INTELLECTUAL PROPERTY & PUBLICALLY FUNDED RESEARCHBayh-Dole & the EU

Alison Campbell OBE PhD RTTP

Belgrade 30 October 2012

My background Independent consultant

in technology transfer & knowledge transfer

International client base of universities and research institutes

20 years leading technology transfer and research management in research intensive organisations

Industry bioscientist Non Executive Director

of PraxisUnico Chair of PraxisUnico

training Advisory roles with UK

research funding agencies

OBE for service to knowledge transfer, 2010

PraxisUnico

Is the UK’s leading Technology Transfer Association (top 88% of UK universities are PraxisUnico members)

More than 97% of UK university research funding is spent in PraxisUnico member institutions

Is structured to make the biggest impact for our members and customers. 

Is run by the UK’s leading Technology Transfer practitioners on a voluntary basis

Sharing best practice

With an International institutional member base PraxisUnico deliversAnnual conferenceEventsNetworkingTrainingAnd leads on advocacy with key opinion leaders and policy makers for the sector

PraxisUnico training Technology & knowledge transfer programmes geared to those

working at the interface of academia and industry To date delivered in

UK | India | China | Brazil | Colombia | Japan | South Africa | Australia| Mainland Europe | Ireland

2 days – 1 week programmes Fundamentals of Technology Transfer Advanced Licensing New Venture Creation Consultancy Research Contracts Business Development TT for academics

Taught by expert knowledge transfer professionals 2,500 individuals have been trained through PraxisUnico

Alliance of Technology Transfer professionals (ATTP)

Founded by the major global TT organisations to recognise the profession

Individuals apply to become a Registered Technology Transfer Professional (RTTP)

International peer review

Association of University Technology Managers (AUTM) | PraxisUnico | Knowledge Commercialisation Australasia (KCA) | Association of Science and Technology Professionals (ASTP)

ATTP global coverage

Bayh-Dole Act P.L. 96-517, Patent and Trademark Act Amendments of

1980 Enacted on December 12, 1980 Created a uniform patent policy amongst US federal

agencies that fund research Enabled small businesses and non-profit making

entities including universities to retain title to inventions made under federally-funded research programmes

The legislations was co-sponsored by Senators Birch Bayh of Indiana and Robert Dole of Kansas

Main provisions of the Bayh-Dole Act

Non-profits, including universities, and small businesses may elect to retain title to innovations developed under federally-funded research programmes

Universities are encouraged to collaborate with commercial concerns to promote the utilisation of inventions arising from federal funding

Universities are expected to file patents on inventions they elect to own

Universities are expected to give licensing preference to small businesses

The government retains a non-exclusive license to practice the patent throughout the world

The government retains march-in rights

Requirements on recipients of federal research funding

Report each disclosed invention to the funding agency Elect to retain title in writing within a statutorily prescribed

timeframe File for patent protection Grant the federal government a non-exclusive, non-transferable,

irrevocable, paid-up licence to practice or have practiced on its behalf throughout the world

Actively promote and attempt to commercialise the invention Not assign the rights to the technology, with a few exceptions Share royalties with the inventor Use any remaining income for education and research

Exclusions to Bayh-Dole If an invention is made outside the research activities of

the federally funded research "without interference with or cost to the government-funded project," then the invention does not fall under the Act

The invention does not fall under the Act if it arises in closely related research outside the "planned and committed activities" of the federally funded project, and the closely related research does not "diminish or distract from the performance" of the federally funded project

Many institutions have assumed that where federal funds have been used anywhere in a lab, an invention is governed by the Act

March-in rights

To date, no federal agency has exercised its march-in rights Despite some petitions by industry

A march-in decision could have adverse effects on federal efforts to encourage firms to commercialise federally funded research.

Bayh-Dole was good, right?

Yes but……

‘Today’s universities function more like corporate research laboratories…….In trying to power the innovation economy, we have turned America’s universities into cut-throat business competitors, zealously guarding the very innovations we so desperately want behind a tangled web of patents and royalty licenses.’’

New York Times,2008

Ownership of IPR in EU Universities

Confused and fragmented

 EU National IPR regulations

Countries where institutional ownership already existed before 2000, but was not enforced due to weak university autonomy

FranceGreece Italy (until 2001)

Countries which implemented a “professor’s privilege” system but switched to institutional ownership after 2000

Germany Denmark Finland Norway Austria

Early adopters (and enforcers) of the institutional ownership system

UK Switzerland Spain

Countries where IPR ownership was assigned to the State and which switched to institutional ownership after the early 1990s

Former Eastern bloc

Countries currently implementing a “professor’s privilege” system Sweden Italy (since 2001) 

And even then…… Academics may own the IPR and are obliged to assign

to the university or; Academics may own the IPR and the university must

ask for assignment within a defined period od time (differs) or;

The university may own all IPR created by its academics unless it is wholly outside of their normal duties or;

The university may own IPR created by its academics that is not funded by the university itself or;

Etc.

And in the USA

Academics never owned their own IPR It was owned by the government And this was thought to inhibit commercialisation

Bayh-Dole brought IPR commercialisation closer to the academic But didn’t give the rights to them

And then we have EU university by-laws…..

Different treatment of IPR in different cases E.g. where the work has been done with external

parties such as a company Different incentives and inventor reward

schemes

So what makes a difference?

National expectations Funder requirements University culture Professional support systems The academics

Boosting commercialisation 10 years ago, EU performance in commercialisation was reviewed.

Problems cited included: a continued over-reliance on a ‘linear’ approach to innovation,

which assumed that investment in the supply side would automatically result in marketable innovations downstream;

measuring academic success on the basis of research papers or academic citations, with intellectual property creation, for example, often not given parity of esteem as a research publication;

peer review (and lack of external examination), which may tend to prevent academic networks opening up to external scrutiny; and

academics being given insufficient time, or promotion incentives to engage in commercial activities.

The European Union, Economic Policy Committee, Working Group on Research and Development, Report on Research and Development, EPC/ECFIN/01/777-EN, 34 (January 22, 2002).

Has this changed?

Experience from the UK 1949 National Research Development

Corporation(NRDC) Central office commercialising government funded

research 1987 rights to government funded IPR given to

universities 1990s rise of the TTO created to focus on IPR,

licensing and spin-outs 2000s TT broadened to Knowledge Transfer

wider relationships with business

Ways this has been encouraged Higher Education Innovation Fund (HEIF)

2001 – present Support for creation of KTOs in all universities Strategy, metrics, reporting

2004 Lambert Report, Technology Strategy Board 2005 Lambert Agreements 2008 emergence of the impact agenda

Funding Councils, Research Councils Award criteria, development awards, impact competitions etc.

2014 Research Excellence Framework (REF) 20% weighted on impact

Shift in expectations

Research innovation and impact

Is it working?

Unico /Library House Report 2009“[Views of US colleagues] suggest that, compared to the US, the UK is advanced in both the measurement and variety of knowledge transfer activities that are undertaken in UK universities.”

Three quarters of UK academics now engage in some form of external activity; nearly a fifth provide consultancy services and 13% have taken out a patent

To make it easy and transparent for Licensees Investors Commercial partners The TTO The academic

To engage in knowledge transfer and commercialisation

In summary, our objectives should be….

Will an EU Bayh-Dole fix this?

No But Setting the right national and local frameworks And providing on the ground support To allow academics to adopt new behaviours Will have the greatest effect

Contact details

www.alisoncampbellassociates.com

www.praxisunico.org.uk

www.attp.info

alison@alisoncampbellassociates.com