Legal Issues of ELNs ELNs & Advanced Laboratory Solutions Colin G. Sandercock September 29, 2009
Topics of Presentation <ul><li>The importance of ELN records as legal documents in US litigation </li></ul><ul><li>Using E...
The Importance of ELN Records as Legal Documents in US Litigation
ERs Are Now A ( The ) Primary Source of Evidence in US Court Proceedings <ul><li>Dramatic shift in the use of ERs in US Co...
Courts Consistently Find ERs Admissible <ul><li>Party presenting ER  must be prepared  to prove record  is trustworthy </l...
Using ELN Records to Obtain and Support Patents
Use ELNs to Obtain & Enforce Patents (ELNs must contain the right evidence) <ul><li>A small but “not insubstantial” number...
Admissibility:  Two-Step Analysis   (ELNs must get into evidence) <ul><li>Evidence must first be authenticated under Rule ...
Hearsay <ul><li>FRE 802 states that “hearsay is not admissible except as provided by these rules. . .” </li></ul><ul><li>H...
Business Record Exception to Hearsay <ul><li>A memorandum, report, record, or data compilation,  in any form , . . .  made...
Establish a Foundation for Getting ELNs into Evidence in the USPTO and Courts <ul><li>Company policies must require scient...
Create Credible ERs to Support Litigation (ELNs must be persuasive evidence) <ul><li>Credibility will depend on how the ER...
Giving Up ELN Records in US Litigation
All  Electronically Stored Information Is Discoverable <ul><li>“ Rules 26(b) and 34 of the Federal Rules of Civil Procedur...
New e-Discovery Rules <ul><li>Rule 16  - court’s pre-trial scheduling order can include provisions concerning ER; parties ...
Bottom Line <ul><li>If ER is possibly important, you likely will be required to find it and produce it </li></ul><ul><li>Y...
General Considerations In Designing ELN Systems, Policies And Procedures
Questions of Any ER (4 Ws) <ul><li>W ho created it? </li></ul><ul><li>W hen was it created? </li></ul><ul><li>W hat was it...
Types of Systems   <ul><li>Fully electronic </li></ul><ul><ul><li>How is permanent availability ensured? </li></ul></ul><u...
Who Created The ER? <ul><li>Electronic signatures (e.g., ID and password) or digital signatures (e.g., smart cards, SAFE t...
When Was The ER Created?   <ul><li>Is a time stamp authority employed?   </li></ul><ul><ul><li>How often is accuracy check...
What Was Its Content When Created? <ul><li>Does the system contain an audit trail? </li></ul><ul><li>Does the system autom...
Has The Record Since Been Altered? <ul><li>How is the record archived?  Company accessible? </li></ul><ul><li>Is it possib...
Whether It Can Be Reproduced In Human Readable Form? <ul><li>What is the form of the record?  PDF versions with metadata? ...
Questions and Comments <ul><li>Colin G. Sandercock  </li></ul><ul><li>Perkins Coie LLP 607 Fourteenth Street N.W. Washingt...
Upcoming SlideShare
Loading in...5
×

Legal Issues Of ELNs

3,931

Published on

Colin Sandercock's presentation of the Legal Issues of ELNs at the ELNs and Advanced Laboratory Solutions, Brussels, Sept 2009

0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total Views
3,931
On Slideshare
0
From Embeds
0
Number of Embeds
4
Actions
Shares
0
Downloads
0
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

