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Company threatens to sue volunteers who 3D-printed valves for coronavirus aid (theverge.com)
209 points by danso 22 days ago | hide | past | web | favorite | 140 comments

$11,000 for a plastic valve. Unreal. No wonder hospitals are always stretched to the limit when they're being gouged like this.

Think of it this way, a hospital could buy 10 valves or hire a physician for a year. Are these valves typically re-used? Are they going through them faster because they don't want to risk infecting other people?

I wouldn’t feel too bad for the hospitals. They are happy to mark up prices by an outrageous amount. My company does medical devices. One device goes for around 20k to the hospital. I have heard that the hospital often charges 80-100k for the device plus the cost for doctors and facility which is often another 50k or more.

I don't feel bad for hospitals, I feel bad for the patients in hospitals who suffer because of the greed of private companies.

I doubt that's the case in Italy.

In the US yes, thanks god not every country has 3rd world healthcare.

The third world finds this comparison rather offensive.

This was an Italian hospital, not an American one. Devices and drugs are dispensed at cost, or lower, and that number often comes out considerably less than the public list price.

Either which way, typical healthcare profiteering is not going to end well here. There is simply too much on the line to allow people to block or threaten progress.

Considering your company probably makes them for <5k I'd say it's sad all around

It's not $11,000 for a plastic valve. It's $11,000 for a plastic valve and the many thousands of hours of R&D, testing, validation, certification and risk.

> It's not $11,000 for a plastic valve. It's $11,000 for a plastic valve and the many thousands of hours of R&D, testing, validation, certification and risk.

Nope. Sorry. Not buying that argument this time. I accept that argument for patent exclusion periods and high prices on medication, because the R&D has enormous risk costs when medications don't work or don't get approval. Allowing pharmaceutical companies to recoup those costs is vital to innovation and public health. This is a piece of plastic that's part of a larger machine. There was no enormous R&D budget required to develop the replaceable component. By all means let them make money on the machine, but the argument doesn't hold up for this simple maintenance component.

You don't get to, "not buy the argument," because R&D costs are constrained by layers of unimaginably complex legislation and compliance. The company had to jump through ridiculous hoops for every component of said machine. Until you pull out the book and say, "Nope, see here Section 93...they did not have to do X, it's needless," you don't really have a good counterpoint because this is the case for all medical equipment. You can't just out of the blue say, "Yeah but not this one!" The entire medical regulatory and compliance system is overly complex. You're making the $10000 toilet seat argument...yeah, well the toilet seat needed to be delivered to a highly regulated aircraft. Ironically those $10,000 toilet seats are now $300 because they are 3d printed.

Nobody has mentioned how much an entire ventilator costs. Best I can find is between $5-50k usd. For example a Puritan Bennett 980 quoted as around $50k (by the manufacturer) with a $2k a year service contract.


So why is a valve $10k? Note that a replacement battery for the above ventilator costs < $1k.

Is the valve a disposable part (at 20% cost of the whole unit?) Is it some special valve that is the core IP (that other medical valves can't replace?) Is it made from some special material? Do they have to make each one from scratch? Does individual certification cost a fortune (and maybe this is a fixed cost regardless of what you're testing)? How much does a similar replacement valve cost for a similar ventilator?

Bear in mind that $10k implies a $3k cost to the company, at a typical hardware engineering markup.

I don't think we can handwave "Rnd" or some mystical "compliance" cost without knowing more details.

Seems like a valve for anaesthesiology is a Class II medical device, which may be a start?


> So why is a valve $10k? Note that a replacement battery for the above ventilator costs < $1k.

I'm guessing the valves are single-use (due to contamination), so the cost is passed along to the customer. They can't charge every customer for a battery (I mean, they could prorate it, but that's not how medical billing works). The hospital doesn't care what a valve costs if they're passing-along 100% of the cost to you.

If that is the case, then I have even less sympathy for the manufacturer.

> The entire medical regulatory and compliance system is overly complex.

And big companies take advantage of their position as the only ones who can navigate such a system to justify their sky high prices, and then they lobby to maintain that position.

