Associate Prof. Dr. Timo Minssen Centre for Information & Innovation Law (CIIR)

1. Standardization, IPRs & Open Innovation with large bioresources DNA Bioresources: Goals, Challenges & Proposals Associated with IP and Open Innovation28 January 2016, Trinity HallUniversity of Cambridge Associate Prof. Dr. Timo Minssen Centre for Information & Innovation Law (CIIR) Copenhagen Biotech & Pharma Forum (CBPF) University of Copenhagen

2. AGENDA • Focus today: SynB and SysBio (SB) • SB & intellectualpropertyrights • SB & ”open” innovation • SB & standardization • Preliminary conclusions & challenges • Recommendations • Ongoing research

3. 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. Specific features of SB/SysB and the challenge they present to the current IPR framework

4. Patents & SPCs Copyrights Trademarks SB/SysB & selected intellectual property rights

5. European Data Base Protection • Regulatory Exclusivities • Utility models • Plant Variety Rights • Trade secrets etc. Sui Generis (Intellectual) Property Rights

6. Open Innovation- increasinglyimportant Ethos of openess in SB - flourishing,highly interdisciplinarycommunity - Bottom up development - ”shareyour parts” Stronganti-IPR movement Some valid points………BUT: Positive aspects, opportunities& mitigatingeffects of IPR criteriaoftenignored New OI platforms with new contractual &collaborative licensing solutions alsodeveloped in industry Effective and just exploitation of resources for innovation needs supportiveinfrastructure SB & open innovation

7. 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) The value of standardization to SB and openess

8. 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)

9. Data presentation & exchange 2. Biomarkers Physical composition/Design Fabrication Functional composition (characteriz.) Units of measurement (characteriz.) 7. Operation of bio-systems Different forms of standards in systems biology and synthetic biology

10. 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 actorssufficientlyconsidered&adressedthisquestion? In how far is ICT system for IP & standards transferrable to SB? Depends on type of standards, drivers/stakehold. & how it evolved Potential clashes between technical standards & IP in SB.

11. 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 Preliminary conclusions & challenges

12. 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 6 Recommendations for SB and IPRs(! Limited to IPR framework!)

13. 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. Selected publications & ongoing research

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

15. 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/ Any questions or comments?