11 August 2020
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3D printing” was first developed in the 1980s as a technique for rapid prototyping. Since then, 3D printing technologies have found widespread uses over a wide variety of technologies, as evidenced by a recent EPO study showing a 36% average annual growth of 3D printing-related EP patent applications between 2015 and 20181. The plethora of possible applications of 3D printing range from the building of bespoke parts for rockets and personalised pills3 to the formation of artificial tissues from bio-printed cells4. However, as high-quality 3D printers are now readily accessible and affordable, what legal challenges lie ahead as the line between manufacturer and consumer is blurred?

3D printing in Brief

3D printing” is a narrow term applied in recent years to a broad set of technologies, more accurately described as “additive manufacturing”. In 3D printing, 3D objects are formed by moving a nozzle back and forth to lay down a liquid material, much like a standard inkjet printer. However, instead of laying down ink to form a 2D image on a surface, a filament such as a wax, a polymer or even a metal is deposited in successive layers to produce a three-dimensional object.

Digital models can be built up from scans of real life objects, or designed on a computer to create a CAD (computer-aided design) file for the desired object. Software then converts the digital model into slices, which the 3D printer prints as layers. Further post-processing techniques are often also used to improve the quality of the final 3D product.

There are several different categories of 3D printing processes. These include photocuring processes (e.g. stereo-lithography (SLA) where liquid photopolymer is exposed to a light source to harden exposed regions of the photopolymer) and heat processes (e.g. fused deposition modelling (FDM) where small beads of material are fed into a heated extrusion nozzle. The material is molten as it passes through the nozzle and hardens immediately after extrusion to form a solid layer). Other categories of 3D printing processes include material jetting, binder jetting, powder bed fusion, direct energy deposition and sheet lamination.

Applications

3D printing processes are no longer used in the manufacturing industry merely for prototyping. In situations where only low numbers of a complex product are required it can be far more cost-efficient to 3D print that product. Products with complex geometries can be manufactured without specialised and expensive tooling equipment. For example, ArianeGroup now print single piece injector heads for rockets, which previously required the assembly of 248 separate components. Rolls Royce has invested extensively in developing 3D printed parts for their engines, notably producing a plane engine containing a 1.5 meter diameter 3D printed titanium structure (the largest 3D printed structure ever flown) in 2015.

3D printing techniques can also provide environmental and cost benefits to industrial manufacturers by significantly reducing manufacturing waste. For example, WAAM3D have used wire based additive manufacturing (WAAM) techniques to rapidly produce titanium alloy pressure vessels for space crafts. The pressure vessels waste 200 kg less titanium alloy per item compared to vessels produced by traditional manufacturing processes.

In the medical sector, 3D printing has found many applications in personalised medicine. Custom prosthetics and replacement joints have been printed from a range of biocompatible polymers and metal materials. As of 2019, over 600,000 implants have been produced by 3D printing techniques. The number of implants produced in this way is forecast to exceed 4 million by 2027.

Additionally, the printing of pills3 is not the only application of 3D printing set to transform the pharmaceutical industry. Researchers at the University of Glasgow are using 3D printing to “digitalise chemistry”. Professor Cronin and his group have designed bespoke chemical reactors whose designs could be downloaded and printed at remote locations, allowing the synthesis of drugs at the point-of-need. Traditional bench-top glassware is replaced by modular, plastic “reactionware that can be printed and used to produce pharmaceuticals from widely available starting materials with limited input needed by an end user9.

Even the food industry is embracing the 3D printing revolution, with products such as chocolate and pasta being viable candidates for printing. The printing of plant-based meat analogs has also been explored. Meat alternatives, containing pea and rice proteins, have been printed to mimic the nutritional value and texture of meat.

3D Printing at Home

In the late 2000s, a number of significant patents on 3D printers expired. Around the same time open source projects such as RepRap emerged, encouraging rapid innovation in the 3D printing space. Together with an advancement in computational capabilities, these factors have resulted in a drastic reduction in the price of 3D printers. Where 3D printers originally cost $200,000, they are now available for less than $2,000, and simple, basic 3D printers are now even available for purchase for under $100. The ability for consumers to print products from home has also been facilitated by easy access to printable design files online. Printable designs can be downloaded and exchanged on a vast network of online market places and forums, through websites such as Thingiverse and Shapeways.

Legal Challenges

A 3D printed object and its design file may be protectable by one or more forms of intellectual property (IP), such as design rights, copyright and patent rights.

