VOICES FROM THE INDUSTRY: Lab notebooks can prove an invention’s conception

In some countries, Europe, for example, an invention belongs to the first person to file a patent for it. In the United States, the conception determines ownership of an invention.

In other words, an invention is “born” when the inventor first conceives it.

What does this
mean for scientists, inventors and businesses? That it’s incumbent upon them to prove that they came up with the idea first and therefore own the patented invention. If they can’t prove the date of conception, they can lose their patent to another, in an “interference” proceeding, regardless of who filed for a patent first. It all comes down to who can prove that they were “first to invent.”

Three things determine who was first:

1. Conception: A definite idea of the invention in the mind of the inventor.

2. Reduction to practice: The actual construction of the invention in physical form.

3. Diligence: Steady, uninterrupted work following the conception of the invention.

Such cases often are won or lost on the quality of recordkeeping-specifically, laboratory notebooks.

A recent Federal Circuit case related to Claritin, the popular and profitable allergy medication, shows the importance of good laboratory notebook record-keeping.

In Medichem v. Rolabo, two companies had filed interfering patent applications for the same invention. Both claimed that they were first and therefore owned the patent rights to a process for making loratadine, the active ingredient in Claritin. Medichem had filed its patent application after Rolabo, but sought to prove that it actually invented the process first. Specifically, Medichem had to prove that its inventor conceived the invention prior to Rolabo and that Medichem was reasonably diligent in reducing the invention to practice after conception.

That’s a lot to prove, and, for the defendant, a lot to protect. The case came down to recordkeeping-specifically, laboratory notebooks. Because the notebooks Medichem used as evidence weren’t signed, dated, witnessed or properly maintained, they were not sufficient to prove that Medichem was first. Medichem lost any patent rights it had to the process for making loratadine because its researchers didn’t exercise good lab notebook practice.

Would your laboratory notebooks hold up in this type of trial? Consider these strategies to ensure that they do:

Describe your ideas

The ideas in your notebook must be presented so clearly that someone else could follow them and bring an invention to life. This is proof of “conception.”

For example, if your invention is a new compound, your notes must define the new compound and describe how to make it. A description of the chemical reactions used
is not enough. Your notebook entry must show that you appreciated that you made the new compound and characterized it. Note your thought processes, discussions and meeting notes, and be sure to include the date of each discussion, the people who participated and their contributions.

Record your experiments

Proving “reduction to practice” means proving “the actual construction of the invention in physical form,” according to the U.S. Patent and Trademark Office.

For a machine, that means the actual building of the machine. For a process, it means the actual carrying out of the steps of the process. It usually also involves operating, demonstrating or testing the invention for its intended use. Include an outline, rationale and description of every experiment or test performed to develop the invention, including the date each was performed, the reasons they were performed and the significance of the results.

You also should attach drawings, diagrams, flow charts and photographs, or include them in a separate packet.

Involve a witness

In order to prove that your notebook is genuine, every idea and experiment should be dated and signed by the inventor. The signing and dating should take place in a timely manner-daily, weekly or monthly. Choose someone who is not a co-inventor or involved in the experiment to witness your ideas, process and notebooks. He or she should have the education and experience to understand what you’re disclosing in your notes.

Keep it on paper

There are guidelines available for electronic notebooks, but those formats can be more challenging to verify than paper because electronic records can be changed. In most circumstances, a hard-bound notebook is still best from a legal perspective. Number each notebook and assign one notebook to one person at a time. When the notebook is complete and has been signed and witnessed, make a copy of the entire thing, keep the original in a safe place and the copy in a separate location.

Avoid appearance of tampering

The whole point of careful recordkeeping in scientific notebooks is to prevent fraud. Leave no room for doubt. Write with a pen, not a pencil, and make sure your notebook includes consecutively numbered pages. Never remove pages from your notebook, never skip pages or leave no empty areas. Include no erasures or “white-outs.”

Keep up the good work

Consider establishing a policy for maintaining lab notebooks, and ensure that employees follow it. If you should ever need to prove you were “first to invent,” a well-kept notebook can make the difference between winning and losing your patent.