Home > Topics > Inventors and Inventions > How to Start–and Keep–a Laboratory Notebook: Policy and Practical Guidelines > Editor's Summary, Implications and Best Practices

Proper documentation of research is a critical component of best practices in IP management. Clear and consistent documentation is essential for patentability determinations, drafting and prosecuting patent applications, and (if necessary) protecting patents from third-party challenges such as prior-art challenges or patent-interference proceedings. Methodical documentation will make patent management an easier task, which will, in turn, ensure that the maximum value of inventions is captured and that patents can be protected against challenges.

Institutions must have documentation policies (such as institutional laboratory notebook policies) and protocols in place, and should train their employees to follow those policies and protocols.

Properly kept laboratory notebooks are one of the most important sources of documentation. A laboratory notebook should contain detailed records of every experiment that has been planned or executed, including the date it was performed, the reasons for performing it, the methodology used in performing it, the results of the experiment, and the significance of those results.

Laboratories typically have rapid personnel turnovers: scientists move on, post-docs move up, students graduate, and technicians are promoted. After a while, it may be impossible to contact certain researchers, and impossible for researchers to remember the details of past experiments. Laboratory notebooks are instruments of institutional memory. They enable scientists to pick up where their predecessors left off and, if necessary, reproduce those results.

Notebooks are also key pieces of evidence in legal disputes over priority of invention and inventorship. Under U.S. patent law (and under patent laws in most countries), a patent is granted to whoever is first to invent, not first to file an application. Therefore, laboratory notebooks provide essential evidence of the date of conception and reduction to practice. Furthermore, notebooks are helpful in interference proceedings, because they can prove diligence in developing the invention and reducing it to practice after the conception.

The contents of laboratory notebooks are confidential and of great value. Notebooks should be stored in a safe place and any loss or theft should be reported immediately. Laboratory managers and supervisors should know the location of all laboratory notebooks. Notebooks are owned by the institution where the work is done (essentially by the employer of scientists). Therefore, when personnel leave an institution permanently, they must turn their notebooks over to their supervisors.

Scientists may not initially appreciate the importance of documentation protocols, so it is important that technology transfer offices emphasize the importance of proper documentation. Any investment in the creation and institution of documentation policies and IP management systems will pay off in the long term.

Key Implications and Best Practices

Given that IP management is heavily context specific, these Key Implications and Best Practices are intended as starting points to be adapted to specific needs and circumstances.

For Government Policymakers

• Public-sector research institutions have much to gain by recording laboratory data. This is common practice in any private sector R&D center and for good reasons. Comprehensive research records are fundamental to good research practices in both science, regulatory and IP management, and will help institutions make the most of their research.
• Ensure that public-sector institutions have the resources to design and implement best practices in documentation of research results.

For Senior Management (university president, R&D manager, etc)

• Typically, institutional administrators take the lead in establishing and enforcing data-recording policies and even protocols. Heads of laboratories are then implementing those protocols.
• Institutions cannot file patent applications or protect their own patents and patent applications without complete and careful documentation of experiments.
• Scientific fraud is a problem in all countries, including developing countries. By vigilantly monitoring laboratory notebooks, universities and research institution can detect fraudulent practices in their own laboratories.
• Researchers should be encouraged to note the significance of their findings in their laboratory notebooks, so as to indicate that the research personnel indeed realize the implications of their own work.
• Make sure your head of research has the support it needs to formulate and implement record-keeping procedures, to train employees to follow those procedures, and to ensure its implementation as well as proper backup storage procedures.

For Scientists

• Your own research, as well as your laboratory or research program, will benefit from proper record-keeping. Good record-keeping achieves both scientific goals (it facilitates the writing of publications and grant proposals) and legal goals (good records make it easier to obtain and defend patents).
• But good record keeping goes beyond publications and IP management. Especially in institutions dealing with the development of products and clinical trials in health, or biosafety research in agriculture, record keeping may be essential to providing regulators the necessary documentation that good laboratory practices have been followed and may underpin regulatory filings. In many cases, experiments conducted years before regulatory filings can become valuable for regulatory filings and, unless laboratory detailed notebooks were kept, may have to be repeated at great cost and may lead to delay in filings.
• At regular intervals, all laboratory notebooks must be checked and signed by a supervising scientist, usually the head of the laboratory or her/his representative.
• Occasional spot checks will ensure that laboratory notebooks are being kept properly and that no fraudulent claims are being made.
• Encourage your staff to properly document their research activities. Set aside time every day for scientists to record information in their notebooks.
• Attend education and training sessions on documentation policies and procedures that are offered by your technology transfer office.
• And yes, the above applies to research assistants, Master students, PhD students, post-docs, and everyone else working in a laboratory.

For Technology Transfer Officers

• Proper record-keeping is not only critical for preparing, filing and prosecuting patent applications; it also helps ensure the continuity of projects.
• Encourage laboratory employees to clearly and consistently record data in their notebooks, and encourage laboratory heads to check their researchers’ notebooks regularly. Encourage all researchers to establish a culture of careful data recording and checking.
• Provide training sessions and informational resources on documentation protocols to your institution’s staff and scientists. Encourage your institution’s administration to require employees to attend these training sessions.