1. The Role of Patents, Universities, and Non-Profits in the Promotion of Health Care Access Nina Gandhi

2. From the Lab to the Marketplace Major players:  Public Research Institutions

3. From the Lab to the Marketplace Major players:  Public Research Institutions  Pharmaceutical Research Institutions

4. From the Lab to the Marketplace Major players:  Public Research Institutions  Pharmaceutical Research Institutions  Pharmaceutical companies

5. From the Lab to the Marketplace Major players:  Public Research Institutions Pharmaceutical Research Institutions  Pharmaceutical companies  ** Universities and Non-profit organizations

6. Key Terms: What is a patent?  A patent grants an inventor sole rights to an invention for a given amount of time. wordnet.princeton.edu/perl/webwn http://www.sustainability.jhu.edu/bin/ z/v/side_GreenIdea.jpg

7. Key Terms: What is a patent?  A patent grants an inventor sole rights to an invention for a given amount of time.  Drugs on patent = EXPENSIVE, exclusive  Drugs off patent = generic, normally inexpensive wordnet.princeton.edu/perl/webwn

8. Key Terms: What is licensing?  Licensing refers to contractual agreements granting permission for the use of intellectual property under specific conditions. http://www.pddoc.com/copyright/glossary.htm http://www.ci.university- place.wa.us/Business%20Licensing/business.jpg

9. Key Terms: What is the Bayh-Dole Act?  A way for a university or non-profit to own rights to its research and license out these rights http://biospectrumindia.ciol.com/images/content/2005/jul/Cover Story_Bayh-Dole.jpg

10. Key Terms: What is the Bayh-Dole Act?  A way for a university or non-profit to own rights to its research and license out these rights  Bypasses government institutions ** http://biospectrumindia.ciol.com/images/content/2005/jul/Cover Story_Bayh-Dole.jpg

11. Key Terms: What is the Hatch-Waxman Act?  Allows generic drugs into the market before patents expire. http://www.law.duke.edu/journals/dltr/articles/2003dltr0018.html http://www.buckeyeinstitute. org/uploaded_images/Pres cription%20Drugs.jpg

12. Key Terms: What is the Hatch-Waxman Act?  Allows generic drugs into the market before patents expire.  Created ANDA process http://www.law.duke.edu/journals/dltr/articles/2003dltr0018.html http://www.stipkalalaw.com/ shared/Editor/assets/court_ room.jpg

13. Key Terms: What are the FDA and FTC?  FDA  Center for Drug Evaluation and Research http://www.healthtalk.umn.edu/kare/fda/home.htmlhttp://www.healthtalk.umn.edu/kare/fda/home.html, www.fda.govwww.fda.gov

14. Key Terms: What are the FDA and FTC?  FDA  Center for Drug Evaluation and Research  Evaluates scientific research http://www.healthtalk.umn.edu/kare/fda/home.htmlhttp://www.healthtalk.umn.edu/kare/fda/home.html, www.fda.govwww.fda.gov

15. Key Terms: What are the FDA and FTC?  FDA  Center for Drug Evaluation and Research  Evaluates scientific research  Approves of safety of drugs http://www.healthtalk.umn.edu/kare/fda/home.htmlhttp://www.healthtalk.umn.edu/kare/fda/home.html, www.fda.govwww.fda.gov

16. Key Terms: What are the FDA and FTC?  FTC  Enforce “true in advertising” claims www.ftc.gov

17. Key Terms: What are the FDA and FTC?  FTC  Enforce “true in advertising” claims  Bureau of Competition www.ftc.gov

18. Key Terms: What are the FDA and FTC?  FTC  Enforce “true in advertising” claims  Bureau of Competition  Monitors relationship between drug companies and generics www.ftc.gov

19. From the Lab to the Marketplace Drug Research and Conception FDA Approval (NDA) Clinical Trials, Testing ($$$ and time) Patented Drug (lasts 10-12 years) Availability of Generics BIG PHARMA + GOV’T REVENUE

20. The Role of Universities

21. Domestic Research, Outsourced Drug Rights  Universities receive funding through grants and awards. http://community.elevatorup.com/ok wu/images/money%203.jpg http://www.diginovations.com/storag e/images/video-award-shelf.jpg

22. Domestic Research, Outsourced Drug Rights  Universities receive funding through grants and awards  Government makes an investment in research and expects new discoveries. http://www.jdsblog.com/wp- content/uploads/government- grants.jpg

23. Domestic Research, Outsourced Drug Rights  The innovations are shared with Technology Transfer Offices (TTO’s)  Research patented by the university is licensed to pharmaceutical companies for production http://sartorius-bbi- systems.sartoserver.de/media/ productpics/bioscipro_(novo)_ 23_copy.jpg

24. What Can Be Improved? Implications for Developing Countries and Accessible Global Health  AUTM’s 9th point  Universities should use research money for neglected diseases http://files.blog- city.com/files/aa/32997/p/f/pov erty_3_0146.gif

25. What Can Be Improved? Implications for Developing Countries and Accessible Global Health  AUTM’s 9th point  Universities should use research money for neglected diseases  Ensure that underprivileged populations have access to these medicines http://www.borgenproject.org/sitebuilder/im ages/Africa_poverty-383x480.png

26. What Can Be Improved? Implications for Developing Countries and Accessible Global Health  Organizations that promote point #9:  Technology Managers for Global Health  Universities Allied for Essential Medicines http://uaem.berkel ey.edu/image005.j pg www.ghatm.com

27. Role of Non-profit Companies (not an oxymoron anymore!)  Benefits of non-profit pharmaceutical companies  R&D team http://content.healthaffairs.org/cgi/content/full/24/4/1057

28. Role of Non-profit Companies (not an oxymoron anymore!)  Benefits of non-profit pharmaceutical companies  R&D team  Research, clinical trials, prepare paperwork, etc. http://content.healthaffairs.org/cgi/content/full/24/4/1057

29. Role of Non-profit Companies (not an oxymoron anymore!)  Benefits of non-profit pharmaceutical companies  R&D team  Research, clinical trials, prepare paperwork, etc.  No obligation to a specific demographic http://content.healthaffairs.org/cgi/content/full/24/4/1057

30. Non-profit Example: Carolina Vaccine Institute http://www.med.unc.edu/cvi/  Develops vaccines for neglected diseases for developing countries

31. Non-profit Example: Carolina Vaccine Institute http://www.med.unc.edu/cvi/  Develops vaccines for neglected diseases for developing countries  Uses revenue to fund more research

32. Non-profit Example: Carolina Vaccine Institute http://www.med.unc.edu/cvi/  Develops vaccines for neglected diseases for developing countries  Uses revenue to fund more research  An example of universities and non-profits for the promotion of global health

33. From the Lab to the Marketplace Drug Research and Conception FDA Approval (NDA) Clinical Trials, Testing ($$$ and time) Patented Drug (lasts 10-12 years) Availability of Generics BIG PHARMA + GOV’T REVENUE

34. How Universities and Non-profit Companies Fit In Drug Research and Conception FDA Approval (NDA) Clinical Trials, Testing ($$$ and time) Patented Drug (lasts 10-12 years) Availability of Generics BIG PHARMA + GOV’T REVENUE Reduced $$$ and time Production and Distribution REVENUE University Research and Work of TTOs

35. What WE Can Do!  "When it comes to global health, there is no 'them'... only ' us.'" - Global Health Council