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Volunteers 3D-Print Unobtainable $11,000 Valve For $1 To Keep Covid-19 Patients Alive; Original Manufacturer Threatens To Sue

from the patents-are-more-important-than-patients dept

Update: One of the people who helped 3D-print the valve in Brescia says that they didn’t receive a legal threat from the original manufacturer, Intersurgical, according to a new report in The Verge. Another person who helped make things happen, Massimo Temporelli, who earlier said they received legal threats for alleged patent infringement, is quoted as saying: “The group we asked for the files refused and said it was illegal”. Intersurgical also denies threatening to sue. It states that it could not supply details for the valve because of “medical manufacturing regulations”. Another news item says the official list price was not as high as the original Italian report suggested, but without giving a revised figure.

Whatever the details, the episode underlines why the 3D files of these kind of devices should be made available routinely to hospitals. That would allow them print in cases of urgent need, regardless of any claimed patents, so that this kind of situation doesn’t arise at all, and lives are not put at risk. Original story follows:

Techdirt has just written about the extraordinary legal action taken against a company producing Covid-19 tests. Sadly, it’s not the only example of some individuals putting profits before people. Here’s a story from Italy, which is currently seeing more new coronavirus cases and deaths than anywhere else in the world. Last Thursday, a hospital in Brescia, in the north of Italy, needed supplies of special valves in order to use breathing equipment to help keep Covid-19 patients alive in intensive care (original in Italian). The manufacturer was unable to provide them because of the demand for this particular valve. The Metro site explains what happened next:

With the help of the editor of a local newspaper Giornale di Brescia and tech expert Massimo Temporelli, doctors launched a search for a 3D printer — a devise that produces three dimensional objects from computer designs.

Word soon reached Fracassi, a pharmaceutical company boss in possession of the coveted machine. He immediately brought his device to the hospital and, in just a few hours, redesigned and then produced the missing piece.

Actually, it wasn’t quite as simple as that suggests. Business Insider Italia explains that even though the original manufacturer was unable to supply the part, it refused to share the relevant 3D file with Fracassi to help him print the valve. It even went so far as to threaten him for patent infringement if he tried to do so on his own. Since lives were at stake, he went ahead anyway, creating the 3D file from scratch. According to the Metro article, he produced an initial batch of ten, and then 100 more, all for free. Fracassi admits that his 3D-printed versions might not be very durable or re-usable. But when it’s possible to make replacements so cheaply — each 3D-printed part costs just one euro, or roughly a dollar — that isn’t a problem. At least it wouldn’t be, except for that threat of legal action, which is also why Fracassi doesn’t dare share his 3D file with other hospitals, despite their desperate need for these valves.

And if you’re wondering why the original manufacturer would risk what is bound to be awful publicity for its actions, over something that only costs one euro to make, a detail in the Business Insider Italia article provides an explanation: the official list price for a single valve is 10,000 euros — about $11,000. This is a perfect example of how granting an intellectual monopoly in the form of a patent allows almost arbitrarily high prices to be charged, and quite legally. That would be bad enough in any situation, but when lives are at stake, and Italian hospitals struggle to buy even basic equipment like face masks, demanding such a sum is even worse. And when a pandemic is raging out of control, for a company to threaten those selflessly trying to save lives in this way is completely beyond the pale.

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Comments on “Volunteers 3D-Print Unobtainable $11,000 Valve For $1 To Keep Covid-19 Patients Alive; Original Manufacturer Threatens To Sue”

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149 Comments
This comment has been deemed insightful by the community.
Paul B says:

Re: Medical Patent SOPA Moment

Personally, If I was in the above situation I would be just as happy to print the part and tell them, "if I live, you can sue me later". The sad fact is they wont sue the guy, they will sue his business, the hospital that used the printed part, and anyone else with money they can get their hands on.

If there was a case to go to Jury, I think this would be one.

Anon says:

Re: Re: Medical Patent SOPA Moment

Not sure how it works in Italy – in Canada, all hospitals are non-profit organizations paid by the government out of provincial health care budgets. Go ahead and sue – you’re suing the government and hence the taxpayer. Try to imagine what a jury of taxpayers thinks about that circumstance.

Federico (profile) says:

Re: Re: Re: Non-profit hospitals in Italy

That’s incorrect. The biggest hospitals in Italy are those which have the "IRCSS" label, meaning they can do both healthcare and research. They’re usually connected to a university so they can train and employ undergraduates and graduates before they’ve completed their education ("specializzazione").

