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<img class="alignright wp-image-3313 size-medium" src="https://healthlawupdate.bakerhostetlerblogs.com/wp-content/uploads/sites/19/2015/09/science-iStock_000043049872_Full-300x200.jpg" alt="" width="300" height="200" />With the enactment of the Leahy-Smith America Invents Act (AIA), the U.S. patent system moved to a “first inventor to file” approach for examining all applications having an effective filing date on or after March 16, 2013. Under the new law, in most circumstances it is no longer possible to remove a critical prior art reference by providing notebook data that establishes an earlier date of invention. Moreover, patent interferences are no longer available to resolve priority disputes between competing patents and applications that are subject to the AIA. These changes have led some to consider whether the time and expense devoted to documenting and maintaining laboratory notebooks is still warranted.

But data memorialized in a properly maintained lab notebook is still valuable at various critical stages in the patenting process. For example, notebook information is still useful before the U.S. Patent and Trademark Office (USPTO) and before courts of law to:
<ul>
	<li>Establish conception/ownership (i.e., prove that the invention wasn’t derived or procured from a third party)</li>
	<li>Provide evidence to establish the correct inventorship of a patent</li>
	<li>Defend an allegation of prior user rights</li>
	<li>Establish the rights to a trade secret</li>
	<li>Supplement data to support the information set forth in a patent specification</li>
</ul>
Whether the notebook is electronic or paper, there are a number of “best practices” that should be followed for entering data into and maintaining the notebook so as to ensure that the notebook will be considered reliable evidence if needed. For paper notebooks:
<ul>
	<li>Ensure that the pages are complete and the notebook securely stored</li>
	<li>Make entries in permanent ink</li>
	<li>Limit blank spaces</li>
	<li>Put experiments in chronological order</li>
	<li>Sign, date, and witness each page as soon as possible (ideally daily)</li>
	<li>Use a bound notebook, not loose leaf or perforated pages</li>
	<li>Sequentially number pages (e.g., use pre-numbered notebooks)</li>
	<li>Strike out all changes and never remove pages</li>
	<li>Physically attach copies of spectral and other data</li>
</ul>
Because there are many computer programs designed for the sole purpose of keeping laboratory data, it is difficult to provide recommendations for such record keeping. However, it is clear that the following are true for electronic notebooks:
<ul>
	<li>Store the electronic data at a safe location, preferably at a location remote from the laboratory</li>
	<li>Back-up the data in the electronic notebook in case of file corruptions</li>
	<li>Link all spectral data to the corresponding experiment</li>
	<li>Use only programs designed for record keeping (i.e., do not use just any program to record and retain your electronic data)</li>
	<li>Have a formal procedure for entering data, signing the “pages,” and having the pages witnessed</li>
	<li>Ensure that procedures are in place so that the data cannot be changed inadvertently or intentionally at a later date</li>
</ul>
Whether using paper or electronic notebooks, it is critical that each page of the notebook is signed, dated and witnessed by a credible witness. A credible witness is an individual who works for the same company and/or has duty of confidentiality, is NOT a co-inventor, understands the subject matter, and attests that (1) he/she "read and understood" the information in the notebook or (2) the work was done.

That being said, if you already have procedures for maintaining notebooks, continue doing so! If not, implement some best practices today for your record keeping. You won't regret it, even in this new AIA era.

Did Recent Changes in the Patent Laws Turn the Page on the Need for Accurate Laboratory Notebooks?