be the tipping point at which a go/no-go decision could be made. The underlying concern in the early days
of the ELN market was whether electronic records were admissible as evidence in a patent interference or patent litigation court case. Strangely, and in retrospect, this appears to be a non-issue since a statement issued by Bruce H. Stoner Jr., Chief Administrative Patent Judge in the Official Gazette (March 10 1998) (6): ‘Admissibility of electronic records in interferences’ states: ‘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.’ In other words, the admissibility of
paper and electronic records is therefore equivalent: it is the evidence that counts, not the medium on which it is presented.
Basically, the evidence must be relevant, reliable and authentic. However, it is important to understand that the factors that impact upon the authenticity of electronic records are different to paper, and that in the adversarial nature of the courtroom, the opposing side will attempt to discredit the record, the record keeping system and the record keeping process. The integrity of the system and the process used to create and preserve records are therefore paramount. The US patent system of ‘First to Invent’
is at the core of the issue. In order to determine who really is first to invent, it is essential to keep records of the conception of an invention, its reduction to practice, due diligence in the reduction to practice, and corroboration. In a dispute, any inventor is assumed to have an interest in the outcome of the case, so their testimony must be corroborated. In the context of the US Federal Rules of Evidence, the lab notebook is considered to be hearsay, but the ‘business records exception’ allows
a laboratory notebook to be admitted as evidence if it can be demonstrated to be relevant, reliable and authentic. The following criteria must therefore be met: • Records must be kept in the course of business;
• The particular record at issue must be one that is regularly kept;
• The record must be made by a knowledgeable source;
• The record must be made contemporaneously; and
• The record must be accompanied by testimony by a custodian (e.g. company records manager). This set of criteria defines the
requirements of a laboratory notebook policy and associated SOPs. It is essential that a company explicitly identifies the need for laboratory scientists to keep records in a laboratory notebook, defines what the content of the notebook should be and specifies the workflow (contemporaneous entries, signatures, and corroboration).
➤ 25
Using E Lns
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36