Nucleic Acid Sequencing Patents Failed to Enable the Full Scope of the Claimed Inventions
Updated: May 19, 2021
In Pacific Biosciences of California, Inc. v. Oxford Nanopore Technologies, Inc., No. 20-2155 (Fed. Cir. May 11, 2021), the Federal Circuit refused to disturb the jury’s verdict that invalidated PacificBio’s patent claims.
In this case, PacBio sued Oxford in the United States District Court for the District of Delaware, accusing Oxford of infringing two U.S. patents. The patents claim “nanopore” methods of sequencing nucleic acids, such as DNA. As the name suggests, nanopore sequencing involves drawing nucleic acids through nanometer-sized holes in an ionically charged substrate. The nucleotide sequences are characterized based on changes occurring in the electronic charge of the substrate as the nucleic acids pass through the substrate pores.
At trial, the jury found that Oxford infringed all asserted patent claims. However, the jury also found that each patent claim was invalid because the patents fail to disclose sufficient information enabling the implementation of the claimed nanopore technology. The district court denied PacBio’s motion for a new trial. See Pacific Biosciences of California, Inc. v. Oxford Nanopore Technologies, Inc., Nos. 1:17-cv-00275-LPS, 1:17-cv-01353-LPS (D. Del. March 31, 2020).
On appeal, the Federal Circuit noted that U.S. patent law requires patent owners to teach the public how to implement the full scope of the claimed invention. Id. (citing 35 U.S.C. § 112). According to the evidence at trial, the examples disclosed in the patents were narrowly confined to the sequencing of short synthetically made nucleic acid sequences. However, the patents broadly claim methods for sequencing not only synthetic nucleic acids but also naturally occurring biological nucleic acids, including DNA. In fact, the first known successful nanopore sequencing of naturally occurring biological DNA did not occur until two years after the patents’ priority date.
The Federal Circuit, therefore, concluded that the evidence supports the jury’s verdict of patent invalidity, because the patents did not enable implementation of the full scope of the asserted claims.