Concert Pharmaceuticals Inc Annual Reports

9.02(c) Guidelines for Invention ("Laboratory") Notebooks

[Note: The following procedures were developed to guide the preparation and maintenance of so-called "laboratory notebooks," which are often used to record the process of invention in a reliable way. This will permit an informed decision about whether to protect an invention as a trade secret or to seek a patent, and will provide a record of who contributed to the invention and when they did their work. If the decision is made to apply for a patent, the notebook might be used as evidence in any related litigation.]

I. Procedures

A. Type of Notebook

Inventors should use permanently bound notebooks-i.e., those having a closed spiral binding or a stiff cover, with the pages bound in permanently. Separate loose-leaf sheets or forms should be used only when it is absolutely necessary, and they should be permanently affixed to the next available page(s) in the bound notebook.

B. Tracking the Notebooks

If the notebooks are maintained as part of an organized research program, the lab should keep a catalogue listing all notebooks.

Each notebook should be assigned a number.

Before a notebook is distributed to a person, that person should complete a "request form" and a "receipt form." The "request form" identifies the person who is requesting a notebook. The person receiving the notebook executes a "receipt form" acknowledging that he or she has indeed received the notebook. Each recipient should be admonished that no one other than the recipient should write in a notebook "checked out" to the recipient.

A "distribution list" setting forth the recipient of each notebook, as well as the date the recipient received the notebook, should be maintained.

When the recipient is through with the notebook, the recipient should check it in. The date the recipient checks in the notebook should be recorded on the distribution list.

Similarly, when the recipient leaves the employment of the lab, all notebooks checked out to the recipient should be turned in.

All completed notebooks should be indexed, catalogued and maintained in a central, secure repository.

II. Contents of the Notebooks

A. Basic Mechanics

Entries should be made in ink, and in chronological order.

An entry should never be erased or "whited out." If an entry contains erroneous information, a line should be drawn through that information.

If an entire page is wrong, it should not be torn out; a few lines should be drawn through the page.

An entry made on a previous occasion should never be altered. If data were omitted, the data should be recorded under a new date and cross-referenced to the previous entry.

Blank gaps should never be left between entries. If blank space was left, a cross should be drawn over the blank space and dated so as to prevent subsequent entries.

Each notebook should be signed and dated on the inside front cover. The date is the date the recipient started using the notebook.

Each entry within the notebook should be signed and dated.

B. Contents of the Notebook Entries

(1) Conception of Invention

Legally, "conception" is the "formation in the mind of the inventor, of a definite and permanent idea of the complete and operative invention, as it is thereafter to be applied in practice." To establish conception of the invention, the following information should be recorded:

Notebook entries showing conception of the invention should be signed and dated by the inventor. "Conception" is also subject to the independent corroboration rule. Accordingly, independent witnesses (i.e., persons other than co-inventors or those who performed the particular experiments) should also sign and date the record of conception.

(2) Reduction to Practice

Actual reduction to practice requires that the applicant prove that "the embodiment relied upon as evidence of priority actually worked for its intended purpose." Constructive reduction to practice occurs when a patent application on the claimed invention is filed. Reduction to practice is subject to the "rule of reason" standard. This rule requires the courts to "examine, analyze, and evaluate reasonably all pertinent evidence when weighing the credibility of the inventor's story." To record reduction to practice, the following types of entries may be useful:

Descriptions of tests, including preferred operating conditions, control conditions, operable and preferred ranges of conditions, and alternate specific materials

Test results as well as an explanation of the results. Conclusions regarding the results should be kept to a minimum, and be provided only if they are supported by factual data. Conclusions should be brief and objective.

Photos, sketches, output from laboratory equipment or computer programs, and other such material should be signed, dated, witnessed and affixed to the notebook in proper chronological order. The date the material is affixed to the notebook should be recorded as well. Once affixed to the notebook, this material should not be removed.

C. Witnessing the Notebook

Notebook entries should be witnessed. The reason for this is that in patent priority disputes, the courts require that the inventor's testimony be independently corroborated even if supported by a properly completed notebook. The witnesses should be:

Skilled in the art. Witnesses who know of the experiments only generally cannot provide sufficient corroboration. The corroborating witness must be capable of understanding, and in fact have understood, how the claimed invention worked to produce the desired results.

Independent. Corroborating witnesses should not be those who performed the particular experiments. Co-inventors should not witness notebook entries.

The observations of the corroborating witnesses should be contemporaneous with the experiments, as well as with the consequent notebook entries. While one witness may be sufficient, two or more are preferred. This will increase the likelihood that at least one witness will be available in the event he or she must later testify.

III. The Completed Invention

The notebooks recording conception and reduction to practice of an invention should be maintained in a safe place. Unless a priority contest arises, nothing more than that really needs to be done with the notebooks. However, they of course constitute a record of the process of, and investment in, research and development. As such, they can be useful in any dispute (for example, trade secret litigation) in which the company might want to reconstruct relevant research.

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