Laboratory Notebooks: Importance and Legal Implications

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Laboratory Notebooks: Importance and Legal Implications Jenifer Slinskey Tarasi Associate Director, Intellectual Property

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A Lab Notebook Is… •

A complete record of procedures (the actions you take), the reagents you use, the observations you make (these are the data), and the relevant thought processes that would enable another scientist to reproduce your observations.

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An explanation of why the experiments were done, including any necessary background and references, how the experiments were preformed and the results of the experiments.

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A legal document. In the case that your research contributes to the issuing of a patent, it will be closely scrutinized because it documents your group’s claim to the invention. Also, if any allegations of fraud are brought against your published work, your lab notebook is used to validate your findings and defend your claims.

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Your scientific legacy for that lab. Long after you have moved on from the lab, your notebook will remain and be referenced. Others will be building on the research that you are doing now and it is imperative that they can replicate what you have done.

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Recording and Intellectual Property – Why Does It Matter?

Three primary reasons for properly maintaining a lab notebook with respect to protecting IP: •Proving true inventors •Proving date of invention •Providing evidence for supporting patentability

July 11, 2013

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Importance of Inventorship Inventorship = ownership Incorrect inventorship = invalid or unenforceable U.S. patent

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Who is an Inventor?

Described by courts as “one of the muddiest concepts in the muddy metaphysics of the patent law.”

Inventorship = Conception An inventor is a person who conceives of the subject matter of a claim.

“The formation in the mind of the inventor, of a definite and permanent idea of the complete and operative invention, as it is hereafter to be applied in practice.” Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367 (Fed. Cir. 1986).

An invention is considered “conceived” if every feature is described so that actual reduction to practice requires only ordinary skill in the art.

Inventorship is determined in a patent claim-by-claim basis.

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Who is an Inventor?

Joint Inventorship A person can be a joint inventor on an entire application even if they only conceptually contributed to a single claim in the application.

Ethicon v. United States Surgical Corp, 135 F.3d 1456, 1460 (Fed. Cir. 1998).

Some basic guidelines for determining joint inventorship: •Actual collaboration is required.

•Joint inventor must make a contribution “this is not insignificant in quality, when that contribution is measured against the dimension of the full invention.” Fina Oil and Chemical Co. v. Ewen, 123 F.3d 1446 (Fed. Cir. 1997).

•“[A] person will not be a co-inventor if he or she does no more than explain to the real inventors concepts that are well known and in the current state of the art.” Hess v. Advanced Cardiovascular Sys., Inc., 106 F. 3d 976, 981 (Fed. Cir. 1997).

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Who should be keeping a lab notebook? • All researchers involved in the project should be keeping their own lab notebook • This not only helps to determine who did what and when, it will also assist your patent attorney in determining inventorship.

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Inventorship = Ownership An inventor owns the patent or patent application in the absence of an assignment to another.

In the absence of an agreement to the contrary, each patent owner has an equal undivided right in the patent without having to account to the other owners.

Typically obtain an agreement between university and third party for applications/patents jointly owned between the university and third party that manages licensing rights and royalties.

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Inventorship - Examples One who only suggests a general research topic is not an inventor because not “definite and permanent.”

One who only outlines advantageous features of a potential product without conceiving of how to achieve these features is not an inventor because not “complete and operative.”

One who only performs experiments based on the guidance of another is not an inventor since no conceptual contribution (i.e., one who only reduces an invention to practice is not an inventor).

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First-to-Invent vs. First-to-File The U.S. patent system moved from first-to-invent to first-trueinventor-to-file in March 2013 due to passage of the America Invents Act (AIA).

Under either system, inventorship is important, and thus so are notebooks.

Inventorship issue could be raised in Federal Court or before the U.S. Patent and Trademark Office

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Derivation Proceedings Under the current U.S. patent system there is a process for determining who is a true inventor – process is known as a “Derivation” proceeding.

First-to-file patent applicant is not awarded patent if they “derived” invention from someone else not named as an inventor on the application or patent.

Petition must be supported by “substantial evidence” of derivation.

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Derivation Proceedings The derivation proceedings are designed to ensure that a person will not be able to obtain a patent for an invention that he or she did not actually invent under the first-inventor-to-file system.

