The COVID-19 health emergency that has overwhelmed the planet in recent months has placed the role and function of patent rights at the centre of the international community's attention, revealing their potentially obstructive characteristics. In Italy, a number of daring private initiatives have distinguished themselves in the fight against COVID-19 and provided an incentive to identify and evaluate the tools that, at the present time and in the absence of extraordinary measures on the matter, the legal system can provide to deal effectively with the current challenges and guarantee and enhance underlying patent protection.
The health emergency has highlighted the need to reconcile the urgency in offering a response to the spread of COVID-19 with the need to continue ensuring the effectiveness of patent protection. For this purpose, the Italian legal system offers a number of solutions based on legitimising the use of a pre-existing patent without the owner's consent to deal with the COVID-19 emergency on the one hand and guaranteeing the accessibility of patented inventions to the greatest number of people without having to deny the owner's exclusive rights on the other.
Both of the recent admirable private initiatives which offered food for thought can be attributed to Cristian Fracassi, CEO and founder of Isinnova. The first of these cases is Isinnova's reproduction of valves for respirators, covered by a patent, using 3D printing technology in response to an appeal from the Hospital of Chiari in the province of Brescia. The 3D printing of the valves allowed a prompt supply that the official distributor of the devices had already stated that it would be unable guarantee in time. The success of that case has inevitably increased the number of requests from other hospitals. However, in order to avoid possible legal repercussions while continuing its work, Isinnova has drawn up a protocol, with the approval of the Ministry for Technological Innovation and Digitisation, according to which, Isinnova can intervene only when there is a failure or insufficient response from the official supplier and after a hospital has declared that it is operating in a state of need.
The second case recently highlighted in the news concerns the transformation of cheap snorkelling masks for use with emergency respirators thanks to a special connection component designed by Fracassi and Renato Favero. The connection valve has been patented, but the patent has been granted with a non-exclusive and free right licence.
The peculiarities of the events in question offer an opportunity to reconsider some of the principles of Italy's legal system in light of the current emergency needs. In the first case under consideration, the extraordinary circumstances in which Isinnova's initiative occurred, which could constitute patent infringement to all intents and purposes, would allow recourse to the following exemptions. The state of necessity is a general liability exemption. In fact, Isinnova's protocol refers to it. In the context of extra-contractual liability, the legal principle excludes the illegal nature of patent infringement, as long as:
- it was done in order to save the infringer or others from danger of serious damage to their life or health; and
- the dangerous situation was unforeseeable, inevitable and involuntary.
In addition to compensatory credit, which is always due in the event of a harmful act, relying on the previously mentioned exemption could create an obstacle over time relating to the lack of unpredictability and inevitability of danger. Although such conditions appear to be incontestable in recent months, they may be difficult to invoke in the event of future waves of COVID-19. In fact, in light of the emergency circumstances, the Supreme Court has already expressed some perplexities regarding the use of the exemption by a hospital, stating that:
[a] hospital that performs emergency surgery cannot invoke the state of need referred to in Article 2045 of the Civil Code, which implies the element of unpredictability of the emergency situation, the planning of which would instead be part of the activities of each health facility.(1)
The fact that the reproduced valves were donated and not sold to the hospital in question implies that a possible infringement was carried out outside of a commercial context. In such cases, the exception of use for non-commercial purposes under Article 68 of the Industrial Property Code could be invoked. According to Article 68(1)(a) of the code, the exclusivity granted by a patent does not extend "to acts carried out in the private sphere and for non-commercial purposes". The provision seems to be subject to an extensive interpretation that allows the use of an invention regardless of the subjective state of knowledge of the patent and without limitation regarding the type of use as long as it is not for business or professional purposes (ie, with the aim of creating profit). However, in the case of the first and subsequent donation of medical equipment, it would seem difficult to deny in absolute terms the commercial purpose of 3D printing laboratories, even if only in advertising terms. A further limitation to this exemption lies in the regulation of indirect infringement. Articles 66(2)bis and (2)quater of the Industrial Property Code forbids suppliers of materials from implementing or realising a patented invention under the Article 68 exemption. Isinnova's reproduction of the respirator valves would thus fall under the exception in question.
With regard to the infringement of industrial property rights, the principle of proportionality pursuant to Article 124(6) of the Industrial Property Code is extremely relevant. This principle requires the judicial authority eventually applied to balance interests at the decision-making stage. Indeed, in ordering the measures and penalties provided for by the provision, the court should evaluate the gravity of an infringement, taking into account the interests of the third parties involved. In light of the following paragraph relating to industrial secrets, but which may be interpreted extensively, third-party interests may also be extended to the general public interest or the need to protect fundamental rights.
The instruments examined so far exclude the liability of the potential infringer. However, the second case focuses attention on different legal principles which, based on a patent that is useful or decisive to deal with the COVID-19 emergency, allow the state to guarantee access to an invention, even coercively, in return for payment of a fee to the rights holder. The first of these principles is a licence voluntarily made available to all of the interested parties by the owner when registering the invention. The licence of right, regulated by Article 80 of the Industrial Property Code, is to all intents and purposes a public offer of a non-exclusive licence, which may also be offered free of charge. In order to facilitate the use of this legal principle, a reduction of half of the annual registration rights is envisaged.
The most notable of the legal instruments under consideration is a compulsory licence pursuant to Article 70 et seq of the Industrial Property Code, a principle provided for and governed by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) that is present, in different terms, in almost all Western patent systems. A compulsory licence is an instrument aimed at mitigating the exclusivity of a patent right and which recognises the power of the state to force patent holders to grant the non-exclusive use of patents to the public administration or other requesting parties in return for a fee and under certain conditions. In Italy, the existence of this type of licence is based on the presence of two alternative conditions:
- the non-implementation or insufficient implementation of the patented invention for more than three years from the date of issue of a patent, or four years from the date of filing of an application, if this term expires later; or
- the existence of dependent inventions (ie, when the implementation of a subsequent invention requires the use of an earlier patent which can in any case take place to the extent necessary to exploit the invention and provided that the second invention represents important technical progress of considerable economic importance).
Moreover, Article 72 of the Industrial Property Code imposes further conditions on the grant of the patent, including, in addition to the necessary licensing fees and provision of the indispensable guarantees for the satisfactory implementation of the invention, proof that it was impossible to obtain a contractual licence on equal terms from the patent holder. Notably, the corresponding Article 31 of the TRIPs Agreement allows countries to overcome the burden of proof in the event of a national emergency or other circumstances of extreme urgency. However, the legislature has provided for no exceptions in this regard as yet. This fact combined with the difficulty of proving that the application of an invention is in serious disproportion with the needs of the state and the complexity of the administrative procedure for granting such a licence means that this principle has rarely been applied to date.
Finally, it is worth recalling the expropriation principle provided for in Article 141 of the Industrial Property Code, which provides for patent expropriation by the public administration "limited to the right of use for the needs of the State", in return for compensation. This last provision seems to constitute the hypothesis of a compulsory licence for public utility in favour of the state.
Therefore, a precarious balance between the need for urgent intervention, the accessibility of patented inventions and the enhancement of patent protection seems to be achievable through the provisions currently in force in Italy. In the absence of extraordinary measures as adopted by neighbouring France and Germany, it could be hoped for a reconsideration of the institution of compulsory licensing according to the more flexible form configured by the TRIPs Agreement. In fact, it seems clear that a correct implementation of this institution would represent the best response to face the emergencies while continuing to guarantee the importance deserved to the instances underlying patent protection.
Endnotes
(1) Civil Cassation, Section III, Decision 13,919 of 7 July 2016.
