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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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November 21, 2006

The Paper Mountain

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Posted by Derek

Another thing a large research site has, and in mighty impressive quantities, is paper. Something's got to be done with it, but not all laboratory paper is created equal.

Of course, a lot of the mass represents hard copies of files that exist in digital form. Non-proprietary stuff (journal articles that are no longer needed, etc.) will go into big recycling bins to be handled by guys who really have some long days ahead of them. A serious office move (and this is about as serious as it gets) is a good chance to toss ancient literature folders whose contents have become outdated. I just heaved out a pile of that stuff the other day, since I don't thing that 1991 reviews of Alzheimer's pathology are going to come back into fashion. I also had a bunch of miscellaneous hard copies of the Journal of Organic Chemistry from the early 1990s stuffed into a file cabinet - out they went. They were joined by old copies of C&E News, local phone books, 3-ring binder contents of short courses whose contents I don't expect to ever need, and a pile of chemical company and lab equipment catalogs.

Pages with proprietary data on them are a different matter. They're to be tossed in a special shredder box, to be picked up later by some other guys who are also going to earn their money. There are trailer-size portable shredder operations that you can hire for occasions like this. Compound lists, graphs of in vivo activity, photocopies of notebook procedures, handouts from project meetings - all that stuff is headed down this path. Different people save different amounts of this material. I save all the computer files, but heave most of the paper when a project finishes up, so I don't have as much in this category.

Things like printed NMR spectra used to be in a special category, because back in the days of expensive digital storage the hard copy was all you had. I guarded my NMR spectra pile fiercely in grad school, since I was going to need that data to get out of there. And in my first years in the industry, digital archiving was spotty. Now that gigabytes are carried around on key chains, all spectral data are automatically archived, so hard copies are just a convenience.

At the top of the paper mountain are lab notebooks. We switched over to an electronic notebook system a few years ago, but it didn't relieve us of the obligation of keeping a hard copy. Printouts are to be taped into the good ol' notebooks, and signed and witnesses just like the handwritten pages of yore. That's a legal requirement, and scientists at research sites across this great nation are regularly harangued about keeping up to date on it. It does little good. Researchers are just not wired to get things countersigned on a regular basis.

That can lead to some real problems for US patents in particular. We're still a "first to invent" country, while the rest of the world is mostly "first to file". And if you get in an argument about the date of an invention, well, lab notebooks are probably where you're going to end up. An invention that isn't signed and witnessed until a year or so later isn't going to help much in that situation. Admittedly, it's rare that things get to that point, but when they do it means that serious money is at stake.

So no one's throwing away any notebooks, that's for sure. And we're all getting them up to date, signed off on, etc. Companies keep track of every extant lab notebook - they're all numbered, and completed ones no longer in immediate use are kept under lock and key. Nothing's going to be allowed to slide.

Comments (4) + TrackBacks (0) | Category: Closing Time | Closing Time | Drug Industry History | Patents and IP


COMMENTS

1. Andrew Gilmore on November 21, 2006 4:58 PM writes...

Derek,
You are right about the need for physical records when it comes to patent litigation. While many companies have gone to electronic lab notebooks, they realize that eventually they may be required to convince a jury that they actually invented the product when they say they did. While electronic records are admissible, the decision will likely turn on which side has the "best evidence". The side with a sequentially numbered physical lab notebook will be able to show any jury, sophisticated or otherwise, a permanently bound book with documentation in the inventors own handwriting with original signatures. The other side will be left explaining how the electronic records have been safeguarded throughout the years and have not been tampered with courtesy of a wide range of complex electronic and other means. The jurors are the same people that hear on the tv and radio about identity theft and computer hacking. All the side with the physical books has to do is put enough doubt in the minds of the jury that the electronic records are easily manipulated and you cannot trust them. The side with the physical lab notebooks will be in a much more believable position.

Permalink to Comment

2. richard blaine on November 21, 2006 7:24 PM writes...

I've been using an e-notebook at my company for about 4 years, including electronic signing & witnessing. Regarding fidelity of the information, my company has contracted with an outside firm to stockpile the files & record checksums on the data, so subsequent tampering should be almost impossible. I don't know if e-notebooks have ever been tested in court. However, I wouldn't want to be the attorney who has to explain the verification system to a jury that likely doesn't understand computers or math.

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3. Tim Mayer on November 23, 2006 12:43 AM writes...

Hot dog, at least you have the chance to shut things down in an orderly manner. I've seen too many chemists get the boot with only a few hours to clean out their desks and lab benches. Just business, you know.

Permalink to Comment

4. Daniel Newby on November 25, 2006 7:53 PM writes...

"The other side will be left explaining how the electronic records have been safeguarded throughout the years and have not been tampered with courtesy of a wide range of complex electronic and other means."

Cryptographic checksums are rather reliable these days. There are any number of escrow companies that will date and store them for you. If you are especially twisted, you can put them in small print on a legal scare letter and send it to the competitor, whose lawyers will dutifully escrow it for you.

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