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The United States of America is one of the world's largest markets for goods and services. Therefore, possession of a US patent can provide the owner with a tremendous commercial advantage. The purpose of this memo is to point out the importance of keeping good, reliable laboratory records to ensure that the necessary evidence is readily available should a US patent dispute arise regarding the date of invention. When two or more parties make an identical invention at about the same time, in all other countries except the US, the first to file a patent application wins. For historical reasons the US has a system where the first to invent wins. With multiple similar applications, the US Patent Office declares an "Interference" and begins the complex legal proceedings to ascertain who was the first party to make the invention. A well-documented laboratory notebook can help maximize the chances to obtain a US patent.
|Explanation of US Patent Law|
Invention in the US comprises two elements: the "conception" of the innovation and the "reduction to practice". In order to prove a date of invention for US purposes, it is necessary to have proof of conception of the invention and also to show diligence in its reduction to practice. Reduction to practice can be "constructive", by filing a patent application, or "actual", which is the demonstration of the invention by building of a prototype or the synthesis of a chemical compound.
Changes in the US Patent law effective from January 1, 1996 permit an applicant to establish a date of invention based on evidence of inventive activity occurring outside, as well as inside, the US.
|Evidence and Diligence|
In order to prove the date of invention, the US and foreign applicants will need to provide evidence of the date of conception of an invention and proof of diligence in its reduction to practice.
Evidence may take a variety of forms, but the most convenient and well accepted is the laboratory notebook. The evidence must clearly show that the inventive act was carried out by the inventor on the date indicated and must be signed and dated by both the inventor and a corroborating witness, who is not an inventor. US interference law requires that evidence be corroborated by someone who has read and understood the work, but is independent of the invention.
For example, if the worker is a graduate student, the witness should not be their supervisor, since the supervisor is likely to become a co-inventor.
The witness must have read and understood the work described before signing and dating the page. It is not necessary for the witness to write anything. A signature and date under the statement "read and understood" is sufficient. The notebook pages should be signed and dated daily, but no less than weekly. Lack of this witness signature can prove fatal, since the presentation of uncorroborated records, even if accompanied by sworn statements, might not be accepted as credible. All witnesses must understand the need to maintain confidentiality.
Diligence in the reduction to practice of an invention means that, as far as possible, generally steady, uninterrupted and constant work occurred following the conception of an invention. It follows that when a project is in progress, it is safest to have the notebook witnessed by someone who is working on an unrelated project. People involved in the same project are potential co-inventors and their signatures could be worthless. In an interference action, unexplained periods of inactivity may result in the loss of the patenting rights, especially where invention dates are separated by a matter of days. All activities must be documented, even if it is only to note that you were waiting for a sample analysis or outside test results that resulted in a delay. Even apparently irrelevant entries noting a vacation or lengthy trip should be included.
Interference claims take place often years after the invention was made and, unless accurate personal diaries and journals are kept, the careful recording of laboratory notebooks may be the only way of recalling the actual events that occurred at that time. The proper use of laboratory notebooks provides an advantage over personal papers, since notebooks are witnessed. The careful keeping and witnessing of notebooks recording progress is vital to proving diligence.
|First to Invent|
There are three simplified scenarios when determining who is the first to invent:
1. Party 1 was the first to conceive and reduce to practice.
2. Party 1 was the first to conceive but Party 2 was the first to reduce to practice.
Party 1 did not show diligence
3. Party 1 was the first to conceive and was diligent in reducing the invention to
A well conceived, maintained and witnessed notebook could be crucial in establishing a date of invention and proof of diligence in a US interference proceeding. Many discoveries will happen simultaneously among different research groups around the world. The notebook could make the difference between getting a US patent or not!
|Keeping a Notebook|
The following is intended as a general guide on how to keep a notebook.
The Record Book: It is important to use a record book that has a permanent binding. Loose-leaf, spiral-bound or other temporarily bound books that allow for page removal or insertion are not suitable. The pages of the notebook should be numbered, which significantly reduces the possibility of a successful challenge to the validity of any entry. The keeping of laboratory notebooks entirely electronically is not advisable, since computer records and the date of entry are easily altered. If the notebook is computer generated, each page should be dated and glued, or affixed in some permanent way onto successive numbered pages of a permanently bound laboratory notebook, and then signed, dated and witnessed.
Paper Quality: The permanence of the records is a prime consideration and it is important that good quality paper be used. The notebook may become important years and even decades latter.
Ink Quality: When recording experiments, do not use pencil or strange-colored inks. Ensure that the ink is permanent, not water or solvent reactive, and does not smear. It should also be light stable.
Entries: The entries in the notebook should be legible and factually complete. For all inventions, but perhaps especially for chemical and biotechnical inventions, it is important to describe in as full detail as possible all experimental procedures. This information includes all conditions of the experiment and all apparatus with sketches if appropriate. For mechanical/electrical inventions, full details of the apparatus, including circuits and settings, must be provided.
Drawings, including formulae in chemical inventions and sequence listings in biotechnological inventions, may be important. If there is any doubt, always include the supporting documentation. As a general guideline, there should be enough information in the notebook to enable someone working in the field to duplicate the effort and the results.
Rules and Observations: Record carefully all results and note all observations. In the chemical area, the notebook should include references to all analytical data and details of any calculations. Any graphs, drawings or other loose sheets should be carefully affixed in the book by some permanent method, i.e., staples or adhesive, and reference made to them and their contents and conclusions. Data that become available later should be added to the notebook on a separate page with a reference to the original entry. Never leave a page incomplete. Draw lines through unused pages or parts of pages.
Facts and Not Opinions: Record all novel concepts and ideas relating to the work. The notebook should be limited to factual, quantitative and qualitative results. Do not express opinions in notebooks because they could lead to misinterpretation. Statements like "the experiment failed", "the idea is obvious", "I think it is unpatentable", or "perhaps would infringe patent X" should be avoided. Do not use slang, abbreviations and unduly technical jargon. The notebook must be understandable to others, not only to patent attorneys, but also to judges, juries and potential licensees.
Supporting Documentation: Additions to the notebook of support records, i.e., photographs, computer pages, or test results, should not be haphazard. If support records cannot be added to the notebook itself, then reference to them should be consistent and they should be stored in an orderly, readily available and retrievable manner.
Signing Off: Ensure that each page is signed and dated by the author and witnessed as soon as possible. Do not leave any pages undated, unsigned or unwitnessed. Unsigned or undated or unwitnessed pages are virtually worthless and may undermine the credibility of the entire notebook. Have the pages witnessed at least weekly. A long delay between the signing of the page by the inventor and the witness will raise awkward questions.
Errors: Errors should not be erased or obliterated beyond recognition. Neither should liquid paper be used. Simply cross out an error so that it is apparent what the error was. Explain all errors and mistakes as they occur and initial them. Never remove pages from the notebook.
Safe Keeping: The notebook should be regarded as a legal document and its use and access should be controlled. When completed, it should be stored in a safe place and should not be treated as a freely available publication.
The purpose of this memo is to highlight the importance of keeping good, reliable laboratory records that will assist in patent prosecution. This note does not contain definitive legal advice and should not be used as a substitute for the advice of your lawyer or patent attorney. For additional information or for answers to specific questions, please call the Office of Research and ask for a Technology Transfer person.