Intellectual Property & Technology Commercialization Basics



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Intellectual Property & Technology Commercialization Basics Judith Sheft Assistant Vice President Technology Development NJIT (973) 596-5825 Sheft@njit.edu

Disclaimer I am not a lawyer

What is Intellectual Property? Intellectual Property = Products of the mind Inventions or ideas Intangible assets Intellectual Property Rights = Legal rights associated with IP Intellectual Property can be protected by: Patents Copyrights Trade secrets Trademarks

Intellectual Property Rights Intellectual Property Rights are a negative right that prevent others from practicing an invention by unauthorized manufacture, copy, use or sale of the invention for a defined period of time As of June 1995, an issued US patent affords the owner a 20 year monopoly from filing date over the invention which is claimed

Why is IP Important? An analysis by Coopers & Lybrand found that 2/3 of the market value of publicly traded companies was attributed to intangible assets In the pharmaceutical industry drugs under patent protection earn a 90% gross margin versus 50% for generic products For start up companies having an IP position is an important consideration in raising capital

Types of IP Patents protects the concepts and ideas of function and design Copyrights protects written expression and the communication of ideas reduced to tangible form Trademarks protects identifying symbols Trade Secrets protects proprietary material which if kept secret provides a commercial advantage to the owner

Patent Basics Protection for processes, machines, items of manufacture, compositions of matter Item must be new, useful and non-obvious Invention must be distinguishable over prior art US rights are granted by the Federal Government through the US patent and Trademark Office Foreign rights must be obtained separately by filing in the appropriate foreign patent office As of June 1995, a US patent provides a 20 year monopoly from filing date on the invention which is claimed in the patent Ongoing interaction between the inventor and the prosecuting attorney is key in drafting patent claims

Inventorship Determining the inventors on a patent is a matter of law. Having the inventorship wrong can invalidate a patent Inventors are not the same as co-authors on a paper, students in the lab, supervisors or thesis advisors An analysis of the claims of the patent is used to determine inventorship

Patent Filing Timing Requirements US filings must take place within 1 year from public disclosure or offer for sale Foreign fling must take place prior to public disclosure or offer for sale Public disclosure can involve web postings, publications, discussions with a few as one person, presentations at meetings

Lab Notebooks Good record keeping is essential for effective patenting since it serves to document critical dates and inventorship Lab Notebooks basics: Use a bound notebook Maintain an on going record of activity Have material signed and dated Have a colleague familiar with the work but not involved with it sign and witness weekly Do not erase or remove pages. Cross out errors

Copyrights Protection of an original work of authorship fixed in any tangible medium but not the idea Protects against copying the work not the creation of similar or identical works Can be used to protect: Literary works, dramatic works, choreographic works, pictures, graphics, sculptures, movies, sound recordings, computer programs and screen displays

Copyright Registration Federal rights automatic upon creation Can include a copyright notice on material Judith Sheft 2003 Can file an application with the US Copyright Office

Trademarks A word, symbol, name device or combination used to identify goods or services Federal Rights vest upon registration Marks should be distinctive

Trade Secrets Information that is not generally known or discernable and if kept secret provides an economic advantage to its owner Trade secrets can protect financial, business, economic or engineering information Examples include computer software distributed in object code only, recipes or formulas, business plans, customer lists

Trade Secret Protection Physical Security Internal Procedures: Use of Non-Disclosure Agreements Limited Access to Material Need to Know

IP Protection Example Patent protection can be obtained on a new medical device. The user manual and associated software can be copyrighted The name of the device and or graphics can be trademarked

University Mission Elements A Public Research University Instruction Research Public Service Economic Development

IP in the University Context IP and Tech Transfer can foster activities that support the fundamental academic mission of NJIT by: Recognizing/rewarding inventors Developing closer ties with industry Promoting economic growth Commercializing research Generating income for research & education

Office of Technology Development - Mission To promote the commercialization of NJIT research results through: - technology licensing and - sponsored research activities in a manner consistent with the research, teaching and public policy objectives of the university and in compliance with government regulations To provide guidance to faculty/staff and students on IP matters To provide an additional source of funds to support research and education at NJIT To recognize and reward the contributions of individual inventors through royalty sharing

Office of Technology Development (OTD) OTD is responsible for managing the IP developed by NJIT faculty, staff and students and /or which utilized NJIT resources, time and facilities or services during their conception or development. Key functions include the identification, protection, transfer and commercialization of IP assets. http://www.njit.edu/research/intellectual_property.php Contacts: Judith Sheft Brian Tierney Assistant Vice President Assistant General Counsel Technology Development Intellectual Property 973-596-5825 973-596-8437

