Technology Transfer & Inventing in Academia

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Technology Transfer & Inventing in Academia Markey Pathway Students August 28, 2014 Nichole R. Mercier, Ph.D. Associate Director, Office of Technology Management http://otm.wustl.edu

Office of Technology Management Moved December 2013 @4240 Building in the CORTEX District Boeing Ventures

What is Technology Transfer? AUTM Definition: Formal transfer* of rights to use and commercialize new discoveries and innovations to another party. *Universities typically transfer technology through protecting (using patents and copyrights), then licensing new innovations.

Bayh-Dole Act Passed by Congress in 1980 Applies to all federally funded research (e.g. NIH, NSF grants) Mandates that Patent Rights vest to the University Universities to manage IP from federal grants The University has the responsibility to promote public utilization/commercialization of inventions at fair market value Share of revenue by University with Inventors

Washington University in St. Louis WU Medical School and BJC/Children s Hospitals Danforth Campus OTM Mission To promote the public utilization of University innovations created by faculty and employees through the formation and management of commercial partnerships

Why Technology Transfer? Fits our mission - Develop new devices, drugs, diagnostic tests for the good of society Increased awareness of university name and core strengths Increased notoriety for faculty Commercial relationships for faculty The university cannot do it alone

OTM Service Focus* Triage all WUSTL invention disclosures; file patents or return IP to inventors Management of WU patent portfolio Licensing of patented and unpatented IP Revenue distribution to WU and inventors Material Transfer Management (MTAs) Education and awareness of tech transfer * Industry Sponsored Research Agreements are now handled by OSRS-Contracts OTM advises on IP issues

OTM Statistics ACTIVITIES FY08 FY09 FY10 FY11 FY12 FY13 Invention Disclosures 98 125 104 136 143 151 US/PCT Patents Filed 94 106 76 83 98 121 Licenses Technologies 42 44 41 48 40 41 Licenses - Copyright (industry) N/A N/A N/A 2 3 5 MTAs - Academic 674 817 718 70 639 791 0 -Industry 51 62 61 95 88 105 Revenue $17.0M $7.9M $6.4M $6.3M $6.2M $7.0M Start-up companies 4 2 2 2 2 4

Intellectual Property What is Intellectual Property (IP)? Creations of the mind - inventions, literary and artistic works, symbols, names, images, and designs What are Intellectual Property Rights? Ownership and associated rights relating to IP Property Copyrights Trademarks Trade Secrets Patents

WU Intellectual Property Policy All intellectual property (including lab notebooks, cell lines and other tangible research property) shall be owned by the University if : significant University resources were used, or it is created pursuant to a research project funded through corporate, federal or other external sponsors Applies to all WUSTL faculty, staff, graduate students and post-docs (but not undergraduate students, unless they are employed by WUSTL)

Patent Protects new, useful, and non-obvious materials and processes Utility Patent Design Patent Plant Patent Grants inventor the right to exclude others from making, having made, using, leasing, offering to sell, selling, or importing an invention Limited by geographic location in which patent is granted Provides exclusive rights for 20 years from the date of filing

The Patent Application Written specifications - a description of the invention, referencing the drawings, such that someone skilled in the art can understand what it is, how it works, how it is assembled, and what its attributes are. Claims - the legal part of the patent. They specifically define what the invention is. Declaration by Inventors

Provisional Patent Application 12 months PCT Application 18 months US Application Canadian Application European Patent Office Application Australian Application France Germany UK

What is a Public Disclosure? Public Disclosure Any description of the idea, written or verbal, made to non-wu employees or students who are not bound by a confidentiality agreement Enabling Public Disclosure provides enough of a description of the invention to teach a person with ordinary skill in the art to understand, duplicate and practice it.

What is a Public Disclosure? Activity YES NO OTM Invention Disclosure Article in Science Jumbotron at Busch Stadium News article in the WU Record Poster session at a conference Lab Meeting Talking to family at Thanksgiving dinner Thesis or Dissertation Tweet on Twitter page Grant application Conversation with an industry representative Lab Website

OTM Process Invention Disclosure Submission Product Commercialization (Revenue Distribution) Invention Assessment OTM Licensing Pathway Product Development Invention Protection Licensing Event https://otm.wustl.edu

DECISION Patent Copyright License w/o protection Return

Decision Making The algorithm is simple: Is it patentable? Is it marketable? Is it licensable?

Technology Assessment Envision the Product Patentability Breadth of potential claims Patent enforceability Potential for workaround Freedom to operate Enablement Are the claims enabled Timeframe to enable claims Marketability Market need/unmet need Competition landscape Competitive advantage of potential product Stage of development Potential for additional proof-of-concept studies Other barriers License-ability License Strategy Target Companies

Decision to Not to File Licensing without Protection or Publishing Sometimes the best way to reach the largest audience License without protection (cell lines, animal models, other tangible material) Return If the IP is not WU s (does not fall under IP Policy) Simple letter from creators and creators department and OTM will issue a formal letter If the Technology Assessment suggests filing a patent isn t prudent or the market forces suggest a difficulty in licensing the technology 60+ days to return to the creators if NIH money is used If no NIH money, OTM will issue a letter to the investigator

Decision to File Copyright No need to file formally in copyright office Use Washington University in St. Louis 2014 (year of original copyright) Term is 70 years following the life of the author Patent Patent attorney will work with OTM and inventor team to draft patent application Manuscript is best, but anything written by the inventors is helpful to draft the patent Inventors provide data set graphs, raw data or otherwise Attorney drafts the patent application Inventors review specification & claims, answer any outstanding questions Starts the 12 month time clock 0

Patent Timeline $ $$ $$$$ Invention Disclosure & T.A. Non- Provisional/ PCT & C.A.P. National Phase TIME (months) 0 12 18 30 Provisional Patent Patent Application Publishes

Licensing Challenges Data to entice a licensee is critical Enablement for a patent is not the same as attracting a licensee What we see Early data; early patents Limited funding for translational research studies

Recent Start-up Companies AcuPlaq, LLC BIOCLASSIFIER

OTM Initiatives Faculty and Students Bear Cub Program Balsa Intern Program OTM Trainee Program Student/Post-Doc Technology Transfer Workshop Technology Commercialization Seminars Internship in Marketing Women Innovation and Entrepreneur Project (WIE) Faculty Tech Transfer Workshop FastTrac Start-up Program

OTM Organization

Office of Technology Management 4240 Duncan Ave, Suite 110 otm@otm.wustl.edu Contact Information: Nichole Mercier, PhD Associate Director 314-747-1903 nmercier@wustl.edu