The valve in question looks to be for IV drug delivery, which is not a new technology. It's probably just a simple check valve.

> And big companies take advantage of their position as the only ones who can navigate such a system to justify their sky high prices, and then they lobby to maintain that position.

This is something most people don't comprehend. People tend to think that it's the government putting in place these regulations and the companies are against them, but more often than not the regulations exist at the behest of the incumbents to constrain competition.

It's hard to climb up, but it's harder to stay at the top, so they put barriers behind once they have reached high enough.

In a sense, it's the government. It's just that, thanks to massive donations, committee stuffing and other shenanigans, they got to write the regulations themselves.

> There was no enormous R&D budget required to develop the replaceable component.

Are you sure about this? Just because it is one small part of a complex device doesn't make it low cost.

> By all means let them make money on the machine

Ok...so the machine becomes (for example) $1m instead of $10k. The financial cost to use the machine remains the same.

Let's say the regulatory costs add up to $100,000,000 and the valve has a marginal cost of $1.00 to make and distribute. They would have to sell just 10,000 units to more than offset their investment. I think I'd wager the world needs more than 10,000 air valves.

How can one justify this kind of vicious exploitation of publicly funded healthcare?

I seriously doubt any critical medical part can be made for $1. If that part fails, there are likely serious consequences for the patient. Sure the plastic is cheap, but the manufacturer will likely do several expensive steps to reduce the failure rate:

Each part is traceable from all raw materials to finished product

Each part is manually tested/calibrated

Each part may be tested with non-destructive testing (x-ray, ultrasound, dye crack inspection etc)

For every lot of parts, several parts will be tested destructively

Each part comes with liability, so the manufacturer will likely purchase liability insurance

Also, the regulatory costs are paid years in advance of a single unit being sold. Once the device is approved (that is, if it's approved at all), the units are sold slowly over years. So the regulatory costs must be financed.

> So the regulatory costs must be financed.

Absolutely. Why does the "financing" in this case have to go through a hospital's purchasing department? The obvious reason for why they charge such incredible amounts per unit is because they can. If there was any amount of competition or marketplace for it, it would be cheaper. There clearly isn't.

Explain to me how this way of doing things is not holding the public hostage.

> I seriously doubt any critical medical part can be made for $1.

Seems like these things that were 3D printed could be. At least at a marginal cost.

A few failures is a lot less deadly than what is happening in Italy right now

What specifically is this valve for? A lot of medical equipment is surprisingly low volume. The UK for instance has 5000 ventilators in the entire country. Ventec was interviewed on NBC News this evening, they said they normally produce 150 ventilators per month.

There are tons of medical devices that are low enough volume that most hospitals don't even have a single unit. There's a reason why we have hospitals with varying levels of status, capabilities, and specialties. There are fairly common surgeries that require equipment that only exists in 2 or 3 digit quantities in the entire world.

So few are available because they are hideously expensive.

They are hideously expensive because so few are bought.

All three of your numbers are purely hypothetical and are likely out by one or two orders of magnitude.

My point is that people saying that it is overpriced don't understand the input costs of medical devices.

"Let's say the regulatory costs add up to $100,000,000 and the valve has a marginal cost of $1.00 to make and distribute."

That's two numbers relating to the cost of production. The second is the cost that a 3D printer doing one off prints actually costs (it's in the article, as a rough estimate.) The first number is a deliberately chosen "insane" example figure to show the absurdity of an $11,000 part. A medical test n license for a single part of a device does not cost anything like $100M.

Now as to the market for these things - the third number. Nearly 8,000 people have died so far. I can't be arsed to extrapolate further but I recall reading that these are single use devices.

The very likely overpriced. The healthcare industry made over $100 billion in the US only in 2018. I've experienced it first hand, UCSF tried to force me into buying a ($174) kneebrace for over $2400...

And the fact that they are threatening to sue for something they couldn't sell is disgusting.

You're right, it's probably closer to a billion dollars to develop and $0.10 to produce. Doesn't change my argument very much.

