Guest post by Prof. Lucas Osborn, Campbell University School of Law.
Never waste an opportunity in a pandemic to incur a PR disaster. That appears to be the mantra – if initial reports are believed – of an Italian company who holds a patent on a valve used in breathing machines that are critical for coronavirus patients. The company could not meet the surging demand for its valves. In response to the shortage, two engineers used 3D printers to make these essential devices locally near Brescia in northern Italy, a region the coronavirus has hit particularly hard. In response, the patent holder allegedly threatened a patent infringement lawsuit against them.
In a remarkable testament to the speed and flexibility of 3D printing technology, on the same day the engineers learned about the shortage of valves, they were able to create a digital version of the valve and 3D print working valves. Within a day they had made over 100. (As an aside, 3D printing is at the core of a rapid move to create an open source ventilator to combat shortages.)
To be fair, the company, and one of the individuals doing the 3D printing, denies a threat was made. Although the company did refuse to share the design file with the individuals, forcing them to create a 3D printable digital file from scratch.
Regardless, this episode represents the first widely publicized instance of 3D printing technology being used to (arguably) infringe a patent on a medical device. Patent infringement and 3D printing involves several interesting patent issues on which I have previously written here (with Professor Tim Holbrook) and here.
The key to appreciating the unique patent infringement issues with 3D printing is to keep in mind the difference between the digital and physical version of the patented device. In just about every case, the patent covers only the tangible object, not the digital version of it. Therefore, merely creating a 3D printable file of the device is not an act of direct infringement.
Direct Infringement
On the other hand, anyone who prints the physical valve commits direct infringement for “making” the patented device. But even the issue of who performs the actual printing will not always be clear. For instance, assume that X makes the digital file, but does not have the appropriate 3D printer. X takes the file to Y, an on-demand 3D print shop, who prints the object on X’s behalf. Did X or Y “make” the invention? In the copyright context, companies like YouTube have avoided liability for direct infringement by arguing they are passive conduits for their users’ actions. Perhaps 3D print shops will be able to make the same argument.
Indirect Infringement
Getting back to the digital file, although the engineers printed lots of valves for local use, they declined to share the file with others out of fear of patent liability. Their fear was not misplaced. A person can be liable for indirect patent infringement for helping or inducing others to commit direct patent infringement. And the person can be potentially liable in any and all countries where the direct infringement occurred or was facilitated (unlike the US, many other countries do not require a specific act of direct infringement as a precursor to indirect liability).
In the US, the relevant indirect liability would be inducement under 35 U.S.C. § 271(b), which states simply that, “Whoever actively induces infringement of a patent shall be liable as an infringer.” Although the statute does not say so, liability for inducement requires that the accused have knowledge of the specific patent and that the induced acts constitute patent infringement. Global-Tech Appliances, Inc. v. SEB S.A., 563 U.S. 754, 765-68 (2011). If the engineers in Italy were in fact warned of a specific patent, that would likely be enough to meet the knowledge requirement.
Knowledge can be negated by a good faith belief of noninfringement, but it cannot be negated by a good faith belief in the patent’s invalidity. Commil USA, LLC v. Cisco Sys., Inc., 135 S. Ct. 1920, 1928 (2015). 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 of noninfringement. Would a layperson’s study of the patent suffice, or must they incur the huge expense of a formal legal opinion?
In most European countries, indirect liability applies where someone
supplies or offers to supply in [the country] . . . with any of the means, relating to an essential element of the invention, for putting the invention into effect when he knows, or it is obvious to a reasonable person in the circumstances, that those means are suitable for putting, and are intended to put, the invention into effect in the [the country].
See, e.g., UK Patent Act § 60(2). (Most European countries have similar provisions because their statutes are all based on the 1975 Community Patent Convention.) Although the statute requires actual or constructive knowledge, the details of that knowledge requirement are unsettled: must the infringer have knowledge of the specific patent or merely knowledge of the acts that the direct infringer will take. If courts only require knowledge of the induced acts, liability would attach regardless of any specific knowledge of the patent.
In short, creators of 3D printable files, especially those with knowledge of a relevant patent, should be wary of making them available for others on the internet.