There are 51 such hospitals and only 21 are considered "public" (~state-owned):
https://it.wikipedia.org/wiki/Istituto_di_ricovero_e_cura_a_carattere_scientifico
http://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=794&area=Ricerca%20sanitaria&menu=ssn

Granted, many of the other 30 are non-profit foundations, often ultimately controlled or semi-controlled by some public administration (like a university or a municipality), but some are just normal businesses, including (most famously) the San Raffaele hospital owned by the Vatican.
https://en.wikipedia.org/wiki/San_Raffaele_Hospital

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Anonymous Coward says:

Re: Re: Re: Medical Patent SOPA Moment

Given the very long (and contagious) incubation period for this virus, not all who have it are showing any symptoms at all. And even if you have the symptoms it might not be COVID-19. It’s important to know what you’re treating to apply the correct treatment.

There is no cure and (probably) never will be. This is a virus. Like the flu, the virus that has been around forever and still have no cure. Chasing down a cure is probably nothing more than a waste of time and money.

We already have treatment. That part isn’t the problem. The problem is knowing who has COVID-19 so we can act accordingly and for that we need… wait for it… tests! So yeah, you’re wrong. We need test kits and we need them now, in very large quantities.

Anonymous Anonymous Coward (profile) says:

Re: Re: Re:2 Medical Patent SOPA Moment

Exactly, test as many as you can and then segregate those that test positive. Getting those that HAVE the virus into quarantine is what will stop the spread.

This social distancing is a bit of overkill as it isn’t everyone that needs to be segregated, though with the exception of the possibly very serious economic harm social distancing will cause, it isn’t necessarily bad.

The testing priorities should be those that have symptoms, those that have been near those with symptoms, and most definitely those that have been near anyone that has contracted Covid-19 (and maybe isolated), whether they have symptoms or not, need to be tested (and maybe repeatedly) and then, if necessary, isolated. Then testing some beyond those mentioned above, especially people over 60, and people that have a lot of contact with others.

That calls for a lot of testing, and for the US probably more like 400 million test kits than anything less. We don’t have them and nothing I have read is telling me about our ability to get them soon. Then, there are a few billion other people that need them as well.

Anonymous Coward says:

Re: Re: Re:3 Medical Patent SOPA Moment

"This social distancing is a bit of overkill as it isn’t everyone that needs to be segregated, though with the exception of the possibly very serious economic harm social distancing will cause, it isn’t necessarily bad."

Are you suggesting containment is still possible?

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Anonymous Coward says:

Re: Re: Re:4 Medical Patent SOPA Moment

That’s the mentality that put Italy in it’s current state. Everyone kept saying.. no it will happen to everyone else and ignored the warnings. Reduce unnecessary risk and you will mitigate the risk, flatten the curve

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Stephen T. Stone (profile) says:

Re: Re: Re:3

This social distancing is a bit of overkill as it isn’t everyone that needs to be segregated

Incorrect. People young and old can carry the virus, and in doing so, they become a disease vector to everyone else — not just family and friends, but the general public as well. And since people can carry the virus without showing symptoms, nobody can know for sure if they have it (and if they’re unwittingly spreading it). Since we have no effective treatments and no vaccine (which is still months away at best), the only way to mitigate the spread of COVID-19 is social distancing.

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bazzazio (profile) says:

Re: Re: Re:3 Medical Patent SOPA Moment

Actually, we have screwed up any chance we had to contain this outbreak. Testing will not help at this point, because we would need to test everyone. We are now in the mitigation phase, which is why the government has asked everyone to stay home, not to congregate in groups over ten, and not to go out to restaurants or bars. You don’t seem to get just how severe this is going to get in our country. We are all so spoiled as we’ve watched other countries suffer, that we think it won’t happen here. Well, it’s here. Italy’s case mortality rate stands at 8%. They have one of the best healthcare systems in Europe, but that means nothing if you’ve got a total of 1,000 ICU beds available while 100,000 need them. We aren’t just looking at people dying from this virus either. When you have 100,000 people vying for 1,000 beds (and those in ICU need WEEKS of treatment) guess what happens? Those people you know who have heart problems? No one has a bed for them. Diabetics in diabetic coma? No help. Car accidents, shootings, everyday normal emergencies? Forget getting an ambulance, let alone a hospital bed. All of this stems from a total failure to prepare and take action by this administration, but forget about that for now. People MUST stay home. Young people, old people, healthy people, and sick people. Sorry if these measures inconvenience you, but I’m sure 2,2 MILLION deaths from this would inconvenience all of us, even you…and WE are the only thing between what I just described, and something that will still be horrific but with deaths in the high hundred thousands, rather than millions.

