There shouldn't be any private data to steal.
We grant these companies patents so they can be open about their tech.
If they have secret data, that really ought to be a reason to withdraw their patent.
We grant these companies patents so they can be open about their tech.
If they have secret data, that really ought to be a reason to withdraw their patent.
> no BioNTech or Pfizer systems have been breached in connection with this incident and we are unaware that any study participants have been identified through the data being accessed
Yes, your argument is trivially true, how does it help us move forward?
The parent commenter helpfully explained how such statement is trivially false, in that there is value in keeping some data secret even though patents are involved.
Thank you! I mean that
edit: note that subjects can still be identified with this data, just not directly.
This is likely an attempt at IP theft. Probably a second rate state actor.
As I said in another comment - the only data the pharma company gets to "take home" is anonymized (partially, ie. a number instead of a name) and blinded (you don't know if they received drug or placebo)
The company must reconcile the patient data with the trial data (on premise), in a scenario like: "liver enzymes abnormal after administration of vaccine, is there anything in the patient data that could clarify that (apart from the vaccine itself)". Someone has to painstakingly go through all that data.
Source: this was my job
During efficacy/side-effect analysis you should definitely use only blinded data. After confirmatory statistical analysis, it seems reasonable to go over the data in an exploratory pass to possibly discover/hypothesize why/when/how the medicine works/fails/interacts. Or do they just get the aggregate report?
if it were useful to big pharma to have that info, they’d have it.
And even if it was, they'd be breaking half a dozen rules at the risk of getting the whole study trashed and billions lost, for almost no benefit.
Getting a study invalidated is the nightmare scenario of every pharma company. And it's not just the FDA or EMEA but also scientific journals that go through this stuff.
The deal with patents was transparency in return for a short-term monopoly.
If we get one and not the other, it's a bum deal.
EU patent office says a patent must provide enough information to be reproduceable by a competent proffeshional - that's the whole point of a patent, to be usefull after it expires. It is not there to list things the company would lile to protect.
https://www.epo.org/law-practice/legal-texts/html/caselaw/20...
Thus, depending on what the claims cover, plenty of detail about complete systems can be omitted from the patent specification. For example, if the claims of a patent are directed to cache management for a messaging platform, most details about how the messaging platform works can be omitted as long as the cache management system is sufficiently described.
If there are unique features of the messaging platform that enable the new cache management system to work, detailed description of those features would need to be included in the patent specification. But unrelated stuff, such as, routing mechanisms, protocol optimizations, security, and so on, that may be part of the messaging platform can be omitted from the cache management patent specification.
Thus, the messaging platform org could keep plenty of trade secrets about other parts of their platform while still obtaining a patent on their cache management system.
That's if it's a process patent. There's also molecule patents, etc. I could be wrong but typically pharmas don't take out process patents because they are hard to prove and you need a warrant which has a nearly unattainable level of discovery to get on premises and determine if the process has been copied. With a molecule patent you can buy a sample and prove infringement with an analytical technique.
While the fda has disclosure requirements on a pharma manufacturing process, it does not have to be disclosed to the public.
Because it is a process, I have to go on their premises and prove that they are stealing my process. You must obtain a warrant to do that (because otherwise it is trespassing), and because competitors could just willy nilly claim "you're stealing my process" in a spurious fashion to gain access to the premises (and learn about what competitors are doing), judges typically put up a very high burden of proof to issuing those warrants.
You'll effectively never be able to enforce a process patent, so you're better off never patenting it and keeping it a trade secret instead, that way you have a bit of a moat.
By contrast, for a molecule or plant patent, the existence of the product is proof of infringement, so it's easier to enforce infringement.
For a molecule patent, you do not need to disclose the method you use to make it. IANA(P)L, You might be required to disclose one way of making the molecule, but it almost certainly doesn't have to be the way that you do it "in prod".
Ultimately, if you rely on keeping a process secret, you will most likely fail. Processes are trivial to copy, patent or not, and if you don't file a patent then it's not even illegal to copy your process when, not if, it becomes known.
Warrants are granted to law enforcement, not in civil suits between corporations. The word is subpoena, and if you knew even the basics of what you're talking about, you'd use correct terminology.
Legal discovery usually doesn't have a "very high burden of proof," because there are very reasonable ways to compartmentalize information. Legal discovery usually leads to a ton of transparency, at least to the legal teams on both sides (and a firewall, so that can't go over to the engineers).
MOST executives are diligent about responding to subpoenas. Judges have broad discretion for contempt-of-court, up to and including prison. If you're the CEO of BioCorp, and you can:
1) Respond promptly, completely, and accurately. Risk: You might wipe $200 million off of your books and cost each investor $2
OR
2) Stonewall the court or lie. Risk: You might get thrown in prison.
