Good Laboratory Notebook Practice

I don’t think there is any doubt that the uptake of Electronic Lab Notebooks was slowed down by concerns about the admissibility of electronic evidence in patent interferences and litigation cases.  Those concerns are more or less history now, and there’s enough information and good advice around for anybody about to embark on an ELN project to implement a robust process for patent evidence creation.  We already have posts on The Integrated Lab addressing these issues:

• Tips on creating a lab notebook that contains convincing evidence
• Walking the tightrope between scientists and lawyers
• An overview of Patent Law

In addition, on the Contur website, there is an Interview with legal expert Colin G. Sandercock on the subject of ‘Understanding the legal issues surrounding electronic laboratory notebook (ELN) records’.  (You need to scroll some way down the page to find the interview.)  Anybody who has attended an ELN conference over the past few years is likely to have come across Colin and recognise his reputation as a leading authority on the legal compliance of ELNs.

I was therefore surprised to come across an article on the Linex Legal website entitled ‘The importance of good laboratory notebook practice’ which contained the sentences: ‘Significantly, USPTO has not yet recognised electronic laboratory notebooks in patent interferences……….  Therefore, a hard copy of all electronic records should be kept until electronic data is accorded the same legal status.”  The article was published in Chemistry in Australia (May 2009).

You will need to subscribe (free) to Linex Legal in order to read the article.

Colin Sandercock states in his interview “- To be clear, the admissibility of electronic records has been recognized by major U.S. courts for over 30 years. And in 2006, the U.S. Supreme Court promulgated new rules of the Federal Rules of Civil Procedure, which new rules specify procedures relating to discovery of electronic records. These new rules make clear what has been the practice in courts for decades, namely that electronic records (in human-readable form) are admissible evidence.”

Unfortunately, the Chemistry in Australia article is rather misleading on this point, which is a shame since the rest of the article gives an excellent account of good laboratory notebook practice.