Inventions, Data Sharing, Reports to NIH, and other Intellectual

Property Considerations

2015 NIH Regional Seminar on Program Funding and Grants Administration October 2015

Presented By:

Ann M. Hammersla, J.D., Director & Policy Officer

Division of Extramural Inventions & Technology Resources (DEITR),

Office of Policy for Extramural Grants Administration (OPERA), OER

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Objectives

• 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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Resources….

• 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 (GrantsInfo@nih.gov)

• “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 Institutiono Funded Institution is responsible for compliance with the

laws, regulations, policies, and other rules under the award

• 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

Intellectual Property

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Technology Transfer

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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Technology Transfer

Technology

TransferInvention Evaluation

Marketing &

Licensing

Data

Research

Publications

Inventions & Patents

Policies

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Technology Transfer Goals

• 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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Examples of Technology Transfer Agreements

Technology

Transfer

Clinical Trial

Agreements

Cooperative

Agreements

Sponsored

Programs

Employee Invention Reports

Material Transfer Agreeme

nts

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NIH Mission

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

• 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.

What is Intellectual Property?

• 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, plantso http://www.uspto.gov

Patents & Copyrights- What They Protect?

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Patents and Copyrights

• 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

• 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 & Copyrights-Rights

• Patents – 20 years from earliest filing claimedo 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 creationo For Pre-1978 creations, up to 95 years

Patents & Copyrights-Terms

• Can be anything new and useful:

o Processes (process, act or method, and primarily includes industrial or technical processes);

o Machines;o Articles that are Manufacture;o Compositions of matter; oro Any new and useful improvement of the above (derivative)

Patents-What is Patentable?

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What is copyrightable? And When?

• Copyright = putting in a tangible form.• Protection occurs as soon as it is in a tangible form.• Tangible form:

o Writingo Software – on a disco Designo Picture – on canvaso Etc.

• Speech, spontaneous music (vs written music)

• 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; $40-50K+

Patents-Utility Application

• 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)

Patents: Losing Rights through Public Disclosure

• 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.

Patents: Protecting Rights from Public Disclosure

• 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

Patents: Protecting Rights from Public Disclosure

• 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

Freedom Of Information Act (FOIA) - Safeguarding Grant Application Information &

Invention Disclosures

• 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

Bayh-Dole Act

Policy & Objective (35 U.S.C. 200):o Use the patent system to promote the utilization of inventions

arising from federally supported research or development;o Encourage participation of small businesses;o Promote collaboration between commercial concerns and

nonprofit organizations;o Ensure inventions are used in a manner to promote free

competition and enterprise without unduly encumbering future research and discovery;

o Promote the commercialization and public availability of inventions made with federal support; and

o Ensure that the Government obtains sufficient rights in federally supported inventions.

Bayh-Dole Act:Federal Funding Agreements

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)

Bayh-Dole Act:Selected Definitions

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.

Bayh-Dole Act:Selected Definitions

• 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

Bayh-Dole Act:Recipient Rights & Responsibilities

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What is iEdison?

• 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 inventionso Identifies legal protection is timely and properly obtained.o Monitors regulatory complianceo Reminder messages for required reportso NIH – annual commercialization reports

Where does Edison fit in the Award Process?

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

Post-AwardPerform

Research WorkCloseout

Make / License Discoveries

HHS-568

Report using Edison

Recipient Process

NIH

Recipient

Employee Inventor

Submits EIR

Awards research funds

Funds researcher

Discovers Invention

Office of Technology Licensing Initial

report to NIH

Report commercialization

and licensing

Done Using Edison

Decide to pursue protection or commercial

development or not for EIR

Report patent/pvp

progress – keep NIH up-to-date

Report FDA approvals and royalty/other

income

• 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

Invention Reporting Requirements of NIH Grantees and Contractors

• 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

Bayh-Dole Act:Government 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)

Bayh-Dole Act:Government Use License

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)

Bayh-Dole Act:March-In Rights

No. But has considered:o CellPro, Inc. (1997)

• http://www.nih.gov/icd/od/foia/cellpro/o Norvir (2004) Abbott Laboratories, Inc.

• http://www.ott.nih.gov/policy/March-In-Norvir.pdfo Xalatan (2004) Pfizer, inc.

• http://www.ott.nih.gov/policy/March-In-Xalatan.pdfo Fabrazyme (2010) Genzyme

• (http://www.ott.nih.gov/policy/March-in-Fabrazyme.pdf)o Norvir (2012) See above

Bayh-Dole Act: Has NIH ever exercised March-In Rights

• 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://s-edison.info.nih.gov/iEdison/ManufacturingWaiver.jsp

Bayh-Dole Act:U.S. Manufacturing Requirement

• 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)

Bayh-Dole Act: Requires Approval of Nonprofit’ Assignments

• “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)

Bayh-Dole Act: Subawardee’s Has Bayh-Dole Rights

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Globalization of Health Problems and Their Relevance to Domestic Health

Global Health Research, Technology Transfer & Licensing

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Licensing Principles

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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AAU & APLA Licensing Principles

• 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-committees-recommend-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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AAU & APLA Licensing Principles – cont.

• #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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AAU & APLA Licensing Principles – cont.

• #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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AAU & APLA Licensing Principles – cont.

• #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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License Types

• Exclusive Patent Commercialization

• Non-exclusive Patent Commercialization

• Non-exclusive Patent Internal Use

• Start-Up Exclusive Evaluation Option

• Start-Up Exclusive Patent Commercialization

• Commercial Evaluation License

• Biological Material Commercialization

• Biological Material Internal Use

• Interference or Dispute Settlement

• Inter-institutional

NIH Office of Technology Transfer

• 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 consento Use is for Government purposes onlyo 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

Select Data and Copyright Issues

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Sharing NIH-Funded Resources

• 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 Studentso Fellowso Trainees o Researcherso 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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How Sharing Affects Your Funding

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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Availability of Research Results

• NIH Sharing Policies and Related Guidance on NIH-Funded 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.

Sharing & Use & Distribution Highlighting Select NIH Sharing Policies

• 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 NIHo 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.

Highlighting Select NIH Sharing Policies

• 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).

Highlighting Select NIH Sharing Policies

• 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

Highlighting Select NIH Sharing Policies

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Highlighting Select NIH Sharing Policies – cont.

• 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 large-scale 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

Tools for NIH Sharing

• 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.

• 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_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 NIH-conducted research. http://gds.nih.gov/

Highlighting Select New Developments

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Additional Developments/Information

• 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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Additional evelopments/Information – cont.

• 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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- Thank You

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: hammerslaa@od.nih.gov; Telephone: (301) 451-4235

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

NIH… Turning Discovery Into Health

WE VALUE YOUR INPUT!

2015 NIH REGIONAL SEMINAR

Session Evaluations: http://surveymonkey.com/s/nihsessions

Overall Evaluations: http://surveymonkey.com/s/nihoverall

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