2012 small business innovation/small business technology transfer

2012 Small Business

Innovation/Small Business

Technology Transfer (SBIR/STTR) Workshop Presentation

Bioscience Association of Maine and Intellectual Property

May 9, 2012

Presented by

Karin A. Gregory, MPH, Managing Partner

Karin A. Gregory

• Business/Finance/Venture Capital/Law

• Worked as a VC for 7 years, on Board of 2 VC funds, advise corporate, large venture capital

• Co-founder of many businesses

• Founded FG in 2005 to work with startup and small businesses:

– Product

– Service

– Non-profit

• Offices in Boston and Biddeford

5.9.2012 2 © 2012 Furman Gregory Deptula

The Year in Review

• Bioscience is defined by a broader definition using a national system of economic measurement which compares directly with all other states (BIO/Battelle defined NAICS) – Now includes medical devices, medical labs and diagnostic imaging centers

– MTI feasibility study, cluster grant application

– Claire Deselle as new Executive Director

– Networking

– 3rd annual conference

– 2012 BIO International Convention

• Bioscience more directly and accurately identifies the job categories needed by all employers, primary focus being scientists jobs


Membership/Benefits • Benefits of Membership

– Full participation in all BAM sponsored events

– Automatic membership in New England Biotechnology Association (NEBA)

– Website profiles, individual and organization, additional content through digital library, biotech related resources

• Advocacy at the state level

• Inclusion in group purchasing from BIO, AdvaMed, MassBio Purchasing Consortium, Manufacturers Association of Maine’s Business to Business program and state cooperatives

• Attend NH Biomedical Association, Mass Bio and MassMedic events at member rates

• Leverage from BIO and AdvaMed on legislative initiatives at state and federal levels

• Access to marketing efforts at BIO and other national conferences


2010-2011 Maine Bioscience Economic Facts

• 2nd highest average wage ($66,861) of all tech sectors

• 67% higher wages than average Maine employee ($40,020)

• 12 of 16 NAICS defined bioscience businesses are manufacturing

• New medical device initiative—MTI

• Potential cluster of over 60 companies that participate in the medical sector in Maine

• Wages for medical instrumentation/equipment increased from $9M in Q2 of 2010 to over $13M in Q2 2011

• Trending higher than the national average


Bottom Line

• Revised organization - industry focused

• Focus on membership education, networking and providing benefits to members and their employees

• Improve collaborations between non-profit organizations, research entities, and for profit commercial companies

• Providing external linkages to strengthen company growth and partnering options

• New educational initiative – CIB/MBEC

• Educational programs - BioPro training program (Oregon Bioscience Association)


Intellectual Property Background

• Bayh Dole Act in 1982

• Title to IP

• Use of data

• Inventorship


Intellectual Property Outline

• What is intellectual property?

• How do you develop and/or recognize it?

• How do you protect it?

• How do you monetize it?


Intellectual Property Defined

• Patents

• Copyrights

• Trademarks

• Service marks

• Trade secrets/Know-How


The process….

Invention “disclosed”

Review of its patentability-utility, non-obviousness

Protecting the Proprietary invention… $$$ filing and maintenance fees

WATCH OUT FOR PUBLIC DISCLOSURE

File a patent (provisional or full) - US/ROW


Copyrights

• Original works of authorship

– writings, brochures, books, websites, databases, video games, pictures, digital works, music

– Software

– Inexpensive to use and maintain

– “All works fixed in a tangible medium of expression are protected in copyright” (no need to register)

– MUST have Notice - ©

– Term-life of the author plus 50 years

“Work for hire”


Trademarks/Service marks

Word, symbol, phrase… that identifies and distinguishes the source

of goods/services of a party

• Establish a mark by its use in the marketplace-Federal registration have many advantages

• Notice - TM/SM NOT ® unless registered with the USPTO not while pending

• Branding Strategy


Trade Secrets and Know-How

• To produce a product - manufacturing, method, formula, pattern, design

• MUST BE KEPT SECRET

• Know-how is information and experiential expertise related to using formulas or processes


Ways to Monetize the IP Asset

• Sell it outright, if not critical to future business plans

• License it-different “field of use”

• Develop, Protect and Build it into your business to be sold/valued with the business-your brand


