Patent Pools As Public Health Meta Collaborations: the Experience of NIH and the Medicines Patent Pool

Transcription

1 Patent Pools As Public Health Meta Collaborations: the Experience of NIH and the Medicines Patent Pool Steven M. Ferguson, CLP Deputy Director, Licensing & Entrepreneurship NIH Office of Technology Transfer

2 Today s Topic: Is There An Additional Way to Stimulate Innovation & Improve Access to HIV Therapeutics? DISCOVERY Lead identification / optimization Basic research Patents Translational research Demand for new / improved tools and post marketing research 3D INNOVATION CYCLE DEVELOPMENT Lead identification / optimization Basic research & more patents DELIVERY Getting products to patients Markets Market approval and manufacture Source: MPP & Public Health, Innovation and intellectual property rights (WHO)

3 But First A Word From Our Sponsor: Annual budget of $ 30.9 billion (FY12) ~10% of funding for intramural research 6,000 intramural scientists / 18,000 staff Basic & clinical research discoveries Partners commercialize into products! But what are partners?

4 What Exactly Do We Mean By Partners Anyway? Traditionally, this has been companies who have used licenses & other T2 mechanisms to help launch new products However, these partners are no longer exclusively companies! Example: PATH Meningitis Vaccine Project product launch December 2010

5 Companies Have Launched A Number of Innovative HIV Products Based Upon NIH Research Videx (ddi) BMS & generics Hivid (ddc) Roche Prezista (Protease Inhibitor) Tibotec HIV Test Kit Abbott & many others HIV Protease genotyping assay; drug target And hopefully future products via other non-company organizations --

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7 Why Might A Patent Pool Be Useful For HIV Therapeutics?

8 Despite Progress There Are Still Significant Treatment Needs 35 > 6 million people in developing countries on ART by end of 2009 People (Millions) Will Need Treatment In Need of Treatment Treated But further 10 million people are in urgent need of treatment as per WHO guidelines An additional 18 million people are HIV positive and will need treatment million new people on treatment in 2009, but 2.6 million new infections Source: World Health Organization. Towards universal access: Scaling up priority HIV/AIDS interventions in the health sector. and MPP Source: MPP

9 Generic competition central to treatment scale-up of past decade Price of 1 st line drug therapies down to under 1% of original price Widespread patenting of newer drugs in developing countries MPP s Rationale Back For Establishing A Patent Pool Limited generic availability and limited price reductions Differential pricing: not same impact on pricing as robust generic competition Promising fixed-dose combinations (FDCs) / formulations often not developed WHO Committee on Essential Medicines has identified opportunities Financial crisis budgets for purchase of HIV medicines not growing Treatment Needs WHO Treatment Guidelines (earlier start; drugs with less side effects) People in developing countries developing resistance to 1 st line Special (unmet) needs of children with HIV New evidence: HIV treatment prevents transmission of HIV Source: MPP

10 Origins of Medicines Patent Pool: Integral Part of UNITAID's Strategy A common goal : " improving access to quality, affordable, effective, welladapted HIV medicines in developing countries " A common market based approach: Converging goals through a focus on market impact to lower the prices of medicines Influence of global patenting on the medicines' market dynamics Market incentives to channel the demand Bridging the gap between accessible and affordable Strategic use of intellectual property (changing international rules that limit competition and lower cost production) Source: UNITIAID

11 The UNITIAD Story Begins: The Air Ticket Levy Contributions from 11+ countries 80% of UNITAID funds from air ticket tax 20% multi budgetary contributions Applied to all fights departing from countries Amount can vary and decided by government Around $US 1 domestic economy Over $US 40 business international Predictable, sustainable funding UNITAID hosted & administered by WHO Over US$ 2 billion raised since 2006 Source: UNITAID

12 94 Countries Receive UNITAID support Through Partnerships: WHO, UNICEF, STOP TB, UNAIDS & Others HIV / AIDS 49 recipient countries - Pediatric ARV - Second line ARV -PMTCT US$592 m Malaria 29 recipient countries - LLIN - ACT - AMFm US$318 m Tuberculosis 72 recipient countries - First line TB - Pediatric TB - MDR-TB - Diagnostics US$211 m Cross cutting programs: US$109 m for PQ of drugs & diagnostics and transversal programs Source: UNITAID

13 Why Would NIH Want to Work With The Medicines Patent Pool? MPP Is Attractive To NIH Because of Public Health Vision & Mission: MPP Public Health Vision To improve access to appropriate affordable HIV treatments in developing countries Medicines Patent Pool Mission The patent pool will bring down the prices of HIV drugs, facilitate the development and production of improved formulations (e.g., fixed dose combinations and pediatric and heat-stable formulations) by providing access to intellectual property relating to these products Source: MPP