Which do you do? Most executives pick responding promptly. Not all, but most.
Most companies are super-careful not to infringe patents that they know about, because it's not fun. Unless it's a case of mutually-assured destruction. There are whole industries where everyone infringes, and no one sues anyone.
To use a more obvious example, your bank account information should in fact be secret, but that does not invalidate the claim that Pfizer-Biontech shouldn't have any private data to steal, because they should not have that data.
And Pfizer-BioNTech is running the trials and analyzing the data. Why wouldn't they have that data? Are you suggesting they try to get their drug approved without it?
I'm so confused.
Personal data about a (particular) patient should be possesed only by that patient and probably their doctor. The party distributing drug doses knows "<patient UUID> care of <doctor's post office box> is recieving <experimental/placebo>", but doesn't know who the patient is and ideally shouldn't even know which doctor they're mailing it to. The evaluators (plural) each recieve "patient with <age/sex/preexisting conditions/etc> equal to <value> <improved/worsened> <a lot/a little/not detectably>", with each evaluator bucketing and adding up the data for their particular trait (eg "18-25-year-olds did this well, 25-40-year-olds did this well, etc"). The company that has a obvious conflict of interest (incentive to corrupt the trial results) shouldn't be involved at all besides shipping a crate of medication to the dose distributer.
In practice things wouldn't be quite as strictly compartmentalized as they in principle should be, but if the patients' personal infomation is ever all present in one place to get 'stolen', your healthcare system is so fucked up it's not even funny.
(Note, preemptively, that I am not claiming that your healthcare system is not so fucked up it's not even funny. I'm making normative claims here, not descriptive ones.)
Yes, the company has a conflict of interest, but by sharing patient level data, the gov't can replicate any analysis. It's transparency in the process, data collection and data that makes for a reliable system. Masking personal data to the point that the gov't doesn't even know what the data represents sounds stupid.
I mean, your personal doctor collects all this data and stores it. Why would you not do the same with clinical trial data? It's medical treatment, albeit, experimental medical treatment.
And you think the Canadian healthcare system is "so fucked up it's not funny"? Or did you just assume I'm American?
We also have EU wide law that protects these companies from lawsuits for side effects, instead the company, a governments gets sued.
As said good luck to humanity.
The OP's argument is a theoretical argument that's only good in an idealized world that doesn't exist.
Because we shouldn't allow people to have their pie and eat it too, at our expense.
What should have happened, is what you are saying. But that's not how it went down and it seems, not how this world works.
What you argue is that there should be no trade secretes.
After patent is granted, it becomes public knowledge and stays public knowledge (not when it expires).
Patent's are just the top of the iceberg. Lots of research and methods related to covid-19 is not patented.
That's the problem. Patents aren't useful to the public because they don't describe enough to make a useful product when combined with public knowledge. The monopoly granted is supposed to be in exchange for expanding the public knowledge after expiry, but if most of the knowledge is kept secret, then the patent system isn't striking the bargain it was meant to strike.
But personal data should be. And data about business processes have no reason to be accessible. Work data can be misleading too.
Imagine you are working on a software project, there is a massive bug in your code, you know it is there and you intend to work on it before release. Now, imagine a competitor, trying to do the same and trying to get some advance, he steals your code, but he doesn't know about the bug and releases his own software based on it. You don't want that to happen with a vaccine...
If only we could design a method to openly share the source data, perhaps even with a way to track those bugs. Alas, it's totally impossible for humans to collaborate like that.
But working in collaboration is always a hassle, you spend a lot of energy in reporting and getting people to agree. So what you usually do it to do your work locally, maybe have your own TODO list, and when you are done, you clean up your work and make a nice commit. Sometimes you can't even do that, you have to send it to an integrator who then assigns your work to a reviewer and write a test, and... lots of stuff.
What you see on GitHub tends to lag significantly behind what is actually being worked on. In fact, a lot of developers tend to dislike messy histories. They take great care of squashing and rebasing so that the history looks like a nice, linear, well documented process. This is not reality, reality is "forgot to add file", "removed debug trace", "fixed merge didn't compile".
Now back to the spying. Imagine you are working on an open source project, with a bug tracker, continuous integration, and all the bells and whistles of a modern collaborative platform. Because you don't want to show others the ugly truth of actual development work, if can take a few days before the thing you are working with appears on the platform, if not weeks.
Now imagine a rogue actor who doesn't like to collaborate and really wants to get an edge. Instead of getting the nice, clean version from the main repository, he goes to the main developer computer and copies his workspace, and then rush to release something before the next nice commit hits the mainline.
