1. © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

2. © National Council of University Research Administrators GOALS OF IP PRIMER Knowing where to begin. When to ask questions. What to ask. Knowing where to begin. When to ask questions. What to ask.

3. © National Council of University Research Administrators GOALS OF IP PRIMER contd. To whom do you ask your questions? Understanding when IP rights conflict. To whom do you ask your questions? Understanding when IP rights conflict.

4. © National Council of University Research Administrators GOALS OF IP PRIMER contd. To know what information is needed to discuss and negotiate intellectual property clauses in a research agreement.

5. © National Council of University Research Administrators DISCUSSION TOPICS What is intellectual property? What is a patent? What is intellectual property? What is a patent?

6. © National Council of University Research Administrators DISCUSSION TOPICS What are the US federal government rights in patents and copyright?

7. © National Council of University Research Administrators DISCUSSION TOPICS contd. What is a copyright? What is data and how is it handled under federal grants and contracts? What is a copyright? What is data and how is it handled under federal grants and contracts?

8. © National Council of University Research Administrators DISCUSSION TOPICS contd. What are material transfer agreements and how is the intellectual property handled?

9. © National Council of University Research Administrators DISCUSSION TOPICS contd. Are there any issues when the intellectual property is developed in a building that has been financed with bonds?

10. © National Council of University Research Administrators N & M CASE STUDY Context for N&M research agreement. –Reality –Not unusual Context for N&M research agreement. –Reality –Not unusual

11. © National Council of University Research Administrators N & M CASE STUDY Where do you begin?

12. © National Council of University Research Administrators CHECKLIST First – Understand what research is being done. Second – Understand what the goals of the research are. First – Understand what research is being done. Second – Understand what the goals of the research are.

13. © National Council of University Research Administrators CHECKLIST contd. Read contract a minimum of 2-3 times BEFORE reacting. Each paragraph or section of a contract is NOT independent of each other. Read contract a minimum of 2-3 times BEFORE reacting. Each paragraph or section of a contract is NOT independent of each other.

14. © National Council of University Research Administrators CHECKLIST contd. Assume you are the PI when reading the contract/IP terms – what are the restrictions and responsibilities.

15. © National Council of University Research Administrators CHECKLIST contd. Know and understand your university policies and how much flexibility you have. Communication – aka the “wedge effect” Know and understand your university policies and how much flexibility you have. Communication – aka the “wedge effect”

16. © National Council of University Research Administrators WHERE DO YOU FIND IP CLAUSES? Everywhere Intellectual Property clauses Publication Everywhere Intellectual Property clauses Publication

17. © National Council of University Research Administrators WHERE DO YOU FIND IP CLAUSES? contd. Everywhere Royalty clause Whereas clauses Everywhere Royalty clause Whereas clauses

18. © National Council of University Research Administrators WHERE DO YOU FIND IP CLAUSES? contd. Everywhere Patent Prosecution Confidentiality/non-disclosure Everywhere Patent Prosecution Confidentiality/non-disclosure

19. © National Council of University Research Administrators WHERE DO YOU FIND IP CLAUSES? contd. Statement of Work Licenses Definition section Statement of Work Licenses Definition section

20. © National Council of University Research Administrators WHERE DO YOU FIND IP CLAUSES? contd. Payment clauses Indemnification Background and future rights Payment clauses Indemnification Background and future rights

21. © National Council of University Research Administrators CASE STUDY Discussion

22. © National Council of University Research Administrators SECTION II INTRODUCTION TO INTELLECTUAL PROPERTY CONCEPTS

23. © National Council of University Research Administrators WHAT IS IP? Ideas, inventions, processes, works of authorship, which are protectable under patent, copyright, trademark or trade secret law

24. © National Council of University Research Administrators WHAT IS IP? contd. Owners, holders and assignees of intellectual property (IP) rights are protected by law against unauthorized use by another party

25. © National Council of University Research Administrators WHY DO WE CARE ABOUT IP? Cornerstone of academic culture Dissemination of information and sharing of technology is critical to the university mission Cornerstone of academic culture Dissemination of information and sharing of technology is critical to the university mission

26. © National Council of University Research Administrators WHY DO WE CARE ABOUT IP? contd. Revenue to investigators/faculty and to University programs Legal and regulatory obligations to sponsors Revenue to investigators/faculty and to University programs Legal and regulatory obligations to sponsors

27. © National Council of University Research Administrators WHAT IS A LICENSE? "A legal agreement or contract that permits one party to use intellectual property belonging to another under mutually agreed upon terms.“

28. © National Council of University Research Administrators WHAT IS A LICENSE? Grant of a right to use

29. © National Council of University Research Administrators WHAT IS A ROYALTY? "The consideration or compensation paid to the licensor in exchange for certain rights in the technology that the licensor is providing to the licensee"

30. © National Council of University Research Administrators WHAT IS A ROYALTY? Royalty-free vs. royalty-bearing

31. © National Council of University Research Administrators ACADEMIC PRIORITIES Education Research Service Education Research Service

32. © National Council of University Research Administrators ACADEMIC PRIORITIES contd. Promote the public good Preserve academic freedom Publish research results –usually after peer review Promote the public good Preserve academic freedom Publish research results –usually after peer review

33. © National Council of University Research Administrators ACADEMIC PRIORITIES contd. Regional economic development Preservation of tax exempt status –Internal Revenue Procedure 97- 14 Regarding Guidelines for Research Agreements (Jan 10, 1997) Regional economic development Preservation of tax exempt status –Internal Revenue Procedure 97- 14 Regarding Guidelines for Research Agreements (Jan 10, 1997)

34. © National Council of University Research Administrators ACADEMIC PRIORITIES contd. –Internal Revenue Procedure 97- 14 Regarding Guidelines for Research Agreements (Jan 10, 1997)

35. © National Council of University Research Administrators INDUSTRY PRIORITIES Protect intellectual property Safeguard proprietary/confidential property Profits to company and shareholders Protect intellectual property Safeguard proprietary/confidential property Profits to company and shareholders

36. © National Council of University Research Administrators INDUSTRY PRIORITIES contd. Protection of market Future employees Maintain competitive edge Protection of market Future employees Maintain competitive edge

37. © National Council of University Research Administrators Focused product research and development Sharing and dissemination of federally funded research results to the scientific community and public Focused product research and development Sharing and dissemination of federally funded research results to the scientific community and public FEDERAL GOVERNMENT PRIORITIES

38. © National Council of University Research Administrators Licensing and utilization of inventions supported by federal funding Use of intellectual property for government purposes Licensing and utilization of inventions supported by federal funding Use of intellectual property for government purposes FEDERAL GOVERNMENT PRIORITIES contd.