Love Your Neighbor, or At Least Your Reputation
Although the coronavirus pandemic inflames passions when needed medical equipment is in short supply, it is important to remember that in emergencies Article 31 of TRIPS, the key international patent treaty, provides flexibilities for governments to use – and authorize others to use – patents without the consent of patent holders.
The above analysis focuses only on the legal issues. Even if the patent holder is more interested in making money than saving lives, it may be wise to consider the reputational and other costs associated with denying live saving equipment to hospitals in need. Others, including patent holders relating to vaccine development, have initially threatened patent infringement suits only to backtrack after a storm of public outrage. So even if the patent holder made a threat to someone in Italy (and it is not at all clear that it did), it would be no surprise that it decided to change tactics.
Great post Prof Lucas.
As we sit at home looking at the sky and feeling just a little bit helpless, we all want to contribute in some way to saving lives, or at least reducing the stress on our health care professionals so they can care for us and our loved ones -when it’s our turn.
Perhaps we in the IP community (and I am thinking of the many commentators and bloggers out there – as well as black letter law readers/studious types – who really know their stuff) can provide reassurance three ways
1) lobby and provide helpful constructive insight to governments into how IP rights can be used in the present emergency and the licence of right/ compulsory licencing/crown use and compensation arrangements that may be used in each jurisdiction
2) provide insight to companies with IP rights that could be used to help now on how to make these available in a constructive way – which may not be at no cost but may be low cost – e.g. licences of right – for the duration of the emergency.
3) provide some measure of reassurance to volunteer groups and companies who want to 3d print components through articles, blogs and position papers – explaining the low risk (if indeed it is low risk) of being sued for IP infringement, and the potential for reputational damage to those who do the suing.
In a remarkable testament to the speed and flexibility of 3D printing technology, on the same day the engineers learned about the shortage of valves, they were able to create a digital version of the valve and 3D print working valves.
Just wait until the StarTrek-like personal replicator arrives in every personal dwelling…
link to images.app.goo.gl
A digital printing case that comes to mind: link to cafc.uscourts.gov
Good catch:
CLEARCORRECT OPERATING, LLC v. ITC p. 31:
“In sum, the literal text, the context in which the text
is found within Section 337, and the text’s role in the
totality of the statutory scheme all indicate that the
unambiguously expressed intent of Congress is that
“articles” means “material things” and does not extend to
electronically transmitted digital data.19”
… see post 4 (and then recall that famous quote about how ‘no one would ever want a personal computer’)…
Do you really think someone is very likely to pay a trial attorney for a patent suit against something made on someone’s personal home 3D printer?
Would I really think that someone would hire a trial lawyer to go after someone violating a copyright in their personal space,
There seems to be remarkably little specific information on what it takes for an oxygen respirator other than a tank of oxygen, a pressure reduction valve, a small balloon, and a simple face mask? They were already in common use in military planes by WWII for all flying above 10,000 feet in altitude, and are located above every seat in commercial jet airplanes. So why would mass producing [or even converting them] be much of a challenge other than for FDA approval delays for medical use?
I do not think it to be that simple.
Although, if anything, you do point out that those infringing the patent need not have been doing so…
In the prior discussions of infringement by 3D printing in general it was noted that even if 3D printing of a patented device is practical, it may be unlikely to be economically competitive with other manufacturing methods for competitive mass production. Especially devices requiring more than one material. Also probably normally not worth patent suit costs against small infringing production runs except for unusually high-profit-margin items. Of course the latter can include certain equipment not just patented but also [and often more importantly] government approved for medical use.
“So why would mass producing [or even converting them] be much of a challenge”
The simple but complete answer is that a ventilator is not the “oxygen respirator” you describe. “In the unlikely event of cabin depressurization,” airline passengers are not expected to insert an endotracheal tube through their nose and rely on a machine to inflate and deflate their lungs. Compare the Model T to the Tesla.
Thanks Thomas for the technical term correction. But one dying of lack of oxygen from this virus will be happy to get more oxygen breathing from an oxygen ventilator even without the additional lung inflation feature, versus dying with none from equipment shortages, as is already happening in Italy.
