LABORATORY RECORD KEEPING

Reprinted with permission from Nature Biotechnology v. 15 (August 1997) pp.799-800.]
8.1.1997

Keeping a proper notebook is critical to establishing yourself as the inventor


Unlike most other countries in the world, the US patent office awards a patent to the person who is the "first to invent." In other words, in the US, the first person who conceived the invention, and successfully reduced it to practice, is awarded a patent - not the first person to file a patent application on the invention. In the US system, a problem in determining who made the invention first occurs when one of two events happen: Either two or more inventors working independently file patent applications claiming the same subject matter, or a person challenges an issued patent alleging that he/she is the first inventor.

If either of these events occur, the issue is resolved in an administrative proceeding known as an interference. During the interference, evidence is submitted to show the dates of invention of the respective parties. At this point, properly signed, dated, and witnessed notebook records that clearly show inventive activity become critical in proving the earliest date of invention to the US Patent and Trademark Office (PTO; Washington, DC). This article describes the steps for keeping a laboratory notebook to assure the strongest possible position in a hearing of this type.

A tale of two inventions
To illuminate the reasons for taking the time to keep a proper laboratory notebook, I will consider the hypothetical case history of Bob Clark, a former researcher at the large pharmaceutical company Superpharm. Clark had performed many experiments in drug design in the 12 years that he worked at the company, but he was not very careful about recording data and results so they looked presentable. One day, in preparing for one of these meetings, he realized that a compound he had invented showed great promise for the treatment of prostate cancer - potentially worth millions of dollars to Superpharm. Bob brought the discovery to his supervisor and then to Superpharm's patent attorneys, who immediately prepared and filed a patent application on the new compound.

At the PTO, the examiner in charge of Bob's application noticed that the claimed compound was identical to a compound claimed in a patent application filed some eight months previously by Megapharm, Superpharm's competitor. An interference was declared between the two parties to determine who discovered the compound first.

At the interference proceeding, laboratory record evidence submitted by Megapharm showed that their researchers had conceived of the compound and reduced it to practice on April 1, 1995. The laboratory records kept by Bob showed a date of invention of January 15, 1995. However, the Board of Patent Appeals and Interferences declared that the notebooks submitted by Bob and Superpharm to support their January 15, 1995 invention date did not meet proper record keeping and corroboration requirements set out by the PTO and the courts, and therefore were not sufficient to support that date of invention. According to the Board, the earliest date that Superpharm could show conception and reduction to practice of the new compound was June 1, 1995, two months after the earliest showing by Megapharm. Since Superpharm could not prove an invention date before April 1, 1995, the Board declared that the Megapharm researchers were the first inventors. The Megapharm compound was patented, commercialized, and Megapharm now enjoys a revenue stream of about $20 million annually in sales and license royalties.

Standards of proof
While the account above is fictitious, Bob's case reflects a situation that happens all too often. Many researchers wind up forfeiting their intellectual property rights by not keeping acceptable laboratory notebooks. Most often, they are taught to keep a laboratory notebook in order to publish research in peer-reviewed journal - a completely different goal than gaining intellectual property rights.

In order to understand where Bob went wrong, one needs to understand how the US Court of Appeals for the Federal Circuit - the court that decides most important issues of patent law in the United States - views establishing proof of priority in determining inventorship.

According to the court, the person asserting that they made a particular invention before the filing date of an issued patent has a heavy burden in establishing an earlier date of invention. That burden is met, in part, by the testimony of the inventor. However, it is well established at the PTO and in the courts that the inventor's own testimony, standing alone, is insufficient to support claims to conception or reduction to practice. The independent testimony of a non-inventor proving that the activities of the inventor actually occurred must corroborate the inventor's testimony. 1

This corroborating evidence must generally meet two basic criteria. First, and most obviously, it must be independent of the inventor. This is most commonly achieved through the confirmation of the inventor's records by a witness at the time they are created. The witness verifies that he has read and understands the inventor's records promptly after they are recorded, and then signs and dates the records. The witness should have an understanding or familiarity with the inventor's work, but not be a coinventor because this type of corroboration is self-serving. Generally, laboratory technicians who were not involved in the conception of the invention, but were involved in its reduction to practice, make good witnesses. Other corroborating witnesses include a scientist, student, or technician who performed experiments under the inventor's direction, or a coworker or supervisor who actually observed the inventor's work. Preferably, the witness should be a person who is available or can be easily reached for the next several years.

