1. HARVARD UNIVERSITY Office of Technology Development Responsible Conduct of Research Harvard School of Public Health Intellectual Property 20 September 2013

2. HARVARD UNIVERSITY Office of Technology Development Concept of Intellectual Property (IP) Harvard’s IP Policy Patents and patent applications IP in academic setting Harvard’s Office of Technology Development –What is it? –How do you find us? –When do you contact us? Case discussion 2

3. HARVARD UNIVERSITY Office of Technology Development Creations of the mind subject to legal protection Patents, copyrights, trademarks & trade secrets - Patents confer right to exclude others from making, using, selling or importing the invention - Copyrights protect expression or presentation of ideas but not the ideas themselves - Trademarks identify and distinguish goods/services of one commercial provider from those of others; e.g. logo, brand name, tagline - Trade secrets are any valuable commercial information that is not made public & that can be used for competitive advantage; no formal registration process Also: unpublished data & results, materials, protocols 3

4. HARVARD UNIVERSITY Office of Technology Development Federal agency that funded research had principal authority over patenting decision No unified federal patent policy across agencies Patchwork of waivers and agreements between some universities and government agencies Federal government owned rights to thousands of patents but would not grant exclusive licenses Lack of clear ownership & rights to commercialize was disincentive for technology development 4

5. HARVARD UNIVERSITY Office of Technology Development Patent & Trademark Law Amendments Act (1980) Co-sponsored by Senators Birch Bayh & Robert Dole Congress’s objectives: –promote dissemination and commercial development of inventions arising from government-funded research –foster collaboration between universities and industry Major provisions: ­Universities can own inventions resulting from federally-funded research ­Universities encouraged to partner with industry ­Universities expected to file patent applications and license them to companies ­Royalties to be shared with inventors and to be used to fund research/education 5

6. HARVARD UNIVERSITY Office of Technology Development http://otd.harvard.edu/resources/policies/IP/ Covers ownership of patents, copyrights, software, and unpatented materials In general, Harvard has ownership of patentable inventions, software, and unpatented tangible materials made with funds provided by or administered by Harvard, or made with non-incidental use of Harvard’s resources In most cases, authors have ownership of copyrights in books, films, works of art, musical works, etc. ­ Copyright in software handled more like patentable inventions Obligation to report inventions to OTD Must sign Participation Agreement: http://otd.harvard.edu/resources/agreements/participation/ 6

7. HARVARD UNIVERSITY Office of Technology Development Sharing of net royalties on inventions reported after 10/04/2011 Administrative fee – 15% Of the remainder: Creator personal share – 35% Creator research share – 15% Creator Department/Center share – 15% * Creator School share – 20% President’s share – 15% * If within FAS, or if no Department or Center, to be allocated by Dean of the Creator's School for research purposes) 7

8. HARVARD UNIVERSITY Office of Technology Development http://otd.harvard.edu/faculty/ Click on “Report of Invention Form” Information on Contributors Funding sources 3 rd party materials or code Public disclosures (posters, presentations, publications) Upload detailed description or draft manuscript Once submitted, you will receive a emailed confirmation, it will be assigned a case number at OTD, and someone from OTD will follow up with you 8

9. HARVARD UNIVERSITY Office of Technology Development Does not grant the right to do anything ­ Dominating patent owned by another party? Right to exclude others from making, using, selling, offering for sale, or importing the patented invention for the term of the patent (now 20 years from the application filing date) OTD mostly concerned with “Utility” patent applications Patentable subject matter - Compositions of matter, manufacturing processes, chemical synthesis routes, methods of treating, devices, algorithms New, useful, non-obvious; must also be enabled March 16 2013, US changed from “first to invent” system to a “first inventor to file” system 1-year US grace period concept weakened Want to file early and BEFORE public disclosure 9

10. HARVARD UNIVERSITY Office of Technology Development Once ROI filed, OTD will work with inventor to: - Assess patentability -- subject matter, prior art, public disclosures - Assess commercial potential - Assess ability to license – existing company, start-up - Assess ability to detect infringement and/or enforce patent 10 Can’t enforce pending patent application – only an issued patent T=030 months Examination begins 12 months18 months Typical Filing Path at a University

11. HARVARD UNIVERSITY Office of Technology Development Material Transfer Agreements (MTAs) ( 1,873 in FY13) Ownership of IP resulting from use of material Provider’s rights to review manuscript before publication Ownership of derivatives and modifications of material Submit MTAs to OTD for processing online: http://otd.harvard.edu/faculty/ http://otd.harvard.edu/faculty/ click “incoming” or “outgoing” Confidential Disclosure Agreements (CDAs) - Common when exchanging confidential information with a company unpublished data, results, methods, inventions Contact OTD whenever a CDA might be required or has been sent to you 11

