Presented By:
J.P. Kim, J.D., M.B.A., M.P.P., M.Sc., M.A.L.S.
(Email: jpkim@nih.gov), Director & Policy Officer,
Division of Extramural Inventions & Technology Resources (DEITR),
Office of Policy for Extramural Grants Administration (OPERA), OER
• 2014 NIH Regional Seminar on Program Funding and Grants
Administration, Baltimore, Maryland
• June 2014
• Where to get information to be able to appropriately manage data,
inventions, publications, and other resources developed with NIH
funding
• How to safeguard intellectual property rights to discoveries and
inventions made with NIH funds
• How to work towards sharing NIH-funded data and other research
resources to advance research for benefits to the public and public
health
• To truly make this YOUR session, we also need to know what you
want to discuss….
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• Where to get information to be able to appropriately manage data,
inventions, publications, and other resources developed with NIH
funding
• Know the rules and policies that govern your NIH funding awards
o NIH Grants Policy Statement (GPS)
o Notice of Award (e.g., terms and conditions of award)
o NIH GrantsInfo (GrantsInfo@nih.gov)
• “Grantee” as the responsible funded Institution
o PI is an employee of the funded Institution
o Funded Institution is responsible for compliance with the laws,
regulations, policies, and other rules under the award
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• How to safeguard intellectual property rights to discoveries
and inventions made with NIH funds
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• What is Intellectual Property?
• The why and how of protecting Intellectual Property
• Patents & Copyrights Generally
o Patents specifically
o Additional Data and Copyright Issues
• The Bayh-Dole Act: Recipient Rights &
Responsibilities
• Special Considerations
• The concept of legal protection for original creations
• Certain creations of the human mind that have
commercial value and are given the legal aspects of a
property right, such as:
o patent, trademark, unfair competition, copyright,
trade secret, the right of publicity, and plant variety
protection
• Patents - embodiments of new and useful ideas (utility
patents), designs, and plants
o http://www.uspto.gov
• Copyrights – original works of authorship (including
literary, dramatic, musical, artistic, and certain other
intellectual works) that are fixed in a tangible form of
expression
o http://www.copyright.gov
• Patent – the right to exclude others from making, using,
offering for sale or selling the invention throughout the
United States, or importing the invention into the
United States and its territories and possessions
• Copyright – the right to reproduce, prepare derivative
works, distribute, and to perform and display the work
publicly, including performing the work by a digital
audio transmission
• Patents – 20 years from earliest filing claimed (subject
to the payment of maintenance fees as provided by law)
o Terms may be extended for certain pharmaceuticals
and for certain circumstances as provided by law
• Copyrights – the life of the (last) author plus 70 years
(for Post-1977 creations)
o For Works-Made-For-Hire or Anonymous Works,
the shorter of 95 years from publication or 120 years
from creation
o For Pre-1978 creations, up to 95 years
• Why
o To attract investors
o To secure market position/exclusivity
o For further research & development
• How
o U.S. Constitution
o Federal statutes
o Others: state statutes, common law, contracts
• Can be any new and useful:
o Processes (process, act or method, and primarily
o
o
o
o
includes industrial or technical processes);
Machines;
Articles that are Manufactured;
Compositions of matter; or
Any new and useful improvement thereof
• Novelty (Newness)
• Useful (having utility) – specific, credible, and
substantial utility
• Non-obviousness (e.g., the improvement was not
obvious to a person having ordinary skill in the area of
technology related to the invention)
• Not a mere idea or suggestion
• Extensive data is not necessarily required
• A patent application with prophetic claims could be
granted
• Additional supporting data could be submitted later
during patent prosecution in a subsequent Rule 132
Declaration
• Most international rights can be lost by making an
enabling public disclosure before filing a patent
application (limited exceptions may include the U.S.
(1), Canada (1), Australia (0.5;1), Japan (0.5))
• U.S. rights can be lost by making an enabling public
disclosure more than one (1) year before filing a patent
application
• Risk of losing all rights by failing to timely disclose an
invention to the Government (see Bayh-Dole)
• File enabled patent application prior to disclosing, e.g.,
disclosing through posters, presentations, publications,
talks, etc.
• Limit discussions/exchanges with parties who are under
confidentiality obligations
o E.g., use confidential disclosure agreements (CDAs)
whenever possible for discussions or other exchanges
with potential investors, collaborators, licensees, et al.
• Grant application abstracts or summaries should be
written as if they will be made publicly available
immediately
• Take appropriate steps to protect confidential information,
e.g., marking it as “confidential”, withholding it if
appropriate, submitting a substitute, or simply filing a
patent application on it as soon as possible
• Take the appropriate precautions (markings, etc.)
o 5 U.S.C. § 552(b)(4) provides an exemption for “trade
secrets and commercial or financial information
obtained from a person and privileged or confidential”
• Predisclosure Notification: Executive Order # 12600.
