Manufacturer Threatens To Sue Volunteers who printed a valve
techdirt.com
techdirt.com
Now suppose someone publishes, anonymously, the design file online...
This isn't actually complicated. We're talking about saving lives in a pandemic. Who gives a shit about IP law?
I doubt Fracassi is open to any legal liability at all. The hospital might be guilty of some IP infringement, especially if they charged someone for use of the part, or for the part itself.
I’d guess the bigger liability would come from the patients suing for the use of non-approved medical devices (which I doubt will happen, or would hold up in this case).
Note: not a lawyer, and certainly not an italian lawyer.
INAL, but I'm pretty sure that's not true. If that were the case MP3 patents would not have been such a big problem for OSS software. Similar things apply(/applied) to open source hardware designs for 3D printing technology.
I tried to find out many times how far patents prevent non-profit usage, but also never arrived at a clear conclusion.
[1] https://craphound.com/overclocked/Cory_Doctorow_-_Overclocke...
[2] E-book download: https://www.gutenberg.org/ebooks/19000
There aren't many clear, easy choices in a situation like this.
Here's one.
You could say that about many patents, probably most medicine ones. Also no one would want to do business with Italy, and it probably breaks EU & international laws.
I find it hard to believe that $11k was a justifiable price or that the valve design was novel or sophisticated enough that someone reproduced the geometry from scratch so trivially (without even using sophisticated 3D scanning techniques I might add, as I understand it).
A lot of businesses strategically buy and sell patents in processes to prevent others from implementing the full process and to force royalties on single pieces. Patents have really got out of hand and in my opinion, stifle innovation more than secure and foster it the way they're currently being abused.
IP protections do need to exist but there's a lot in terms of protection that is just garbage.
The prices would be insane, if that was the case.
I think a lot of the high prices charged for medical gear isn't so much to recoup the variable cost of production of that item, it's to recoup the initial/fixed cost of bringing the gizmo to market. If people can "photocopy" someone else's device by just covering the variable cost, it might cripple companies' incentives for developing for the medical market.
And I believe it's true that if a patent holder doesn't go after every known infringement, it becomes much more difficult to go after any known infringement.
Not saying that 3d printing these valves doesn't feel like the right thing to do in this case. Just saying that feels like a more nuanced situation, rather than being cut/dry.
It’s not too hard to convert a DICOM file, and most hospitals have a CT scanner than is up to the task if you give cake to the right person. Engineering departments know this well.
Its typically used outside of hospital environments for scanning. The large scanners won't give you the level of detail you'd need, at least not the ones I worked with.
They definitely ought to be named and shamed.
I did find this: https://www.archyde.com/italian-start-up-3d-prints-valves-to...
Edit: Charging 10000 EUR for a 1 EUR part in a breathing device is typical scumbag behavior. Doing that during a pandemic rises to criminal. Suing people who 3D print parts for free is grounds for nationalization.
No, it's grounds for abolition of intellectual property. Don't blame the player for crappy rules.
> Let me ask a question: when was the last time that America’s chair industry hiked the price of chairs 400% and suddenly nobody in the country could afford to sit down? When was the last time that the mug industry decided to charge $300 per cup, and everyone had to drink coffee straight from the pot or face bankruptcy? When was the last time greedy shoe executives forced most Americans to go barefoot? And why do you think that is?
https://slatestarcodex.com/2016/08/29/reverse-voxsplaining-d...
Remember this is something that we decided to add. Absent the laws, and more importantly the captured regulatory process which enforces it, it wouldn't be happening.
I'm not convinced this is a requirement to having rules at all.
I doubt the medical device industry would exist w/o patent protection. It is just too expensive to bring products to market without the limited monopoly that patents provide. And you have to consider the potential for product liability lawsuits after products get to market. That has to be built into the price as well.
Didn’t Tesla declare their IP free use because Elon Musk preferred their propagation for the benefit of humanity’s survival over profits?
