UL Lafayette: Intellectual Property: Maintaining Laboratory Notebooks

UL Lafayette: Intellectual Property: Maintaining Laboratory Notebooks: "

Maintaining Laboratory Notebooks
PATENT LAW YOU CAN USE™ By Howard M. Eisenberg © 2000
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Abstract - Proof of the date of an invention is often critical, especially if there is a dispute as to which of two different inventors is the first to invent or if there is a need to establish patentability in view of an existing publication. This proof cannot be the uncorroborated testimony of the inventor. Rather documentary evidence is required. Most commonly, this evidence is in the form of properly maintained laboratory notebooks. In patent practice in the United States, it is often essential to be able to prove the date on which a claimed invention was actually invented. This issue arises typically in one of two contexts. The first is when it must be determined whether a publication published less than one year before the filing date of a patent application is applicable as prior art against the application. If the applicant can prove that he or she invented the invention before the publication date, then the publication can be removed as a bar to patentability. The second context is when more than one party files a patent application covering the same invention. In this situation, referred to as an interference, the party that can prove an earlier date of invention will be entitled to the patent and the party with the later date of invention will lose all patent rights in the invention. The date of invention cannot be proved by the uncorroborated testimony of the inventor. Rather, documentary evidence is required. This evidence must establish the dates on which the necessary acts of invention occurred, including the conception of the invention and the efforts made to reduce the invention to practice. Conception is the formulation in the mind of an inventor of the complete means for solving a problem in such a way that one of ordinary skill in the art could practice the invention without unduly extensive research or experimentation. Reduction to practice is the making and testing of the invention, and determining that it will work for its intended purpose. Documentary evidence to show the dates of conception and reduction to practice may take many forms. For example, this evidence may be in the form of invoices showing the purchase of items especially suited for the invention, photographs, letters to a colleague disclosing the invention, or a letter from a journal indicating receipt of a manuscript describing the invention. The most common and most convincing evidence is a well maintained laboratory notebook that documents the conception of the invention and clearly shows the steps that were taken to reduce the invention to practice. Therefore, I strongly recommend that all researchers become familiar with how to keep convincing laboratory notebooks and that they actually take the steps to keep them. The suggestions that follow are not to be construed as all-or-nothing. No notebook will ever be perfect, but the closer it comes to this goal, the better it will be. So, if you cannot do some of the suggestions, do what you can. Also, you might have additional ideas which can be used with my suggestions to increase the persuasiveness of your laboratory notebooks. Use my suggestions as guidelines. The laboratory notebook must be bound, so that pages cannot be removed and replaced. Remember that the notebook is an evidentiary document. If pages can be removed and added, there would be no way to prove that a particular entry was not inserted at some later date. For the same reason, all entries should be in non-erasable ink. The first page of the notebook should list the name of the principal investigator, the names of other investigators, the title of the study, and the date the study began. You may also indicate the goal of the study and the problems that the study attempts to address. If more than one notebook is used for an invention, they should be serially numbered. Notebook entries should be made contemporaneously with your ideas and experiments. It is important to include your ideas and not just data in the notebook. Remember that the notebook is to serve for corroboration of the conception of the invention. Conception is an idea. If only experimental data is entered and ideas are not, it may not be clear until a much later entry why the data was generated and what it was intended to show. Therefore, the date of conception that can be determined from the notebooks will be later. Ideas concerning what the invention is, what problems it addresses, and how it differs from what was done before should be entered in the laboratory notebook. Comments should be objective and accurate, and derogatory comments about the work of others should be avoided. Make regular contemporaneous entries of experiments that are performed. Preferably, this is done on a daily basis, but if this is not practical, do it as often and as close to the date of the experiment as possible. State why an experiment was performed and make a brief assessment based on facts of what the experiment shows. Do not make any conclusory statements based on incomplete data and do not make derogatory comments about your ideas. Use past tense to show work that was actually performed and use present or future tense to describe work not yet done. When recording an experiment, it is important to include enough information so that the experiment will be reproducible. Write down information relating to the equipment that was used, and the times, conditions, and methods of the experiment. Make sure to define all abbreviations and acronyms the first time they appear in the laboratory notebook. Data that is generated may be incorporated in the notebook by photocopying and stapling it into the notebook. The data should also be described with peculiarity so that there will be no doubt that the data attached to the notebook is genuine. Data that cannot be stapled into the notebook should be maintained in an orderly manner and its location should be cross-referenced in the notebook. In this instance, it is especially important to record what the data is and what it shows so that it is verifiable that the external data is indeed what is referred to in the notebook. It is often useful to record what occurred at laboratory group meetings, especially if suggestions concerning the invention were made. Record the suggestions and who made them. This may be helpful in documenting conception and inventorship. Do not make any erasures in the notebook. If an entry was made in error, it should be crossed out, taking care to make sure it remains legible. Each page of the notebook should be dated. It is also a good idea to start each dayÕs entry on a new page. Any blank space on a page should be marked with a cross or a diagonal line so that no further entries may be made on that page. It is extremely important that the notebook entries be witnessed. This means that someone who is not an inventor should read and understand the entries, and should sign and date the entries. The reason for this is so that the notebook will not be based solely upon the testimony of the inventor. The signature of the witness corroborates that what the researcher described really did happen. For this reason, the witness must be someone who is not a co-inventor of the invention. Also, it is preferable if the witness actually observed the events that are described in the notebook. The witness should sign the notebook often, preferably daily. If there is a gap in time between the date an experiment was performed and entered into the notebook and the date that the entry was witnessed, the inventor will be entitled to a corroborated date only as of the date of the witnessing. A few additional suggestions concerning the witness are that the first time the witness signs the notebook, his or her name should be printed above or below the signature. Also, no changes should be made to an entry after the witnessing of a page. If changes must be made at a later date, the witness should re-witness the entry by signing and dating next to the correction. The procedures that I’ve outlined above may appear to be somewhat burdensome and tedious, especially at first. However, if they are permitted to become a routine part of laboratory practice, they will become easier, almost automatic, with time. The day may come when the question as to the date of invention becomes an issue. On that day, you will be happy that you maintained good quality laboratory notebooks.
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Reprinted by permission from the author. Howard M. Eisenberg is a biotechnology and life sciences patent attorney who represents a number of university clients. His particular area of concentration is in patents involving human or veterinary medicine.

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