Where sample management meets electronic lab notebook


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Preparing for patent filing with an electronic lab notebook

One of the questions that often comes up when people are considering adopting an electronic lab notebook is whether ELNs generally and the particular ELN being considered can be used to record research which may be used in a patent filing.  Often people get caught up in a theoretical conundrum about this question, but thankfully an increasing amount of practical guidance is available on the web from knowledgeble sources, i.e. practicing IP attorneys and legal scholars.  In this post I am going to highlight two recent examples.

The first is a recent blog post byJohn Boger.  He makes the following recommendations for groups  using an ELN to record research for use in patent filings:

“(1) institute a written policy for electronic record-keeping that is distributed to all involved employees; (2) establish a firm schedule for creating permanent back-up copies of all electronic lab notebooks.  All electronic signatures should be completed prior to the back-up process.  “Write-once” media should be used for the back-up; (3) number all discs (in progress and back-up) in consecutive order with permanent labels that note the disc number, start and end date; (4) validate the computer system used to ensure that it is operating properly and is free of viruses or other malicious applications; (5) all daily entries should be dated or time-stamped via a separate server.  Consistent use of electronic signature is a must with encryption software; (6) any commercial software package or bundle purchased should use “write once, read many times” technology; and (7) access to the computer and/or computer system should be restricted with screen and keyboard locks and password protection in place.”

The second is a webast by Professor Lisa Dolak at the Syracuse University School of Law titled, Establishing First to Invent and Electronic Lab Notebooks.  Professor Dolak echoes John Boger in making the point that in the case of both paper lab notebooks and ELNs, to prove admissibility, credibility and corroboration of evidence submitted in support of patent claims courts will scrutinize what SOPs have been put in place, for example relating to signing records, and whether those SOPs were followed in practice.

The point that strikes me about the perspectives brought to bear by both Professor Dolak and John Boger is their focus not on the ELN, but rather on the SOPs that need to be put in place to support a patent filing.  For many small labs, considering the adoption of an ELN should therefore be the beginning, not the end, of the process of thinking about putting in place a robust patent preparation strategy.

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