Karl (profile) says:

Re: Re: Re:4 Medical Patent SOPA Moment

The death rate in Italy is much higher than 8%. The death rate (for Italy) is about 46% based on completed cases. A completed case is where the patient either recovered or died. They have 31,000 total cases with about 5,400 completed cases in which about 2,500 have died and 2900 have died.

duuuude says:

Re: Re: Re:2 Medical Patent SOPA Moment

The problem with the flu/common cold is that there are like 150 different strains and they are mutatingso a single vaccine is not effective. There have been atempts for a vaccine but they cost to much to develop. If we don’t let it spread that much we can develop a cheap one strain vaccine and be done with it. Maybe the vaccine industry will even get a boost after this crisis and they will takle the flu for good. Imagine that.

Anonymous Coward says:

Re: Re: Re:2 Medical Patent SOPA Moment

"There is no cure and (probably) never will be. This is a virus. Like the flu, the virus that has been around forever and still have no cure."

The corona virus is not influenza.
Influenza mutates at a higher rate than the corona virus.
Why do you think there will never be a cure?
You claim one disease has no cure therefore no other diseases will have a cure, this makes no sense.

Anonymous Coward says:

Re: Re: Re:3 Medical Patent SOPA Moment

To say the coronavirus mutates slower than the influenza virus is ahead of where we are scientifically. To date we know that the coronavirus has had substantial mutations twice within a 6 month span.
The first was when it mutated allowing human to human transmission.
The second was developing a new strain (yup, now there are two versions of the coronavirus out there!).

One of the reasons that the CDC and various health agencies around the world are so worried is that this is a Novel virus (meaning previously it did not infect humans) and so therefore we have no natural immunity or resistance to it and two that it is mutating so quickly.

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PatMurph says:

Re: Re: Re: Medical Patent SOPA Moment

You can be infected and not show any symptoms and put everyone around you at risk…

How is advanced testing less important than the cure?

We already have the test. That doesn’t take away resources for finding a cure.

Anonymous Coward says:

Re: Re: Re:4 Medical Patent SOPA Moment

At this point, I think a test is almost pointless. You would have to test everyone at basically the same time and everyone would have to stay away from everyone else, basically stay at home until you got the results. There is not a remote chance of having enough test kits available. You’re also not going to be able to keep everyone home until there are results.

You get tested, found out you’re clean, but you got it right after the test because of all the people around you also getting tested at the time time. Or you catch it a couple of days later from someone. The test says you’re clean, but you are in fact infected. So really, what is testing going to do for people at this point?

The best thing to do is to stay at home as much as you can. Stay 6 feet away from others if at all possible. Don’t touch things with your hands. Don’t touch your face, which can be pretty hard. Wash your hands all the time.

I sure as hell won’t go anywhere near a hospital until it’s something really serious. As in needing an operation, or a broken bone. Not to go get tested for this Virus which I could get just showing up there to get tested. No thanks.

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Anonymous Coward says:

Re: Re:

pecunia ante populi

Nothing else matters to these people. Which is why they should loose every last cent of their precious money. It’s not even theirs to begin with. All forms of money are an IOU from the society that issued it. If you intend to use such large favors against them, the society has no reason to honor their debt to you.

Jesse Covner says:

Re: Re:

A valve is a machine. It is designed. And like any other design, it can have a patent.

That being said, the new value is not the same; it is a compatible part to the bigger machine. Patents don’t prevent making compatible parts, especially if the nature of the patent was used just to prevent competition, not for an actual technical innovation.

The manufacturer is going to get screwed by this. IF they sue and if the 3d printer company counters.

In the United States, in many states, the hospital can even take the medical device manufacturer to court for price gouging during emergencies.

David says:

Re: Re: Re: Re:

You are confusing patents with copyright. Copyright treats knowledge as infectious and rewards infection rates. For patents, inspiration does not count. The only criterion is whether the manufactured mechanism meets the description or not.

You can use the original valve as thoroughly as you want for thinking up a replacement, and design the replacement consciously to circumnavigate the patent description.

