Transcript Electronic Laboratory Notebooks: Requirements, Selection

Electronic Laboratory
Notebooks:
Requirements, Selection & Best
Practices
John Gase
Leydig, Voit & Mayer, Ltd.
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
9
Legal Requirements
Corroboration: Legal standard applicable to an
inventor’s testimony regarding his or her own
invention
– An inventor’s testimony regarding inventorship
must be corroborated by independent evidence
– Example: Notebook records signed by a noninventor 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
inventor’s 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 user’s
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
Digital Verification Process
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 inventor’s handwritten date
and a witness’s 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? (cont’d)
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
Digital Timestamp Process
Digital Timestamp (cont’d)
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? (cont’d)
• 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? (cont’d)
• 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 it’s 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?
Thank You
John L. Gase
(312) 616-5644
[email protected]
www.leydig.com
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