Predisclosure Notification Procedures for Confidential
Commercial Information
• Contractor may establish claim to copyright subsisting in any
data first produced in the performance of the contract (FAR
52.227-20(c))
• Databases as compilations may be copyrightable, there is no
copyright protection for the underlying data
• SBIR Data Rights: “SBIR Rights Notice” (FAR 52.227-20(d))
o Four (4) year period of “non-disclosure” by Government
without contractor’s consent
o Use is for Government purposes only
o After 4 year period, non-disclosure prohibitions no longer
apply – Government may use for Government purposes
but may also authorize others to use on its behalf
•
•
•
•
Federal Funding Agreements
Selected Definitions
Recipient Rights & Responsibilities
Government Rights
The Bayh-Dole Act addresses patent rights for a
contractor under funding agreements by a federal
agency (e.g., grants, contracts, and cooperative
agreements) for performance of experimental,
developmental, or research work funded in whole or in
part by the Federal Government.
Invention: “Any invention or discovery which is or may be
patentable or otherwise protectable under this title or any
novel variety of plant which is or may be protectable under
the Plant Variety Protection Act (7 U.S.C. 2321 et seq.).”
35 U.S.C. § 201(d)
Subject Invention: “Any invention of the contractor conceived
or first actually reduced to practice in the performance of work
under a funding agreement: Provided, That in the case of a
variety of plant, the date of determination (as defined in
section 41(d) of the Plant Variety Protection Act (7 U.S.C.
2401(d))) must also occur during the period of contract
performance”
(35 U.S.C. § 201(e))
Caveat: A preexisting company invention could fall under the
definition of a “Subject Invention” if it was conceived of prior
to funding but was first actually reduced to practice under the
SBIR/STTR and the SBC owned that invention.
• Recipient owns Rights in discoveries by having
appropriate assignments in place and timely electing
title to subject inventions
• Recipient has Responsibilities to meet reporting
requirements
o Extramural Invention Reporting Compliance
Responsibilities
• https://sedison.info.nih.gov/iEdison/timeline.jsp
• Implement Employee Agreements  as needed
• Disclose Each Invention  within 60 days
• Resolve Election or Waive of Title  within 2 years
• File Patent  within 1 yr. of election
• Provide License to the Govt.  upon title election
• Indicate Govt. Support on Patent  with patent appl.
• Product Manufacturing in U.S.  required
• Report on Invention Utilization  annually
• Final Invention Report  at award close out
• Government Use License
• March-In Rights (35 U.S.C. § 203)
o Compare to Non-Federally Funded Patents under
28 USC § 1498
• U.S. Manufacturing Requirement
• Approval of Assignments by Nonprofit Organizations
• Subawardee’s Bayh-Dole rights
With respect to any invention in which the contractor elects
rights, the Federal agency shall have a nonexclusive,
nontransferrable, irrevocable, paid-up license to practice or
have practiced for or on behalf of the United States any subject
invention throughout the world.
35 U.S.C. § 202 (c)(4)
The Federal funding agency shall have the right…to
require the contractor, an assignee or exclusive
licensee of a subject invention to grant a nonexclusive,
partially exclusive, or exclusive license in any field of
use to a responsible applicant or applicants, upon
terms that are reasonable under the circumstances, and
if the contractor, assignee, or exclusive licensee
refuses such request, to grant such a license itself.
35 U.S.C. § 203(a)
No.
o CellPro, Inc. (1997)
o
o
o
o
• http://www.nih.gov/icd/od/foia/cellpro/
Norvir (2004) Abbott Laboratories, Inc.
• http://www.ott.nih.gov/policy/March-InNorvir.pdf
Xalatan (2004) Pfizer, inc.
• http://www.ott.nih.gov/policy/March-InXalatan.pdf
Fabrazyme (2010) Genzyme
• (http://www.ott.nih.gov/policy/March-inFabrazyme.pdf)
Norvir (2012) See above
(a) Whenever an invention described in and covered
by a patent of the United States is used or
manufactured by or for the United States without
license of the owner thereof or lawful right to use or
manufacture the same, the owner's remedy shall be by
action against the United States in the United States
Court of Federal Claims for the recovery of his
reasonable and entire compensation for such use and
manufacture.” (28 U.S.C. § 1498(a))
• 28 U.S.C. § 1498 was reportedly part of the
discussions the Government had with Bayer regarding
CIPRO supplies after the anthrax situation
• Authorization and Consent
o FAR 52.227-1
• No licensee shall be granted the exclusive right to use or
sell any subject invention in the United States unless such
person agrees that any products embodying the subject
invention or produced through the use of the subject
invention will be manufactured substantially in the United
States.
