September 9, 2019
In the race to patent or publish in life sciences, time is critical. For any researcher, securing Intellectual Property (IP) is equally critical. In order to receive a patent on an invention, inventors must be able to document the work they did to prove that the invention substantially performs against the claim. Additionally, this proof must be corroborated by someone (e.g., custodian of records) not directly involved in the work. Effective documentation and corroboration of the work done on an invention is also necessary to protect IP against challenges to the U.S. Patent and Trademark Office (USPTO) and possible litigation from competing inventors.
One of the most hotly contested research areas currently is in the area of CRISPR, the gene editing technology platform that has spawned a billion-dollar industry and countless biotech startups. This technology was developed by multiple organizations, including researchers from the Broad Institute, Harvard University, MIT and University of California – Berkeley. First developed in prokaryotic cells at UC Berkeley, later, the Broad Institute implemented the technology in eukaryotic cells. At issue is whether genome editing in eukaryotic (mammalian) cells is made obvious/trivial once it is accomplished in non-mammalian cells. Obviously, this dispute has required both sides to pour over experiment records to search for evidence to support arguments, as well as to establish timing and a full audit trail of events leading to the invention. If your organization is working on bleeding edge technology platforms such as CRISPR or novel biologic therapeutic classes, for example, considering your IP protection strategy is business critical and could have major impacts on your company’s future.
Today, most established companies and many academic labs involved in R&D have made the shift from paper to electronic laboratory notebooks (ELN) in order to create a searchable repository of experimental data that researchers can access to facilitate collaboration. An ELN can also be a key element in your IP protection strategy by supporting scientists in keeping complete, accurate and witnessed records of all research. If you are looking for a new ELN, or want to bolster your IP protection for an existing ELN implementation, there are many elements to consider in order to effectively secure IP.
Baseline Features in ELNs for Securing IP
R&D partnerships continue to increase, and many organizations are looking to the cloud to host ELN systems to open up data sharing and experiment data capture across the globe. With new and emerging cloud-based ELN vendors having developed commercial offerings in the last five years or so, it is important to take a close look at the ‘baseline’ features and security controls that should be there to protect your IP. Many of these features are in fact commoditized and readily available in most platforms for the last ten years, but it is always important to check the boxes – particularly when you are working with a smaller, less established ELN vendor who may be new to the market.
Features which you should look for when choosing an ELN to support IP protection include:
21 CFR Part 11 Regulations on Electronic Records and Signatures
The regulations established in 21 CFR Part 11 dictate many of the features that should be in any ELN. As such, any ELN should have the ability to time, date and user stamp any data entered into the system. Equally important, audit trails should be available to track all the changes to a record, as well as chain of custody for the data. Electronic signatures should be assigned as a result of a controlled workflow that is consistent with the organization’s policies and procedures for witnessing experiments.
Any quality ELN will have the ability to close off access to all or parts of the experiment to selected user groups. With so many collaborators and experiments being developed jointly across organizations, it is critical that the system provide a way to fence off certain programs, projects, or individual experiments to the appropriate people – creating a path to assign IP ownership rights accordingly.
Electronic (Structured) Environment for Projects, Programs and Targets
Paper notebooks are stand-alone – meaning you can’t easily back them up, you can’t search by keyword, and when they’re archived, they are essentially lost. Trying to find information in a paper notebook world is often so cumbersome and difficult that it’s faster to just redo the experiment. Having the information in an electronic format increases the likelihood that the knowledge will be shared rather than lost, and sometimes more importantly, can help show a concerted progression of work against a piece of intellectual property.
To make it easier to navigate, the system should support many ways of structuring the experimental data, consistent with the scientific programs, projects and targets. Being able to quickly pull up all of the sample data by scientist and experimental results for a given program or project by target class or other meaningful criteria is not only convenient but may also be critical for building your case in court or simply working with a collaborator to flesh out ownership rights.
Archiving Immutable Experiment Records
In order to secure IP, the ELN should support creation of immortalized, time-stamped, unalterable record for archiving (usually PDF of completed experiment) that documents everything that was done during the experiment. This document needs to be archived either within the ELN itself or in a database behind the company firewall.
ELN’s must protect company IP from possible theft by both external parties and company employees. For protection against internal theft, your ELN should have a folder-based security paradigm in which security permissions (read, write, modification, delete) are set at the root folder of a notebook, project, study or experiment. These rights will then cascade down to the new folders and entities underneath the root. Once an experiment record has been approved and locked down with the electronic signature workflow, it can be released to a wider audience for data-sharing purposes. Users performing searches in the system should only be able to see records for which they have been given viewing rights.
