COVID-19 and IP rights: production of life-saving respiratory valves using 3D printers

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On March 13, 2020, the hospital of Chiari (province of Brescia, Italy) experienced a (further) emergency caused by the Covid-19 pandemic. The hospital faced a shortage of the valves used in automatic respirators needed to treat critically ill patients suffering from respiratory deficiency. The necessary supplies were requested, but the manufacturer supplying the hospital (the “Supplier”) was unable to meet the need, as it had quickly run through its production of these valves and no additional material was in stock, and therefore there were no valves available to be sent to the hospital.

However, given the circumstances and the critical need for the valves, two young Italian engineers volunteered to help the hospital and were able to solve the problem posed by the shortage of valves by printing and producing them using a 3D printer.

They requested the blueprints from the Supplier, but the latter declined to share those because the design documents relate to a patented device. So, the two engineers analyzed one of the original valves (in terms of design and dimensions) and used their 3D printer to create copies of the patent-protected valves.

The above leads us to consider and analyze the implications of three-dimensional printing in relation to industrial property rights (“IP rights”).

3D printing is an innovative manufacturing technique whose invention dates back to the 1980s. This technology works through a digital “computer-aided design” model, created by man using specific CAD software. That digital model is then sent to a printer, which, on the basis of the indications received, deposits one layer of the chosen material (whether in liquid or powder form) on top of the other until the desired object is completed. Due to these specific features, a 3D printer is capable of producing any item in any shape: for example, this technique is widely used in the biomedical field, where it is possible to model items such as custom prostheses on a computer and then print them in three dimensions.

On the one hand, the advantages in terms of increased production capacity and relevant cost-savings for firms are unquestionable. On the other hand, 3D printers pose a significant risk of counterfeit for owners of IP rights to the objects that are printed using this technique, e.g., patent protection. In this regard, it is important to recall that pursuant to Article 67 of the Italian Industrial Property Code (“IPC”), the owner of a patent is allowed to prohibit third parties from producing, using, marketing, selling, or importing the product in question for such purposes without his/her express consent. As a consequence, it is crystal-clear that the activity of 3D printing can be considered in violation of patent rights, among others.

According to prominent Italian commentators^[1], making use of 3D printers to produce items covered by patent protection does not fall within any of the exceptions established by the IPC, unless it specifically falls under the scope of application of Article 68 IPC. This provision identifies specific circumstances in which the implementation of a patent-protected item is not considered illegal: in brief, and as relevant here, this occurs if the item covered by patent protection is used for private and non-commercial purposes only, or for experimental purposes.

On the basis of the above, the issue of whether a violation of IP rights could have occurred in relation to the 3D printing of respiratory valves, can be considered legitimate in light of the provisions of the Industrial Property Code.^[2]

UK patent legislation establishes the so called “Crown exception” ^[3]. This provides a means for the UK government to authorize others to make use of any patent rights without the prior authorization of the patent owner, to the extent that they are “for the services of the Crown”^[4], which may include health emergency situations that require special measures to be adopted. The patent owner is compensated appropriately later, by negotiation with the appropriate government department, and government authorization for the use can be given retroactively.

Lacking any corresponding provision to the “Crown exception” in the Industrial Property Code, the only exception to the patent rights is the one already mentioned under Article 68 IPC: leaving aside the “private use exception”^[5], Article 68(b) IPC^[6] establishes that patent protection does not cover the use of patented items in the context of studies and experimental activities aimed at discovering new pharmaceutical products. The ratio behind this rule is to allow progress in the pharmaceutical and medical sector and it is devoted to the ultimate purpose to protect the health and wellbeing of Italian citizens, according to the fundamental right established under Article 32 of the Italian Constitution^[7].

Therefore, that rule is inspired by the general principle of the right to health, but only in the sense that IP rights cannot stand as an impediment to scientific and technological progress as long as it is geared to discovering new ways to protect human health more effectively.

One of the two engineers who produced the valves using the 3D printer specified that they acted “only to face the emergency”^[8], without any intention of exploiting this situation “beyond the strict necessity” ^[9]. The point here is that the IPC does not specifically contain and/or refer to this situation of “strict necessity”, such as the type of widespread health emergency that we are currently witnessing.

The open question is, then, whether such fundamental right to health could be invoked to de facto justify a violation of IP rights caused by the current situation of vastly increased demand for supply of healthcare items that are out-of-stock and made absolute necessary due to Covid-19, leading to going beyond the literal interpretation of Art. 68(b) IPC.

In conclusion, there are many phenomena and situations that place legal norms under discussion and require us to think about the suitability of existing legal regimes. We have experienced significant shakes with the upraising of new digital technologies, such as artificial intelligence systems, just to mention the most recent development in technology. In these circumstances, the most frequently recurring issue is whether legal systems are sufficiently equipped to cope with new legal demands and to regulate adequately the range of situations that might arise as a consequence of these technological developments.

This time, we are not experiencing a technological development but, on the contrary, a health emergency that can be considered one of the most significant and disruptive of the last century. Once again, the possibility must be considered to allow legal actors to adjust legal rules to new and, unfortunately, unexpected situations in order to make them more reflective of the factual circumstances of the situations at hand.

[1] C. Galli, A. Contini, Stampanti 3D e proprietà intellettuale: opportunità e problemi, Rivista di Diritto Industriale, fasc. 3, 2015, p. 115.

[2] We would like to conduct our reflection by taking into consideration only the Italian industrial property legal regime. In fact, it is well-known that the Italian Civil Code provides under Article 2045 the possibility that in an objective situation of necessity, the subject who committed the wrongdoing (in the case at hand, the violation of patent rights of the Supplier) is called upon to pay compensation to the subject whose rights and interests have been violated by the said wrongdoing.

^[3] Article 56.03 of the UK Patents Act 1977 (as amended). More information on the Crown exception available here.

[4] Ibid.

[5] Article 68 of Industrial Property Code: “1. The exclusive faculty conferred by patent law does not extend, whatever the subject matter of the invention: […]

1. a) acts done privately and for non-commercial purposes; […]” [translation from Italian by the authors].

[6] Article 68 of Industrial Property Code: “1. The exclusive faculty conferred by patent law does not extend, whatever the subject matter of the invention: […]

1. b) to studies and experiments aimed at obtaining, also in foreign countries, of a marketing authorization and the resulting practical requirements, including the preparation and use of pharmacologically active raw materials as strictly necessary; […]” [translation from Italian by the authors].

[7] Article 32 of the Italian Constitution: “The Republic protects health as a fundamental right of the individual and in the interest of the community and guarantees free care for the needy.

No one can be obliged to a certain health treatment except by law. The law can in no case violate the limits imposed by respect for the human person.”

[8] The Verge, Volunteers produce 3D-printed valves for life-saving coronavirus treatments, published on March 17, 2020—full article accessible here. In particular, the article reports the declaration made by one of the two volunteers, published the first time on his Facebook page profile.

[9] Ibid.