Recent news reports have highlighted how 3D printing can be applied to manufacture components for much needed medical equipment during the current COVID-19 pandemic. But what are the intellectual property risks?
The press have highlighted the case of two Italian volunteers with 3D printing equipment who produced a number of vital valves urgently needed by a hospital in Brescia, Italy for connecting breathing equipment to oxygen tanks. The Italian volunteers, who run a small start-up manufacturing company, printed a prototype valve for testing from a component donated by the hospital within a period of three hours, and started production shortly after the hospital confirmed the valve was acceptable. A number of the valves were supplied by the volunteers at a price of $1 – the usual price tag is higher than this. To date, at least 10 lives have been saved.
3D printing covers a variety of processes in which liquid or powder material is applied in successive layers to build a three-dimensional shape. The technology is not new - it has been around in some form since the 80s, but the evolution of 3D printing processes means the technology can now be used to manufacture very complex parts, with a high degree of precision. The process is repeatable and cost effective. Products can be manufactured quickly with minimal waste.
A prerequisite for producing any 3D printed part is a digital 3D model or a computer aided design (CAD) file. It is very easy to produce a digital 3D model by scanning an existing component or part – which can often be sourced very easily. The Italian volunteers reportedly scanned a valve from the hospital’s own stock.
On its face, 3D printing presents an ideal opportunity for any socially responsible volunteers or manufacturers with the necessary equipment to quickly step in to the production of components in short supply, including parts for life saving medical equipment.
What 3D manufacturers need to know
Manufacturers should be aware of the complex intellectual property issues concerned with this 3D printing technology. Parts such as valves or other medical devices and equipment are capable of protection by patent and/or registered design. Unregistered design rights and copyright will also apply to the part itself and/or the digital model or CAD file. Some or all of these rights might apply in respect of a single component.
In scanning a component such as a valve, and manufacturing a part using 3D printing equipment, there is a risk that this action will infringe an existing patent, design or copyright which protects the component, leading to an injunction or claim from the rights holder for damages or other remedies
In scanning a component such as a valve, and manufacturing a part using 3D printing equipment, there is a risk that this action will infringe an existing patent, design or copyright which protects the component, leading to an injunction or claim from the rights holder for damages or other remedies (such as delivery up of infringing parts).
The Italian volunteers may find themselves in in a legal dispute. While the owner of the patent which protects the valve has not made a firm threat to sue, it has refused to hand over the CAD file and technical documentation for manufacture of the valve, and has notified the volunteers that manufacture of the valve by 3D printing would be illegal.
From the patent holder’s point of view, it would potentially suffer significant loss to its business as a result of infringing copies being made. It will undoubtedly have made a very significant investment in research and development to design, produce and testing the valve for supply to hospitals, and the usual per valve price tag is likely to be representative of that investment.
This case goes to show that it is very important that socially responsible manufacturers and volunteers recognise the complex legal implications of producing copies of life-saving parts. To avoid finding themselves on the receiving end of legal action, any person or company intending to manufacture parts using 3D printing should carry out some due diligence to identify:
- who ultimately holds the intellectual property rights in the component;
- whether the part is protected by patent or registered design; and
- whether the rights holder is willing to permit the parts to be manufactured in return for a small or nominal royalty for the wider public benefit;
- whether any regulatory approval is needed for supply of the parts.
This situation highlights the need for a collaborative approach between rights holders and those able to help with much needed manufacturing capacity in this unprecedented situation.