reprinting the law - 3d printing event 2014
TRANSCRIPT
Reprinting the law
Paradigm shifts and concerns in supply
chain, warranties, liabilities and IP
Ernst-Jan Louwers
3D Printing Event
Eindhoven, 21 October 2014
Why am I here?
• 3D space = entering legal swamp
• Let a lawyer guide you
o (re)design your business
o safeguard your time to market
o avoid getting sued...
• Now, let’s suppose I was your lawyer …
I would tell you:
“shift happens because of 3D…”
(Product)
liability
Supply chain
Intellectual Property
And 3D is changing the game…
• Consumers become prosumers
• Users become manufacturers
• Doctors becoming engineers
• Engineers becoming doctors
• Dentists print implants
• Hospitals become suppliers
We would discuss redesigning your
business: many topics...
Ownership
Intellectual
property
Data
Secrecy
Human tissue & cells
Compliance
Standards & certificates
Criminal laws
Privacy
Import & export
restrictions
R&D
Collaboration
Background IP &
knowhow
Foreground IP & knowhow
Valorisation & exploitation
Supply chain
Changing rolls
Relationships
Risk
Liability
Miscellaneous
Environment
Permits
Labour conditions
We would discuss fundamental issues
Intellectual Property
Materials
Methods &
Tools
Output
Liability
Risk
Who?
When?
Supply chain
Manufacturer
Reseller (?)
Consumer
Are materials you use patentable?
• In principle: yes, if novel and inventive step
• Products of nature: in principle not patentable
• Isolated human genes? o US: NO, but…
AMP/Myriad case
o Europe: until now YES
Comparable to plant breeding
o Public opinion…
Are methods patentable?
• In principle: yes, if novel and inventive step
• US: also business methods… EU: only tech
• Products directly resulting from method?
o in principle YES: ‘product by process’
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
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)
• 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
What’s cooking? Spare parts
• GE: by 2020 60,000 spare parts printed locally by
carriers
• 3D printing customer
• Warranty?
• (Product) liability?
• Recall?
Service providers
• Responsibility? Notice and
takedown
• Liability?
• Warranty?
• Agency?
Shapeways
Thingiverse
Terms of Service
Notice and Takedown
Open Hardware license model
Consumer ‘prosumer’
• Private space:
o in principle no infringement in EU
o but in US and other countries possibly also
infringing!
• Liability & warranty?
• Taxes (VAT…)?
Prosumer
Design and
CAD file
Material
Output
Printer
Possibly leading to product liability
• Defective products
• Who is responsible?
• Who is liable?
o “producer”: who is producer?
o where is production?
Spare parts printed by customers or
service points
• What about warranty?
• Who is liable?
• Which liability for what?
• Product liability?
• Recall?
Health care: hospital as reseller
• Approvals?
• Own responsibility?
• Liability?
• Warranty?
• Agreements?
• Remove?
• Recall?
Let’s roll the dice:
whatever your game is…
Protect Contract Manage
Reposition Reconsider Reorganize
Not only prepare business plan
What is your roadmap to market?
Let ‘legal’ enable your business
Material Methods Hardware Software and data
Output