Transcript • Where to get information to be able to appropriately manage data, inventions, publications, and other resources developed with NIH funding. • Why.

• Where to get information to be able to appropriately manage data,
inventions, publications, and other resources developed with NIH
funding.
• Why and how to safeguard intellectual property rights to
discoveries and inventions made with NIH funds.
• NIH Licensing Principles.
• Grantee’s rights and obligations in inventions made with NIH
funding.
• When and how to report inventions to NIH.
• How to work towards sharing NIH-funded data and other research
resources to advance research for benefits to the public and public
health.
• The balance between protection of inventions and data sharing.
• Discussion of your questions and examples……
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• Where to get information to be able to appropriately
manage data, inventions, publications, and other
resources developed with NIH funding
o NIH Grants Policy Statement (GPS) – 3/31/2015
(http://grants.nih.gov/grants/policy/policy.htm)
o Notice of Award (e.g., terms and conditions of award)
o NIH GrantsInfo ([email protected])
• “Grantee” is the funded entity and is responsible for
the terms and conditions of an NIH funding award.
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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What is Technology Transfer?
What is Intellectual Property?
The why and how of protecting Intellectual Property
Patents & Copyrights Generally
The Bayh-Dole Act: Government and Recipient
Rights & Responsibilities
• Licensing Principles
• Data Sharing
• Special Considerations
What Does This Mean?
* Movement of information,
materials, and technologies from the
research laboratories to the
commercial enterprise *
* To support further research and
develop new products to improve
public health *
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Research
Data
Publications
Inventions &
Patents
Marketing &
Licensing
Invention
Evaluation
Technology
Transfer
Policies
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• Utilize IP appropriately as
incentive for commercial
development of technologies
• Attract new R&D resources
• Obtain return on public investment
• Stimulate economic development
• Benefit the public health
• Financial return to owner and inventors
• Can have academic rewards/promotions/tenure
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Clinical Trial
Agreements
Material
Transfer
Agreements
Cooperative
Agreements
Technology
Transfer
Employee
Invention
Reports
Sponsored
Programs
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To seek fundamental knowledge about the nature and
behavior of living systems and the application of that
knowledge to:
Enhance
health
Reduce
illness
Lengthen
life
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• Intellectual Property =
o Creations of the mind.
o Protected by laws:
• patent, trademark, unfair competition,
copyright, trade secret, the right of
publicity, and plant variety protection
o IP system aims to foster an environment in which
creativity and innovation is created, supported,
developed, protected, all with benefits to the public.
o Enables creator(s) to earn recognition or financial
benefit from what they invent or create.
• Patents – protects inventions = a discovery a finding
o Invention must be:
• Novel - - new – not known before; not a product
of nature
• Useful – has utility, specific and credible.
• Non-obviousness – was not obvious to a person
having ordinary skill in the area of the invention.
o Types of patents: utility, design, plants
o http://www.uspto.gov
• Copyrights – protects original works of authorship
(including literary, dramatic, musical, artistic, and
certain other intellectual works (including software)
o Needs to be fixed in a tangible form of expression –
thoughts are not eligible for copyright protection
o http://www.copyright.gov
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• Patent Protection:
o
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 Protection:
o
the right to (and permit others): 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
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
• Can be anything new and useful:
o Processes (process, act or method, and primarily includes
o
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o
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industrial or technical processes);
Machines;
Articles that are Manufacture;
Compositions of matter; or
Any new and useful improvement of the above (derivative)
• Copyright = putting in a tangible form.
• Protection occurs as soon as it is in a tangible form.
• Tangible form:
o Writing
o Software – on a disc
o Design
o Picture – on canvas
o Etc.
• Speech, spontaneous music (vs written music)
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• Not an idea or suggestion
• Extensive data is not necessarily required
• A patent application with descriptive claims
describing the metes and bounds of the invention to
be protected
• Usually diagrams
• Additional supporting data can be submitted later
during patent prosecution
• Usual length of patent prosecution = 3 years; $4050K+
• 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
• Applies to most federal funding agreements
• Sets forth rights and responsibilities of
grantee/contactor and Government for:
o Inventions and discoveries made in whole or in part with
federal funding.
