Electronic Laboratory Notebooks: Requirements, Selection

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Electronic Laboratory Notebooks Requirements,
Selection Best Practices
John Gase Leydig, Voit Mayer, Ltd.
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Scope of the Presentation

• What is an Electronic Laboratory Notebook (ELN)?
• When might an ELN be used as evidence?
• Why are there concerns about using an ELN instead
  of a traditional paper notebook?
• What are the legal requirements for use of an ELN
  in court or before the U.S. Patent and Trademark
  Office?
• How does an ELN try to satisfy the legal
  requirements?
• Other considerations

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What is an Electronic Laboratory Notebook (ELN)?

• An ELN is paperless system designed to replace
  the traditional paper-based laboratory notebooks
• An ELN is not
• Merely storing electronic copies of paper records
• Wet signed print-outs of computer-generated
  pages

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Lab Notebooks as Evidence

• Whenever the Who What or When of
  inventorship is called into question
• Interference Proceedings (Conception, diligence,
  reduction to practice)
• Validity Challenges (Antedating prior art)
• Misappropriation of trade secrets correction of
  inventorship
• Issues might be raised in Federal Court or before
  the U.S. Patent and Trademark Office

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Concerns

• Electronic evidence is routinely used in court
• Federal Rules of Evidence specifically provide
  for the use of electronic evidence
• Electronic evidence can be used in interferences
  to the extent allowed by the federal rules
• Still, ELNs have not been tested in court, and
  there is uncertainty as to whether ELNs satisfy
  legal evidentiary requirements

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Concerns

• Electronic evidence presents special problems
• Fear that information is easily changed, and that
  changes are hard to detect
• Sometimes difficult to determine authorship or
  time of creation
• As a result, electronic evidence can require a
  rigorous foundation that can be difficult to
  prove (e.g., AmEx Travel v. Vinhnee (9th Cir.
  2005))

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Concerns

• If it is critical to the success of your case
  to admit into evidence computer stored records,
  it would be prudent to plan to authenticate the
  record by the most rigorous standard that may be
  applied.
• - Judge Paul W. Grimm Lorraine v. Markle Am.
  Ins. (D. Md. 2007)

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Legal Requirements

• Admissibility The Gatekeeper function of the
  court, ensures a minimum threshold of quality and
  reliability of evidence.
• Relevant
• Authentic
• Not hearsay, or falls within an exception to the
  hearsay rule

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Legal Requirements

• Credibility Once admitted, how much weight
  is the evidence entitled
• All factors can be considered, including the
  criteria for admissibility
• Bolster credibility by establishing the
  trustworthiness and reliability of the evidence
  and witnesses

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Legal Requirements

• Corroboration Legal standard applicable to an
  inventors testimony regarding his or her own
  invention
• An inventors testimony regarding inventorship
  must be corroborated by independent evidence
• Example Notebook records signed by a
  non-inventor who has read and understood the
  record

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Legal Requirements

• Establishing the legal elements requires proof
  that addresses the following questions
• What is the record being offered?
• Who authored and witnessed the record?
• When was the record created?
• How was the record maintained, and has it changed?

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What is the record being offered?

• Traditional Notebook
• Looks and feels like a laboratory notebook
• Easily established by custodian or author
• Electronic Notebook
• Any of a variety of different formats
• Witness testimony that the printouts are accurate
  copies of the data stored in the ELN

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Who authored or witnessed the record?

• Traditional Notebook Each page bears the
  inventors and witnesses unique handwritten
  signatures
• ELNs No way to associate a traditional signature
  with an entry, and must have an electronic
  solution

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Electronic Signatures

• Key Functions of a signature
• Uniquely identifies the signor
• Associates the signor with a particular document
• By being an affirmative act, signifies approval
  or consent
• Electronic signature should perform these same
  functions

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Electronic Signatures

• Electronic Signature encompasses a variety of
  signing methods that have different levels of
  integrity
• Generally, an Electronic Signature must
• Assign a unique identifier to a user
• Authenticate the user to the ELN system
• By an affirmative act, associate the users
  identifier with the document

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Soft E-Signatures

• Common Attributes
• An ID and password are assigned to a user
• The system authenticates the user, generally by a
  login procedure using the ID and password
• By an affirmative act (e.g., clicking a link),
  the ELN signs a document and converts it to a
  read only format
• The user (by user ID) is linked to the signed
  document through a log

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Soft E-Signatures

• Common problems
• ID/password combination identifies the user only
  within a given system
• Third-party cannot validate the signature (need
  computer logs)
• No way to verify what was signed except through
  circumstantial evidence (e.g., access logs,
  witnesses, etc.)

