1. © Hagit Messer-Yaron, 2012 Prof. Hagit Messer-Yaron President, OUI hagitm@openu.ac.il Baku, October 24, 2012

2. © Hagit Messer-Yaron, 2012

3. Universities as “Intellectual and Economic Engines” – Calls for Academia-Industry Partnership

4. © Hagit Messer-Yaron, 2012 University vs. Industry- Contrasting Cultures: University Social responsibilities Basic, curiosity driven research Create new knowledge Freedom of research Publications & collaborations Sharing of material Open, global community and sharing of research results Corporate Shareholders responsibilities Applied research Develop new products Specific objectives, product focused Ownership and secrecy Control of material Aiming to global market

5. © Hagit Messer-Yaron, 2012 The Death Valley Academia Science "Valley Death" Products Industry

6. © Hagit Messer-Yaron, 2012 Bridging over the “Death Valley” – WHY? Better exploitation of knowledge to the benefit of the public (e.g., new drugs, environmental technologies, alternative energy). A natural source of innovation. To foster knowledge-based economy; direct contribution to short term growth. “Fair” and efficient use of public support.

7. © Hagit Messer-Yaron, 2012 Bridging over the “Death Valley” – HOW? Modern relations between universities and industries : New venture formation/Spin-offs R&D agreements Licensing deals Traditional: Teaching and students practice Individual entrepreneurship

8. © Hagit Messer-Yaron, 2012 Industry, university, government industry university knowledge money Researchers (people!), Faculties, Administration, etc. Entrepreneurs VCs Productions Marketing Management Stocks holders etc. Technology/knowledgeTransfer Government

9. © Hagit Messer-Yaron, 2012 The Role of Governments 1. Financial support for academic, basic research. Public support is essential for academic freedom. 2. Intervention programs for “bridging the gap”. 3. Legal infrastructure: intellectual property rights (IPR) laws, Taxations, innovation law, etc. IPR

10. © Hagit Messer-Yaron, 2012 The case of ISRAEL ISRAEL is an R&D state - the expenditure on civilian research and development (R&D) as a percentage of the gross domestic product (GDP) is the highest in the world: Source: ISRAEL CBS

11. © Hagit Messer-Yaron, 2012 Israel: Recent Nobel Laureates Dan Shechtman,Chemistry, 2011 - Technion Ada E. Yonath, Chemistry, 2009 - Wiezmann Inst. Ada E. Yonath Robert Aumann, Economics, 2005 - HUJI Robert Aumann Aaron Ciechanover, Chemistry, 2004 - Technion Aaron Ciechanover Avram Hershko, Chemistry, 2004 - Technion Avram Hershko Daniel Kahneman, Economics, 2002 - HUJI Daniel Kahneman

12. © Hagit Messer-Yaron, 2012 Lessons from IL experience – How to maintain top level Science AND successful High-Tech Industry?

13. © Hagit Messer-Yaron, 2012 Higher Education in Israel - Expanding system 1989/90: 21 HEI (8 universities + 13 colleagues), 88,800 students. 2010/11: 67 HEI, (8 universities + 36 academic colleagues, 23 pedagogical colleagues) 297,800 students. All HEIs are independent legal entities; All but NBC are heavily supported by the government.

14. © Hagit Messer-Yaron, 2012 The 7+1 universities: The TechnionThe Technion The Hebrew University in JerusalemThe Hebrew University in Jerusalem Tel Aviv UniversityTel Aviv University Bar Ilan UniversityBar Ilan University Ben Gurion University in the NegevBen Gurion University in the Negev Haifa UniversityHaifa University The Weizmann InstituteThe Weizmann Institute The Open UniversityThe Open University

15. © Hagit Messer-Yaron, 2012 University vs. Colleague Teaching: Undergrad Teaching & research: Faculty, Graduate students Research: Grants, TT, Facilities, Inst. PRO HEI

16. © Hagit Messer-Yaron, 2012 Technology Transfer Partners: Academia: The Researchers The University The TTO/TTC Industry: Entrepreneurship Investment Production The GOVERNMENT

17. © Hagit Messer-Yaron, 2012 In Israel: Government’s involvement mainly by intervention programs. Each university decides on its own policy and regulations independently. However, they share common principles. Each university has its own TTC. TTCs are for-profit companies, own by the universities. TTCs are handling universities IP and are responsible for commercialization, following the university’s policy.

