Addressing Innovation and Access Through Voluntary Licensing: The Medicines Patent Pool Chan Park Washington, D.C. 25 July 2012

Patenting of ARVs in developing countries has increased over recent years 2 Source: Medicines Patent Pool Database Patenting of ARVs in developing countries is more common for medicines developed after 1995 than for those developed before 1995 (date of entry into force of the TRIPS agreement)

As a result, newer drugs are more widely patented today 3 Pre-1995 ARVsPost-1995 ARVs

Many secondary patents on ARVs complicate the issue further 4 Pre-1995 Post-1995 Only includes some select secondary patents: but there are many more

Patent expiry is still a long way away TRIPS Transition for Developing Countries TRIPS Transition for Least Developed Countries Zidovudine Didanosine Stavudine Saquinavir Nevirapine Abacavir Emtricitabine Lamivudine Indinavir Efavirenz Darunavir Ritonavir `Lopinavir Atazanavir Tenofovir DF Fosamprenavir Maraviroc Etravirine Rilpivirine Raltegravir Elvitegravir Dolutegravir Cobicistat SPI

Challenges for Fixed Dose Combinations may be particularly problematic Out of 11 recommended FDCs with at least one supplier, potential IP barriers to generic competition for at least 9 All 7 FDCs under development or recently approved appear to face patent barriers to generic competition in some developing countries Source: Medicines Patent Pool, Challenges for the Uptake of Fixed- Dose Combinations: An Analysis of Intellectual Property Issues Some needed FDCs also not being developed, including for paediatric HIV Source: Joint submission by Medicines Patent Pool, WHO and UNITAID to the WHO Committee on the Selection and Use of Essential Medicines

Mechanisms to overcome patent barriers UNAIDS-UNDP-WHO policy brief analyses a number of mechanisms: – Use of TRIPS flexibilities E.g.: Extension of the exception for LDCs Limit what is patentable (e.g. India) Use of competition law to increase number of producers (e.g. South Africa) Opposition procedures Compulsory licences or government use (e.g. Brazil, Malaysia, Mozambique, Rwanda, Thailand, Zambia, Zimbabwe) Others unaidspublication/2011/JC2049_PolicyBrief_TRIPS_en.pdf – Voluntary Licences: can result in improved access. But need to include key public heath safeguards.

Concerns With Existing Bilateral Voluntary Licences Licences are secret. Only basic features are disclosed. Wide range of restrictions may impact negatively on access Licences given to few hand-picked manufacturers No voluntary licences for a number of products (e.g. dolutegravir, lopinavir, maraviroc, ritonavir) Very restrictive ones for others (e.g. darunavir, etravirine, raltegravir) Patent Holders Generics Bilateral Licences

Core Principles for Pool Licences Generics Consultative Process Board EAG Medicines Patent Pool Patent Holder s Pool Licences Licenses negotiated from a public health, pro-access perspective Improvement for as many people living with HIV in LMICs as possible Ensure terms and conditions are consistent with the use of TRIPs flexibilities Improving industry norms for voluntary licensing Manage licences with a public health focus Work with partners to promote the development of needed formulations

The Medicines Patent Pool: an Innovative Public-Health Oriented Voluntary Licensing Mechanism for HIV 10

Accelerate the availability of generic versions of new antiretrovirals in developing countries Enable the development of fixed dose combinations (FDCs) of which the patents are held by different entities Enable the development of adapted formulations for children or for specific developing country needs (e.g., heat stable) Three Main Objectives 11 Prioritise HIV medicines Invite patent holders to negotiate Negotiate public health- oriented licences Sign agreements Sub-licence to generics Enhance access How does it work?

