CONFIDENTIAL
© 2012 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is confidential, proprietary and the property of Barnes & Thornburg LLP, which may not be disseminated or disclosed to any person or entity other than the intended recipient(s), and may not be reproduced, in any form, without the express written consent of the author or presenter. The information on this page is intended for informational purposes only and shall not be construed as legal advice or a legal opinion of Barnes & Thornburg LLP.
BAYH-DOLE: TALES FROM THE FRONT
ALICE O. MARTIN, Ph.D., J.D.PARTNER
BARNES & THORNBURG, LLP
CONFIDENTIAL
© 2012 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is confidential, proprietary and the property of Barnes & Thornburg LLP, which may not be disseminated or disclosed to any person or entity other than the intended recipient(s), and may not be reproduced, in any form, without the express written consent of the author or presenter. The information on this page is intended for informational purposes only and shall not be construed as legal advice or a legal opinion of Barnes & Thornburg LLP.
22
BASIS FOR THE PRESENTATION
QUESTIONS FOR DISCUSSION
WERE PRESENTED TO
INTERVIEWEES FROM A SMALL
GROUP OF TECH TRANSFER
OFFICES, INDUSTRY (SMALL,
LARGE), AND INVESTORS
CONFIDENTIAL
© 2012 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is confidential, proprietary and the property of Barnes & Thornburg LLP, which may not be disseminated or disclosed to any person or entity other than the intended recipient(s), and may not be reproduced, in any form, without the express written consent of the author or presenter. The information on this page is intended for informational purposes only and shall not be construed as legal advice or a legal opinion of Barnes & Thornburg LLP.
33
IN WHAT CONTEXT HAVE YOU ENCOUNTERED BAYH-DOLE?
• RECEIVED FEDERAL FUNDING
– UNIVERSITIES
– SPIN-OFFS, SBIRS
• NEGOTIATED LICENSES WITH ENTITIES WHO RECEIVED FEDERAL FUNDING
• OTHER OR BOTH
CONFIDENTIAL
© 2012 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is confidential, proprietary and the property of Barnes & Thornburg LLP, which may not be disseminated or disclosed to any person or entity other than the intended recipient(s), and may not be reproduced, in any form, without the express written consent of the author or presenter. The information on this page is intended for informational purposes only and shall not be construed as legal advice or a legal opinion of Barnes & Thornburg LLP.
44
WHAT HAVE BEEN THE POSITIVE ASPECTS
OF BAYH-DOLE IN YOUR AREA?
• SOME INTERVIEWEES GREW UP WITH BAYH-DOLE - NO BASIS FOR COMPARISON!
• MADE INVENTIONS USEFUL TO THE PUBLIC
• UNIVERSITIES MORE PART OF COMMUNITY
• REVENUE STREAM, SETS MILESTONES
• UNIVERSITIES SHARE PROFITS WITH INVENTORS
• ENCOURAGED FACULTY ENTREPRENEURS
• STRENGTHEN CONTACTS BETWEEN INVENTORS AND INVENTION
CONFIDENTIAL
© 2012 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is confidential, proprietary and the property of Barnes & Thornburg LLP, which may not be disseminated or disclosed to any person or entity other than the intended recipient(s), and may not be reproduced, in any form, without the express written consent of the author or presenter. The information on this page is intended for informational purposes only and shall not be construed as legal advice or a legal opinion of Barnes & Thornburg LLP.
55
WHAT HAVE BEEN THE POSITIVE ASPECTS OF BAYH-DOLE IN YOUR AREA?
• ATUM, LES• CREATED ENVIRONMENTS FAVORABLE FOR
SMALL COMPANIES, SPINOFFS
• PHARMA TONING DOWN R&D; FUNDING UNIVERSITIES, SMALL COMPANIES
• INCREASED INCENTIVE TO INVEST IN PIONEER (EARLY STAGE) INVESTMENTS
CONFIDENTIAL
© 2012 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is confidential, proprietary and the property of Barnes & Thornburg LLP, which may not be disseminated or disclosed to any person or entity other than the intended recipient(s), and may not be reproduced, in any form, without the express written consent of the author or presenter. The information on this page is intended for informational purposes only and shall not be construed as legal advice or a legal opinion of Barnes & Thornburg LLP.
66
WHAT HAVE BEEN THE NEGATIVE ASPECTS OF BAYH-DOLE IN YOUR AREA?
