This article focuses on some of the legal problems 3-D printing may cause. It also defines the legal solutions which the applicable Bulgarian legislation provides. All problems and solutions in this article are addressed in the context of an actual case that took place in the Republic of Italy.
At the beginning of March 2020, a hospital in one of the most COVID-19 affected areas in Italy, was in need for valves for the respirators used to keep patients in a critical condition alive. The manufacturer of these valves could not meet the demands of the hospital quickly enough. The founder of an innovative company for additive manufacturing (3-D printing) (“3-D Company”) and its employees started working on a cheaper 3-D printed version of the valves. The manufacturer and the owner of the patent for the valves refused to provide them with the information needed for the production of the valves. The engineers of the 3-D Company had to study the technology for the production of the valves through reverse-engineering of an original valve. Only a few days later the 3-D printed models were tested, and the required qualities were produced.
Infringement of the patent rights
The patent entitles its owner to the exclusive rights over its invention. This exclusive right grants him/her the right to use the invention, the right to transfer his/her rights, and a prohibition for other persons to use the invention without the patent owner`s consent. The use of the invention includes its manufacture, the offer for sale, and the sale of the invention, the application of the patented method. The Bulgarian Patents and Utility Models Registration Act (“PUMRA”) defines the infringement of patent rights as any use of an invention which is covered by the patent protection without the patent owner`s consent.
In the case above the 3-D Company produced the 3-D printed valves despite the patent owner refused to provide the necessary information for their production. Had this case taken place in Bulgaria, these actions would have been defined as an infringement of the patent rights.
What are the remedies for the patent owner?
PUMRA regulates the following patent infringement proceedings:
- A claim to ascertain the fact of infringement – the court resolution just declares that there is an infringement of the patent rights;
- A claim for compensation of the damages suffered and the profits lost – if the court upholds the claim, the infringer shall pay compensation for the damages and lost profits incurred by the patent owner;
- A claim to enjoin the infringement – if the court upholds such claim the infringer shall cease all actions representing an infringement of the patent rights of the patent owner.
The claimant may also request the publication of the resolutions delivered on the latter two claims in two journals at the expense of the infringer or a request for the destruction of the subject of the infringement and the devices used for the production of the invention.
What could the infringer have done?
This question is relevant to the case above because a great number of lives were saved due to this infringement.
As we can see the patent owner did not consent to the production of the valves by the 3-D company. It also refused to provide the information necessary for its manufacture. Therefore, the infringer could have not relied on the conclusion of a licensing agreement.
A lot of people would justify the infringement because a great number of lives were saved as a result of the production of these valves. However, the PUMRA entitles any person to apply for a compulsory licensing when a licensing agreement could not be signed, and public interests necessitate the use of the invention. If this case had taken place on the territory of Bulgaria, the 3-D Company could have applied for a compulsory licensing to before the Bulgarian Patent Office. Had it done it, its actions would not have constituted an infringement.