In the United States, the first to invent is entitled to obtain a patent on an invention. When more than one patent application is filed by different inventors or groups of inventors claiming an identical invention, the U.S. Patent Office may hold an interference proceeding to determine the first inventor(s). This determination focuses on the date of invention by establishing the competing inventors’ dates of conception and reduction to practice, and potentially, the diligence of the parties to reduce their invention to practice following conception. Similarly, establishing the date of invention to determine the first to invent or to antedate prior art may be required in litigation.
Paper lab notebooks have long been accepted as evidence of invention in interference proceedings at the Patent Office. Properly kept paper lab notebooks are well suited as evidence of conception, reduction to practice, and diligence, and as proof of the contribution of parties to an invention because they provide a complete, continuous record on consecutively numbered pages containing data and results, narrative, names, dates, and signatures. Paper lab notebooks can be signed and dated by non-inventor witnesses, which is important because as a matter of law, one cannot establish the date of invention without corroboration. Further, paper lab notebooks can be stored for decades and can be authenticated by ink and paper dating.
Although paper lab notebooks will continue to be well accepted for Patent Office purposes, in many cases the advance of technology is making them obsolete for their primary purpose, that is, for use by researchers to record their results. Paper lab notebooks are not well suited to storing large data sets, are limited as to the types of graphical representations that can be included, cannot be easily shared over the Internet, and are not electronically searchable. To overcome these drawbacks, electronic notebooks are increasingly replacing paper lab notebooks.
According to the United States Patent Office, electronic records are admissible in patent interferences: “To the same extent that electronic records are admissible under the Federal Rules of Evidence,” which requires authentication by sufficient evidence that the record in question is what its proponent claims it to be. Thus, admitting into evidence electronic lab notebooks that haven’t been prepared with authentication in mind may be difficult. Unless a system is in place that rules out uncontrolled access, system errors, hacking, etc., electronic lab notebooks may be subject to accusations of tampering or other alteration of files, date changes, and difficulty in proving the authenticity of signatures. In view of these potential problems in authenticating electronic records, the Court in Lorraine v. Markle Am. Ins., 241 F.R.D. 534 (D. Md. 2007) warned “If it is critical to the success of your case to admit into evidence computer stored records, it would be prudent to plan to authenticate the record by the most rigorous standard that may be applied.” Therefore, a custodian of electronic records should be able to establish the trustworthiness of the records being submitted by testifying to details of the computer system and software, computer policy, control of access to the system, recording and logging of changes, backup practices, and audit procedures. In short, one must provide evidence that the electronic records being submitted have not been altered from the original records, that signatures are authentic, and that dates are accurate.
Technologies have been developed to support the verification of electronically stored information and thereby satisfy the rigorous requirements of authentication. For example, the Public Key Infrastructure (PKI) uses cryptographic keys to apply authenticable digital signatures and digital time stamps to electronic documents. Also, the SAFE-BioPharma Association protocol is an example of an industrydeveloped standard for applying digital signatures and timestamps to electronic documents (www.safe-biopharma.org).
The switch to electronic lab notebooks appears inevitable, if it has not already occurred, in most areas of research. Although the path to widespread acceptance of the use of electronic notebooks as evidence has seen many questions raised about the reliability of computer stored records, if properly authenticated, electronic lab notebooks are admissible in patent interference proceedings and in court proceedings. However, to guarantee that electronic lab notebooks can be relied upon as admissible evidence in the future, careful thought must be given now about how to create, store, and authenticate the records, including providing foundational testimony as to the trustworthiness of the electronic records, to satisfy potential future scrutiny.