18. © Hagit Messer-Yaron, 2012 IP legislation (and more) in Israel The patent law (1967) defines “service invention” as one which has been invented by an employee as a result of his/her service to the employer. The law doesn’t cover many aspects of academic life, as: students, visitors, sabbaticals, retired stuff, etc. Thus, universities had to regulate it internally. No legislation w.r.to industrial R&D projects done in universities. It is up to the parties to agree on the conditions. In general, government doesn’t claim ownership of publicly sponsored research.

19. © Hagit Messer-Yaron, 2012

20. The rules – main common principles: Researchers must disclose to the university any research of commercial potential. Universities own the IP of “institute inventions” (service invention). Institute inventions are discoveries of employees and others, related to the university. Institute inventions are commercialized solely by the TTC. Commercialization revenues are shared by the inventors (40- 50%; 50-60%) and the university. If the TTC chooses not to file for patent, the inventors can do it at their own expense.

21. © Hagit Messer-Yaron, 2012 Weizmann InstituteYeda 1959 Hebrew UniversityYissum1964 Tel Aviv UniversityRamot1973 1980’s1990’s1998 TTCs in Israel

22. © Hagit Messer-Yaron, 2012 Tech. Transfer Company (TTC) mission Identify research results with commercial potential. Actively seek interested commercial entities and sign licensing agreements or establish spin-off companies. Collect royalties. File for patents and other propriety rights.

23. © Hagit Messer-Yaron, 2012 Different Institutional TT strategies, all managed by the TTC Research and development agreements Licensing deals New venture formation / Spin-offs

24. © Hagit Messer-Yaron, 2012 Institutional TT (1) Academia Science "Valley Death" Products Industry R&D agreements

25. © Hagit Messer-Yaron, 2012 Institutional TT (2) Academia Science "Valley Death" Products Industry Licensing deals

26. © Hagit Messer-Yaron, 2012 Institutional TT (3) Academia Science "Valley Death" Products Industry Spin offs

27. © Hagit Messer-Yaron, 2012 The technology transfer process at TAU Revenues 40-20-40 IDF Discovery & Innovation Evaluation Patenting & Marketing Strategy Business Development Follow Up on Contract Academic Basic and Applied Research “Bridging the Gap”Sponsored Research publications To inventors

28. © Hagit Messer-Yaron, 2012 Example: the Weizmann Inst. Responsible technology transfer*

29. © Hagit Messer-Yaron, 2012 Example (cont): the Weizmann Institute - Policy

30. © Hagit Messer-Yaron, 2012

31. Lipimix | Tubilux Lipimix | Tubilux Exelon ® | Novartis Exelon ® | Novartis Doxil ® | J&J Doxil ® | J&J Cherry Tomatoes | BonTom Cherry Tomatoes | BonTom Periochip | Dexcel Periochip | Dexcel Selected TT Success Stories: Yeda, Yissum & Ramot (2009) QuantomiX TM | QX Capsule QuantomiX TM | QX Capsule Copaxone ® | Teva Copaxone ® | Teva Rebif ® | Merck Serono Rebif ® | Merck Serono Encryption Algorithm | NDS Encryption Algorithm | NDS GeneCards TM | XenneX GeneCards TM | XenneX NanoLub TM | Nanomaterials NanoLub TM | Nanomaterials Dunaliella | Nikken Sohonsha Dunaliella | Nikken Sohonsha Erbitux TM | ImClone Erbitux TM | ImClone Total sale of Weizmann based products €6 Bilion/year

32. © Hagit Messer-Yaron, 2012 Univ. of California system297 Fraunhofer-Gesellschaft182 CNRS146 MIT131 Univ. of Texas 96 California Inst. Tech. 84 Johns Hopkins 76 Univ. of Michigan 74 Columbia Univ. 68 Riken 67 Univ. of Florida 67 Hebrew Univ. 56 Weizmann Institute 54 Stanford 54 Academic institutions with more than 50 PCTs/year (2004)

