Walking the tightrope
between scientists and
lawyers
Simon Coles
CTO & Co-founder

Walking the tightrope between
scientists and lawyers
• My Background
• A perspective on The Problem
• Some thoughts
2

Copies of these slides
http://www.amphora-research.com/ 3

About Amphora
• Started in ELNs in 1996
• Globally deployed, fully electronic ELN for
Kodak
• Grew from there...
4

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
http://www.amphora-research.com/ 7

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
http://www.amphora-research.com/ 8

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
http://www.amphora-research.com/ 9

Your Company
• Your circumstances are the biggest variant
• Commercial environment
• Scientific area
• Working styles
http://www.amphora-research.com/ 10

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.
http://www.amphora-research.com/ 11

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
http://www.amphora-research.com/ 12

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!
http://www.amphora-research.com/ 13

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
http://www.amphora-research.com/ 14

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
http://www.amphora-research.com/ 15

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
http://www.amphora-research.com/ 16

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!
http://www.amphora-research.com/ 17

This Presentation
• 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/ 18

Typical issues
in the Notebook Process
• Who keeps Notebooks
• What they put in them
• What they keep elsewhere
http://www.amphora-research.com/ 19

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
http://www.amphora-research.com/ 20

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
http://www.amphora-research.com/ 21

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
http://www.amphora-research.com/ 22

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
http://www.amphora-research.com/ 23

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
http://www.amphora-research.com/ 24

Some Good News
• 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)
http://www.amphora-research.com/ 25

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
http://www.amphora-research.com/ 26

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
http://www.amphora-research.com/ 27

Dealing with Diversity
y s,
nc es
te oc
Corporate aspects
sis , Pr
Focus IP concerns
on e
C lin
here
(Records, IP protection, Sharing)
ip
isc
D
Medicinal Chemistry
Process Chemistry
Molecular Biology
Pharmacology s
Let them use
o whatever systems
ha
they want here
C
Etc.
(because they will
ive
anyway)
at
re
C
http://www.amphora-research.com/ 28

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
http://www.amphora-research.com/ 29

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 Programmes
Projects
Experiments
Not so interesting, Long Term Interpreted Data/Reports
Harder to preserve anyway Raw Data
http://www.amphora-research.com/ 30

What goes in the
notebook
Programmes
Projects
Corporate aspects Experiments
(Records, IP protection, Sharing)
Interpreted Data/Reports
Medicinal Chemistry
Process Chemistry
Molecular Biology
Pharmacology
Raw Data
Etc.
http://www.amphora-research.com/ 31

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
http://www.amphora-research.com/ 32

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
http://www.amphora-research.com/ 33

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
http://www.amphora-research.com/ 34

Pitfalls for the unwary
• Communication gaps
• IT departments
• Records Management
• Commercial issues
http://www.amphora-research.com/ 35

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!
http://www.amphora-research.com/ 36

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
http://www.amphora-research.com/ 37

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
http://www.amphora-research.com/ 38

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
http://www.amphora-research.com/ 39

Records Management
• The unsung heros of organisations
• Make sure you nominate a Custodian of
every IP-critical system you have, at the
outset
http://www.amphora-research.com/ 40

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
http://www.amphora-research.com/ 41

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
http://www.amphora-research.com/ 42

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…
http://www.amphora-research.com/ 43