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

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

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

© National Council of University Research Administrators

SECTION ISECTION I

INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY

FOR THE RESEARCH ADMINISTRATOR

INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY

FOR THE RESEARCH ADMINISTRATOR

Page 2: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

GOALS OF IP PRIMERGOALS 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.

Page 3: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

GOALS OF IP PRIMER contd.

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.

Page 4: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

GOALS OF IP PRIMER contd.

GOALS OF IP PRIMER contd.

• To know what information is needed to discuss and negotiate intellectual property clauses in a research agreement.

• To know what information is needed to discuss and negotiate intellectual property clauses in a research agreement.

Page 5: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

DISCUSSION TOPICSDISCUSSION TOPICS

• What is intellectual property?

• What is a patent?

• What is intellectual property?

• What is a patent?

Page 6: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

DISCUSSION TOPICSDISCUSSION TOPICS

• What are the US federal government rights in patents and copyright?

• What are the US federal government rights in patents and copyright?

Page 7: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

DISCUSSION TOPICS contd.

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?

Page 8: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

DISCUSSION TOPICS contd.

DISCUSSION TOPICS contd.

• What are material transfer agreements and how is the intellectual property handled?

• What are material transfer agreements and how is the intellectual property handled?

Page 9: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

DISCUSSION TOPICS contd.

DISCUSSION TOPICS contd.

• Are there any issues when the intellectual property is developed in a building that has been financed with bonds?

• Are there any issues when the intellectual property is developed in a building that has been financed with bonds?

Page 10: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

N & M CASE STUDYN & M CASE STUDY

• Context for N&M research agreement.

–Reality

–Not unusual

• Context for N&M research agreement.

–Reality

–Not unusual

Page 11: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

N & M CASE STUDYN & M CASE STUDY

• Where do you begin?• Where do you begin?

Page 12: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

CHECKLISTCHECKLIST

• 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.

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© National Council of University Research Administrators

CHECKLIST contd.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.

Page 14: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

CHECKLIST contd.CHECKLIST contd.

• Assume you are the PI when reading the contract/IP terms – what are the restrictions and responsibilities.

• Assume you are the PI when reading the contract/IP terms – what are the restrictions and responsibilities.

Page 15: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

CHECKLIST contd. 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”

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© National Council of University Research Administrators

WHERE DO YOU FIND IP CLAUSES?

WHERE DO YOU FIND IP CLAUSES?

Everywhere

• Intellectual Property clauses

• Publication

Everywhere

• Intellectual Property clauses

• Publication

Page 17: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

WHERE DO YOU FIND IP CLAUSES? contd.

WHERE DO YOU FIND IP CLAUSES? contd.

Everywhere

• Royalty clause

• Whereas clauses

Everywhere

• Royalty clause

• Whereas clauses

Page 18: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

WHERE DO YOU FIND IP CLAUSES? contd.

WHERE DO YOU FIND IP CLAUSES? contd.

Everywhere

• Patent Prosecution

• Confidentiality/non-disclosure

Everywhere

• Patent Prosecution

• Confidentiality/non-disclosure

Page 19: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

WHERE DO YOU FIND IP CLAUSES? contd.

WHERE DO YOU FIND IP CLAUSES? contd.

• Statement of Work

• Licenses

• Definition section

• Statement of Work

• Licenses

• Definition section

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© National Council of University Research Administrators

WHERE DO YOU FIND IP CLAUSES? contd.

WHERE DO YOU FIND IP CLAUSES? contd.

• Payment clauses

• Indemnification

• Background and future rights

• Payment clauses

• Indemnification

• Background and future rights

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© National Council of University Research Administrators

CASE STUDYCASE STUDY

DiscussionDiscussion

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© National Council of University Research Administrators

SECTION IISECTION II

INTRODUCTION TO INTELLECTUAL PROPERTY

CONCEPTS

INTRODUCTION TO INTELLECTUAL PROPERTY

CONCEPTS

Page 23: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

WHAT IS IP? WHAT IS IP?

• Ideas, inventions, processes, works of authorship, which are protectable under patent, copyright, trademark or trade secret law

• Ideas, inventions, processes, works of authorship, which are protectable under patent, copyright, trademark or trade secret law

Page 24: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

WHAT IS IP? contd.WHAT IS IP? contd.

• Owners, holders and assignees of intellectual property (IP) rights are protected by law against unauthorized use by another party

• Owners, holders and assignees of intellectual property (IP) rights are protected by law against unauthorized use by another party

Page 25: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

WHY DO WE CARE ABOUT IP?