33. © Hagit Messer-Yaron, 2012 Licensing Income Survey 2006 top 10 Universities * #Institution Licensing Income ($M) 1Univ. of California System193 2NYU157 3Stanford Univ.61 4Wake Forest Univ.60 5Univ. of Minnesota56 6MIT43 7Univ. of Florida42 8Univ. of Rochester38 9Northwestern Univ.29 10Harvard Univ.20 * Source: AUTM Licensing Survey 2006 Licensing Income of top 10 US universities

34. © Hagit Messer-Yaron, 2012 Government’s involvement in university-industry relations Under the responsibility of the office of the Chief Scientist at the ministry of Industry, Trade and Labor (OCS). Different intervention programs for university- LOCAL industry collaboration. Restrictions on internationalization of knowledge created under these programs.

35. © Hagit Messer-Yaron, 2012 Intervention Programs KAMIN 100% 90% 60%

36. © Hagit Messer-Yaron, 2012Summary Most Israeli Universities had Technology Transfer policy and programs before the BDA of 1980. The government has not been involved in the universities TT policy and/or implementation. IL TT policy is (was) VERY successful, with top universities leading both in academic achievements (e.g., the Shanghai ranking) and in TT revenues. RESPONSIBLE technology transfer The key for success is a RESPONSIBLE technology transfer policy and implementation.

37. © Hagit Messer-Yaron, 2012 Commercialization of academic research results – all win??? Commercialization of academic research results is here. It has different forms and different mechanisms, depending mainly on the discipline and on the regulatory system. It is generally considered as a desired goal. Advancing of the commercialization of research results is the policy of governments all over the world. Apparently, it serves the interests of all partners involved: the industry, the individual researchers, and the universities.

38. © Hagit Messer-Yaron, 2012 Turning technology into gold NATURE| VOL 426| 11 DECEMBER 2003

39. © Hagit Messer-Yaron, 2012 Making money in the UK The Scientist, November 13, 2003 Making money in the UK Signs that British universities are doing better at generating cash from inventions By Stephen Pincock Universities in the United Kingdom are getting better at commercializing their intellectual property, a survey of the university technology sector showed on Thursday (November 13).

40. © Hagit Messer-Yaron, 2012 The Bayh-Dole Act The Bayh-Dole Act is "perhaps the most inspired piece of legislation to be enacted in America over the past half-century," according to The Economist. "Innovation's Golden Goose," an opinion piece published in the Dec. 12, 2002, edition the respected publication, states: "Together with amendments in 1984 and augmentation in 1986, this unlocked all the inventions and discoveries that had been made in laboratories throughout the United States with the help of taxpayers' money. More than anything, this single policy measure helped to reverse America's precipitous slide into industrial irrelevance."

41. © Hagit Messer-Yaron, 2012 Echoes of Bayh-Dole? Gr egory D. Gr aff, Research Economist, PIPRA, U.S.A., and Visiting Research Fellow, Department of Agricultural and Resource Economics, University of California, Berkeley, U.S.A.

42. © Hagit Messer-Yaron, 2012 BUT: Warning signs in TT Institutional changes: may change the direction of faculty research. Restrict dissemination of research results Increase dependency of science on governance – regulation, support. Institutional as well as individual freedom of research are in risk. Potential conflict of interests and conflict of commitments (institutional and individual).

43. © Hagit Messer-Yaron, 2012

44. The Costs of Commercializing Academic Research Does university licensing impede life science research and development? By Ted Agres The Scientist Volume 17 | Issue 16 | 58 | Aug. 25, 2003

45. © Hagit Messer-Yaron, 2012

46. Research tool patents debated Supreme Court appeal could limit licensing income for research tool makers | By Alison McCook Alison McCook April 22, 2005 The US Supreme Court heard arguments this week from both sides of a 10-year debate that essentially pits the interests of the research tool industry against those of drug developers. The case tests the limits of an imprecise federal law, which states that researchers conducting experiments reasonably related to new drug approvals do not have to pay licensing fees to use proprietary products. One side argues that if extended to cover too many experiments, the exemption could hurt the research tool industry, which depends on licensing fees. However, as it stands, those fees may be limiting drug development, the opponents note. The debate has divided the life sciences industry, with large pharmaceutical companies and patient advocates lending support to drug developers and tool makers throwing their hats in the ring for the research tool industry.

