The Federal Circuit continues its recent run of decisions extending the reach of the enablement requirement of 35 U.S.C. 112(a) to invalidate patents in Pacific Biosciences of California, Inc. v. Oxford Nanopore Technologies, Inc. (albeit in this case, affirming denial of motion for JMOL in the face of a jury verdict of non-enablement).

The matter arose when Pacific Biosciences asserted U.S. Patent Nos. 9,546,400 and 9,772,323 directed to methods for sequencing nucleic acid (DNA) using nanopore technology.  As explained in the opinion, the DNA being sequenced passes through the nanopores causing a change in electrical current specific for each nucleotide base (which is then recognized by the machine).  Pacific Biosciences asserted Claim 1 of the '400 patent:

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.

A jury found that Oxford infringed the asserted claims but that the claims were invalid for failure to satisfy the enablement requirement, based in part on conflicting testimony from each party's experts.  The District Court denied Pacific Biosciences' pos-trial motion for judgment as a matter of law (JMOL), leading to this appeal.

The Federal Circuit affirmed, in an opinion by Judge Taranto, joined by Judges Lourie and Stoll.  According to the opinion, "[w]hat matters is the scope of the asserted claims," which in relevant part extended to determining the sequence of a template nucleic acid without any limitation regarding the "character" of the nucleic acid, including differentiating between "particular types of DNA" (what the Court understood any of this to mean is unclear).  The opinion discusses the relevance of the "N nucleotides" limitation in the claims, which was one basis for Oxford's expert's testimony that the claims were not enabled.  The opinion also notes testimony from more than one witness that nanopore sequencing technology was not performed in the art until 2011 (after the 2009 priority dates of the patents at issue) and not based on the disclosures of those patents.  The opinion notes also that Pacific Biosciences' specification was constructive and that there was no "real-world reduction to practice" achieved at the time of filing.  (There was also evidence presented to the jury that Pacific Biosciences had intended to "'tangle . . . up' and 'fool' competitors with its patents" which the opinion understood might have pointed the jury away from deciding that Pacific Biosciences had an enabled method.)  The remainder of the panel's opinion on enablement was focused on whether the District Court properly denied Pacific Biosciences' motion for JMOL and whether the jury could reasonably have arrived at its verdict in view of the conflicting testimony of the witnesses.  The panel stated that in its opinion "there was ample evidence to support a finding that, before the 2009 priority date of the '400 and '323 patents, relevant 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," citing Idenix Pharms. LLC v. Gilead Sciences Inc., 941 F.3d 1149 (Fed. Cir. 2019), Enzo Biochem, Inc. v. Calgene, Inc., 188 F.3d 1362 (Fed. Cir. 1999), and Union Carbide Chems. & Plastics Tech. Corp. v. Shell Oil Co., 308 F.3d 1167 (Fed. Cir. 2002), in support.

But as Paul Harvey used to say, here's the rest of the story (which has nothing to do with patent law and as such is discussed herein subservient to the patent law aspects of the decision).  The trial was held beginning on March 9, 2020, and Pacific Biosciences was concerned that Oxford not be able to intimate to the jury that finding its patents infringed and not invalid would hamper efforts to combat COVID-19 (specifically based on Pacific Biosciences' status as a non-practicing entity or its patent being a "paper patent").  To this end, Pacific Biosciences sought and received a motion in limine that Oxford not be able to make or hint any such conclusion to the jury.  Both parties mentioned the pandemic in their opening statements, but Pacific Biosciences objected to how Oxford made its mention of the issue (and obtained a curative instruction from the Court the next day).  The judge also admonished both parties not to "'turn this really into a trial about an ongoing global health crisis that has to be on the minds of the jury,' which would be 'unfair' and 'improper' and would 'inflam[e] the jury' and 'would create a real risk of a verdict' not based on the evidence."  Pacific Biosciences raised similar objections to Oxford's closing argument.  In addition to its motion for JMOL, Pacific Biosciences moved under Rule 59 for a new trial, based on undue prejudice caused by Oxford's violation of the motion in limine; the District Court denied this motion because Pacific Biosciences did not provide evidence that Oxford had violated the in limine motion after its statements in its opening argument or that the jury had been inflamed by those statements.

The Federal Circuit also affirmed the District Court's denial of the motion for a new trial.  One solid basis for this decision is that the panel opined that the District Court's views of the matter should be given "considerable weight" in view of that court's being in a better position to observe the demeanor of the jury, party counsel, and witnesses, citing Draper v. Airco, Inc., 580 F.2d 91, 97 (3d Cir. 1978) (the Federal Circuit applying Third Circuit law to this question).  Another basis in the opinion was that Pacific Biosciences did not object when presented with advance notice that Oxford intended to make the purportedly inflammatory statements.  Further, the opinion notes that the District Court gave just the curative instruction Pacific Biosciences requested the day after the purported violation occurred, and required each party to inform to each other any further instances of argument or testimony to each other before eliciting testimony or making arguments related to COVID-19 before the jury.  Accordingly, the opinion asserts that "[g]iven all the circumstances, we do not see a basis for disturbing the district court's assessment that there was an insufficient likelihood that the improper opening remarks had an adverse impact on the ultimate verdict to justify a new trial in this case."

Pacific Biosciences of California, Inc. v. Oxford Nanopore Technologies, Inc. (Fed. Cir. 2021)
Panel: Circuit Judges Lourie, Taranto, and Stoll
Opinion by Circuit Judge Taranto