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CONFIDENTIAL © 2012 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is confidential, proprietary and the property of.

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Presentation on theme: "CONFIDENTIAL © 2012 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is confidential, proprietary and the property of."— Presentation transcript:

1 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

2 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. 2 2 BASIS FOR THE PRESENTATION QUESTIONS FOR DISCUSSION WERE PRESENTED TO INTERVIEWEES FROM A SMALL GROUP OF TECH TRANSFER OFFICES, INDUSTRY (SMALL, LARGE), AND INVESTORS

3 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. 3 3 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

4 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. 4 4 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

5 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. 5 5 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

6 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. 6 6 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?

7 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. 7 7 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

8 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. 8 8 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

9 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. 9 9 “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

10 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. 10

11 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. 11 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

12 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. 12 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

13 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. 13 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

14 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. 14 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

15 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. 15 THANK YOU. ALICE O. MARTIN, PH.D., J.D.

16 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. 16 Thank You! Sponsor: Program Coordinator: Moderator: Andrew B. Freistein Lynn C. Tyler


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