• This requirement may be waived by agency upon showing
that reasonable but unsuccessful efforts have been made to
grant licenses on similar terms to potential licensees that
would be likely to manufacture substantially in the United
States or that under the circumstances domestic
manufacture is not commercially feasible.
• 35 U.S.C. § 204
• For NIH, see https://sedison.info.nih.gov/iEdison/ManufacturingWaiver.jsp
• Approval of the Federal Agency required for assignments
by “Nonprofit Organizations” which includes
universities under an STTR
• Exception “where such assignment is made to an
organization which has as one of its primary functions
the management of inventions (provided that such
assignee shall be subject to the same provisions as the
contractor).” 35 U.S.C. § 202 (c)(7)(A)
o Nonprofits would retain a reversion of rights if the
subject invention is no longer pursued by the
management organization
• “The subcontractor will retain all rights provided for
the contractor in this clause, and the contractor will
not, as part of the consideration for awarding the
subcontract, obtain rights in the subcontractor's subject
inventions. ” 37 CFR § 401.14 (g)(1)
• Share NIH-funded data and other research resources to
advance research for benefits to the public and public health
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NIH Data and Resource Sharing Plans
Giving unto others as you would have them….
Non-Sharing:
- Duplicative funding to recreate same data/resources
Less funding for other original research
Revalidate new resources, slows research
- Block/Impede research (e.g., patent suits against researchers)
People block research when using patents inappropriately
Sharing:
- Helps research dollars go further
- Allows more funding to go to more original research
- Promotes faster research advances (no need to recreate resources) and
comparable research results
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- Provides synergies-Whole is greater than sum of its parts
• NIH Sharing Policies and Related Guidance on NIH-Funded
Research Resources (http://sharing.nih.gov)
It is NIH policy that the results and accomplishments of the
activities that it funds should be made available to the
public. PIs and funding recipient institutions are expected to
make the results and accomplishments of their activities
available to the research community and to the public at large.
Some researchers have incorrectly said sharing of NIH-funded
resources didn’t apply until after 1999....
NIH mission to improve
public health through
research and its
longstanding legislative
mandate to make available
to the public the results of
the research activities that it
supports and conducts….
• NIH Grants Policy Statement (Availability of Research Results)
(10/2011) - Section of the NIH Grants Policy Statement
discussing the availability of research results developed with
NIH funding, including publications, data, unique research
resources, and intellectual property (inventions and patents).
• Developing Sponsored Research Agreements (Considerations for
Recipients of NIH Research Grants and Contracts) (11/1994) Issues and points to consider in developing sponsored research
agreements with commercial entities, where such agreements
may include research activities which are fully or partially
funded by NIH, in order to assist funding recipients ensure such
agreements comply with the requirements of the Bayh-Dole Act
and NIH funding agreements while upholding basic principles of
academic freedom.
• Biological Materials Policy (NIH Procedures for Handling NonElection of Title to Patentable Biological Materials) (05/1996) NIH policy for allowing NIH funding recipients to retain and
license biological materials for which patent protection might
not be pursued.
• NIH Research Tools Policy (Principles and Guidelines for
Recipients of NIH Research Grants and Contracts on Obtaining
and Disseminating Biomedical Research Resources) (12/1999) Policy designed to provide NIH funding recipients with guidance
concerning appropriate terms for disseminating and acquiring
unique research resources developed with federal funds, and
intended to assist recipients in complying with their obligations
under the Bayh-Dole Act and NIH funding policy.
• NIH Data Sharing Policy (Final NIH Statement on Sharing
Research Data) (02/2003) - Policy concerning the sharing of
research data for funding applications seeking $500,000 or more
in direct costs in any year of the project period (e.g., expects a
sharing plan)
• NIH Model Organism Sharing Policy (NIH Policy on Sharing of
Model Organisms for Biomedical Research) (05/2004) - Policy
concerning the sharing and distributing of model organisms and
related research resources generated using NIH funding (e.g.,
expects a sharing plan).
• NIH Public Access Policy (02/2005) - Policy on Enhancing Public
Access to Archived Publications Resulting from NIH-Funded
Research.
• NIH Genome-Wide Association Studies (GWAS) Policy (Policy
for Sharing of Data Obtained in NIH Supported or Conducted
Genome-Wide Association Studies (GWAS)) (08/2007) - Policy
concerning sharing of GWAS data obtained in NIH supported
or conducted research.
