1. Centre for Information and Innovation LawOctober 9, 20151 Standardization, IPRs & Open Innovation with large bioresources DNA Bioresources: Goals, Challenges & Proposals Associated with IP and Open Innovation 28 January 2016, Trinity Hall University of Cambridge Associate Prof. Dr. Timo Minssen Centre for Information & Innovation Law (CIIR) Copenhagen Biotech & Pharma Forum (CBPF) University of Copenhagen

2. Centre for Information and Innovation LawOctober 9, 20152 AGENDA 1.Focus today: SynB and SysBio (SB) 2.SB & intellectual property rights 3.SB & ”open” innovation 4.SB & standardization 5. Preliminary conclusions & challenges 6. Recommendations 7. Ongoing research

3. Centre for Information and Innovation LawOctober 9, 20153 Specific features of SB/SysB and the challenge they present to the current IPR framework applies principle of engineering to biology= abstraction, decoupling & standardization. Highly interdisciplinary approaches that boost range & complexity of genetically encoded functions in integrated bio-systems. Traditionally, specific uses of functions protected & shared via IPRs. SB & innovation gaps challenge trad. IPR system & governance.

4. Centre for Information and Innovation LawOctober 9, 20154 SB/SysB & selected intellectual property rights Patents & SPCs Copyrights Trademarks

5. Centre for Information and Innovation LawOctober 9, 20155 Sui Generis (Intellectual) Property Rights European Data Base Protection Regulatory Exclusivities Utility models Plant Variety Rights Trade secrets etc.

6. Centre for Information and Innovation LawOctober 9, 20156 SB & open innovation Open Innovation- increasingly important Ethos of openess in SB - flourishing,highly interdisciplinary community -Bottom up development -”share your parts” Strong anti-IPR movement Some valid points………BUT: Positive aspects, opportunities & mitigating effects of IPR criteria often ignored New OI platforms with new contractual & collaborative licensing solutions also developed in industry Effective and just exploitation of resources for innovation needs supportive infrastructure

7. Centre for Information and Innovation LawOctober 9, 20157 The value of standardization to SB and openess Economic/utilitarian bringing down transaction and R&D costs, more effective innovation. Normative collaborative tool enhancing sharing & collaborative tools. Strategic Offers different emphasis on variation and stabilization of technology that may be fitted to specific market, technological level of development etc.; Structural Offering infrastructure for interfacing and combination of knowledge. (enhancing interoperability & dispersed innovation)

8. Centre for Information and Innovation LawOctober 9, 20158 Where do standards come from and who the drivers of standardization Where do they come from? Who are the drivers of SB standardization? Industry Biobricks foundation Biohackers DIY bio COMBINE ISO -Informal/deliberative Community driven (Biobricks may be seen as moving towards SSO status) FormalIn-formal Deliberative SSO ’ s Community driven (i.e. Linux operating system) Authoritative RegulationPractice of market leaders (i.e. Apple iPhone or user interface in MS office) De facto & pervasive Public procurement policy/ Public Private Partnerships Market adoption/ (i.e. Network effects in high tech markets)

9. Centre for Information and Innovation LawOctober 9, 20159 Different forms of standards in systems biology and synthetic biology 1.Data presentation & exchange 2.Biomarkers 3.Physical composition/Design 4.Fabrication 5.Functional composition (characteriz.) 6.Units of measurement (characteriz.) 7.Operation of bio-systems

10. Centre for Information and Innovation LawOctober 9, 201510 Potential clashes between technical standards & IP in SB. Tech. standards pot. problematic if patents form essential part. ICT sector & SSOs: disclosed patents either subject to free licensing or on a FRAND basis Risks: unpredictable value, high transaction costs, hold ups & protracted litigation. (! NB: CJEU- Huawei vs. ZTE!) In how far do IPRs have an impact on SB standards? Have SB actors sufficiently considered & adressed this question? In how far is ICT system for IP & standards transferrable to SB? Depends on type of standards, drivers/stakehold. & how it evolved