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

Page 26: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

WHY DO WE CARE ABOUT IP? contd.

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

Page 27: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

WHAT IS A LICENSE?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.“

• "A legal agreement or contract that permits one party to use intellectual property belonging to another under mutually agreed upon terms.“

Page 28: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

WHAT IS A LICENSE?WHAT IS A LICENSE?

• Grant of a right to use• Grant of a right to use

Page 29: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

WHAT IS A ROYALTY?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"

• "The consideration or compensation paid to the licensor in exchange for certain rights in the technology that the licensor is providing to the licensee"

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© National Council of University Research Administrators

WHAT IS A ROYALTY?WHAT IS A ROYALTY?

• Royalty-free vs. royalty-bearing• Royalty-free vs. royalty-bearing

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© National Council of University Research Administrators

ACADEMIC PRIORITIESACADEMIC PRIORITIES

• Education

• Research

• Service

• Education

• Research

• Service

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© National Council of University Research Administrators

ACADEMIC PRIORITIES contd.

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

Page 33: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

ACADEMIC PRIORITIES contd.

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)

Page 34: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

ACADEMIC PRIORITIES contd.

ACADEMIC PRIORITIES contd.

–Internal Revenue Procedure 97-14 Regarding Guidelines for Research Agreements (Jan 10, 1997)

–Internal Revenue Procedure 97-14 Regarding Guidelines for Research Agreements (Jan 10, 1997)

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© National Council of University Research Administrators

INDUSTRY PRIORITIESINDUSTRY 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

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© National Council of University Research Administrators

INDUSTRY PRIORITIES contd.

INDUSTRY PRIORITIES contd.

• Protection of market

• Future employees

• Maintain competitive edge

• Protection of market

• Future employees

• Maintain competitive edge

Page 37: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© 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

FEDERAL GOVERNMENT PRIORITIES

Page 38: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© 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.

FEDERAL GOVERNMENT PRIORITIES contd.

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FACULTY PRIORITIESFACULTY 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

Page 40: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

FACULTY PRIORITIES contd.

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

Page 41: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

BENEFITS TO COLLABORATEBENEFITS TO

COLLABORATEINDUSTRY

• Access to early stage technology

• Commercialization opportunities

INDUSTRY

• Access to early stage technology

• Commercialization opportunities

Page 42: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

BENEFITS TO COLLABORATEBENEFITS TO

COLLABORATEINDUSTRY

• Financially attractive

• Employment opportunities

INDUSTRY

• Financially attractive

• Employment opportunities

Page 43: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

BENEFITS TO COLLABORATE contd.

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

Page 44: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

THERE ARE RISKSTHERE ARE RISKS

• Perception of serving only business concerns and priorities

• Conflict of interest

• Perception of serving only business concerns and priorities

• Conflict of interest

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© National Council of University Research Administrators

THERE ARE RISKS contd.

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

Page 46: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

THERE ARE RISKS contd.

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

Page 47: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

CASE STUDYCASE STUDY

DiscussionDiscussion

Page 48: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

SECTION IIISECTION III

INTRODUCTION TO PATENT LAW

INTRODUCTION TO PATENT LAW

Page 49: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

AUTHORIZATION FOR IPAUTHORIZATION FOR IP

• U.S. Constitution (Article 1, Sec. 8, Cl. 8)

• U.S. Constitution (Article 1, Sec. 8, Cl. 8)

Page 50: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

AUTHORIZATION FOR IP contd.

AUTHORIZATION FOR IP contd.

• “The Congress shall have the power…to promote the progress of science and useful arts, by …

• “The Congress shall have the power…to promote the progress of science and useful arts, by …

Page 51: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

AUTHORIZATION FOR IP contd.

AUTHORIZATION FOR IP contd.

• … securing for limited times to authors and inventors the exclusive right to their respecting writings and discoveries.”

• … securing for limited times to authors and inventors the exclusive right to their respecting writings and discoveries.”

Page 52: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

PATENT PROTECTIONPATENT PROTECTION

• The right to EXCLUDE others from making, using, selling, or offering to sell the claimed invention during the patent term.

• The right to EXCLUDE others from making, using, selling, or offering to sell the claimed invention during the patent term.

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© National Council of University Research Administrators

PATENT PROTECTIONPATENT PROTECTION

• Cannot exclude others until AFTER the patent ISSUES.

• Cannot exclude others until AFTER the patent ISSUES.

Page 54: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

PATENT PROCESSPATENT 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)

Page 55: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

PATENT PROCESS contd.