Legal Issues Of ELNs

  1. 1. Legal Issues of ELNs ELNs & Advanced Laboratory Solutions Colin G. Sandercock September 29, 2009
  2. 2. Topics of Presentation <ul><li>The importance of ELN records as legal documents in US litigation </li></ul><ul><li>Using ELN records to obtain and support patents </li></ul><ul><li>Giving up ELN records in US litigation </li></ul><ul><li>General Considerations In Designing ELN Systems, Policies And Procedures </li></ul>
  3. 3. The Importance of ELN Records as Legal Documents in US Litigation
  4. 4. ERs Are Now A ( The ) Primary Source of Evidence in US Court Proceedings <ul><li>Dramatic shift in the use of ERs in US Courts </li></ul><ul><ul><li>Companies use computers for almost all records, transactions and communications </li></ul></ul><ul><ul><li>People use e-mail instead of letters </li></ul></ul><ul><li>ERs now prime source of evidence (esp. e-mails!) </li></ul><ul><li>US Supreme Court’s e-discovery rules (Dec. ‘06) show that courts understand and accept ERs </li></ul>
  5. 5. Courts Consistently Find ERs Admissible <ul><li>Party presenting ER must be prepared to prove record is trustworthy </li></ul><ul><li>Opponent must be allowed inquiry into accuracy of ER and how ER created and maintained </li></ul><ul><ul><li>Record management procedures will be critical if there is a dispute – especially in those few cases where dates seem “fishy” </li></ul></ul><ul><li>ERs can qualify under “business record exception” to hearsay </li></ul>
  6. 6. Using ELN Records to Obtain and Support Patents
  7. 7. Use ELNs to Obtain & Enforce Patents (ELNs must contain the right evidence) <ul><li>A small but “not insubstantial” number of US litigations and interferences involve proving dates of invention </li></ul><ul><li>Keep in mind the legal requirements for proving dates of invention when implementing an ELN system </li></ul><ul><ul><li>Conception </li></ul></ul><ul><ul><li>Reduction to Practice </li></ul></ul><ul><ul><li>Diligence </li></ul></ul><ul><ul><li>Corroboration </li></ul></ul><ul><li>ERs are of little value if they don’t prove inventive acts </li></ul>
  8. 8. Admissibility: Two-Step Analysis (ELNs must get into evidence) <ul><li>Evidence must first be authenticated under Rule 901 </li></ul><ul><ul><li>E.g., by creator, recipient or custodian of ER </li></ul></ul><ul><li>Evidence then must be admissible under a specific FRE rule </li></ul><ul><ul><li>Relevant evidence generally admissible (FRE 402) </li></ul></ul><ul><ul><li>But, must recognize and account for possible “hearsay” which can bar admissibility </li></ul></ul>
  9. 9. Hearsay <ul><li>FRE 802 states that “hearsay is not admissible except as provided by these rules. . .” </li></ul><ul><li>Hearsay: “a statement [ either written or oral ] other than one made by the declarant while testifying at trial, offered in evidence to prove the truth of the matter asserted.” FRE 801 </li></ul>
  10. 10. Business Record Exception to Hearsay <ul><li>A memorandum, report, record, or data compilation, in any form , . . . made at or near the time by , or from information transmitted by, a person with knowledge , if kept in the regularly conducted business activity , and if it was the regular practice of that business activity to make such [record ], all shown by the testimony of the custodian or other qualified witness, unless the source of the information or the method or circumstances of preparation indicate lack of trustworthiness . . . </li></ul>
  11. 11. Establish a Foundation for Getting ELNs into Evidence in the USPTO and Courts <ul><li>Company policies must require scientists to: </li></ul><ul><ul><li>Record their research activities, including possible new inventions, in the normal course of duties; </li></ul></ul><ul><ul><li>Make their records at or near the time that they conduct their research; and </li></ul></ul><ul><ul><li>Create/maintain their records according to company policies </li></ul></ul><ul><li>Companies must establish a custodian for their ERs </li></ul>
  12. 12. Create Credible ERs to Support Litigation (ELNs must be persuasive evidence) <ul><li>Credibility will depend on how the ER is created, stored and reproduced in human readable form </li></ul><ul><li>Implement available technology and follow records management procedures to create reliable ERs </li></ul><ul><ul><li>“ Optics” may be important in a small percentage of cases so consider use of system safeguards and/or trusted third parties/escrow agents </li></ul></ul><ul><li>Review ER technology, policies and procedures before litigation to uncover weaknesses – ask hard Qs! </li></ul><ul><ul><li>“ Ethical hacking” test </li></ul></ul>
  13. 13. Giving Up ELN Records in US Litigation
  14. 14. All Electronically Stored Information Is Discoverable <ul><li>“ Rules 26(b) and 34 of the Federal Rules of Civil Procedure instruct that computer-stored information is discoverable under the same rules that pertain to tangible, written materials.” - In re Brand Name Prescription Drug Antitrust Litig. , 1995 WL 360526, at *1 (N.D. Ill. June 5, 1995). </li></ul>
