ELNs and IP protection

1. Harnessing your
scientists in an
electronic world
Simon Coles
CTO
http://www.amphora-research.com/ 1

2. A copy of this
presentation can be
downloaded from our
web site
http://www.amphora-research.com/ 2

3. What we do
• We make Lawyer’s lives less stressful – we hope!
• Software & expertise
• Which helps you to Create & Preserve evidence of
Scientific activity
• In a reliable, consistent manner
• Without stressing the scientists too much
• And without costing a fortune
• Organisations of all sizes, in many different
industries, around the world
• Primary problem is US Patent Law but there’s lots
of other considerations too
http://www.amphora-research.com/ 3

4. Some of the people we help
4

5. Two different worlds
• Scientists & IP Lawyers need each other
• But they live in very different worlds
• They have contrasting interests
• The relationship between the two can be a little
stressful
• Especially under the US “First to Invent” system
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6. Scientists’ World
• Creativity
• Change
• The science is the main event
• Record keeping for other people’s benefit is at
best a sideshow
• Little interest in the long term implications of
their Notebooks
• Little interest in Legal Discovery implications of
keeping everything forever
http://www.amphora-research.com/ 6

7. IP Lawyers’ World
• Charged with keeping the company out of
trouble
• And being able to profit from IP, often by
Patents or Trade Secrets
• Defend the company when needed
http://www.amphora-research.com/ 7

8. What most lawyers need
• You need to know what they’ve actually
invented!
• For US Patents
• Good evidence of scientific activity
• Demonstrate a priority date of invention
• Conception, Reduction to Practice, Diligence
• For Governments, Auditors, Tax authorities
• What your scientists did, where, and when
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9. US Patent Law
• In most cases US Patent concerns are why
people are cautious about moving away from
Paper Notebooks
• This concern is less of an issue, but you still
need to be careful
• There are other more complex problems
starting to bubble up
http://www.amphora-research.com/ 9

10. Electronic Evidence
• March 10 1998, Official Gazette
Admissibility of electronic records in
interferences:
Pursuant to 37 CFR 1.671, electronic records are
admissible as evidence in interferences before the Board
of Patent Appeals and Interferences to the same extent
that electronic records are admissible under the Federal
Rules of Evidence. The weight to be given any particular
record necessarily must be determined on a case-by-case
basis.
http://www.amphora-research.com/ 10

11. US Patent Reform
• If it happens…
• Won’t remove the need to Create & Preserve
detailed records of inventive activity
• Requirement to demonstrate inventorship & date
• Could well cause other patenting authorities to
require records too
• Introduction of the one year “Grace Period” for
prior art
http://www.amphora-research.com/ 11

12. 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.
• They’re working electronically and their only
notebook is a paper one!
http://www.amphora-research.com/ 12

13. 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
• And all the other reasons you need notebooks
http://www.amphora-research.com/ 13

14. 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/ 14

15. 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/ 15

16. Typical issues
in the Notebook Process
• Who keeps Notebooks
• What they put in them
• What they keep elsewhere
http://www.amphora-research.com/ 16

17. 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/ 17

18. 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/ 18

19. 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
• 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/ 19

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

21. 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/ 21

22. 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/ 22

23. Dealing with Diversity
y s,
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Corporate aspects
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Focus IP concerns
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here
(Records, IP protection, Sharing)
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isc
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Medicinal Chemistry
Process Chemistry
Molecular Biology
Pharmacology s
Let them use
o whatever systems
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they want here
C
Etc.
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ive
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at
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C
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24. 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/ 24

25. What’s Important
• Most scientific activity
creates electronic “Stuff”
• Some of this is more
useful than others
•
Programmes
Useful to look at things
as a pyramid Projects
Experiments
Not so interesting, Long Term Interpreted Data/Reports
Harder to preserve anyway Raw Data
http://www.amphora-research.com/ 25

26. What goes in the notebook
Programmes
Projects
Corporate aspects Experiments
(Records, IP protection, Sharing)
Process Chemistry
Interpreted Data/Reports
Molecular Biology
Pharmacology
Chemistry
Medicinal
Raw Data
Etc.
http://www.amphora-research.com/ 26

27. 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
• 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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28. 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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29. Pitfalls for the unwary
• Communication gaps
• IT departments
• Records Management
• Commercial issues
http://www.amphora-research.com/ 29

30. 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/ 30

31. 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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32. 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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33. 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/ 33

34. Records Management
• The unsung heros of organisations
• Make sure you nominate a Custodian of every
IP-critical system you have, at the outset
• 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
http://www.amphora-research.com/ 34

35. 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/ 35

36. 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/ 36