Bioprinting the law. Paradigm shifts and concerns in supply chain, warranties, liabilities and IP. Ernst-Jan Louwers

Transcription

1 Bioprinting the law Paradigm shifts and concerns in supply chain, warranties, liabilities and IP Ernst-Jan Louwers QED Conference Brussels, 4 November 2014

2 Who are we? Eindhoven The Hague IP Innovation Privacy Security IT Procurement Internet Ecommerce Anticipate - Advise - Solve Manage risks - Contract Litigate Service - Maintain

3 Bioprinting: Frankenstein revisited?

4 By 2016, 3D printing of tissues and organs (bioprinting) will cause a global debate about regulating the technology or banning it for both human and nonhuman use. Gartner 2013

5 It s not easy Many topics to consider Ownership Compliance R&D Supply chain Body parts or cells Existing regulations* Collaboration Changing rolls Implants Ethics and codes of conduct Background IP and knowhow Relationships Data Fundamental rights Foreground IP and knowhow Risk Intellectual property and secrecy Privacy Valorisation and exploitation Liability * Among others EU Directives and US FDA regulations on admission and classification of medical devices.

6 What to discuss today? Awareness! Intellectual Property Supply chain Liability Material R&D Risk Method Factory Who? Output Reseller When?

7 IP main driver: protect it!

8 Material Method Hardware Software and data Output Your business plan to market

9 Material patentable?

10 Starting material patentable? Products of nature: in principle not patentable Isolated human genes? o US: NO, but o AMP/Myriad case o Europe: until now YES o Comparable to plant breeding o Public opinion Nonhuman (synthetic): YES

11 Methods patentable? Technology of bioprinting: YES Products directly resulting from method? o in principle YES ( product by process )

12 Hardware

13 Software, design file and data

14 Tissue and parts: IP protected? Can you patent an ear? Printed using human cells from Lieuwe van Gogh, great-grandson of Vincent van Gogh (sharing 1/16th of the same genes)

15 Output: IP protected? Can you patent an ear? Printed human tissue or organs patentable? o function and structure significantly different from human cells o not simply products of nature Inventive step? Novelty? o right ear is same as left ear - no novelty? Output of method: product by process

16 Protheses and dental

17 Protheses and dental & IP 3D printed jaw patentable? 3D printed joints patentable? Shape and function? Or only the material? BUT again: Method and output as product by process Mixtures and intermediate result may be patentable

18 Personalised medicine & IP

19 Challenge: IP enforcement IP = in principle national law 3D designs easily shared on internet

20 Supply chain Shift happens Liability

21 Changing the game Hospitals to become factories Doctors becoming engineers Engineers becoming doctors Dentists printing implants Industry becoming suppliers of human tissue and spares

22 Rolling the dice Reconsider your position and relationships! Where do you stand in the value chain of the future?

23 What if something goes terribly wrong?

24 Risks Contamination Rupture of implant

25 Product liability Defective products Who is liable? o who is producer? Legislation! o who is responsible? o who is liable? Legislation!

26 Hospital as reseller Own responsibility? Liability? Warranty? Agreements?

27 Spare parts and implants Print it yourself protheses? Limited warranty? Product liability? Remove? Recall? Existing regulations and classifications?

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29 Roadmap to market Material Method Hardware Software and data Output Not only business plan But also legal plan

30 Let s roll the dice: whatever your game is Reconsider Reposition Reorganize Protect Contract Manage

31 Share (and save) Sharing o best practices o legal insights o policies Agreements o consortium agreements o licenses o R&D

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