic area of the new license will allow generic Abacavir to be supplied in 118 countries where 98.7% of children living with HIV reside. The license does not require any royalty payments, does not designate countries where the drug is manufactured, is non-discriminatory as regards manufacturers, allows the product to be used in new fixed dose combinations or formulations, and provides that the licenses may be used even by companies that seek compulsory license or challenges to Abacavir patents. The patent coverage for Abacavir is uneven, and non-existent in many countries in the licensed area, but the ViiV/MPP license expands the market for generic products and provides more certainty for generic manufacturers. By offering the license, ViiV has created new momentum for open licensing of HIV/AIDS related patents, and that is a good thing.
Patent Landscape
Abacavir is an older compound, but the license covers eight patents related to its manufacture, formulation and use, including at least one patent in 65 countries. The patent landscape is set out in Appendix A to the license (pages 24-29 of the license).
Grant back provisions
Section 8 of the license addresses the issues of intellectual property relating to grant backs to improvements, and includes a grant back of a “perpetual, irrevocable, worldwide, royalty free, non-exclusive license to use any Improvement, Improvement Patent and related know how” to both the MPP and ViiV. Without negotiating additional rights, ViiV is entitled to grant sublicenses only to its Affiliates or contract manufacturers, distributors and service providers, and solely relating to the commercialization of ViiV products. Section 8 also provides that MPP can enter into negotiations for further sublicensing of any improvements developed by the licensee.
The ViiV/MPP Memorandum of Understanding
The four page MoU between ViiV and the MPP provides details of future collaboration between ViiV and the MPP for new pipeline products for pediatric AIDS. According to the MoU, the intention is to make the products available in the same 118 countries covered in the Abacavir license. One of the pipeline products is the new integrase inhibitor dolutegravir, a highly regarded product developed in collaboration with Shionogi.
Test data
Section 5.7 of the license extends the rights to include rights in regulatory test data.
5.7 ViiV shall provide any Sublicensee with NCE Exclusivity or other regulatory exclusivity waivers to the extent required by the applicable regulatory authorities in order to manufacture or sell Product in the Territory in accordance with the terms of the Sublicence. ViiV shall further provide to any Sublicensee such consents which it has the legal capacity to give as are necessary to enable such Sublicensee to perform its obligations under Clauses 3.2 and 3.3 of the Sublicence.
Comparison to the Gilead license
The primary advantages of the ViiV/Abacavir license to the earlier Gilead license are the freedom to manufacture APIs in different countries (Gilead restricted API manufacturing to India), and the larger geograpic scope. The new license territory includes the following countries that were were not covered in the Gilead license agreement for tenofovir (TDF): Algeria, Argentina, Azerbaijan, Chile, Colombia, Costa Rica, Korea DPR, Egypt , Federated States of Micronesia, Iraq, Iran, Kosovo, Lebanon, Libya, Marshall Islands, Malaysia, Morocco, Panama, Paraguay, Philippines, Tunisia, West Bank and Gaza. Many also see the zero royalty in the ViiV Abacavir license as an advantage.
On the other hand, the Gilead licenses cover more products and include licenses to pipeline products that have subsequently received FDA approval, and importantly, a broader field of use. The ViiV MoU limits the field of use of pediatric HIV/AIDS, while the Gilead licenses covered not only both pediatric and adult AIDS, but also other indications. In the Gilead license, for products using TDF as a sole ingredient, the field of use is HIV and Hepatitis B. For EVG and COBI, the field of use includes “any use that is consistent with” the labels approved by the US FDA or other “applicable foreign regulatory authority.”
Transparency
Unlike virtually all other voluntary licenses in this area, the MPP legal documents are available in unredacted form, and this is itself a significant benefit and welcome precedent that we hope others will follow, including governments and PDPs involved in licensing intellectual property rights.
Concluding Comments
As noted above, the new ViiV license gives the MPP fresh momentum in its efforts to expand the freedom to manufacture generic versions of drugs for HIV/AIDS. Attention should shift now to Johnson and Johnson, Abbott and other companies that have refused to license products to the patent pool, and to the challenge of adding more “middle income” countries to the geographic area of the licenses. To this end, low and middle income government should play a larger roll in pushing companies to license to the MPP — something that will add more products and expand the geographic area of the licenses. Given how complex are these negotiations, we would also note that the staff of the MPP, and its governance board and expert advisory board have demonstrated sensitivities to the most important issues in ensuring that the licenses promote robust generic competition and do not undermine the use of compulsory licenses or challenges to patent validity.
Additional details
The Memorandum of Understanding (MOU) can be found here.
The abacavir license can be found here.
The countries in the Territory include:
Afghanistan
Algeria
Angola
Argentina
Armenia
Azerbaijan
Bangladesh
Belize
Benin
Bhutan
Bolivia
Botswana
Burkina Faso
Burundi
Cambodia
Cameroon
Cape Verde
Central African Republic
Chad
Chile
Colombia
Comoros
Congo, Dem. Rep. Of The
Congo, Rep
Costa Rica
Côte d’Ivoire
Cuba
Djibouti
Dominican Republic
E.Timor
Ecuador
Egypt
El Salvador
Equatorial Guinea
Eritrea
Ethiopia
Fiji
Gabon
Gambia
Georgia
Ghana
Guatemala
Guinea
Guinea-Bissau
Guyana
Haiti
Honduras
India
Indonesia
Iran
Iraq
Jamaica
Kenya
Kiribati
Kosovo
Lao, People’s Dem. Rep.
