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Akins, Assoc. Dir., UI Research Foundation brenda-akins@uiowa.eduhd0$6M  Workshop OverviewTechnology Transfer [Brenda Akins, UIRF Assoc. Dir.] Patent Basics [Brian Meadows, Needle & Rosenberg] Licensing [Brenda Akins, UIRF Assoc. Director] UI Entrepreneurship and Spinouts [Pamela York, UIRF Executive Director, and Mark Arnold, OSTC Director]\Z # $#F What is technology transfer and how does it fit within the University mission? National and local affects of academic technology transfer UIRF mission and activities How to disclose new inventions Licensing UI inventions D%  fWhat is academic technology transfer? Construed most broadly, includes: %university graduates %scholarly publications Specifically, refers to: %licensing: grant of patent rights to a third party to make and have made, to use and have used, to sell and have sold licensed products. &PP&$##"#"""#" "  #  eOverarching Academic Missions: education and research: teach, create and share knowledge service !PC%%B(BF@@D"B@F`,G$ Licensing technology fulfills the university s missions in a very tangible way: part of research cycle moves new discoveries from academic centers and laboratories to the marketplace enables the public and consumers to benefit from the new knowledge generated by UI faculty, staff and students. propels new research collaborations, interactions with industry |P%P%PPPBbB@ b  oBefore 1980, inventions made under federal funding were owned by the federal government. The Bayh-Dole Act of 1980 Passed by Congress to give incentives to universities and small businesses to invest in patenting, licensing, and commercial development of inventions made under federal funding. incentives later extended to federal agencies and large corporations u%Z%Z%ZZX$E" " _  yMajor provisions of the Bayh-Dole Act include: Non-profits, including universities, and small businesses may elect to retain title to innovations developed under federally-funded research programs Universities are encouraged to collaborate with commercial concerns to promote the utilization of inventions arising from federal funding Universities are expected to file patent applications on inventions they elect to own Universities are expected to give licensing preference to small businesses The government retains a non-exclusive license to practice the patent throughout the world The government retains march-in rights. /PJ%P-<%<?/*X^ [Outcomes of Bayh Dole Academic transfer office activities [patent protection and licensing] increased exponentially Universities have applied tenets of Bayh-Dole to all sources of funding Ongoing reporting obligations to the federal government (invention and utilization reporting) Supports entrepreneurship and enables spin-out opportunities. HF%$^"",   National and Local Impacts due to Academic Technology Transfer Nationally [from latest AUTM 2005 survey data]: Of the 151 institutions that identified themselves reported collectively: a total of 4,053 new licenses and options executed 9,079 new patent applications filed 2,835 U.S. patents issued 404 start-up companies formed %At least two dozen universities each earned more than $10-million from their licensing of rights to new drugs, software, and other inventions p?P{P%PP? "   National and Local Impacts Due to Academic Technology Transfer Recent UI success stories: CMV Promoter Used in the manufacture of therapeutic protein drugs and in research reagents for drug discovery 100+ nonexclusive licenses in various fields of use UIRF receiving royalties on 13 therapeutic products ($10mil + annually) 1st application filed 1985, first patent issued 1992; 2nd patent issued 1995. ?P0P %P0P? 5" 6Coley Pharmaceutical, Inc. Novel class of molecules that activate the human immune system to fight disease. Products = optimized synthetic oligonucleotides sequences to treat disease. Applications include: cancer, infectious disease, respiratory disorders, vaccines Biopharmaceutical company founded in  97 Arthur Krieg; Founder; Sr. VP R&D & CSO (Former UI Prof Int. Medicine) 1st UI spinout company to become publicly traded $13M in license revenue $7M in patent cost reimbursement (including $2M patent interference legal costs) - 153 pending apps, 71 US; 87 issued patents of which 9 US Substantial royalties in  09 if Phase III clinical trials are successful%P PPPPpPIPPD 9I OVERVIEW UI Research Foundation (UIRF) ORGANIZATION: 501C3 Foundation 13 employees; UIRF Board of Directors; Advisory Board FUNCTION: Ventures, Licensing & IP Services Licensing is primary source of revenues FY06 $19.4MM operating revenues PORTFOLIO: Technologies and Companies 1000 technologies 25% licensed 80 invention disclosures annually 15 new pre-companies or companies NEW MISSION Champion the commercialization of selected UI inventions for public benefit Catalyze economic development and an entrepreneurial culture in Iowa Build the vitality and sustainability of the university and the community Serve the research mission for continued innovation (P !P8P,!PHP&!PcP !PP( 37 "3H     3b         3D    3  =    3  3E    3  .     [FY 2006 UIRF Activity Disclosures Received 89 U.S. Patent Applications Filed: 120 (plus 28 foreign and 30 PCT) Patents Issued: 56 (33 foreign) Licenses / Options executed: 43 External legal expenses: $3.8 mil (65% reimbursed by licensees) License income received: $16.9 mil License income distributed: $12.6 milb0Z (pZ 0Z $C QT   TNational and Local Impacts due to Academic Technology Transfer Local: 7 Year Trends 0TT   ~The UIRF is the designated entity to own, manage, license, and dispose of proprietary rights in ideas, creations, discoveries, inventions, and processes of any nature made by University faculty, staff, and students under the terms and conditions of The University of Iowa s intellectual property policy. A separate non-profit organization established in 1975 that reports to the UI s Office of the VP for Research. (Bayh Dole enacted in 1980) `1%Z%ZZL.     TUnder UI policies, the activities, responsibilities and prerogatives of the UIRF include: seek an assignment of ownership rights from the inventor or inventors: engage and pay outside counsel seek licensed users of the invention receive and distribute earnings derived from licenses monitor the performance of any license holders. ZO%A$%ZK Under UI policies, the activities, responsibilities and prerogatives of the UIRF include: New Distribution policy the 1st 100,000 net earnings to go to inventors, then split as follows: 25% to inventor(s); 25% to UIRF; 20% to VPR Enrichment Fund; 15% to academic department(s); 15% to academic college(s). The policy provides for sharing by central University if net revenues exceed $10 million per year for any particular licensed subject matter. ZPPI%PPu%P%P$PZ$Iq    > F   &Invention Disclosures: What to Submit0'$37&Invention Disclosures: When to Submit<'  3% submit after you ve conceived of the invention and the concept is reduced to practice or you ve determined how it can be reduced to practice; % data is necessary; manuscript is helpful % industry contacts are excellent but not required for submission. |!` d d""*  "A Process Steps from Science to Commercialization 1) UI researcher makes a new discovery. 2) Researcher discloses new discovery to the UIRF. 3) UIRF evaluates invention for patentability and commercial potential. 4) UIRF files for patent protection. 5) As required by federal law when federal funding is involved, and as required by UI policy, UI inventors assign rights in invention to UIRF. `0P(2%/W' Process Steps from Science to Commercialization (cont.) 6) UIRF solicits companies interested in commercializing the invention, including interest by any of the UI inventors. 7) New venture or existing company requests license, option or standstill agreement from UIRF. 8) For new ventures: UI inventors obtain any approvals required under UI policies including conflict of interest and conflict of commitment. 9) New venture / existing company submits business plan for evaluation by UIRF. 10) UIRF and new venture / existing company negotiate and execute terms of a license agreement. 11) Licensee submits progress reports and meets diligence criteria set forth in the license. 12) UIRF distributes net earnings to UI inventors, dept(s), college(s), VPR in accordance with governing UI policy. R%P%P7, 1The IP & License Pipeline ( UIRF selects a company to license new technology based significantly on: the nature of the invention the company s interest and capacity to advance the UI invention to the marketplace [resources, management, business plan] existing company v. new ventureFI%H$$ A note regarding UIRF s philosophy on licensing inventions arising from the UIRF: Making technologies available for public use and public good is a top priority Nationally and internationally Local and regional economic development This is typically contingent upon an associated revenue stream or otherwise well-funded and well-managed approach TO%ZG%Zt%ZZT"OGqH | License considerations: The nature of the technology to be transferred and various ways it might be used Non-exclusive v. exclusive licenses Fields of use (exclusivity or non-exclusivity within the field) Licensee s ability to grant sublicenses Due diligence requirements / reporting / termination Insurance / indemnification Financial terms  costs, milestone fees, running royalties No warranties / representations re: potential infringement vkS$@$S  Questions?/4-/01234568 9   0` 333MMM` fBtg` 3f3ff___` 3fwww3f%i` 3fZX___i3` XfZX3fmo3` 3f\Iqy`eӢ` f3f3f3fz` Vbr(FwwwKpfܹ` 3f3f$DjQ333` 3f3j33f` ffMMM>>\6X~!p` -\- 5d_/z3f>?" dP@(|?" dd@   " @ ` n?" dd@   @@``PR    @ ` `,p>>  (    6 "P@  T Click to edit Master title style! !$  0 "p@`  RClick to edit Master text styles Second level Third level Fourth level Fifth level!     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G T   @` ", <X %? G ]125,(#   #, < %? G ]138,(#   $, <d%? G wSponsored Research IP Support* #   %, <P%?9   \29,(#   &, <)%?Q 9  \46,(#   ', <D3%?j Q  \40,(#   (, <<%? j  \53,(#   ), <tG%?  \42,(#   *, <Q%?  \53,(#   +, <Z%?   \56,(#   ,, <, < 2&?Q9/  d834('   ?, <<&?j Q/  d734('   @, <HF&? j /  d774('   A, <P&?  /  e1014('   B, <`Z&? /  e1184('   C, <d&?/  e1154('    D, <x&?/  U.S. Patent Applications Filed2H  ' /   E, <Hz&?9  d794('   F, <D&?Q9 d844('   G, <&?j Q d654('   H, <&? j  d884('   I, < &?   d754('   J, <p&?  d864('   K, <&? d834('   L, <D&? 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