Addressing Innovation and Access Through Voluntary Licensing: The Medicines Patent Pool

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

2. Patenting of ARVs in developing countries has increased over recent years • 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) Source: Medicines Patent Pool Database

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

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

5. Patent expiry is still a long way away...

6. 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 developingcountries 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

7. 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 • http://www.unaids.org/en/media/unaids/contentassets/documents/unaidspublication/2011/JC2049_PolicyBrief_TRIPS_en.pdf • Voluntary Licences: can result in improved access. But need to include key public heath safeguards.

8. Concerns With Existing Bilateral Voluntary Licences Bilateral 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

9. Core Principles for 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 Pool Licences Board EAG Medicines Patent Pool Generics Patent Holders Consultative Process

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

11. Three Main Objectives • Accelerate the availability of generic versions of new antiretroviralsin 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) How does it work? Prioritise HIV medicines Invite patent holders to negotiate Negotiate public health-oriented licences Sign agreements Sub-licence to generics Enhance access

12. 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

13. Medicines Patent Pool ARV Priorities Prioritise HIV medicines Invite relevant patent holders to negotiate Negotiate public health-oriented licences Sign agreements Sub-licence to generics Enhance access * Indicates pipeline product

14. By-product of Prioritization: the Patent Status Database Prioritise HIV medicines Invite relevant patent holders to negotiate Negotiate public health-oriented licences Sign agreements Sub-licence to generics Enhance access • 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. "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

15. Prioritise HIV medicines Invite relevant patent holders to negotiate Negotiate public health-oriented licences Sign agreements Sub-licence to generics Enhance access

16. 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

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

18. Achievements so far… Prioritise HIV medicines Invite relevant patent holders to negotiate Negotiate public health-oriented licences Sign agreements Sub-licence to generics Enhance access • Unprecedentedpublicationof 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

19. …but a lot to be done Prioritise HIV medicines Invite relevant patent holders to negotiate Negotiate public health-oriented licences Sign agreements Sub-licence to generics Enhance access • 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

20. Supporting Statements “"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 “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 “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 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

21. THANK YOU www.medicinespatentpool.org