OTD Involvement Activities Research Research Continuum Technology Transfer Ongoing IP administration for existing contracts, royalty collection and distributions Transfer of materials agreements Negotiating research agreements Faculty assistance on IP issues Assist in identifying/evaluating new disclosures Managing confidentiality and non-disclosures Initial patent applications and copyrights Identifying Licensees Negotiating license agreements Managing new company creation Evaluating new company creation Copyright AUTM

JS1 IP at the University: The Historical Backdrop 1980 Bayh - Dole Act Introduces: A fundamental change to the patent law: title to inventions made with government funding by small businesses, universities and other non-profit entities belongs to those entities, and not to the government Created a uniform intellectual property policy for all government agencies

Slide 22 JS1 JSheft, 8/18/2003

Bayh-Dole Act - Obligations Universities must file patents on inventions they elect to own Preference for small business licensees Licensed products manufactured in U.S. Royalties must be a.) shared with inventor and b.) used for research and education Government retains non-exclusive right University reporting obligations

Invention Commercialization Model Research & Development Intellectual Property Prototype Development The process is not as linear as it is shown!! Product Development Commercialization

NJIT IP Process Flow ( Abbreviated): Grants & Sponsored Research Research Activity / Inventions Invention Disclosure & Inventor Interview NJIT IP Technology Commercialization Committee Review Filing Decision: Yes/No - Full / Provisional Waive Rights to Inventor Technology Commercialization/Marketing License/Start Up Research Continuum

NJIT IP Policy Invention Disclosure In order to preserve patent filing rights and obligations to Sponsors Inventors are required to disclose all inventions to the Office of Technology Development prior to any disclosure to the public or a private entity This includes enabling disclosures to potential licensees, scholarly publications, colloquium, and web postings If necessary for evaluation of inventor record of accomplishment or student thesis/dissertation evaluation - documents may be reviewed by NJIT agents under confidentiality agreements

Factors in Assessing a Disclosure: Patentability Novel / Non-obvious (prior art) Publication / Disclosure On Sale Bar Commercial Viability Market Size / Growth Rate Competitors / Potential Licensees Current or Future market Invention Foundation or extension concept Third party IP involved Ease of design around / detectability Funding Sponsor Rights

Industrial Sponsored Research Industrial sponsored research is a growing component of NJIT s overall research program Frequently multiple sources of funds are used to support a research activity Working with industry can present challenges due to differing missions and culture: Open Disclosure/Academic Freedom vs. Confidentiality Knowledge for Knowledge s Sake vs. Use of Knowledge for Profit Areas that tend to be problematic include IP rights, publications, warranties, deliverables

The Typical University Commercialization Process Licensing Activities DISCLOSURE Sponsor rights PRELIMINARY EVALUATION Sponsor commitments Patentability assessment Commercial potential Tangible research products Invention overlap Strategy Considerations: Exclusive/non-exclusive Field of use Territorial If no sponsor rights ELECTION PERIOD Sponsor declines option If unsuccessful negotiations IDENTIFY and CONTACT POTENTIAL LICENSEES LICENSE (or OPTION) NEGOTIATION Grant License issue fee Prosecution reimbursement Minimum royalties Earned royalties Diligence provisions Reporting obligations Problem resolution Commercialization Contract Admin. Copyright AUTM

Challenges in University Tech Transfer Stage of development is embryonic IP valuation is difficult Substantial further investment is required for technology and market development Is it a license or is it a company? Who will fund and manage a start up? Government / State funding & rights Exclusivity requests by licensees

Technology Transfer The Reality Most inventions are NOT the BIG WINNER According to AUTM, in FY2001 : 131 out of 22,806 active licenses generated more than $1M in revenue 68% of licenses executed were with start ups or small companies 49% of all licenses executed were exclusive According to Stanford University The University cannot count on royalties for operating expenses 50% of the cases produce less than $10K in income!!

Licensee Selection Factors Leading Edge Technology / IP Position Cash Position Technology Transfer Expertise Product/Market Fit Experience with Licensee Licensee Cultural Match Management Relationships

Patent / Technology Licensing (Almost) Every Deal Is Different Every technology is different stage of development industry Inventor relationships are different Licensee relationships are different IP protection is different

Possible Situations You have a developed a new medical device and associated software program for measuring intraocular eye pressure and will be presenting the results at a regional seminar. Industry will be attending the meeting and you hope to have detailed discussions about possible license and/or sponsored research opportunities. You call your device the One Touch I-Press Monitor. What should you be concerned about from an IP perspective??

Making NJIT Successful at IP Inventor involvement is key Early notification of research work Include OTD in seminars / industry meetings Identification of potential licensees Assistance in the transfer process Keep notebooks Get OTD involved in sponsored research negotiations

Putting the IP Pieces Together Contact Office of Technology Development with ANY Questions Keep a Lab Notebook Use NDAs When Appropriate Create New IP Comply with IP terms in Grants and Industry Sponsored Agreements Stay involved with Commercialization