14 MPP Guiding Principles 1 Public health driven 8 Quality assurance 2 Focus on HIV 9 Standardised licenses 3 Voluntary 10 Non discriminatory licenses 4 Developing country focus (low & middle income) 11 Additional / complementary to existing mechanisms Price reductions Enable product development Flexible Operate within current intellectual property framework Independent entity Source: MPP

15 Three Main Objectives For MPP 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) Accelerate the availability of generic versions of new ARVs in developing countries Source: MPP

16 MPP Context: HIV/AIDS Market Global ARV Sales 6% Global Sales 2nd and 3rd Line ARVs 3% 94% Rest of the World US + Europe 97% Rest of the World US + Europe Low and middle income countries represent a small proportion of current global sales for HIV/AIDS (a fraction of 6%) and highly concentrated in a handful of countries. For 2 nd and 3 rd line drugs: less than 3% But over 90% of the disease burden Source: MPP

17 Context: Patents on some new ARVs Product +/- Expiry date Atazanavir (Novartis) 2017 Cobicistat (Gilead) 2027 Darunavir (J&J/Tibotec) 2023 Etravirine (J&J/Tibotec) 2019 Fosamprenavir (ViiV) 2018 GSK 572 Dolutegravir (ViiV) 2026 Raltegravir (MSD) 2025 Rilpivirine (J&J/Tibotec) 2022 Ritonavir hs (Abbott) 2024 Tenofovir DF (Gilead) 2018 Maraviroc (Pfizer) 2019 Source: MPP

18 How the MPP Pool Works Royalties Licensor Sub- Licensee Sub- Licensee Licensor Patents Sub- Licensee Licensor Patents Pool Sub- Licensee Licensor Patents Sub- Licensee Sub- Licensee Licensor Sub- Licensee Royalties Source: MPP

19 Patent Pool Partnerships UNITAID: Initiated the Medicines Patent Pool project 08 Funds operations of Pool under a 5-year MOU WHO: Medicines quality assurance (WHO PQ Department) Identification of priority medicines (HIV/AIDS Dept. and Expert Committee on Essential Medicines) WIPO Licensing terms and conditions (co-organization of expert workshop in 2010) Arbitration Patent status information Many others (WTO, Global Fund, UNAIDS, ANRS, EPO, MSF etc.) Source: MPP

20 HIV Medicines Patent Status Database The WIPO and the National Patent Offices have provided/verified the patent status information Public resource for HIV drug development Source: MPP

21 Medicines Patent Pool: Progress to Date The Medicines Patent Pool opened in 2010, and a dialogue has been opened with all known patent holders The NIH became the first to license patents to the Pool Negotiations on terms and conditions are on-going with other potential licensors Consultations have also been held with generic manufacturers External legal / licensing experts in collaboration with WIPO Prioritisation based on latest scientific evidence in collaboration with the WHO and UNITAID Continued engagement with governments in developing and developed countries Information about and produced by the Pool made available on the website Source: MPP

22 MPP: Recent Developments Gilead Sciences: tenofovir (TDF), emtricitabine (FTC), cobicistat (COBI), elvitegravir (EVG) & Quad [a combination of TDF, FTC, COBI, and EVG]. MPP secured its second license agreement from Gilead Sciences in July It was the first agreement the Pool has made with a pharmaceutical company patent holder. MedChem: tenofovir (TDF), emtricitabine (FTC), cobicistat (COBI), elvitegravir (EVG) & Quad [a combination of TDF, FTC, COBI, and EVG]. In July 2011, MedChem became the Pool's first generic company sublicensee. MedChem is a new player in the HIV field. Attracting generic producers will help increase production capacity. Aurobindo Pharma Limited: emtricitabine (FTC), cobicistat (COBI), elvitegravir (EVG) & Quad [a combination of TDF, FTC, COBI, and EVG]. In October 2011, the Pool signed a sublicensing agreement with key generics manufacturer Aurobindo.

23 MPP: Recent Developments Larus Laboratories: tenofovir (TDF), emtricitabine (FTC), cobicistat (COBI), elvitegravir (EVG) & Quad [a combination of TDF, FTC, COBI, and EVG]. In November 2012, MPP signed a sublicensing agreement with another key generics manufacturer Larus Laboratories. ViiV Healthcare: abacavir for pediatric AIDS. In February 2013, Viiv Healthcare -- a joint venture of GlaxoSmithKline, Pfizer, and Shionogi - agreed to facilitate greater availability of critically needed medicines by MPP for children living with HIV. Abacarvir included now -- new pipeline products in the future. Shashun Pharmacueticals: emtricitabine (FTC), cobicistat (COBI), elvitegravir (EVG) & Quad [a combination of TDF, FTC, COBI, and EVG]. In March 2013, the Pool signed a sublicensing agreement with another key generics manufacturer Shashun Pharmaceuticals.

