Avoid First-to-File Roadblocks: ELN Considerations for Protecting Intellectual Property
The concept of intellectual property and ownership of discovery and innovation can be quite controversial. The only real problem I personally dealt with regarding intellectual property was when my boss regularly gave credit to my coworker for my ideas, experiments and data. I don’t think it was intentional, but it was aggravating nonetheless. When you have a good idea you want to get credit for it, especially when other people acknowledge that it’s innovative. If you’re able to make money off the idea, then you definitely want to make sure you get credit for it!
In most industries, patents are the predominant form of ensuring intellectual property. A patent protects inventions, which may be a product or a process, and gives the inventor the right to exclude other entities from making, using or selling their invention for a limited time.
On March 16, 2013, drastic changes were made to the U.S. Patent System. Simply put, The Leahy–Smith America Invents Act (AIA) switched the U.S. system from a “first to invent” to a “first inventor to file” system. A major part of the law declares that, under U.S. Patent Law, the inventor is defined as the first person to file an application for a patent on an invention.
The switch wasn’t instantaneous, however. There will be some leniency with regards to priority contests for a claimed invention between near-simultaneous inventors. What this means is that, if a party disputes a patent, even if they were first to file, a derivation proceeding will take place to determine who the actual inventor is.
The process to prove inventorship can be tough, especially if you don’t have reliable records. However, an electronic laboratory notebook can help alleviate the stress of protecting intellectual property and provide a system with which to defend your work. Consider these factors when determining how to implement an ELN at your company:
What an ELN must include in order to prove legal and factual issues
Electronic records are not new within the U.S. legal system. Emails, voice recordings, computer records and even GPS tracking data have been used in successful prosecution and defense cases. However, your ELN must include certain information to support your claim as an inventor. Your claim should include:
a) Conception – the complete idea of how to make and use the later-claimed invention
b) Reduction of practice – evidence that the invention is actually made and works
c) Diligence – must show continuous and reasonable reduction to practice
d) Corroboration – testimony required for inventors, but rule of reason applied
e) Witnessing – notebook witnesses may help corroborate
Factors that determine the admissibility of ELN records as proof of invention in court
Not all notebook records, digital or handwritten, are created equal. In fact, some handwritten notebooks may hold up better in court than a poorly utilized ELN. Therefore, it’s important to know what the judge will consider when determining if your ELN is admissible in the USPTO. Most importantly, your ELN must be found credible. That may mean that you will need to prove and defend its trustworthiness. Credibility will depend on how the ELN was created, stored and reproduced. The best approach to prepare for this scenario is to establish and consistently follow ELN policies and procedures.
Designing your ELN system
Since not all notebooks are created equal, it is up to you to implement an ELN system that will protect your intellectual property. A simple way to design your ELN policies and procedures is to consider the 4 Ws:
- Who created the record? Electronic and digital signatures, verifying entries and witnessing can help with validation.
- When was the record created? Time stamping, locking and versioning experiments can create a chronological record of experiments.
- What was the content when the entry was created? Proving alterations, maintaining an audit trail and archiving can help prove originality.
- Whether the ELN can be reproduced in readable form – The entries should be backed up and include auxiliary files.
Keeping these design tips in mind, one other consideration is the need for simplicity and flexibility. For large firms, multiple user types mean that the ELN platform should be accessible for users, regardless of their data and needs. Company-defined templates and standards will help consistency across the firm.
The credibility of your ELN is paramount in defending your intellectual property and claim to an invention. An Accelrys ELN can help set you on a straight path to recording, capturing and storing the necessary information to secure your intellectual property.