By Lucas Osborn

Law360 (March 20, 2020, 5:39 PM EDT )

Lucas Osborn

In Italy, a shortage of vital medical equipment has brought together the worlds of patent law and 3D printing.

The equipment, which is apparently patented, is a special valve used in breathing machines that are needed to treat seriously ill COVID-19 patients. In northern Italy, where the coronavirus has hit particularly aggressively, hospitals are overwhelmed with patients and are unable to obtain the valves from their normal supply chains.

A hospital in Brescia got put in touch with two nearby engineers who quickly designed a digital version of the valve and, without permission from the patent holder, used 3D printers to manufacture valves. His reward? In addition to the profuse thanks from many hospital staff and patients, he purportedly received a threat of a patent infringement lawsuit from the patent owner.[1]

The patent holder denies having threatened a lawsuit, but regardless, this seems to be the first widely publicized instance of 3D printing technology's being used to (arguably) infringe a patent on a medical device.   

The situation involves several interesting patent issues.[2] To understand these issues, it is important to appreciate the difference between the digital version and the tangible version of the relevant device.

Direct Infringement

Almost always, a patent holder has a patent only on the physical device, not a digital version of it. Thus, merely making a digital version of the valve is not an act of direct patent infringement.

At the same time, assuming there is a patent on the physical version, whoever 3D prints the valve is a direct infringer for making the patented device.[3] Note, however, that the issue of who printed it is not necessarily straightforward. If a person designs the digital file but rents or borrows a company's 3D printer, who should be deemed to have printed it: the person or the company owning the printer?

In copyright law, companies like YouTube Inc. have avoided liability for direct copyright infringement because the users, not YouTube, upload the infringing content. Perhaps 3D print shops can escape direct infringement in the same way.

In addition, the creator of the digital file could potentially save more lives by sharing his digital file on the internet for others to use. The engineers in Italy chose not to share their file in part for fear of liability. Whether they would be guilty of patent infringement for sharing the digital file involves tricky questions of indirect patent infringement, a form of infringement that results when someone helps another to commit direct patent infringement.

Indirect Infringement in the U.S.

In the U.S., sharing a 3D printable file could result in liability for inducement under Title 35 U.S. Code Section 271(b), which provides: "Whoever actively induces infringement of a patent shall be liable as an infringer." The courts have fleshed out this barebones provision with several requirements.

First, the patentee must prove that the alleged inducement actually led to an act of direct infringement.[4] Thus, the patent holder would have to show that a recipient of the digital file actually printed it in the U.S.

Second, courts require that the accused have an intent to induce infringement, which includes having actual knowledge of the patent (or willful blindness of the patent's existence).[5] Thus, the patent holder would have needed to point the Italian engineers to a specific patent covering the valve.

Importantly, however, the intent to infringe can be negated by the accused's good faith belief of noninfringement, but (strangely, perhaps) not by a good faith belief in the patent's invalidity.[6] Courts have not had an opportunity to explore what is required for an individual, as opposed to a company, to form a good faith belief in noninfringement. Would a layperson's study of the patent suffice, or must he or she incur the huge expense of a formal legal opinion?

Indirect Infringement in Europe

In most European countries, indirect liability applies where someone:


The language varies slightly from one country to the next, but most European countries' patent infringement provisions are similar because they are based on the 1975 Community Patent Convention.

Indirect infringement in Europe differs from the U.S. in at least two important ways. First, in Europe there is no requirement to prove an underlying act of direct infringement.[7] This makes the patent holder's case comparatively less burdensome.

Second, although the laws in Europe require actual or constructive knowledge, it is unclear what level of knowledge is required. Does the statute require (1) merely knowledge of the underlying conduct or (2) that knowledge plus knowledge that those acts infringe a patent (i.e., a mentally culpable state)?

To the best of this author's knowledge the courts in European countries have simply failed to address this issue. In some ways, this is not unusual.

U.S. courts danced around the issue for years before the U.S. Supreme Court finally ruled in favor of the stricter standard.[8] Suffice it to say that those who share digital versions of patented objects should be especially wary in Europe because they may face liability despite not having any knowledge of a patent.

Dollars and Sense

On the legal front, it is important to remember that Article 31 of the Agreement on Trade-Related Aspects of Intellectual Property Rights, the key international patent treaty, provides flexibilities in emergencies for governments to use — and authorize others to use — patents without the consent of patent holders.[9]

Law aside, amid a pandemic one would hope that patent holders would do all they could to help people in immediate need. Even for those inclined to put money above mankind, common sense suggests that threatening patent infringement suits in the face of dire shortages might not be the best business strategy.[10] Let us hope that our better angels prevail in this trying time.

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Lucas Osborn is of counsel at Michael Best & Friedrich LLP.

The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firm, its clients or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.

[1] Jay Peters, Volunteers Produce 3D-Printed Valves for Life-Saving Coronavirus Treatments, The Verge (Mar. 17, 2020, 6:51 PM), https://www.theverge.com/2020/3/17/21184308/coronavirus-italy-medical-3d-print-valves-treatments. In an update, the article relates that both the patent holder and one of the engineers denied there was a threat of a patent infringement lawsuit.

[2] Lucas S. Osborn, 3D Printing and Intellectual Property (2019); Timothy R. Holbrook & Lucas S. Osborn, Digital Patent Infringement in an Era of 3D Printing, 48 U.C. Davis L. Rev. 1319 (2015).

[3] 35 U.S.C. § 271(a).

[4] Limelight Networks, Inc. v. Akamai Techs., Inc. , 572 U.S. 915 (2014).

[5] Global-Tech Appliances, Inc. v. SEB S.A. , 563 U.S. 754, 765-68 (2011).

[6] Commil USA, LLC v. Cisco Sys., Inc. , 135 S. Ct. 1920, 1928 (2015).

[7] Marc Mimler, 3D Printing, the Internet and Patent Law­—A History Repeating?, in Big Data, Challenges and Opportunities 55, 62 (2013), available at http://edcp.uoc.edu/proceedings_idp2013.pdf.

[8] See Jason A. Rantanen, An Objective View of Fault in Patent Infringement, 60 Am. U. L. Rev. 1575, 1596-1604 (2011).

[9] Uruguay Round Agreements Act, Pub. L. No. 103-465, §§ 531-533, 108 Stat. 4809 (1994).

[10] See, e.g., Hasan Chowdhury & Laurence Dodds, SoftBank-Owned Patent Firm Backtracks on Lawsuit Targeting Coronavirus-Test Technology, The Telegraph (Mar. 17, 2020, 12:28 PM), https://www.telegraph.co.uk/technology/2020/03/17/softbank-owned-patent-firm-backtracks-lawsuit-targeting-coronavirus.

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