47. © Hagit Messer-Yaron, 2012

48. Commercialization of research results – not “all win” Why YES Direct contribution to short term growth. “Fair” and efficient use of public support. Improves exploitation of knowledge to the benefit of the public (e.g., new drugs). Why NO Risk the base of the academic culture: openness, freedom of research, diversity of topics, etc. May hazard innovation and therefore growth in the long run. Calls for RESPONSIBLE TT

49. © Hagit Messer-Yaron, 2012 Technology Transfer Nowadays Under the Bayh-Dole Act (BDA), the duty to commercialize is put on the universities. Following the BDA, In most of the developed countries, universities are responsible for TT. As in Israel, in most cases universities have proven to perform RESPONSIBLE technology transfer.

50. © Hagit Messer-Yaron, 2012 Guidelines offered for responsible technology licensing by: CalTech Cornell Harvard MIT Stanford UC U of Illinois, Chicago U of Illinois, Chicago, Urbana-Champaign Univ. of Washington Wisconsin Alumni Research Foundation Yale AAMC (Assoc. of American Medical Colleges) March 2007

51. © Hagit Messer-Yaron, 2012 In the Public Interest: Nine Points to Consider in Licensing University Technology 1. Universities should reserve the right to practice licensed inventions, and to allow other nonprofit and governmental organizations to do so. 2. Exclusive licenses should be structured in a manner that encourages technology development and use. 3. Strive to minimize the licensing of "future improvements." 4. Universities should anticipate and help to manage technology transfer related conflicts of interest.

52. © Hagit Messer-Yaron, 2012 In the Public Interest (cont.) 5.Ensure broad access to research tools. 6. Enforcement action should be carefully considered. 7. Be mindful of export regulations. 8. Be mindful of the implications of working with patent aggregators. 9. Consider including provisions that address unmet needs, such as those of neglected patient populations or geographic areas, giving particular attention to improved therapeutics, diagnostics and agricultural technologies for the developing world.

53. © Hagit Messer-Yaron, 2012 Major US Universities - 2006 ($ Million)

54. © Hagit Messer-Yaron, 2012 Main points in responsible TT Ownership of IP : The IP generated by a university team is owned by the University, irrespective of sponsorship or where it was conceived. The IP is licensed, not sold. Open vs. close license : The license is limited to certain patents and field of use, the results of a sponsored research, and well defined know-how, and does not cover any other un-sponsored research performed by same or other University researchers, past, present and future.

55. © Hagit Messer-Yaron, 2012 Main points in responsible TT (cont.) No shelving : The essence of the license is the introduction of licensed products by the licensee to the market. The licensee is obliged to develop the product under agreed upon program, else the license is terminated. No shelving of the technology, for any reason. The right to publish : the right of the researchers to perform research within the license perimeter and the freedom of publication of the research results is guaranteed. Liability : Licensor does not provide any warranty as to the applicability of the licensed technology, the enforceability of the patents, or obtaining certain results thru the research.

56. © Hagit Messer-Yaron, 2012 The Problem Public support to universities is decreasing Tuition is regulated Donations are limited. How to get more income???

57. © Hagit Messer-Yaron, 2012 The Dilemma Unlike other universities’ financial adventures, technology transfer is considered as a desired goal, in line with the interests of the private sector, the governments, and the individual researcher. Apparently*, the main source for compensation of the decreased public support is from commercialization of research results. Under need for money: responsible Self regulation responsible TT – is it sustainable??? ________________________ * On the average and for most universities, TT is loosing money….

58. © Hagit Messer-Yaron, 2012 Self regulation or what? Regulation by governments? No. Governments should be kept away from universities. Regulation by market forces? No – since all sides (industry, university, researcher) win financially from successful TT, the market forces do not guarantee the public interest in the long run. Self regulation by universities? Risky. Under direct and indirect pressure of the private sector and governments to enable and to ease technology transfer, the challenge to the university in self regulation is huge.

59. © Hagit Messer-Yaron, 2012 Mixed regulation? A possible solution may be that governments dictate TT guidelines, under which universities should operate, including: 1. IPR ownership 2. No shelving 3. Free publication

60. © Hagit Messer-Yaron, 2012 Thank You! Thank You! hagitm@openu.ac.il hagitm@openu.ac.il