39. © National Council of University Research Administrators FACULTY PRIORITIES Right to disclose and publish research findings –Right to control access to research data Right to disclose and publish research findings –Right to control access to research data

40. © National Council of University Research Administrators FACULTY PRIORITIES contd. Establishment of productive research relationships and collaborations with various sponsors Training and education of students Establishment of productive research relationships and collaborations with various sponsors Training and education of students

41. © National Council of University Research Administrators BENEFITS TO COLLABORATE INDUSTRY Access to early stage technology Commercialization opportunities INDUSTRY Access to early stage technology Commercialization opportunities

42. © National Council of University Research Administrators BENEFITS TO COLLABORATE INDUSTRY Financially attractive Employment opportunities INDUSTRY Financially attractive Employment opportunities

43. © National Council of University Research Administrators BENEFITS TO COLLABORATE contd. UNIVERSITIES New source of funding Access to new technologies and market needs Employment opportunities UNIVERSITIES New source of funding Access to new technologies and market needs Employment opportunities

44. © National Council of University Research Administrators THERE ARE RISKS Perception of serving only business concerns and priorities Conflict of interest Perception of serving only business concerns and priorities Conflict of interest

45. © National Council of University Research Administrators THERE ARE RISKS contd. Loss of the public trust Loss of publication rights Loss of intellectual property rights and future income Loss of the public trust Loss of publication rights Loss of intellectual property rights and future income

46. © National Council of University Research Administrators THERE ARE RISKS contd. Omission of federal rights Violation of tax-exempt status Violation of tax-exempt bond covenants Omission of federal rights Violation of tax-exempt status Violation of tax-exempt bond covenants

47. © National Council of University Research Administrators CASE STUDY Discussion

48. © National Council of University Research Administrators SECTION III INTRODUCTION TO PATENT LAW

49. © National Council of University Research Administrators AUTHORIZATION FOR IP U.S. Constitution (Article 1, Sec. 8, Cl. 8)

50. © National Council of University Research Administrators AUTHORIZATION FOR IP contd. “The Congress shall have the power…to promote the progress of science and useful arts, by …

51. © National Council of University Research Administrators AUTHORIZATION FOR IP contd. … securing for limited times to authors and inventors the exclusive right to their respecting writings and discoveries.”

52. © National Council of University Research Administrators PATENT PROTECTION The right to EXCLUDE others from making, using, selling, or offering to sell the claimed invention during the patent term.

53. © National Council of University Research Administrators PATENT PROTECTION Cannot exclude others until AFTER the patent ISSUES.

54. © National Council of University Research Administrators PATENT PROCESS Patent is issued by the federal government. –U.S. Patent and Trademark Office (part of the Department of Commerce) Patent is issued by the federal government. –U.S. Patent and Trademark Office (part of the Department of Commerce)

55. © National Council of University Research Administrators PATENT PROCESS contd. Patent examiners within the Patent Office examines the application to determine if the application meets the patent standards.

56. © National Council of University Research Administrators PATENT PROCESS contd. Time to issuance of a patent = 2-4+ years (university patents issue in approx. 3 1/2 years. Term of a patent = 20 years from filing Time to issuance of a patent = 2-4+ years (university patents issue in approx. 3 1/2 years. Term of a patent = 20 years from filing

57. © National Council of University Research Administrators PATENT PROCESS contd. Cost to obtain U.S. patent $8K - $50K+, depends on the complexity of the invention and the issues encountered during prosecution

58. © National Council of University Research Administrators PATENT PROTECTION? Anything that is (1) useful, (2) novel, (3) unobvious, and Subject matter must be within patentable subject matter. Anything that is (1) useful, (2) novel, (3) unobvious, and Subject matter must be within patentable subject matter.

59. © National Council of University Research Administrators PATENT PROTECTION? 3 Types of Patents Utility Design Plant 3 Types of Patents Utility Design Plant

60. © National Council of University Research Administrators NOT PATENTABLE Ideas per se, but... Mathematical formulas (algorithms), but... Ideas per se, but... Mathematical formulas (algorithms), but...

61. © National Council of University Research Administrators NOT PATENTABLE Laws of nature Anything repugnant to morals or public policy Laws of nature Anything repugnant to morals or public policy

62. © National Council of University Research Administrators DEFINITION OF AN INVENTION Only 2 parts Conception = the lighting of the light bulb Only 2 parts Conception = the lighting of the light bulb

63. © National Council of University Research Administrators DEFINITION OF AN INVENTION contd. Reduction to Practice Actual = the invention is built and tested so that those skilled in the art know that it works Reduction to Practice Actual = the invention is built and tested so that those skilled in the art know that it works

64. © National Council of University Research Administrators DEFINITION OF AN INVENTION contd. Constructive = Filing of a patent application that meets the statutory requirements

65. © National Council of University Research Administrators INVENTIONS THAT ARE PATENTABLE New and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.

66. © National Council of University Research Administrators NOT PATENTABLE 2 major reasons for universities –When they were known or used by others in the US OR … 2 major reasons for universities –When they were known or used by others in the US OR …

67. © National Council of University Research Administrators NOT PATENTABLE contd. … Patented or described in a printed publication in US or foreign country BEFORE the applicant of the patent invented.