11. Centre for Information and Innovation LawOctober 9, 201511 Preliminary conclusions & challenges Standards inscreasingly important for SB and open innovation Multifacted clashes with IP possible SSOs and lawyers should be pro-active Within IPR framework problems can be tackled pre- and post grant But also user-generated solutions and alternative incentives for promoting innovation must be considered on case—by-case basis Interface with competition law crucial, Art. 101 & 102 TFEU. Equally important: management strategies & better organization, coordination & govern. of standard. processes, tech & data transfer

12. Centre for Information and Innovation LawOctober 9, 201512 6 Recommendations for SB and IPRs (! Limited to IPR framework!) RECOMMENDATION 1 – Enhance empirical Evidence & Open Source Software Tools RECOMMENDATION 2 – Encourage and facilitate use of Public Domain Tools RECOMMENDATION 3 – Improve Patent Quality, Transparency & Trust by better collaboration between SB community, SSOs etc. and patent offices. RECOMMENDATION 4 – Adopt and promote New Licensing Practices RECOMMENDATION 5 – Explore new models for Private Ordering Mechanisms RECOMMENDATION 6 – Legislative and Regulatory Changes reg. e.g.: Utility Model Protection Research/fair use and bolar-type exemptions Special exception rules on incubators and SB intermediaries

13. Centre for Information and Innovation LawOctober 9, 201513 Selected publications & ongoing research Torrance, Andrew W. and Kahl, Linda J., Bringing Standards to Life: Synthetic Biology Standards and Intellectual Property (2014). Santa Clara High Technology Law Journal, Vol. 30, No. 2, 2014. Contreras, Jorge L.; Rai, Arti. K.; Torrance, Andrew W., Intellectual Property Issues and Synthetic Biology Standars, Nature Biotechnology, No.1, Vol. 33, pp. 24 -25 (2015) Minssen, Timo; Wested, Jakob, Standardization, IPRs and open innovation in synthetic biology. / Innovation, Competition and Collaboration. red. / Dana Beldiman. Cheltenham, UK : Edward Elgar Publishing, Incorporated, 2015. pp. 34-66. Natalie J Stanford, Katherine Wolstencroft, Martin Golebiewsk et al. The evolution of standards and data management practices in systems biology, Molecular Systems Biology, Volume 11, Issue 12, December 2015. Verlinden, Michiel; Minssen, Timo; Huys, Isabelle, Reconciling IPRs and openness in biobanking, European Intellectual Property Review, Vol. 38, Nr. 1 (2016), 01.01.2016. Minssen, Timo; Rutz, Berthold; van Zimmeren, Esther, Six recommendations on Synthetic Biology & Intellectual Property Rights, Biotechnology Journal, Vol. 10, Nr. 2, 09.02.2015, s. 236-241. In progress: Minssen, Timo; Wested, J.; van Zimmeren, Esther, Legal Models for Promoting Synthetic Biology & Systems Biology: Balancing Openness, Standardization & Intellectual Property Rights, to be submitted in mid-February.

14. Centre for Information and Innovation LawOctober 9, 201514 Open Innovation ecosystem: What would it look like? Quadruple-Helix where Industry, Academia, Government and Citizens can exchange ideas, problems and communities can collectively progress science and health more effectively.

15. Centre for Information and Innovation LawOctober 9, 201515 Any questions or comments? Thank you for your attention ! E-mail: Timo.Minssen@jur.ku.dk Web:www.ciir.dk KU course in EU Pharma Law, IPR & Life Science (for students): https://sis.ku.dk/kurser/viskursus.aspx?knr=139161 CPH Summer school in Pharma Law & Policy (for professionals): http://copenhagensummeruniversity.ku.dk/en/courses/pharmalawpolicy/

16. Centre for Information and Innovation LawOctober 9, 201516