The source business insider article gives Massimo Temporelli as the source that a single unit is 10,000 EUR. Temporelli is not someone involved in the medical industry and might be easily confused by the way pricing works, assuming that "1 unit" is a single piece.
"Naming and shaming" (= causing a PR disaster for them) is one of the few recourses we have left to try and get companies to behave ethically.
No special court orders are required. Neither can the infringed sue to stop the US gov (or its contractors) from infringing. If a US state infringes it may be protected by sovereign immunity (assuming it has not waived that protection)
Of course Italian law may be different, but they or the EU probably have similar immunities.
Edit to add:
I am an IP attorney so I appreciate that to some people this article may seem like it contradicts some of what I said. IP law is hard.
But as far as I could tell, with one quick read, it basically confirms what I said.
Also, thanks for the link, I hadn't seen this article before.
But there are probably immunities or limitations of liability at play here based on the circumstances.
Generally, the medical device industry is cut throat and patent heavy. They patent every tweak they can to fend off competitors. It makes some sense because of the expense associated with bringing a medical device to market.
You might be thinking of clean room design [1], where one team does the reverse engineering and writes spec, and another team implements it from the spec.
Since the manufacturer was unable to supply the part, I would argue that 3D printing it was most certainly a "necessity", at least until either patients stop requiring it, or more parts can be procured.
There are some civil law analogs such as being able to trespass someone else's property in emergency situations.
The manufacturer may threaten, huff and puff, but juries are filled with human, who will feel same same wrongness we do.
In theory, everybody cares about FDA certification and all the legal details like HIPPA and stuff.
In practice, when SHTF ie in a situation like 9/11, most humans beings seem to do the best they can with what they have.
No one should refuse to act just by fear of being sued for doing something, when inaction will guarantee the death of other human beings.
In nearly all of the USA, he could be shot if he were in the victim's home. Most states do not have a duty to flee when in the home, and the attacker's continued presence is considered a threat. Only in Vermont and Washington, D.C. is there a duty to attempt to flee when in the home.
Outside the home, in most states he probably could be shot, at least if he weren't clearly departing. He can't just stay there being a threat. There is no duty for the victim to attempt to flee, even if outside the home.
An interesting case involves a purse snatcher in a Texas parking lot. A bystander pulled out a huge revolver with a laser sight, fired, and killed the purse snatcher to recover the purse. It was legal.
I guess they are not in consumer space and donate valves would not have any real return.
https://news.ycombinator.com/item?id=22588619
Are the manufacturers forced by any legal precedent to sue in order to defend their patents?
If other hospitals do indeed need this valve, we should be spending our time doing this.
edit: also, you really need a working machine to ensure that the design that you have created works is properly functional
Finally, forced licensing is another option.
Canada have just made it illegal ($5000 fine) for trying to profit off sales of toilet paper or sanitizer, and listings for them have been banned from eBay and Kijiji (Canada's version of Craigslist). Of course, under normal circumstances it's perfectly fine for Nike to make a pair of shoes for $3 (paying people terrible wages) and then sell them for $300 dollars. Their share price goes up and the Capitalists are happy.
Under normal circumstances patents are a good way to protect IP, and nobody cared last month that a part was $11,000 dollars and they had a monopoly on making it.
As one twitter post said "COVID-19 is a blacklight and it's revealing a lot of nasty stains on our Capitalist society"
The problem is that there's lots of regulatory capture in the medical industry and that lots of people don't mind it so long as they get to elect people that say the things they want to hear. Plenty of people care, just not a voting majority.
However, laws against price gouging are not the whole solution.
Laws against price gouging do not prevent hoarding or panic buying. Thus, holding the price of the goods artificially low in the face of increased demand leads to shortages. (Unsurprisingly)
If you have laws against price gouging you need to have laws that limit the number of units purchased to reduce hoarding. Otherwise, you inevitably will have short term shortages.
The real problem is that some people want to make shortages like this permanent by going full communism.