That's the idea behind such hacks: try to copy a work in progress, not understanding what went behind it, and, by limiting collaborative effort and testing, try to get something out as fast as possible.
Like let's look at it. The argument here is that it was funded with public money so the data should be public. As a big OSS person I really like this idea. But who should the data be open to (and what data)? Germany?[0] (the funder) The EU? {North Korea,South Korea,Iran,Vietnam,China,Russia}?(the accused) The world? Public usually refers to the citizens of the country but can also colloquially mean "human."
Then we have to consider money (or resources, capital, whatever you want to call it. Time and effort was spent doing this and there was a loss of resources by some party). Is it fair for company A/Country A to spend a year or research time and money and Company B/Country B to steal that and make a profit through it because they can sell it for cheaper (i.e. B stole resources from A, that A spent time producing)? Do we know about how it is being produced? Are they vetted? There's all kinds of complications here that not only include resource recuperation (i.e. ignoring the capitalism component, which we can't because you can't just burn resources (capital) indefinitely) but there are also safety concerns.
Lots of companies decline to issue patents because they don't often protect their production rights. Often what happens is that the company produces a patent and 1) another company uses that knowledge to create something similar but distinct enough or 2) produces the same product in a country that does not respect the former country's patents. 1) is basically that student that copied your homework but made things unique enough that they technically weren't plagiarizing (but did they cheat?) and 2) is someone who copy pasted your assignment and turned it into a different professor. I don't think people feel great about either of these, but slightly better with 1. But you can also see a situation where the cheater turns in the assignment first and you get accused of cheating. The whole process is a mess!
Patents are difficult enough when you're operating in one country but get way more complex when you introduce other countries into the situation. I do think there needs to be major patent reform and personally I'd love to live in a world where all scientific advancements are available to anyone, but I'm not sure such a situation can exist until we advance to a post scarcity world. We're all familiar with OSS here and you'll always see people saying things like "Facebook is using that person's code, they should be a good guy and kick back a few grand for the free work." That's because we don't live in a post scarcity world. But in the mean time (until we get there) let's not trivialize the situation and try to view things from the situation we're in and how to advance things towards the dream situation.
[0] https://www.bloomberg.com/news/articles/2020-11-09/pfizer-va...
Vaccines require the running of clinical trials during development and approval. Trial data was not stolen in this case (according to the companies), but obviously this is private "vaccine data".
The breached data concerns "confidential information about the vaccine and its mechanism of action, its efficiency, its risks & known possible side effects and any unique aspects such as handling guidelines". What strikes me is the fact that this information is confidential at all.
For technical information (how to make the vaccine) this means it's not private.
For personal (including medical) information about clinical trial participants this means Pfizer-Biontech should not have the information in the first place.
Such stories to me do not seem to survive the slightest bit of critical thought, and yet the same stories keep getting pushed repeatedly. The only potential negative I can foresee for the public is that if there were an abundance of data available publicly, funded anti-vaxxers may be able to misrepresent them – but I still think the benefits would outweigh such downsides. In any case, public faith is rather lower than many would have hoped.
No. Hard no.
A patent is used to grant some exclusivity to the patent holder because it assumes the patented thing can be readily duplicated.
The idea is that they want the patent holder to have time to profit from their idea before it can be copied and undercut.
It has nothing to do with being open or sharing.
If a patent is for a tool, there is no requirement that the patent cover things like how to manufacture said tool. If the patent is for a process, there's no obligation that you provided details on the exact application of the process and it's intended purpose.
https://www.epo.org/law-practice/legal-texts/html/caselaw/20...
Part of the reason for patents is that someone else could devise a method of reproducing your patent cheaper or more affordably and undercut you.
Wrong. In exchange for being granted a patent, the "invention" needs to be described in great detail, with all the necessary information, so that others can replicate it (once the patent protection expires).
At least, that's how it is supposed to work.
There's no requirement that the information in the patent be via beyond replicating the patent.
If the patent can be reproduced via alternate means that are cheaper or faster, those need not be disclosed. In fact the point of a patent is to protect the patent holder from someone finding a cheaper or faster means of reproducing it.
The patent description must include enough information so the invention as recited in the claims could be replicated. Patent descriptions do not have to disclose details about the supporting/surrounding components of the whole system or platform.
E.g., a patent claiming a method for selecting 5G channels does not need to describe how to build out a 5G network.
A patent is a form of intellectual property that gives its owner the legal right to exclude others from making, using, or selling an invention for a limited period of years in exchange for publishing an enabling public disclosure of the invention.
So, yes, an _enabling_ public disclosure is exactly the purpose of a patent.