Prioritise HIV Medicines by Clinical and Market/IP Priority Prioritise HIV medicines Invite relevant patent holders to negotiate Negotiate public health-oriented licences Sign agreements Sub-licence to generics Enhance access Clinical / Medical Priority Market / IP Priority ARV Prioritisation Working Paper +=

Medicines Patent Pool ARV Priorities 13 CompoundClinical Priority Market / IP Priority Level 1 Priorities Atazanavir (ATV)High Dolutegravir (DLG)*High Cobicistat (COB)*High Elvitegravir (EVG)*High Lopinavir (LPV)High Rilpivirine (RIL)HighMedium Ritonavir (RTV)HighMedium Efavirenz (EFV)HighMedium Tenofovir (TDF)HighMedium Etravirine (ETV)MediumHigh Raltegravir (RAL)MediumHigh Abacavir (ABC)Medium Darunavir + Medium CompoundClinical Priority Market / IP Priority Level 2 Priorities Lamivudine (3TC)HighLow Nevirapine (NVP)HighLow Zidovudine (AZT)HighLow Emtricitabine (FTC)MediumLow Level 3 Priorities Fosamprenavir (FPV)LowHigh Maraviroc (MVC)LowHigh Didanosine (ddI)LowMedium Saquinavir (SQV)LowMedium * Indicates pipeline product Prioritise HIV medicines Invite relevant patent holders to negotiate Negotiate public health-oriented licences Sign agreements Sub-licence to generics Enhance access

By-product of Prioritization: the Patent Status Database What Is It? Patent status data collected for 24 HIV compounds in 76 low and middle income countries Provided for the first time a clear understanding of what is patented where Included in a searchable database on our website Today: most complete single source of patent status data on HIV medicines. Widely used by public health actors. Prioritise HIV medicines Invite relevant patent holders to negotiate Negotiate public health-oriented licences Sign agreements Sub-licence to generics Enhance access "Knowing the patent status of different ARVs is important when looking at whether or not there are barriers for treatment providers to import these drugs into a particular country. The patent status database is an incredibly useful resource as it provides the most comprehensive pool of the available information on patent statuses, and combines this into one easy to use search engine.” MSF “UNICEF's aim is to have as complete, a factual picture as we can on patents for HIV medicines in developing countries, which can affect whether the medicine can be sent to a particular country. The Medicines Patent Pool’s Patent Status Database for Selected HIV Medicines takes an invaluable step towards furthering access to treatment of HIV/AIDS amassing information from numerous patent registries and jurisdictions into an easily navigable resource available to the public.” - UNICEF “In the midst of a current patent regime that is at times not so transparent, this database is a great and valuable tool for players in the field, and one we regularly check as part of our procedures for determining a patent status. [It] ultimately allow[s] us to focus more of our energy into the actual delivery of HIV medicines to the ones who need it.” IDA Foundation "The Medicines Patent Pool database is an essential impartial reference source for Global Fund Principal Recipients to understand the patent status of ARVs in their country – and it should be further expanded to include more countries.” The Global Fund

Patent HolderQ4 2010Q1 2011Q2 2011Q3 2011Q4 2011Q1 2012Q Abbott Laboratories Sent letter on 1 December Not currently in negotiations. Reply received 26 January. Not currently in negotiations. Not currently in negotiations Boehringer- Ingelheim Sent letter on 1 December Not currently in negotiations. Reply received 19 January. Not currently in negotiations. In negotiations. Bristol-Myers Squibb Sent letter on 1 December Not currently in negotiations. Reply received 26 January. Not currently in negotiations. In negotiations. F. Hoffman-La Roche Sent letter on 1 December Preparing for negotiations. In negotiations. Gilead Sciences Sent letter on 1 December In negotiations. Reply received 14 February In negotiations. Licence agreement signed July Licence agreement signed July Amended in November Merck & Co. Sent letter on 1 December Not currently in negotiations. Reply received 28 January. Not currently in negotiations. Tibotec/J&J Sent letter on 1 December Not currently in negotiations. Reply received 31 January Not currently in negotiations. Not currently in negotiations. J&J’s decision received in December. Not currently in negotiations. Pool responds to J&J’s decision in January. Not currently in negotiations. US NIH Licence agreement signed Sept In negotiations. ViiV Healthcare (GSK/Pfizer) Sent letter on 1 December In negotiations. 15 Prioritise HIV medicines Invite relevant patent holders to negotiate Negotiate public health-oriented licences Sign agreements Sub-licence to generics Enhance access

