2008 06 17 IP Protection

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ELNs and IP protection

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2008 06 17 IP Protection

  1. 1. Harnessing your scientists in an electronic world Simon Coles CTO http://www.amphora-research.com/ 1
  2. 2. A copy of this presentation can be downloaded from our web site http://www.amphora-research.com/ 2
  3. 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. 4. Some of the people we help 4
  5. 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 http://www.amphora-research.com/ 5
  6. 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. 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. 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 http://www.amphora-research.com/ 8
  9. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 23. 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/ 23
  24. 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. 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. 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. 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 http://www.amphora-research.com/ 27
  28. 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 http://www.amphora-research.com/ 28
  29. 29. Pitfalls for the unwary • Communication gaps • IT departments • Records Management • Commercial issues http://www.amphora-research.com/ 29
  30. 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. 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 http://www.amphora-research.com/ 31
  32. 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 http://www.amphora-research.com/ 32
  33. 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. 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. 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. 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

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