Italian Volunteer Faces Potential Infringement Suit for Saving COVID-19 Patients

Edward Maggio, J.D., M.S.

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— Updated on April 16, 2020

Italian Volunteer Faces Potential Infringement Suit for Saving COVID-19 Patients

Italy’s struggle to combat COVID-19—also known as the Coronavirus—has been an uphill battle. As of now, a total of 3,405 people in Italy have died of the COVID-19 virus. With supplies and logistics past the breaking point, any opportunity to relieve the overburdened health care system are necessary. Logistical shortcomings came to fruition last week at the Chiari Hospital in Brescia in Northern Italy.

A Plea for Help

Chiari Hospital quickly ran into problems maintaining medical supplies for intensive care patients. A demand began emerging for special breathing valves. These breathing valves are necessary for the operation of breathing equipment for treating COVID-19 virus patients in their intensive care unit of the hospital. In turn, the hospital put out a large scale media plea for assistance.

The hospital soon ran out of the breathing valves as they became inundated with patients. With the manufacturers unable to keep up with the demands of production, doctors began seeking any resources or help available. The media plea did not go unnoticed.

A Call to Action

The head of FabLab, led by noted physicist, Massimo Temporelli, began assembling a team, including engineers from the Isinnova group. Ultimately, a technician and engineer from Isinnova, Christian Fracassi, used a 3D printer to make replica breathing valves. Francassi said publicly that “there were people in danger of life, and we acted. Period,” as reflected on Facebook.

Chiari Hospital notes Fracassi saved at least 10 lives by recreating the valve. Furthermore, the Italian government praised the actions of Francassi and the team. Paola Pisano, Italy’s minister of technological innovation. Pisano stated publicly, “Congratulations to Cristian Fracassi, @temporelli73 and all the people who helped him in the business of 3D printing the missing valves for the respirators of the Chiari Hospital in Brescia.”

Infringement Versus Public Necessity

Italy’s pandemic still hasn’t influenced medical device manufacturers to assist in the fight against the virus. Valve manufacturers have refused to share their blueprints for production and are considering suing for copyright and design patent breaches. The reason being the cost of the breathing valve itself.

The official list price for a single breathing valve is around $11,000. Fracassi was able to use a 3-D printer to recreate them for the equivalent of $1 per breathing valve. That means for every patient saved, there is a loss of income for the manufacturers. This loss of revenue is a major concern for manufacturers, even during this global Coronavirus crisis.

Similar Challenges

This is also not the only isolated incident of potential intellectual monopolies and the COVID-19 virus. Currently Labrador Diagnostics is currently suing BioFire for launching three Coronavirus tests built off company technology. The company is demanding the use of those tests be blocked by court order.

Potential Solutions

The issue here raises concerns over protection of intellectual property versus claims of public necessities. And, whatsmore, preventing intellectual monopolies on necessary supplies. A solution may arise if the Italian government agrees to cover costs or purchase a license for the team to continue making 3D replicas of breathing valves.

We also have to consider the possibility that these types of life or death situations can occur domestically as well. This puts manufacturers on notice to consider their profits versus the current public necessity. It’s also a challenge for attorneys to consider how to protect their manufacturing clients while maintaining a positive public image.

Future Concerns

During this difficult time in our world’s history, legal challenges such as this situation will continue. It’s a difficult balancing act to preserve established legal principles while trying to combat the danger posed by COVID-19.

Emergency needs are likely to increase. All relief efforts are actively combating this virus at a national and international level. It’s important to discuss such public policy and copyright issues with experts who can assess the right course of action for your company.

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