Thanks for posting this – its an interesting and timely topic. Alarmingly, the information that BookFactory is spreading at electroniclabnotebook.com is nothing more than FUD, so we wanted to weigh in with some points to consider.
Importantly, many bio-pharma and life sciences organizations (and other R&D heavy industries where intellectual property represents the organization’s lifeblood), moving to electronic records management and intellectual property protection doesn’t necessarily mean deploying an Electronic Lab Notebook solution from an industry vendor. Every organization is different. For large bio-pharma organizations, a powerful ELN offers many benefits, and may be needed. For small to mid-sized organizations, an ELN may be overkill. In every instance, what organizations need is an easy, non-intrusive way for scientists to capture, store, manage and protect their scientific intellectual property. We on this very topic last summer: powerofproof.wordpress.com/2009/07/14/before-your-organization-invests-in-an-electronic-lab-notebook-eln…
In its argument, BookFactory tries to create fear of electronic intellectual property protection, which is simply unfounded. By using an informatics system (which include a wide variety of solutions, including but not limited to specific ELN software), and integrating digital, trusted time-stamping into the process, R&D heavy organizations can build in the legal defensibility and long-term protection they require for their data, as well as reduce the manual “signing” and “witnessing” processes that paper-based systems require.
Our company, Surety (surety.com), provides third party trusted time-stamping solutions like this, and one of the reasons bio-pharma organizations are integrating digital timestamps into their workflows is the longevity of the timestamps themselves. We have more about how the process works on our site, but this specific information helps underscore why BookFactory’s longevity FUD is simply unfounded:
Surety Integrity Seals provide
long-term integrity protection and
have the evidentiary quality to stand
up under the most intense scrutiny. We
use our own patented technique called
"hash-chain linking" where the binding
of a time value to an electronic
record is accomplished by combining
and hashing the file and time value
and then linking the results into
Surety's continuous hash chain. The
integrity of the chain itself is
protected and auditable through our
widely-witnessed process, where once a
week we publish the hash-chain’s
integrity value in the Public Notices
section of the New York Times. This
enables a third party to validate a
Seal without placing any trust on
another party's people, processes, or
systems, including Surety.
Of course, nothing speaks more strongly than case studies in this regard. In one case (see page 8), a large global semiconductor company had more than seven years worth of paper lab notebooks. Shortly after one of its scientists joined a competitor, a new product launched at the competitor company – a product that had been in development at the semiconductor company for years. The original semiconductor company took the battle to court, and as a result, bore the legal burden of proof of IP ownership of the asset in question. After two years, $1 million in legal fees and significant lost revenue, the global semiconductor company lost its case – all because the company could not authenticate one credible paper-based record to support its claim. Since this instance, the semiconductor company migrated from paper to electronic lab notebooks, and has improved its IP protection. Case study here: www.surety.com/LinkClick.aspx?fileticket=BQ1ivzCoVy0%3d&tabid=150
On the flip side, there are several instances where bio-pharma organizations are using informatics solutions and achieving significant benefits:
- In this article from Health Management Technology, Dr. Nicole Vaughn-Spickers from Ferring Pharmaceuticals does an excellent job outlining how Ferring’s migration to ELNs not only created efficiencies, but also helped improve their intellectual property protection: www.surety.com/LinkClick.aspx?fileticket=ukLOgHc28Ts%3d&tabid=150
- The Joint Bio-Energy Institute (JBEI) integrated our time-stamping service into its knowledge management system to protect scientific intellectual property: www.surety.com/News/Press-Releases/Joint-BioEnergy-Institute-Selects-Surety.aspx
- Ansaris integrated Surety’s AbsoluteProof into its Lab Informatics Systems to both protect IP and improve the “signing and witnessing” process: www.surety.com/News/Press-Releases/Biotech-Company-Ansaris-Selects-Surety-.aspx (Q&A with Ansaris on this process here: www.surety.com/LinkClick.aspx?fileticket=b2hFcyxV7L0%3d&tabid=150)
We’d be interested in hearing from you. What concerns do you have about scientific intellectual property protection in ELNs (or other informatics solutions)?