HIV Treatment and Intellectual Property Rights: The Experience of the Medicines Patent Pool Esteban Burrone Melbourne – International AIDS Conference July

Innovation in HIV treatment 29 new ARV molecules developed for the treatment of HIV since virus discovered Several fixed dose combinations developed that contain 3 or 4 ARVs in one single pill Innovation on an unprecedented scale Need to ensure access

TRIPS Transition for Developing Countries TRIPS Transition for Least Developed Countries Zidovudine Didanosine Stavudine Saquinavir Nevirapine Abacavir Emtricitabine Lamivudine Indinavir Efavirenz Darunavir `Lopinavir Atazanavir Tenofovir Disproxil Fumarate (TDF) Fosamprenavir Maraviroc Etravirine Tenfovir Alfenamide Fumarate (TAF) Rilpivirine Raltegravir Elvitegravir Ritonavir heat-stable Dolutegravir Cobicistat * Secondary patents on some of these products may extend patent protection beyond the date shown. Patents on new ARVs 3

Increased Patenting of ARVs in Developing Countries Increased patenting of ARVs in developing countries for ARVs developed since 1995 Analysis based on information for 75 developing countries accounting for 80% of people living with HIV 4 Source: Medicines Patent Pool Patent Status Database on Selected ARVs (2012)

Pattern particularly visible in key countries of production of generic ARVs 5 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)

Challenges for Fixed Dose Combinations Generic access Patent held by A  Fixed-dose combinations improve treatment adherence for adults and children alike But patents on single ARV can impact on the development of whole FDC There are also patents on the combinations themselves Generic access

Long Lag from Originator Market Approval to Generic Availability FDA/EMA Approval Timeline From Originator Approval to Generic Availability: Generic Approvals Years Time from US FDA approval of new ARV molecules to availability as quality assured generics for developing countries has generally ranged from 5 to 10 years

THE MEDICINES PATENT POOL 8

PATENT HOLDERS Licences Sub- Licences Medicines MANUFACTURERSPEOPLE LIVING WITH HIV ROYALTIES Medicines Patent Pool Established in 2010 with the support of 9

Key objectives Promote robust competition to enable price reductions for new ARVs Facilitate the development of fixed-dose combinations Promote development of special formulations needed for children living with HIV Accelerate availability of new ARVs in developing countries

Prioritising HIV Medicines Clinical Analysis: “Which drugs are most important for HIV treatment?” IP Analysis: “Which drugs are patented in developing countries?” MPP priorities + =

List of MPP Product Priorities COMPOUNDSCLINICAL PRIORITYMARKET/IP PRIORITY AtazanavirHigh DolutegravirHigh LopinavirHigh RitonavirHigh TAFHigh CobicistatHigh ElvitegravirHigh Abacavir (paediatrics)HighMedium EmtricitabineHighMedium (comb patents) EfavirenzHighMedium (comb patents) TDFHighMedium (comb patents) DarunavirMedium/HighMedium NevirapineMedium/HighMedium EtravirineMediumHigh RaltegravirMediumHigh RilpivirineMediumHigh

Key Elements of MPP licences Negotiated from a public health perspective Non-exclusive licensing to qualified generic manufacturers Publication of full text of all licences More developing countries are able to benefit Enable development of fixed-dose combinations and paediatric formulations Possibility of technology transfer Enable supply to countries using TRIPS flexibilities Seek inclusion of provisions to open up markets for key medicines Raising the bar for licensing in the HIV field

MPP Agreements Medicines Patent Pool Bristol- Myers Squibb Gilead Sciences National Institutes of Health Roche Viiv Healthcare AbbVie Gilead Sciences Merck/MSD 14 Atazanavir Tenofovir Disoproxil Fumarate (TDF) Emtricitabine Cobicistat Elvitegravir Darunavir (only secondary patent) Valganciclovi r (discounted price) Abacavir (paediatric) Dolutegravir Concluded AgreementsUnder negotiation Raltegravir (paediatric) Tenofovir Alafenamide Fumarate (TAF) Lopinavir (paediatric) Ritonavir (paediatric)

Medicines Patent Pool Out-Licensing MPP Sublicensees Aurobindo Cipla Desano Emcure Hetero Laurus Micro Labs Mylan Shasun Shilpa MPP has licensed 7 ARVs to 10 generic partners: Tenofovir Disproxil Fumarate Emtricitabine Elvitegravir Cobicistat Abacavir (paediatric) Atazanavir Dolutegravir Currently managing 35 sub- licences 15

Key Challenge: inclusion of certain middle- income countries in licences Proportion of people living with HIV by country income category, Source: UNAIDS, IMF 2012

One possible approach to address challenge in some MICs Market Segmentation (public/private) – In many countries, national treatment programs cater for vast majority of people on treatment – Generics able to supply national treatment programs – Originators continue to cater for small private market Introduce royalties that are differentiated according to countries’ socio-economic circumstances – Enables countries to benefit from robust generic competition which results in lower prices – Royalty could take into account different variables: GDP per capita, inequality, disease burden, others

Thank you 18