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Sequencing Method Not Enabled for Full Scope of Nucleic Acids

Last week, a pair of nucleic acid sequencing patents failed to find new life on appeal, after a trial court ruled that they did not enable sequencing of any template nucleic acid. The case, a Federal Circuit decision in Pacific Biosciences v. Oxford Nanopore Technologies, underscores the need to consider the enabled limits of the discoveries underling a patent, especially in biotechnology.

The patents at issue claimed a sequencing method, which moves a template nucleic acid through a nanopore, then determines the sequence based on changes in electric current. The claims did not limit the nucleic acid template in any way—thus encompassing DNA hairpins, biological DNA, single strand DNA or RNA, and any other form of template nucleic acid. The patent owner acknowledged that the patents at issue did not differentiate between “[p]articular types of DNA.”

At trial, the defendant’s expert admitted that a person of ordinary skill in the art could have performed the patented method, given known art at the time of the patents’ priority date. However, as determined by the courts, the expert made this admission in a context that could have been limited only to DNA hairpins, and would not have applied to other template nucleic acids. Other parts of the expert’s testimony, and other evidence on the record during trial, indicated that this type of sequencing was not known to be possible with biological DNA as of the patents’ priority date.

The Federal Circuit cited a number of previous cases which establish the principle that “a patentee chooses broad claim language at the peril of losing any claim that cannot be enabled across its full scope of coverage.” Finding substantial evidence to support the jury’s conclusion that the patents were not enabled for the full scope of template nucleic acids, the Federal Circuit therefore upheld the jury verdict of non-enablement, which had also survived a patent owner motion for judgment as a matter of law at the trial court.

Aside from the enablement issue, the patent owner also appealed on the grounds that the defendant had discussed ongoing COVID-19 issues at trial. The patent owner asserted that this was contrary to the trial court’s order to exclude the defendant from discussing “consequences of this litigation.” The Federal Circuit upheld the trial court’s determination that these remarks probably did not influence the jury’s verdict.

myersEric Myers