The entrepreneurs in the 3D printing industry will likely co-create a new regulatory regime as they try to build new profitable business models. We will find that the regulations that will accompany this space will most certainly affect the financial, legal and regulatory 3D printing landscape.
Here are five questions to consider:
1. What are some of the most pressing legal issues that may affect the 3D printing industry and innovation?
It is a little hard to predict just one pivotal issue for the 3D printing industry because 3D printing is actually implemented across many varied industries. 3D printing has implications on industries from medicine to consumer products and everything else in between.
Pivotal 3D printing issues may differ from one industry to another. Generally, however, major 3D printing legal issues will likely fall into the following three categories:
A. Intellectual property
B. Regulatory compliance/safety and
C. Product liability.
Underlying these three major issues are enforcement concerns and implications for privacy and constitutional rights. For example, how can we effectively stop people from improperly 3D printing dangerous or counterfeit products in their homes, without jeopardizing constitutional liberties?
2. What security issues, such as the use of 3D printing to create firearms, that may be in the regulatory crosshairs in the near future? How will the regulatory climate for 3D printing evolve?
Regulatory issues of security and public safety, especially in certain industries, will be prominent. The ability of a 3D printer to replicate explosive devices, guns, or dangerous machinery may potentially threaten public safety and well-being.
Even replication of non-violent goods can be a threat, such as complicated medical devices that require specialized training to operate.
Although there are laws and regulations on the books that likely already apply, such as export controls and FDA regulations, I am certain that these will be tightened to specifically account for the emerging technology of 3D printers.
After all, the prospect of receiving a counterfeit 3D printed heart valve is terrifying (especially one that ultimately fails).
And these concerns aren’t limited to just those who purchase 3D printed goods.
A neighbor who manufactures revolvers right next door can make counterfeit goods the least of your worries.
3. How has and will 3D printing dealt with the possibility of IP infringement legal challenges and will IP infringement become a larger issue once 3D printing becomes more widespread?
Because 3D printing technology is based on physically replicating items (intellectual property – including copyright, trademark, trade dress, patents, and trade secrets), – it may gain new life and ultimately new case law interpretation.
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Numerous intellectual property issues such as counterfeiting, file sharing, a likelihood of confusion, and fair use (both in trademarks and copyrights), as well as direct, indirect, and willful infringement, may be tested with 3D printing technology much like in the past with P2P file sharing, semiconductors, and the Internet.
3D printing technology will certainly test the limit of intellectual property laws. On the bright side, it won’t be the first time intellectual property laws have evolved to embrace new technology.
The advents of radio, copy machines, file sharing, and the Internet all led to new applications of intellectual property laws to technology that didn’t exist at the time the laws were created.
4. What complex liability issues 3D printed products may face if they cause harm to or are used to harm consumers?
Much of 3D printer technology will be consumer-facing and consequently raise defective product, warranty, and other consumer-related issues.
The traditional manufacturing and purchasing models, along with their associated laws and established risk allocations, will likely be disrupted.
Example
The ultimate consumer may no longer be buying well-tested, final, ready-to-use, neatly packaged products. Instead, she may be buying the raw materials, 3D printing technology, digital files, and blueprints to make certain parts or products on her own.
If the final product causes property damage or bodily injury, that may be in part due to user error or unforeseen conditions such as temperature or light intensity.
In that case, who is ultimately responsible? If the consumer/producer shares liability with the designer and/or supplier, how is the joint responsibility allocated?
These new facts will most certainly push the limits of century-old legal principles.
3D printing technology will certainly challenge traditional definitions of “product,” “manufacturer,” “seller,” “reseller,” and “ownership.”