68. © National Council of University Research Administrators NOT PATENTABLE contd. –Invention was patented or described in a printed publication in US or foreign country, OR Was in public use or on sale –Invention was patented or described in a printed publication in US or foreign country, OR Was in public use or on sale

69. © National Council of University Research Administrators NOT PATENTABLE contd. BOTH MORE THAN ONE YEAR PRIOR TO THE DATE OF THE PATENT APPLICATION

70. © National Council of University Research Administrators WHO CAN BE AN INVENTOR? Inventorship is a legal decision. Inventorship rules are NOT the same as authorship rules Inventorship is a legal decision. Inventorship rules are NOT the same as authorship rules

71. © National Council of University Research Administrators WHO CAN BE AN INVENTOR? contd. U.S. patent application must be filed in the name of the inventors “But for” relationship of inventors U.S. patent application must be filed in the name of the inventors “But for” relationship of inventors

72. © National Council of University Research Administrators WHO CAN BE AN INVENTOR? contd. Inventor = anyone who contributes to the conception OR the reduction to practice and is NOT a “pair of hands”.

73. © National Council of University Research Administrators WHO CAN BE AN INVENTOR? contd. Pair of Hands - Someone operating at the direction of someone else.

74. © National Council of University Research Administrators JOINT INVENTORS Do not have to physically work together. Each co-inventor does not have to make the same type or amount of contribution to the invention. Do not have to physically work together. Each co-inventor does not have to make the same type or amount of contribution to the invention.

75. © National Council of University Research Administrators JOINT INVENTORS contd. Each do not have to contribute to each claim.

76. © National Council of University Research Administrators JOINT INVENTORS contd. Each joint inventor has the right to practice the patent without permission from the other joint inventors and no accounting of income is required to each co- inventor unless agreed to otherwise.

77. © National Council of University Research Administrators PROVISIONAL PATENT APPLICATIONS No formal requirements for filing a PA. A regular full patent must be filed within one year of filing PA. No formal requirements for filing a PA. A regular full patent must be filed within one year of filing PA.

78. © National Council of University Research Administrators PROVISIONAL PATENT APPLICATIONS contd. Provides earlier filing date BUT only on that part of the invention which is disclosed in the provisional patent application.

79. © National Council of University Research Administrators PROVISIONAL PATENT APPLICATIONS contd. The filing of a manuscript as a PA will not necessarily protect the technology and all of the claims.

80. © National Council of University Research Administrators REQUIRMENTS FOR PATENT APPLICATION The invention and the process of making and using the technology must be disclosed: –in full, clear, concise exact terms The invention and the process of making and using the technology must be disclosed: –in full, clear, concise exact terms

81. © National Council of University Research Administrators REQUIRMENTS FOR PATENT APP. contd. –to enable any person skilled in the art to make and use the invention without undue experimentation

82. © National Council of University Research Administrators REQUIRMENTS FOR PATENT APP. contd. Best mode contemplated by inventor at time of filing. Application must contain specification, claims, and drawings if required. Best mode contemplated by inventor at time of filing. Application must contain specification, claims, and drawings if required.

83. © National Council of University Research Administrators REQUIRMENTS FOR PATENT APP. contd. Oath - each inventor must sign an oath stating that they believe that they are the first inventor.

84. © National Council of University Research Administrators UNIVERSITY POLICIES When does your university own the invention and require assignment of the inventor rights to the university?

85. © National Council of University Research Administrators UNIVERSITY POLICIES contd. –Use of university financial and/or physical resources?? –All inventions?? –State law?? –Use of university financial and/or physical resources?? –All inventions?? –State law??

86. © National Council of University Research Administrators UNIVERSITY POLICIES contd. Need to know and understand policy interpretations.

87. © National Council of University Research Administrators CASE STUDY Discussion

88. © National Council of University Research Administrators SECTION IV PATENTS UNDER FEDERAL GRANTS AND CONTRACTS

89. © National Council of University Research Administrators WHAT IS BAYH-DOLE? The federal law governing rights to inventions conceived or first reduced to practice during research under a federally funded grant, contract or cooperative agreement

90. © National Council of University Research Administrators CITATIONS Bayh-Dole may be found at: 37 USC 200-212 (statute) 37 CFR Part 401 (regulations) May also be referred to as Public Laws 98-620 and 96-517 Bayh-Dole may be found at: 37 USC 200-212 (statute) 37 CFR Part 401 (regulations) May also be referred to as Public Laws 98-620 and 96-517

91. © National Council of University Research Administrators HISTORY OF BAYH- DOLE Prior to enactment of Bayh-Dole, title to inventions under federal funding vested in the funding agency unless the individual institution and agency had entered into an agreement regarding rights to the inventions

92. © National Council of University Research Administrators HISTORY OF BAYH- DOLE contd. Very little patenting by federal agencies Inventions were not being commercialized for the public good Very little patenting by federal agencies Inventions were not being commercialized for the public good

93. © National Council of University Research Administrators HISTORY OF BAYH- DOLE contd. Industry was hesitant to fund scope of work research at a university because of uncertainty of rights to inventions

94. © National Council of University Research Administrators HISTORY OF BAYH- DOLE contd. Public Law 96-517 was enacted in 1980 Established a uniform patent policy for federally funded inventions Public Law 96-517 was enacted in 1980 Established a uniform patent policy for federally funded inventions

95. © National Council of University Research Administrators WHEN DOES BAYH- DOLE APPLY? Federally funded grant, contract or cooperative agreement Invention conceived or reduced to practice during research funded in whole or in part under the federal agreement Federally funded grant, contract or cooperative agreement Invention conceived or reduced to practice during research funded in whole or in part under the federal agreement

96. © National Council of University Research Administrators WHEN DOES BAYH- DOLE APPLY? Contd. Recognition that there may be an invention from projects that are closely related but arise from non- government research and are therefore not covered under Bayh- Dole

97. © National Council of University Research Administrators PURPOSE OF BAYH- DOLE To promote collaboration between commercial concerns and non- profit organizations including universities

98. © National Council of University Research Administrators PURPOSE OF BAYH- DOLE contd. To promote utilization of inventions arising from federally- sponsored research or development