PATENT PROCESS contd.

• Patent examiners within the Patent Office examines the application to determine if the application meets the patent standards.

• Patent examiners within the Patent Office examines the application to determine if the application meets the patent standards.

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© National Council of University Research Administrators

PATENT PROCESS contd.

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

Page 57: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

PATENT PROCESS contd.

PATENT PROCESS contd.

• Cost to obtain U.S. patent $8K - $50K+, depends on the complexity of the invention and the issues encountered during prosecution

• Cost to obtain U.S. patent $8K - $50K+, depends on the complexity of the invention and the issues encountered during prosecution

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© National Council of University Research Administrators

PATENT PROTECTION?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.

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© National Council of University Research Administrators

PATENT PROTECTION?PATENT PROTECTION?

3 Types of Patents

• Utility

• Design

• Plant

3 Types of Patents

• Utility

• Design

• Plant

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© National Council of University Research Administrators

NOT PATENTABLENOT PATENTABLE

• Ideas per se, but...

• Mathematical formulas (algorithms), but...

• Ideas per se, but...

• Mathematical formulas (algorithms), but...

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© National Council of University Research Administrators

NOT PATENTABLENOT PATENTABLE

• Laws of nature

• Anything repugnant to morals or public policy

• Laws of nature

• Anything repugnant to morals or public policy

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© National Council of University Research Administrators

DEFINITION OF AN INVENTION

DEFINITION OF AN INVENTION

• Only 2 parts

• Conception = the lighting of the light bulb

• Only 2 parts

• Conception = the lighting of the light bulb

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© National Council of University Research Administrators

DEFINITION OF AN INVENTION contd.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

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© National Council of University Research Administrators

DEFINITION OF AN INVENTION contd.DEFINITION OF AN INVENTION contd.

• Constructive = Filing of a patent application that meets the statutory requirements

• Constructive = Filing of a patent application that meets the statutory requirements

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© National Council of University Research Administrators

INVENTIONS THAT ARE PATENTABLE

INVENTIONS THAT ARE PATENTABLE

• New and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.

• New and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.

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© National Council of University Research Administrators

NOT PATENTABLENOT 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 …

Page 67: © National Council of University Research Administrators SECTION I INTRODUCTION TO PRIMER ON INTELLECTUAL PROPERTY FOR THE RESEARCH ADMINISTRATOR

© National Council of University Research Administrators

NOT PATENTABLE contd.

NOT PATENTABLE contd.

•… Patented or described in a printed publication in US or foreign country BEFORE the applicant of the patent invented.

•… Patented or described in a printed publication in US or foreign country BEFORE the applicant of the patent invented.

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© National Council of University Research Administrators

NOT PATENTABLE contd.

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

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© National Council of University Research Administrators

NOT PATENTABLE contd.

NOT PATENTABLE contd.

• BOTH MORE THAN ONE YEAR PRIOR TO THE DATE OF THE PATENT APPLICATION

• BOTH MORE THAN ONE YEAR PRIOR TO THE DATE OF THE PATENT APPLICATION

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WHO CAN BE AN INVENTOR?

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

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© National Council of University Research Administrators

WHO CAN BE AN INVENTOR? contd.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

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© National Council of University Research Administrators

WHO CAN BE AN INVENTOR? contd.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”.

• Inventor = anyone who contributes to the conception OR the reduction to practice and is NOT a “pair of hands”.

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© National Council of University Research Administrators

WHO CAN BE AN INVENTOR? contd.WHO CAN BE AN

INVENTOR? contd.• Pair of Hands - Someone operating

at the direction of someone else.

• Pair of Hands - Someone operating at the direction of someone else.

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JOINT INVENTORSJOINT 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.

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JOINT INVENTORS contd.

JOINT INVENTORS contd.

• Each do not have to contribute to each claim.• Each do not have to contribute

to each claim.

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JOINT INVENTORS contd.

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.

• 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.

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PROVISIONAL PATENT APPLICATIONS

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.

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PROVISIONAL PATENT APPLICATIONS contd.PROVISIONAL PATENT APPLICATIONS contd.

• Provides earlier filing date BUT only on that part of the invention which is disclosed in the provisional patent application.

• Provides earlier filing date BUT only on that part of the invention which is disclosed in the provisional patent application.

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PROVISIONAL PATENT APPLICATIONS contd.PROVISIONAL PATENT APPLICATIONS contd.

• The filing of a manuscript as a PA will not necessarily protect the technology and all of the claims.

