ELNs & Patent Evidence
Simon ColesCTO & Co-founder
ELNs & Patent Evidence
• 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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Who we work with
Who we work with
Who we work with
Industry
What we do
• Patent Evidence Creation & Preservation
• Make lawyers happy
• Which means you can make scientists happy
• Sometimes our stuff is used...
• Standalone (e.g. J&J presentation)
• In conjunction with other “ELN” products (e.g. Solvay, Array, J&J etc.)
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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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So you want to replace your Bound Notebook
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How do you make lawyers happy?
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Understand their problem
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Understand their problem
• If you all do your jobs, and invent some valuable stuff
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Understand their problem
• If you all do your jobs, and invent some valuable stuff
• Someone will try to take it away from you
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Understand their problem
• If you all do your jobs, and invent some valuable stuff
• Someone will try to take it away from you
• It’s your legal team’s job to
• Prepare you for that eventuality
• Reduce the risk of it happening
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Their problem
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Their problem
• At that point they’re going to have to convince the world that
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Their problem
• At that point they’re going to have to convince the world that
• You invented it
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Their problem
• At that point they’re going to have to convince the world that
• You invented it
• You invented it first
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Their problem
• At that point they’re going to have to convince the world that
• You invented it
• You invented it first
• Conceived first
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Their problem
• At that point they’re going to have to convince the world that
• You invented it
• You invented it first
• Conceived first
• Reduced it to practice
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Their problem
• At that point they’re going to have to convince the world that
• You invented it
• You invented it first
• Conceived first
• Reduced it to practice
• Were diligent in the pursuit of your invention
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To do this
• Need evidence of what you were doing
• Need to be able to get this evidence in court
• Need this evidence to be compelling
• Need to be able to resist attacks on credibility by very intelligent, highly paid opponents
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How the game is played
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How the game is played
• If the facts of the case are against you
• Argue about the evidence
• If the evidence is against you
• Discredit the evidence
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What’s Victory?
• The other side settles
• Quickly
• And to your great advantage
• Failing that, the court case is swift and decisive
• Whenever you see a piece of case law, that was a lucky escape
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What this means for ELNs
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What this means for ELNs• If the scientists do their job
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What this means for ELNs• If the scientists do their job
• If the lawyers do their job
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What this means for ELNs• If the scientists do their job
• If the lawyers do their job
• If sales & marketing do their job
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What this means for ELNs• If the scientists do their job
• If the lawyers do their job
• If sales & marketing do their job
• If the customers buy it
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What this means for ELNs• If the scientists do their job
• If the lawyers do their job
• If sales & marketing do their job
• If the customers buy it
• If your competitors can’t compete
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What this means for ELNs• If the scientists do their job
• If the lawyers do their job
• If sales & marketing do their job
• If the customers buy it
• If your competitors can’t compete
• .... then a whole army of very clever people are going to spend a lot of money trying to make you look incompetent
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What’s worse
• You’re going to have to run this process consistently
• Over long periods of time
• And you’ll need to be able to use this evidence over long periods of time
• 30 years, Lifetime of the Company etc.
• Many many commercial lifetimes (for you and the vendor!)
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How scary is the problem?
For as long as anyone can remember your organisations have been happy to take ~10% productivity hit in their
most Knowledge-sensitive and potentially profit-generating area
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You do this carefully
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It isn’t about the technology
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Getting approval to move
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• Most lawyers are happier to approve
• A specific tool
• Installed in a specific way
• With specific SOPs around it
• Asking for blanket approval tends to get a blanked “No”
Keys to Success
• Recognise reality
• Split the solutions
• Dependancies
• Pay attention to what you’re creating
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Your Organisation is Stupid
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Your Organisation is Stupid
• I don’t worry about the integrity of things in the short term
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Your Organisation is Stupid
• I don’t worry about the integrity of things in the short term
• I do worry about 10, 20, 30 years in the future
• Murphy’s law hasn’t been repealed
• Simplicity and accountability is key
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Split the Systems
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Split the Systems
• Keeps the lawyers out of the scientist’s tools
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Split the Systems
• Keeps the lawyers out of the scientist’s tools
• Can build/buy the science-facing ELNs as needed, and manage as appropriate
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Split the Systems
• Keeps the lawyers out of the scientist’s tools
• Can build/buy the science-facing ELNs as needed, and manage as appropriate
• The Patent Evidence system can be unperturbed by science-driven change, and run with a focus on integrity
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Split the Systems
ELN system
ELN system
Microsoft Office
...the future...
Self-containedPatent
Evidence Creation
Preservation
Dependancies
• For this problem, dependancies bring complication risk and little reward
• They can only help with a few small areas, which should be easy to do internally
• Generally on balance of risks, it isn’t worth it
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Dependancies
• You really want everything under your control
• Makes it easier to run the system
• Makes it easier to defend the system
• Makes sure everyone pays attention
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Dependancies
• This applies to internal infrastructure as much as it does to external parties
• Your infrastructure team might not be prepared for a legal invasion
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Simplicity
• Simple is easy to understand
• Simple is easy to explain
• Simple is easy to run
• Simple is easy to keep running properly
• Simple stands the test of time
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Records Management
• The Cinderella problem
• Turns out to be key
• Very hard problem to solve on a large scale
• The biggest issue to come out of our fire drills
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Run a fire drill
• Amusing and sobering experiences
• Starts the conversation
• Generally wssential for legal to fully approve the most
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Typical Fire Drill Outcomes
• Lawyers understand how the scientists work and what’s convenient
• Scientists understand what the lawyers need
• IT understand what they’ll need to do
• Scientists understand the need for Records Management
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Communication Gaps
• Most lawyers don’t want to torture the scientists
• Most scientists aren’t trying to avoid their record keeping obligations
• Most IT depts. aren’t trying to frustrate everyone
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SOPs
• Fairly simple
• Write down what you are planning to do
• Do it
• Avoid the temptation to be overly ornate
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Pay attention to what you’re creating
• Not just about experimental write ups
• More data isn’t better
• We spend a lot of time making sure we don’t store “unhelpful” things
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Paper Vs Electronic
• It isn’t a “One is better than another” choice
• Depends on your circumstances
• Clear move to completely electronic systems
• But we do see paper-preservation in specific cases
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Sources of Inspiration
• Airline security
• Nuclear power plant design
• RISKS list
• Bruce Schneier
• Ross Andersen
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A good ELN & PECP
• Better evidence
• More complete coverage (not just experiment writeups)
• Consistent application of policies
• Happier users
• Calmer lawyers
• Easier location of the evidence you need
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