99. © National Council of University Research Administrators PURPOSE OF BAYH- DOLE contd. To ensure that invention are used to promote free competition and enterprise

100. © National Council of University Research Administrators BAYH-DOLE PROVISIONS University has right to elect to retain title to inventions developed through government funding University must file patent on inventions they elect to own University has right to elect to retain title to inventions developed through government funding University must file patent on inventions they elect to own

101. © National Council of University Research Administrators BAYH-DOLE PROVISIONS contd. NIH has created an exception to this provision for biological materials

102. © National Council of University Research Administrators BAYH-DOLE PROVISIONS contd. University must make disclosure of the invention to the federal government within two months after receipt of disclosure

103. © National Council of University Research Administrators BAYH-DOLE PROVISIONS contd. University must make written election of title within two years of the disclosure The period may be shorten if there are concerns about a statutory bar University must make written election of title within two years of the disclosure The period may be shorten if there are concerns about a statutory bar

104. © National Council of University Research Administrators BAYH-DOLE PROVISIONS contd. If title is elected, University must file patent prior to any statutory bar The government retains certain rights in the invention If title is elected, University must file patent prior to any statutory bar The government retains certain rights in the invention

105. © National Council of University Research Administrators BAYH-DOLE PROVISIONS contd. Government rights includes a royalty-free, non-exclusive license for governmental purpose including subcontractors

106. © National Council of University Research Administrators BAYH-DOLE PROVISIONS contd. University may not assign it rights, except to a patent management entity, without the agency’s permission

107. © National Council of University Research Administrators BAYH-DOLE PROVISIONS contd. Government may exercise March- in rights

108. © National Council of University Research Administrators BAYH-DOLE PROVISIONS contd. March-in rights allow Government to order the university to grant certain licenses if necessary for such things as ensuring public use or health and safety

109. © National Council of University Research Administrators BAYH-DOLE PROVISIONS contd. Requires sharing royalties with inventor(s) Requires balance of royalties be utilized for the support of scientific research or education Requires sharing royalties with inventor(s) Requires balance of royalties be utilized for the support of scientific research or education

110. © National Council of University Research Administrators BAYH-DOLE PROVISIONS contd. Requires written agreement with all persons working on the research except for clerical or non- technical staff

111. © National Council of University Research Administrators BAYH-DOLE PROVISIONS contd. Reasonable attempt to license small business Substantial manufacture of product in US if exclusively licensed Reasonable attempt to license small business Substantial manufacture of product in US if exclusively licensed

112. © National Council of University Research Administrators INVENTION DISCLOSURE University should have a invention disclosure process Document creation and funding source University should have a invention disclosure process Document creation and funding source

113. © National Council of University Research Administrators BAYH-DOLE DOESN’T APPLY Determination of Exceptional Circumstances (DEC) Specific legislation overrides (ATP) Research not federally funded – BUT TAKE CAUTION HERE Determination of Exceptional Circumstances (DEC) Specific legislation overrides (ATP) Research not federally funded – BUT TAKE CAUTION HERE

114. © National Council of University Research Administrators CASE STUDY Discussion

115. © National Council of University Research Administrators SECTION V INTRODUCTION TO COPYRIGHT LAW

116. © National Council of University Research Administrators GENERAL PRINCIPLES Purposes: Foster growth of learning and dissemination of information Purposes: Foster growth of learning and dissemination of information

117. © National Council of University Research Administrators GENERAL PRINCIPLES Balance: Encourages creativity and fosters competition by encouraging creation of public goods by giving to individuals exclusive rights for a limited period of time Balance: Encourages creativity and fosters competition by encouraging creation of public goods by giving to individuals exclusive rights for a limited period of time

118. © National Council of University Research Administrators COPYRIGHT PROTECTION Literary works Musical works, including any accompanying words Dramatic works, including any accompanying music Literary works Musical works, including any accompanying words Dramatic works, including any accompanying music

119. © National Council of University Research Administrators COPYRIGHT PROTECTION contd. Pantomimes and choreographic works Pictorial, graphic, and sculptural works Pantomimes and choreographic works Pictorial, graphic, and sculptural works

120. © National Council of University Research Administrators COPYRIGHT PROTECTION contd. Motion Pictures and other audiovisual works Sound records Architectural works Motion Pictures and other audiovisual works Sound records Architectural works

121. © National Council of University Research Administrators COPYRIGHT PROTECTION contd. NOTE: Categories are read broadly –Example: Computer programs and most “compilations” may be registered as “literary works”. NOTE: Categories are read broadly –Example: Computer programs and most “compilations” may be registered as “literary works”.

122. © National Council of University Research Administrators COPYRIGHT PROTECTION contd. –Maps and architectural works maybe registered as pictorial, graphic, and sculptural works.

123. © National Council of University Research Administrators WHAT IS “OUT” AT THE COPYRIGHT OFFICE? Ideas or concepts Lists showing no originality Titles, names, short phrases, slogans Ideas or concepts Lists showing no originality Titles, names, short phrases, slogans

124. © National Council of University Research Administrators WHAT IS “OUT” AT THE COPYRIGHT OFFICE? contd. Type styles Factual information Public domain information Works not fixed in tangible form Type styles Factual information Public domain information Works not fixed in tangible form

125. © National Council of University Research Administrators COPYRIGHT PROTECTION Right to reproduce one or more copies –Exception: libraries, archives,home recordings, fair use Right to reproduce one or more copies –Exception: libraries, archives,home recordings, fair use

126. © National Council of University Research Administrators COPYRIGHT PROTECTION contd. Right to prepare derivative works (including translations)

127. © National Council of University Research Administrators COPYRIGHT PROTECTION contd. Right to distribute or disseminate copies

128. © National Council of University Research Administrators COPYRIGHT PROTECTION contd. Right to display publicly –Exceptions: instructional broadcasting, religious services,news, advertising Right to display publicly –Exceptions: instructional broadcasting, religious services,news, advertising

129. © National Council of University Research Administrators COPYRIGHT PROTECTION contd. Right to perform publicly In cases of sound recordings, to perform work publicly by means of a digital audio transmission. Right to perform publicly In cases of sound recordings, to perform work publicly by means of a digital audio transmission.