  15. 15. New e-Discovery Rules <ul><li>Rule 16 - court’s pre-trial scheduling order can include provisions concerning ER; parties must meet and confer on e-discovery issues </li></ul><ul><li>Rule 33(d): Parties may reference “electronically stored information” as a type of business record from which answers to interrogatories may be derived </li></ul><ul><li>Rule 34 : “Ordinary” (a/k/a “native”) file format or “reasonably useable” form is production default – must include metadata if requested </li></ul><ul><li>Rule 37 : Provides “safe harbor” (i.e., no discovery sanctions) for inadvertent e-data loss if based on “routine, good faith operation” of an IT system </li></ul>
  16. 16. Bottom Line <ul><li>If ER is possibly important, you likely will be required to find it and produce it </li></ul><ul><li>You may want to obtain it more than your opponent </li></ul><ul><li>So make sure that (i) it still exists, and (ii) you can find and retrieve it fairly easily </li></ul><ul><li>Especially important with auxiliary files and databases associated with the ELN </li></ul>
  17. 17. General Considerations In Designing ELN Systems, Policies And Procedures
  18. 18. Questions of Any ER (4 Ws) <ul><li>W ho created it? </li></ul><ul><li>W hen was it created? </li></ul><ul><li>W hat was its content when it was created? Corollary – has it since been altered? </li></ul><ul><li>W hether it can be reproduced in human readable form? </li></ul><ul><li>Many acceptable solutions for ensuring 4 Ws (no two solutions are exactly the same) </li></ul><ul><ul><li>Credibility will depend, e.g., on SOPs, system policies & procedures, record format and archival processes </li></ul></ul>
  19. 19. Types of Systems <ul><li>Fully electronic </li></ul><ul><ul><li>How is permanent availability ensured? </li></ul></ul><ul><li>Electronic with tangible media back-up </li></ul><ul><ul><ul><li>Microfilm, paper, optical, magnetic </li></ul></ul></ul><ul><li>Hybrid of paper and electronic </li></ul><ul><ul><ul><li>Wet signatures/witnessing or electronic/digital </li></ul></ul></ul><ul><li>Auxiliary files? If so, what kind and how stored </li></ul><ul><li>How does ELN System satisfy the 4 Ws? </li></ul>
  20. 20. Who Created The ER? <ul><li>Electronic signatures (e.g., ID and password) or digital signatures (e.g., smart cards, SAFE token) </li></ul><ul><ul><li>How are passwords. IDs, and digital signatures assigned and verified by the system? ( See 21 CFR Part 11) </li></ul></ul><ul><ul><li>When the author or witness signs, does the system verify his/her authority? </li></ul></ul><ul><li>Timely signing and witnessing </li></ul><ul><ul><li>Do policies and procedures assure timely signing and witnessing? </li></ul></ul><ul><ul><li>How long can an experiment be held open? </li></ul></ul>
  21. 21. When Was The ER Created? <ul><li>Is a time stamp authority employed? </li></ul><ul><ul><li>How often is accuracy checked? </li></ul></ul><ul><li>How long can experiments be held open? </li></ul><ul><ul><li>Are dates recorded while the experiment is open? </li></ul></ul><ul><ul><li>Automatically or by the researcher? </li></ul></ul><ul><li>Are experiments periodically locked and versioned? </li></ul><ul><ul><li>Must an experiment be checked in periodically? </li></ul></ul><ul><li>Does the system include laptops that can be disconnected from the server? </li></ul><ul><ul><li>Can system record dates while off-line? </li></ul></ul>
  22. 22. What Was Its Content When Created? <ul><li>Does the system contain an audit trail? </li></ul><ul><li>Does the system automatically version? </li></ul><ul><li>How are records committed? Rendered as PDFs with some metadata? </li></ul><ul><li>Is underlying data retained in the ELN or an auxiliary file/data repository? Is some data not retained? </li></ul><ul><li>How are changes made after signing/ witnessing? Can records be unlocked by an administrator? If so, is a change record automatically generated? </li></ul>
  23. 23. Has The Record Since Been Altered? <ul><li>How is the record archived? Company accessible? </li></ul><ul><li>Is it possible to somehow alter copies of an ER w/o detection? If so, who is required for collusion? </li></ul><ul><li>Are trusted third parties/escrow agents involved in maintaining any part of the archive? </li></ul><ul><ul><li>E.g., electronic or microfilm copies of records, metadata, or other evidence of content such as hashes, checksums, transmission reports, etc.? </li></ul></ul><ul><ul><li>Once committed to the third party, what access does the company have? </li></ul></ul>
  24. 24. Whether It Can Be Reproduced In Human Readable Form? <ul><li>What is the form of the record? PDF versions with metadata? </li></ul><ul><li>Is there a tangible media back-up to the ER? </li></ul><ul><li>Are there auxiliary files stored outside the ELN? </li></ul><ul><ul><li>If so, are they linked or cross-referenced to the ELN? </li></ul></ul><ul><ul><li>What is the possibility for error in the cross-reference? </li></ul></ul><ul><ul><li>Can the link be lost? </li></ul></ul><ul><ul><li>What is the plan to ensure retrieval? </li></ul></ul>
  25. 25. Questions and Comments <ul><li>Colin G. Sandercock </li></ul><ul><li>Perkins Coie LLP 607 Fourteenth Street N.W. Washington, D.C. 20005-2003 PHONE: 202.434.1630 FAX: 202.654.9673 E-MAIL: csandercock@perkinscoie.com </li></ul>

×