Reprinting the law - legal aspects of 3D bioprinting - Ernst-Jan Louwers

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