Lebanon
Lesotho
Liberia
Libya
Madagascar
Malawi
Malaysia
Maldives
Mali
Marshall Islands
Mauritania
Mauritius
Micronesia
Moldova, Rep. of
Mongolia
Morocco
Mozambique
Myanmar
Namibia
Nauru
Nepal
Nicaragua
Niger
Nigeria
Pakistan
Palau
Papua New Guinea
Panama
Paraguay
Philippines
Republic Kyrgyz
Democratic People’s Republic of Korea
Rwanda
Samoa
São Tomé and Príncipe
Sénégal
Seychelles
Sierra Leone
Solomon Islands
Somalia
South Africa
South Sudan
Sri Lanka
Sudan
Swaziland
Syrian Arab Republic
Tajikistan
Tanzania, U. Rep. of
Thailand
Togo
Tonga
Tunisia
Turkmenistan
Tuvalu
Uganda
Uzbekistan
Vanuatu
Vietnam
West Bank and Gaza
Yemen
Zambia
Zimbabwe
Excerpt of the Licence Agreement (Section 2 “Grant of Sublicence”):
2 GRANT OF SUBLICENCE2.1 Subject to the terms and conditions of this Agreement and to the extent to which the Licensor has the right to grant a licence in respect of the Patents, the Licensor hereby grants to the Licensee a non-exclusive, royalty-free, non-sublicensable, non-transferable licence under the Patents to:
(a) manufacture, use, sell, supply, import or export in the Territory Raw Materials for use in the manufacture of Products to be supplied in the Territory solely for use in antiretroviral for HIV / AIDS; and
(b) manufacture, use, sell, supply, import or export Products in the Territory and solely for use in antiretroviral therapy for HIV / AIDS.
2.2 Subject to the terms and conditions of this Agreement and to the extent to which the Licensor has the right to grant a licence in respect of the Non-Territory Patents, the Licensor hereby grants to the Licensee a non-exclusive, royalty-free, non-sublicensable, non-transferable licence under the Non-Territory Patents to:
(a) manufacture use, sell, supply, import or export outside the Territory Products exclusively for use, sale, supply, import or export of such Products in the Territory and solely for use in antiretroviral therapy for HIV / AIDS;
(b) manufacture, use, sell, supply, import or export outside the Territory Raw Materials exclusively for supplying to the Territory for use in the manufacture of Products in the Territory and solely for use in antiretroviral therapy for HIV / AIDS; and
(c) manufacture, use, sell, supply, import or export outside the Territory Raw Materials for the manufacture of Products outside the Territory exclusively for use, sale, supply, import or export in the Territory and solely for use in antiretroviral therapy for HIV / AIDS.
2.5 The Licensee shall, acting in compliance with all applicable laws and regulations, use its best endeavours to maximise access to the Products in the Territory.
2.6 It is expressly acknowledged by the Licensee that this Agreement confers no intellectual property rights whatsoever on the Licensee other than those expressly granted in Clauses 2.1 and 2.2 for the term of this Agreement. Without prejudice to the generality of the foregoing, other than as expressly granted in Clause 2.1 and 2.2, no licence is granted to the Licensee to perform any acts or omissions which infringe:
(a) any rights (including, but not limited to, patent rights) of the Licensor, ViiV and/or any of their Affiliates and/or their sublicensees inside or outside the Territory; and/or
(b) any rights of any Third Party (including, without limitation, ViiV and their Affiliates) inside or outside the Territory.
The collaboration detailed in the MOU between the Medicines Patent Pool and ViiV Healthcare states that the parties “wish to accomplish the following objectives through this Collaboration”:
a) Licensing of Abacavir and Abacavir-containing formulations for paediatric HIV treatment.
b) If and when ViiV receives FDA or EMA approval for any of its current pipeline products, such products for paediatric HIV treatment will be eligible to be licensed to the MPPF for the same territorial scope of the Abacavir licence agreement referenced in sub-clause (a), subject to agreement of the terms of such licence.
c) The Parties acknowledge that in the field of paediatric HIV treatment, there are formulations for which access to patents alone is likely not to be sufficient for rapid development and access to paediatric formulations of ARVs. In such cases the Parties further agree that (i) formulation development and manufacturing technology transfers, (ii) access to regulatory data, and (iii) partnerships that develop new fixed dose combinations (FDCs) can all serve as catalysts (“Catalytic Interventions”) for development of products that would otherwise not be developed. ViiV and the MPPF are committed to collaborate on the use of such Catalytic Interventions to improve access to paediatric HIV products, including, but not limited to, approaching third parties with relevant IP and/or expertise for the development of needed paediatric ARV formulations.
d) Both Parties will seek to support the development of generic manufactured paediatric products in a manner consistent with World Health Organisation pre-qualification standards or the standards of a Stringent Regulatory Authority to optimise access and scale up of paediatric treatment.
e) Where novel ARVs formulations are developed by MPPF licensees, ViiV and MPPF will explore further mechanisms to ensure their availability outside the defined licensed territory to as many children in need as possible.
f) MPPF will carry out detailed research to define the clinical unmet product(s) and formulation(s) need within the existing paediatric treatment landscape for ViiV’s products to be used for paediatric HIV treatment and will share such research with ViiV.
g) MPPF will identify appropriate generic manufacturing or other partners that have the R&D, manufacturing and/or commercial capabilities to produce and supply paediatric products derived using ViiV’s patents and Catalytic Interventions at prices that will facilitate access to such products, and will provide to ViiV such supporting information as ViiV reasonably requests to support such identification.