• The filing of a manuscript as a PA will not necessarily protect the technology and all of the claims.

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REQUIRMENTS FOR PATENT APPLICATIONREQUIRMENTS 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

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REQUIRMENTS FOR PATENT APP. contd.REQUIRMENTS FOR PATENT APP. contd.–to enable any person skilled in the

art to make and use the invention without undue experimentation

–to enable any person skilled in the art to make and use the invention without undue experimentation

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REQUIRMENTS FOR PATENT APP. contd. 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.

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REQUIRMENTS FOR PATENT APP. contd.REQUIRMENTS FOR PATENT APP. contd.

• Oath - each inventor must sign an oath stating that they believe that they are the first inventor.

• Oath - each inventor must sign an oath stating that they believe that they are the first inventor.

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UNIVERSITY POLICIESUNIVERSITY POLICIES

• When does your university own the invention and require assignment of the inventor rights to the university?

• When does your university own the invention and require assignment of the inventor rights to the university?

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UNIVERSITY POLICIES contd.

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??

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UNIVERSITY POLICIES contd.

UNIVERSITY POLICIES contd.

• Need to know and understand policy interpretations.

• Need to know and understand policy interpretations.

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CASE STUDYCASE STUDY

DiscussionDiscussion

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SECTION IVSECTION IV

PATENTS UNDER FEDERAL GRANTS AND CONTRACTS

PATENTS UNDER FEDERAL GRANTS AND CONTRACTS

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WHAT IS BAYH-DOLE?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

• The federal law governing rights to inventions conceived or first reduced to practice during research under a federally funded grant, contract or cooperative agreement

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CITATIONSCITATIONS

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

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HISTORY OF BAYH-DOLE

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

• 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

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HISTORY OF BAYH-DOLE contd.

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

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HISTORY OF BAYH-DOLE contd.

HISTORY OF BAYH-DOLE contd.

• Industry was hesitant to fund scope of work research at a university because of uncertainty of rights to inventions

• Industry was hesitant to fund scope of work research at a university because of uncertainty of rights to inventions

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HISTORY OF BAYH-DOLE contd.

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

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WHEN DOES BAYH-DOLE APPLY?

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

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WHEN DOES BAYH-DOLE APPLY? Contd.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

• 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

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PURPOSE OF BAYH-DOLE

PURPOSE OF BAYH-DOLE

• To promote collaboration between commercial concerns and non-profit organizations including universities

• To promote collaboration between commercial concerns and non-profit organizations including universities

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PURPOSE OF BAYH-DOLE contd.

PURPOSE OF BAYH-DOLE contd.

• To promote utilization of inventions arising from federally-sponsored research or development

• To promote utilization of inventions arising from federally-sponsored research or development

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PURPOSE OF BAYH-DOLE contd.

PURPOSE OF BAYH-DOLE contd.

• To ensure that invention are used to promote free competition and enterprise

• To ensure that invention are used to promote free competition and enterprise

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BAYH-DOLE PROVISIONSBAYH-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

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BAYH-DOLE PROVISIONS contd.

BAYH-DOLE PROVISIONS contd.

• NIH has created an exception to this provision for biological materials

• NIH has created an exception to this provision for biological materials

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BAYH-DOLE PROVISIONS contd.

BAYH-DOLE PROVISIONS contd.

• University must make disclosure of the invention to the federal government within two months after receipt of disclosure

• University must make disclosure of the invention to the federal government within two months after receipt of disclosure

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BAYH-DOLE PROVISIONS contd.

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

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BAYH-DOLE PROVISIONS contd.

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

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BAYH-DOLE PROVISIONS contd.

BAYH-DOLE PROVISIONS contd.

• Government rights includes a royalty-free, non-exclusive license for governmental purpose including subcontractors

• Government rights includes a royalty-free, non-exclusive license for governmental purpose including subcontractors

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BAYH-DOLE PROVISIONS contd.

BAYH-DOLE PROVISIONS contd.

• University may not assign it rights, except to a patent management entity, without the agency’s permission

• University may not assign it rights, except to a patent management entity, without the agency’s permission

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BAYH-DOLE PROVISIONS contd.

BAYH-DOLE PROVISIONS contd.

• Government may exercise March-in rights

• Government may exercise March-in rights

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BAYH-DOLE PROVISIONS contd.

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

• 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

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BAYH-DOLE PROVISIONS contd.

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

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BAYH-DOLE PROVISIONS contd.

BAYH-DOLE PROVISIONS contd.