If it does not match the description in the patent, it is not covered by the patent, no matter how thoroughly you consulted the description and the original in order not to match it.

There is no such thing as a "cleanroom implementation" like with copyrightable matter. You can be as dirty as you want to.

Anonymous Coward says:

Re: Re: Re:2 Re:

The danger here is confusing US patent law with Italian patent law, an then there will be some EU directive. But given the infection rate/mortality rate of covid 19 (and how everyone is going to personally know someone who died) if this gets to court it will be impossible to find a judge or jury that does not have a bias against pandemic profiteers.

Anonymous Coward says:

Re: Re: Re: Re:

Disclaimer: based on UK Copyright Designs and Patents Act 1988

If it is a replacement part manufactured to fit within the product then it comes under the "must fit" exception s.213(3) (b) this exceptional is specifically to allow replacement parts to be made by a third party.

For an example of how this has applied see https://www.humphreys.co.uk/articles/intellectual-property-acquiescence-estoppel-must-fit/

Shufflepants (profile) says:

Re: Re:

Because it seems the patent office now takes the meaning of the word "novel" to be literally anything they haven’t seen before (and they very often haven’t seen much of what’s actually out there), instead of "new or unusual in an interesting way." i.e. something that not everyone and their mothers would have and could have easily designed if they had had the need.

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Anonymous Coward says:

Re: Re:

It’s not. It is impeding the treatment of sick people because they want $11000 for a device that probably costs well under $100 to make and they don’t seem to have any to sell.

The problem that needs to be solved is forcing companies to charge reasonable prices for medical goods and services, and punishing those who don’t. Yeah, patents are still a problem but fixing those isn’t the best way to solve the larger issue for medical professionals.

Anonymous Coward says:

Re: Re: Re:

One observation. The cost in these parts isn’t the manufacturing. It’s the certification process. Takes years, huge costs, the whole shooting match.

Seriously, you can have someone design a part, figure out the manufacturing process, etc. and be maybe $50K in the hole for it. Then you go to certify and you burn $20 million.

When your expected market is 5000 of these a year, suddenly a $10K list price starts looking reasonable, just so you can pay off the $20m legal bil for dealing with the FDA and it’s EU equivalent.

Anonymous Coward says:

Re: Re: Re: Re:

I work in the aviation industry, and I can attest to this as well. For example, there are switches in the cockpit of an airliner that can be bought from the supplier for $20, but if you want to use it on an aircraft, it needs to have the full paper trail for each switch all the way back to certification for use on that particular model of aircraft. The same switch then sells for upwards of $1000.

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Anonymous Coward says:

I work in the medical device field and although I do believe that if there is a part that is desperately needed to save lives, especially in an emergency situation, then there should be some protections for those coming up with a solution. You also have to understand that there may be a very good reason the valve is so special.

If the valve is in part of the breathing system then a 3D printed value may shed plastic parts that could get into someones lungs. Lungs are extremely sensitive especially when infected. That is just one of many issue that are possible, and just letting any random person 3D print medical parts with no testing or over site could make the problem much worse. Just look at how easy it can be for a medical company who is doing testing to screw up and have a problem with a medical device.

That said, It sounds like that company that made those valves could have worked with someone to develop a solution to save lives. That company would have a lot of knowledge about how the valves work and what materials would be safe to use. They should be working on solutions, that even if they are not perfect, could be much better than nothing.

They also could have temporarily licensed rights to make the valve until this crisis is over.

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Paul B says:

Re: Re:

Keep in mind the hospital was willing to pay for the parts, the parts were simply not available to be sold. Also this is not some random person but "pharmaceutical company boss", thus this person already has technical staff who could quickly get up to speed with adjustments needed for all the items you brought up.

The seller could quite easily create a contract, provide expert staff, and also make bloody well sure that this is an emergency situation and that the parts are not built to spec and no liability for quality should come back to them.

Of course italy tosses scientists in jail for badly predicting an earthquake so who knows how they would rule when building life saving medical equipment replacement parts from unapproved sources.

Anonymous Coward says:

Re: Re:

Given the stated difficultly in obtaining the "coverted" 3D printer it may not be a FDM machine (the common cheap type that melt plastic together) it could be SLS which can produce metal parts or SLA which uses a laser to cure a special resin. Neither of which would shed plastic parts.

