The document discusses the legal implications of electronic lab notebooks (ELNs) in the U.S. legal context, highlighting their role as crucial records in litigation and patent support. It outlines the requirements for ensuring that ELNs are admissible as evidence in court according to e-discovery rules, including proper record management and authenticity verification. The document also emphasizes the importance of designing ELN systems with credibility, security, and compliance in mind to withstand legal scrutiny.

1. Legal Issues of ELNs ELNs & Advanced Laboratory Solutions Colin G. Sandercock September 29, 2009

2. Topics of Presentation The importance of ELN records as legal documents in US litigation Using ELN records to obtain and support patents Giving up ELN records in US litigation General Considerations In Designing ELN Systems, Policies And Procedures

3. The Importance of ELN Records as Legal Documents in US Litigation

4. ERs Are Now A ( The ) Primary Source of Evidence in US Court Proceedings Dramatic shift in the use of ERs in US Courts Companies use computers for almost all records, transactions and communications People use e-mail instead of letters ERs now prime source of evidence (esp. e-mails!) US Supreme Court’s e-discovery rules (Dec. ‘06) show that courts understand and accept ERs

5. Courts Consistently Find ERs Admissible Party presenting ER must be prepared to prove record is trustworthy Opponent must be allowed inquiry into accuracy of ER and how ER created and maintained Record management procedures will be critical if there is a dispute – especially in those few cases where dates seem “fishy” ERs can qualify under “business record exception” to hearsay

6. Using ELN Records to Obtain and Support Patents

7. Use ELNs to Obtain & Enforce Patents (ELNs must contain the right evidence) A small but “not insubstantial” number of US litigations and interferences involve proving dates of invention Keep in mind the legal requirements for proving dates of invention when implementing an ELN system Conception Reduction to Practice Diligence Corroboration ERs are of little value if they don’t prove inventive acts

8. Admissibility: Two-Step Analysis (ELNs must get into evidence) Evidence must first be authenticated under Rule 901 E.g., by creator, recipient or custodian of ER Evidence then must be admissible under a specific FRE rule Relevant evidence generally admissible (FRE 402) But, must recognize and account for possible “hearsay” which can bar admissibility

9. Hearsay FRE 802 states that “hearsay is not admissible except as provided by these rules. . .” 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

10. Business Record Exception to Hearsay 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 . . .

11. Establish a Foundation for Getting ELNs into Evidence in the USPTO and Courts Company policies must require scientists to: Record their research activities, including possible new inventions, in the normal course of duties; Make their records at or near the time that they conduct their research; and Create/maintain their records according to company policies Companies must establish a custodian for their ERs

12. Create Credible ERs to Support Litigation (ELNs must be persuasive evidence) Credibility will depend on how the ER is created, stored and reproduced in human readable form Implement available technology and follow records management procedures to create reliable ERs “ Optics” may be important in a small percentage of cases so consider use of system safeguards and/or trusted third parties/escrow agents Review ER technology, policies and procedures before litigation to uncover weaknesses – ask hard Qs! “ Ethical hacking” test

13. Giving Up ELN Records in US Litigation

14. All Electronically Stored Information Is Discoverable “ 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).

15. New e-Discovery Rules Rule 16 - court’s pre-trial scheduling order can include provisions concerning ER; parties must meet and confer on e-discovery issues Rule 33(d): Parties may reference “electronically stored information” as a type of business record from which answers to interrogatories may be derived Rule 34 : “Ordinary” (a/k/a “native”) file format or “reasonably useable” form is production default – must include metadata if requested 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

16. Bottom Line If ER is possibly important, you likely will be required to find it and produce it You may want to obtain it more than your opponent So make sure that (i) it still exists, and (ii) you can find and retrieve it fairly easily Especially important with auxiliary files and databases associated with the ELN

17. General Considerations In Designing ELN Systems, Policies And Procedures

18. Questions of Any ER (4 Ws) W ho created it? W hen was it created? W hat was its content when it was created? Corollary – has it since been altered? W hether it can be reproduced in human readable form? Many acceptable solutions for ensuring 4 Ws (no two solutions are exactly the same) Credibility will depend, e.g., on SOPs, system policies & procedures, record format and archival processes

19. Types of Systems Fully electronic How is permanent availability ensured? Electronic with tangible media back-up Microfilm, paper, optical, magnetic Hybrid of paper and electronic Wet signatures/witnessing or electronic/digital Auxiliary files? If so, what kind and how stored How does ELN System satisfy the 4 Ws?

20. Who Created The ER? Electronic signatures (e.g., ID and password) or digital signatures (e.g., smart cards, SAFE token) How are passwords. IDs, and digital signatures assigned and verified by the system? ( See 21 CFR Part 11) When the author or witness signs, does the system verify his/her authority? Timely signing and witnessing Do policies and procedures assure timely signing and witnessing? How long can an experiment be held open?

21. When Was The ER Created? Is a time stamp authority employed? How often is accuracy checked? How long can experiments be held open? Are dates recorded while the experiment is open? Automatically or by the researcher? Are experiments periodically locked and versioned? Must an experiment be checked in periodically? Does the system include laptops that can be disconnected from the server? Can system record dates while off-line?

22. What Was Its Content When Created? Does the system contain an audit trail? Does the system automatically version? How are records committed? Rendered as PDFs with some metadata? Is underlying data retained in the ELN or an auxiliary file/data repository? Is some data not retained? How are changes made after signing/ witnessing? Can records be unlocked by an administrator? If so, is a change record automatically generated?

23. Has The Record Since Been Altered? How is the record archived? Company accessible? Is it possible to somehow alter copies of an ER w/o detection? If so, who is required for collusion? Are trusted third parties/escrow agents involved in maintaining any part of the archive? E.g., electronic or microfilm copies of records, metadata, or other evidence of content such as hashes, checksums, transmission reports, etc.? Once committed to the third party, what access does the company have?

24. Whether It Can Be Reproduced In Human Readable Form? What is the form of the record? PDF versions with metadata? Is there a tangible media back-up to the ER? Are there auxiliary files stored outside the ELN? If so, are they linked or cross-referenced to the ELN? What is the possibility for error in the cross-reference? Can the link be lost? What is the plan to ensure retrieval?

25. Questions and Comments Colin G. Sandercock 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