• Requires written agreement with all persons working on the research except for clerical or non-technical staff

• Requires written agreement with all persons working on the research except for clerical or non-technical staff

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BAYH-DOLE PROVISIONS contd.

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

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INVENTION DISCLOSUREINVENTION 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

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BAYH-DOLE DOESN’T APPLY

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

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CASE STUDYCASE STUDY

DiscussionDiscussion

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SECTION VSECTION V

INTRODUCTION TO COPYRIGHT LAW

INTRODUCTION TO COPYRIGHT LAW

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GENERAL PRINCIPLESGENERAL PRINCIPLES

Purposes:

• Foster growth of learning and dissemination of information

Purposes:

• Foster growth of learning and dissemination of information

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GENERAL PRINCIPLESGENERAL 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

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COPYRIGHT PROTECTIONCOPYRIGHT

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

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COPYRIGHT PROTECTION contd.

COPYRIGHT PROTECTION contd.

• Pantomimes and choreographic works

• Pictorial, graphic, and sculptural works

• Pantomimes and choreographic works

• Pictorial, graphic, and sculptural works

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COPYRIGHT PROTECTION contd.

COPYRIGHT PROTECTION contd.

• Motion Pictures and other audiovisual works

• Sound records

• Architectural works

• Motion Pictures and other audiovisual works

• Sound records

• Architectural works

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COPYRIGHT PROTECTION contd.

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”.

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COPYRIGHT PROTECTION contd.

COPYRIGHT PROTECTION contd.–Maps and architectural works

maybe registered as pictorial, graphic, and sculptural works.

–Maps and architectural works maybe registered as pictorial, graphic, and sculptural works.

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WHAT IS “OUT” AT THE COPYRIGHT OFFICE?

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

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WHAT IS “OUT” AT THE COPYRIGHT OFFICE?

contd.

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

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COPYRIGHT PROTECTIONCOPYRIGHT

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

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COPYRIGHT PROTECTION contd.

COPYRIGHT PROTECTION contd.

• Right to prepare derivative works (including translations)

• Right to prepare derivative works (including translations)

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COPYRIGHT PROTECTION contd.

COPYRIGHT PROTECTION contd.

• Right to distribute or disseminate copies

• Right to distribute or disseminate copies

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COPYRIGHT PROTECTION contd.

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

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COPYRIGHT PROTECTION contd.

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.

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“JOINT WORK”?“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.

• 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.

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“DERIVATIVE WORK”?“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.

• A copyrighted work based on 1 ore more preexisting works, such as a translation, musical arrangement, dramatization, fictionalization, motion picture version, sound recording.

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“DERIVATIVE WORK”? contd.

“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

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“WORK MADE FOR HIRE”?

“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.

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“WORK MADE FOR HIRE”? contd.

“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.

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COPYRIGHT SYMBOLCOPYRIGHT SYMBOL

• AUTOMATICALLY as soon as a work has been fixed in a tangible form

• AUTOMATICALLY as soon as a work has been fixed in a tangible form

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COPYRIGHT SYMBOL contd.

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

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COPYRIGHT SYMBOL contd.

COPYRIGHT SYMBOL contd.

• When notice is used it may diminish the defense of innocent infringement

• When notice is used it may diminish the defense of innocent infringement

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COPYRIGHT SYMBOL contd.

COPYRIGHT SYMBOL contd.

• When using notice, place notice to give reasonable notice of the claim of copyright

• When using notice, place notice to give reasonable notice of the claim of copyright

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COPYRIGHT DURATIONCOPYRIGHT 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

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COPYRIGHT DURATION contd.

COPYRIGHT DURATION contd.

• Joint Work: 70 years after the last surviving author’s death

• Joint Work: 70 years after the last surviving author’s death

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COPYRIGHT DURATION contd.

COPYRIGHT DURATION contd.

• Employer Owned/Works for Hire/Anonymous & Pseudonymous Works: 95 years from publication or 120 years from creation whichever is shorter

• Employer Owned/Works for Hire/Anonymous & Pseudonymous Works: 95 years from publication or 120 years from creation whichever is shorter

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EXEMPTIONS TO COPYRIGHT

EXEMPTIONS TO COPYRIGHT

• Archival Exemption

–One copy for computer software

• Archival Exemption

–One copy for computer software

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EXEMPTIONS TO COPYRIGHT contd.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

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EXEMPTIONS TO COPYRIGHT contd.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

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4 FACTOR TEST4 FACTOR TEST

• Commercial vs. nonprofit use

• Number of copies

• Amount of text copied

• Commercial vs. nonprofit use

• Number of copies

• Amount of text copied

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4 FACTOR TEST contd.4 FACTOR TEST contd.