Iggy says:

Honestly, I say just keep printing the part, and hand the 3D file over to any hospital that needs it. Italy was already smart enough not to leave their health care system in the hands of profiteers. If the company is dumb enough to go through with their lawsuits, maybe they can finally get rid of the stupid patents for good.

David says:

Re: Re:

So you’re trying to suck the blood out of somebody dying of an infectious disease… are you REALLY SURE you want to do that?

If only. Basically they have a toothache and are currently unable to suck the blood out of somebody dying of an infectious disease, so they want him to continue dying without waiting for them to suck the blood out.

Everybody would have been fine with them sucking the blood out of the dying person. And actually, with a socialized health care system, it’s not even the particular person’s blood they are sucking. It’s more a collective blood-letting. But they currently don’t have their sucking teeth available, so they’d rather have this person die to set an example or something.

tom (profile) says:

While the original poster seems rather against profiting from patents, seems likely there was some reason why hospitals were paying $11,000 for replacement valves in the first place. Possible it really is worth that much more vs whatever system that it replaced.

That said, IP laws are an artificial construct setup by governments for economic reasons. Should be no reason why there can’t be some kind of Emergency Declaration Override of patent/copyright protections where the needs of the country in crisis outweigh the economic benefits/needs of the IP owner.

If nothing else, just declare that the parts can be freely copied and the bills will be settled by any remaining survivors.

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Stephen T. Stone (profile) says:

Re:

Possible it really is worth that much more vs whatever system that it replaced.

I doubt the creation of a replacement valve costs whatever price the manufacturer sets for buying the valve. They know they can get away with that kind of markup because of the necessity for those valves.

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Rekrul says:

Re: Re:

While the original poster seems rather against profiting from patents, seems likely there was some reason why hospitals were paying $11,000 for replacement valves in the first place. Possible it really is worth that much more vs whatever system that it replaced.

The prices that companies charge for things rarely have any relation to how much quality goes into the product. Last fall I looked online for a plastic "elbow" for a used leaf blower that I found in the trash, so that I could attach a bag to it. They wanted about $30 for the part and it’s literally just a plastic tube with a flared end. I ended up modifying a similar part meant for a different model, which I also found in the trash. Now I know that $30 seems trivial compared to the $11,000 in the article, but there’s no way that a plastic tube cost them $30 to make, or that it contains $30 worth of quality. It should have cost at most $10, and even that would have been overpriced for something that probably cost them $0.25 to make.

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That One Guy (profile) says:

Re: 'Your money or their lives' provides a hefty motivation to pay

While the original poster seems rather against profiting from patents, seems likely there was some reason why hospitals were paying $11,000 for replacement valves in the first place.

There is, it’s called ‘either you pay our demanded price or your machine is useless, because we’ll sue you into the ground if you or anyone else try to make a replacement part.’ Just because they demanded $11K does not mean or even suggest that the part was actually worth that much.

crinisen (profile) says:

Re: Re:

Nah, I have nothing against profiting from patents in theory. I do have a problem with excessive profits and the many shady things that have been done by organizations producing medicine and medical things. That being said, I have no information to say one way or another if this particular company has done anything I would object to. That doesn’t mean that something like this ,added to the recent joy people who need insulin and EpiPens, won’t be the trigger for enough public outrage to cause a massive overhaul of the medical patent system.

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Bloof (profile) says:

In a sane world, we would come out of the Covid-19 pandemic realising just how capitalism as it exists now is failing humanity at nearly every turn. Unfortunately, we’ll probably be told everything’s fine and that humanity has failed capitalism if anything, and enough people will believe that to prevent anything being done.

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Anonymous Coward says:

Needed balance

Technology and instant communications have reduced the cost to manufacture life saving devices to mere pennies on the dollar. But don’t fret, lawyers and investors have stepped in to artificially inflate the costs back to threaten lives.

Anony E moose says:

Bringing it back to reality

It might be important to understand how expensive R&D is before going all guns cocked.

Let’s walk through the steps.

You start a company and create a medical device product on spec.

In order to get the product approved you go through hundreds of iterations while it gets tested.

For this you need to pay medical people, engineers, lawyers, get IP work done to protect your work, etc.

Then your first round of R&D is done and you are lucky enough to have built a product that suits a need. This need is not the scale you are thinking about right now. Let’s call it the normal need is in the hundreds while today’s need is in the tens of thousands.

Simple parts reflect the unbelievable cost of manufacture and keeping the company alive (aka paying people to be there to improve the product and support the product).