130. © National Council of University Research Administrators “JOINT WORK”? A copyrighted work prepared by 2 or ore authors with the INTENTION that their contributions be merged in INSEPARABLE or INTERDEPENDENT parts of a unitary whole.

131. © National Council of University Research Administrators “DERIVATIVE WORK”? A copyrighted work based on 1 ore more preexisting works, such as a translation, musical arrangement, dramatization, fictionalization, motion picture version, sound recording.

132. © National Council of University Research Administrators “DERIVATIVE WORK”? contd. –Ownership of the new work – new author –Ownership of the underlying work – prior author –Ownership of the new work – new author –Ownership of the underlying work – prior author

133. © National Council of University Research Administrators “WORK MADE FOR HIRE”? A copyrighted work prepared by an employee within the scope of his or her employment. A copyrighted work specially ordered or commissioned. A copyrighted work prepared by an employee within the scope of his or her employment. A copyrighted work specially ordered or commissioned.

134. © National Council of University Research Administrators “WORK MADE FOR HIRE”? contd. Needs to be in writing. A copyrighted work that by contract has been agreed to be a copyrighted work. Needs to be in writing. A copyrighted work that by contract has been agreed to be a copyrighted work.

135. © National Council of University Research Administrators COPYRIGHT SYMBOL AUTOMATICALLY as soon as a work has been fixed in a tangible form

136. © National Council of University Research Administrators COPYRIGHT SYMBOL contd. Notice and registration are NOT required to establish copyright protection –Notice = © Massachusetts Institute of Technology, 2003 Notice and registration are NOT required to establish copyright protection –Notice = © Massachusetts Institute of Technology, 2003

137. © National Council of University Research Administrators COPYRIGHT SYMBOL contd. When notice is used it may diminish the defense of innocent infringement

138. © National Council of University Research Administrators COPYRIGHT SYMBOL contd. When using notice, place notice to give reasonable notice of the claim of copyright

139. © National Council of University Research Administrators COPYRIGHT DURATION For works originally created after 1/1/1978 Author Owned: Author’s life plus 70 years after author’s death For works originally created after 1/1/1978 Author Owned: Author’s life plus 70 years after author’s death

140. © National Council of University Research Administrators COPYRIGHT DURATION contd. Joint Work: 70 years after the last surviving author’s death

141. © National Council of University Research Administrators COPYRIGHT DURATION contd. Employer Owned/Works for Hire/Anonymous & Pseudonymous Works: 95 years from publication or 120 years from creation whichever is shorter

142. © National Council of University Research Administrators EXEMPTIONS TO COPYRIGHT Archival Exemption –One copy for computer software Archival Exemption –One copy for computer software

143. © National Council of University Research Administrators EXEMPTIONS TO COPYRIGHT contd. Fair Use –Right to reproduce and distribute on a limited basis without permission of the copyright holder Fair Use –Right to reproduce and distribute on a limited basis without permission of the copyright holder

144. © National Council of University Research Administrators EXEMPTIONS TO COPYRIGHT contd. Fair Use –Can only be used for: criticism (parody), comment, news reporting, home use teaching / scholarship / research Fair Use –Can only be used for: criticism (parody), comment, news reporting, home use teaching / scholarship / research

145. © National Council of University Research Administrators 4 FACTOR TEST Commercial vs. nonprofit use Number of copies Amount of text copied Commercial vs. nonprofit use Number of copies Amount of text copied

146. © National Council of University Research Administrators 4 FACTOR TEST contd. Effect on market potential (dilution factor)

147. © National Council of University Research Administrators CASE STUDY Discussion

148. © National Council of University Research Administrators SECTION IV RESEARCH DATA UNDER FEDERAL GRANTS AND CONTRACTS

149. © National Council of University Research Administrators DEFINITION OF DATA Primary Data –Original observations and findings in any format, usually not interpretable without additional information; includes “raw” data, primary video recordings, cell lines Primary Data –Original observations and findings in any format, usually not interpretable without additional information; includes “raw” data, primary video recordings, cell lines

150. © National Council of University Research Administrators DEFINITION OF DATA contd. Secondary Data –Primary data transformed to make understandable to scientific peers;statistically analyzed data, summary charts, photographic montages Secondary Data –Primary data transformed to make understandable to scientific peers;statistically analyzed data, summary charts, photographic montages

151. © National Council of University Research Administrators DEFINITION OF DATA contd. Published Data –Final interpretation and presentation of results Published Data –Final interpretation and presentation of results

152. © National Council of University Research Administrators WHAT ARE RESEARCH DATA? Results of original observations Notebooks Photographs Computer files Results of original observations Notebooks Photographs Computer files

153. © National Council of University Research Administrators WHAT ARE RESEARCH DATA? contd. Clinical records Laboratory strains Instrument printouts Clinical records Laboratory strains Instrument printouts

154. © National Council of University Research Administrators WHEN DO FEDERAL RIGHTS APPLY? Data/software first developed or specifically used or required for performance (depends on agency and award document)

155. © National Council of University Research Administrators WHEN DO FEDERAL RIGHTS APPLY? AND the definition of “data” will vary...