• Effect on market potential (dilution factor)

• Effect on market potential (dilution factor)

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CASE STUDYCASE STUDY

DiscussionDiscussion

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SECTION IVSECTION IV

RESEARCH DATA UNDER FEDERAL GRANTS AND

CONTRACTS

RESEARCH DATA UNDER FEDERAL GRANTS AND

CONTRACTS

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DEFINITION OF DATADEFINITION 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

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DEFINITION OF DATA contd.

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

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DEFINITION OF DATA contd.

DEFINITION OF DATA contd.

• Published Data

–Final interpretation and presentation of results

• Published Data

–Final interpretation and presentation of results

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WHAT ARE RESEARCH DATA?

WHAT ARE RESEARCH DATA?

• Results of original observations

• Notebooks

• Photographs

• Computer files

• Results of original observations

• Notebooks

• Photographs

• Computer files

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WHAT ARE RESEARCH DATA? contd.

WHAT ARE RESEARCH DATA? contd.

• Clinical records

• Laboratory strains

• Instrument printouts

• Clinical records

• Laboratory strains

• Instrument printouts

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WHEN DO FEDERAL RIGHTS APPLY?

WHEN DO FEDERAL RIGHTS APPLY?

• Data/software first developed or specifically used or required for performance (depends on agency and award document)

• Data/software first developed or specifically used or required for performance (depends on agency and award document)

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WHEN DO FEDERAL RIGHTS APPLY?

WHEN DO FEDERAL RIGHTS APPLY?

• AND the definition of “data” will vary ...

• AND the definition of “data” will vary ...

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HOW IS DATA DEFINED?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, …

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HOW IS DATA DEFINED? contd.

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”

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HOW IS DATA DEFINED? contd.

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

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HOW IS DATA DEFINED? contd.

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

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OBLIGATIONS FOR DATA

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:

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OBLIGATIONS FOR DATA

OBLIGATIONS FOR DATA

–Obtain, reproduce, publish or otherwise use the data first produced under an award; and

–Obtain, reproduce, publish or otherwise use the data first produced under an award; and

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OBLIGATIONS FOR DATA contd.

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:

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OBLIGATIONS FOR DATA contd.

OBLIGATIONS FOR DATA contd.

–Authorize other to receive, reproduce, publish or otherwise use such data for federal purposes

–Authorize other to receive, reproduce, publish or otherwise use such data for federal purposes

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OBLIGATIONS FOR DATA contd.

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 …

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OBLIGATIONS FOR DATA contd.

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, …

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OBLIGATIONS FOR DATA contd.

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

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OBLIGATIONS FOR DATA contd.

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

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OBLIGATIONS FOR DATA contd.

OBLIGATIONS FOR DATA contd.

• Access to data (e.g., in scientific misconduct cases)

• Access to data (e.g., in scientific misconduct cases)

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OBLIGATIONS FOR DATA contd.

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,

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OBLIGATIONS FOR DATA contd.

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)

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OBLIGATIONS FOR DATA contd.

OBLIGATIONS FOR DATA contd.

NIH Statement on Sharing Research Data (2/03)

NIH Statement on Sharing Research Data (2/03)

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OBLIGATIONS FOR DATA contd.

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)

• 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)

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OBLIGATIONS FOR DATA contd.

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

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OBLIGATIONS FOR DATA contd.

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

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OBLIGATIONS FOR DATA contd.

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

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A REALITY CHECKA REALITY CHECK

• Not many universities have specific policies on data ownership, but may have policies on data access and retention

• Not many universities have specific policies on data ownership, but may have policies on data access and retention

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A REALITY CHECKA REALITY CHECK

• Generally, the university will allow the PI to retain custody of the data, but will retain ability to access

• Generally, the university will allow the PI to retain custody of the data, but will retain ability to access

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HOW IS DATA DEFINED?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.

• “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.

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HOW IS DATA DEFINED? contd.

