Bioprinting the law Paradigm shifts and concerns in supply chain, warranties, liabilities and IP Ernst-Jan Louwers QED Conference Brussels, 4 November 2014
Who are we? Eindhoven The Hague IP Innovation Privacy Security IT Procurement Internet Ecommerce Anticipate - Advise - Solve Manage risks - Contract Litigate Service - Maintain
Bioprinting: Frankenstein revisited?
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
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.
What to discuss today? Awareness! Intellectual Property Supply chain Liability Material R&D Risk Method Factory Who? Output Reseller When?
IP main driver: protect it!
Material Method Hardware Software and data Output Your business plan to market
Material patentable?
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
Methods patentable? Technology of bioprinting: YES Products directly resulting from method? o in principle YES ( product by process )
Hardware
Software, design file and data
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)
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
Protheses and dental
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
Personalised medicine & IP
Challenge: IP enforcement IP = in principle national law 3D designs easily shared on internet
Supply chain Shift happens Liability
Changing the game Hospitals to become factories Doctors becoming engineers Engineers becoming doctors Dentists printing implants Industry becoming suppliers of human tissue and spares
Rolling the dice Reconsider your position and relationships! Where do you stand in the value chain of the future?
What if something goes terribly wrong?
Risks Contamination Rupture of implant
Product liability Defective products Who is liable? o who is producer? Legislation! o who is responsible? o who is liable? Legislation!
Hospital as reseller Own responsibility? Liability? Warranty? Agreements?
Spare parts and implants Print it yourself protheses? Limited warranty? Product liability? Remove? Recall? Existing regulations and classifications?
Roadmap to market Material Method Hardware Software and data Output Not only business plan But also legal plan
Let s roll the dice: whatever your game is Reconsider Reposition Reorganize Protect Contract Manage
Share (and save) Sharing o best practices o legal insights o policies Agreements o consortium agreements o licenses o R&D
www.louwersadvocaten.nl @louwerslaw @ejlouwers louwers@louwersadvocaten.nl +31 40 2393200 +31 6 52 048154