• The Bayh-Dole Act (1980) – few changes since 1980
Policy & Objective (35 U.S.C. 200):
o Use the patent system to promote the utilization of
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o
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inventions arising from federally supported research or
development;
Encourage participation of small businesses;
Promote collaboration between commercial concerns and
nonprofit organizations;
Ensure inventions are used in a manner to promote free
competition and enterprise without unduly encumbering
future research and discovery;
Promote the commercialization and public availability of
inventions made with federal support; and
Ensure that the Government obtains sufficient rights in
federally supported inventions.
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 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 has Responsibilities in order to retain their
right to elect title and keep title:
o Extramural Invention Reporting Compliance
Responsibilities
• https://edison.info.nih.gov/iEdison/timeline.jsp
• Electronic Data base used by 25+ federal agencies to
enable grantees/contractors to report their federally
funded discoveries/inventions.
• Information submitted is confidential under statute.
• Information provided by grantees/contractors:
o Technical information on inventions
o Identifies legal protection is timely and properly obtained.
o Monitors regulatory compliance
o Reminder messages for required reports
o NIH – annual commercialization reports
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At the End (but starts in the middle)
- Always Post Award
- Registrant has Award No.
- Direct or Indirect Party to Award or Assignee
(usually Inventor) thereof
Done
Using
Edison
Awards research funds
Funds researcher
Discovers Invention
• 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
For 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. But has considered:
o CellPro, Inc. (1997)
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o
o
o
• http://www.nih.gov/icd/od/foia/cellpro/
Norvir (2004) Abbott Laboratories, Inc.
• http://www.ott.nih.gov/policy/March-In-Norvir.pdf
Xalatan (2004) Pfizer, inc.
• http://www.ott.nih.gov/policy/March-In-Xalatan.pdf
Fabrazyme (2010) Genzyme
• (http://www.ott.nih.gov/policy/March-in-Fabrazyme.pdf)
Norvir (2012) See above
• 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)
• “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)
Humanitarian
Objectives
Economic
Development
and Political
Stability
Globalization of
Health Problems
and Their
Relevance to
Domestic Health
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Granting only the appropriate scope of rights
Permit research uses
Preference for non- or partial exclusivity
Specified fields of use
Enforceable milestones and benchmarks
Maximize development of products for the public health
Ensure appropriate return on public investment
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• Association of American Universities (AAU) & Association of
Public & Land-grant Universities (APLU) – March 27, 2015
Recommended Principles for University TT Policy:
(http://www.aplu.org/news-and-media/News/aau-aplu-committeesrecommend-principles--for-university-technology-transfer-policy)
• AAU: “The system of public-private technology transfer that was
established under the Bayh-Dole Act has been extraordinarily
successful in moving university discoveries from research
laboratories to the marketplace.”
• AAU: “Technology transfer has provided a rich return on public
funding for basic research in the form of countless innovative
products that benefit consumers, create jobs, and contribute to
U.S. economic competitiveness and technological leadership
internationally.”
o #1: The Primary focus of university technology transfer efforts
should be to advance the public interest and public good.
• A clear mission or purpose statement should be developed by
universities.
• National Research Council’s 2010 report “Managing University
Intellectual Property in the Public Interest” – 1st recommendation
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• #1: The Primary focus of university technology
transfer efforts should be to advance the public
interest and public good.
• A clear mission or purpose statement should be
developed by universities.
• National Research CouNcil’s 2010 report “Managing
University Intellectual Property in the Public Interest” –
1st recommendation.
• #2: Universities should have high-level policies in
place to ensure that intellectual property
management and technology transfer practices align
with both the public interest and their core research,
education and service missions.
o TT practices must not conflict with these missions.
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• #3: Universities should not deal with patent trolls.
o Patent Trolls = entities that license but do not develop IP or
commercial products and often sue for infringement of a
patent.
• #4: Technology transfer operations should be
evaluated and assessed by several means, not
solely or even primarily revenue generation.
o Revenue generation: positive outcome to provide
resources for further research
o Primary goal should be the transfer of knowledge
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• #5: It is critical for universities to share best
practices for managing intellectual property and
improving technology transfer operations in ways
that serve the public interest.
o Effective practices especially those that ensure the quick
movement of new ideas and technologies generated with
federal support from the laboratory to the marketplace.