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)

• 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)

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UNDER FEDERAL CONTRACTS

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

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UNDER FEDERAL CONTRACTS contd.UNDER FEDERAL

CONTRACTS contd.• Since 1987, agencies have tried but

have been unable to devise a uniform approach to rights in data

• Since 1987, agencies have tried but have been unable to devise a uniform approach to rights in data

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UNDER FEDERAL CONTRACTS contd.UNDER FEDERAL

CONTRACTS contd.• Government rights:

May vary depending upon agency, statement of work or source of funds

• Government rights:May vary depending upon agency, statement of work or source of funds

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UNDER FEDERAL CONTRACTS contd.UNDER FEDERAL

CONTRACTS contd.• Government rights:

Normally receives a royalty-free, non-exclusive, irrevocable, worldwide license to use, disclose, reproduce, …

• Government rights: Normally receives a royalty-free, non-exclusive, irrevocable, worldwide license to use, disclose, reproduce, …

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UNDER FEDERAL CONTRACTS contd.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”

• Government rights: … prepare derivative works, distribute copies to the public and perform and display publicly the copyrighted data for data “first produced”

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GOVERNMENT RIGHTSGOVERNMENT RIGHTS

• Unlimited Rights: Government has rights in data for any purpose, and to have or permit others to do so

• Unlimited Rights: Government has rights in data for any purpose, and to have or permit others to do so

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GOVERNMENT RIGHTS contd.

GOVERNMENT RIGHTS contd.

• Government Purpose Rights: Government has rights in data and may permit others, but must be on behalf of the government

• Government Purpose Rights: Government has rights in data and may permit others, but must be on behalf of the government

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GOVERNMENT RIGHTS contd.

GOVERNMENT RIGHTS contd.

• Limited Rights Data: Data may be reproduced and used by the government, but may not, without written permission of contractor …

• Limited Rights Data: Data may be reproduced and used by the government, but may not, without written permission of contractor …

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GOVERNMENT RIGHTS contd.

GOVERNMENT RIGHTS contd.

• … be used or disclosed outside the government (may be some exceptions listed in contract)

• … be used or disclosed outside the government (may be some exceptions listed in contract)

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GOVERNMENT RIGHTS contd.

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)

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GOVERNMENT RIGHTS contd.

GOVERNMENT RIGHTS contd.

–Government receives unlimited rights

–Government receives unlimited rights

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GOVERNMENT RIGHTS contd.

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

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GOVERNMENT RIGHTS contd.

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

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RIGHTS IN DATA-GENERAL

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

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RIGHTS IN DATA-GENERAL contd.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 …

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RIGHTS IN DATA-GENERAL contd.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”

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RIGHTS IN DATA-GENERAL contd.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)

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RIGHTS IN DATA-GENERAL contd.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

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RIGHTS IN DATA-GENERAL contd.RIGHTS IN DATA-GENERAL contd.

–Cannot be used if purpose of contract is development of software

–Cannot be used if purpose of contract is development of software

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RIGHTS IN DATA-GENERAL contd.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

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RIGHTS IN DATA-GENERAL contd.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

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ASSERT OWNERSHIP OF DATA?

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

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ASSERT OWNERSHIP OF DATA? contd.

ASSERT OWNERSHIP OF DATA? contd.

• Transfer of software and copyrightable data to licensees for commercialization

• Transfer of software and copyrightable data to licensees for commercialization

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RIGHTS IN DATA (FAR 52.227-17)

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

• 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

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RIGHTS IN DATA (FAR 52.227-17)

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

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RIGHTS IN DATA (FAR 52.227-17) contd.

RIGHTS IN DATA (FAR 52.227-17) contd.• Release distribution and

publication of delivered data is restricted

• Release distribution and publication of delivered data is restricted

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DOD ACQUISITION REGULATIONS

DOD ACQUISITION REGULATIONS

• Computer software and other types of technical data governed by two separate regulations

• Computer software and other types of technical data governed by two separate regulations

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DOD ACQUISITION REGULATIONS contd.

DOD ACQUISITION REGULATIONS contd.

• Make no distinction between commercial organizations and nonprofit educational institutions

• Make no distinction between commercial organizations and nonprofit educational institutions

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DOD ACQUISITION REGULATIONS contd.

DOD ACQUISITION REGULATIONS contd.

• Standard license rights granted to government may be modified through negotiations with DoD

• Standard license rights granted to government may be modified through negotiations with DoD

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DOD ACQUISITION REGULATIONS contd.

DOD ACQUISITION REGULATIONS contd.

• Allocation of rights in technical data described in three different categories(recognizes source of funds):

• Allocation of rights in technical data described in three different categories(recognizes source of funds):

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DOD ACQUISITION REGULATIONS contd.

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)

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DOD ACQUISITION REGULATIONS contd.

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)

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A FEW LAST WARNINGSA 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

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A FEW LAST WARNINGS contd.

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:

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A FEW LAST WARNINGS contd.

