Last week we talked about sharing your work in iCERF for the iPad. The reason we need great collaboration tools like iCERF is because we frequently do need to share our work and show it to other scientists – that’s how progress is made, by bouncing ideas off of one another, and by building on the work of other scientists. Why don’t scientists share more? Well, for one thing, we (whether it’s us scientists directly, or the people that we report to) need to be sure that we aren’t giving away the farm by showing someone else the cool new thing we’ve discovered. In short, we need to protect our intellectual property, or IP.
Lots of scientists don’t worry about protecting their IP. That’s because most of us went into science because we love science, not so that we could get rich. But it’s important to remember that IP represents time and money invested in developing an idea, or potential product. If you discover something that could lead to a better treatment, or even a cure, for cancer, wouldn’t you like to get credit for it? And even if you’re only in it for the love of science, think of how awesome your basement lab would be if you actually reaped some financial gains from your discoveries!
So – how does one protect their IP?
It’s actually very simple. You need to be able to prove that you did something, and when you did it.
The patent laws in the US used to say that “first to discover” was all that mattered. That means that if you could prove that you discovered something first (say, by having a signed notebook page describing your finding), that you could get the patent for that discovery.
Actually it was a bit more complicated than that – you had to not only be the first to discover, but you had to have reasonable evidence indicating that you understood the implications of your finding, and that you were moving towards developing it. That little modification ensured that discoveries would actually be developed – since whether or not you discovered it first, if you sat on it, or didn’t realize it’s value, the next person to come along and discover it could patent it (providing that they did move towards developing it).
Now things are a bit more complicated – the US patent law has moved towards a “first to file” system, meaning that it doesn’t matter who discovered something, or when – what matters is who filed the application for the patent first – which often is still related to who discovered it first, but if it’s a close race between multiple individuals, often it can come down to a simple question of who got their paperwork filled out fastest. However, if the ownership of a patent is ever questioned, or brought to court, even this new system can be informed by the old “first to discover” information.
Let me get to my point – if you want to benefit from your discoveries, you need to protect your IP. That means that you need to have a way of recording everything in a way that is easy to retrieve later (making it easier to fill out all of that paperwork) – and you need to have a way of proving who did what, and when they did it.
There’s one more thing you really need to do to validate and authenticate your work – and it’s one of those things that many scientists never do – sign off on our work. Signing your experiments (and having them witness and countersigned) is a way of validating your work. Why don’t we do this at the end of every experiment? Because it’s an interruption to our day – you have to get up, walk around, find your witness, sign in front of them, watch them sign, and then get back to the bench. What we end up doing instead is either not signing (bad), or signing off on everything at the end of the week, or the end of the month. Problem is, unsigned IP is unsecured IP, and if we forget to sign, well, that’s another strike against us if/when we try to patent that particular thing.
Luckily the FDA has come up with a set of guidelines that cover how our electronic records need to be handled, which also safeguards them in terms of IP and patent submission. That rule-set is called 21CFR11 (for Code of Federal Regulations Title 21 Part 11). 21CFR11 covers things like role-based access (meaning I can’t see things unless they have been specifically shared with me, and even then I’m given a specific level of access like “guest” or “editor” that controls what I can do), time/date/user stamping, digital signatures, and audit trails (a way of keeping track of what has happened to all of the data in the system).