2007 09 28 ELNs as Patent Evidence Systems

ELNs & Patent Evidence Simon Coles CTO & Co-founder

ELNs & Patent Evidence • My Background • A perspective on The Problem • Some thoughts 2

About Amphora • Started in ELNs in 1996 • Globally deployed, fully electronic ELN for Kodak • Grew from there... 3

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.) 8

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 9

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 10

Your Company • Your circumstances are the biggest variant • Commercial environment • Scientiﬁc area • Working styles 11

So you want to replace your Bound Notebook 12

How do you make lawyers happy? 13

Understand their problem 14

Understand their problem • If you all do your jobs, and invent some valuable stuff 14

Understand their problem • If you all do your jobs, and invent some valuable stuff • Someone will try to take it away from you 14

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 14

Their problem 15

Their problem • At that point they’re going to have to convince the world that 15

Their problem • At that point they’re going to have to convince the world that • You invented it 15

Their problem • At that point they’re going to have to convince the world that • You invented it • You invented it ﬁrst 15

Their problem • At that point they’re going to have to convince the world that • You invented it • You invented it ﬁrst • Conceived ﬁrst 15

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 15

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 15

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 16

How the game is played 17

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 17

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 18

What this means for ELNs 19

What this means for ELNs • If the scientists do their job 19

What this means for ELNs • If the scientists do their job • If the lawyers do their job 19

What this means for ELNs • If the scientists do their job • If the lawyers do their job • If sales & marketing do their job 19

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 19

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 19

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 19

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!) 20

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 21

You do this carefully 22

It isn’t about the technology 23

Getting approval to move • 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” 24

Keys to Success • Recognise reality • Split the solutions • Dependancies • Pay attention to what you’re creating 25

Your Organisation is Stupid 26

Your Organisation is Stupid • I don’t worry about the integrity of things in the short term 26

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 26

Split the Systems 27

Split the Systems • Keeps the lawyers out of the scientist’s tools 27

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 27

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 27

Split the Systems ELN system Self-contained ELN system Patent Evidence Creation Microsoft Ofﬁce Preservation ...the future...

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 29

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 30

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 31

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 32

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 33

Run a ﬁre drill • Amusing and sobering experiences • Starts the conversation • Generally wssential for legal to fully approve the most 34

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 35

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 36

SOPs • Fairly simple • Write down what you are planning to do • Do it • Avoid the temptation to be overly ornate 37

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 38

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 39

Sources of Inspiration • Airline security • Nuclear power plant design • RISKS list • Bruce Schneier • Ross Andersen 40

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 41

2007 09 28 ELNs as Patent Evidence Systems

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