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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