That is part of the reason why a simple part costs $10,000. If they sold hundreds of thousands of the product it would cost less.

Yes, there is gouging, but the benefits of the technology of medicines and machines we have today cost billions, collectively.

These companies build Ferraris, they don’t build Hondas.

Before you judge, take a moment to consider that real life takes money and a shit ton of risk.

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Anony E moose says:

Bringing it back to reality

It might be important to understand how expensive R&D is before going all guns cocked.

Let’s walk through the steps.

You start a company and create a medical device product on spec.

In order to get the product approved you go through hundreds of iterations while it gets tested.

For this you need to pay medical people, engineers, lawyers, get IP work done to protect your work, etc.

Then your first round of R&D is done and you are lucky enough to have built a product that suits a need. This need is not the scale you are thinking about right now. Let’s call it the normal need is in the hundreds while today’s need is in the tens of thousands.

Simple parts reflect the unbelievable cost of manufacture and keeping the company alive (aka paying people to be there to improve the product and support the product).

That is part of the reason why a simple part costs $10,000. If they sold hundreds of thousands of the product it would cost less.

Yes, there is gouging, but the benefits of the technology of medicines and machines we have today cost billions, collectively.

These companies build Ferraris, they don’t build Hondas.

Before you judge, take a moment to consider that real life takes money and a shit ton of risk.

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Anonymous Coward says:

Re: Bringing it back to reality

When people are dying and in desperate need of the device and it’s a global pandemic this understanding that it takes real money and risk to do this doesn’t matter. Hope you realize it’s an exceptional situation where rules and laws should be broken.

OldMugwump (profile) says:

Re: Re: Is that worth more than a single human life?

At some point, yes, money is worth more than a single human life.

We can save lives by spending money.

If we spend more than the amount needed to save a life, then yes, that amount of money is worth more than a single human life.

Because it could save more than one life.

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Anonymous Coward says:

Patent is not the problem

Has it occured to any of you that the company would not have made the life saving valve if the first place had their not been a patent to protect it? Need does not justify a claim on their life. The same 1 euro of plastic could have gone into making a cheap toy, your not buying 1 euro of plastic, your buying the thought and effort of dozens of people over a long period of time to bring it to market. The real problem here is not the patent its the lack of a robust supply chain.

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Anonymous Coward says:

Re: Patent is not the problem

These aren’t ordinary circumstances. Ordinarily, you might have something of a point, but right now, when resources like these medical devices are (so far as Italy is concerned) one of the most necessary commodities on the face of the planet for an increasing number of people, and they refuse to drop prices, what they’re tacitly saying is "screw the patients, pay us." Supply chain be damned, economy is a means to an end, and right now, they’re after the wrong end.

It’s easy to wax philosophical and to be hypothetical about what would or wouldn’t be the best for all parties when lives aren’t really on the line and it’s an abstraction. It’s not an abstraction, though, it’s a serious crisis. If people live or die on the basis of these valves, the company is lucky that this is thus far the extent of action on the part of others–to copy their designs independently. Plenty of people would have no ethical qualms about flatly stealing it.

Soon, there won’t be much left to steal. It decided to immolate its own reputation over this particular patent. Sufficient pressure applied to its customers would easily be enough to ruin it, and who could blame them with PR this bad? This was a terrible decision on their part, and my guess is that unless they’re very lucky and this blows over, their company is not long for this world. If its R&D department is smart, it’ll quit while it’s ahead.

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ryuugami says:

Re: Re: Patent is not the problem

and they refuse to drop prices

Price wasn’t the issue. Parts were out of stock.

… which somehow makes it even worse. They’re not even "protecting" their profit, they’re just being evil for evil’s sake.

WorBlux says:

Re: Patent is not the problem

They made their money with the price of the machine. The patent is likely exhausted vis a vi that particular machine. It’s like having to send ford a royalty check every time you rotate the tires on a car because they patented 5 other things pertaining to the drive-train system.

Anonymous Coward says:

Re: Re: Patent is not the problem

This is correct. Patent from the whole machine does not apply to the parts that makeup the machine:

https://www.wrays.com.au/insights/industry-insights/copying-replacement-parts/

"Is there any patent protection for the part in question? Generally, it is not an infringement of a patent to make and supply a replacement part for a machine even if the machine itself is subject to patent protection. But there may be patent protection for the part itself. Product documentation may give notice of patent rights. If in doubt, patent searches can be carried out."