12. HARVARD UNIVERSITY Office of Technology Development Industry Collaborations or Sponsored Research Agreements ­ Confidentiality ­ Publication rights ­ Material sharing and ownership ­ Rights in results and IP Foundation Grants ­ Royalty sharing ­ IP reporting obligations ­ Publication rights ­ Sponsored Programs Office (SPA, OSP) or other offices (e.g. OER) will consult with OTD to ensure protection of investigator’s IP rights 12

13. HARVARD UNIVERSITY Office of Technology Development 13 Cambridge –Holyoke Center, Suite 727E –617-495-3067 Harvard Medical School –Gordon Hall, Suite 414 –617-432-0920 HSPH –Bldg 2, Room 119 –617-432-1273 www.otd.harvard.edu Harvard affiliated hospitals have separate offices

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15. HARVARD UNIVERSITY Office of Technology Development 15 Intellectual Property Staff: 8 Alliance Management Staff: 3 Technology Transactions Staff: 7 Finance & Administration Staff: 9 Business Development Staff: 15 Accelerator Fund Staff: 3 Life Sciences Physical Sciences Chief Technology Development Officer Total staff: 45 Faculty VCs/ Industry FAS HMS HSPH HSDM Wyss

16. HARVARD UNIVERSITY Office of Technology Development 16 Expose industry and investors to Harvard research and PIs Market and commercialize specific technologies Attract industry to collaborate and fund research Expose faculty to industry and investor interests/practices

17. HARVARD UNIVERSITY Office of Technology Development 17 Protect IP and market to industry License to established organizations Execute Industry Sponsored Research Agreements & Strategic Alliances Create start-ups 17

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21. HARVARD UNIVERSITY Office of Technology Development You may have an invention –Processes –Machines –Assays, screening methods –Compositions of matter –Algorithms, software, database –New and useful improvements of the above Report potential inventions to OTD asap, BEFORE –Submitting an abstract –Presenting a poster –Giving a talk –Publishing a paper –Sharing information about the work with third party on non-confidential basis 21

22. HARVARD UNIVERSITY Office of Technology Development Company wants to speak with you Company requests confidentiality agreement Institution/Company requests transferable material You want material from Institution/Company You seek non-federal funds You are unsure about need to contact OTD 22

23. HARVARD UNIVERSITY Office of Technology Development David Jacobson, Associate Director of Business Development –HSPH, Bldg 2, Room 119, 617-432-1273 –Experience at Cytyc Corp & Wyeth Pharmaceuticals –PhD Chemistry, University of CA San Diego –MBA, Boston University TBD, Director of Business Development –Based at HSPH & in Cambridge 23

24. HARVARD UNIVERSITY Office of Technology Development Award specifications –Gov’t of Peru will own all data & IP produced during the project –Researchers may publish findings only with prior approval from Gov’t of Peru –Final award installment will be paid only if Gov’t of Peru satisfied with recommendations deriving from the work Potential impacts of these grant terms –Professors Smith (Engineering) and Park (SPH) –Dr. Lim (Medicine) –Graduate students Since Professors Smith and Park are comfortable with the grant terms & are eager to get started, can they direct grants management office to sign the award? With whom should they consult about these terms & conditions of the award? 24

25. HARVARD UNIVERSITY Office of Technology Development Thank You! 25 David Jacobson 617-432-1273 david_jacobson@harvard.edu www.otd.harvard.edu

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27. HARVARD UNIVERSITY Office of Technology Development In 1980 –Government held title to 28,000 patents –Fewer than 5% licensed for commercialization –Universities held ~500 patents By 2005 –US university tech transfer programs increased 8X –Over 8,000 patent filings –Universities held ~3,300 patents –Thousands of university-licensed products & new US companies from federally funded research 27 www.autm.net Nature Methods (2011) 8(10):1728

28. HARVARD UNIVERSITY Office of Technology Development University of California: recombinant DNA technologies that launched biotech industry Stanford: Google NYU: therapy for rheumatoid arthritis (Remicade) MGH: therapies for rheumatoid arthritis (Enbrel) and age-related macular degeneration (Visudyne) Harvard/MIT: Cardiolite cardiovascular SPECT imaging agent MIT: one of the largest internet content delivery networks (Akamai) Yale: Stavudine anti-retroviral treatment for HIV/AIDS Florida State University: synthetic method for paclitaxel 28

29. HARVARD UNIVERSITY Office of Technology Development 29 2009 2010 2011 2012 2013 New ROIs 277 301 351 368 414 New Patent Applications 172 133 204 197 231 U.S. Patents Issued 45 38 60 65 74 Licenses 36 37 45 34 34 Total Licensing Revenue (MM) $12.4 $10.1 $13.8 $11.5 $15.2 Startup Companies 8 7 9 10 9 Industry Sponsored Research 37 45 75 73 81 ($millions) $20.7 $26.0 $37.2 $42.5 $42.3 Material Transfer Agreements 1,055 1,284 1,530 1,731 1,878