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• Exclusive Patent
Commercialization
• Commercial Evaluation
License
• Non-exclusive Patent
Commercialization
• Biological Material
Commercialization
• Non-exclusive Patent
Internal Use
• Biological Material
Internal Use
• Start-Up Exclusive
Evaluation Option
• Interference or Dispute
Settlement
• Start-Up Exclusive Patent
Commercialization
• Inter-institutional
NIH Office of Technology Transfer
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• 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 52.22720(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
• Share NIH-funded data and other research resources to
advance research for benefits to the public and public
health
• Rights in data made/developed with NIH funds extends
to:
o
o
o
o
o
Students
Fellows
Trainees
Researchers
Public
• In all cases, NIH is granted a royalty-free, non-exclusive
and irrevocable license for the Federal Government to
reproduce, publish, or otherwise use the material and to
authorize others to do so for Federal purposes.
• Data developed by a consortium participant is also
subject to NIH’s data sharing requirements/policy.
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NIH Data and Resource Sharing Plans and Expectations:
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
- Provides synergies-Whole is greater than sum of its parts
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• NIH Sharing Policies and Related Guidance on NIHFunded Research Resources (http://sharing.nih.gov)
• Data sharing essential for expedited translation of
research results into knowledge, products, and
procedures to improve human health.
• NIH policy: (Grants Policy Statement: 8.2 –
Availability of Research Results, Intellectual
Property Rights, & Sharing Research Resources)
o Results and accomplishments of the activities that it funds
should be made available to the public.
o 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.
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• NIH Grants Policy Statement (Availability of Research Results)
o (03/2015) - 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)
o Issues and points to consider in developing sponsored
research agreements with commercial entities
o Fully or partially funded by NIH
o 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
Non-Election 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., a data
sharing plan required)
• 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; GPS 8.2.2) Policy on Enhancing Public Access to published
results of NIH-Funded Research.
o Policy ensures the public has access to the published
results of NIH funded research at:
o Requires electronic submission of peer-review publication
no later than 12 months from official date of publication to
NIH on NIH “Pub Med Central”
http://www.pubmedcentral.nih.gov
o Requires submission no later than 12 months after the
official date of publication of author’s final peer-reviewed
manuscript
o http://publicaccess.nih.gov
• 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; GPS 8.2.3.3)
o Policy sets forth expectations that ensure the broad and
responsible sharing of genomic research data.
o Applies to all NIH-funded research that generates largescale human or non-human genomic data, as well as the
use of these data for subsequent research.
o Supplemental Information:
http://gds.nih.gov/pdf/supplemental_info_GDS_policy.pfd
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• See NIH Sharing Policy webpage at http://sharing.nih.gov or Email
at [email protected] (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.
• 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/o
stp_public_access_memo_2013.pdf
• 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 NIHconducted research. http://gds.nih.gov/
• Patent Reform Bills Pending:
o The Innovation Act (H.R.9)
• “Bill to address the ever increasing problem of abusive
patent litigation.”
o The Strong Patents Act (S. 632)
• “Bill to strengthen America’s patent system and target
abusers.”
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• United States Patent & Trademark Office (USPTO)
o Implementing Executive Actions to Improve Patent System”
• Focus on making information ,ore accessible to the
public, generating ideas through crowdsourcing,
assisting under-resourced inventors, and offering more
robust technical training to patent examiners.
o USPTO “Patents for Humanity Competition”
• Intended to promote game-changing innovations to
solve long-standing development challenges
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For any questions on extramural invention reporting,
data and resource sharing, or other related
extramural intellectual property policy issues:
Contact Information:
Ann M. Hammersla, J.D. , Director & Policy Officer,
Email: [email protected]; Telephone: (301)
451-4235
Websites: http://sharing.nih.gov; http://iEdison.gov;
http://inventions.nih.gov
Email: [email protected]; [email protected];
[email protected]
DEITR Telephone & iEdison HelpDesk: (301) 435-1986
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