As the capabilities of home 3D printers expand, it throws up questions of regulation: how can an IP rights holder control the exploitation of their technologies? How can the home printing of illicit goods be policed?

IP infringement

Due to the growing network of online platforms for sharing (legally or illegally) 3D design files, manufacturers and inventors face similar challenges to those faced by the music industry in the early 2000s, where sharing platforms allowed easy, unlicensed distribution of music files.

Normally, an IP rights holder would look to sue a large-scale counterfeiting manufacturer for infringement of those rights, for example to prevent further preparation of products and to recover damages for any loss suffered. However, when a consumer 3D prints a product at home, the manufacturer is omitted from the normal chain of product production. It is extremely undesirable for an IP right holder to sue individual consumers. Legal action is expensive and the level of damages recoverable from any one individual will be minimal. Consumers using 3D design files downloaded from online platforms are also likely to reside across multiple jurisdictions, with varying levels of IP protection. Additionally, UK patent and design law (as well as that of many European jurisdictions) contains provisions protecting acts carried out for private and non-commercial use. This means that a private user may circumvent infringement of IP rights by directly printing a consumer good at home for their own use.

One potential approach for an IP rights holder to take to tackle unauthorised use of their work, is to pursue intermediaries, who are typically the suppliers of the 3D printing technologies. These intermediaries might be websites that allow the sharing of CAD files that are the subject of the IP protection, or third parties that print orders for products that infringe IP rights. Some websites, for example Thingiverse, have already been issued with so-called take down notices.

Another issue facing right holders is how to track unauthorised use of the printed product. Some companies are exploring various methods of making an object or a 3D design file incorporating a unique label or feature to monitor use. Other market places are reducing the risk of unauthorised sharing by streaming 3D design files directly to an individual’s printer, instead of first providing the 3D design file to a consumer12.  

Illicit goods 

In certain areas, the legal implications of 3D printing can extend to more life-and-death matters, as evident from the widespread discussion about 3D printing of polymer guns. With suitable designs readily available on the internet, concerns extend beyond those of IP infringement in relation to tracking the production of illegal goods. 3D printed guns do not possess identifying serial numbers, making them virtually untraceable through normal channels.  

However, one possible strategy for identifying both illegal goods and counterfeit goods which infringe IP rights has been developed by researchers at the University of Buffalo. Dr Wenyao Xu and his team have designed a method of tracking 3D printed objects by identifying “fingerprints” left in the objects by the specific 3D printer used, in the form of unique “in-fill patterns13. These “in-fill patterns” vary depending on the filament type, model type, system inertia, motor speed and the nozzle size of the 3D printer used. The study focused on the printing of 5 door keys from 14 different 3D printers. Researchers digitally enhanced photos of the keys to analyse their in-fill pattern and sorted the images with an algorithm to match them to the correct printers, with 99.8% accuracy. Their results were repeatable after 10 months, and damaged variations of the keys were also matched with 92% accuracy.  

The world of 3D printing is producing an explosion of exciting and revolutionary innovation.

However, with this innovation comes many legal challenges as right owners, lawyers and law enforcement agencies alike grapple with the changes that 3D printers will make to the traditional supply chain model.


 

References

  1. EPO Study (2020) “Patents and additive manufacturing – Trends in 3D-Printing
  2. Norman, James, et al. "A new chapter in pharmaceutical manufacturing: 3D-printed drug products." Advanced drug delivery reviews108 (2017): 39-50.
  3. Murphy, Sean V., and Anthony Atala. "3D bioprinting of tissues and organs." Nature biotechnology8 (2014): 773-785.
  4. Kitson, Philip J., et al. "Digitization of multistep organic synthesis in reactionware for on-demand pharmaceuticals." Science6373 (2018): 314-319.
  5. Bechtold, Stefan. "3D printing, intellectual property and innovation policy." IIC-International Review of Intellectual Property and Competition Law5 (2016): 517-536.
  6. Li, Zhengxiong, et al. "PrinTracker: Fingerprinting 3D printers using commodity scanners." Proceedings of the 2018 ACM sigsac conference on computer and communications security. 2018.
Genevieve is a trainee patent attorney in our chemistry team. She has a degree in Chemistry with research abroad (Msci) from Imperial College London. Her PhD is in Chemistry from University College London. Her doctoral research focused on the development of DNA origami nanopores for use in biosensing devices.
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