23 March, 2020
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Legal threats to Italian volunteers who are producing 3D-printed valves used in life-saving COVID-19 treatments: true or false?

The current COVID-19 outbreak put the whole world in an extremely difficult position. It poses a huge challenge to all countries, but especially to those with an extremely large number of infected persons and casualties. As of 18 March, 2020, Italy has the highest number of active coronavirus cases, with more than double the number of active cases compared to any other country.

In these circumstances, numerous challenges need to be addressed, including the shortage in adequate medical devices and the insufficient quality of devices that are available. For instance, a hospital in Brescia, a city in northern Italy where the COVID-19 outbreak was particularly severe, ran out of valves which are used to connect patients to respirators. The hospital had 250 coronavirus patients in its intensive care unit and the respirator valves are only designed to be used for eight hours at a time. Given that these valves connect the breathing apparatus to the oxygen cylinders, they are an essential part of these life support machines for people who are unable to breathe independently.

Desperate times call for desperate measures

The hospital’s usual supplier, a medical company who is the patent holder for this device, stated that they are unable to produce enough valves in time to treat all the patients. Since an alternative solution was desperately required, the hospital launched a search for a way to 3D-print valve replicas that could be used instead. Two volunteers from Isinnova, an Italian tech start-up which specializes in 3D-printing, offered to distribute 3D-printed versions of these valves, i.e. unofficial copies of the patented valve, which was in short supply in Italian hospitals.

When they asked the medical company for blueprints that could be used to print replicas, the company refused. As one of the volunteers from Issinnova told the BBC News, they moved ahead anyway by inspecting the valves, creating a prototype and starting to print new valves. They tested them on a device that was helping a patient and it worked well. In order to meet the demand, they joined forces with another local 3D-printing company called FabLab, since they have just a few printers and each valve takes about an hour to print. The day after, they had 100 valves printed.

What is 3D-printing, how does it work, and why would one risk its reputation for 1 EUR worth valve?

The term “3D-printing” covers a variety of processes for making three-dimensional solid objects from a digital file. 3D-printers are machines that can produce objects from all sorts of different materials, e.g. plastics or pharmaceutical materials.  In a nutshell, the object to be “printed” is designed using software on a computer, and then the 3D-printing process slices the object into hundreds of layers which are finally printed on top of one another to create the desired object. This makes 3D-printing the best option when only one or just a few items are required at a quick turnaround time and at a low-cost, or when the object’s geometry makes it difficult to produce using any other manufacturing technology.

According to the BBC, the 3D-printed valves cost less than EUR 1 to produce per unit and the prototype took three hours to design. Those who wonder why the original producer would risk extremely bad publicity for their actions, should be aware that the valve typically costs about USD 11,000.  However, both devices serve a purpose: the official valves are a better long-term solution because they are more durable or are re-usable, but hospitals could use this cheap alternative valve to manage a sudden, drastic increase in demand. So far, the valves they made worked in helping more than 10 patients as of 14 March, 2020.

To save lives or to be sued for patent infringement?

Volunteers emphasized that their intention was not to steal a patented design, or share and profit from it – they simply felt obliged to act and help people in vital danger. However, the news spread that the patent holder threatened them with an infringement claim.  Shortly after, both sides denied such threats. In an interview with The Verge, one of the volunteers said that the company had simply refused to share the technical specifications for producing the valves because they are the company’s property. Even the managing director of the manufacturing company stated that the information is totally false and malicious.

Before you start criticizing the patent holder…

…let us try to briefly answer the question whether their claim for protection of patent rights would have merits.

The basic and generally accepted right of patent holders is to prevent any third parties, who do not have their consent, to produce, offer for sale, market or use products that are manufactured as protected inventions or to import or store those product for aforementioned purposes.  This means that patent holders can economically exploit their inventions, which in turn, significantly encourages them to make further investment in research and development, and thus support technological progress.

As always, certain exceptions are provided. The Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS”) sets out specific provisions to be followed for issuing a compulsory license, but leaves space for legislations of each jurisdiction to define those provisions in detail. It should be noted that all the major patent systems comply with TRIPS. Some examples of situations in which a compulsory license may be granted include failure or inability of a patent holder to meet demand for a patented product.  The principal requirement is that attempts to obtain a license from the patent holder under reasonable commercial terms must have failed over a reasonable period of time. This requirement may be waived in certain situations, particularly in the cases of national emergencies or extreme urgency or cases of public non-commercial use. Such use of patented product will be non-exclusive and terminated if and when the circumstances which led to this exception cease to exist and are unlikely to recur. The patent holder should be paid adequate remuneration in the circumstances of each case.

The Serbian patent system also complies with the TRIPS.  The Act on Patents allows public authorities to issue the compulsory license if the patent holder does not use or underuses their invention in Serbia, in cases where public danger threatens the survival of the state or citizens, or in the case of public non-commercial use. Thus, the patent holder may act in compliance with the public interest, but their true ability to use or produce the invention may not be sufficient to satisfy public interest concerning the use or production of the invention. It looks like the circumstances of the current pandemic fit the criteria for such extraordinary situations.

Conclusion

3D-printing is a rapidly developing technology that comes with its unique set of advantages and opportunities for companies. It, however, also poses challenges, especially concerning civil liability and intellectual property rights. In situations like pandemics, where (i) patent holders are unable to use or produce their inventions sufficiently in order to meet the demand, (ii) third parties who have the ability to use or produce these items but do not intend to make a profit from them, and (iii) there is a current extreme emergency, it seems that there is a room for compromise. Needless to say, that compromise would most probably entail payment of a certain fee to the patent holders, unless otherwise agreed.  Ultimately, we have seen that a competent state authority could issue a compulsory license in such circumstances, whereby all interests must be taken into account and the conditions for use of the invention in question must be carefully determined. For now, it remains to be seen what kinds of actions, if any, will be taken by patent holders.

 

For more information, please contact us via covid19@geciclaw.com