Licensing

An arrangement whereby an inventor or assignee grants another person or company the right to make, have made, use IP

• Source of new capital-fees and royalties

• Profitable if properly structured and invention succeeds in marketplace

• Added value for business


Another Advantage of Phase III Status: SBIR Data Rights

• The Government must insert the SBIR Data Rights Clause into all SBIR Contracts, including Phase IIIs

– Under the SBIR Data Rights Clause: • Agencies must protect and cannot disclose all data generated

under an SBIR funding agreement (except for limited purposes)

– Protection period starts on contract start date and lasts for: • 5 years for defense contracts from the end of the project

• 4 years for non-defense contracts from the end of the contract


What Happens When SBIR Data and Proprietary Data Are Mixed Together? • The Government gets a royalty-free license only in what is

developed under the SBIR contract, not in what the SBC developed at its expense

• You can enhance your SBIR deliverables

• The Government does not receive SBIR Data Rights in modifications/enhancements if they are developed at the SBCs private expense

• This can elevate SBIR rights to the best data rights available to contractors

– limited rights or restricted rights (For computer software or documentation) because the Government can never disclose proprietary data


Insertion of the SBIR Data Rights Clause • Agencies must insert the SBIR technical data

rights clause in every Phase III

• SBIR technical data rights are non-negotiable

• Agencies may not in any way make issuance of an SBIR award conditional on data rights

• Agencies may not diminish or remove SBIR Data Rights during contract administration


Sample Clause – Patents and Inventions Section 13. Title to any trade secrets, inventions, developments, or discoveries, works of authorship, whether patentable or not (collectively referred to as "Intellectual Property"), resulting directly from the Scope of Work, shall be allocated according to applicable employment contracts and U. S. Patent Law (Title 35 U. S. Code) and U.S. Copyright Law (Title 17 U.S. Code) in effect at the time the Intellectual Property was created. For that Intellectual Property determined to be solely owned by SUBCONTRACTOR, the GRANTEE is granted an option to negotiate a license, on reasonable terms, to such Intellectual Property, such option to be exercised within six (6) months of notification of the Intellectual Property. For that Intellectual Property determined to be jointly owned by GRANTEE and SUBCONTRACTOR, an exclusive option is provided to GRANTEE to negotiate for an exclusive license, on reasonable terms, to SUBCONTRACTOR's rights, such option to be exercised within six (6) months of notification of the Intellectual Property. For that Intellectual Property determined to be solely owned by GRANTEE, SUBCONTRACTOR shall claim no rights. GRANTEE is granted a non-exclusive license, for internal use only, to all original works developed within the Scope of Work for which SUBCONTRACTOR owns the copyright.


Sample Clause - Data

Federal Acquisition Regulation (FAR)

• FAR 52.227-11, PATENT RIGHTS -- RETENTION BY THE CONTRACTOR (SHORT FORM) (JUN 1997) shall apply to patentable Intellectual Property); and

• FAR 252.227-7018 (JUN 1995), Rights in Noncommercial Technical Data and Computer Software -- Small Business Innovation Research (SBIR) Program shall apply to copyrightable Intellectual Property, as defined in this Section 13

“GRANTEE AND SUBCONTRACTOR agree to protect any and all technical data by the use of the appropriate legends regarding confidential information including all technical data being provided to the SPONSORING AGENCY.”


Mark SBIR Deliverables With the SBIR Legend

• 16SBIR Contractors must mark all SBIR data (generated under an SBIR contract) with the data rights legends contained in:

– DFARS 252.227-7018 for defense agency contracts; and

– FAR 52.227-20 for non-defense agencies

• Use the exact wording contained in those clauses

• Annotate them to indicate the "roll-over"

• "Mark it or lose it" when it comes to data rights


Summary

• Know how to recognize IP

• Create but protect it before public disclosure

• Desire to have government use royalty free

• Subcontractor rights in data and IP

• Grants such as SBIR’s know the data rules


Questions | Answers

Karin A. Gregory, Esq.

Managing Partner, Furman Gregory Deptula

[email protected]

MA 617.912.5140 | ME 207.571.9365

www.fgd-law.com


mailto:[email protected]



2012 small business innovation/small business technology transfer

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