Ownership & (intellectual) property rights in publicly funded biobanks - Challenges, Opportunities & Alternatives - 45 min Assoc. Prof. Timo Minssen Centre for Information and Innovation Law (CIIR) Copenhagen Biotech & Pharma Forum (CBPF) University of Copenhagen

Introduction Public good rationale for the establishment of biobanks: facilitate health and medical research and the translation of the outcomes. Does not necessarily preclude the involvement of for-profit entities. Support from the private sector will almost invariably be required to bring health care products to the market. Wide spectrum of various legal issues at different stages Focus of this presentation: What role do/should ownership & IPRs play for the exploitation of (publicly funded) biobanks? (i.e. no focus on ethical and informed consent issues) How can the current system be optimized? What (alternative) mechanisms could be used?

WP 4 Part 2: commercialization [TM]

Structure Ownership & biobanks Different types of biobanks reg. purpose & financing IPRs & biobanks 4. Future challenges 5. Conclusions

1. Ownership & biobanks

Forms of changing custody: Exchange – where custody is transferred without a fee being charged Trade – includes payment for a good or a service. Commercialisation – trade where a fee is charged for the purpose of making a profit.

Potential arguments with regard to ownership there can never be full property rights in human tissue, there can be some form of property in human tissue when it has undergone transformation there may be ownership of human tissue by the person providing the tissue, but they ‘abandon’ any claims to ownership when they provide the tissue the person providing the tissue has ownership rights in it and retains some of those right.

2. Different types of Biobanks

2.1 Different types of Biobanks (reg. goals & purpose) Biobanks of human samples can be distinguished by various categories depending on purpose and design. population-based biobanks disease-oriented biobanks case control biobanks tissue biobanks biobanks within the context of clinical trials. Basic categories could be further divided into more specific subgroups, such as stem cell biobanks, tumor biobanks or cord-blood banks……

2.2 Three basic models of financing (with many subtypes) the entrepreneurial biobank model the biosocial model; and the public biobank model

3. IPRs & biobanks

3.1 Definition, nature & relevant forms of IPRs Simplified definition of IPRs: Various rights granted to creators and owners of works that are the result of human intellectual creativity IPR-holder receives (limited) rights to control how specific creations are used Most relevant forms of IPRs in the biobank context - Patents - Trademarks - Copyrights - Industrial designs - Data base protection (particularly in Europe) - Trade secrets & regulatory exclusivities

3.2 IPRs & biobanks – an overview The creation phase - upstream (I) - What type of biobank? Protection of IP depends on strategy & policy, rarely lucrative - Copyrights (e.g. interview/ security software, health questionnaires etc.) - Patents (innovative equipment) - Trademarks (biobank name, logo) The collection phase - upstream(II) - Collected samples usually not subject matter of IPR. But what about data? - In Europe: Collected data protectable through IPR/data base protection. - US: No equivalent protection, but protect. of data org. & vs. unfair competition. - Law on confidentiality, ethics, privacy, informed consent more significant. The access phase – mostly downstream(III) - IPR developed during this phase are mostly downstrean IPRs Copyrights and TM (later publications). Most important: Patents !!! Biobanks should adress these proactively & develop IP policies/access agreements

3.3 IPR & Biobanks - direct involvement in downstream IPRs? Any justification for involvement? Higher transaction costs and additional access hurdles through involvement in downstream IPRs Monetary returns might be unpredictable

4.1 Future challenges I (a selection) which organizational and legislative choices in biobanking? Should publicly funded biobanks engage in tech-transfer and the protection of research results through IPRs, or …consider alternate policy choices to strike a balance between the interests of stakeholders and benefit sharing? mechanisms to prevent exclusive licensing (as required by most IPR holders). contract obligations to return research results to the biobank. Lobbying for stricter patent thresholds and a reform of the research exemption.

4.2 Future challenges II (a selection) How to use of new collaborative models of innovation such as public– private partnerships, ‘crowd-sourcing’, and open-source sharing? How do legal and scientific developments contribute to the current ‘paradigm shift’ in pharmaceutical R&D? How does this affect biobanking? Which role can biobanks play in developing orphan drugs and treatments against rare or neglected diseases ?

5. Conclusions Important to discuss strategies & policy choices for publicly funded biobanks and their various users with regard to IPRs Alternative strategies important both outside & within IPR Balancing of stakeholder’s interests and drawing a reasonable line between openness and closeness very challenging. Setting should be flexible but also sufficiently robust and predictable. Public trust in biobanks, decisions must be made within controllable & transparent institutional settings & by well-trained professionals.

Any questions or comments? Thank you for your attention ! Contact: Timo.Minssen@jur.ku.dk