Federal Circuit Affirms Invalidity of Nanopore Sequencing Patents for Failing to Enable, and Affirms Denial of New Trial on the Basis of Defendant’s Allegedly Prejudicial Remarks Regarding the COVID-19 Crisis

On May 11, 2021, the Federal Circuit affirmed the District Court of Delaware’s judgment that patents belonging to Pacific Biosciences of California (“PacBio”) were invalid for lack of enablement under 35 U.S.C. § 112.1 A Delaware jury had found that defendant Oxford Nanopore Technologies (“Oxford”) infringed PacBio’s patents, but that those patents were invalid for lack of enablement; the district court then denied PacBio’s motion for judgment as a matter of law and a new trial on enablement. The Federal Circuit also affirmed the District Court’s rejection of PacBio’s argument that Oxford utilized fear over the coronavirus to get a favorable verdict.

PacBio’s patents, U.S. Patent Nos. 9,546,400 and 9,772,323, describe and claim methods for sequencing nucleic acids, such as DNA, using “nanopore technology.” Their claims refer to one or more template nucleic acids, but do not limit the character of the nucleic acid. For example, the patents do not differentiate between “particular types of DNA.”

PacBio mainly relied on trial testimony of Oxford’s technical expert, Dr. Goldman. Goldman was asked whether a person of ordinary skill in the art in 2009 “with the Akeson grant in front of them” would be able to successfully perform the claimed method; Goldman answered “yes.” The Akeson grant was a grant application filed by another Oxford witness prior to 2009. The Federal Circuit was not persuaded that this alleged “admission” required a finding of enablement. The jury could have, the Court noted, understood Dr. Goldman to be saying no more than that an artisan could have performed the claimed method on the particular subset of nucleic acids addressed in the Akeson grant (“DNA hairpins,” which are synthesized nucleic acids).

Considering all of the evidence, the Court found that substantial evidence supported the finding that before the 2009 priority date of the patents, artisans did not know how to perform nanopore sequencing for more than a narrow range of the full scope of nucleic acids covered by the asserted claims. That evidence included that (a) whereas the Akeson grant related specifically to “DNA hairpins,” the first successful nanopore sequencing of biological DNA molecules did not occur until 2011; (b) there was no indication that that 2011 success was made possible by PacBio’s patent disclosure; (c) the 2011 success was regarded as a major advance by the industry; (d) PacBio had never performed the claimed methods itself and had no evidence of actual reduction to practice of its own, and (e) the jury had evidence that conveyed an intent by PacBio to “tangle … up” and “fool” competitors with its patents.” The record thus supported the legal conclusion that the patents did not enable the full scope of the relevant claims.

An interesting, additional argument that PacBio presented on appeal was that it was entitled to a new trial because of prejudicial statements made during Oxford’s opening remarks regarding the coronavirus.

The trial began on March 9, 2020, as concern about coronavirus SARS-CoV-2 were spreading throughout the United States. Prior to the trial, the District Court granted PacBio’s Motion in Limine (MIL) “to prevent [Oxford] from . . .presenting evidence about the consequences of this litigation.” Specifically, the Order stated “it would be inappropriate to put before the jury evidence or argument about the potential impact of a verdict in favor of PacBio— such as higher prices or slower medical research—as these issues are not for the jury to decide.” During its opening statements, Oxford spoke at length about the coronavirus and implied that PacBio was stifling response to a potential outbreak by excluding Oxford from the market.

After opening arguments, PacBio moved for curative instructions to be given to the jury to counteract “the exploitation of the violation of the MIL [Order].” The District Judge criticized Oxford for violating the MIL in part because of the Covid-19 references. The judge warned the parties about “turn[ing] this really into a trial about an ongoing global health crisis that has to be on the minds of the jury.” He emphasized that such a trial would be “unfair,” “inflam[e] the jury,” and “would create a real risk of a verdict” not based on the evidence. The Judge gave the requested curative instructions, stating, inter alia, that “if you find [Oxford] liable for patent infringement . . . you are only being asked to award monetary compensation to PacBio. You are not being asked to exclude any [Oxford] product from the market or to stop any research work being performed on [Oxford] products.”

PacBio moved for a new trial after the jury’s invalidity verdict, arguing that “Oxford’s statements regarding COVID-19 violated the MIL Order and were so prejudicial that the case should be retried.” The District Court denied PacBio’s motion and explained, “[t]here is just no indication . . . that this jury was inflamed, that it was not careful,” or that the jury otherwise failed to properly consider the evidence because of the mentions of COVID-19.”

On appeal, the Federal Circuit deferred to the District Court Judge on whether a new trial was needed due to Oxford’s opening remarks about the coronavirus implications of the case. The Federal Circuit explained that a new trial is necessary if “the appellee made prejudicial remarks and it is ‘reasonably probable’ those prejudicial remarks influenced the jury’s verdict.” The Court explained that improper trial conduct is properly discerned by the judge who supervised the trial, unless there is a showing of abuse of discretion. The panel did not find any such abuse.

1Pacific Biosciences of California, Inc. v. Oxford Nanopore Technologies, Inc., 996 F.3d 1342 (Fed. Cir. 2021).