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Digital Signatures

• Common Attributes
• Unique encryption key pair is assigned to a user
  by a Certification Authority (CA)
• Key pair private key used by the signor to sign
  a document, and a public key used by any third
  party to verify the signature
• System is known as Public Key Infrastructure (PKI)

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Digital Signing Process
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Digital Verification Process
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Digital Signatures

• Advantages of Digital Signature using PKI
• Unique to a high degree of probability without
  regard to the system used
• Verifiable by third-parties independent of the
  system used to create the signature
• Signature is inextricably associated with the
  document itself
• A valid signature confirms the integrity of the
  document

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Strength of Electronic Signatures

• Other factors affecting strength
• Identity Vetting How is the identity of a user
  verified before issuing a user ID or PKI
  Certificate?
• User Authentication How does the ELN identify
  the user?
• Weak Private key resides on a server and is
  password protected
• Strong (Multi-Factor) Private key resides on
  a hardware token protected by a password

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When was the record created?

• Traditional Notebook
• Each page bears the inventors handwritten date
  and a witnesss handwritten date
• In a continuous, bound volume of dated materials,
  a dated page has some degree of trustworthiness

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When was the record created? (contd)

• Electronic Records
• Most often dated by the computer or server on
  which they reside
• Dates can change with duplication
• A computer or server date clock is subject to
  failure and easily manipulated
• May need circumstantial evidence to date the
  document

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Digital Timestamp

• Third-Party Timestamp Authority (TSA) is a
  widely-used, trusted time/date clock
• Using its own digital key pair (PKI), the TSA
  digitally timestamps and signs the document
• Digital timestamp is associated with the document
  in the same manner as a digital signature

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Digital Timestamp Process
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Digital Timestamp Process
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Digital Timestamp (contd)

• Advantages of Digital Timestamps
• Inextricably associated with the document itself
• Any change to the document invalidates the
  Timestamp
• Thus, a valid timestamp verifies no changes were
  made after the timestamp was applied

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How was the record maintained, and has it changed?

• Regardless of the system, witnesses must be
  available to testify as to the policies and
  procedures for creating and keeping records
• Controlled access to laboratory notebooks is
  important
• The ability to detect changes is key

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How was the record maintained, and has it
changed? (contd)

• Handwritten documents Changes can be discovered
  forensically by examining the document itself
• Electronic records Some changes can be
  discovered forensically by examining computer
  logs, metadata, etc.

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How was the record maintained, and has it
changed? (contd)

• Digital Signatures with digital timestamps offer
  a major advantage Any change to a signed
  document will invalidate the digital signature
  and timestamp
• Thus, the validity of the signature and timestamp
  itself provides evidence that the document has
  not been altered

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Legal Requirements - Conclusions

• An ELN employing true digital signatures and
  timestamps should satisfy the requirements of
  admissible evidence, but its a sliding scale

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Legal Requirements - Conclusions

• Improve chances of success by
• Digital signatures and timestamps, using (PKI) or
  equivalent
• A reputable and widely-used Certificate Authority
  and Timestamp Authority
• Strong user authentication
• Controlled access to stored documents
• People knowledgeable about the systems who can
  serve as witnesses

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Other Considerations

• Obsolescence Aside from the storage medium,
  consider whether the format of the electronic
  document (e.g., .pdf) will be accessible
  long-term
• Content Be conscious of how the system treats
  embedded/hyperlinked materials when a page is
  signed or document closed for storage
• Hybrid systems If wet signed printouts of
  an ELN are used, consider serial numbers or other
  method to replicate the bound and continuous
  characteristic of traditional lab notebooks

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Questions?
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Thank You
John L. Gase [phone] jgase_at_leydig.com www.l
eydig.com
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