Written by Simon Portman (Of Counsel at UT Partner Marks & Clerk).

3D printing’s ability to facilitate higher quality and more adaptable and flexible design and manufacture at a lower cost is increasing exponentially and getting more and more newsworthy. As a result, the interest in it and the range of sectors it can be used in is growing at the same rate. However, we should not let this enthusiasm blind us to the potential risks which aren’t exactly new per se but, as with other developing areas like genetics, AI and XR, existing regulatory and legal frameworks may struggle to accommodate them and they are not always immediately obvious. The main ones can be categorised as follows:

LIABILITY

The existing rules on civil lability aren’t quite fit for purpose. Normally, if there is an accident or some other incident giving rise to liability or damage, the person responsible could (depending on the circumstances) potentially be any of:

· the creator or vendor of the 3D file;

· the producer of the printer or the software;

· the supplier of the materials used; or

· the person creating the object.

However, in the context of 3D printing, the entity at the beginning of this supply/manufacture chain has diminishing control the further down the chain one goes. At the moment there are no legal precedents regarding civil liability for products that were created with 3D printing so manufacturers don’t know what to expect.

The EU is looking at how the civil liability regime might be adapted to impose clarity but, meanwhile, each party needs to be protected contractually i.e. limiting its liability, requiring limits on what printers or printed products may be used for and imposing warranties and indemnities regarding use of printers to make defective products. Now it is no longer in the EU the UK will have to tackle these problems on its own, as will other countries. Obviously, for a potentially global industry, one hopes that there will be some uniformity of approach.

The insurance industry, increasingly adept at specialising in distinct industry sectors, may also need to put together cover tailored to the 3D printing sector. Some insurance companies are already doing this (see more on this below).

PRIVACY

CADs and replicas might contain personal data. For example, 3D printers are often used to test surgical procedures, meaning that the doctor will manufacture a perfect copy of the patient’s organ in order to see what problems may crop up in surgery. Currently, hospitals are very unlikely to require patients to sign an informed privacy consent document to allow the 3D printing of their organs. Moreover, such forms (and the procedures they are designed to comply with) will also need to cover what happens to that 3D printed organ after surgery. It might be used for research, but might be even made available to third parties so the information contained in it (such as the type of disease affecting the patient) might be used to perform direct marketing activities. Consent would be required for all this too and anonymization may be necessary so the 3D printed organ can’t be linked to an identifiable patient.

Similar issues may arise in connection with the production of 3D printed medical implants and prosthetics.

INTELLECTUAL PROPERTY ISSUES

Ample consideration has already been to the impact of 3D printing on the patent landscape. Other less obvious challenges include the following:

3D file exchange platforms exist via which one can reproduce a protected work. This will include works of art and they are most at risk of counterfeiting. There will be more and more copyright issues once 3D printing is used on an industrial scale.
It may also be necessary to develop, agree and adopt a FRAND-style standard licensing structure for 3D printing so that users can print an object without breaking the law or infringing IP rights, while the original developer a suitable return.

RISK MANAGEMENT

As was said above, the insurance sector will also have to play catch-up. Along with the expected risk of IP infringement, underwriters are likely to categorise the risks as follows:

Property damage risk. The risk of physical damage to, or loss of use of, tangible property due to a 3D printed object failing to function as intended.
Bodily Injury Risk - Liability will fall upon any of three possible parties: the product designer, the manufacturer who printed the product, or the raw material supplier or any of those three.
Professional Indemnity risk – The supplier could be held liable for economic loss from the failure of a printed product to work as intended, due to an error, omission or negligent act.
1st and 3rd party Cyber risk - Any 3D printed product must be designed using CAD software, which produces files that may contain proprietary information. This is vulnerable to being infringed, infringing third party IP and data breaches. Encryption and file protection are also crucial to prevent people illegally downloading or reproducing these files and copyrighted objects or duplicating illicit objects.

Insurance cover will need tweaking to accommodate all of the above and, as ever, the challenge will be to spate damage caused by defective design or manufacture from damage caused by misuse.

As well as managing liability in contracts and securing and appropriate level of insurance cover, parties operating in this sphere will be able to mitigate risk by taking the following practical steps:

Regular routine design reviews and QA and QC procedures
In depth risk analysis
Build in cybersecurity procedures and software
Acceptance testing and regular testing post-adoption
Ensure training in and adherence to industry standards
Lobby for suitable industry standards
Clear safety and use instructions with conspicuous warning labels
Effective maintenance
Well-documented compliance

Cyber and IP risks could be managed by:

Securing 3D printers and imposing similar obligations on users
Encrypting critical data elements
Using Cloud providers with a good track record for capacity and security
IP searches to ensure freedom to operate.
Protecting IP generated.

Taking all these measures will cost money so suppliers and licensors in the 3D printing field will need to factor this into the grant funding they apply for, the investment they seek and prices they charge. However, in the long run that will be considerably cheaper than disregarding one of the elephant traps detailed above and tumbling into it.

About Marks & Clerk

Marks & Clerk is one of the world’s leading intellectual property firms. Its team of patent attorneys, trade mark attorneys, and lawyers provides a full-service IP offering, from the initial filing of patents and registration of trade marks, through to litigation and commercial exploitation.

Marks & Clerk’s patent attorneys and lawyers operate across all industry sectors. Its client base is diverse, ranging from new ventures to well-known multinational corporations. It has offices in 18 locations, including nine in the United Kingdom, and others in France, Canada, Luxembourg, mainland China, Hong Kong, Malaysia, and Singapore, allowing it to tap into local expertise, globally.

Marks & Clerk was established 135 years ago and has 300 IP practitioners worldwide.

See www.Marks-Clerk.com for more information.

3D Printing – New opportunities, but new pitfalls too