Second, the corroborating evidence, as a whole, must meet a "rule of reason" test for sufficiency. Under the rule, no single formula is followed in proving corroboration. Rather, all pertinent evidence is evaluated as a whole so that a sound determination of the credibility of the inventor's story can be reached. 2 Factors bearing on the inventor's credibility and whether the inventor's testimony has been adequately corroborated include the interest of the corroborating witness, contradiction or impeachment of the witness, the impact of the invention on the industry, and improbability of prior use considering the state of the art.3

Under the rule of reason analysis, an inventor can prove prior conception with multiple pieces of evidence, although no single pieces of evidence, in and of itself, establishes the prior conception. It is sufficient if the picture painted by all of the evidence taken collectively gives an abiding conviction that the inventor's prior conception is "highly probable". 4 Accordingly, researchers should be aware of all the documents they produce in the course of their experiments, such as notes of laboratory work or laboratory meetings, seminar notes, progress reports, grant applications, draft manuscripts, purchase orders, etc., and treat these documents as pieces of a record that can support dates of invention.

Further afield
It should be noted that in light of the North American Free Trade Agreement (NAFTA) and the implementation of the World Trade Organization (WTO), proper laboratory record keeping has taken on significance for non-US inventors as well. Under the amendments recently passed by Congress,
5 inventive activities in a NAFTA or WTO member country may be used as evidence of the date of invention in proceedings before the US PTO or the US courts for patent applications filed after January 1, 1996.

Therefore, researchers worldwide are well advised to keep laboratory records with the view that someday they will be used to support the date of the invention, and understand that the more information that is recorded and can be referred to in testimony without relying on the recollection of a witness, the better the likelihood of proving the date of invention.

Conclusions
Most researchers in academia and industry keep laboratory records with an eye toward peer review and publication of the findings, and not patenting the potential commercial products of the research. As we have seen, these goals have quite different standards of proof.

As long as the US patent system maintains a "first to invent" priority system, researchers should understand that the most important function of laboratory records from an intellectual property perspective is to support the testimony of the inventor regarding dates of conception, reduction to practice, and diligence. Without properly maintained and corroborated laboratory records, priority to patent rights in an invention could be lost together with the financial incentives associated with the patent grant.

Notebook keeping: 11 steps to protect your invention

The following is a list of suggested practices for researchers who must maintain laboratory records. In general, the laboratory records should contain enough information so that a technically sophisticated nonexpert can understand what was done.

  1. The records should be maintained in a bound and numbered laboratory notebook. An index at the front of the notebook outlining the titles of the experiments is also useful. All entries should be in permanent ink, preferably a single color. Changes or additions to the record should be initialed and dated. Abbreviations and codes should be clearly defined.

  2. The dates when and idea was formed and when work on the idea was begun and completed should be recorded. This information is important in establishing a clear date of conception and reduction to practice.

  3. Each experiment should start with a clear statement of the objective. An initial statement allows one to get an idea of what the inventor was thinking before the experiment took place.

  4. Experiments should be recorded in the notebook in chronological order on numbered pages. Skipped or blank pages or pages dated out of order can create suspicion of tampering with the record. Pages left initially blank should be indicated as such.

  5. All essential facts should be recorded, such as equipment used, conditions, times, temperatures, pH, materials used including source and quality, yields, characterizing data, and so forth. Protocols, experimental design, and calculations should also be recorded.

  6. The record of an experiment that takes more than one page should make clear reference to previous and subsequent pages so the entire experiment can be followed (i.e., "continued on page 7," "continued from page 15," or "page 2 of 4."

  7. If a standard or routine procedure is being followed, reference to the location of a full description of that procedure should be made. For example, "The DNA sequence was determined by the method of Maxam and Gilbert (1977) PNAS USA 74:560-564."

  8. Analytical or other test results should be dated and attached or copied into the record. It is advisable to sign and date across both the added document and the underlying notebook page. Experimental results that degrade over time should be converted to a more permanent form. For example, gels that use color reagents should be photographed or scanned and the photograph or scan mounted into the notebook. Electronic records raise new issues concerning record keeping. The technology is so new that neither the PTO nor the courts have determined the legal rules with respect to these types of records. At this time, the best advice for researchers who keep electronic records is to print hard copies and affix them to the bound notebook, as outlined above.

  9. The record should draw a conclusion and evaluate the experimental results, if possible. This practice is particularly desirable with experiments that investigate new conditions or synthesize new compounds. A conclusion and evaluation are significant because recognition of success is an important element in the reduction to practice of an invention.

  10. Every page of every experiment in an notebook or other invention record should be signed and dated by the inventor. In addition, at least one non-inventor witness should corroborate the record by reading, signing, and dating the record on every page. The witness should sign and date as soon as possible after the inventor has recorded the entries.

  11. A designated custodian should be responsible for sequentially numbering and assigning new notebooks and later cataloging notebooks.

    Acknowledgements
    The author wishes to thank
    Dale L.Carlson and Mary R. Norris both of Wiggin & Dana.

    1. Hahn v. Wong , 13 USPQ 2d 1313 (Fed. Circ. 1989).

    2. Coleman v. Dines, 224 USPQ 857 (Fed. Circ. 1985).
    3. In Re Reuter, 210 USPQ at 255, no.9. 
    4. Price v. Symsek, 20 USPQ 2d 1031 (Fed. Circ. 1993).
    5. 35 USC 104.

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