1. Solutions: UAEM’s Framework for Advancing University Policy, Changing Practices & Closing the Research Gap Michael Lin and Gloria Tavera UAEM National Conference 2010 October 9, Duke University

2. Overview Changing University Licensing Policy What is the EAL? What is the GALF? Facilitating Access to Intellectual Property Patent Pools Closing the Research Gap Neglected Disease Innovation Mechanisms Where do we stand now? The Statement of Principles and Strategies

3. Changing University Licensing Policy

4. Equitable Access License (EAL)

5. The Global Access Licensing Framework (aka GALF) A flexible document of 5 points to guide university licensing negotiations 1) Access to medicines and health-related technologies for all is the primary purpose of technology transfer of health-related innovations. 1) Technology transfer should protect access to the final end product needed by patients (e.g., formulated pills or vaccines).

6. The Global Access Licensing Framework (aka GALF) 3) Generic provision is the best way to ensure access in resource-limited countries for products that also have markets in developed countries.

7. The Global Access Licensing Framework (aka GALF) 4) Proactive licensing provisions are essential to ensure that follow-on patents and data exclusivity cannot be used to block generic production. Other barriers may need to be addressed for the licensing of biologics. 4) University licensing should be systematic in its approach, sufficiently transparent to verify its effectiveness, and based on explicit metrics that measure the success of technology transfer by its impact on access and continued innovation.

8. Patent Pools: What are they? A method to streamline the licensing of IP- protected technology in order to reduce transactional costs Patents relating to a particular technology are licensed to a patent pool, who then sub- licenses the patents to manufacturers There Is A Solution, Here's How A Patent Pool Could Work (Patent Pool 4 of 4) http://www.youtube.com/watch?v=dXdCSKeWAO A

9. Patent Pools: An example

10. Neglected Disease Innovations The Role of Universities: By increasing funding not only for global health research, but also for research in NTDs, universities could make an impact twice as strong Universities should develop new seed funds for NTD research Universities should eliminate barriers concerning intellectual property around neglected diseases New metrics for faculty appointments that value neglected disease research should be implemented The Role of Industry: There is some industry interest (i.e. Novartis’s Fund for R & D in Neglected Disease) aims to: – Allocate resources to the discovery and development of the promising compounds to address neglected diseases, whether placed with pharmaceutical industry/ biotech players, public research institutes or product development partnerships (PDPs).

11. Product Development Partnerships (PDPs) A non-profit drug research and development organization that creates new treatments for NDs

12. UAEM in Action! Neglected Disease & Innovation Symposium Washington, D.C., on November 20, 2010! American University, Washington College of Law, Washington, D.C UAEM is holding a symposium on the role of universities as non-profit institutions in the medicine innovation system (PDPs and pharmaceutical stakeholders), particularly related to their role in finding cures for neglected diseases as well as open-source research methods. The meeting will bring together product development partnerships (PDPs), university administrators, researchers, industry actors, technology transfer officials, funding institutions and students to explore the role of universities in the broader innovation system and directions for university policy to best improve both innovation and access to medicines.

13. Bridging the Gap: Increasing Access to Neglected Tropical Disease Diagnostics, Treatment and Care Through Improved University, PDP and Industry Collaboration American Society of Tropical Medicine and Hygiene Meeting Symposium Thursday, November 4 th, Atlanta Georgia Will communicate to a large and broad audience in the NTD research and medical fields on: Methods to increase access to neglected tropical disease (NTD) research Recent collaborative academic efforts to increase neglected tropical disease research and development. Current barriers, and their proposed solutions, surrounding the translation of therapies specific to neglected tropical diseases. Presenters Dr. Peter Hotez (GW/PLoS) Dr. Bernard Pécoul (ED, DNDi) Dr. Anthony D. So (Duke, SPH) Dr. Rebecca Goulding (UAEM UBC) Dr. Michael Gretes Gloria Tavera

14. Statement of Principles and Strategies for the Equitable Dissemination of Medical Technologies (SPS) Drafted and signed by a consortium of 7 universities in Fall 2009 Since then, signatories include 18 universities and hospitals in the US, Canada, Mexico, and Turkey; plus the CDC, NIH, AUTM, and 1 private institution. Bilkent University Boston University Brigham & Women's Hospital Brown University Duke University and Duke Medicine El Colegio de México Florida State University Harvard University Jawaharlal Nehru University Massachusetts General Hospital New York University Oregon Health & Science University Tecnologico de Monterrey University of Pennsylvania University of British Columbia University of Illinois Chicago University of Illinois Urbana-Champaign University of Vermont and State Agricultural College Yale University Association of University Technology Managers Centers for Disease Control and Prevention National Institutes of Health Najit Technologies, Inc.

15. “Our intellectual property should not become a barrier to essential health-related technologies needed by patients in developing countries. In cases where universities can fully preclude intellectual property barriers to generic provision by not patenting in developing countries, or by filing and abandoning patents, we will pursue these strategies.” Statement of Principles and Strategies for the Equitable Dissemination of Medical Technologies (SPS)

16. It is not always possible at the time of license negotiation to anticipate all of the ways a health-related technology may be used in developing countries. Accordingly, we will strive to preserve our institutions’ future rights to negotiate effective global access terms through implementation of such measures as notice requirements coupled with “agreements to agree.” 5 Statement of Principles and Strategies for the Equitable Dissemination of Medical Technologies (SPS)

17. Without regard to the economic value to our respective institutions, we will further support the development of new health- related technologies aimed at diseases that disproportionately burden individuals in the developing world. Statement of Principles and Strategies for the Equitable Dissemination of Medical Technologies (SPS)

18. Share with one another our collective experience from working with our licensees in implementing these principles to continually advance our goals. To that end, we will cooperate in the creation of: 1.A compendium of best practices, tools and techniques; and 2.A consistent means of reporting on our global access initiatives and activities. 3.Revisit these principles on a biennial basis, to ensure that they reflect currently-understood best practices Statement of Principles and Strategies for the Equitable Dissemination of Medical Technologies (SPS)

19. Questions or comments?