A hell of a lot of advertising, r&d etc goes into a can of Coke too. It doesn't cost 11,000 dollars

Coke cans don’t have the same regulatory hurdles and moreover there your coke can R&D is amortized over something like a trillion units. There’s a real argument for why this lawsuit is dumb, but this ain’t it.

Are you comparing a can of Coke to a medical device? It's surprising that I need to say this but the economies of scale are completely different.

I've seen up close how medical devices are made. I've also been in a softdrink bottling plant. Based on those experiences I think your chances of acquiring some disease from a softdrink vs acquiring one from a medical device are about equal.

Lovely. Duplication of fixed costs lead to natural monopolies. Sounds like there is room for intervention.

If your plan is to finance yourself by charging $11k for a piece of plastic maybe you need another plan because people will rightfully crucify you.

Still too much.

Maybe you (or someone) should go into the respirator business and undersell them on price?

And risk getting sued by extremely well funded corporations protected by broad scope patents. It may well be the case that it is prohibitive to get proper regulatory approval to sell such a device.

Ventilators are early 1900s technology. You're not *going to "get sued" for a basic unit.

And yeah, it costs a ton of money to get regulatory approval.

So where do you think all that money comes from? Think maybe they have to build that into the price of the ventilator, so maybe it's not so "overpriced" at all? Maybe?

you forgot all the medical savings groups(cartels) that won't buy from you because they're paid commission that the hospitals have contracts with so they can't buy from you.

Sounds like that's already happening with a new price of "free" and they're not happy about it.

someone just did and they are getting sued

What are you basing that on? How much was spent on development that $11,000 is too much? $100k, $1m, $1b ?

Seriously, unless the inside of that value is really, really, really complex, I can't imagine it would take that much R&D, relative to the rest of the machine. I would think relative to that, this value was dead trivial.

Um, $11k for your life is not a legal contract.


Part of the cost is certainly regulatory / insurance underwriting approval, isn't it?

And the rest is pure profit.

If it was that profitable there'd be dozens of competitors.

... or there was and they consolidated to increase profits since antitrust is rarely enforced these days

Unless there are patents involved.

Not if the barrier to entry is high enough (and then also assuming there is zero collusion)

It's also that entrenched, as well.

Let's say it did cost a million to certify the valve. That's covered in the first 100 valves sold.

From then on, which should be like after a week, every single dollar is profit.

Yes, it is. Medical devices have to be FDA approved (or the equivalent in other countries) and that costs LOTS of money.

On top of that, you have to account for the potential lawsuit if your 3D-printed knockoff respirator valve fails and someone dies.

As opposed to not having a valve at all? The hospital wouldn't need knockoff valves if they had the real thing. In such dire circumstances I don't think any judge would fault you for going the unconventional route to deliver results. It's similar to how captains on boats and airplanes are allowed to break almost any regulation in the book to ensure the safety of their passengers.

This. I have set this policy as the first rule of our SRE response teams to make it clear the broad extent of their power. Because it’s our written policy, it’s incorporated into our PCI and SOX compliance programs as well. The auditors don’t always love it, but we’ve always gotten them to understand.

The aviation law: https://www.law.cornell.edu/cfr/text/14/91.3

> On top of that, you have to account for the potential lawsuit if your 3D-printed knockoff respirator valve fails and someone dies.

In that case, the alternative was a few people over there going to die by slow asphyxiation, so the 3D-printed knockoffs were a really good thing, even if some of them failed.

Except, that the 3D printer plastic might not hold up to the medical grade plastic and might cause system wide infections that hadn't been accounted for culminating in a brain or spinal infection that leaves a person in a coma for the rest of their painful life while the family watches. The family then Sue's malpractice, doctor's lose their medical license and hospitals lose millions which could go to treat patients. Hypotheticals can go both ways.

Yes, this is a difficult decision. If you were a doctor what would you do? Let the patient die today, or try the newly 3D printed valve that looks and feels like the real one but may have unintended side effects?

Thats why they printed so many, that they can change them for each patient.