Geographical Scope of Voluntary Licences Prioritise HIV medicines Invite relevant patent holders to negotiate Negotiate public health-oriented licences Sign agreements Sub-licence to generics Enhance access Pool Licences # of countries

Sub-Licence to Generics Four sub-licences signed Three have made use of key flexibility negotiated by the Pool opening up the market for TDF Advanced discussions with several other potential licensees Prioritise HIV medicines Invite relevant patent holders to negotiate Negotiate public health-oriented licences Sign agreements Sub-licence to generics Enhance access MPP’s Post-Licensing M&E Process Decision Point Licensing Step Reporting Step Only If Required Sign In- Licences Send Expression of Intent (EOI) Screen EOI Replies Negotiate Out- Licences Sign Out- Licences Conduct First Quarterly Review Kick-Off Generic Collaboration Conduct Tech Transfer per licence terms 1 st originator approval for pipeline product 1 st originator approval for pipeline product Liaise with WHO PQ, as appropriate Monitor Registration Status Conduct Progress Reporting Monitor Royalties Annual Review of Licensors + Sub-Licensees Collect Market Feedback on Sub-Licensees Assess Impact Initiate Dispute Resolution

Achievements so far… Unprecedented publication of full text of licence Patent transparency on what HIV medicines are patented in which countries Two patent holders in the Pool, and several others in negotiation Higher standard on number of countries covered by licence (but still long way to go) Recognition of importance of licensing medicines as early as possible (e.g. pipeline compounds) to reduce delay in developing countries Provisions in licences consistent with the use of TRIPS flexibilities Recognition of a new business model for ARV licensing, through an entity with a public health mandate Prioritise HIV medicines Invite relevant patent holders to negotiate Negotiate public health-oriented licences Sign agreements Sub-licence to generics Enhance access

…but a lot to be done Successfully negotiating public-health oriented licences with key flexibilities from more patent holders Further expanding number of countries benefitting from licences Contributing to opening up the markets for second-line, third-line and pipeline ARVs in more countries Enabling the development of new fixed dose combinations and adapted formulations that meet treatment needs Providing for greater diversification in manufacturing of ARVs Continue to change industry norms towards greater public health focus in licensing practices Prioritise HIV medicines Invite relevant patent holders to negotiate Negotiate public health-oriented licences Sign agreements Sub-licence to generics Enhance access

Supporting Statements “We welcome the Patent Pool Initiative launched by UNITAID…and we invite the voluntary participation of patent owners, private and public, in the project.” – G8 Summit, Deauville, France, May 2011 I commend UNITAID for taking the initiative to establish the Medicines Patent Pool and commend the companies that are in negotiations with the Patent Pool -Margaret Chan, Director General of WHO, July 2011 “Encourage the use of new mechanisms such as the UNITAID Medicines Patent Pool to help reduce treatment costs and promote the development of new treatment formulations, including paediatric formulations and fixed-dose combinations.” – Sao Paulo Parliamentary Declaration on Access to Medicines and Other Pharmaceutical Products, Global Fund Partnership Forum, June 2011 Partnership Forum “"A successful patent pool will help in accelerating the scaling up of access to care and treatment and will reduce the risk of stock out of medicines in the developing world.“ – Michel Sidibe, Executive Director, UNAIDS, July 2010 “Encouraging the voluntary use, where appropriate, of new mechanisms such as partnerships, tiered pricing, open-source sharing of patents and patent pools benefiting all developing countries, including through entities such as the Medicines Patent Pool, to help reduce treatment costs and encourage development of new HIV treatment formulations, including HIV medicines and point-of-care diagnostics, in particular for children.” -UN General Assembly Political Declaration on HIV/AIDS

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