24 . MPP Open Letter: Key Elements of Licenses Licenses will be for products needed for the treatment & prevention of HIV/AIDS. Licenses will be available on a non-exclusive and non-discriminatory basis to qualified entities to enable the production and development of HIV medicines, including adapted formulations and fixed dose combinations, for use in developing countries. Licensors will be compensated through royalties. Reasonable rates of remuneration that take into account different countries' ability to pay, disease burden, and other relevant factors, will be considered in an effort to expand the benefits of the licenses to as many low- and middle-income countries as possible. Licenses will include quality assurance provisions leveraging existing mechanisms (e.g. World Health Organization Prequalification Program, United States Food and Drug Administration tentative approval and European Medicines Agency). The Pool will operate in a transparent manner, in recognition of the critical nature of the public health issues at stake and the widespread public interest in its work. Therefore, the terms and conditions of the licenses will be made public.

25 Focus of MPP License Negotiations: NIH Patents Concerning Darunavir

26 NIH Patent: Methods of Use For Darunavir & Similar Compounds Method claims only Important for treating drug-resistant HIV Joint invention with University of Illinois Chicago Managed under NIH-lead Inter- Institutional Agreement Previously licensed non-exclusively: Tibotec, Sequoia

27 Inventors For NIH Patent Rights John W. Erickson (NCI) Sergei V. Gulnik (NCI) Hiroaki Mitsuya (NCI) Arun K. Ghosh (UIC)

28 NIH Licensed Patent Rights US Application 09/720,226 issued (7,470,506) US Application 11/870,931 (pending) Canada Application (pending) Australia Application 48280/99 issued ( ) Australia Application (issued) Australia Application (issued) Japan Application /2000 (issued) Japan Application /2009 (allowed) EPO Application (issued)

29 NIH License: Licensed Territory United States, Canada, Australia, Japan Austria, Belgium, Switzerland, Cyprus, Germany, Denmark, Spain, Finland, France, Great Britain, Greece, Ireland, Italy, Liechtenstein, Luxembourg, Monaco, Netherlands, Portugal, and Sweden.

30 Licensed Fields of Use Treatment and prevention of medical conditions affecting humans

31 NIH License: Term & Termination This Agreement shall expire, on a country-by-country basis within the Licensed Territory, on the last to expire patent containing a valid claim, unless previously terminated under Article 7.

32 NIH License: Grant Of Rights PHS hereby grants and Licensee accepts, subject to the terms and conditions of this Agreement, a royalty-free nonexclusive license under the Licensed Patent Rights in the Licensed Territory to make, have made, and to use, but not to sell the Licensed Products and Licensed Processes in the Licensed Fields of Use for the purposes of supplying the Licensed Products in low and middle-income countries, as defined by the World Bank.

33 NIH License: Right To Sublicense Licensee may enter into sublicensing agreements under the Licensed Patent Rights, provided that such sublicenses do not have a further right of sublicense and are granted in accordance with the Development Plan as described in Appendix C. Sublicenses shall be issued without discrimination to any sublicensee with the demonstrated commitment, ability and readiness to use the sub-license.

34 Support for the Medicines Patent Pool "One promising initiative that can help decrease the cost of patents for the Index Countries is the patent pool initiative of UNITAID" ATM Index 2010 (Engagement with PP included as one of the issues measured in the Index) We urge all public institutions and pharmaceutical companies to follow the measures taken by the NIH, and to share without delay their patents on this and other antiretrovirals with the Medicines Patent Pool, in order to facilitate access to these treatments at the lowest possible price for countries in need Prof. Kazatchkine, Executive Director Global Fund We think that the Medicines Patent Pool is an important initiative towards achieving universal access to the newer HIV medicines.at WHO we will be pleased to give priority to any of the newly developed FDCs for assessment by our WHO/ UN Prequalification Programme in order to facilitate its rapid uptake by the funding agencies and national governments. Dr. Hans Hogerzeil, Director Essential Medicines and Pharmaceutical policies (October 2010) "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, UNAIDS Executive Director (July 2010) This license underlines the U.S. Government s commitment to the Medicines Patent Pool and its goal to increase the availability of HIV medicines in developing countries. We are now discussing licensing to the Medicines Patent Pool other patents that could have a positive impact on the treatment of HIV/AIDS. NIH Director Francis S. Collins, M.D., Ph.D. Source: MPP

35 Award Recognition: 2012 Deals of Distinction One of the top national awards given for technology transfer activities Citations for an innovative endeavor in facilitating access to HIV treatment in developing countries And showcases the success of public-private partnerships to improve availability of medicine

36 NIH and MPP: Lessons To Date Too early to tell if MPP will ultimately be successful good start is continuing NIH license jump started the MPP to give credibility to effort Not a vehicle for major financial returns, but NIH and MPP share key public health goals Non-traditional partners important means for NIH technology to developing countries