Anonymous Coward says:

Re: Patent is not the problem

If the product they created can be copied for a dollar and they cant produce it in a life threatening situation, then they are responsible for the deaths they cause. If one piece costs 11,000 then they long ago made their money back and you know what, in most cases these types of products in the medical industry are created using public grants/funding, so the people already paid for them. The patent is corporate exploitation. As I said if they can’t make a life saving device then that product is actually worthless, that’s on them and their garbage manufacturing.

This comment has been deemed insightful by the community.
Don says:

Medical device

1) In an emergency situation, "go for it".
2) While $11,000 is quite a lot, it certainly more than a $1 for a company, even to produce these in low volume (high volume is cheaper). Production costs for a limited run, injection mold, setup fees, mold fees etc would easily make it a $20 part.
3) In US getting FDA approval for a part can be quite costly as well. As someone mentioned above, if it’s used in a breathing device the testing could be expensive. In a low volume device your amortization of those original costs are only covered by higher costs. so $100-$1000 is actually possible. $100 is more realistic if it’s used in any sort of volume.
4) The guy reverse engineered by measuring the original product. Even for a direct fit part you’d need separation. The guy wasn’t selling it though, was trying to save lives, etc. Sue him and reap the whirlwind. Just as seen here the threat of suing will probably lose this company any goodwill.

K says:

Let's actually talk about reality

Not many companies today build things from the ground up, most of them build on older technologies and many of them were developed using public funds, and other private sector money tied to public institutions. There is just no way this valve is worth 11000 euros. To believe they are charging what it’s actually worth is exceedingly naive.

This comment has been deemed insightful by the community.
That One Guy (profile) says:

When profits matter more than lives, you just might be evil

Actually, it wasn’t quite as simple as that suggests. Business Insider Italia explains that even though the original manufacturer was unable to supply the part, it refused to share the relevant 3D file with Fracassi to help him print the valve. It even went so far as to threaten him for patent infringement if he tried to do so on his own.

Because nothing says ‘we are totally not a bunch of evil sociopaths’ like threatening someone should they create a vital part for a device needed to save lives.

They could have come out of this looking positively golden, making a statement that since lives were literally on the line and they were out of stock they would provide the needed file so that he could create a temporary replacement while they worked to create (one would assume) higher quality replacement parts and offered them at a sharp discount to help with the pandemic.

Sure it would have resulted in a a financial hit, but it also would have resulted in the kind of PR boost that money cannot buy, and more importantly it would have prevented this very situation, where they just dragged their reputation through the mud and shot it, showing everyone watching that they care more about profits than lives, to the point that they are willing to threaten someone who has different priorities and might actually care that people are suffering and dying.

Anonymous Coward says:

Re:

One observation. The cost in these parts isn’t the manufacturing. It’s the certification process. Takes years, huge costs, the whole shooting match.

Seriously, you can have someone design a part, figure out the manufacturing process, etc. and be maybe $50K in the hole for it. Then you go to certify and you burn $20 million.

When your expected market is 5000 of these a year, suddenly a $10K list price starts looking reasonable, just so you can pay off the $20m legal bil for dealing with the FDA and it’s EU equivalent.

pepe says:

It is also what about the right to use a machine you bought. Law should be change in EU and worldwide. If you own a machine you can replace parts if is need, use exchange parts of second companies and more over if the manufacturer is not providing the parts of lack of supply, abusive costs (like 10.000 euros a plastic piece), …

Even if we pure tons of money to our health systems if we don’t cut cost never will be enough with pharma vampires sucking money abusively.

tgafpc (profile) says:

Please everyone, spare the indignation

That price also has to cover the capital cost of developing the device and getting it approved. Sure, materials might be $1, but that’s not the only cost involved. Most of this cost is driven by the Government.

Also, while desperate times, using unapproved parts opens these providers to huge liabilities should these emergency parts cause a failure. 100% some lawyer has seen this and will be investigating every casualty even remotely related to these parts.

Finally, I would not be surprised if the original manufacturer declared any device that used these parts is no longer supported/compliant and cannot be used until re-certified.

Medical devices have much stricter controls than consumer devices for reasons of life and safety. This costs $$$.

Anonymous Coward says:

Re: Please everyone, spare the indignation

There are times when even medical personal are allowed to takes risks, and this is one of them. The choice is let the patient die, or use a 3d printed valve to give them a chance of surviving, and that make use of the 3d printed valve a perfectly reasonable and acceptable action.

