Update on the Medicines Patent Pool

Transcription

1 Update on the Medicines Patent Pool Sandeep Juneja November 06, 2012

2 How the Pool works* The Pool is an innovative licensing mechanism for HIV medicines Licensors Patents Feedback Market Impact Product introductions Royalties Pool Out- Licenses License Management by the Pool Sub- Licensees The Pool seeks public health oriented licences that take into account legitimate interests of all parties Improvement over status-quo Using its IP & legal expertise, the Pool aims to continually improve existing agreements and sign new and better agreements. It strives to: o o Include as many low and middle income countries as possible Promote terms that maximise public health benefits and ensure lowest sustainable cost for quality medicines in as many countries as possible Funded by UNITAID Operational since end-2010 * Generalized schematic; may be different for specific licenses 2

3 Ensuring access in the changing ARV patent landscape 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

4 Support to the Pool from key stakeholders in global health National Health Organizations and Communities Originator Companies Global Health Organizations The Medicines Patent Pool has potential to support access to more appropriate and affordable ARVs in developing countries by setting incentives for product adaptation and generic production. We will encourage the pharmaceutical sector to engage actively with the Medicines Patent Pool to support the availability of more appropriate and affordable ARVs. Generics Companies Donor Agencies - Towards zero infections: The UK s position paper on HIV in the developing world, 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 We welcome the Patent Pool Initiative launched by UNITAID in order to facilitate production of affordable generic medicines well-adapted for use in resource-poor settings, and we invite the voluntary participation of patent owners, private and public, in the project. Group of 8 Declaration, G8 Summit of Deauville, France, May

5 Support to the Pool from key stakeholders in global health (2) 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, June 2011 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. - Hans V. Hogerzeil, former director, WHO Essential Medicines and Pharmaceutical Policies, October 2010 UNAIDS strongly encourages other antiretroviral patent holders to establish agreements with the Pool, and for generic manufacturers to utilize the licenses that the Pool can facilitate to expand access to antiretroviral treatment. - Paul De Lay, Deputy - Executive Director, - UNAIDS, October 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, Global Fund Partnership Forum, June 2011 The Medicines Patent Pool offers a way forward that could work for both people living with HIV and for companies where patents exist, the Pool is a way to manage them so that public health goals are still achieved, and people living with HIV are not barred from getting the medicines they need. NEPHAK, Press Release, December

6 Licensing-in Concluded US NIH Gilead Sciences In negotiations Boehringer Ingelheim Bristol Myers-Squibb F. Hoffman-La Roche Viiv Healthcare Not in Negotiations Abbott Laboratories Merck & Co Tibotec / Johnson & Johnson

7 Licensing-out: Gilead products Aurobindo Emcure Hetero Laurus Medchem Cobicistat Cobicistat Cobicistat Cobicistat Cobicistat Elvitegravir Elvitegravir Elvitegravir Elvitegravir Elvitegravir Emtricitabine Emtricitabine Emtricitabine Emtricitabine Emtricitabine Quad Quad Quad Quad Quad Tenofovir Tenofovir

8 Licensing processes to ensure market impact 1 Sign inlicences Review Expression of Interest forms from generics Negotiate outlicences Sign outlicences Monitor incountry registration status Monitor WHO PQ, USFDA, SRA approval status 2 Kick-Off generic collaboration Conduct technology transfer 3 Progress reviews Monitor royalties Dispute resolution Assess impact Collect & report market feedback Phase 1: Out-licensing Phase 2: Development Phase 3: Commercialization Reporting step Licensing step Only as required 8

9 Status of Gilead licences 1 Sign inlicences Review Expression of Interest forms from generics Negotiate outlicences Sign outlicences Monitor incountry registration status Monitor WHO PQ, USFDA, SRA approval status 2 Kick-Off generic collaboration Conduct technology transfer 3 Progress reviews Monitor royalties Dispute resolution Assess impact Collect & report market feedback Phase 1: Out-licensing Phase 2: Development Phase 3: Commercialization Reporting step Licensing step Only as required 9

10 Further developments on the Gilead licence Added amendments to improve current agreement 1. Included South Sudan 2. Incorporated language based on CS feedback: a) clarified covenant not to sue on FTC post TDF termination b) clarified Gilead s position on Compulsory Licences 3. Waived the Pool s administrative fee Started technology transfer Cobicistat/Elvitegravir: API technology transfer to Pool licensees accomplished Quad: formulation technology transfer to follow FTC process improvement: shortly Earned LES Deals of Distinction Award 2012 Gilead & NIH licences with MPP awarded deals of distinction by the Licensing Executives Society USA & Canada 10

11 Expression of Interest process Potential Licensees An Expression of Interest (EOI) process to enable potential licensees to seek licences online has been designed and is being implemented The EOI process includes details such as Capabilities in R&D and manufacturing Product development plan and strategy Regulatory timelines Fitment of the product in the overall ARV/business strategy The Pool aims to fairly offer sub-licences to all qualified generics manufacturers while exercising due care and diligence to not undermine stability of the generic ARV market 11

12 Priority products for the Pool Working paper, updated annually; Preview of the update outcome alongside; full paper out shortly - comments will be welcome. Watch out at: ol.org/licensing/targetmedicines/ Compounds with (*) are pipeline compounds

13 Patent status database Most complete single source of ARV patent status data Covers 24 compounds in 78 countries Searchable by compound and by country (or region) To be regularly updated Starting point for more thorough searches

14 Thank You