Beyond the laboratory


Building a Smart Laboratory 2018


to maintain the integrity of each system, and the consistency of the content between them. Similarly, the use of generic systems for such a task can increase discovery concerns and also increase the likelihood of problems. Further guidance should be sought from records management personnel and legal advisors within the organisation, in order to determine policy. A recommended approach to help uncover


and resolve legal/patent concerns is to work with the company’s lawyers and patent attorneys to simulate the presentation of ELN evidence in the courtroom, and then work back to the creation of that evidence in the laboratory.


The America Invents Act – implications


be corroborated. Most organisations require these notebooks to be signed by the author (‘I have directed and/or performed this work and adopt it as my own’) and also by an impartial witness (‘I have read and understood this work’).[10, 11] Evidence in US patent interferences is


subject to the Federal Rules of Evidence. Tere are a number of important hurdles that need to be overcome, in particular the Hearsay Rule (by definition, if the author cannot be present, then the evidence is hearsay) and the Business Records Exception. Te Business Records Exception is an


exception to the hearsay rule, which allows business records such as a laboratory notebook to be admitted as evidence if they can be demonstrated to be relevant, reliable and authentic. Te following criteria must be met: n Records must be kept in the ordinary course of business (e.g. a laboratory notebook);


n Te particular record at issue must be one that is regularly kept (e.g. a laboratory notebook page);


n Te record must be made by or from by a knowledgeable source (e.g. trained scientists);


n Te record must be made contemporaneously (e.g. at the time of the experiment); and


n Te record must be accompanied by testimony by a custodian (e.g. company records manager).


Any doubt about the admissibility of electronic records was largely removed by this statement from the Official Gazette (10 March 1998 [12]


:


‘Admissibility of electronic records in interferences: 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


34


that electronic records are admissible under the Federal Rules of Evidence. Te weight to be given any particular record necessarily must be determined on a case-by-case basis.’ In terms of admissibility, paper and


electronic records are therefore equivalent. Te judgment is made on the evidence, not the medium in which it is presented. However, it is important to understand the factors that impact upon the authenticity of electronic records and that in the adversarial nature of the courtroom, the opposing side may attempt to discredit the record, the record-keeping system, and the record-keeping process. Te integrity of the system and the process used to create and preserve records are therefore paramount. Many organisations still require their


scientists to keep bound laboratory notebooks. Tis is because there isn’t the case law or other experience for most legal advisors to feel as comfortable with electronic records as they are with paper. Te issue is not one of admissibility, but of the weight that the record will have in court. Unfortunately, we are unlikely to see a suitable body of case law for many years. Te high-stakes nature of the problem,


lack of experience, and long-term accessibility concerns have caused a number of organisations to adopt a hybrid solution, using an electronic lab notebook (ELN) front-end tool to create records, and then preserving the resulting records on paper. Tis gives the benefits of paper records (for the lawyers) while providing the scientists with the benefit of new tools. A fully electronic system will require scientists to sign documents electronically, and the resulting record to be preserved electronically. Using multiple systems for patent evidence


creation and preservation can expose an organisation to increased risk, due to the need


Patent-reform legislation, in the form of the Leahy-Smith America Invents Act 2011, changed the US system from First to Invent to First to File in March 2013. It is very tempting to view this change as an opportunity to relax some of the procedural requirements of ELNs used in research laboratories. However, there are clauses in the Act that


would suggest it’s wise not to make such an assumption. It is likely that patent interferences and interfering patent actions will continue for many years for patents and applications filed aſter March 2013. [13] Tere are specific circumstances described


in the America Invents Act that, for example, require proof of inventive activities to remove prior art for joint research activities, or to preserve the right to an interference if the application contains, or contained at any time, a claim to an invention filed before March 2013. Until the act becomes effective, and there is clarification about the implications of the new legislation, there is no reason to change in-house procedures for keeping laboratory notebooks, or for vendors to revise the procedures and workflows in their ELN products. Te more immediate concerns are: n Tere is a loophole that will allow people to prosecute a patent under the old First to Invent rules for many years to come. First to File isn’t dead even aſter 16 March 2013 – there are some changes that mean proof of inventive activities will be especially important for joint research activities. Te retention of other documentation related to joint research projects may need to improve; and


n Derivation proceedings will also require proof of inventorship.


To add further uncertainty, there’s always a chance (or indeed probability) that things are going to end up in the US Supreme Court to examine the constitutional implications of a move away from First to Invent. So it does


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