• ANTAGONISTIC FACULTY, PUBLIC
– RAISED FACULTY EXPECTATIONS
– PUBLIC OFFENDED – TAX DOLLARS FOR RESEARCH
• BUREAUCRACY, UNDERSTAFFING = SLOW RESPONSE ADEQUATE MONITORING?
• U.S. MANUFACTURING DIFFICULT TO FIND (FOR PRODUCTS SOLD IN U.S.)
• UNIVERSITIES BEAR BURDEN OF COSTS
• MULTIPLE LAYERS CONTROL
• TOO MUCH FOCUS ON PATENTS, LESS ON COMMERCIALIZATION
• DOES BAYH-DOLE PERFORMANCE BY UNIVERSITIES AFFECT GETTING GRANTS?
CONFIDENTIAL
© 2012 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is confidential, proprietary and the property of Barnes & Thornburg LLP, which may not be disseminated or disclosed to any person or entity other than the intended recipient(s), and may not be reproduced, in any form, without the express written consent of the author or presenter. The information on this page is intended for informational purposes only and shall not be construed as legal advice or a legal opinion of Barnes & Thornburg LLP.
77
HAS THE DECISION IN STANFORD V. ROCHE HAD ANY IMPACT ON YOUR WORK?
• SUPREME COURT: INVENTORS’ RIGHTS TO INVENTIONS NOT AFFECTED BY BAYH-DOLE
• TITLE TO INVENTION: “… CONCEIVED OR FIRST ACTUALLY REDUCED TO PRACTICE IN THE PERFORMANCE OF WORK UNDER A FUNDING AGREEMENT”
• DUE DILIGENCE BY INVESTORS INCREASED
CONFIDENTIAL
© 2012 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is confidential, proprietary and the property of Barnes & Thornburg LLP, which may not be disseminated or disclosed to any person or entity other than the intended recipient(s), and may not be reproduced, in any form, without the express written consent of the author or presenter. The information on this page is intended for informational purposes only and shall not be construed as legal advice or a legal opinion of Barnes & Thornburg LLP.
88
HAS THE DECISION IN STANFORD V. ROCHE HAD ANY IMPACT ON YOUR WORK?
• COMPANIES WANT GUARANTIES
• REVISED ASSIGNMENT POLICIES
• BAYH-DOLE LANGUAGE REGARDING TITLE NOT CLEAR
• HARD TO DECIDE WHERE AND WHEN CONCEPTION IF MULTIPLE INVENTORS
CONFIDENTIAL
© 2012 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is confidential, proprietary and the property of Barnes & Thornburg LLP, which may not be disseminated or disclosed to any person or entity other than the intended recipient(s), and may not be reproduced, in any form, without the express written consent of the author or presenter. The information on this page is intended for informational purposes only and shall not be construed as legal advice or a legal opinion of Barnes & Thornburg LLP.
99
“OWNERSHIP OR STEWARDSHIP?” GEN, FEB. 1, 2012
“UNIVERSITIES NEED TO RECONSIDER PATENT POLICIES IN LIGHT OF STANFORD V. ROCHE RULING”
• MANY TECH TRANSFER OFFICES TRYING TO END “FACULTY-LED INVENTION MANAGEMENT”
• UNIVERSITIES POLICIES REQUIRE FACULTY ET AL. TO ASSIGN RIGHTS
• BAYH-DOLE BLAMED FOR REQUIRING FACULTY TO ASSIGN FEDERALLY FUNDED INVENTIONS
ANSWER• PATENT LAW DEFINES INVENTORSHIP• EMPLOYER/EMPLOYEE RELATIONSHIP CONVEYS RIGHTS• BAYH-DOLE NOT AUTOMATIC “TITLE-VESTING”• INVENTORS WHO RETAIN TITLE STILL SUBJECT TO THE
BAYH-DOLE ACT• FACULTY RARELY CAN COMMERCIALIZE
CONFIDENTIAL
© 2012 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is confidential, proprietary and the property of Barnes & Thornburg LLP, which may not be disseminated or disclosed to any person or entity other than the intended recipient(s), and may not be reproduced, in any form, without the express written consent of the author or presenter. The information on this page is intended for informational purposes only and shall not be construed as legal advice or a legal opinion of Barnes & Thornburg LLP.
1010
CONFIDENTIAL
© 2012 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is confidential, proprietary and the property of Barnes & Thornburg LLP, which may not be disseminated or disclosed to any person or entity other than the intended recipient(s), and may not be reproduced, in any form, without the express written consent of the author or presenter. The information on this page is intended for informational purposes only and shall not be construed as legal advice or a legal opinion of Barnes & Thornburg LLP.