156. © National Council of University Research Administrators HOW IS DATA DEFINED? OMB Circular A-110,1999 Revision now defines data: As “the recorded factual material commonly accepted in the scientific community as necessary to validate research findings, … OMB Circular A-110,1999 Revision now defines data: As “the recorded factual material commonly accepted in the scientific community as necessary to validate research findings, …

157. © National Council of University Research Administrators HOW IS DATA DEFINED? contd. OMB Circular A-110,1999 Revision now defines data: … but not any of the following: preliminary analysis, drafts of scientific papers, plans for future research, peer reviews, or communications with colleagues” OMB Circular A-110,1999 Revision now defines data: … but not any of the following: preliminary analysis, drafts of scientific papers, plans for future research, peer reviews, or communications with colleagues”

158. © National Council of University Research Administrators HOW IS DATA DEFINED? contd. A-110 excludes from the definition: physical objects (lab samples) Trade secrets, commercial information, materials necessary to be held confidential A-110 excludes from the definition: physical objects (lab samples) Trade secrets, commercial information, materials necessary to be held confidential

159. © National Council of University Research Administrators HOW IS DATA DEFINED? contd. A-110 excludes from the definition: Personnel and medical information and similar information A-110 excludes from the definition: Personnel and medical information and similar information

160. © National Council of University Research Administrators OBLIGATIONS FOR DATA OMB Circular A-110, 1999 Revision The federal government has the right to: OMB Circular A-110, 1999 Revision The federal government has the right to:

161. © National Council of University Research Administrators OBLIGATIONS FOR DATA –Obtain, reproduce, publish or otherwise use the data first produced under an award; and

162. © National Council of University Research Administrators OBLIGATIONS FOR DATA contd. OMB Circular A-110, 1999 Revision The federal government has the right to: OMB Circular A-110, 1999 Revision The federal government has the right to:

163. © National Council of University Research Administrators OBLIGATIONS FOR DATA contd. –Authorize other to receive, reproduce, publish or otherwise use such data for federal purposes

164. © National Council of University Research Administrators OBLIGATIONS FOR DATA contd. OMB Circular Continued In response to a FOIA request for research data relating to published research findings produced under an award that were used by the federal government in developing … OMB Circular Continued In response to a FOIA request for research data relating to published research findings produced under an award that were used by the federal government in developing …

165. © National Council of University Research Administrators OBLIGATIONS FOR DATA contd. OMB Circular Continued … an agency action that has the force and effect of law, the federal awarding agency shall request, and the recipient shall provide, … OMB Circular Continued … an agency action that has the force and effect of law, the federal awarding agency shall request, and the recipient shall provide, …

166. © National Council of University Research Administrators OBLIGATIONS FOR DATA contd. OMB Circular Continued … within a reasonable time, the research data so that they can be made available to the public through the procedures established by FOIA OMB Circular Continued … within a reasonable time, the research data so that they can be made available to the public through the procedures established by FOIA

167. © National Council of University Research Administrators OBLIGATIONS FOR DATA contd. Other obligations: Institutional dissemination and sharing Retention of data for 3 years after project completion Other obligations: Institutional dissemination and sharing Retention of data for 3 years after project completion

168. © National Council of University Research Administrators OBLIGATIONS FOR DATA contd. Access to data (e.g., in scientific misconduct cases)

169. © National Council of University Research Administrators OBLIGATIONS FOR DATA contd. National Science Foundation (only one example) NSF expects investigators to share with other researchers, at no more than incremental cost and within a reasonable time, the primary data, samples, National Science Foundation (only one example) NSF expects investigators to share with other researchers, at no more than incremental cost and within a reasonable time, the primary data, samples,

170. © National Council of University Research Administrators OBLIGATIONS FOR DATA contd. National Science Foundation (only one example) … physical collections, and other supporting materials created or gathered in the course of the research” (Important Notice 106, April 17, 1989) National Science Foundation (only one example) … physical collections, and other supporting materials created or gathered in the course of the research” (Important Notice 106, April 17, 1989)

171. © National Council of University Research Administrators OBLIGATIONS FOR DATA contd. NIH Statement on Sharing Research Data (2/03)

172. © National Council of University Research Administrators OBLIGATIONS FOR DATA contd. Supports timely release and sharing of final research data from NIH supported studies (e.g., no later than the acceptance for publication of the main findings from a final data set)

173. © National Council of University Research Administrators OBLIGATIONS FOR DATA contd. NIH Statement on Sharing Research Data (2/03) Starting with October 1, 2003, PI’s submitting an application for $500,000 of more in direct costs in any single year are expected to include a plan NIH Statement on Sharing Research Data (2/03) Starting with October 1, 2003, PI’s submitting an application for $500,000 of more in direct costs in any single year are expected to include a plan

174. © National Council of University Research Administrators OBLIGATIONS FOR DATA contd. Proposed and Suspended PHS Policy on Responsible Conduct for Research included “data acquisition, management, sharing and ownership” as a key component of instruction Proposed and Suspended PHS Policy on Responsible Conduct for Research included “data acquisition, management, sharing and ownership” as a key component of instruction

175. © National Council of University Research Administrators OBLIGATIONS FOR DATA contd. Proposed and Suspended PHS Policy on Responsible Conduct for Research many institutions have implemented instruction absent a federal requirement Proposed and Suspended PHS Policy on Responsible Conduct for Research many institutions have implemented instruction absent a federal requirement

176. © National Council of University Research Administrators A REALITY CHECK Not many universities have specific policies on data ownership, but may have policies on data access and retention

177. © National Council of University Research Administrators A REALITY CHECK Generally, the university will allow the PI to retain custody of the data, but will retain ability to access

178. © National Council of University Research Administrators HOW IS DATA DEFINED? “Data” as used in this clause, means recorded information regardless of form or the medium on which it is recorded. The term includes technical data and computer software.

179. © National Council of University Research Administrators HOW IS DATA DEFINED? contd. The term does not include information incidental to contract administration, such as financial, administrative, cost or pricing, or management information (FAR 52.227(a), June 1987)

180. © National Council of University Research Administrators UNDER FEDERAL CONTRACTS Ownership of data is determined by terms of the contract agreement Rights in technical data and computer software prescribed by the FAR and its supplements Ownership of data is determined by terms of the contract agreement Rights in technical data and computer software prescribed by the FAR and its supplements

181. © National Council of University Research Administrators UNDER FEDERAL CONTRACTS contd. Since 1987, agencies have tried but have been unable to devise a uniform approach to rights in data

182. © National Council of University Research Administrators UNDER FEDERAL CONTRACTS contd. Government rights: May vary depending upon agency, statement of work or source of funds

183. © National Council of University Research Administrators UNDER FEDERAL CONTRACTS contd. Government rights: Normally receives a royalty-free, non-exclusive, irrevocable, worldwide license to use, disclose, reproduce, …

