Part of the "2016 Annual Conference: Big Data, Health Law, and Bioethics" held at Harvard Law School on May 6, 2016. This conference aimed to: (1) identify the various ways in which law and ethics intersect with the use of big data in health care and health research, particularly in the United States; (2) understand the way U.S. law (and potentially other legal systems) currently promotes or stands as an obstacle to these potential uses; (3) determine what might be learned from the legal and ethical treatment of uses of big data in other sectors and countries; and (4) examine potential solutions (industry best practices, common law, legislative, executive, domestic and international) for better use of big data in health care and health research in the U.S. The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School 2016 annual conference was organized in collaboration with the Berkman Center for Internet & Society at Harvard University and the Health Ethics and Policy Lab, University of Zurich. Learn more at http://petrieflom.law.harvard.edu/events/details/2016-annual-conference.

1. Centre for Information and Innovation LawMay 6th, 2016 1
Big Data & Intellectual Property Rights in the
Health & Life Sciences
2016 Annual Conference: Big Data, Health Law, and Bioethics
Harvard Law School
Prof. Dr. Timo Minssen
Centre for Information and Innovation Law (CIIR)
University of Copenhagen (DK)

2. Centre for Information and Innovation LawMay 6th, 2016 2
Introduction
• Big Data = challenges & opportunities for health & life sciences
• Sharing is caring: Paradigm shift demands co-operation & data sharing
• IPRs relevant when R&D translated into ”real world”- applications
• Availability, benefits & draw-backs of IPRs? Re-calibration required?
• Different choices for different areas of Big Data Science

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Agenda
1. Most relevant IP &
”sui generis” rights in Big Data
2. 5 selected problematic ares
in health and life scieces
3. Potential remedies
4. Conclusions

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6 overlapping IPRs & ”sui generis”
IPs relevant for Big Data
PATENTS Copyrights TRADEMARKS
Data Base
Protection
Trade Secets Regulatory
Exclusivities

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5 overlapping problems at the interface
of Big Data & IPRs in health & life science
1.IPRs, standardization
& competition law
2. Large research
infrastructures
3. Public involvement &
IPRs
4. IPRs, data transparency &
sharing initiatives
5. R&D incentives in
Precision Medicine

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Potential remedies
•Transparency, better patent-search tools & high quality patents
•Better training and involvement of scientific community
•Clarify research exemptions & open innovation-platforms
•User-generated models (FRAND, pat-pools & clearing houses)
P1-Standards &
competition
•See above- plus case-dependent IP user-modalities
•Clear IP & data policy (cf. ESS-ERIC & BBMRI-Eric)
•Grant-back clauses, non excl. & non-discr. licensing
•Clarify international guidelines on co-authorship & data transfer
P2-Research
Infrastructure
•Coherency between open data policies & public IPR ownship
•Case-by-case decisions on (1) Pure Open Data models, (2)
Conditioned models & Properietary models.
•Better sharing platforms.
P3-Public Involv.
•Re-consider interplay between transparency with IPRs & TS
•Facilitate complementary & alternative incentives
•Safe-guards with regard to misuse & privacy
•Improved fair use clauses & research exemptions
•New licensing regimes & better tools for FTO analysis
P4–Transparency
& sharing
•Changes in patent law unlikely.
•Alternative incentives for data-sets, algorytms & validation.
•US data base protection
•More flexibility with regard to reg. exclusivities & prizes
P5-Incentives in
precision medicine

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Conclusions
• Many different IP relevant to Big Data
• Paradigm shift results in overlapping IP challenges on different levels
• Interplay between IPRs, new policies & business strategies requires further
studies
• Trad. IP system fails to support Big Data due to law, business & tech. changes
• Flaws results in both IP lack of incentives & potential blocking effect due to new IP
strategies.
• Re-calibration of substantial & procedural IP rules + governance
• Need for cross (Atlantic)-fertilization , studies
& alignment of strategies

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• Utilization of Big Data only sustainable if Privacy, Competition,
Regulation of test-services, sharing tools & data quality are addressed
&….
• Legislation is supported by public (erosion of gate-keeper barriers)
• Education & sufficient transparency
are the key
´
-/14,
Conclusions II

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Questions or Suggestions?
Thanks for your attention !
E-mail: Timo.Minssen@jur.ku.dk
Reseach page: http://jura.ku.dk/ciir/ansatte/?pure=da/persons/381631