The Laboratory Informatics Experts

First-to-File Patents: Do we still need an ELN?

February 6, 2014

First to File PatentsPresident Obama signed the Leahy-Smith America Invents Act (AIA) into law in September of 2011. This affected many sections of the existing U.S. patent statutes, the most talked about being the shift from a first-to-invent patent system to a first-to-file system. The first-to-file patent system went into effect in March of 2013.

In the “old days” our patent system granted the patent to an invention based on who could prove they came up with the idea first. This is the “first-to-invent” patent world. To prove who was first you needed “business records” which are court admissible records that are dated, signed, witnessed records that you could prove have not been changed or tampered with. Business records could be electronic and an Electronic Laboratory Notebook (ELN) was the perfect system to capture and store them. ELNs provided date/time stamping, electronic signatures, and audit trails. Intellectual property preserved! ELN justified and paid for!

Now our patent laws have changed. Now, the first person to file the patent or disclosure is the one granted the patent. This is the “first-to-file” patent world. So the need for business records goes away! Uh oh! Do you still need ELNs? The quick answer to this question is yes! Here’s why.

Business Records

Business records are still needed for the patent filings. ELNs still provide a great framework and the features to capture and ensure that your electronic records are properly documented and authenticable. This includes; electronic signatures, digital time stamps, and proof that the record has not changed (i.e. audit trail).

Speed is the key

The new mantra when it comes to patents is “File early! File often!”. The speed at which one is able to file a patent is now critical. ELNs greatly enhance an organization’s ability to search for, find and aggregate data and records in support of both pre-filing disclosures and patent filings.

Derivation Proceedings – prior art

Derivation proceedings have replaced interference proceedings in the new “first-to-file” patent world. During a derivation proceeding, a first inventor with a later filing date challenges an earlier filer for patent ownership. The goal of the later filer is to prove that the first filer derived their invention from their prior art. This prior art may very well be an electronic record within an ELN and the ELN would have tracked who else worked on the project and had access to the experiments, data, and any project notes. If you prove that the earlier filer had access to the prior art then your case for derivation would be won and the later file will get the patent rights.

In conclusion, it is clear that there are a number of reasons that use of Electronic Laboratory Notebooks in the new First-to-File patent world is not only viable but is recommended. ELNs offer the framework and technology to assist an organization in establishing and maintaining authentic electronic records and the ability to track who had access to them and when. ELNs also facilitate your organization’s ability to quickly find and aggregate critical data and information in support of your disclosures and fillings since speed of filing is more critical than ever.

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Do you like the change they made from interference proceedings to derivation proceedings? Have you been affected in a positive or negative way by this change? Share your story below.

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