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3D printing boom stirs legal questions

Read time 5min 20sec

Though full of possibilities, 3D printing also raises many legal, ethical and practical concerns.

This is according to analysts and legal experts, as manufacturing industries, healthcare providers and supply chains accelerate their practical uses of 3D printing.

3D printing, also known as additive manufacturing, is a technique that uses a device to create physical objects from digital models.

The output can be a prototype, tooling, jig, fixture or finished good. 3D printing consists of seven manufacturing technologies to produce items from a wide range of plastic, ceramic, glass, metal and biomaterials. The range of 3D-printable materials has grown significantly, making the technology appealing to a wider array of organisations.

According to market analyst firm Gartner, worldwide more than 100 manufacturers produce enterprise-class 3D printers, costing from $2 500 to several million dollars.

It notes the number of providers has more than doubled over the past three years, the result of research and investments by public and private institutions worldwide. While Gartner does not count their numbers, materials providers that formerly focused on conventional manufacturing are now also providing powders, filaments and resins for use in 3D printers.

Science fiction

Claire Kotze, a candidate attorney at law firm Norton Rose Fulbright SA, says for many years, 3D printing was nothing more than science fiction.

She notes this changed dramatically with the lapse of important patents in 2009 and 2014, giving 3D printing an enormous boost in its development and making it increasingly accessible to the average person, both in terms of usability and price.

However, describing the legal, ethical and practical concerns, Kotze says, for example, it is very difficult to control what is printed.

“While any form of homemade weaponry is illegal in South Africa, foreign courts have had to rule on the legality of 3D-printed weapons, a consequence which was unfathomable 10 years ago.”

According to Kotze, in terms of intellectual property law, questions arise concerning copyright, patent, design and trademark protection.

“From a copyright point of view, an important distinction needs to be made between a 3D-printed object for private use versus commercial use. Most countries provide for specific copyright infringement exceptions where copies are made for private or educational use.”

She explains that copyright law (but not the law of passing off) allows for a further exception in the case of “reverse engineering”, which is a process whereby an object with a practical purpose, available in the public domain, is reverse-engineered in order to make some sort of copy of that object.

Whether the 3D scanning and printing of an object will fall under the reverse-engineering exception is yet to be determined, says Kotze.

She adds that other important issues arise in terms of civil liability and insurance. “In South Africa, manufacturers have strict liability for products which they manufacture. Consumers may have remedies in terms of the Consumer Protection Act and the common law for harm that is causally linked to a defective product. But who bears the risk for harm caused by a 3D-printed object?

“Is the manufacturer the creator of the Computer-Aided Design file, the owner of the printer, the software developer, the supplier of the materials, the end seller, or even the machine itself?

“The answer depends on who is responsible for the defect causing harm or otherwise negligent. The insurance industry will need to price for risks related to 3D printing technology. Brokers and insurance providers will have to consider new possibilities around product recall, product liability risk and professional indemnity due to 3D printing,” says Kotze.

Counterfeiting and performance

Pete Basiliere, Gartner research VP for additive manufacturing, points out that the extent of challenges to 3D printing from a legal perspective will vary by country.

Nonetheless, he says overall, the challenges fall into two areas: counterfeiting and performance.

According to Basiliere, counterfeit manufacture of existing products with 3D printers has not been an issue to date, as the number of enterprise-class 3D printers that have been sold worldwide is still very small.

“Couple that with the fact the 3D printers that have been sold are spread across seven technologies and 200 vendors, and you can see there are few 3D printers that could be used to counterfeit a product.

“A crook would have to have access to the 3D printer, access to the materials, access to the print files and the skill to operate the 3D printer. And just as a smart crook would not counterfeit a R10 banknote because the reward is not worth the penalty when caught, counterfeiting of a manufactured part would mean copying something that has high value and a large number of users that could be fooled.”

Basiliere believes potential performance issues are more real, as 3D-printed items are being used for medical implants and critical machinery components, among other uses, where failure can be life-threatening.

“Failure of 3D printed items – as well as failure of their conventionally manufactured counterparts – will result in legal complications for the manufacturer.”

Basiliere says the hearing aid industry uses 3D printing extensively, with all the major providers offering 3D-printed hearing aid shells and speaker housings.

He adds the clear dental brace industry (where a plastic-moulded brace replaces traditional post-and-wire hardware) would not be possible without 3D printing, as every one of the clear dental braces has a unique 3D printed mould around which the brace is formed.

“Healthcare providers are using colour 3D-printed models as part of surgical preparations. Surgeons are able to hold colour models in their hands, enabling not only better planning but also practise runs. The surgical team can better coordinate who does what, especially on difficult and complex operations.”

The EU Parliament has started to discuss how to deal with 3D printing, and it seems the accepted solution is to create entirely new legislation.

“In South Africa, we await 3D printing to be raised in Parliament,” Kotze concludes.

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