1. Centre for Information and Innovation LawMarch 5, 20131 Reinventing the Law for Synthetic Biology? – A brief overview on some emerging legal challenges Center for Synthetic Biology Yearly Meeting – 5-6. March 2013 at Copenhagen Zoo (20 min) Ass. Prof. Dr. Timo Minssen Centre for Information and Innovation Law (CIIR) Copenhagen Biotech & Pharma Forum (CBPF) University of Copenhagen

2. Centre for Information and Innovation LawMarch 5, 20132 I. AGENDA I.Intro & Agenda II.SB’s features and”the law” III.SB & property rights IV.SB & ”open” innovation (cf. Jakob) V.Technical standards in SB & competition law (cf. Jakob) VI.SB & human rights VII.SB & regulatory law VIII.Conclusions & our tasks

3. Centre for Information and Innovation LawMarch 5, 20133 II) Specific features of SB and the challenge they present to the current legal framework SB: an emerging field applying principles of engineering to the study of biology - great private and public investments Advances in DNA syntheses & gen. engineering boost range & complexity of genetically encoded functions within integrated bio-systems. Traditionally, specific uses of such functions were mostly protected and shared via a IPR based framework of rights. SB is challenging the traditional IPR system. Pressing need to understand if and how the IPR system and IP standards might best be applied or modified to support continued innovation in SB. SB also create special challenges for i.a., organization & administration of open innovation-models, standard setting, HR issues & regulatory law.

4. Centre for Information and Innovation LawMarch 5, 20134 III) SB & (intellectual) property rights SB & patents SB & copyrights SB & trademarks

5. Centre for Information and Innovation LawMarch 5, 20135 III) SB & (intellectual) property rights - The patent issue-. warnings for a ‘perfect storm’ – fuelled by an accumulation of patent law’s problem children, i.e. patents related to biotechnology and software Patent eligible subject matter & definition of invention, more patents? New standards for inventive step, person skilled in the art? Resources of patent offcies and courts? More cooperation between reseach community and patent offices? How to enhance patent quality? New formulation of fair use and research exemptions

6. Centre for Information and Innovation LawMarch 5, 20136 III) SB & (intellectual) property rights - The copyright issue

7. Centre for Information and Innovation LawMarch 5, 20137 III) SB & (intellectual) property rights - The trademark issue

8. Centre for Information and Innovation LawMarch 5, 20138 IV) SB & open innovation Open Innovation- the concept Open (synthetic) biology Pooling & licensing solutions for synthetic biology Industry specific solution and mitigating current standards and modifications within the patent system? (see above)

9. Centre for Information and Innovation LawMarch 5, 20139 V) Technical standards in SB and competition law technical standards can be problematic if patents form essential part. In IT & telecom sector, standards-essential-patents are subject to licensing on a FRAND basis – ‘fair, reasonable and non-discriminatory’. Such patents often have unpredictable value, and can lead to high transaction costs, hold ups and protracted litigation. In how far is the IT&telecom systems for standards transferrable to SB? trademarks can play a vital role in setting standards resulting in further questions about interrelationship between trademarks & patents in SB

10. Centre for Information and Innovation LawMarch 5, 201310 VI) SB & human rights cf: D. Ruggiu, Synthetic Biology and Human Rights in the European Context 31 Bio. L. Rep. 4, 337 (2012) Both production & distribution of SB products raise questions with regard to the health and safety of both workers, patients and consumers. Impact on environment by dispersion of SB organisms → risks for health Principle of autonomy: right of patient in free & informed consent/ right of consumers to make free & informed choices → proper labeling of products. Human dignity: modification of genome of complex organisms, including humans, via artificial chromosomes Anti –discrimination: human enhancement and right for access to health 3 levels of legal analysis necessary: (1) international legal framework (UN, WMA, WHO treaties etc.); (2) EU law & CJEU case law; and (3) the Council of Europe & the European Court of Human Rights (ECtHR).

11. Centre for Information and Innovation LawMarch 5, 201311 VII) SB & regulatory law BioSafety must be guaranteed by product & activity specific regulation (risk for terrorism) Regulation of early stage biotech & life science research -Good Laboratory Practice (GLP) -Specific rules on SB Human Tissue and Cells, necessary? -Micro-Organisms I: Protection of workers/researchers -Mirco-Organisms II: Controls on ”contained use” Specific clincal trial & pharmacovigilance regulation of SB products, necessary?

12. Centre for Information and Innovation LawMarch 5, 201312 VIII) (Preliminary) conclusions & our envisaged tasks within the project Pressing need to examine organization & governance of open innovation models and the optimizations of patent systems, laws & regulation Statutory changes to enhance SB innovation without excluding per se the enforceability of patent claims on the specific use of functions? How to achieve better co-operation of SB community with patent offices/agencies to improve the quality of necessary SB patents? How to make ownership more transparent? Legal solutions enhancing analysis of patent threats/freedom to operate? How to improve (best) practices for the licensing of IPRs in core SB tech?

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14. Centre for Information and Innovation LawMarch 5, 201314 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: CPH Summer school: http://copenhagensummeruniversity.ku.dk/en/courses/pharmalawpolicy/

15. Centre for Information and Innovation LawMarch 5, 201315