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2014 NIH Regional Seminar on Program Funding and Grants Administration, Baltimore, Maryland June 2014 Presented By: J.P. Kim, J.D., M.B.A., M.P.P., M.Sc.,

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Presentation on theme: "2014 NIH Regional Seminar on Program Funding and Grants Administration, Baltimore, Maryland June 2014 Presented By: J.P. Kim, J.D., M.B.A., M.P.P., M.Sc.,"— Presentation transcript:

1 2014 NIH Regional Seminar on Program Funding and Grants Administration, Baltimore, Maryland June 2014 Presented By: J.P. Kim, J.D., M.B.A., M.P.P., M.Sc., M.A.L.S. ( Director & Policy Officer, Division of Extramural Inventions & Technology Resources (DEITR), Office of Policy for Extramural Grants Administration (OPERA), OER

2 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…. 2

3 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 “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 3

4 How to safeguard intellectual property rights to discoveries and inventions made with NIH funds 4

5 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

6 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

7 Patents - embodiments of new and useful ideas (utility patents), designs, and plants o 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

8 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

9 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

10 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

11 Can be any new and useful: o Processes (process, act or method, and primarily includes industrial or technical processes); o Machines; o Articles that are Manufactured; o Compositions of matter; or o Any new and useful improvement thereof

12 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)

13 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

14 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)

15 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.

16 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

17 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 # Predisclosure Notification Procedures for Confidential Commercial Information

18 Contractor may establish claim to copyright subsisting in any data first produced in the performance of the contract (FAR (c)) Databases as compilations may be copyrightable, there is no copyright protection for the underlying data SBIR Data Rights: “SBIR Rights Notice” (FAR (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

19 Federal Funding Agreements Selected Definitions Recipient Rights & Responsibilities Government Rights

20 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.

21 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 et seq.).” 35 U.S.C. § 201(d)

22 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.

23 Recipient owns Rights in discoveries by having appropriate assignments in place and timely electing title to subject inventions

24 Recipient has Responsibilities to meet reporting requirements o Extramural Invention Reporting Compliance Responsibilities https://s- edison.info.nih.gov/iEdison/timeline.jsp https://s- edison.info.nih.gov/iEdison/timeline.jsp

25 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

26 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

27 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)

28 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)

29 No. o CellPro, Inc. (1997) o Norvir (2004) Abbott Laboratories, Inc. Norvir.pdf Norvir.pdf o Xalatan (2004) Pfizer, inc. Xalatan.pdf Xalatan.pdf o Fabrazyme (2010) Genzyme (http://www.ott.nih.gov/policy/March-in- Fabrazyme.pdf)http://www.ott.nih.gov/policy/March-in- Fabrazyme.pdf o Norvir (2012) See above

30 (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))

31 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

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

33 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

34 “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 § (g)(1)

35 Share NIH-funded data and other research resources to advance research for benefits to the public and public health 35

36 36 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 - Provides synergies-Whole is greater than sum of its parts

37 NIH Sharing Policies and Related Guidance on NIH-Funded Research Resources (http://sharing.nih.gov)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

38 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….

39 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). NIH Grants Policy Statement (Availability of Research Results) 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. Developing Sponsored Research Agreements (Considerations for Recipients of NIH Research Grants and Contracts)

40 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. Biological Materials Policy (NIH Procedures for Handling Non- Election of Title to Patentable Biological Materials) 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 Research Tools Policy (Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources)

41 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 Data Sharing Policy (Final NIH Statement on Sharing Research Data) 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 Model Organism Sharing Policy (NIH Policy on Sharing of Model Organisms for Biomedical Research)

42 NIH Public Access Policy (02/2005) - Policy on Enhancing Public Access to Archived Publications Resulting from NIH-Funded Research. NIH Public Access Policy 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. NIH Genome-Wide Association Studies (GWAS) Policy (Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS))

43 White House Office of Science and Technology Policy (OSTP) Memorandum for Increasing Access to the Results of Federally Funded Scientific Research (February ) – 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. c_access_memo_2013.pdf White House Office of Science and Technology Policy (OSTP) Memorandum for Increasing Access to the Results of Federally Funded Scientific Research 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. *Draft NIH Genomic Data Sharing Policy (GDS Policy)http://gds.nih.gov/

44 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?)

45 See NIH Sharing Policy webpage at or at (Examples of sharing plans (e.g., Data, Model Organisms) help program and funding applicants review/match acceptable 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. Key Elements to Consider in Preparing a Data Sharing Plan under NIH Extramural Support 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. Example Plan addressing Key Elements for a Data Sharing Plan under NIH Extramural Support

46 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 statements/WTX htm statements/WTX 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

47 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 (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.” 47

48 Leahy-Smith America Invents Act (AIA) – And unto US a new law was signed (September 16, 2011) turning-ideas-jobs turning-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 o Possible implications to timing of reporting requirements 48

49 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, Telephone: (301) 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 Websites: DEITR Telephone & iEdison HelpDesk: (301)


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