Full Scope of Claimed Invention Must Be Enabled

By on May 20, 2021
Posted In Patents

In a case relating to nucleic acid sequencing, the US Court of Appeals for the Federal Circuit upheld a jury verdict of non-enablement because a skilled artisan would have only known how to successfully practice a narrow range of the full scope of the nucleic acids covered by the asserted claim at the time of the invention. Pacific Biosciences of California, Inc. v. Oxford Nanopore Technologies, Case No. 21-2155, -2156 (Fed. Cir. May 11, 2021) (Taranto, J.)

PacBio sued Oxford for infringement of two patents related to methods for sequencing nucleic acids (such as DNA) using nanopore technology. The methods involve drawing nucleic acids through a nanometer-sized hole formed in a substrate. A voltage is applied to the substrate, and as the nucleic acids pass through the hole, the identity of each nucleic acid is identified based on changes in electric current passing through the substrate.

At trial, Oxford’s lawyer made opening remarks that included references to the potential applications of Oxford’s accused products to the then-emerging global COVID-19 crisis. PacBio immediately objected, and the district court gave exactly the curative instruction that PacBio requested. The district court also required that going forward, the parties give advance notice if they intended to make any reference to COVID-19. Ultimately, the jury found all asserted claims infringed, but also determined that the claims were invalid for lack of enablement under 35 USC § 112. In post-trial motions, the district court denied PacBio’s request that the court grant a new trial because of Oxford’s remark during opening statements regarding the accused products’ potential application to the then-emerging COVID-19 crisis. PacBio appealed.

On appeal, PacBio argued that the jury’s finding of lack of enablement was unsupported by the evidence, citing to testimony from its expert that a person skilled in the art at the priority date would have been able to successfully perform the methods of the asserted claims. The Federal Circuit disagreed, noting that the expert only demonstrated successful practice of the asserted claims for a narrow subset of nucleic acids covered by the claims—namely DNA hairpin molecules. The Court cited evidence where PacBio admitted through a stipulation that it had never performed the nanopore sequencing methods of the asserted claims, meaning its reduction to practice was purely constructive. The Court also noted that Oxford produced evidence that it was not until 2011 (two years after the priority date) that anyone in the field was able to use nanopore sequencing to sequence biological DNA—a different type of nucleic acid within the scope of the asserted claims. Thus, the Court found that PacBio had only demonstrated that a person of skill in the art would have been able to successfully practice a narrow range of the full scope of the nucleic acids covered by the asserted claim. The Court explained that it is not enough for enablement that the relevant artisans knew how to perform some nanopore sequencing before the priority date. Instead, what matters is the scope of the asserted claims, which relate to sequencing any template nucleic acid. Accordingly, the Court affirmed the finding of lack of enablement.

Turning to the remarks made during the opening statement, the Federal Circuit found that there was not a high enough likelihood, in light of the curative instructions, that Oxford’s improper opening tainted the jury’s consideration of the issues to justify ordering a new trial. Ultimately, the Federal Circuit deferred to the trial judge’s decision, as that judge was present and able to evaluate the impact of counsel’s remarks and assess any prejudicial impact of the statements.

Amy MahanAmy Mahan
Amy Mahan focuses her practice on intellectual property matters in the life sciences, pharmaceutical and biotechnology sectors. She works on a variety of patent infringement litigation cases involving monoclonal antibody biologics, cell-based immunotherapies and small molecule drugs. Read Amy Mahan's full bio.

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