> On top of that, you have to account for the potential lawsuit if your 3D-printed knockoff respirator valve fails and someone dies.

Where does this meme that companies get sued for parts made by completely independent third parties come from?

The most obvious reason that wouldn't be true is that without a patent on the part or similar, companies generally have no right to prevent third parties from making replacement parts for their equipment. It would be pretty silly to impose liability for something they have no control over.

> Where does this meme that companies get sued for parts made by completely independent third parties come from?


Where does your your that malpractice lawsuits are just "memes" come from? Because I can assure you that they exist in the real world. As do massive fines for using equipment that hasn't been FDA approved.

Late stage capitalism

> A medical device manufacturer has threatened to sue a group of volunteers in Italy that 3D printed a valve used for life-saving coronavirus treatments. The valve typically costs about $11,000 from the medical device manufacturer, but the volunteers were able to print replicas for about $1 (via Techdirt).

What's the name of the manufacturer?

Right. I'm wondering the same. Enough bad pr and this will change quickly.

No it won't. What are we gonna do, stop buying from them? We are not their customers to begin with, hospitals' procurement departments are.

> No it won't. What are we gonna do, stop buying from them? We are not their customers to begin with, hospitals' procurement departments are.

You're wrong. We're not living in some capitalist cartoon. Even the greediest CEO doesn't want to be a villain in a lifesaving story like this.

Where did this company "threaten" to sue? All I can find is the following source

"Now, despite the country battling an unprecedented health crisis, there is potential for a legal battle with local media reporting that the manufacturers of the valves are refusing to share their blue print for further production and could potentially sue for copyright breaches."

So they may have the option to sue?

> However, when the pair asked the manufacturer of the valves for blueprints they could use to print replicas, the company declined and threatened to sue for patent infringement, according to Business Insider Italia. Fracassi and Ramaioli moved ahead anyway by measuring the valves and 3D printing three different versions of them.

Which links to https://it.businessinsider.com/coronavirus-manca-la-valvola-..., in Italian, and I don't understand Italian.

> Lui e i suoi collaboratori si sono recati in ospedale a Chiari ieri mattina (venerdì, ndr) e dopo aver chiesto all’azienda produttrice i file 3D per stamparli e aver ricevuto risposata negativa – anzi hanno ricevuto anche minacce di denuncia per violazione brevetto

Basically doesn't add anything - the company isn't named.

It's a really nice story though, a bright spot in very dark times.

Translate to the rescue!

"having received a negative remarry - indeed they also received threats of complaint for patent infringement"

Coming from Massimo Temporelli, so checks out

"received a negative remarry"


I don't speak Italian, but I think the issue is this:

> risposata negativa

"Risposata" is "remarry." Presumably they wanted "risposta," which is "response." Probably just a typo.

I speak Italian, can confirm

It’s an automatic translation (put the original Italian in to google translate and that is what you get).

I guess the parent post was to illustrate in a humorous manner the limitations of machine translation.

See my comment: the original text has a typo. The translation is correct.

Doesn't change my point though. A human translator almost certainly would have caught an error like this.

"Response", not "remarry".

Right on the heels of SoftBank-owned Labrador Diagnostics LLC suing over COVID tests: https://news.ycombinator.com/item?id=22598988

Which company is suing over the 3D-printed valves? We need to name and shame. If we're unwilling to call out monopolists putting profits over even human life, then we, too, are complicit.

On another note, I'm of the increasingly-strong belief that patent suits should be deemed automatically dismissed if the "infringement" is a response to either an inability or unwillingness of the patent holder to actually use that patent productively (i.e. produce something using that patent). In this case, if the original manufacturer is out of stock, 3D printing replacements should be fair game. Likewise, if we don't have enough testing kits, making and distributing more should be fair game.

> we are not going to spread the drawing.

This part seems less than optimally ethical. If it's a choice between helping other hospitals to save lives and to avoid additional legal liability, this seems like a good hill to go bankrupt on.

But...if someone slipped the file to me I wouldn't publish it either. So I can't fault them for being as faulty as me.

