Why and how Swiss academic institutions patent and license

1. Why and how Swiss academic institutions patent and license

2. Why patent ? Technology transfer in Switzerland Commercializing an invention

3. you competition Competition • Best product • First to market • Best salesforce Exclusivity

4. Life of a pharmaceutical product 2000 2002 2004 2006 2008 2010 2012 2014 2016 2018 2020 2025 800 Mio $ I II III Discovery Preclinical Clinical Regulatory approval Sales Generics

5. Life of a pharmaceutical product 2000 2002 2004 2006 2008 2010 2012 2014 2016 2018 2020 2025 I II III Discovery Preclinical Clinical Regulatory approval Sales Generics

6. Exclusivity Life of a pharmaceutical product 2000 2002 2004 2006 2008 2010 2012 2014 2016 2018 2020 2025 Patents I II III Discovery Preclinical Clinical Regulatory approval Sales Generics

7. Patents • Exclusive right granted by a government • Limited term (20 years) • Obligation to disclose

8. Advantages of patenting • Exclusivity - keeps off the competition - scares off the competition - marketing tool (« Patent pending ») • Once patent application has been filed, you don’t need to keep innovation secret anymore.

9. Disadvantages of patenting • Costs • Not always easy to enforce • Disclosure (information used by competition, risk of infringement…)

10. Commercializing an invention • Make an invention • Patent the invention • Develop a product • Sell the product

11. Make an invention • Patent the invention • Develop a product • Sell the product University exploitation rights Industry Academic inventions

12. Grant of rights Exclusivity Life of a pharmaceutical product 2000 2002 2004 2006 2008 2010 2012 2014 2016 2018 2020 2025 Patents I II III Discovery Preclinical Clinical Regulatory approval Sales Generics

13. Transfer of patent rights Material property Intellectual property sell assign rent license

14. Why commercialize technologies? Licensing academic technologies allows you to... ... turn the results of your research into useful products and services that society can benefit from … put a new spin on your research ... obtain additional funding for your research ... buy a Ferrari

15. * * * * * Academic inventions that have “changed the world” • Magnetic Core Memory • Cephalosporin C • Heart-Lung Machine • Polio Vaccine • Fluoride Toothpaste • Pacemaker • Ultrasound • Warfarin (coumarin) • Seat Belt • Carcinoembryonic Antigen • Gatorade • LCD • Hepatitis B Vaccine • MRI Scanner • Electronic Computer • Cisplatin  • Recombinant DNA Technology • Canine Parvovirus Vaccine • Kennel Cough Vaccine • Restasis • Adenocard • Factor IX Gene Product • LASER Cataract Surgery • Allegra • Synthetic Taxol • Trusopt • Emtriva • Combination PET/CT Scanner • CAT Scan • Saccharin • Rocket Fuel • Insulin • Vitamin D Fortification • Concrete Steam Curing • Plexiglass • Pablum • Electron Microscope • Drunk-O-Meter • Penicillin • Pap Smear • Blood Preservation • Ultrasound • Streptomycin * *

16. World-class research

17. High-impact publications D.A. King, The scientific impact of nationsNature430, 311 - 316 (2004)

18. Swiss strengths in research

19. R&D expenses

20. Political message Excellent research – more innovation! (Innovation = idea + need + implementation)

21. Swiss institutions and their TT offices ETH Transfer - ETHZ SRI - EPFL Unitec - UniGE/HUG PACTT - UniLA/CHUV Unitectra - UniZH/UniBE/UniBS/hospitals Smaller universities, research institutes and applied research universities

22. Founded in 2003 Currently over 120 members from over 20 institutions

24. Technology Transfer Office (TTO) • Assess commercial potential of new technologies • Protect intellectual property • License material and intellectual property • Distribute royalties • Negotiate agreements with industry (MTAs, CDAs, collaboration agreements, …) • (Manage proof-of-concept funds) • (Coach and support spin-offs)

25. IP protection Marketing Negotiation Monitoring License Licensing an invention Invention disclosure Triage

26. Invention Disclosure 1. What’s the invention ? 2. Who are the inventors ? 3. Whom does the technology belong to? 4. Publications ?

27. Invention Disclosure 1. What’s the invention ?  Triage 2. Who are the inventors ? 3. Whom does the technology belong to? 4. Publications ?

28. Invention Disclosure 1. What’s the invention ? 2. Who are the inventors ? 3. Whom does the technology belong to? 4. Publications ?

