Lab Notebooks: Protecting Your Intellectual Property
The determination of priority of invention in U.S. patent law for patents filed prior to March 16, 2013 is based on the premise that the first person to make an invention that is new, useful, and non-obvious is entitled to a patent on that invention. This legal principle may be invoked in several situations during the enforceable term of the patent.
Laboratory notebooks are commonly used by university and industry scientists to document the progress of experiments, observations and results thereof. In addition to being an important resource in interpreting experimental results and planning future experiments, a properly kept laboratory notebook can be invaluable in proving a company or university's right to obtain a U.S. patent for an invention related to the research recorded therein.
Generally, the invention date is presumed to be the date a complete application disclosing the invention is filed in the U.S. Patent and Trademark Office. An earlier presumed invention date can be obtained by claiming the priority date of 1) an earlier filed U.S. provisional application 2) the inventor's earlier filed foreign national patent application, or 3) an earlier filed Patent Cooperation Treaty (PCT) patent application, as long as the earlier filed application discloses the same invention and is within the time constraints defined by U.S. law.
However, in some situations, it is desirable or necessary to establish an invention date that is earlier than the presumed date. It may be necessary to antedate a particular target date of another's work, which would preclude the patentability of an invention. Typical target dates are the date of a prior art reference that discloses or suggests the invention, or the date on which another party claims to have conceived that same invention. An invention date that predates a target date may be established with evidence of inventive activity occurring before the target date. In the context of U.S. patent law, inventive activity may be placed into one of three categories related to the invention process. The first category is conception, or the formation in the inventor's mind of a specific idea of an invention. The second category is reduction to practice. Reduction to practice occurs when the inventor has either 1) constructed a physical embodiment of the inventive concept that is demonstrated to another and is workable for its intended purpose (i.e., achieved an actual reduction to practice) or 2) filed a patent application having a disclosure that teaches to one of ordinary skill in the field how to make and use the invention (i.e., a constructive reduction to practice). Inventive activity occurring between conception and reduction to practice falls into the third category, diligence. As a general rule, an inventor is entitled to claim the date of conception as his invention date if a reduction to practice is made in a reasonable period of time following conception (i.e., as long as the inventor is diligent between the conception of his idea and actual or constructive construction of the invention) and such activity can be proved. Up until recently inventive activity related to conception, actual reduction to practice, and diligence had to take place in the U.S. or one of its territories in order to claim the date of conception as a date of invention. Foreign applicants and patentees prior to January 1, 1996, who generally conducted their inventive acts outside the U.S. could not avail themselves of this option. U.S.-based research organizations enjoyed a legal advantage over their foreign counterparts in administrative and court proceedings dealing with the issue of first to invent. After passage of the North American Free Trade Agreement (NAFTA) on December 8, 1993, and agreements with World Trade Organization (WTO), individuals or organizations seeking to obtain a U.S. patent stand in the same shoes as a US inventor. One of the implications of this change in U.S. patent law is that University researchers seeking to obtain a U.S. patent need, now more so than ever, to be prepared to provide contemporary evidence of inventive activity (i.e., documentation generated at the time the inventive activity occurred). One of the best sources of such contemporary evidence is a properly kept laboratory notebook.
Laboratory notebooks used to document inventive activity should have at least three attributes:
- The pages of the notebook should be permanently bound together and consecutively numbered.
- Entries in the notebook should be legibly recorded in ink or some other permanent marking without generating large white spaces between text.
- The pages should be signed and dated after inked entries by the person or persons performing the activity and by at least one corroborating witness. Each of these attributes may play a part in proving the accuracy or authenticity of the notebook in any future legal proceedings. For example, a bound laboratory notebook with numbered pages will provide evidence that no one has removed or inserted pages in the notebook. Entries made in ink help to guarantee that text has not been erased or altered. Signing and dating text with limited white space ensures that no later entries occurred. The dated signature immediately after an entry (in both time and position) helps prove who did the activity and when it was done and shows that no entries were made after dating and signing. The authors recommend that in keeping the laboratory notebook the following guidelines be considered.
- Each scientist and engineer should have his or her own bound laboratory notebook, which should be used to record all experiments and results.
- For projects requiring team effort, the individual members of the team may record their activity in their own bound notebook, allowing the preparation of duplicate records (i.e., a record that is a permanent page immediately followed by a removable page on which information recorded on the permanent page is transferred using carbon or carbonless paper). The removable pages from each team member can be assembled in a loose leaf notebook to generate a record of the team's progress on a project.
- For convenience, reserve the first 15-20 pages of the notebook for a table of contents.
- Write the date that the work begins for the project in the upper right hand corner of the page.
