The following is Part I of a three-part series on “Preserving the Evidentiary Strength of Your High-Value Electronic R&D Data.” The series is based on a one-hour webinar, which can be accessed in its entirety at: www.surety.com/news/webinars.htm. Webinar panelists are: Michael H. Elliott, president of Atrium Research; Randy Whitmeyer, Partner at Hutchison Law Group; and Tom Klaff, CEO of Surety.

Part I – ELN Considerations for the Long Term
Presented by Michael H. Elliott, president of Atrium Research & Consulting

I would like to explore four key issues. First, R&D organizations understand the importance of migrating to electronic R&D processes, and many are in various stages of doing so. Second, certain market forces make this migration decision palatable, not the least of which is the need to get products from the laboratory to market in the fastest, safest manner. Third, I would like to dispel widely held myths about the virtues of maintaining paper records versus committing to a fully electronic R&D process. Finally, I would like to discuss the thought and planning that must go into deploying an electronic lab notebook (ELN) application.

Migration to eR&D
Most laboratories, when considering a migration from paper to electronic record management processes, do so in a controlled, conscientious manner. That is, they look before they leap and deploy a hybrid record-management process that includes paper copies with natively generated electronic records. Approximately 90 percent of the webinar audience we polled indicated that they either have deployed or are in the process of deploying such a hybrid record-management system.

The migration to a fully electronic system is the next step, and laboratories and the legal departments that influence them will need to make hard trade-offs based on these key factors:

• Over a short time span, there have been rapid hardware and software improvements in detection, data analysis, laboratory automation, and data visualization.
• Major pharmas can produce, on average, multiple terabytes of scientific data each year.
• It is very difficult to aggregate, analyze, and annotate these data in a timely manner using analog methods.

Organizations can either adopt ELN and hybrid record-management systems, enabling rapid collaboration and time-to-market at the perceived risk of legal defensibility, or remain in a paper-based culture and lose first-to-market advantages, but retain peace of mind in the legal department.

Technology Advances Reduce Risk
I predict that labs and legal departments that believe paper-based processes, such as bound laboratory notebooks, are the only acceptable methods in patent interference cases will lose out to rapidly innovating, fully electronic laboratories whose legal departments understand that electronic and paper records are equally acceptable from a legal standpoint. ELN technology advancements are moving the market to a clear tipping point where even the pragmatists see less risk to adoption. There are more than 25 vendors that sell ELNs to over 15 percent of all R&D operations in the world. The ELN market is the fastest growing segment in the scientific informatics market, growing at 30 percent CAGR.

As ELN technology has improved, many of the following pitfalls traditionally associated with paperbound notebooks have been exposed:

• Data collection is inefficient. Scientists should spend most, if not all, of their time performing experiments and discovering new products and technologies, rather than integrating lab notes and pasting drawings in books.
• Attestation is inefficient. Friday afternoon book-signing pizza parties defeat the purpose of legally attesting to origination date of discovery, and could be used against the company if the attestation process was ever challenged.
• Collaboration is limited. Since bound lab notebooks are archived, it is very difficult to draw data from previous experiments and collaborate with fellow researchers to resolve discovery roadblocks.
• Paper notebooks are difficult to search. Compared to ELNs, which have search capabilities, paper notebooks do not have efficient search indices.
• Legibility is problematic. If scientists have poor handwriting, notes will be difficult to decipher.
• Poor security. Paperbound notebooks may easily leave with scientists, and they are especially vulnerable to destruction.

There are many advantages to deploying an electronic R&D process, including the following:

• Less duplication of work. Scientists can quickly review past experiments and data, resulting in a 20 percent average improvement in experimental throughput.
• Higher quality of work. Scientists will be far more comprehensive in their research using an eR&D process because they understand that other scientists will be re-reading and reviewing their work sometime in the future.
• Equal if not better legal attestation. Unlike Friday afternoon signing sessions, digital signature and third-party time-stamping technologies may provide irrefutable, traceable dates of invention, which could defend a patent claim and potentially save billions of dollars in downstream revenue.
• Better collaborative environment. eR&D processes enable better capture and retrieval of institutional knowledge to advance innovation more efficiently.

Myth vs. Reality
Many myths are associated with paper-based IP record-keeping:

• Myth: R&D data are analog. Reality: The majority of R&D lab data are generated natively in electronic format.
• Myth: Only paper records are susceptible to inspection and subpoena. Reality: Any and all supporting records, whether paper-based or electronic, are open to inspection.
• Myth: Attestation is time- and date-sensitive. Reality: Researchers are so busy doing research that in many organizations, they designate certain days to sign each others’ notebooks regardless of when the ideas and records were generated.
• Myth: Paperbound notebook processes are legally defensible. Reality: Just because labs elect to record their intellectual property in paper-bound notebooks does not mean that their record-keeping processes are pristine. Chen (Bristol-Myers) v. Bouchard (Rhone Poulenc Rorer) dispels this claim.
• Myth: The USPTO only accepts paper records. Reality: The USPTO views electronic patent filings as equal to paper filings based on amended FRE guidelines.

Ready for eR&D?
When organizations decide to embark on an eR&D initiative, much careful thought and planning should go into this decision. Strong leadership in the organization is an absolute prerequisite to ensure end-user adoption and promote an eR&D culture. A clear vision and strategy should be thought through and communicated. The organization must also be carefully aligned, and in order to do this, it is imperative to recruit the best talent from IT, business, R&D, and legal to assure that necessary resources are allocated to the project. Project leadership should be handed to the most talented in this stakeholder group to ensure that the eR&D initiative has a chance to be accurate, on time, and on budget.

With project leadership in place, the R&D process must be re-engineered to map to the electronic environment, technology must then be selected to automate some of the process steps, and the initiative should gradually be rolled out. The stakeholders should build in good assessment and monitoring tools and also consider future trends and requirements. Underlying the eR&D initiative is sound electronic record-management and security. Data integrity controls must be built into the eR&D workflow to ensure that the organization can defend the data supporting its patents for however long it is required.

Read Part II of this series.