They said they would print them for free for any hospital that needed them, I assume they would also send the drawings if asked by a hospital

At least in the US, I believe so long as you do not sell or transfer items, you can make them for your own use without licensing the patent. To win a law suit, the company would have to "show harm". They can't. They lost exactly zero sales.

This is the opposite of true in that US patent law forbids even personal use but most European jurisdictions permit it.

It doesn't forbid it. It enfringes on the patent and the holder can sue for damages.

Force majeure.

In the US:

FM is between parties to a contract. FM clauses allocate the risk of unforeseen events to the parties as per the language in the contract.

If FM is in play at all, it would probably protect the manufacturer by relieving it of its promise (if any) to provide the valves.

Note, I have no idea how contract law works in Italy or the EU.

However, in this case, there is probably an Italian or EU law that shields the hospital from liability. Especially if the hospital is part of a government health system. (The US has such laws)



I think "Necessity" is more applicable https://en.wikipedia.org/wiki/Necessity_(criminal_law)

In italian: "Stato di necessità" https://it.wikipedia.org/wiki/Stato_di_necessit%C3%A0

Rough translation: Cannot punish someone for something if he did it to save himself or others from a grave damage, due to a danger he did not cause voluntarily, and not avoidable in other ways, if the thing done is proportional to the danger


Plus lets be honest (not sure if civil law still has jury trials), NO jury, not even if they imported a single person from several random countries would convict them. Not a single one.

Jury trials in Italy are only for the gravest crimes (like some murders)



35 USC 271: Except as otherwise provided in this title, whoever without authority makes, uses, offers to sell, or sells any patented invention, within the United States or imports into the United States any patented invention during the term of the patent therefor, infringes the patent.


Hmmm.. OK, I wonder if that is a change in the law from some years ago?

AFAIU not since 2010 at the most recent:

(July 19, 1952, ch. 950, 66 Stat. 811; Pub. L. 98–417, title II, § 202, Sept. 24, 1984, 98 Stat. 1603; Pub. L. 98–622, title I, § 101(a), Nov. 8, 1984, 98 Stat. 3383; Pub. L. 100–418, title IX, § 9003, Aug. 23, 1988, 102 Stat. 1563; Pub. L. 100–670, title II, § 201(i), Nov. 16, 1988, 102 Stat. 3988; Pub. L. 100–703, title II, § 201, Nov. 19, 1988, 102 Stat. 4676; Pub. L. 102–560, § 2(a)(1), Oct. 28, 1992, 106 Stat. 4230; Pub. L. 103–465, title V, § 533(a), Dec. 8, 1994, 108 Stat. 4988; Pub. L. 108–173, title XI, § 1101(d), Dec. 8, 2003, 117 Stat. 2457; Pub. L. 111–148, title VII, § 7002(c)(1), Mar. 23, 2010, 124 Stat. 815.)

In the US a patent holder can absolutely exclude you from making or using their patented inventions.

However, the US gov can infringe at will without any court orders or special laws.

If a US gov agent (any low level CDC or health agency employee could do it) told the hospital to print valves, there is nothing the patent holder can do about it except get paid for the value of the valves sometime later.

I think you are wrong. The key I think is "for use". If you made patented item and are using it you can get sued. Of course nobody really gonna chase an individual but officially you can not.

I getting downvotes for reporting simple fact? That's the spirit. Never let the facts get in a way ...

Here: "US law is more strict. It forbids anyone from making, using or selling the invention, even when the use is strictly personal." - https://www.iusmentis.com/patents/crashcourse/rights/

Conversely, if you make it for the lulz, you should be fine. Unless the intended use is for the lulz. I so wish there to be jurisprudence on this...

But in this case, it'd be for the hospital's use, so they would have lost sales technically and it'd be easy to show harm.

May be having the inability to produce for the required (life-saving) demand should invalidate the “lost sales” argument. Anyways, wait for the deaths to mount and they will all come around in fear of retribution

They should hire them instead. Maybe together they can cut production costs so this life saving equipment doesn't have to be sold for $11,000.

