The Legal Implications of 3D Printing in the Fight Against COVID-19

By: Alyssa Valdes

3D Print of a SARS-CoV-2

3D print of a SARS-CoV-2 virus particle

 

In the midst of the COVID-19 pandemic, medical equipment and other essentials have run out of supply, paving the way for 3D printing to alleviate these supply shortages. The increased need for certain products, such as masks, face shields, and ventilator valves, has led to a gap in supply and demand. Owners of 3D printing technology have stepped in to produce more of these products and prevent further spread of COVID-19, but their acts of kindness come with some potential risks.

The 3D printing of copyrighted or patented products raises liability concerns to those printing them. The potential for intellectual property infringement suits is a real possibility for those producing products that are in short supply on the market. One of the earlier incidents sparking this question of liability arose when engineers in Brescia, Italy began 3D printing ventilator valves that were in short supply at a local hospital. It is still unclear whether the original manufacturer of the valves threatened to sue the engineers. However, considering the dire need for certain essential products, many have said that it would be unwise to sue those who are 3D printing potentially life-saving products during the pandemic.

Many scholars have noted that even if patents or copyrights are being infringed during the current pandemic, manufacturers might want to think twice before suing for infringement. Filing suit against individuals using 3D printing technology to combat the virus could negatively impact a manufacturer’s reputation and result in bad publicity for the company. Regardless, individuals planning to 3D print products should remain cautious and take measures to become aware of whether or not a product or online design is copyrighted or patented. If there is an existing patent or copyright on a product, it would be wise to stop production once the supply gap has been filled.

The question of liability during the current pandemic has also prompted commentary about liability exemptions for essential products. Since the pandemic began, exemptions like the Public Readiness and Emergency Preparedness Act (“PREP Act”) and the Defense Production Act (“DPA”) have been implemented to limit liability risks for the 3D printing of medical supplies necessary to combat COVID-19. The PREP Act, effectuated February 4, 2020 by the Secretary of Health and Human Services, provides liability immunity to covered persons involved in the production, distribution, or use of covered countermeasures related to COVID-19. The covered countermeasures encompass drugs or devices used to diagnose, treat, or mitigate the virus. The PREP Act was later amended on April 10, 2020 to include protective masks. Now, products that typically require FDA approval can be manufactured quickly for emergency use. The PREP Act does not provide absolute immunity but it has drastically limited the amount of liability that those involved in 3D printing might face during the pandemic.

Additional immunities were guaranteed through President Trump’s executive order invoking the DPA. The DPA was invoked to bolster the production of necessary medical supplies, such as protective equipment and ventilators. Those covered under the DPA’s protection receive additional immunities from “claims of potential breach of contract, product liability, and intellectual property infringement.” Although the PREP Act and the DPA do not grant absolute immunity, those printing COVID-19 related products that are not covered under these Acts are encouraged to seek a license or covenant-not-to-sue from the intellectual property owner. During this time of crisis, several companies have provided free temporary licenses to certain intellectual property rights to help contain COVID-19. These companies include Amazon, Facebook, IBM, Intel, Microsoft, and Sandia National Laboratories. Ultimately, those taking part in 3D printing have several avenues of liability protection that have opened in response to the universal fight against COVID-19.

While the risk of liability for those who are 3D printing has been narrowed, the safety of the products being printed remains an important consideration. Many of the 3D printed products ordinarily require FDA approval, but this requirement has been relaxed to allow for quicker production of necessary supplies. 3D printed products may look the same as their original counterparts, but they may not be as effective. In regards to 3D printed personal protective equipment (“PPE”), the FDA has said that printed PPE are “unlikely to provide the same fluid barrier and air filtration protection as FDA-cleared surgical masks and N95 respirators.” While the printed products might not be as effective, there continues to be a massive supply shortage that needs to be filled. The 3D printing of essential products has ultimately played a vital role in the fight against COVID-19 by filling this gap.

 

Alyssa Valdes is a rising second-year law student at Wake Forest University School of Law. She holds a Bachelor of Science in Psychology from the University of Florida. Upon graduation, she intends to practice transactional law.