29. Inventors Case 1: Professor says he’s the sole inventor and the postdoc has had no inventive contribution whatsoever. Case 2: All 10 authors of the paper are listed as inventors. The patent is easily invalidated if the inventors list is incorrect

30. Invention Disclosure 1. What’s the invention ? 2. Who are the inventors ? 3. Whom does the technology belong to? 4. Publications ?

31. Swiss law

32. University law (e.g. Unige) University law [extract]: Art. 15 Propriété intellectuelle 1. A l’exception des droits d’auteur sur les publications, l’université est titulaire des droits de propriété intellectuelle portant sur toutes les créations intellectuelles ainsi que les résultats de recherches, y compris les programmes informatiques, obtenus dans l’exercice de leurs fonctions par les personnes ayant une relation de travail avec l’université. Est réservée la cotitularité entre l'université et les Hôpitaux universitaires de Genève des droits de propriété intellectuelle lorsque ces inventions émanent de personnes ayant également une relation de travail avec les Hôpitaux universitaires de Genève.

33. Collaboration/MTA with another university Collaboration/MTA with a company Ownership Postdoc with fellowship Invited professor Unpaid diploma student IP rights might not belong to the institution

34. Invention Disclosure 1. What’s the invention ? 2. Who are the inventors ? 3. Whom does the technology belong to? 4. Publications ?

35. Patents and publication Case 1: Submitted a paper – to be published in less than 2 weeks Case 2: Presented data at a conference Novelty might have been compromised

36. Novelty – the Cohen/Boyer case • Stanley Cohen (Stanford University) • Circular DNA (=plasmids) and their implication in bacterial antibiotics resistance • Herbert Boyer (University of California) • Proteins involved in bacterial DNA mutations (=restriction enzymes) • Invention: how to cut out a piece of DNA, paste it into a plasmid and express it in bacteria (=recombinant DNA)

37. Novelty – the Cohen/Boyer case 1) Inventors publish article 2) Stanford OTL learns about the invention in the New York Times. Disclosure prior to patent filing Saved by « grace period »  only in the US! US licensing revenue: $300 Mio ($20Mio per inventor) Estimated loss: $300 Mio !!!

38. Disclosures • Problematic: • Publication of scientific article • Poster • Printed abstract • Web site • Public seminar • In principle, OK: • Submission of scientific article • Grant proposal • Departmental seminar

39. Patenting doesn’t mean you can’t publish!!! Patent and publication Publish or perish Publish and perish Date of patent filing must be anterior to date of publication

40. IP protection Marketing Negotiation Monitoring License Licensing an invention Triage

41. Triage criteria • Commercialization prospects • IP situation • Inventor profile • Technology profile

42. Commercialization prospects Regulatory aspects Barriers to entry What’s the product? Who will use the product? Is there a market? Time? Revenue? Alternative approaches/direct competitors? Acceptance barriers?

43. Intellectual property situation Novelty Application Inventive step • Is it necessary to patent? • Is it possible to patent? Scope of claims Ease of detecting infringement Dependence on other patents • Is it worth patenting?

44. Inventor profile • Scientific reputation • Team know-how • Contacts with industry • Motivation

45. Technology profile • State of development • Future developments • Complexity

46. Triage results License to spin-off ~1/3 Yes ~9/10 Licence to existing company Come back later No

47. IP protection Marketing Negotiation Monitoring License Licensing an invention Evaluation

48. Claims Commercial value of patent: claims Scope of the claims as broad as possible (even if no data to support them… = « prophetic patents »)

49. Claims – « prophetic patents » Experimental result: Glomerulopathy patients have increased expression of HGR57 in urine WHAT IS CLAIMED IS: 1. A method of assessing whether an individual has or is at risk for developing a renal disorder comprising the steps of: a) obtaining a biological sample from the individual; b) analyzing the sample to determine the presence, absence or amount of one or more biomarkers selected from the group consisting of HGR57, HFR34, NBP1, LN49, LNBP35, ratatine, aubergine, citadine; and c) assessing from said presence, absence or amount of the one or more biomarkers whether the individual has or is at risk for developing a renal disorder.

50. Scope of claims – Celebrex case Background: University of Rochester files a patent application for the use of COX-2 inhibitors as an anti-inflammatory drug. While waiting for the patent to be granted, UR notices that Searle&Co (bought up by Pfizer) is commercializing such an inhibitor under the name Celebrex™ for the treatment of arthritis.