Post on 19-Oct-2014
description
Reprinting the law
How to position yourself?
Ernst-Jan Louwers
3D Bioprinting Conference
Maastricht, 19 June 2014
• IP, innovation, technology and privacy
• Risk management, compliance and governance
• Advice, contracts and litigation
• On top of tech developments
• Lean & mean in premier league
Intro
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… Topics to consider
Ownership
Body parts or cells
Implants
Data
Intellectual property and
secrecy
Compliance
Medical legislation
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
Your first legal challenges
Intellectual Property
Material
Method
Output
Liability
Risk
Who?
When?
Supply chain
R&D
Factory
Reseller
IP main driver: protect it!
Material Method Hardware Software and data
Output
Your business plan to market
Materials
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
Methods patentable?
• Technology of bioprinting: YES
• Products directly resulting from
method? o in principle YES (‘product by process’)
Hardware, software and data
Hardware and embedded software:
patent, copyright, database
Software and data: patent, copyright, database
Tissue and spare parts
Tissue and spare 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
• 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
Personalised medicine & IP
Cost of genome generation
Source: http://www.kpcb.com/internet-trends
• Pharma as usual?
• Or paradigm shift?
BUT obstacles:
• Genetic privacy
• Lack of regulation and
pharma/diagnostic co-development
guidelines
Personalised medicine
Protect and enforce
Reprint your partner: infringement?
Be prepared
Define your IP strategy
Identify, register and enforce your IP
Manage valuable intellectual assets
Manage your licenses (in/out)
Secrecy and NDAs
Consortium agreements
Manage your contracts and risks
Shift happens…
Liability
Supply chain
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?
Output - risks
Contamination
Rupture of implant
Product liability
• Defective products
• Who is liable?
owho is producer? Legislation!
owho is responsible?
owho is liable? Legislation!
Hospital as reseller
• Own responsibility?
• Liability?
• Warranty?
• Agreements?
Spare parts and solving implants
• Print it yourself protheses
• Limited warranty?
• Product liability?
• Remove?
• Recall?
Not only prepare business plan
Roadmap to market
But also your legal plan
Material Method Hardware Software and data
Output
Share (and save)
• Agreements o consortium agreements
o licenses and cross-licenses
o R&D and produce
• How about sharing? o best practices
o legal insights
o policies
www.louwersadvocaten.nl
@louwerslaw
@ejlouwers
louwers@louwersadvocaten.nl
+31 40 2393200
+31 6 52 048154