1111
DO YOU THINK THE AIA WILL HAVE ANY IMPACT ON IMPLEMENTATION OF BAYH-DOLE?
• FIRST TO FILE FORCES EARLIER DECISIONS REGARDING PUBLICATIONS, PROVISIONALS
– COVER PAGE PROVISIONALS MUST ENABLE
– PUBLICATION MAY BAR FOREIGN FILING
• BAYH-DOLE CONTRACTORS MAY NOT BE ABLE TO ASSERT RIGHTS.
• COMPANIES MAY FUND R&D AT UNIVERSITIES, SMALL BIOTECHS EARLIER
CONFIDENTIAL
© 2012 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is confidential, proprietary and the property of Barnes & Thornburg LLP, which may not be disseminated or disclosed to any person or entity other than the intended recipient(s), and may not be reproduced, in any form, without the express written consent of the author or presenter. The information on this page is intended for informational purposes only and shall not be construed as legal advice or a legal opinion of Barnes & Thornburg LLP.
1212
WHAT SUGGESTIONS DO YOU HAVE TO IMPROVE BAYH-DOLE?
• MORE RESPONSIVE, EASIER EDISON REPORTING
• MORE OVERSIGHT BY GOVERNMENT e.g. PRICES TO CONSUMERS
• BETTER PUBLIC RELATIONS
CONFIDENTIAL
© 2012 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is confidential, proprietary and the property of Barnes & Thornburg LLP, which may not be disseminated or disclosed to any person or entity other than the intended recipient(s), and may not be reproduced, in any form, without the express written consent of the author or presenter. The information on this page is intended for informational purposes only and shall not be construed as legal advice or a legal opinion of Barnes & Thornburg LLP.
1313
DOES THE "MARCH IN RIGHTS" PROVISION AFFECT YOUR DECISIONS THAT INVOLVE BAYH-DOLE?
• NEVER USED FOR U.S. LICENSES
• MULTINATIONALS EXPECT
• PROBLEM FOR FOREIGN LICENSEES (COMPANIES & COUNTRIES)
• INTERNATIONAL AGREEMENT (IIA)
– FOLLOW-ON WORK
– NOT ALL BAYH-DOLE
CONFIDENTIAL
© 2012 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is confidential, proprietary and the property of Barnes & Thornburg LLP, which may not be disseminated or disclosed to any person or entity other than the intended recipient(s), and may not be reproduced, in any form, without the express written consent of the author or presenter. The information on this page is intended for informational purposes only and shall not be construed as legal advice or a legal opinion of Barnes & Thornburg LLP.
1414
EXCLUSIVE V. NON-EXCLUSIVE LICENSING COMPLICATIONS
• TECH TRANSFER ACT, 1986, EXCLUSIVE LICENSING
• TRICKY WITH SPONSORED PROJECT RESEARCH – “COMMINGLING WITH FEDERAL FUNDS”
• MAY WANT CERTIFICATION NO COMMINGLING SPONSORED PROJECT RESEARCH & FEDERAL FUNDS
• CONFLICT MANAGEMENT NEEDED – FACULTY COMMERCIAL INTERESTS
• NIH GUIDELINES– EXEMPT RESEARCH TOOLS?– BEST PRACTICES– POOLING
CONFIDENTIAL
© 2012 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is confidential, proprietary and the property of Barnes & Thornburg LLP, which may not be disseminated or disclosed to any person or entity other than the intended recipient(s), and may not be reproduced, in any form, without the express written consent of the author or presenter. The information on this page is intended for informational purposes only and shall not be construed as legal advice or a legal opinion of Barnes & Thornburg LLP.
1515
THANK YOU.
ALICE O. MARTIN, PH.D., J.D.
CONFIDENTIAL
© 2012 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is confidential, proprietary and the property of Barnes & Thornburg LLP, which may not be disseminated or disclosed to any person or entity other than the intended recipient(s), and may not be reproduced, in any form, without the express written consent of the author or presenter. The information on this page is intended for informational purposes only and shall not be construed as legal advice or a legal opinion of Barnes & Thornburg LLP.
1616
Thank You!Thank You!
Sponsor:
ProgramCoordinator:
Moderator:
Andrew B. Freistein
Lynn C. Tyler
Top Related