184. © National Council of University Research Administrators UNDER FEDERAL CONTRACTS contd. Government rights: … prepare derivative works, distribute copies to the public and perform and display publicly the copyrighted data for data “first produced”

185. © National Council of University Research Administrators GOVERNMENT RIGHTS Unlimited Rights: Government has rights in data for any purpose, and to have or permit others to do so

186. © National Council of University Research Administrators GOVERNMENT RIGHTS contd. Government Purpose Rights: Government has rights in data and may permit others, but must be on behalf of the government

187. © National Council of University Research Administrators GOVERNMENT RIGHTS contd. Limited Rights Data: Data may be reproduced and used by the government, but may not, without written permission of contractor …

188. © National Council of University Research Administrators GOVERNMENT RIGHTS contd. … be used or disclosed outside the government (may be some exceptions listed in contract)

189. © National Council of University Research Administrators GOVERNMENT RIGHTS contd. For most agencies other than DOD, DOE and NASA, FAR 52.227-14 applies –Title to all data and software belongs to the institution (if Alternate IV used) For most agencies other than DOD, DOE and NASA, FAR 52.227-14 applies –Title to all data and software belongs to the institution (if Alternate IV used)

190. © National Council of University Research Administrators GOVERNMENT RIGHTS contd. –Government receives unlimited rights

191. © National Council of University Research Administrators GOVERNMENT RIGHTS contd. For most agencies other than DOD, DOE and NASA, FAR 52.227-14 applies –If Government and third party funding used, then government usually receives government purpose rights For most agencies other than DOD, DOE and NASA, FAR 52.227-14 applies –If Government and third party funding used, then government usually receives government purpose rights

192. © National Council of University Research Administrators GOVERNMENT RIGHTS contd. For most agencies other than DOD, DOE and NASA, FAR 52.227-14 applies –If only funded by private expense AND if MARKED government usually receives limited rights For most agencies other than DOD, DOE and NASA, FAR 52.227-14 applies –If only funded by private expense AND if MARKED government usually receives limited rights

193. © National Council of University Research Administrators RIGHTS IN DATA- GENERAL FAR 52.227-14(c) –Requires express written approval of Contracting Officer to establish copyright in all other data FAR 52.227-14(c) –Requires express written approval of Contracting Officer to establish copyright in all other data

194. © National Council of University Research Administrators RIGHTS IN DATA- GENERAL contd. FAR 52.227-14(c) –Contractor may establish, without prior approval from the government, copyright in scientific and technical articles if these contain … FAR 52.227-14(c) –Contractor may establish, without prior approval from the government, copyright in scientific and technical articles if these contain …

195. © National Council of University Research Administrators RIGHTS IN DATA- GENERAL contd. FAR 52.227-14(c) –… “data first produced in the performance of the contract and published in the academic, technical, or professional journals, symposia proceedings or similar works” FAR 52.227-14(c) –… “data first produced in the performance of the contract and published in the academic, technical, or professional journals, symposia proceedings or similar works”

196. © National Council of University Research Administrators RIGHTS IN DATA- GENERAL contd. FAR 52.227-14, Alternate IV –Provides universities with right to claim copyright without limitation in any data (including technical data and computer software) FAR 52.227-14, Alternate IV –Provides universities with right to claim copyright without limitation in any data (including technical data and computer software)

197. © National Council of University Research Administrators RIGHTS IN DATA- GENERAL contd. FAR 52.227-14, Alternate IV –Required to be used in contracts for basic or applied research to be performed solely by universities and colleges FAR 52.227-14, Alternate IV –Required to be used in contracts for basic or applied research to be performed solely by universities and colleges

198. © National Council of University Research Administrators RIGHTS IN DATA- GENERAL contd. –Cannot be used if purpose of contract is development of software

199. © National Council of University Research Administrators RIGHTS IN DATA- GENERAL contd. FAR 52.227-14, Alternate IV –For data, enables government to reproduce, prepare derivative works, distribute copies to the public and perform publicly and display publicly, by or on behalf of the Government FAR 52.227-14, Alternate IV –For data, enables government to reproduce, prepare derivative works, distribute copies to the public and perform publicly and display publicly, by or on behalf of the Government

200. © National Council of University Research Administrators RIGHTS IN DATA- GENERAL contd. FAR 52.227-14, Alternate IV –For software, government does not have right to distribute copies of software to public FAR 52.227-14, Alternate IV –For software, government does not have right to distribute copies of software to public

201. © National Council of University Research Administrators ASSERT OWNERSHIP OF DATA? Future use of data used or created Protect ability to publish University-Industry collaborations Future use of data used or created Protect ability to publish University-Industry collaborations

202. © National Council of University Research Administrators ASSERT OWNERSHIP OF DATA? contd. Transfer of software and copyrightable data to licensees for commercialization

203. © National Council of University Research Administrators RIGHTS IN DATA (FAR 52.227-17) Required to be inserted in contracts primarily intended for production/compilation of data for Government internal use or where there is a need to limit distribution

204. © National Council of University Research Administrators RIGHTS IN DATA (FAR 52.227-17) Government acquires unlimited rights to data, including technical data and computer software Contractors may not establish copyright Government acquires unlimited rights to data, including technical data and computer software Contractors may not establish copyright

205. © National Council of University Research Administrators RIGHTS IN DATA (FAR 52.227-17) contd. Release distribution and publication of delivered data is restricted

206. © National Council of University Research Administrators DOD ACQUISITION REGULATIONS Computer software and other types of technical data governed by two separate regulations

207. © National Council of University Research Administrators DOD ACQUISITION REGULATIONS contd. Make no distinction between commercial organizations and nonprofit educational institutions

208. © National Council of University Research Administrators DOD ACQUISITION REGULATIONS contd. Standard license rights granted to government may be modified through negotiations with DoD

209. © National Council of University Research Administrators DOD ACQUISITION REGULATIONS contd. Allocation of rights in technical data described in three different categories(recognizes source of funds):