Under the rules, if a dispute arises as to which of two applicants is a true inventor (as opposed to who invented it first), it will be resolved through a derivation proceeding conducted by the USPTO’s Patent Trial and Appeal Board.

The petition must state with particularity the basis for finding that a named inventor in the earlier application derived the claimed invention without authorization. The petition must also be filed within one yearof the publication of the earlier application.

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Proving Derivation Derivation proceedings more likely directed to communications between petitioner and alleged deriver where there is no public disclosure or in situations where there is a research paper and additional communication between petitioner and alleged deriver.

LAB NOTEBOOKS!

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Admissible Evidence Admissible evidence: Relevant Authentic

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Corroborating Evidence Once admitted, how much “weight” is given to the Evidence?” Is it credible? Evidence emanating solely from inventor must be corroborated by evidence independent of the inventor.

Contemporaneously made records – LAB NOTEBOOKS! However, “unwitnessed laboratory notebooks on their own are insufficient to support” a claim of inventorship. Stern v. Trustees of Columbia University, 434 F.3d 1375, 1378 (Fed. Cir. 2006), cert. denied 127 S. Ct. 83 (2006).

Circumstantial evidence e.g., documentation showing obtaining a reagent; date-stamped email, lab meeting notes, etc.

Oral testimony of someone other than the alleged inventor.

WITNESSES OF LAB NOTEBOOKS!

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Legal Requirements For Notebooks Proof requires evidence that answers the following questions: •What is the record?

•Who authored the record?

•When was it created?

•How was it maintained and was it changed?

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What: Key Features • No matter what type of notebook is used (paper or electronic), policies and procedures must be in place for creating, updating and keeping records.

• There must be an ability to detect any changes • Early on, you may only have a brief written description and perhaps some sketches • Carefully describe your idea including alternatives

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What: Good Notebook Practices •

Record ideas (“definite,” “complete,” “operative”), experimental protocols, results (e.g. structures of novel materials), observations (e.g., appreciation of significance of results). BE PROMPT!

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Document potential variations of concept, even if do not intend to actually reduce the variations to practice.

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Document communications to others, particularly with people outside of the University – important for proving joint inventorship or derivation (who? what? when?)

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Identify abbreviations, acronyms, shorthand notations, etc. if not commonly understood.

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Who: Authorship and Witness • Paper notebook: Each page has the inventors and the witnesses’ signature • Have another researcher (not one directly involved with the project who can understand the entries) sign and date regularly • Each entry should be complete enough so that the person corroborating the entry can understand it without additional explanation

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When: Creation of a Record (Date) • Traditional notebooks have the inventor’s and witnesses’ handwritten dates in a continuous bound volume.

• Use ink • Do not erase or white-out. If you must make a correction, cross out and write correct entry (avoid writing above or using margin writing).

• Do not skip or tear out pages • Loose pages separately prepared or photos should be pasted in the notebook

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How: Maintenance and Changes • Forensic examination of written documents can detect changes • Establish a policy furnished to each researcher and adopt policy as part of normal lab/department policy.

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Ethics •

As previously noted, one of the purposes of keeping a good lab notebook is to protect you from allegations of fraud. There are ethical standards you must follow to allow your notebook to act as a form of protection.

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Below are a few of the more important guidelines and most commonly made mistakes: – All data should be recorded in your notebook – including data that are hard to interpret, contradictory to previous data or “outliers”. Even if your experiment fails completely, you need to record the negative data and/or describe what happened.

– No pages come out of the notebook – as a means of assuring the integrity of your notebook. In bound notebooks it is important not to skip pages and to cross out any unused parts of a page. This prevents you or someone else from going back and adding things after the fact.

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Ethics (continued) – Correct mistakes, do not remove them – it is important that your notebook be accurate, but mistakes happen. To correct a mistake, cross it out with a single line. If you pasted the wrong thing in your notebook, cross it out and paste in the correct item without covering up anything already in the notebook. You need to sign and date all corrections so that they can be authenticated.

– Honestly is the best policy – no matter how bad the data or how embarrassing the mistake, honesty is always the best policy.

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Contact information Office of Technology Management University of Pittsburgh 200 Gardner Steel Conference Center O’Hara & Thackeray Streets Pittsburgh, PA 15260 US Phone: 412-648-2206 Web: http://innovation.pitt.edu

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