Because of the ongoing COVID-19 pandemic, there have been some reports in the media about shortages of the most needed products, such as medicines, personal protection articles, or spare parts for medical apparatus. In Italy, where the situation is the most serious, a manufacturer of spare parts for respirators was not able to produce their sufficient amount to meet the current demand, which has recently grown extremely high. However, two volunteers luckily offered their help: Cristian Fracassi and Alessandro Romaioli proposed to make the needed elements by means of a 3D printer for just a fraction of the normal commercial price. Unfortunately, there appeared an obstacle to do so, which was a patent owned by the manufacturer of the original parts.
Finally, the story did not turn out to be so dramatic, as the patent holder decided not to make any objections to the two volunteers starting the process of manufacturing the so much desired respirator spare parts (although it appears that the patent holder refused to provide them with the relevant patent drawings).
However, one may ask a question what might have happened if the patent holder decided to claim his rights more aggressively? Does the right to a patent really guarantee its holder the possibility to prevent third parties from using the claimed subject matter even under such extreme circumstances? Or in the state of emergency, could the patent holder be prevented from blocking the use of the patented invention for the needs of fighting the emergency?
The right to a patent confers upon the holder the exclusiveness to use a specific technical solution for commercial or professional purposes (in a particular territory and for a specified term). However, in the majority of jurisdictions there exist some limitations, intended among others exactly to prevent the situations, in which the holders would be abusing their rights to the detriment of the whole society.
As regards Poland, the appropriate regulations were introduced with the Act of 30 June 2000 – the Industrial Property Law (Journal of Laws of 2020 item 286, with amendments) (hereafter the IP Law). Consequently, the State Authorities were granted by the relevant act a handful of extraordinary measures to be taken if necessary. In case of the need to prevent or remove a threat to the essential interests of the State, in particular a threat to the national security and public order, the use of an invention for the needs of the State - within the necessary scope and without having an exclusive right - shall not constitute the infringement of a patent (Art. 69 section 2 of the IP Law). What is essential to note is that in practice the State is hardly capable of implementing the patented solution directly on its own (for example, launching a process of manufacturing a medicine), but usually - in case of emergency - it provides third parties with the possibility of manufacturing the patented invention, by establishing the so-called compulsory license.
The compulsory license is a measure, which may enable third parties to use the patented solution, despite the lack of consent of patent holders, or even in the face of an objection made by the patent holder. However, usually the party using the license must pay a royalty fee to the patent holder. Such royalty should be adequate in relation to the market value of the license. The compulsory license is intended to be an extraordinary solution allowing to respond to the public needs.
As regards Poland, a compulsory license has not been implemented so far on the basis of the current IP Law (on the other hand, there were some cases of implementation of the compulsory license for fire extinguishing equipment in coal mines based on earlier regulations). Obviously, under the current circumstances of the COVID-19 growing pandemic, the implementation of a compulsory license may become more necessary.
The Patent Office may grant third parties (including the institutions of the State) a permission to use a patented invention in three cases specified in the Act:
The first case of granting the compulsory license is when it is required to prevent or remove a threat to the safety of the State, including in particular a threat in the field of defense, public order, protection of human life and health, and protection of natural environment. This situation will undoubtedly occur if the patent holder is not able to produce the required amount of a medicine or spare parts for medical apparatus in the state of pandemic.
The second case is described as a situation when it is found that the right to a patent has been abused. Then, the Patent Office may decide on the possibility of applying for granting the compulsory license and make the relevant announcement to the public in the Official Journal of the Patent Office (WUP).
In practice, such abuse of the right to a patent takes place for example if the holder is not utilizing the patent, e.g. the patent concerns a product (such as a medicine), which is not manufactured by the patentee, with the patentee not having granted a license on its manufacture to any third party either. The Polish law does not impose an obligation to use a patent. However, if the patent holder is not implementing the relevant solution by themselves, and at the same time they are impeding third parties from doing so despite the fact that the particular technical solution is required on the market, or it is needed for public interest, then such behavior will be regarded as an abuse of the right to a patent. This provision could be applied in the above described case of the manufacturer of respirator spare parts, if the manufacturer did refuse to grant his consent to make the needed spare parts.
However, according to the provisions of the Polish IP Law, regardless of the behavior of the patent holder, one cannot claim the abuse of the patent right if three years have not yet passed from the date of the grant.
The third case allowing the Patent Office to grant a compulsory license in some situations is when the needs of the domestic market cannot be satisfied because the patent holder is blocked by another earlier patent, which covers the holder's solution.
There is one more condition for granting a compulsory license to be fulfilled. If the possibility of applying for granting a compulsory license has not been announced to the public in the Official Journal, or a year has already passed since such announcement, the party applying for such license must prove that earlier it was trying in good faith to obtain the holder's consent. However, what is particularly essential in the present situation, the requirement of earlier attempts to obtain the holder's consent does not concern the cases in which the compulsory license in needed to prevent or remove the threat to the safety of the State.
Therefore, as it can be seen, the State Administration does have the necessary measures to limit the monopoly practices of the exclusive right holders, in particular if these monopoly practices are detrimental to the public interest, and also has the measures to force the holders to use the protected solutions on a broader scale, provided that this is required for handling a crisis or a danger to public safety. Despite these governmental measures, the patent holder does not lose their right and can still make use of their invention (for example, by continuing to make the patented product by themselves). The holder also keeps the right to royalties for granted licenses. However, regardless of the above discussion, it would be most desirable that the pandemic never reached the critical point when all these emergency measures regarding compulsory licenses would have to be applied by the Authorities in Poland.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.