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

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A FEW LAST WARNINGS contd.

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/

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CASE STUDYCASE STUDY

DiscussionDiscussion

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SECTION VIISECTION VII

OTHER REGULATIONSOTHER REGULATIONS

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OTHER REGULATIONSOTHER REGULATIONS

• Other regulations or federal documents may affect the rights available to intellectual property arising from research

• Other regulations or federal documents may affect the rights available to intellectual property arising from research

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IRSIRS

• The tax code sets limits the amount of private business use that can occur in a facility financed with tax-exempt bonds

• The tax code sets limits the amount of private business use that can occur in a facility financed with tax-exempt bonds

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PRIVATE BUSINESS USEPRIVATE BUSINESS USE

• Interest on bonds issued for the benefit of non-profits and governments may be exempt from income tax

• Interest on bonds issued for the benefit of non-profits and governments may be exempt from income tax

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PRIVATE BUSINESS USE contd.

PRIVATE BUSINESS USE contd.

• Tax exempt bonds are attractive to investors and often results in a lower interest rate to issuer

• Tax exempt bonds are attractive to investors and often results in a lower interest rate to issuer

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PRIVATE BUSINESS USE contd.

PRIVATE BUSINESS USE contd.

• Private business use of the bond financed facility may invalidate the tax exemption

• Private business use of the bond financed facility may invalidate the tax exemption

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PRIVATE BUSINESS USE contd.

PRIVATE BUSINESS USE contd.

• No more private business use than 10% for state institutions and 5% for others

• No more private business use than 10% for state institutions and 5% for others

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PRIVATE BUSINESS USE contd.

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

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PRIVATE BUSINESS USE contd.

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

• The legislative history indicated that the free right to publish and retention of intellectual property are essential elements in avoiding private business use

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REV. PROC 97-14REV. 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

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REV. PROC 97-14 contd.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

• License or other use of resulting technology by the sponsor is permitted only on the same terms as would be available to others

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REV. PROC 97-14 contd.REV. PROC 97-14 contd.

• License fee must be determined at the time the resulting technology is available for use

• License fee must be determined at the time the resulting technology is available for use

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NIH GUIDANCE DOCUMENTS

NIH GUIDANCE DOCUMENTS

• Developing Sponsored Research Agreements

• Obtaining and Disseminating Biomedical Research Resources

• Developing Sponsored Research Agreements

• Obtaining and Disseminating Biomedical Research Resources

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DEVELOPING AGREEMENTSDEVELOPING 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

• 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

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DEVELOPING AGREEMENTS contd.

DEVELOPING AGREEMENTS contd.

• Heightened scrutiny for large funding agreements, grants of rights to major component’s IP and agreements of long duration

• Heightened scrutiny for large funding agreements, grants of rights to major component’s IP and agreements of long duration

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BIOMEDICAL RESEARCH RESOURCES

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

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BIOMEDICAL RESEARCH RESOURCES contd.

BIOMEDICAL RESEARCH RESOURCES contd.

• The guidelines stress the importance of assuring consistency with Bayh-Dole

• The guidelines stress the importance of assuring consistency with Bayh-Dole

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CONFLICT OF INTERESTCONFLICT 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

• 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

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CONFLICT OF INTEREST contd.

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 …

• A potential conflict of interest occurs when the individual’s outside interest and his or her university responsibilities diverge such that …

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CONFLICT OF INTEREST contd.

CONFLICT OF INTEREST contd.

• … a reasonable outside observer might question the objectivity of the conduct of the research

• … a reasonable outside observer might question the objectivity of the conduct of the research

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CONFLICT OF INTEREST contd.

CONFLICT OF INTEREST contd.

• What does conflict of interest have to do with intellectual property?

• What does conflict of interest have to do with intellectual property?

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CONFLICT OF INTEREST contd.

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

• Outside activity may influence a claim of ownership or assignment of IP or affect the IP of a graduate student or postdoc

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SECTION VIIISECTION VIII

CASE STUDY

AND

SUMMARY

CASE STUDY

AND

SUMMARY

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N&M CASE STUDYN&M CASE STUDY

• What is left?• What is left?

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N&M CASE STUDYN&M CASE STUDY

• Begin:

–With statement of work

–Discussion with researcher

–Know goals

• Begin:

–With statement of work

–Discussion with researcher

–Know goals

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N&M CASE STUDYN&M CASE STUDY

–Know risks

–Know negotiating parameters

• Call sponsor

–Know risks

–Know negotiating parameters

• Call sponsor