Anonymous Coward says:

valve

You typically can’t sue someone who doesn’t monetize the production.

So if there’s no sale of the valves (in this case) then there’s no IP violation. The whole point of filing patents is that it becomes public domain after the expiration period for the patent.

Patents typically protect use of the protected technology for a gain of some sort. I don’t think it has even been tried in court that the gain is saving someone’s life. It’s almost always (if not always) economic in nature.

Let ’em sue. They can sue for all the profits made ($0) and that’s about it.

Anonymous Coward says:

valve

You typically can’t sue someone who doesn’t monetize the production.

So if there’s no sale of the valves (in this case) then there’s no IP violation. The whole point of filing patents is that it becomes public domain after the expiration period for the patent.

Patents typically protect use of the protected technology for a gain of some sort. I don’t think it has even been tried in court that the gain is saving someone’s life. It’s almost always (if not always) economic in nature.

Let ’em sue. They can sue for all the profits made ($0) and that’s about it.

David Lewis says:

$11k machine valve

Italian Lira? I really want the name of the manufacturer so I can help them improve their manufacturing systems. The valve cartridges shown with the article I have seen seem trivial.
Maybe you have found an instance that should be investigated for criminal behavior.
I can build an iron lung for under $1000. So a valve the price you mention seems an insult.
Best regards.
Stay safe.
Burn the bastards

OGquaker says:

Re: Re: patent

With a priority date of 04 May, 2006, 70% of total run of the valve patent is over and has "Lapsed" for failure to pay dues in some countries; not very protective of their IP ‘rights’. Giovanni Battista Venturi is probably pissed off.

GM let their butt load of electric car patents lapse for failure to pay their USPO dues in 2000 at 50%, allowing the market to flourish. Works for me.

Eric VB (profile) says:

You could all be right

This could be some BS patent this company is milking to charge a fortune for a cheap part.

OR this company could have spent millions of dollars on R&D and this high price is entirely justified because this part is more durable/efficient/etc.

If Microsoft spends $5 billion paying a small army of highly paid software engineers and other professionals to develop their new OS the argument is not they are ripping us off, this software could be pirated for no cost at all.

Let’s imagine this same hospital trying to keep people alive and there is a problem with the licensing server and all their breathing machines go down and the only way to get them going again would be to install pirated software.

I don’t think it would be unreasonable to assume that NOT doing this would constitute negligent manslaughter.

Paul Gunn (profile) says:

Fact Check

Could someone please fact check this alleged $11,000 charge for a single valve (BI “investigation” not withstanding.)? Is it possible that $11,000 is to purchase a batch of them? It looks to be for mixing gases, such as O2 and ambient air, so they would probably be single use, and you wouldn’t typically buy such things piecemeal, so a minimum order of $11,000 for several hundred would make more sense, especially since you have to make sure the materials used are sterile and safe – don’t want nasty stuff (such as silicone release agents and plasticizers) off-gassing and coating the patients’ lungs. Now, it’s a different matter if the valves are platinum coated and delivered on a silk pillow in a cart drawn by unicorns . . .

Anonymous Coward says:

Re: Fact Check

The outrage is not so much driven by price, but rather the manufacturer trying to prevent somebody else supplying what they could not, and under circumstances that are time critical. It not as though hospitals can delay treatment for breathing difficulties for weeks or months until the manufacturer can come up with new supplies.

Toom1275 (profile) says:

Re: Fact Check

Quote in the original article from the tech expert Massimo Temporelli (Run through Gogle Translate):

Of course we are now in the testing phase », underlines Temporelli, « and surely it is an uncertified piece, but we had no alternative! The emergency was buffered thanks to technology and on Monday we will know if the new valve works perfectly ". Furthermore, he adds, "the cost of the piece is about 1 euro, compared to the original one which costs 10 thousand, which however is not available ".

Lkat (profile) says:

Fact Check on the web in Italian

I am Italian and have checked everything I could find online regarding this story and could find no mention of any law suits. Could you please cite the source that mentions legal action being taken? Dr Fracassi, in his own words, says that in this particular situation (emergency, not enough valves available, people’s lives at stake, no gain for the company, will no longer be printed when the emergency subsides), he believes there are no grounds for suing for patent infringement. So that is maybe where this comes from?
https://help3d.it/valvole-stampate-in-3d-a-brescia-facciamo-chiarezza/

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