- Use ink from a ballpoint pen of a single color from the same pen to make all notebook entries that are on the same page. This will facilitate proving that the page is an authentic record of the inventive activity that occurred on the stated date(s).
- Describe in detail the planned experiment, indicating the purpose of the experiment and any expected results. This may include the source of inspiration, a discussion of the prior art, and ways in which the invention is believed to solve problems in the art.
- When applicable, the notebook entry should list chemical reagents, reaction parameters such as times and temperatures, and apparatus to be used in the experiment. Use of experimental terms that are not commonly known in the particular art related to the research should be avoided or if used, explained thoroughly. For example, simply describing a particular procedure known to only the professor and students in a lab as ÒMary's protocolÓ does not provide any proof or evidence of what was done, unless "Mary's protocol" was previously recorded in the notebook and that page number is also referenced. Similarly, materials should preferably not be referred to by their trademarked names alone; the source and composition of the materials should also be listed. In summary, the notebook record of an experiment should be so complete that a person of ordinary skill in the art reviewing the disclosure of the experiment would be able to understand the procedure set forth.
- Sign and date the page where the conception has been set forth. Corroborate conception by describing the idea to another (who is not a co-inventor); this corroborating witness should then read the inventor's notebook and date and sign it also.
- If conception of a new idea recorded in the laboratory notebook is subsequently described in a memorandum to a colleague or described in an invention disclosure and submitted to UM Ventures, the preparation of this memorandum should preferably be referenced in the notebook.
- If work on an invention involves the confidential information of an outside organization, the notebook should precisely describe how the information was used and how it may have assisted in the conception or development of the invention.
Documenting Reduction to Practice
- Make entries directly into the notebook as experiments are carried out and immediately after results are obtained. Pages should not be skipped; if an experiment continues over several days, it is generally acceptable to note at the end of one day's entry the next date work was done on the experiment, followed by that day's entry.
- If some of the experimental work is done by another person, for example, a protein sequencing technician, the data obtained from the technician should be recorded in the bound laboratory notebook as soon as they are received by the researcher. Any graphs, printouts, etc. obtained from a technician can be fastened into the scientist's notebook. Alternatively, if large amounts of supporting materials are produced, they may be kept in a separate book or file that is clearly cross-referenced.
- Write the date that any results, either positive or negative, were obtained or received on the same page where the results are recorded, and identify the results by reference to a prior notebook page that contains a description of the experiment leading to the results.
- Enter all observations about an experiment and any conclusions drawn from the results obtained into the notebook. Avoid categoric statements about the worthlessness or lack of utility of the product or process described; such statements could later be used as evidence of the inventor's failure to appreciate the inventive significance of the recorded experiment.
- Correct an incorrect entry by drawing a single line through the incorrect entry; there should be no attempt to obliterate or erase an entry. A note explaining the error and correction should also be entered on a separate page of the notebook that references the correction.
- As soon as a page of the notebook is completed, it should be initialed and dated by the person actually doing the experiment, even if this person is a laboratory assistant working under the direction of the inventor, and then initialed and dated by any supervisor of the person who actually did the experiment. If there is a blank portion or an unmarked notebook page remaining after an entry, a diagonal line should be drawn through the remainder of the page.
- As soon as possible after the conclusion of an experiment, the inventor, and preferably a corroborating witness who is not an inventor and who understands the experiment, should read and then sign and date the notebook page at a position just below the point on the page where the entry ended; there should be no blank spaces between the entry and the signatures. The inventor and corroborating witness should satisfy themselves that there are no blank spaces on the pages witnessed, that all tables and data are complete, and that the entry witnessed is a full and faithful record of the work observed. In addition, the inventor should initial and date any corrections made to the page. If corrections are made after the notebook has been witnessed, the corrections should be signed and dated by the entrant of the changes and, if possible, by the witness to the original entry.
Tips for Advisors and Laboratory Managers
- Issue only a single notebook to a person per major project. The title page of each laboratory notebook must indicate the following:
- the name of the person receiving the book,
- the department in which the person works,
- the social security number of the person (or University Identification number)
- the project name and the date when the book was issued.
- Once the notebook is filled or projects completed reports are made regarding works within the notebook; a reasonable period for access by the scientist or engineer should be given, and then the notebook should be archived. Remember that in most cases the notebook is the property of the University as well as the rights to any inventions.
- Access to archived notebooks should be controlled. If the student or professor believes access will be frequently required, a copy should be made and given to the her.
- Where the work in the notebook , or at any stage in an experiment, appears to involve patentable subject matter, UM Ventures should be consulted as soon as possible.
For more information, please contact UM Ventures
UM Ventures operates in accordance with the policies established by the University System of Maryland. This document is not intended to replace the advice of an attorney nor does it legally bind UM Ventures or the University of Maryland.