2008 09 16 Walking The Tightrope between lawyers and scientists

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Reconciling the issues between scientists and lawyers

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2008 09 16 Walking The Tightrope between lawyers and scientists

  1. 1. Walking the tightrope between scientists and lawyers Simon Coles CTO & Co-founder
  2. 2. Walking the tightrope between scientists and lawyers • My Background • A perspective on The Problem • Some thoughts 2
  3. 3. Copies of these slides http://www.amphora-research.com/ 3
  4. 4. About Amphora • Started in ELNs in 1996 • Globally deployed, fully electronic ELN for Kodak • Grew from there... 4
  5. 5. Who we work with
  6. 6. Who we work with
  7. 7. 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
  8. 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 http://www.amphora-research.com/ 8
  9. 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 http://www.amphora-research.com/ 9
  10. 10. Your Company • Your circumstances are the biggest variant • Commercial environment • Scientific area • Working styles http://www.amphora-research.com/ 10
  11. 11. 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
  12. 12. 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
  13. 13. 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
  14. 14. 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
  15. 15. 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
  16. 16. 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
  17. 17. 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
  18. 18. 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
  19. 19. Typical issues in the Notebook Process • Who keeps Notebooks • What they put in them • What they keep elsewhere http://www.amphora-research.com/ 19
  20. 20. 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
  21. 21. 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
  22. 22. 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
  23. 23. 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
  24. 24. 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
  25. 25. 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
  26. 26. 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
  27. 27. 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
  28. 28. 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
  29. 29. 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
  30. 30. 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
  31. 31. 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
  32. 32. 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
  33. 33. 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
  34. 34. 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
  35. 35. Pitfalls for the unwary • Communication gaps • IT departments • Records Management • Commercial issues http://www.amphora-research.com/ 35
  36. 36. 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
  37. 37. 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
  38. 38. 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
  39. 39. 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
  40. 40. 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
  41. 41. 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
  42. 42. 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
  43. 43. 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

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