throw the dice! - 3d medical printing series

3D Medical Printing Conference Maastricht, 30th January 2019

© Louwers IP|Technology Advocaten 1

Throw the Dice!

Legal aspects of 3D medical printing

Ernst-Jan Louwers, LLM

Maastricht, 30th January 2019

3D Medical Printing Conference

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Are you aware of your legal position and risksin 3D printing?

What is your role in the value chain of the future of today?

Wake-up!

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• Brief intro

• Medical Devices legislation

• Intellectual property

• Supply chain

• Liability

• Roadmap to market

Agenda Legal roadmap

Gurt Swanenberg

Eindhoven Den Haag

Who are we?

• IP & tech boutique firm

• Experienced & specialised

• To the point & no nonsense

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“We only do what we are damn good at”

Protect & attack

Enable & empower

It’s not easy…Topics to consider

Ownership

Body parts or cells

Implants

Data

Intellectualproperty andtrade secrets

Compliance

Medicaldevices

legislation

Ethics andcodes of conduct

Fundamentalrights

Privacy

R&D

Collaboration

Background IP and

knowhow

Foreground IP and

knowhow

Valorisationand

exploitation

Supply chain

Changing rolls

Relationships

Risk

Liability

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Medical devices legislation EU

• Medical Devices Directive 93/42

• Medical Devices Regulation 2017/745 (entry into force May 2020)

Medical Devices Directive

• 3D printed medical devices: currently ‘custom-made devices’ (Article 1(2)(d) MDD)o specific prescription for sole use of a particular

patient

o not being a mass-produced device adapted to meet specific requirements

• Less requirements than standard medical deviceso no comformity assessment by notified body

o no specific quality management system

o no CE mark

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New EU regulation 2017/745

• Nothing specific about 3D printing

• 3D printed medical devices no longer regulated as ‘custom-made devices’?

Custom-made device under MDR

• Definition ‘custom-made device’ (Article 2(3) MDR)o specifically made in accordance with a written prescription of any

person authorised

o specific design characteristics

o and is intended for the sole use of a particular patient

o exclusively to meet their individual conditions and needs

• Not custom-made deviceo mass-produced devices which need to be adapted to meet specific

requirements

o devices which are mass-produced by means of industrial manufacturing processes

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Consequences of MDR for 3D printed devices

• 3D printed patient-specific devices which are industrially mass-produced

o not ‘custom-made’

o standard medical device

Alternative: ‘in-house’

• Escape: ‘in-house’ 3D printed medical devices

• Recital 30 MDR:“Health institutions should have the possibility of manufacturing, modifying and using devices in-house and thereby address, on a non-industrial scale, the specific needs of target patient groups which cannot be met at the appropriate level of performance by an equivalent device available on the market”

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Requirements ‘in-house’ devices

• Less requirements (article 5(5) MDR)For health institutions established in EU

• But still:

o quality management system

o declaration

o documentation

Alternative: ‘in-house’

• Healthcare facility = ‘manufacturer’ (article2(30) MDR)

“natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark.”

• Negative aspects:

o obligations related to status of ‘manufacturer’

o manufacturer’s liability including product liability

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Some legal challenges

IntellectualProperty

Material

Method

Output

Liability

Risk

Who?

When?

Supplychain

R&D

Factory

Reseller

IP main driver: protect it!

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Material Method HardwareSoftware and data

Output

Your business plan to market

Materials

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Material patentable?

Starting materialpatentable?

• Products of nature: in principlenot patentable

• Isolated human genes?o US: NO, but…

o AMP/Myriad case

o Europe: until now YESo Comparable to plant breeding

o Public opinion…

• Nonhuman (synthetic): YES

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Methods

Methods patentable?

• Technology of bioprinting

o YES

• Products directly resulting from method?

o In principle YES (‘product by process’)

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Hardware, software and data

Hardware and embedded software:patent, copyright, database

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Software and data:patent, copyright, database

Tissue and spare parts

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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’

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Ethical challenges and legislation

• Legal limitations on use of human tissue

• Privacy

• IP?

• Ownership

Protheses and dental

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• 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 bepatentable

Protheses and dental & IP

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Protect and enforce

Reprint your partner: infringement?

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Shift happens…

Liability

Supplychain

Changing the game…

• Hospitals to become factories

• Doctors becoming engineers

• Engineers becoming doctors

• Dentists printing implants

• Industry becoming suppliers of human tissue and spares

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Throw the dice

Reconsider your position and relationships!

Where do you stand in the value chain of the future?

What if something goes terriblywrong?

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Output - risks

Contamination

Rupture of implant

Product liability

• Defective products

• Who is producer? Legislation!

• Who is responsible?

• Who is liable? Legislation!

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Hospital as manufacturer

• Own responsibility?

• Liability? For what?

• Warranty?

• Agreements?

Spare parts and solving implants

• Print it yourself protheses

• Limited warranty?

• Product liability?

• Remove?

• Recall?

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Not only prepare business plan

Roadmap to market

But also your legal plan

Material Method HardwareSoftware and data

Output

Throw the dice:whatever your game is…

Protect? Contract Manage

RepositionReconsider Reorganize

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Prevent your MAYDAY… call your lawyer!

www.louwersadvocaten.nl

@louwerslaw

@ejlouwers

[email protected]

+31 40 2393200

+31 6 52 048154

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throw the dice! - 3d medical printing series

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