The Medicines Patent Pool: An Update. June 2012 Geneva, Switzerland

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1 The Medicines Patent Pool: An Update June 2012 Geneva, Switzerland

2 The Medicines Patent Pool Royalties Licensor Licensor Patents Generics versions of existing compounds Licensor Licensor Patents Patents Pool Fixed-Dose Combinations Adapted formulations (e.g. Licensor paediatrics) Royalties Established in 2010 with the support of

3 New HIV medicines are more widely patented in developing countries Total number of product patents pending or granted, by jurisdiction, for older compounds (pre-1995) and newer compounds (post-1995)* 7/2/2012 Source: Patent Status Database on Selected HIV Medicines (MPP) 2

4 and have many years left before expiry 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

5 Fixed Dose Combinations Analysis of patent-related challenges to the uptake of FDCs undertaken for the Global Fund Market Dynamics and Commodities ad hoc Committee Out of 10 recommended FDCs with at least one supplier, potential IP barriers for 7 in at least one developing country (risk is higher for 3) All 6 FDCs known to be either in development, or having very recently obtained regulatory approval, appear to face patent barriers to generic competition in some developing country jurisdictions

6 Priority Products for the Pool Summary of Priorities for the Medicines Patent Pool Compound Clinical Priority Market/IP Priority Level 1 Priorities (medium or high priority under both criteria) Atazanavir (ATV) High High Dolutegravir (DLG)* High High Cobicistat (COB)* High High Elvitegravir (EVG)* High High Lopinavir (LPV) High High Rilpivirine (RIL) High High Ritonavir (r) High High Efavirenz (EFV) High Medium Tenofovir (TDF) High Medium Etravirine (ETV) Medium High Raltegravir (RAL) Medium High Abacavir (ABC) Medium Medium Darunavir (DRV) Medium Medium Level 2 Priorities (medium or high for clinical and low for market/ip) Lamivudine (3TC) High Low Nevirapine (NVP) High Low Zidovudine (AZT or High Low ZDV) Emtricitabine (FTC) High Low Stavudine (d4t) Medium Low Level 3 Priorities (medium or high for market/ip and low for clinical) Fosamprenavir (FPV) Low High Maraviroc (MVC) Low High Didanosine (ddi) Low Medium Saquinavir (SQV) Low Medium Working paper published for comments available at: entpool.org/what-we- DO/Target-Medicines Compounds with (*) are pipeline compounds In dark green: compounds for which licences have been obtained In light green: compounds for which negotiations are ongoing In light yellow: compounds for which not currently in negotiations

7 Patent Holder Abbott Laboratories Boehringer- Ingelheim Bristol-Myers Squibb F. Hoffman-La Roche Company Engagement: Patent Holders Q Q Q Q Q Q Gilead Sciences Merck & Co. Sequoia Pharma Tibotec/J&J US NIH ViiV Healthcare (GSK/Pfizer) Licence agreement signed Sept Reply received 26 January Reply received 19 January Reply received 26 January negotiations negotiations negotiation In In In negotiations In In In negotiations Preparing for negotiation. In In In In In Reply received 14 February Reply received 28 January In Licence agreement signed July Agreement signed July amendments Agreement signed July amendments In In In In In Reply received 31 January In In In In In In In In In In In formal negotiations Licence agreement signed 6

8 The Pool s licence with Gilead (July 2011) Key Features: Includes: tenofovir (TDF), cobicistat (COBI), elvitegravir (EVG), emtricitabine (FTC) and the combination product the Quad Geographical scope: TDF: 112 countries (87.6% of PLHIV in developing countries) COBI: 103 countries (82.7%) EVG-Quad: 100 countries (82.7%) s can make combination products Royalties 3 5%. No royalties for paediatrics Waiver of any data exclusivity rights Generics can pick and choose products they license Generics can terminate licence at any moment Generics can supply countries that issue compulsory license One time technology transfer Provides for publication of licence agreement s can oppose the patents Main Concerns: Limited to sub-licensees based in India Geographical scope

9 Out-licensing Gilead licence so far out-licensed to: Aurobindo Pharma, Emcure Pharma Large established ARV players Terminated TDF part of the licence on signing; now free to sell TDF where there are no patents, including, e.g. Argentina, Brazil, Chile, Colombia, Malaysia, Peru, Philippines, Ukraine, and Uruguay as long as manufacturers not using patented process Medchem International New player in ARVs 8

10 Patent Status Database Launched in April 2011 and regularly updated Patent status data collected with support of WIPO and national patent offices for 24 compounds in 76 low and middle income countries Included in a searchable database on our website Most complete single source of ARV patent status data Searchable by compound and by country (or region)

11 Patent Status Database The Pool s patent status database is being utilised by different procurement actors to gain clarity on the IP landscape and ultimately minimise costs, where possible Recently added: Albania, Azerbaijan, Bosnia, Bulgaria, Dominican Republic, Lithuania, Moldova, Montenegro and Turkey Recently updated data on: Armenia, Brazil, China, India, Mexico, Peru, South Africa, Ukraine and Uruguay 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 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 "The patent status database is a very helpful tool that provides easy access to patent information that is otherwise hardly available and difficult to obtain. Our procurement specialists use the tool as a starting point in determining the best value supply option for clients." -I+ Solutions "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 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 10

12 THANK YOU