Re-/bioprinting the law - 28 January 2015 - Ernst-Jan Louwers
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Re-/bioprinting the law Paradigm shifts and concerns in supply chain, warranties, liabilities and IP Ernst-Jan Louwers 3D Bioprinting Conference MECC Maastricht, 28 January 2015
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Transcript of Re-/bioprinting the law - 28 January 2015 - Ernst-Jan Louwers
Re-/bioprinting the law
Paradigm shifts and concerns in supply
chain, warranties, liabilities and IP
Ernst-Jan Louwers
3D Bioprinting Conference
MECC Maastricht, 28 January 2015
Eindhoven The Hague
Who are we?
• Lean and mean niche firm
• Specialised and no nonsense
• Focus on intersection of law and
technology
What do we do?
Protect and attack
Enable and empower
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
Shift happens…
What about you?
Are you aware of your legal position and
risks in R&D or commercialisation?
Where is your role in the value chain of
the future?
Agenda
• Topics to consider
• Intellectual property
• (Product)liability
• Roadmap to market
• Joint R&D and (open) innovation
It’s not easy…
Many topics to consider
Ownership
Body parts or cells
Implants
Data
Intellectual property and
secrecy
Compliance
Existing regulations*
Ethics and codes of conduct
Fundamental rights
Privacy
R&D
Collaboration
Background IP and
knowhow
Foreground IP and
knowhow
Valorisation and
exploitation
Supply chain
Changing rolls
Relationships
Risk
Liability
* Among others EU Directives and US FDA regulations on admission and classification of medical devices.
Why?
Awareness, assessment and precaution!
Intellectual Property
Material
Method
Output
Liability
Risk
Who?
When?
Supply chain
R&D
Factory
Reseller
Protect it!
Define your freedom to operate…
Or share and improve in open
innovation…
Material Method Hardware Software and data
Output
Your business plan to market
What is intellectual property?
Copyright
(software)?
Patent?
Utility design?
Knowhow –
trade secret?
Trademark?
Copyright
(shape)?
Overall
impression?
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/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
• 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
Protheses and dental & IP
Personalised medicine & IP
Challenge: IP enforcement
• IP = in principle national law
• 3D designs easily shared on internet
IP
Supply chain
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
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?
Not only business plan
Roadmap to market
But also legal plan
Material Method Hardware Software and data
Output
Let’s roll the dice:
whatever your game is…
Protect Contract Manage
Reposition Reconsider Reorganize
Share (and save)
• Sharing o best practices
o legal insights
o policies
• Agreements o consortium agreements
o licenses
o R&D
Joint R&D – Open innovation
Agreements…
• Input o Efforts
o Background knowhow and IP
• Output o Foreground knowhow and IP
o Exploitation
• Governance (steering committee)
• Secrecy and patents
• Liability
• (De)escalation
Rolling the dice
What about you?
Where do you stand in the value chain
of the future?
Reconsider your (legal) position and
relationships!
• IP strategy: offensive - defensive
• Assessment and compliance
• Formalisation of your role
• Joint R&D - consortium agreements
• Valorisation, licensing and
commercialisation
Legal roadmap