[Likewise for hospice lung cancer patients, as I have observed.]
Does anybody know how many COVID-19 cases put on a ventilator have recovered and come off the ventilator?
Is it most of them? Or just a few of them?
If we all successfully self-isolate, how are we going to engineer any sort of herd immunity? How do we exit the self-isolation phase of the fight against the virus? Wait 2+ years until there is enough vaccine to go round?
Good question on herd immunity.
See also link to en.m.wikipedia.org
And yes, flattening the curve (so very important) will bring along with it extending the duration of that curve.
How long? I have not heard anyone directly talking about this, although talk in the office (now at an interesting six feet apart) has included two related items: China case rate at or near zero, and their time frame of roughly late November/ early December to mid March for their ‘life cycle.’
If one considers that China had a typical ‘spike’ curve (non-flattened), and use that as a beginning consideration, than the flattened curve duration may be estimated (very roughly) at maybe twice that long. We in the States then are looking at the September timeframe when enough have come down with — and then recovered from — COVID-19 to build up enough herd immunity to loosen the social distancing.
That is a long time psychologically.
Of course, extending the curve also runs the risk of the virus persisting long enough and in large enough numbers to mutate into a ‘next’ version, much like we have annual flu (but now we are at the limits of my understanding, so beyond that is just speculation on my part).
I fear you have not yet grasped the difficulty, that for as long as strict isolation is practised, there is no possibility for any herd immunity to develop. Keep an eye on China. They have stopped the spike BUT, when everybody goes back to work, building cars or whatever, the flow of new cases will resume, for at least the next 2 years.
A totalitarian society has better changes to fine tune the rate of flow of the virus through society (and thereby occupancy of the ventilator inventory) than a free Western society. Here in Germany, viewers of the news on TV are having it explained to them what triage means, in the context of which cases are allocated a ventilator.
Frankly, for at least the next two years, the issue whether anybody is infringing a duly issued patent claim is not going to engage anybody’s attention. They are going to have more important things to worry about.
“I fear you have not yet grasped the difficulty, that for as long as strict isolation is practised, there is no possibility for any herd immunity to develop”
I see why you may think that.
Of course, you would not be correct. Your error is in your take of ‘strict isolation’ being equivalent to TOTAL isolation. At least here in the states, that is not what is going on.
I would add that even strict isolation will NOT stop the spread of COVID-19 (nor is it meant to), but instead will SLOW the spread.
I invite you to explore the ‘flatten the curve’ discussion. In that discussion, there is no abrupt halt due to any sort of social distancing (there is NO ‘absolute isolation’ involved).
On “herd immunity” I had supposed that you get there by vaccinating everybody. I had thought that the price of getting there by letting everybody get infected is too high for any humane government.
But wait. Perhaps it makes sense if done like in China. Keep everybody of 50 and older socially isolated. Send back to work all those younger than that, and have them all get infected as soon as possible. Then, when supplies of vaccine arrive, and only then, loosen the isolation of the over 50’s.
Such a scheme might make a lot of sense to the top levels of the CP in China, and might even be a model for the rest of the world to adopt.
I wonder if a patentee announced a verbal temporary license for all, in order to save lives now, [but premised on the honor system that an accounting one day will be made afterward in recompense to those who made the saving of those all lives possible], whether it could somehow be, if not legally binding, at least morally binding on both governments and society… perhaps taking such a route in the hopes of being materially thanked one day is not unreasonable?
Why would anyone need to rely on (even) an honor system…?
That’s just not pragmatic, is it?
Not sure I understand the question. Patent licenses can and have been publicly offered by many patent owners on many patents at many times, and accepted. For free, for a fixed amount, on “fair and reasonable” terms, and/or for a limited field of use or market.
Paul I was unaware of the licenses “publicly” offered… I had thought that getting the paperwork drawn up and properly executed by all of the parties could take days or weeks… and that a verbal announcement, although immediate, would not amount to a kind of binding legal license on “fair and reasonable terms to be paid after the crisis”.
I guess I see these discussions always degrading into an all or nothing zero sum “eat me or eat you” type conclusion… which I do not think is necessary.
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