Why are unalterable experiment records archived in a secure environment so critical? The U.S. Federal Rules of Evidence (FRE) govern whether evidence like laboratory records are admissible in a patent interference or a civil case. There are two ways to admit laboratory notebook records. First, the author who created the records of the experiments can testify as to their validity. This would satisfy the requirement that the evidence was made by the declarant. But, what if the case is many years later, and the inventor is no longer available?
The second way is to classify them in what is commonly called the “business records” exception to hearsay (Rule 803). This exception allows business materials, e.g., lab notebooks, to be admitted as evidence if a proper foundation is established to prove their authenticity. This consists of five elements:
- Records must be kept in the ordinary course of the business.
- The particular record at issue must be one regularly kept.
- The record must be made by or from a knowledgeable source.
- The record must be made contemporaneously.
- The record must be accompanied by testimony from a custodian.
An often-overlooked consideration is the custodian. A custodian is an individual who, in the usual course of a company’s operation, is responsible for the management of business records. A custodian can be called into court to attest to the company’s policies and procedures for documenting and securing the records desired to be admitted. They will be asked to substantiate that procedures are generally followed and the records in question adhere to those standards. Without a designated custodian, there is a risk of non-admittance of company records in a court case.
Best Practices for Laboratory Notebook Policies and Procedures
An ELN can be a big improvement over paper for IP protection, in that it helps to enforce established policies and core capabilities such as time stamping and audit trails. The organized and searchable records that an ELN facilitates can also better prove diligence and reduction to practice. If a company does not have good notebook policies in place to facilitate custodian of record, however, an ELN is no better than paper for securing IP. Good practices always trump technology. Once the necessary foundational notebook policies are in place to protect IP, an ELN can be leveraged to further improve the current state.
Some best practice ELN policies include:
Notebook records can be vital in winning or losing a patent battle, and all records must be incontrovertible. Scientists need to create an accurate, complete and organized record of their work. Laboratory notebooks should include a clear and detailed description of:
- The experiment’s purpose
- How and when the experiment was performed
- What materials and reagents were used (e.g., sources, lot numbers, animal numbers for antisera, etc.).
- What results were obtained
- Citations for publications referenced in notebook entries
- All software used for data analysis.
- Where related computer files, samples, slides, or photos are stored
- Interactions with collaborators, including discussions, data, and exchanges of materials
- Any other information that you or another scientist in your field would need to precisely replicate your experiments
Signing and Witnessing Electronic Records
- All experiments should be signed and dated.
- Joint work should be signed by all the contributors. The text should set forth who is responsible for each part.
- Entries should be witnessed (including the date of the witnessing) in a timely manner.
- Entries for crucial or pivotal experiments should be witnessed immediately upon completion.
- All other entries should be dated within a reasonable period after completion. To be a proper witness, a person must be able to understand the entries they are witnessing
- Any entry which relates to a possibly patentable invention should be signed and dated by two witnesses — with their signatures under the caption, “disclosed to and understood by….”
- A possible co-inventor or other person who was directly involved in the described experiments IS NOT a valid witness.
Archiving Electronic Records
Like paper records, electronic records must be immortalized and witnessed:
- Electronic entries should be regularly (preferably daily, or at least weekly) immortalized in an unalterable form (e.g., read only disk or tape, electronic archive).
- Each unalterable form should be marked with an identification of the software (including version number) needed to read the data contained therein.
- The creator of the unalterable form should sign and date the disk or tape or record.
- The unalterable form should be signed and dated by two witnesses other than the primary creator.
Additionally, proper governance of signed, dated, witnessed, archived unalterable experiment records is vital to prevent potential internal theft of sensitive IP. An appropriate balance needs to be set in terms of who can access stored experimental data – data sharing between scientists needs to be enabled to prevent unnecessary duplication of work, but access must not be so wide that unnecessary opportunities are provided to unscrupulous employees to download and depart with confidential data.
The emergence of ELN technology has helped countless organizations organize and retain research knowledge in ways that support IP protection. A quality ELN, however, is only one element of a successful strategy to protect your IP – poor documentation and inconsistent business processes can drive up risk regardless of the technology chosen.
Companies who are considering an ELN for IP protection must focus first on establishing a proper foundation for IP management with good notebook policies and business practices. Once this is in place, an ELN should be selected that best supports the companies IP protection needs as well as other requirements. Finally, the ELN should be configured/customized to support and enforce the business practices and notebook policies. A quality informatics consultant can support you with the business process analysis and technology selection, development and implementation necessary to optimize your IP protection strategy.