18Jun 2021

In a recent case, Pacific Biosciences of California, Inc. v. Oxford Nanopore Technologies, Inc., the Federal Circuit expanded the meaning of the enablement requirement under 35 U.S.C. § 112(a). Let’s take a look at how the court arrived at this decision. 

The claims at issue were directed to methods for sequencing nucleic acid (DNA) using nanopore technology.  

1.  A method for sequencing a nucleic acid template comprising:

    a) providing a substrate comprising a nanopore in contact with a solution, the solution comprising a template nucleic acid above the nanopore;

    b) providing a voltage across the nanopore;

    c) measuring a property which has a value that varies for N monomeric units of the template nucleic acid in the pore, wherein the measuring is performed as a function of time, while the template nucleic acid is translocating through the nanopore, wherein N is three or greater; and

    d) determining the sequence of the template nucleic acid using the measured property from step (c) by performing a process including comparing the measured property from step (c) to calibration information produced by measuring such property for 4 to the N sequence combinations.

It is a settled law that “[a] claim is not enabled if a relevant artisan would not be able to practice the claimed invention “without undue experimentation,” (Amgen Inc. v. Sanofi).

The District Court found that the defendant was infringing the claims, but that the claims were invalid for lack of enablement. The Federal Circuit affirmed, and stated that all elements needed to be enabled, not just some of the “nanopore sequencing” methods.

The Court noted that the nanopore sequencing technology was not performed in the art until 2011 (after the 2009 priority dates of the patents at issue) and it was not based on the disclosures of those patents. Moreover, before the 2009 priority date of the relevant patents, the skilled artisans would not have known how to perform nanopore sequencing for more than a narrow range of the full scope of nucleic acids covered by the asserted claims.

In other words, according to the Federal Circuit a relevant artisan would have been enabled only for the sequencing of synthetic nucleic acids addressed in the prior art, and not biological DNA, as suggested by the plaintiff. The Federal Circuit therefore upheld the decision of the District Court.

If you need assistance with this or have any questions, please contact me at silvia@salvadorilaw.com.

Silvia Salvadori, PhD

Silvia Salvadori, PhD