I'm sure the cost of these valves are not in the production but in the research of coming up with the design to produce and other things before production. So they price in order to recoup already spent money and get some profit on it too. For sure it doesn't cost them 11k to make.

Valves are mature technology. The expense to develop it is negligible. The expense to push it through regulatory apparatus might not be.

Most likely it is a trivial variation on an already approved design, varied solely for the purposes of obtaining a new patent, and of getting an exclusive requirement for it to be used on the machine.

There is no defensible reason to presume good faith on the part of a medical equipment manufacturer, even though a few do have it.

> There is no defensible reason to presume good faith on the part of a medical equipment manufacturer, even though a few do have it.

I agree and I also think it's incredibly shitty of a medical company to threaten to sue in these trying times. Really exposes what they are all about. I was just trying to see the coin from the other side, trying to understand.

Then maybe they can help them setup a way to license the 3D model so hospitals can print it themselves, but still pay. Whatever the price components are, clearly some innovation is needed here if there are not enough of these in hospitals.

"Maybe together they can cut production costs so this life saving equipment doesn't have to be sold for $11,000

It's not the unit cost, it's the R&D that's expensive.

The $5000 screwdriver definitely is a thing, if you need 5 Engineers to design it but only ever make 5 of them, to be used on the Space Shuttle for example.

FDA approval is a big, big line item too.

For drugs, it's something like $2 billion up front before you sell a single pill. For medical devices it's not as much, but still can be in the tens to hundreds of millions.

i think they like it to cost $11,000 and do things to keep it fixed that way

> life saving equipment doesn't have to be sold for $11,000.

Production costs don't really enter into it. The actual breakdown is probably more like:

Production costs: $25 FDA approval: $100 million dollars

Too bad you got junked. This was a major complaint from folks Peter Attia had on that trying to take a drug etc to market can cost hundreds of millions and years through the FDA process. It actually could have been David Sinclair that was saying that but I might be mistaken.

Yeah, for a supposed entrepreneurial web site, there sure are a lot of people here nowadays who don't understand basic economics.

This site has turned into a tech-flavored subreddit of Think Progress.

This story has been updated since. https://www.theverge.com/2020/3/17/21184308/coronavirus-ital... Basically the company does not plan to sue, and was not selling the part at $10,000.

This article feels like low quality clickbait to me. The company isn’t even named, and there’s no source given for the claim that a lawsuit was threatened.

This. There is insufficient details for the level of outrage people are displaying.

I call bullshit.

Their is no way this valve cost $11,000. A quick google search for PEEP valves for respirators sow that they sell for a few dollars, 20 at most.

It seems unlikely that any company would sue in such circumstances, it would be a PR nightmare.

If the story was true prices would most likely be listed in euros.

When this 3d printed valves story appeared a few days ago those exact figures were cited on Reddit as a joke.

How they ended up presented as "Facts" on TheVerge is anyone's guess.

Having seen the prices charged for drugs and how they then calculate future prices (after the R&D costs have been recovered), I have a very sceptical view of any comments that say we need to consider R&D and regulatory cost recovery before complaining about the prices being charged for anything in the medical technology field. Having also discussed what was seen by someone I know who left the corrupt world of advertising to go to the medical technology world, I also consider anybody saying the same about recovery of R&D and regulatory costs to either being a liar or deluded. The gentleman in question went back to the advertising world because they were innocent children compared to the corruption and price gouging that went on inside the medical technology industries.

There is a captive market here and the seller can sell at any price they want and make any markup they want because they can. There are some very honourable people and companies who do not price gouge in the field. But it seems that these are a very small minority.

Now mind you, this kind of price gouging occurs anywhere there is a captive market. But some industries are more susceptible to it than others.

I'm all for letting companies have a limited monopoly on innovations, but this just seems short-sighted. It's the kind of behavior that gets nations to pass something like "medical necessity" legislation allowing them to infringe patents under certain circumstances, or impose profiteering and price gouging statutes, or re-thing all of their health care systems' compensation levels for equipment & procedures. It's the sort of thing that can raise public ire against the entire medical device industry.

