Building a Smart Laboratory 2012 Business requirements


require their scientists to keep bound laboratory notebooks. Tis is due to the fact that there isn’t the case law and/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 a great 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 ELN front-end tool to author records and then preserving the resulting records on paper. Tis gives the benefits of paper records (for the lawyers) whilst providing the scientists with the benefit of new tools. A fully electronic system will require scientists to sign documents electronically and for the resulting record to then be preserved electronically. Using multiple systems for patent


evidence creation and preservation can expose an organisation to increased risk


due to the need 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 as well as the likelihood of problems occurring. 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 lawyers and patent attorneys to simulate the presentation of ELN evidence in the court room and work back to the creation of that evidence in the laboratory.


The America Invents Act – implications


Patent reform legislation, in the form of the Leahy Smith America Invents Act 2011, will change 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 is 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.[10] 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 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 either change in-house procedures for keeping laboratory notebooks, or any reasons for vendors to revise the procedures and workflows in their ELN products. Te more immediate concerns are: • 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 aſter March 2013;


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