BAYH-DOLE: TALES FROM THE FRONT ALICE O. MARTIN, Ph.D., J.D. PARTNER BARNES & THORNBURG, LLP

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BAYH-DOLE: TALES FROM THE FRONT

ALICE O. MARTIN, Ph.D., J.D.PARTNER

BARNES & THORNBURG, LLP

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BASIS FOR THE PRESENTATION

QUESTIONS FOR DISCUSSION

WERE PRESENTED TO

INTERVIEWEES FROM A SMALL

GROUP OF TECH TRANSFER

OFFICES, INDUSTRY (SMALL,

LARGE), AND INVESTORS

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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

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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

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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

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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?

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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

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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

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“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

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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

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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

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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

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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

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THANK YOU.

ALICE O. MARTIN, PH.D., J.D.

[email protected]

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Thank You!Thank You!

Sponsor:

ProgramCoordinator:

Moderator:

Andrew B. Freistein

Lynn C. Tyler

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BAYH-DOLE: TALES FROM THE FRONT ALICE O. MARTIN, Ph.D., J.D. PARTNER BARNES & THORNBURG, LLP