People are quibbling about money while millions of lives are at stake. We need tens of thousands of these medical devices and we need them fast. Like in the coming weeks.

If companies who suddenly find themselves in a strategic position don't get what they need to do, then the Government needs to take control using emergency powers, and use any available production capacity in the country to ramp up production, fast.

We'll also need to do many other things. We should adopt a wartime mentality, focus on solving the problems at hand, and stop wasting time. At least in Italy they get this now.

I'd like to see them try. To sell this kind of critical equipment to Italian hospitals you have to guarantee there will be no shortages even (especially) in critical conditions. They failed to uphold their part of the bargain with the country and at this moment both the government and the people are very short on patience. Probably, if they even try to sue the volunteers they are going to lose all their contracts with Italian hospitals in a matter of days.

This linked article actually names "the manufacturer" and the lawyers. Name and shame! https://www.techdirt.com/articles/20200316/14584244111/softb...

That appears to be about the troll suing about vaccines, not this situation of an manufacturer suing to stop 3d printing.

Printcrime[1,2] by Doctorov becoming reality in one of the most nasty ways imaginable.

[1] https://craphound.com/overclocked/Cory_Doctorow_-_Overclocke....

[2] E-book download: https://www.gutenberg.org/ebooks/19000

This is adding nothing new over the previous BusinessInsider piece. It's just reporting (again) that this company asserted patent rights after the hospital and the 3D-printing firm requested the design in .STL format due to being unable to secure supplies in an unprecedented emergency. Which is what we knew already.

The world needs IP rules like the FCC (USA) has for Amateur Radio.

The rules are basically if lives are in danger, anything goes.

Same for the FAA, right?

Damn straight. They also already exist by the way. You don't need any license for an ultralight or gyro as I recall.

Let them threaten. This is newsworthy when they actually sue. It would also require them to go on the record, with their names and the names of their executives and lawyers on full display. My money would be on that not happening.

Circumstances such as this call for mandatory licensing or pooling of patents.

The system itself is broken and should be abolished, as has been long and well argued.

At first glance, this reads like the sort of horrible thing only a fictional megalomaniac villain would do, say, in a Bond movie.

This crisis is really showing many ridiculous and completely unnecessary conditions in our systems and these will break down.

For what it worth the company might loose rights for their patent if it can be proven that it does not perform due diligence (chasing violators being one example).

I think you are confused with trademark law.

I am not.

"A patent owner (patentee) may be precluded from enforcing its patent against an alleged infringer after a period of time from the first notice identifying the patent and possible infringement (e.g., 4 ½ years) if the following conditions are met:

Misleading Conduct/Silence: The patent owner, through misleading conduct (or silence), leads the alleged infringer to reasonably infer that the patentee does not intend to enforce its patent against the alleged infringer (e.g., by sending a cease-and-desist letter followed by years of silence); Reliance: The alleged infringer relies on that conduct; and Prejudice: The alleged infringer will be materially prejudiced if the patent owner is allowed to proceed with its claim (e.g., alleged infringer has continued selling and expanding product lines). This legal doctrine known as patent equitable estoppel applies on a case-by-case basis to each patent asserted by the patent owner. Therefore, a patent owner may have other patents to enforce which may not be barred by equitable estoppel." - http://www.patenttrademarkblog.com/consequences-of-patent-ow...

Again I am getting downvotes for reporting facts. I guess mob opinion rules.

It's still a horrible inhuman thing to do. If the responsible CEO of the company were not a sociopath, he would have

1. provided the STL files for the plastic valve when the hobbyist 3D printer asked for them

2. granted a no-cost patent licence.

That way the requirement by law to defend the patent does not arise in the first place.

Did I ever say I like the situation? We are literally surrounded bu stupid and sometime outright criminal (in a normal human sense) laws. Civil forfeiture alone - whoever came up with this brilliant idea deserves a jail time. Go call them a-holes. Feels better?

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