2008 09 16 Walking The Tightrope between lawyers and scientists

Walking the tightrope between scientists and

lawyers

Simon ColesCTO & Co-founder

Walking the tightrope between scientists and lawyers

• My Background

• A perspective on The Problem

• Some thoughts

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http://www.amphora-research.com/

Copies of these slides

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About Amphora

• Started in ELNs in 1996

• Globally deployed, fully electronic ELN for Kodak

• Grew from there...

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Who we work with

Who we work with


What we do

• Patent Evidence Creation & Preservation

• Make lawyers happy

• Which means you can make scientists happy

• Sometimes our stuff is used...

• Standalone With normal Office software

• In conjunction with other “ELN” products

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Is that an ELN?

• Depends what you mean by “Electronic Lab Notebook”

• If you are looking at the records management & patent side, probably

• If your a scientist, the best thing we can be is invisible

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Perspective

• Everything I say is generalisations of complex circumstances

• Most of what’s here is true for most people

• But everything here is contradicted by at least one of our customers

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Your Company

• Your circumstances are the biggest variant

• Commercial environment

• Scientific area

• Working styles

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The Problem

• Getting scientists to create good, reliable Lab Notebooks was hard enough before computers came along

• In the modern lab, it is even harder

• They’re working electronically

• Often with no regard for Records Management issues, Discovery implications etc.

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The Problem

• You need consistent practices across the organisation

• For diverse scientific activity

• Even for every large companies

• You also need to deal with per-country niceties

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Discovery Problems, too

• Everyone knows Electronic records admissible and useful in US Patent disputes

• But if you end up in a fight, anything you’ve got to disclose everything you have

• Unless you’ve got a really good records management programme, there’s going to be a lot of stuff

• Most of the time this can’t help you, and might well hurt you

• And it will cost a fortune to find and disclose!

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ELN projects and IP

• Paper Lab Notebooks are a vital part of your organisation’s IP protection strategy

• Work has been getting increasingly electronic

• Now (often as the final piece) you’re replacing the paper notebook with an ELN

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IP & Digital Science

• It’s not just about the ELN

• You’ve got an awful lot of other systems which might be used in evidence

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IP & Digital Science

• It’s not just about the technology

• In fact it’s very little to do with the technology

• It’s about how you use the systems, and look after them

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Beware

• It is quite possible that the ELN project is the first one to address IP & records issues in R&D for a long time

• It is quite possible the ELN project will open a can of worms!

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This Presentation

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• Not really going to talk about our products

• But we’d be delighted to talk to you later!

• But we will cover

• Typical issues

• Some of the basic lessons which seem to crop up time and again

• Some tools to help you explore some tricky issues

• Some of the common pitfalls


Typical issues in the Notebook Process

• Who keeps Notebooks

• What they put in them

• What they keep elsewhere

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People aren’t keeping notebooks properly

• Typically in most larger organistions

• 20% of the people who are laboriously creating notebooks (fully witnessed) don’t need to because their work isn’t IP sensitive

• A fair number of the most prolific inventors aren’t keeping notebooks at all and there’s very little evidence of their work

• Most companies have a very low compliance with their paper process for signing & witnessing

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They’re writing the wrong stuff down

• Often very difficult for scientists to know what they should be writing up

• Some think all that matters is data, when we really care about what was going on in their brains

• Need simple guidance which can be applied in a variety of situations

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They keep too much stuff

• Most scientists view any data as valuable

• So they keep everything

• Generally anywhere

• With little indexing

• A nightmare when it comes to legal discovery

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They keep too much stuff

• Your Records Manager is your best friend

• A well thought and consistent Records Management process is your best asset

• This isn’t really a Notebook problem – but it is your problem

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Some Good News

• A properly designed Patent Evidence system will give you better more reliable records than the existing paper system

• And save an awful lot of scientist time!

• With an electronic system you get a much better idea of what’s really going on

• You can coach the scientists

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• You will get very high levels of compliance with your requirements

• For example documents tend to be witnessed in less than an hour compared to weeks

• An ELN can enforce some structure (if desired)

Some Good News

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SOP design• Most Standard Operating Procedures are

• Too detailed & specific

• Too long

• Better to have a simple SOP which describes what you want

• “All scientists should write up their experiments in an approved Lab Notebook such that someone skilled in the art can reproduce their work”

• etc.

