Innovators and volunteers are rallying to 3D printing to combat the new coronavirus. But with this ingenuity comes concerns about patent infringement and product safety.
Owners of patents on certain designs of face shields, masks, and ventilator parts could have infringement claims against printers. There is also a risk of lawsuits if supplies are unsafe.
Shortages of masks, gowns, and other protective gear in many cities hit hard by the pandemic have driven innovations. Open-source instructions are readily available, and volunteers are lining up.
More than 4,300 individuals—from Portland, Ore. to Berlin, Germany—have added their names to a Google Doc circulating online with offers to help 3D print medical supplies. Businesses, and even some universities, have also offered help.
“If there’s a patent covering it and you actually 3D print it, then you’re clearly infringing,” said Lucas Osborn, an intellectual property law professor at Campbell University and attorney at Michael Best & Friedrich LLP.
The owners of patents on critical medical technologies may be reluctant to sue for infringement in the middle of a pandemic. But some could be compelled to assert their intellectual property rights to stop the 3D printing of a product if there are safety concerns, attorneys said.
“On the one hand, it’s fantastic to have everybody come together,” Graham Phero, an intellectual property attorney at Sterne Kessler Goldstein & Fox PLLC, said. “On the other hand, we really do need to respect patent rights and we do need to make sure these products are safe for the end consumers.”
Countless 3D printing efforts have sprung up during the pandemic, many of them led by well-meaning individuals who have access to 3D printing technology that has become relatively inexpensive and commonplace.
In upstate New York, 3D printing company Budmen Industries has made hundreds of face shields for local health care workers. A Montana dentist has posted directions to make 3D printed masks, while St. Luke’s University Hospital in eastern Pennsylvania partnered with a local business to print N95 respirator masks and other supplies.
Some have also worked to create open-source ventilators that can be made with 3D printed parts. One such project is the VentilAid, led by a team from the Polish company Urbicum. Their website includes the full list of parts and instructions to create the device.
The Food and Drug Administration has said it’s possible to use 3D printing to make certain parts in short supply but that some complex products might not be easily produced. It has warned that 3D printed masks, for example, might not provide the same level of protection as traditional masks.
Safety risks can arise when organizations or individuals move forward even though they’re unaccustomed to making medical supplies and lack quality-control measures, Matthew Jacobson, a product liability attorney at Reed Smith LLP, said.
Use of a defective 3D printed product and pinpointing its origin—whether the flaw was in the original design, the printing process, or somewhere else—could lead to finger-pointing.
“The goal is not to tell these universities and entities not to do this,” Jacobson said. “It’s to make sure they understand there are potential gaps in the law and potential liabilities they could incur later on if one of these products is found to be defective or causes an injury to someone.”
Anyone who makes or uses a patented invention without permission, possibly including hospitals, can be liable for infringement even if they were unaware of the patent.
For 3D-print volunteers, knowing which designs are covered by patents can be difficult. Analyzing the landscape to assess the risk of infringement can be a time-consuming process that doesn’t fit with the act-fast instinct among volunteers.
Even those who merely provide online 3D-printable product designs or printing instructions could face lawsuits. Patent owners’ legal bar for proving indirect infringement is high, because the instruction-provider must know of the patent.
“But that risk is there as well,” Timothy Holbrook, a professor at Emory University who specializes in IP.
It would be impractical for a patent owner to sue everyone printing supplies on a small scale out of their home or business, said Hunton Andrews Kurth partner Sheila Mortazavi. The optics of filing an infringement lawsuit during the crisis and potential backlash could dissuade litigation.
Still, people with good intentions should proceed with their eyes open to the potential risks, attorneys said.
“My advice would be to think about what you’re doing, and make sure what you’re doing is helping more than hurting,” Phero said. “You need to be prepared for the unintended consequences.”
· For additional legal resources, visit Bloomberg Law In Focus: Coronavirus (Bloomberg Law Subscription)