• White House Office of Science and Technology Policy (OSTP)
Memorandum for Increasing Access to the Results of Federally
Funded Scientific Research (February 22 2013) – OSTP directs each
Federal agency with over $100 million in annual conduct of research
and development expenditures to develop a plan to support increased
public access to the results (peer-reviewed publications and digital
data) of research funded by the Federal Government.
http://www.whitehouse.gov/sites/default/files/microsites/ostp/ostp_publi
c_access_memo_2013.pdf
• *Draft NIH Genomic Data Sharing Policy (GDS Policy)
(Published for 60-day Comment 09/2013) – Proposed policy
promotes sharing, for research purposes, of large scale human
and nonhuman genomic data generated from NIH-supported
and NIH-conducted research. http://gds.nih.gov/
• Who owns what?
o Grants, cooperative agreements, and contracts are generally awarded to
institutions so institutions are responsible for compliance, but PI and other
researchers also need to follow institution’s requirements
o Bayh-Dole Act – Grantee institutions generally have the right to elect
title/own subject inventions developed under their NIH funding (but must
provide Government Confirmatory License)
• Applies to inventions
o If patenting is sought, it should be done appropriately without impeding or
“unduly encumbering future research and discovery”
o Data is generally owned by the funded institution
• Sharing certain data may not be possible under limited circumstances, such as,
for issues of informed consent, human subjects.
• NIH funding must meet its mission and program goals (e.g., how to justify
creating a data dissemination center that won’t share data?)
• See NIH Sharing Policy webpage at http://sharing.nih.gov or Email
at Sharing@nih.gov (Examples of sharing plans (e.g., Data, Model
Organisms) help program and funding applicants review/match
acceptable plans)
• Key Elements to Consider in Preparing a Data Sharing Plan under
NIH Extramural Support (12/2009) – This resource document is
designed to assist the NIH extramural applicant community in
preparing data sharing plans by identifying key elements that should
be addressed in the plan.
• Example Plan addressing Key Elements for a Data Sharing Plan
under NIH Extramural Support (08/2010) - This resource document
is designed to assist the NIH extramural applicant community in
preparing data sharing plans by providing an example that shows
how a sharing plan addresses the key elements for a data sharing
plan. Easy to follow in order.
• We know the Why, but Who, What, Where, When, and How?
o What data will be shared?
o Who will have access to the data?
o Where will the data to be shared be located?
o When will the data be shared?
o How will researchers locate and access the data?
• Sharing is global, e.g., Wellcome Trust and NIH consistent
o http://www.wellcome.ac.uk/About-us/Policy/Policy-and-positionstatements/WTX035043.htm
o Outputs of the funded research should maximise public benefit
o Make research data timely and widely available to the research community
o Share in responsible manner ensuring data can be verified, built upon, and
used to advance knowledge and its application to generate improvements in
health
o Researchers should be credited for discoveries and be able to publish first
• Stanford v. Roche U.S. Supreme Court Case - To assign or not
assign, that is the question – June 6, 2011 Decision
o Holodniy: “will assign” any future inventions to Stanford vs.
“hereby assign” future inventions to Cetus.
o Roche cited MIT as an example of the “hereby assign” language in
its argument
o 37 CFR 401.14(a)(f)(2): “contractor agrees to require, by written
agreement, its employees,” to promptly disclose each subject
invention to contractor’s patent personnel AND “to execute all
papers necessary to file patent applications on subject inventions
and to establish the government’s rights in the subject inventions.”
“The contractor shall instruct such employees through employee
agreements or other suitable educational programs on the
importance of reporting inventions in sufficient time to permit the
filing of patent applications prior to U.S. or foreign statutory bars.”
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• Leahy-Smith America Invents Act (AIA) – And unto US a new
law was signed (September 16, 2011)
• http://www.whitehouse.gov/blog/2011/09/16/america-invents-actturning-ideas-jobs
• Selected Highlights:
o "First to file" system – On or after March 16, 2013
o One year grace period for own publication, but not for public
disclosures by others
o Eliminates interference proceedings, but derivation proceedings
continue (ensure the first to file is actually an original inventor
and the application was not derived from another inventor)
o Post-grant opposition
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o Possible implications to timing of reporting requirements
For any questions on extramural invention reporting, data and resource sharing,
or other related extramural intellectual property policy issues:
Contact Information:
J.P. Kim, J.D., M.B.A., M.P.P., M.Sc., M.A.L.S., Director & Policy Officer,
Email: jpkim@nih.gov; Telephone: (301) 435-0679
Division of Extramural Inventions & Technology Resources (DEITR),
Office of Policy for Extramural Research Administration (OPERA),
Office of Extramural Research (OER), Office of the Director (OD),
National Institutes of Health (NIH), HHS
6705 Rockledge Drive, Suite 310
Bethesda, Maryland 20817
Websites: http://sharing.nih.gov; http://iEdison.gov; http://inventions.nih.gov
Email: Sharing@nih.gov; Edison@nih.gov; Inventions@nih.gov
DEITR Telephone & iEdison HelpDesk: (301) 435-1986
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