• Then have guidance documents for each area

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Some tools for dealing with diversity

• Many projects get stuck on the sheer complexity of the scientific process

• Especially in larger firms

• With many different spheres of activity

• Two frameworks which might help

• Look at the diversity of activity and where to put your attention

• Tease out what data is important and what isn’t

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Dealing with Diversity

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Corporate aspects(Records, IP protection, Sharing)

Med

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Proc

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Etc.

Focus IP concerns here

Let them use whatever systems they want here

(because they will anyway)

Creati

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Discipl

ine, P

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Consis

tency


Don’t be tempted

• Don’t be tempted to mix where the scientists work, and the record keeping system

• We tried that with the paper notebook and that didn’t work out well for anyone

• Creates lots of issues for introduction & ownership

• Also, don’t mix systems for IP protection and Regulatory Compliance

• Different problems

• Very hard (impossible?) to do in one place

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What’s Important• Most scientific activity creates

electronic “Stuff”

• Some of this is more useful than others

• Useful to look at things as a pyramid

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Raw Data

Interpreted Data/Reports

Experiments

Projects

Programmes

Not so interesting, Long TermHarder to preserve anyway


What goes in the notebook

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Raw Data

Interpreted Data/Reports

Experiments

Projects

Programmes

Corporate aspects(Records, IP protection, Sharing)

Med

icin

al C

hem

istr

y

Proc

ess

Che

mis

try

Mol

ecul

ar B

iolo

gy

Phar

mac

olog

y

Etc.



• Nothing need change from the paper notebook process

• Just because you can dump loads of raw data in, doesn’t mean you need to

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• Scientists will often need specific guidance on what to put in for different circumstances

• Often what’s currently happening isn’t what you need

• One advantage of an electronic system is you can sample what they’re doing and offer gentle assistance

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Diversity

• Doesn’t have to be a killer problem

• Moving to an electronic system will make things a lot easier

• However you will uncover issues which have remained hidden

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Pitfalls for the unwary

• Communication gaps

• IT departments

• Records Management

• Commercial issues

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Communication Gaps• The general Patent Evidence problem bridges many

departments

• Legal, Scientists, Management, Business Development, Quality, Librarians etc.

• In most companies the conversation that created the current process happened generations ago

• When you try to modernise this process for the electronic world

• You need to re-have that conversation with new assumptions

• And you now have to involve a new player, IT!

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Communication Gaps

• It seems that there’s precious little common ground between some of these groups

• A surprising amount of our time is spent helping these groups talk with each other

• One powerful tool is the “Fire Drill”

• Take a notebook record “Into court”

• “Depose” the scientist

• Then start asking difficult questions of IT

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Fire Drill outcomes

• Everyone finds them very useful

• Scientists often had no idea what would happen

• Radically change how they write things up

• IT had no idea what happens when a bunch of lawyers start asking questions

• Everyone now understands the fuller picture

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IT Departments• IT is unfortunately generally charged with keeping

costs low

• Unfortunately this means “IT costs”

• There are plenty of times where optimising for low IT costs

• Increases legal costs

• Increases legal risk

• Could completely imperil the evidence you’ve created

• Most IT groups need a fire drill to internalise this

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Records Management

• The unsung heros of organisations

• Make sure you nominate a Custodian of every IP-critical system you have, at the outset

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Records Management

• Most IT tools have well-meaning features which are really nasty from a records perspective

• e.g. regulatory systems which create masses of unhelpful detailed data with no way of purging it

• Few IT tools are built with long term records involved

• It really isn’t in the vendor’s interest to worry

• Most vendors aren’t really all that aware that more is not better

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Commercial Issues

• Most industrial organisations work with partners & governments

• Those contracts contain clauses around confidentiality, “Chinese Walls”, records retention etc.

• Few IT tools deal gracefully with these issues

• Worse, few organisations have an efficient and reliable process for getting the Information required to implement these contracts

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Summary

• IP concerns are often not really something a scientist worries about

• The situation in most organisations could certainly do with some improvement

• An Electronic system can really help improve IP protection, and make scientists happy

• But it does need a little care

• We’d love to talk further…

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2008 09 16 Walking The Tightrope between lawyers and scientists

Technology