Post on 20-Aug-2015
Walking the tightrope between scientists and lawyers
• My Background
• A perspective on The Problem
• Some thoughts
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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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http://www.amphora-research.com/
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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http://www.amphora-research.com/
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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http://www.amphora-research.com/
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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http://www.amphora-research.com/
Your Company
• Your circumstances are the biggest variant
• Commercial environment
• Scientific area
• Working styles
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http://www.amphora-research.com/
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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http://www.amphora-research.com/
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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http://www.amphora-research.com/
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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http://www.amphora-research.com/
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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http://www.amphora-research.com/
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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http://www.amphora-research.com/
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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http://www.amphora-research.com/
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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http://www.amphora-research.com/
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
http://www.amphora-research.com/
Typical issues in the Notebook Process
• Who keeps Notebooks
• What they put in them
• What they keep elsewhere
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http://www.amphora-research.com/
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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http://www.amphora-research.com/
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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http://www.amphora-research.com/
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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http://www.amphora-research.com/
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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http://www.amphora-research.com/
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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http://www.amphora-research.com/
• 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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http://www.amphora-research.com/
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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http://www.amphora-research.com/
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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http://www.amphora-research.com/
Dealing with Diversity
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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.
Focus IP concerns here
Let them use whatever systems they want here
(because they will anyway)
Creati
ve C
haos
Discipl
ine, P
roce
ss,
Consis
tency
http://www.amphora-research.com/
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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http://www.amphora-research.com/
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
http://www.amphora-research.com/
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.
http://www.amphora-research.com/
What goes in the notebook
• 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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http://www.amphora-research.com/
What goes in the notebook
• 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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http://www.amphora-research.com/
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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http://www.amphora-research.com/
Pitfalls for the unwary
• Communication gaps
• IT departments
• Records Management
• Commercial issues
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http://www.amphora-research.com/
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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http://www.amphora-research.com/
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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http://www.amphora-research.com/
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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http://www.amphora-research.com/
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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http://www.amphora-research.com/
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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http://www.amphora-research.com/
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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http://www.amphora-research.com/
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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http://www.amphora-research.com/
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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