210. © National Council of University Research Administrators DOD ACQUISITION REGULATIONS contd. –developed exclusively with government funds (unlimited rights) –developed with mixed funding (government purpose rights) –developed exclusively with government funds (unlimited rights) –developed with mixed funding (government purpose rights)

211. © National Council of University Research Administrators DOD ACQUISITION REGULATIONS contd. Allocation of rights in technical data described in three different categories(recognizes source of funds): –developed exclusively at private expense (limited rights) Allocation of rights in technical data described in three different categories(recognizes source of funds): –developed exclusively at private expense (limited rights)

212. © National Council of University Research Administrators A FEW LAST WARNINGS If funded by DOE or NASA check the grant guidelines or the contract for specific rights –DOE modified in 1997 - may not have ownership of software or technical data If funded by DOE or NASA check the grant guidelines or the contract for specific rights –DOE modified in 1997 - may not have ownership of software or technical data

213. © National Council of University Research Administrators A FEW LAST WARNINGS contd. –NASA - NASA Grants Handbook revised October 2000 University data developed under federal awards may continue to be subject to debate: –NASA - NASA Grants Handbook revised October 2000 University data developed under federal awards may continue to be subject to debate:

214. © National Council of University Research Administrators A FEW LAST WARNINGS contd. –“Sensitive but unclassified” –Access to federally funded data and results –Responsible Conduct of Research component –“Sensitive but unclassified” –Access to federally funded data and results –Responsible Conduct of Research component

215. © National Council of University Research Administrators A FEW LAST WARNINGS contd. Read Every Contract – Do not assume the rights you or the government have Check COGR Homepage for more detailed information on specific agency requirements http://www.cogr.edu/ Read Every Contract – Do not assume the rights you or the government have Check COGR Homepage for more detailed information on specific agency requirements http://www.cogr.edu/

216. © National Council of University Research Administrators CASE STUDY Discussion

217. © National Council of University Research Administrators SECTION VII OTHER REGULATIONS

218. © National Council of University Research Administrators OTHER REGULATIONS Other regulations or federal documents may affect the rights available to intellectual property arising from research

219. © National Council of University Research Administrators IRS The tax code sets limits the amount of private business use that can occur in a facility financed with tax-exempt bonds

220. © National Council of University Research Administrators PRIVATE BUSINESS USE Interest on bonds issued for the benefit of non-profits and governments may be exempt from income tax

221. © National Council of University Research Administrators PRIVATE BUSINESS USE contd. Tax exempt bonds are attractive to investors and often results in a lower interest rate to issuer

222. © National Council of University Research Administrators PRIVATE BUSINESS USE contd. Private business use of the bond financed facility may invalidate the tax exemption

223. © National Council of University Research Administrators PRIVATE BUSINESS USE contd. No more private business use than 10% for state institutions and 5% for others

224. © National Council of University Research Administrators PRIVATE BUSINESS USE contd. Research is considered private business use unless it meets certain criteria Facts and circumstance analysis Research is considered private business use unless it meets certain criteria Facts and circumstance analysis

225. © National Council of University Research Administrators PRIVATE BUSINESS USE contd. The legislative history indicated that the free right to publish and retention of intellectual property are essential elements in avoiding private business use

226. © National Council of University Research Administrators REV. PROC 97-14 Creates a “Safe harbor” for research activity Must be basic research Creates a “Safe harbor” for research activity Must be basic research

227. © National Council of University Research Administrators REV. PROC 97-14 contd. License or other use of resulting technology by the sponsor is permitted only on the same terms as would be available to others

228. © National Council of University Research Administrators REV. PROC 97-14 contd. License fee must be determined at the time the resulting technology is available for use

229. © National Council of University Research Administrators NIH GUIDANCE DOCUMENTS Developing Sponsored Research Agreements Obtaining and Disseminating Biomedical Research Resources Developing Sponsored Research Agreements Obtaining and Disseminating Biomedical Research Resources

230. © National Council of University Research Administrators DEVELOPING AGREEMENTS Grantees must consider Bayh-Dole and refrain from engaging in activities which undermine a grantees ability to fulfill it responsibilities and obligations to the federal government

231. © National Council of University Research Administrators DEVELOPING AGREEMENTS contd. Heightened scrutiny for large funding agreements, grants of rights to major component’s IP and agreements of long duration

232. © National Council of University Research Administrators BIOMEDICAL RESEARCH RESOURCES So-called research tools Often the subject of a material transfer agreement Initial hope that the guidance would be adopted by industry So-called research tools Often the subject of a material transfer agreement Initial hope that the guidance would be adopted by industry

233. © National Council of University Research Administrators BIOMEDICAL RESEARCH RESOURCES contd. The guidelines stress the importance of assuring consistency with Bayh-Dole

234. © National Council of University Research Administrators CONFLICT OF INTEREST Both NIH and NSF require institutions to identify and manage conflict of interests that may affect or appear to affect the objectivity of research funded by the agency

235. © National Council of University Research Administrators CONFLICT OF INTEREST contd. A potential conflict of interest occurs when the individual’s outside interest and his or her university responsibilities diverge such that …

236. © National Council of University Research Administrators CONFLICT OF INTEREST contd. … a reasonable outside observer might question the objectivity of the conduct of the research

237. © National Council of University Research Administrators CONFLICT OF INTEREST contd. What does conflict of interest have to do with intellectual property?

238. © National Council of University Research Administrators CONFLICT OF INTEREST contd. Outside activity may influence a claim of ownership or assignment of IP or affect the IP of a graduate student or postdoc

239. © National Council of University Research Administrators SECTION VIII CASE STUDY AND SUMMARY CASE STUDY AND SUMMARY

240. © National Council of University Research Administrators N&M CASE STUDY What is left?

241. © National Council of University Research Administrators N&M CASE STUDY Begin: –With statement of work –Discussion with researcher –Know goals Begin: –With statement of work –Discussion with researcher –Know goals

242. © National Council of University Research Administrators N&M CASE STUDY –Know risks –Know negotiating parameters Call sponsor –Know risks –Know negotiating parameters Call sponsor